Abstract
AbstractBlood pressure is an important cardiovascular parameter. Currently, the cuff-based sphygmomanometer is a popular, reliable, measurement method, but blood pressure monitors without cuffs have become popular and are now available without a prescription. Blood pressure monitors must be approved by regulatory authorities. Current cuffless blood pressure (CL-BP) monitors are not suitable for at-home management and prevention of hypertension. This paper proposes simple criteria for over-the-counter CL-BP monitoring. First, the history of the sphygmomanometer and current standard blood pressure protocol are reviewed. The main components of CL-BP monitoring are accuracy during the resting condition, accuracy during dynamic blood pressure changes, and long-term stability. In this proposal we recommend intermittent measurement to ensure that active measurement accuracy mirrors resting condition accuracy. A new experimental protocol is proposed to maintain long-term stability. A medically approved automated sphygmomanometer was used as the standard device in this study. The long-term accuracy of the test device is based on the definition of propagation error, i.e., for an oscillometric automated sphygmomanometer (5 ± 8 mmHg) ± the error for the test device static accuracy (–0.12 ± 5.49 mmHg for systolic blood pressure and − 1.17 ± 5.06 mmHg for diastolic blood pressure). Thus, the long-term stabilities were − 3.38 ± 7.1 mmHg and − 1.38 ± 5.4 mmHg, which satisfied propagation error. Further research and discussion are necessary to create standards for use by manufacturers; such standards should be readily evaluated and ensure high-quality evidence.
Funder
Scientific Research (C)
Japan Agency for Medical Research and Development
KYOTO Industrial Support Organization 21
Publisher
Springer Science and Business Media LLC
Subject
Biomedical Engineering,Applied Microbiology and Biotechnology,Bioengineering,Biotechnology
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