Validation of the validity of the new wrist-type fully automatic blood pressure monitor: DBP-2242 according to ISO 81060-2:2018+AMD 1:2020.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE

Blood Pressure Monitoring Pub Date : 2024-12-01 Epub Date: 2024-07-16 DOI:10.1097/MBP.0000000000000716

Yuehong Jin, Xiaoming Bei, Ying Jin

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引用次数: 0

Abstract

Objective: Evaluation of the accuracy of the wrist-type fully automatic blood pressure (BP) monitor: DBP-2242 in adolescent and adult populations according to ISO 81060-2 : 2018+Amd.1 : 2020.

Methods: BP measurements were taken from the subjects using the same-arm sequential method, and BP data measured by a mercury sphygmomanometer was used as the standard.

Results: This study analyzed 262 sets of data from 89 subjects. According to criterion 1, the mean difference between the SBP of the test and reference devices was -0.57 ± 7.31 mmHg, and the DBP was -2.27 ± 7.17 mmHg, which is in accordance with the requirements. According to criterion 2, the average difference between the SBP was -0.57 ± 6.25 mmHg and the DBP was -2.27 ± 5.99 mmHg, which is in accordance with the requirements.

Conclusion: Wrist-type fully automatic BP monitor: DBP-2242 complies with ISO 81060-2 : 2018+Amd.1 : 2020 and can be used for BP measurement in adolescent and adult populations.

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新型腕式全自动血压计的有效性验证：DBP-2242 符合 ISO 81060-2:2018+AMD 1:2020。

目标：评估腕式全自动血压计的准确性根据 ISO 81060-2 : 2018+md.1 : 2020，评估腕式全自动血压计（BP）的准确性：根据 ISO 81060-2 : 2018+Amd.1 : 2020，评估 DBP-2242 在青少年和成年人群中的准确性：方法：采用同臂顺序法对受试者进行血压测量，以水银血压计测量的血压数据为标准：本研究分析了 89 名受试者的 262 组数据。根据标准 1，测试设备和参照设备的 SBP 平均差值为 -0.57 ± 7.31 mmHg，DBP 平均差值为 -2.27 ± 7.17 mmHg，符合要求。根据标准 2，SBP 的平均差值为 -0.57 ± 6.25 mmHg，DBP 的平均差值为 -2.27 ± 5.99 mmHg，符合要求：腕式全自动血压计结论：DBP-2242 符合 ISO 81060-2 : 2018+Amd.1 : 2020 标准，可用于青少年和成年人的血压测量。

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.