Validation of the AViTA upper-arm blood pressure monitor BP636 with multiple cuff sizes in the general population according to the ANSI/AAMI/ISO 81060-2:2018/Amd1:2020.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE Blood Pressure Monitoring Pub Date : 2024-08-09 DOI:10.1097/MBP.0000000000000722

Chung-Yu Lin, I-Chih Huang

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Abstract

Objective: To determine the accuracy of the AViTA BP636 upper-arm home blood pressure (BP) monitor in general populations with small to extra-large arms according to the ANSI/AAMI/ISO Universal Standard (ISO 81060-2 : 2018/Amd1 : 2020).

Methods: The AViTA BPM636 was utilized on 85 adult participants with upper-arm circumferences ranging from 15 to 52 cm, and four cuffs of different sizes (small: 15-22 cm, normal: 22-33 cm, large: 33-42 cm, and extra large: 42-52 cm) were used in this study. The recruitment fulfills the criteria of the ANSI/AAMI/ISO Universal Standard 81060-2 : 2018/Amd1 : 2020 in the general population using the same arm sequential BP measurement method.

Results: For validation criterion 1, the mean ± SD of the differences between the test device and reference blood pressure readings was -0.35 ± 4.68/0.56 ± 3.93 mmHg (systolic/diastolic) for adults. The mean difference of SBP between the test device and the reference device was -0.35 mmHg with a SD of 3.50 mmHg, wh{ich was within the acceptable range for criterion 2 (i.e. less than 6.93 mmHg) Similarly, the mean difference in DBP was 0.56 mmHg with a SD of 3.38 mmHg, which also met the criterion 2 (i.e. within 6.91 mmHg).

Conclusion: AViTA BPM636 passed the criteria of the ANSI/AAMI/ISO 81060-2 : 2018/Amd 1 : 2020 protocol. It can be recommended for home-based BP measurements in the general population and people with extra-large arms ranging from 42 to 52 cm.

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根据 ANSI/AAMI/ISO 81060-2:2018/Amd1:2020，在普通人群中验证 AViTA 上臂式血压计 BP636 的多种袖带尺寸。

目的根据 ANSI/AAMI/ISO 通用标准（ISO 81060-2 : 2018/Amd1 : 2020），确定 AViTA BP636 上臂式家用血压计在小臂至特大臂普通人群中的准确性：对 85 名上臂周长在 15 厘米至 52 厘米之间的成年参与者使用了 AViTA BPM636，并使用了四种不同尺寸的袖带（小号：15-22 厘米，正常：22-33 厘米，大号：33-42 厘米，特大号：33-42 厘米）：大号：33-42 厘米，特大号：42-52 厘米）：本研究使用了四种不同尺寸的袖带（小号：15-22 厘米，正常：22-33 厘米，大号：33-42 厘米，超大：42-52 厘米）。此次招募符合 ANSI/AAMI/ISO 通用标准 81060-2 : 2018/Amd1 : 2020 的标准，在普通人群中使用同臂顺序血压测量方法：在验证标准 1 中，成人测试设备与参考血压读数之间差异的平均值（±SD）为 -0.35 ± 4.68/0.56 ± 3.93 mmHg（收缩压/舒张压）。同样，DBP 的平均差为 0.56 mmHg，SD 为 3.38 mmHg，也符合标准 2（即小于 6.91 mmHg）：AViTA BPM636 通过了 ANSI/AAMI/ISO 81060-2 : 2018/Amd 1 : 2020 协议的标准。可推荐用于普通人群和拥有 42 至 52 厘米超大手臂的人群的家庭血压测量。

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.