Clinical evaluation of the BP2 upper arm blood pressure monitor 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 : 2025-04-01 DOI:10.1097/MBP.0000000000000751

Wan Chen, Yuhan Xiang, Zizhuo Zhu, Fujun Shang

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引用次数: 0

Abstract

Objective: To evaluate the clinical measurement accuracy of the BP2 oscillometric upper arm blood pressure monitor in the general population according to the ISO 81060-2:2018+Amd 1:2020 standard.

Methods: Participants were recruited and the same arm sequential method was used for blood pressure measurement according to the ISO 81060-2:2018+Amd 1:2020. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference results.

Results: A total of 85 participants were included in the final analysis. For the validation criterion 1, the mean ± SD of the differences between the test device and reference readings was -2.93 ± 7.65 and -2.40 ± 6.82 mmHg for systolic and diastolic blood pressure, respectively. For criterion 2, the ±SD of the averaged differences between the test device and reference readings per participant was ±6.16 and ±5.74 mmHg for systolic and diastolic blood pressure, respectively.

Conclusion: The BP2 upper arm blood pressure monitor passed all the requirements of the ISO 81060-2:2018+Amd 1:2020 standard and can be recommended for clinical use and self-measurement in the general population.

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根据ISO 81060-2:2018+Amd 1:2020对BP2上臂血压计进行临床评价。

目的：根据ISO 81060-2:2018+Amd 1:2020标准，评价BP2振荡式上臂血压监测仪在普通人群中的临床测量准确性。方法：招募参与者，根据ISO 81060-2:2018+Amd 1:2020，采用相同的臂序贯方法测量血压。根据方案评估验证结果，并使用Bland-Altman散点图显示测试装置与参考结果之间的差异。结果：85名参与者被纳入最终分析。对于验证标准1，测试装置与参考读数之间的差异的平均值±SD分别为收缩压和舒张压的-2.93±7.65和-2.40±6.82 mmHg。对于标准2，每位参与者的收缩压和舒张压的测试设备和参考读数之间的平均差异的±SD分别为±6.16和±5.74 mmHg。结论：BP2上臂血压计通过ISO 81060-2:2018+Amd 1:2020标准的全部要求，可推荐临床使用和普通人群自我测量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.