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Validation of the Andon KD595 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.0000000000000164
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This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor Andon KD595 for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using the standard mercury sphygmomanometer and the Andon KD595 device. Ninety-nine pairs of comparisons were obtained from 33 participants for analysis. The KD595 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 72/99, 93/99, and 96/99, respectively, for SBP and 72/99, 96/99, and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. A total of 28 and 25 participants had at least two of the three device–observer differences within 5 mmHg (required≥24) for SBP and DBP, respectively. The number of participants without device–observer difference within 5 mmHg was two for SBP and two for DBP (required≤3). The Andon upper arm blood pressure monitor KD595 has passed the International Protocol requirements and it can be recommended for clinical use and self-measurement in adults.

aDepartment of Cardiology, The People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi Zhuang Autonomous Region

bBeijing Hypertension League Institute, Beijing, China

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

Received May 2, 2015

Received in revised form September 23, 2015

Accepted September 29, 2015

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