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
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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 ± SD, which ranged in 0.1 ± 2.6 mmHg for systolic blood pressure (SBP) and 0.5 ± 2.2 mmHg for diastolic blood pressure (DBP). For the device and the observer, the difference in average blood pressure (mean ± SD) was 2.3 ± 4.7 mmHg for SBP and 2.0 ± 4.2 mmHg 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.
KeywordsDigital automatic blood pressure Validation Clinical use Self-management
This work was funded by SK Telecom Co. Ltd and supported by the Technology Innovation Program funded By the Ministry of Trade, Industry and Energy (MOTIE) of Korea (10049785, Development of ‘medical equipment using (ionizing or non-ionizing) radiation’-dedicated R&D platform and medical device technology). The authors thank the Medical Research Collaborating Center at Seoul National University Bundang Hospital for consultation on the statistical analyses.
Compliance with ethical standards
Conflicts of interest
There are no conflicts of interest. This work was supported by SK Telecom Co. Ltd.
This study was funded by SK Telecom Co. Ltd. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.
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