Validation of the AVITA BPM63S upper arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

ABSTRACT

OBJECTIVE: The present study aimed to evaluate the accuracy of the AVITA BPM63S upper arm blood pressure monitor for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. METHODS: Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese (14 women, mean age of 47 years) using a mercury sphygmomanometer (two observers) and the AVITA BPM63S device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. RESULTS: All the blood pressure requirements were fulfilled. The AVITA BPM63S 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, 89/99, and 96/99, respectively, for systolic blood pressure, and 75/99, 95/99, and 97/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Twenty-four and 25 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observers differences within 5 mmHg (required ≥24). One and two participants for systolic and diastolic blood pressure, respectively, had all three device-observers differences greater than 5 mmHg. CONCLUSION: The AVITA BPM63S automated oscillometric upper arm blood pressure monitor has passed the requirements of the International Protocol revision 2010, and hence can be recommended for blood pressure measurement at home in adults.