Validation of the Pangao PG-800B18 upper-arm blood pressure monitor according to the ISO 81060-2:2018+Amd 1:2020 protocol in the general population.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE Blood Pressure Monitoring Pub Date : 2025-06-01 DOI:10.1097/MBP.0000000000000744

Wan Chen, Yuhan Xiang, Rui Cheng, Yang Zhang

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Abstract

Objective: The study aimed to validate the Pangao PG-800B18 oscillometric upper-arm blood pressure monitor in the general population in accordance with the International Organization for Standardization (ISO) 81060-2:2018 and amendment (Amd) 1:2020 protocol.

Methods: Participants were recruited, and the same left-arm sequential method was used for blood pressure measurement in accordance with the protocol. Data validation and analysis were performed according to the protocol, and the Bland-Altman scatter plot was used to show the difference between the test device and reference results.

Results: A total of 86 participants were included in the validation analysis. For the validation criterion 1 of the protocol, the mean ± SD of the differences between the test device and reference readings was -1.21 ± 6.71 mmHg and -0.73 ± 5.83 mmHg for systolic (SBP) and diastolic blood pressure (DBP), respectively. Furthermore, the SD of the differences between the test device and reference readings per participant was 5.81 and 5.02 mmHg for SBP and DBP, fulfilling the criterion 2 with SD values of ≤6.95 for SBP and ≤5.89 for DBP.

Conclusion: The Pangao PG-800B18 upper-arm blood pressure monitor fulfilled the requirements of the ISO validation standard and can be recommended for clinical use and self-measurement in the general population.

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根据ISO 81060-2:2018+Amd 1:2020方案，在普通人群中验证Pangao PG-800B18上臂血压监测仪。

目的：本研究旨在根据国际标准化组织（ISO） 81060-2:2018和修订（Amd） 1:2020协议，在普通人群中验证盘高PG-800B18振荡上臂血压监测仪。方法：招募参与者，按照方案使用相同的左臂顺序法测量血压。根据方案进行数据验证和分析，并使用Bland-Altman散点图显示试验装置与参考结果的差异。结果：共有86名受试者被纳入验证分析。对于方案的验证标准1，测试装置与参考读数之间差异的平均值±SD分别为收缩压（SBP）和舒张压（DBP）的-1.21±6.71 mmHg和-0.73±5.83 mmHg。此外，每位参与者的收缩压和舒张压测试装置与参考读数差异的SD值分别为5.81和5.02 mmHg，满足标准2，收缩压的SD值≤6.95，舒张压的SD值≤5.89。结论：攀高PG-800B18上臂血压计符合ISO验证标准要求，可推荐临床使用和普通人群自我测量。

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.