Validation of TMB-2285-BT wrist blood pressure monitor in general population according to the ISO 81060-2:2018 + Amd.1:2020 Protocol.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE

Blood Pressure Monitoring Pub Date : 2024-09-13 DOI:10.1097/MBP.0000000000000724

Zijian Xie, Bin Peng, Jia Hu, Xinda Wang, Xiaoqin Du, Chaoya Li, Jiahui Liang

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引用次数: 0

Abstract

The objective of this study is to evaluate the accuracy of the wrist blood pressure (BP) monitor (TMB-2285-BT) in general population according to international standard of ISO 81060-2:2018+Amd.1:2020. The TMB-2285-BT BP monitor is an oscillometric device measuring BP from wrist. A single cuff for wrist sizes of 13.5-21.5 cm was used for the test device. The study was performed according to the 'International Standard (ISO 81060-2:2018 + Amd.1:2020) protocol' using the same-arm sequential BP measurement method. Subjects (n ≥ 85) fulfilling the age, gender, BP, and cuff distribution criteria of the protocol were enrolled. For criterion 1, the mean difference of SBP and DBP between the test device and the reference device was -0.27 mmHg and -0.80 mmHg, respectively. For criterion 2, the SD of the averaged paired determinations of SBP and DBP for the test device and the reference device was 2.60 and 2.06 mmHg, respectively, both of which were less than 6.95 and 6.89 mmHg. The accuracy of the test device fulfilled the requirements of the criterion 1 and 2 of ISO 81060-2:2018 + Amd.1:2020. The TMB-2285-BT wrist BP monitor can be recommended for home BP measurement for general population.

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根据 ISO 81060-2:2018 + Amd.1:2020 协议对 TMB-2285-BT 普通人群腕式血压计进行验证。

本研究的目的是根据 ISO 81060-2:2018+Amd.1:2020 国际标准，评估腕式血压计（TMB-2285-BT）在普通人群中的准确性。TMB-2285-BT 血压计是一种从手腕测量血压的示波设备。测试设备使用的单个袖带适用于 13.5-21.5 厘米的手腕尺寸。研究根据 "国际标准（ISO 81060-2:2018 + Amd.1:2020）协议 "进行，采用同臂顺序血压测量方法。符合方案中年龄、性别、血压和袖带分布标准的受试者（n ≥ 85）被纳入研究。在标准 1 中，测试设备与参照设备之间的 SBP 和 DBP 平均差分别为 -0.27 mmHg 和 -0.80 mmHg。就标准 2 而言，测试设备和参照设备的 SBP 和 DBP 成对测定值平均值的 SD 分别为 2.60 和 2.06 mmHg，均小于 6.95 和 6.89 mmHg。测试设备的准确度符合 ISO 81060-2:2018 + Amd.1:2020 标准 1 和 2 的要求。TMB-2285-BT 腕式血压计可推荐用于普通人群的家庭血压测量。

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.