Draft Proposal of an Optical Cuffless Blood Pressure Device
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ORIGINAL PAPER
Draft Proposal of an Optical Cuffless Blood Pressure Device Toshiyo Tamura 1
&
on behalf of strategic committee of new standard development
Received: 1 February 2020 / Accepted: 4 May 2020 # IUPESM and Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Optical cuffless non-invasive blood pressure (NIBP) monitoring, including photoplethysmographic sensing calculated based on the pulse transit time (PTT), pulse contour method, and second derivative signal, is a hot topic in home healthcare. However, previous evaluations of cuffless blood pressure revealed issues with accuracy and validation; cuffless measurements are less accurate than intermittent cuff-based sphygmomanometer measurements. Use of an inaccurate device for blood pressure monitoring represents a health risk. To protect device users, standards need to be formulated. We present a draft optical cuffless blood pressure monitor; opinions and comments are cordially invited. Keywords Optical cuffless non-invasive blood pressure monitor . IEEE . ISO . FDA . CE . Regulation . Regulatory science
1 Introduction
2 Principles of Cuffless NIBP Monitors
Cuff-based automatic sphygmomanometers are commonly used to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP), in both clinical practice and at home. The change in cuff pressure during artery collusion can be measured by these devices. Recently, cuffless non-invasive blood pressure (NIBP) monitoring has been attempted. Although cuff-based BP monitors have been authorized for use and provide accurate readings, cuffless NIBP is being developed as an alternative. Our proposed device is easy to use and has relatively good accuracy when measurements are obtained at rest. However, at present, the only standard that pertains to wearable cuffless BP monitors is Institute of Electrical and Electronics Engineers (IEEE) standard 1708– 2014 and 1708a-2019. Here, we discuss current trends in the regulation and approval of optical cuffless NIBP monitors. We also propose a draft optical cuffless BP monitor, on which comments and contributions are cordially invited.
Optical cuffless NIBP devices operate according to three principles: pulse transit time (PTT), the pulse contour, and the acceleration pulse. Cuffless NIBP monitors are designed to measure trends in BP, beat-to-beat rhythms, and waveforms.
* Toshiyo Tamura [email protected]
2.2 Pulse Contour Method
1
Waseda University, Tokyo, Japan
2.1 PTT-Based Estimation P T T- b a s e d B P d e v i c e s a r e b a s e d e i t h e r o n photoplethysmography (PPG) and electrocardiography (ECG; R wave), or on two PPGs, as shown in Fig. 1. An alternative approach to continuous and non-invasive indirect BP measurement is based on changes in pulse wave velocity (PWV), which is the velocity of a pressure pulse propagating along the arterial wall. This can be calculated from the PTT, which is the time between two pulse waves propagating from two separate arterial sites during the same cardiac cycle. The pulse arrival
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