Validation of the AVITA BPM15S wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.
OBJECTIVE
The present study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor AVITA BPM15S for home blood pressure monitoring according to the International Protocol revision 2010 of the European Society of Hypertension.


METHODS
Systolic and diastolic blood pressures were sequentially measured in 33 Chinese adults (15 women, mean age 51 years) using a mercury sphygmomanometer (two observers) and the AVITA BPM15S device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases.


RESULTS
The AVITA BPM15S 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 were 85/99, 94/99, and 98/99, respectively, for systolic blood pressure, and 82/99, 96/99, and 98/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Thirty-two and 28 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 had all of the three device-observer comparisons greater than 5 mmHg for systolic or diastolic blood pressure.


CONCLUSIONS
The AVITA wrist blood pressure monitor BPM15S fulfilled the requirements of the International Protocol revision 2010 and hence can be recommended for home use in an adult population.
Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Yuan-Yuan
YY
Kang
Wei-Fang
WF
Zeng
Lu
L
Zhang
Yan
Y
Li
Ji-Guang
JG
Wang
D000328:Adult; D000368:Aged; D018660:Blood Pressure Monitoring, Ambulatory / Q000295:instrumentation* / Q000379:methods*; D015924:Blood Pressure Monitors; D002681:China; D005062:European Union; D005260:Female; D006801:Humans; D006973:Hypertension / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D012955:Societies, Medical