Validation of the Kingyield BP101H blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol.
OBJECTIVE
This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor BP101H (Kingyield Technology, Shenzhen, China) for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension.


METHODS
Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese participants (13 women, 52.6 years of mean age) using a mercury sphygmomanometer (two observers) and the BP101H device (one supervisor). Ninety-nine pairs of comparisons were obtained from 15 participants in phase 1 and further 18 participants in phase 2 of the validation study. Data analysis was done using the ESHIP Analyzer.


RESULTS
The BP101H device successfully passed phase 1 of the validation study with a number of absolute differences between device and observers within 5, 10, and 15 mmHg for at least 34/45, 42/45, and 43/45 measurements, respectively. The device also achieved the targets for phase 2.1, with 79/99, 94/99, and 96/99 differences within 5, 10, and 15 mmHg, respectively, for systolic blood pressure, and with 81/99, 94/99, and 98/99 within 5, 10, and 15 mmHg, respectively, for diastolic blood pressure. In phase 2.2, 27 and 28 participants had at least two of the three device-observers differences within 5 mmHg (required ≥22) for systolic blood pressure and diastolic blood pressure, respectively.


CONCLUSIONS
The Kingyield upper arm blood pressure monitor BP101H has passed the International Protocol requirements, and hence can be recommended for home use in adults.
Centre for Epidemiological Studies and Clinical Trials, Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Ruijin 2nd Road 197, Shanghai, China.
Wei-Fang
WF
Zeng
Qi-Fang
QF
Huang
Chang-Sheng
CS
Sheng
Yan
Y
Li
Ji-Guang
JG
Wang
D000328:Adult; D001132:Arm; D044466:Asian People; D001795:Blood Pressure Determination / Q000295:instrumentation; D018660:Blood Pressure Monitoring, Ambulatory / Q000295:instrumentation*; D015924:Blood Pressure Monitors / Q000592:standards*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D015203:Reproducibility of Results