Validation of the AVITA BPM64 upper-arm blood pressure monitor for home blood pressure monitoring 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 (BP) monitor AVITA BPM64 for home BP monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic BPs were measured sequentially in 33 adult Chinese (14 women, mean age 47.0 years) using a mercury sphygmomanometer (two observers) and the AVITA BPM64 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The AVITA BPM64 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 91/99, 98/99, and 98/99, respectively, for systolic BP and 92/99, 99/99, and 99/99, respectively, for diastolic BP. The device also fulfilled the criteria in part 2 of the validation study. Thirty-two participants for both systolic and diastolic BP had at least two of the three device-observer differences within 5 mmHg (required ≥24). Only one participant for systolic BP had all three device-observer comparisons greater than 5 mmHg. The AVITA upper arm BP monitor BPM64 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.