Validation of the TMB-2296-BT blood pressure monitor in adults 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 : 2024-10-04 DOI:10.1097/MBP.0000000000000728

Zijian Xie, Li Zhu, Xiao Zheng, Chaoya Li, Jia Hu, Xinda Wang, Hua Deng, Xiaoqin Du, Jiahui Liang, Bin Peng

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Abstract

This study aimed to validate the accuracy of the test device (TMB-2296-BT) blood pressure (BP) monitor in adults according to International Standard Organization (ISO) 81060-2:2018 + Amd.1:2020 universal standard protocol, which is a digital monitor. Three trained observers used the same arm sequential method to compare the SBPs and DBPs measured by the test device with those measured by the reference device (mercury sphygmomanometer). For the test device with cuff ranging from 22 to 32 cm, there are 88 adults, with a male-to-female ratio of 35 : 53. The mean difference and SD between reference BPs and test device BPs readings were (0.21 ± 2.59)/(0.66 ± 2.12) mmHg for SBP/DBP for criterion 1, and (0.21 ± 2.07)/(0.66 ± 1.76) mmHg for SBP/DBP for criterion 2. For the test device with cuffs ranging from 22 to 42 cm, there are 87 adults, with a male-to-female ratio of 49 : 38. The mean difference and SD between reference BPs and test device BPs readings were (-1.62 ± 2.80)/(0.12 ± 3.01) mmHg for SBP/DBP for criterion 1, and (-1.62 ± 2.35)/(0.12 ± 2.60) mmHg for SBP/ DBP for criterion 2. And for the test device with cuff arm circumference sizes of 22-32 cm and 22-42 cm fulfilled both validation criterion 1 and 2 of the ISO 81060-2:2018 + Amd.1:2020 standard and can be recommended for both clinical and self/home BP measurement in adults.

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根据 ISO 81060-2:2018 + Amd.1:2020 对 TMB-2296-BT 成人血压计进行验证。

本研究旨在根据国际标准化组织（ISO）81060-2:2018 + Amd.1:2020通用标准协议，验证数字式成人血压（BP）监测仪（TMB-2296-BT）的准确性。三位训练有素的观察员使用同一手臂顺序法，将测试设备测得的 SBPs 和 DBPs 与参考设备（水银血压计）测得的 SBPs 和 DBPs 进行比较。测试设备的袖带范围为 22 厘米至 32 厘米，共有 88 名成人使用，男女比例为 35:53。在标准 1 中，参考血压与测试设备血压读数的平均差和标度分别为（0.21 ± 2.59）/（0.66 ± 2.12）毫米汞柱（SBP/DBP）；在标准 2 中，参考血压与测试设备血压读数的平均差和标度分别为（0.21 ± 2.07）/（0.66 ± 1.76）毫米汞柱（SBP/DBP）。在标准 1 中，参考血压与测试设备血压读数的平均差和标度分别为（-1.62 ± 2.80）/（0.12 ± 3.01）毫米汞柱（SBP/DBP）；在标准 2 中，参考血压与测试设备血压读数的平均差和标度分别为（-1.62 ± 2.35）/（0.12 ± 2.60）毫米汞柱（SBP/DBP）。而袖带臂围尺寸为 22-32 厘米和 22-42 厘米的测试设备符合 ISO 81060-2:2018 + Amd.1:2020 标准的验证标准 1 和 2，可推荐用于成人临床和自我/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.