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Validation of the fully automated Pangao PG-800B68 upper-arm device according to the European Society of Hypertension International Protocol revision 2010

Yao, Rui*; Du, You-You*; Li, Ya-Peng; Zhang, Yan-Zhou; Chen, Qing-Hua; Zhao, Luo-Sha; Li, Ling

doi: 10.1097/MBP.0000000000000111
Devices and Technology
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Objective This study aimed to validate the fully automated Pangao PG-800B68 upper-arm device according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010.

Materials and methods Sequential measurements of systolic blood pressure (SBP) and diastolic blood pressure (DBP) were obtained in 33 participants using the standard mercury sphygmomanometer and the test device. The ESH-IP revision 2010 was followed precisely and 99 pairings of test device and reference blood pressure measurements were obtained for analysis.

Results The number of blood pressure differences within 5, 10, and 15 mmHg was 76, 95, and 98, respectively, for SBP and 79, 96, and 99, respectively, for DBP. The device achieved all the required criteria of the ESH-IP revision 2010 with a device–observer difference of −0.03±4.64 mmHg for SBP and −0.64±4.50 mmHg for DBP.

Conclusion According to the validation results on the basis of the ESH-IP revision 2010, the Pangao PG-800B68 can be recommended for clinical use and self-measurement in adults.

Department of Cardiology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China

* Rui Yao and You-You Du contributed equally to the writing of this article.

Correspondence to Yan-Zhou Zhang, MD, PhD, Department of Cardiology, First Affiliated Hospital of Zhengzhou University, No. 1 Jianshe East Road, Zhengzhou 450052, China Tel/fax: +86 371 67967622; e-mail: zhang_yanzhou@163.com

Received October 8, 2014

Received in revised form January 2, 2015

Accepted January 6, 2015

Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.