Validation of the Kingyield BP210 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension-International Protocol

摘要

OBJECTIVE: The present study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor BP210 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 (21 women, 51 years of mean age) using a mercury sphygmomanometer (two observers) and the BP210 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 15 participants in phase 1 and a further 18 participants in phase 2 of the validation study. Data analysis was conducted using the ESHIP analyzer. RESULTS: The BP210 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 33/45, 44/45, and 44/45 measurements, respectively. The device also achieved the targets for phase 2.1, with 77/99, 95/99, and 97/99 differences within 5, 10, and 15 mmHg, respectively for systolic blood pressure, and with 78/99, 97/99, and 99/99 within 5, 10, and 15 mmHg, respectively for diastolic blood pressure. In phase 2.2, 29 and 25 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. CONCLUSION: The Kingyield wrist blood pressure monitor BP210 has passed the International Protocol requirements, and hence can be recommended for home use in adults.