Validation of the A&D BP UA-1100NFC/UA-1100NFC-W, hoseless upper arm-type home blood pressure devices, according to the ISO81060-2:2018/Amd 1:2020 protocol.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE

Blood Pressure Monitoring Pub Date : 2025-01-08 DOI:10.1097/MBP.0000000000000741

Kazuomi Kario, Naoko Tomitani, Satoshi Hoshide

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引用次数: 0

Abstract

The aim of this study was to validate the performance of the A&D UA-1100NFC hoseless devices of two cuff sizes in monitoring blood pressure (BP) in the upper arm according to the International Organization for Standardization (ISO) 81060-2:2018/amendment (Amd) 1:2020 protocol. The accuracy of the UA-1100NFC (for arm circumferences of 22.0-32.0 cm) and the UA-1100NFC-W (for arm circumferences of 22.0-42.0 cm) was assessed using the same-arm sequence protocol as per the ISO 81060-2:2018/Amd 1:2020 standard. Individuals aged >12 years were recruited from the outpatients and volunteers of Jichi Medical University (Tochigi, Japan); 85 participants were included in the final analyses for each device. Both devices performed well against the standard; mean and SD values for the differences between the device-measured and observer-measured SBP and DBP values met both criterion 1 and criterion 2 of the standard [(UA-1100NFC) criterion 1: -3.71 ± 6.82 mmHg and 0.86 ± 6.33 mmHg, respectively; criterion 2: 5.65 mmHg and 5.87 mmHg, respectively; (UA-1100NFC-W) criterion 1: 0.73 ± 7.84 mmHg and 1.72 ± 6.44 mmHg, respectively; criterion 2: 6.49 mmHg and 5.86 mmHg, respectively]. The Bland-Altman plots did not show any systematic variation in the error. Both the UA-1100NFC and UA-1100NFC-W hoseless devices had a high level of accuracy and fulfilled the requirements of the ISO81060-2:2018/Amd 1:2020 validation standard. They are therefore suitable as home BP monitoring tools in patients with hypertension.

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A&D BP UA-1100NFC/UA-1100NFC- w，无软管上臂式家用血压仪，根据ISO81060-2:2018/Amd 1:2020协议进行验证。

本研究的目的是根据国际标准化组织（ISO） 81060-2:2018/修正（Amd） 1:2020协议，验证两种袖口尺寸的A&D UA-1100NFC无软管设备在监测上臂血压（BP）方面的性能。根据ISO 81060-2:2018/Amd 1:2020标准，使用相同的臂序列协议评估了UA-1100NFC（臂周长22.0-32.0 cm）和UA-1100NFC- w（臂周长22.0-42.0 cm）的准确性。从日本栃木市医科大学的门诊患者和志愿者中招募年龄在0 ~ 12岁的个体；85名参与者参与了每种设备的最终分析。这两款设备在标准条件下都表现良好；仪器测量的收缩压和舒张压值与观察者测量的收缩压和舒张压值差异的平均值和SD值符合标准[（UA-1100NFC）标准1的标准1和标准2：分别为-3.71±6.82 mmHg和0.86±6.33 mmHg；标准2：分别为5.65 mmHg和5.87 mmHg；（UA-1100NFC-W）标准1：分别为0.73±7.84 mmHg和1.72±6.44 mmHg；标准2：分别为6.49 mmHg和5.86 mmHg]。Bland-Altman图没有显示出误差的任何系统变化。UA-1100NFC和UA-1100NFC- w无软管设备都具有高水平的精度，并满足ISO81060-2:2018/Amd 1:2020验证标准的要求。因此，它们适合作为高血压患者的家庭血压监测工具。

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.