Validation of the AVITA BPM15S wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010

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Abstract

Objective

The present study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor AVITA BPM15S for home blood pressure monitoring according to the International Protocol revision 2010 of the European Society of Hypertension.

Method

Systolic and diastolic blood pressures were sequentially measured in 33 Chinese adults (15 women, mean age 51 years) using a mercury sphygmomanometer (two observers) and the AVITA BPM15S device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases.

Results

The AVITA BPM15S device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and observers within 5, 10, and 15 mmHg were 85/99, 94/99, and 98/99, respectively, for systolic blood pressure, and 82/99, 96/99, and 98/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Thirty-two and 28 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device–observer differences within 5 mmHg (required≥24). No participant had all of the three device–observer comparisons greater than 5 mmHg for systolic or diastolic blood pressure.

Conclusion

The AVITA wrist blood pressure monitor BPM15S fulfilled the requirements of the International Protocol revision 2010 and hence can be recommended for home use in an adult population.

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