Validation of the Health & Life HL868BA blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol

Abstract

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. 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. 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 > or = 22) for systolic and diastolic blood pressure, respectively. The Health & Life upper arm blood pressure monitor HL868BA can be recommended for home use in adults.