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Validation of the YuWell YE690A upper-arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010

Chen, Qi; Lei, Lei; Li, Yan; Wang, Ji-Guang

doi: 10.1097/MBP.0000000000000278
Devices and Technology
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Objective The present study aimed to evaluate the accuracy of the automated oscillometric upper-arm blood pressure monitor YuWell YE690A for blood pressure measurement according to the International Protocol of the European Society of Hypertension revision 2010.

Participants and methods Systolic and diastolic blood pressures were measured sequentially in 33 adult Chinese (12 women, 44.2 years of mean age) using a mercury sphygmomanometer (two observers) and the YE690A device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases.

Results All the blood pressure requirements were fulfilled. The YuWell YE690A device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 79/99, 96/99, and 97/99, respectively, for systolic blood pressure and 72/99, 95/99, and 98/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Thirty-one and 25 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device–observer differences within 5 mmHg (required ≥24). No participant for systolic and two participants for diastolic blood pressure had all the three device–observer comparisons greater than 5 mmHg.

Conclusion The YuWell blood pressure monitor YE690A has passed the requirements of the International Protocol revision 2010 and hence can be recommended for blood pressure measurement in adults.

Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Shanghai Key Laboratory of Hypertension, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China

Correspondence to Ji-Guang Wang, MD, PhD, The Shanghai Institute of Hypertension, Ruijin 2nd Road 197, Shanghai 200025, China Tel: +86 216 437 0045 x610911; fax: +86 216 466 2193; e-mail: jiguangwang@aim.com

Received November 17, 2016

Received in revised form May 22, 2017

Accepted May 25, 2017

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