Key result
Combei BP880W wrist device meets ISO accuracy standards with ~3 mmHg systolic difference versus mercury reference.
Why the study?
Scientific societies recommend validating the accuracy of electronic blood pressure measurement devices using established protocols, motivating the evaluation of the Combei BP880W wrist device in the general population.
Does the Combei BP880W wrist device accurately measure blood pressure in the general population compared to reference mercury sphygmomanometers?
Observational (n=85)
Single-blind
No
Does the Combei BP880W wrist device accurately measure blood pressure in the general population compared to reference mercury sphygmomanometers?
The Combei BP880W wrist device meets the ISO 81060-2:2018/AMD 1:2020 accuracy requirements, supporting its use for home blood pressure monitoring.
Answers are grounded in this paper and cite their sources.
Meets ISO criteria for wrist BP monitoring; leaves open prospective validation before routine clinical use.
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.
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Hakobyan et al. (2025) conducted an observational in General population (n=85). Combei BP880W wrist device vs. Mercury sphygmomanometer was evaluated on Mean difference between test device and reference measurements for systolic blood pressure (Criterion 1) (Mean difference -2.7 mmHg). The Combei BP880W wrist device met ISO 81060-2:2018 accuracy requirements with a mean systolic blood pressure difference of -2.7 mmHg compared to a reference mercury sphygmomanometer.
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