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Validation of the Rossmax CF175 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010

Zhang, Lu; Kang, Yuan-Yuan; Zeng, Wei-Fang; Li, Yan; Wang, Ji-Guang

doi: 10.1097/MBP.0000000000000089
Devices and Technology
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Objective The present study aimed to evaluate the accuracy of the Rossmax CF175 upper-arm blood pressure monitor for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010.

Method Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese (17 women, mean age 46 years) using a mercury sphygmomanometer (two observers) and the Rossmax CF175 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 Rossmax CF175 device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and observers within 5, 10, and 15 mmHg was 78/99, 94/99, and 98/99, respectively, for systolic blood pressure, and 81/99, 96/99, and 97/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Twenty-nine participants, for both of systolic and diastolic blood pressure, had at least two of the three device–observers differences within 5 mmHg (required ≥24). Only one participant for diastolic blood pressure had all three device–observers comparisons greater than 5 mmHg.

Conclusion The Rossmax automated oscillometric upper-arm blood pressure monitor CF175 fulfilled the requirements of the International Protocol revision 2010, and hence can be recommended for blood pressure measurement in adults.

Centre for Epidemiological Studies and Clinical Trials, 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 21 6437 0045 x610911; fax: +86 21 6466 2193; e-mail: jiguangwang@aim.com

Received July 9, 2014

Received in revised form September 5, 2014

Accepted September 10, 2014

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