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 : 2025-01-28 DOI:10.1097/MBP.0000000000000744

Wan Chen, Yuhan Xiang, Rui Cheng, Yang Zhang

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引用次数: 0

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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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.