Clinical evaluation of the iHealth BP7 wrist blood pressure monitor in general population according to the ISO 81060-2:2018/Amd 1:2020.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE

Blood Pressure Monitoring Pub Date : 2025-02-25 DOI:10.1097/MBP.0000000000000746

Yiming Li, Zizhuo Zhu, Jiaheng Li, Yuan Gu, Yi Wan

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引用次数: 0

Abstract

Objective: The objective of this study is to evaluate the accuracy of the iHealth BP7 wrist blood pressure (BP) monitor for clinical use and self-measurement in general population according to the International Organization for Standardization (ISO) 81060-2:2018/Amendment (Amd) 1:2020 protocol.

Methods: Same arm BP was sequentially measured in 95 qualified participants and compared with a standard mercury sphygmomanometer. A total of 285 comparison pairs were obtained and analyzed according to the ISO 81060-2:2018/Amd 1:2020.

Results: For the validation Criterion 1 of the protocol, the mean ± SD of the differences between the test device and reference BP readings was 0.62 ± 6.18 and -0.20 ± 5.59 mmHg for SBP and DBP, respectively. For Criterion 2, the SDs of the averaged BP differences between the test device and reference BP per subject were 5.79 and 5.28 mmHg (with maximum allowed SDs of 6.90 and 6.95 mmHg) for SBP and DBP, respectively.

Conclusion: The iHealth BP7 wrist BP monitor satisfied all the validation requirements according to the ISO 81060-2:2018/Amd 1:2020 protocol and can be recommended for clinical use and self-measurement in the general population.

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来源期刊

Blood Pressure Monitoring 医学-外周血管病

CiteScore

2.00

自引率

7.70%

发文量

110

审稿时长

>12 weeks

期刊介绍： Blood Pressure Monitoring is devoted to original research in blood pressure measurement and blood pressure variability. It includes device technology, analytical methodology of blood pressure over time and its variability, clinical trials - including, but not limited to, pharmacology - involving blood pressure monitoring, blood pressure reactivity, patient evaluation, and outcomes and effectiveness research. This innovative journal contains papers dealing with all aspects of manual, automated, and ambulatory monitoring. Basic and clinical science papers are considered although the emphasis is on clinical medicine. Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.