Validation of the oscillometric home blood pressure monitor Braun BUA4000 with wide-range cuff in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard.
Vasileios Ntousopoulos, Angeliki Ntineri, Aikaterini Theodosiadi, Panagiota Stathopoulou, Ariadni Menti, Konstantinos G Kyriakoulis, Anastasios Kollias, George S Stergiou
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引用次数: 0
Abstract
Objective: To evaluate the blood pressure (BP) measurement accuracy of the Braun BUA4000 automated oscillometric upper-arm cuff device for self-home use in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018) and its Amendment 1.2020-01.
Methods: Participants were recruited to fulfill the age, sex, BP and limb circumference distribution criteria of the AAMI/ESH/ISO Universal Standard in a general population using the same arm sequential BP measurement method. A single wide-range cuff of the test device was used for arm circumference range 22-42 cm.
Results: A total of 98 individuals were recruited and 85 were analyzed [mean age 60.3 ± 16.1 (SD) years, 44 men, arm circumference 31.5 ± 5.1 cm, range 22-41.5 cm]. For validation criterion 1, the mean difference ± SD between the test device and reference BP readings ( N = 255) was 0.9 ± 6.4/-0.3 ± 6.4 mmHg (systolic/diastolic; threshold ≤5 ± 8 mmHg). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per individual ( N = 85) was 5.15/5.81 mmHg (systolic/diastolic; threshold ≤6.88/6.95 mmHg).
Conclusion: The Braun BUA4000 automated oscillometric BP monitor fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard in a general population and can be recommended for self-monitoring of BP by patients at home.
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.
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