Validation of the AViTA BPM636 upper arm blood pressure monitor in adults and pregnant women according to the ANSI/AAMI/ISO 81060-2:2013.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE

Blood Pressure Monitoring Pub Date : 2023-08-01 Epub Date: 2023-04-05 DOI:10.1097/MBP.0000000000000648

Chien-Nan Lee, Cho-Kai Wu, I-Chih Huang

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引用次数: 0

Abstract

Objective: To evaluate the accuracy of the AViTA oscillometric upper arm home blood pressure (BP) monitor in adult and pregnant populations according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/ International Organization for Standardization (ANSI/AAMI/ISO) Universal Standard (ISO 81060-2:2013).

Methods: BP measurements on the upper arm were performed on 85 adult subjects and 46 pregnant subjects. The AViTA BPM636 and a standard mercury reference sphygmomanometer were applied and followed the same arm sequential BP measurement method. The universal cuff of the test device was used for arm circumference of 22-42 cm.

Results: For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 1.1 ± 5.49/2.9 ± 5.17 mmHg (systolic/diastolic) for adults; and -2.2 ± 5.93/1.5 ± 4.92 mmHg (systolic/diastolic) for pregnant women. For criterion 2, the SD of the averaged BP differences between the test device and reference BP per adult subject was 4.45/4.20 mmHg (systolic/diastolic) and per pregnant women was 4.66/3.96.

Conclusion: The AViTA BPM636 had passed the criteria of the ANSI/AAMI/ISO 81060-2:2013 protocol and can be recommended for home BP measurements in adults and pregnant populations.

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根据ANSI/AAMI/ISO 81060-2:2013对成人和孕妇的AViTA BPM636上臂血压监测仪进行验证。

目的：根据美国国家标准协会/医疗器械进步协会/国际标准化组织（ANSI/AAMI/ISO）通用标准（ISO 81060-2:2013），评估AViTA示波式上臂家庭血压（BP）监测仪在成年和孕妇中的准确性。方法：上臂血压测量对85名成年受试者和46名孕妇进行了研究。应用AViTA BPM636和标准汞基准血压计，并遵循相同的臂顺序血压测量方法。测试装置的通用袖带用于22-42的臂围结果：对于验证标准1，测试装置和参考血压读数之间差异的平均值±SD为1.1 ± 5.49/2.9 ± 5.17 成人为mmHg（收缩压/舒张压）；和-2.2 ± 5.93/1.5 ± 4.92 mmHg（收缩压/舒张压）。对于标准2，每个成年受试者的测试装置和参考血压之间的平均血压差的SD为4.45/4.20 结论：AViTA BPM636已通过ANSI/AAMI/ISO 81060-2:2013方案的标准，可推荐用于成人和孕妇的家庭血压测量。

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.