Validation of the AViTA BPM636 upper arm blood pressure monitor in adults and pregnant women according to the ANSI/AAMI/ISO 81060-2:2013

Abstract

Objective To evaluate the accuracy of the AViTA oscillometric upper arm home blood pressure (BP) monitor in adult and pregnant populations according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/ International Organization for Standardization (ANSI/AAMI/ISO) Universal Standard (ISO 81060-2:2013). Methods BP measurements on the upper arm were performed on 85 adult subjects and 46 pregnant subjects. The AViTA BPM636 and a standard mercury reference sphygmomanometer were applied and followed the same arm sequential BP measurement method. The universal cuff of the test device was used for arm circumference of 22–42 cm. Results For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 1.1 ± 5.49/2.9 ± 5.17 mmHg (systolic/diastolic) for adults; and -2.2 ± 5.93/1.5 ± 4.92 mmHg (systolic/diastolic) for pregnant women. For criterion 2, the SD of the averaged BP differences between the test device and reference BP per adult subject was 4.45/4.20 mmHg (systolic/diastolic) and per pregnant women was 4.66/3.96. Conclusion The AViTA BPM636 had passed the criteria of the ANSI/AAMI/ISO 81060-2:2013 protocol and can be recommended for home BP measurements in adults and pregnant populations.