Validation of the ANDON KD-595 automated upper-arm blood pressure monitor according to the universal standard.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE Blood Pressure Monitoring Pub Date : 2024-04-01 Epub Date: 2023-12-14 DOI:10.1097/MBP.0000000000000686

Kui Liu, Dan Wu, Sen Bing, Lin-Yi Li

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引用次数: 0

Abstract

Objective: To validate the ANDON KD-595 automated upper-arm blood pressure monitor for clinical use and self-measurement blood pressure measurement according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard.

Methods: Same left-arm blood pressure was sequentially measured in 90 qualified adult participants and compared with a standard mercury sphygmomanometer. A total of 270 comparison pairs were obtained and analyzed according to the universal standard.

Results: For the validation Criterion 1 of the universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 0.96 ± 5.35 and 0.82 ± 5.08 mmHg for SBP and DBP, respectively. For Criterion 2, the SDs of the averaged blood pressure differences between the test device and reference blood pressure per subject were 4.84 and 4.64 mmHg (with maximum allowed SDs of 6.87 and 6.89 mmHg) for SBP and DBP, respectively.

Conclusion: The ANDON KD-595 automated upper-arm blood pressure monitor passed all the validation requirements according to the AAMI/ESH/ISO Universal Standard and can be recommended for clinical use and self-measurement blood pressure measurement in the general population.

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根据通用标准对 ANDON KD-595 自动上臂式血压计进行验证。

目的根据美国医学仪器促进协会/欧洲高血压学会/国际标准化组织（AAMI/ESH/ISO）通用标准，验证安东 KD-595 自动上臂式血压计在临床使用和自我血压测量中的有效性：方法：对 90 名合格的成人参与者连续测量相同的左臂血压，并与标准水银血压计进行比较。共获得 270 对对比数据，并根据通用标准进行分析：在通用标准的验证标准 1 中，测试设备与参考血压读数之间的差异平均值（± SD）分别为 0.96 ± 5.35 毫米汞柱（SBP）和 0.82 ± 5.08 毫米汞柱（DBP）。对于标准 2，每个受试者的测试设备和参考血压之间的平均血压差异的 SD 分别为 4.84 和 4.64 mmHg（最大允许 SD 为 6.87 和 6.89 mmHg）：安东 KD-595 自动上臂式血压计通过了 AAMI/ESH/ISO 通用标准的所有验证要求，可推荐用于临床和普通人群的自我血压测量。

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.