Biomedical Engineering Letters

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
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Validation of the mobile wireless digital automatic blood pressure monitor using the cuff pressure oscillometric method, for clinical use and self-management, according to international protocols

  • Yoo, Sooyoung (Office of eHealth Research and Businesses, Healthcare ICT Research Center, Seoul National University Bundang Hospital) ;
  • Baek, Hyunyoung (Office of eHealth Research and Businesses, Healthcare ICT Research Center, Seoul National University Bundang Hospital) ;
  • Doh, Kibbeum (Medical Device Research and Development Center, Seoul National University Bundang Hospital) ;
  • Jeong, Jiyeoun (Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital) ;
  • Ahn, Soyeon (Medical Research Collaborating Center, Seoul National University Bundang Hospital) ;
  • Oh, Il-Young (Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital) ;
  • Kim, Kidong (Medical Device Research and Development Center, Seoul National University Bundang Hospital)
  • Received : 2018.02.04
  • Accepted : 2018.09.18
  • Published : 2018.11.30
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Abstract

The purpose of this study was to evaluate the accuracy of a mobile wireless digital automatic blood pressure monitor for clinical use and mobile health (mHealth). In this study, a manual sphygmomanometer and a digital blood pressure monitor were tested in 100 participants in a repetitive and sequential manner to measure blood pressure. The guidelines for measurement used the Korea Food & Drug Administration protocol, which reflects international standards, such as the American National Standard Institution/Association for the Advancement of Medical Instrumentation SP 10: 1992 and the British Hypertension Society protocol. Measurements were generally consistent across observers according to the measured mean ${\pm}SD$, which ranged in $0.1{\pm}2.6mmHg$ for systolic blood pressure (SBP) and $0.5{\pm}2.2mmHg$ for diastolic blood pressure (DBP). For the device and the observer, the difference in average blood pressure (mean${\pm}$SD) was $2.3{\pm}4.7mmHg$ for SBP and $2.0{\pm}4.2mmHg$ for DBP. The SBP and DBP measured in this study showed accurate measurements that satisfied all criteria, including an average difference that did not exceed 5 mmHg and a standard deviation that did not exceed 8 mmHg. The mobile wireless digital blood pressure monitor has the potential for clinical use and managing one's own health.

Keywords

Acknowledgement

Grant : Development of medical equipment using (ionizing or non-ionizing) radiation'-dedicated R&D platform and medical device technology

Supported by : SK Telecom Co. Ltd, Ministry of Trade, Industry and Energy (MOTIE)

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