Validation of the JAMR upper-arm pressure monitor B23 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 : 2024-07-30 DOI:10.1097/MBP.0000000000000719

Jing Li, Li-Hong Han, Ru Feng, Li-Hao Wu, Jie Cai, Tian-Ying Zeng, Hui Liu, Lei Wang, Ju-Yun Li, Zhong-Qun Zhan

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Abstract

The aim of this study was to evaluate the accuracy of the JAMR upper-arm blood pressure monitor B23 in the general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020). The study recruited participants who met the criteria of the AAMI/ESH/ISO Universal Standard in terms of their number, sex, age, limb size, and blood pressure (BP) distribution. The study involved measuring BP, including both SBP and DBP, using both the test device and a standard mercury sphygmomanometer in sequential measurements. Of 90 participants, 85 qualified participants were analyzed. A total of 255 sets of comparison data (three sets for each subject) were obtained and analyzed. For the validation criterion 1, the mean ± SD of the differences between the JAMR B23 and mercury sphygmomanometer BP readings was -0.24 ± 6.52/-2.67 ± 5.6 mmHg (SBP/DBP). For criterion 2, the SD of the averaged BP (SBP/DBP) differences between the JAMR B23 and reference BP (SBP/DBP) per participant was 5.61/5.13 mmHg (the requirement was ≤6.95/6.43 mmHg by calculation). The JAMR B23 passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020) and can be recommended for clinical and self/home use in the general population.

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根据 AAMI/ESH/ISO 通用标准（ISO 81060- 2:2018/AMD 1:2020）对 JAMR 上臂压力监测仪 B23 进行验证。

本研究旨在根据 AAMI/ESH/ISO 通用标准（ISO 81060-2 : 2018/AMD 1 : 2020）评估 JAMR 上臂式血压计 B23 在普通人群中的准确性。该研究招募了在人数、性别、年龄、肢体大小和血压（BP）分布方面符合 AAMI/ESH/ISO 通用标准的参与者。研究使用测试设备和标准水银血压计依次测量血压，包括 SBP 和 DBP。在 90 名参与者中，对 85 名合格参与者进行了分析。共获得并分析了 255 组对比数据（每个受试者三组）。对于验证标准 1，JAMR B23 和水银血压计血压读数之间差异的平均值（± SD）为 -0.24 ± 6.52/-2.67 ± 5.6 mmHg（SBP/DBP）。对于标准 2，每名参与者的 JAMR B23 和参考血压（SBP/DBP）之间的平均血压（SBP/DBP）差异的 SD 为 5.61/5.13 mmHg（通过计算，要求≤6.95/6.43 mmHg）。JAMR B23 通过了 AAMI/ESH/ISO 通用标准（ISO 81060-2 : 2018/AMD 1 : 2020）的所有要求，可推荐用于普通人群的临床和自我/家庭使用。

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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.