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.

IF 2.6 Q2 PERIPHERAL VASCULAR DISEASE

Vascular Health and Risk Management Pub Date : 2025-02-18 eCollection Date: 2025-01-01 DOI:10.2147/VHRM.S513013

Zoya Hakobyan, Parounak Zelveian, Heghine Gharibyan, Jirar Topouchian, Roland Asmar

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引用次数: 0

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.

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来源期刊

Vascular Health and Risk Management PERIPHERAL VASCULAR DISEASE-

CiteScore

4.20

自引率

3.40%

发文量

109

审稿时长

16 weeks

期刊介绍： An international, peer-reviewed journal of therapeutics and risk management, focusing on concise rapid reporting of clinical studies on the processes involved in the maintenance of vascular health; the monitoring, prevention, and treatment of vascular disease and its sequelae; and the involvement of metabolic disorders, particularly diabetes. In addition, the journal will also seek to define drug usage in terms of ultimate uptake and acceptance by the patient and healthcare professional.