Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010.

Abstract

The aim of this study was to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor HL868ED for clinical use and self-measurement according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressure were measured sequentially in 43 adult Chinese (21 women, mean age 51.7 years) using a mercury sphygmomanometer (two observers) and the HL868ED device (one supervisor). A total of 99 pairs of comparisons were obtained from 43 participants for judgements in two parts with three grading phases. The HL868ED device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10 and 15 mmHg was 68/99, 91/99 and 97/99, respectively, for systolic blood pressure and 85/99, 95/99 and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Twenty-four and 30 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observer differences within 5 mmHg (required ≥24). Three participants for systolic and one participant for diastolic blood pressure had all the three device-observer comparisons greater than 5 mmHg. The Health & Life blood pressure monitor HL868ED has passed the requirements of the International Protocol revision 2010 and hence can be recommended for blood pressure measurements in adults.