Validation of the Omron J7136 and HEM-7361T blood pressure monitors according to the International Organization for Standardization protocol (ISO 81060-2:2018 + Amd.1:2020).
Yi Zhou, Xin-Yu Wang, Yi Zhou, Yan Li, Ji-Guang Wang
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引用次数: 0
Abstract
Objective: This study aimed to evaluate the accuracy of OMRON J7136 and HEM-7361T oscillometric blood pressure (BP) monitors in the general population according to the International Organization for Standardization (ISO) 81060-2:2018 and amendment (Amd) 1:2020 standard.
Method: Subjects were recruited to fulfill the age, gender, BP, and cuff distributions of the ISO Universal Standard in the general population using the same arm sequential BP measurement method. Three cuffs of the OMRON J7136 were used for arm circumference 17-22 cm (small), 22-32 cm (medium), and 32-42 cm (large). A single cuff 17-36 cm was used on the OMRON HEM-7361T.
Results: The mean ± SD of the differences between the OMRON J7136 and reference BP readings was -2.14 ± 6.45/-1.43 ± 5.88 mmHg (systolic/diastolic) for criterion 1. The SD of the average BP differences between the OMRON J7136 and reference BP per subject was 5.49/5.36 mmHg (systolic/diastolic) for criterion 2. For the study on the OMRON HEM-7361T, the corresponding values were -2.56 ± 6.35/-3.18 ± 5.67 mmHg (systolic/diastolic) for criterion 1 and 5.33/5.32 mmHg (systolic/diastolic) for criterion 2.
Conclusion: The OMRON J7136 and HEM-7361T BP monitors both fulfilled the requirements of the ISO Universal Standard (ISO 81060-2:2018/AMD 1:2020) in the general population and can be recommended for self-measurement in adults.
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.