Validation of the DBP-1333b upper-arm blood pressure monitor according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020).

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE

Blood Pressure Monitoring Pub Date : 2024-06-01 Epub Date: 2024-04-24 DOI:10.1097/MBP.0000000000000688

Guocun Hou, Yulu Wu, Jiaying Wang, Jia Zhi

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引用次数: 0

Abstract

To evaluate the accuracy of the DBP-1333b upper-arm blood pressure (BP) measuring device in the adult population according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020). Subjects were recruited in the adult population. The test device was an arm-type electronic sphygmomanometer (DBP-1333b) and the reference device was a desktop sphygmomanometer (XJ11D). Using the BP data measured by the desktop sphygmomanometer as reference BP, the accuracy of the non-invasive BP module of the test device was evaluated to determine whether it met the requirements. Data from 90 individuals were analysed. According to Criterion 1, the mean difference of SBP between the test and reference device was 0.19 mmHg and the SD was 7.45 mmHg. The mean difference of DBP was -0.59 mmHg and the SD was 6.47 mmHg. The mean difference of both SBP and DBP was less than 5 mmHg, and the SD was less than 8 mmHg, which met the requirements. According to Criterion 2, SD of SBP was 5.79 mmHg, which was less than 6.95 mmHg and met the requirements. The SD of DBP was 5.58 mmHg, which was less than 6.93 mmHg and met the requirements. It was concluded that the DBP-1333b complies with the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020) and can be recommended for use by the adults.

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根据 AAMI/ESH/ISO 通用标准（ISO 81060-2:2018+Amd.1:2020）验证 DBP-1333b 上臂式血压计。

根据 AAMI/ESH/ISO 通用标准（ISO 81060-2:2018+Amd.1:2020），评估 DBP-1333b 上臂式血压（BP）测量仪在成年人群中的准确性。受试者从成年人群中招募。测试设备为臂式电子血压计（DBP-1333b），参照设备为台式血压计（XJ11D）。使用台式血压计测量的血压数据作为参考血压，对测试设备的无创血压模块的准确性进行评估，以确定其是否符合要求。对 90 人的数据进行了分析。根据标准 1，测试设备与参考设备之间的 SBP 平均差值为 0.19 mmHg，SD 为 7.45 mmHg。DBP 的平均差值为-0.59 毫米汞柱，标准差为 6.47 毫米汞柱。SBP 和 DBP 的平均差均小于 5 mmHg，标差小于 8 mmHg，符合要求。根据标准 2，SBP 的 SD 值为 5.79 mmHg，小于 6.95 mmHg，符合要求。DBP 的 SD 值为 5.58 mmHg，小于 6.93 mmHg，符合要求。结论是 DBP-1333b 符合 AAMI/ESH/ISO 通用标准（ISO 81060-2:2018+Amd.1:2020），可推荐成人使用。

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.