Validation of the Health & Life HL868BA 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 Health & Life oscillometric upper arm blood pressure monitor HL868BA for home blood pressure monitoring according to the European Society of Hypertension International Protocol for blood pressure measuring devices in adults. METHOD: Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese using a mercury sphygmomanometer (two observers) and the HL868BA 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 performed using the ESHIP Analyzer. RESULTS: The HL868BA 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 31/45, 42/45, and 44/45 measurements (required 25, 35, and 40, respectively), respectively. The device also achieved the targets for phase 2.1, with 68/99, 91/99, and 95/99 differences within 5, 10, and 15 mmHg, respectively, for systolic blood pressure, and with 71/99, 88/99, and 94/99 within 5, 10, and 15 mmHg, respectively, for diastolic blood pressure. In phase 2.2, 22 and 28 participants had at least two of the three device-observers differences within 5 mmHg (required >/=22) for systolic and diastolic blood pressure, respectively. CONCLUSION: The Health & Life upper arm blood pressure monitor HL868BA can be recommended for home use in adults.