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

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). 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. 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. 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.