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Validation of the Andon KD5031 for clinical use and self-measurement according to the European Society of Hypertension International Protocol

Wu, Ning; Zhang, Xuezhong; Wang, Wen; Zhang, Hongye

doi: 10.1097/MBP.0000000000000204
Devices and Technology

Objective: This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor Andon KD5031 for home BP monitoring according to the European Society of Hypertension International Protocol revision 2010.

Methods: Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using the standard mercury sphygmomanometer and the Andon KD5031 device. Ninety-nine pairs of comparisons were obtained from 33 participants for analysis.

Results: The KD5031 device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10, and 15 mmHg was 66/99, 93/99, and 98/99, respectively, for SBP and 72/99, 94/99, and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. Twenty-six participants for both SBP and DBP had at least two of the three device–observer differences within 5 mmHg (required ≥24). The number of participants without a device–observer difference within 5 mmHg was one for SBP and three for DBP (required ≤3).

Conclusion: The Andon upper arm BP monitor KD5031 has passed the International Protocol requirements, and it can be recommended for clinical use and self-measurement in adults.

aThe People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi

bBeijing Hypertension League Institute, Beijing, China

Correspondence to Hongye Zhang, MD, Hypertension League Institute, Room 723, Bailangyuan A2 Duan, No. 36, Fuxing Road Jia, Haidian District, 100039 Beijing, China Tel: +86 108 820 3419; fax: +86 108 820 3420; e-mail: zhy88203419@163.com

Received January 16, 2016

Received in revised form May 19, 2016

Accepted June 7, 2016

Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.