Validation of the ANDON KD-7920 wrist blood pressure monitor in general population according to the ISO 81060-2:2018+AMD1:2020 protocol.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE

Blood Pressure Monitoring Pub Date : 2025-04-01 Epub Date: 2024-12-24 DOI:10.1097/MBP.0000000000000740

Duan Li, Yiming Li, Jiaheng Li, Yuan Gu, Fujun Shang

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引用次数: 0

Abstract

Objective: This study aimed to evaluate the accuracy of the ANDON KD-7920 oscillometric wrist blood pressure monitor in general population according to the ISO 81060-2:2018+AMD1:2020.

Methods: The same arm sequential method was used for blood pressure measurement among qualified participants according to the ISO 81060-2:2018+AMD1:2020. The validation results were assessed following the criteria of the protocol, and the Bland-Altman scatter plot was used to present the difference between the test device and reference results.

Results: A total of 90 participants were included in the study. According to criterion 1 of the validation protocol, the mean ± SD of the differences between the test device and reference readings was 0.76 ± 6.23 mmHg and -0.13 ± 5.57 mmHg for systolic and diastolic blood pressure, respectively, which met the requirements of less than 5 ± 8 mmHg. According to the criterion 2, the average differences between the test device and reference readings per participant were 0.76 ± 5.56 mmHg and -0.13 ± 5.27 mmHg for systolic and diastolic blood pressure, respectively, which also met the requirements.

Conclusion: The ANDON KD-7920 wrist blood pressure monitor passed all the requirements of the ISO 81060-2:2018+AMD1:2020 and can be recommended for clinical use and self-measurement in general population.

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根据ISO 81060-2:2018+AMD1:2020协议，在普通人群中验证ANDON KD-7920腕压监测仪。

目的：本研究旨在根据ISO 81060-2:2018+AMD1:2020标准评估ANDON KD-7920振荡腕压监测仪在普通人群中的准确性。方法：根据ISO 81060-2:2018+AMD1:2020，对符合条件的参与者使用相同的臂序贯法测量血压。根据方案的标准评估验证结果，并使用Bland-Altman散点图来表示测试装置与参考结果之间的差异。结果：本研究共纳入90名受试者。根据验证方案标准1，试验装置的收缩压和舒张压与参考读数差值的平均值±SD分别为0.76±6.23 mmHg和-0.13±5.57 mmHg，满足小于5±8 mmHg的要求。根据标准2，每位受试者的收缩压和舒张压与参考读数的平均差异分别为0.76±5.56 mmHg和-0.13±5.27 mmHg，也符合要求。结论：安东KD-7920腕压监测仪通过了ISO 81060-2:2018+AMD1:2020的所有要求，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.