Validation of the Hingmed DBP-01P clinical automatic blood pressure monitor provided with wide-range cuff, evaluated in a general population according to the ISO 81060-2:2018 protocol.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE

Blood Pressure Monitoring Pub Date : 2023-04-01 Epub Date: 2023-02-17 DOI:10.1097/MBP.0000000000000638

Claudio Fania, Antonella Giletto, Valentina Zanello, Paolo Palatini

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引用次数: 0

Abstract

To determine the accuracy of the Hingmed DBP-01P monitor for clinical automatic blood pressure (BP) measurement according to the International Organization for Standardization (ISO) 81060-2 2018 protocol. The DBP-01P was tested in 85 subjects from the general population (mean age, 69.9 years; 43 men) using a wide-range cuff for arm circumferences from 17 to 42 cm. The mean device-observer difference was 1.32 ± 3.18 mmHg for SBP and 0.78 ± 3.15 mmHg for DBP. These data were in agreement with criterion 1 of the protocol standard requirements (≤5 ± 8 mmHg). Also, criterion 2 was satisfied with the SDs of the 85 participants being well below the maximum values required by the protocol (6.80 and 6.89 mmHg for SBP and DBP pressure, respectively). These data show that the Hingmed BP monitor DBP-01P satisfied the ISO 81060-2:2018 standard requirements for a general population across a wide range of arm sizes using a single wide-range cuff.

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根据ISO 81060-2:2018协议，在普通人群中对配有宽量程袖带的Hingmed DBP-01P临床自动血压计进行了评估。

根据国际标准化组织（ISO）81060-2 2018协议，确定Hingmed DBP-01P监护仪用于临床自动血压（BP）测量的准确性。DBP-01P在来自普通人群的85名受试者（平均年龄69.9 年；43名男性）使用宽范围袖带测量17至42的手臂周长装置观察者的平均差异为1.32 ± 3.18 收缩压为mmHg，收缩压为0.78 ± 3.15 DBP为mmHg。这些数据符合协议标准要求的标准1（≤5 ± 8. mmHg）。此外，标准2得到满足，85名参与者的SD远低于协议要求的最大值（6.80和6.89 SBP和DBP压力分别为mmHg）。这些数据表明，Hingmed BP监测仪DBP-01P满足ISO 81060-2:2018标准对使用单个宽范围袖带的各种手臂尺寸的普通人群的要求。

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.