Affiliation:
1. Department of Cardiology, Fu Jen Catholic University Hospital
2. R&D Software Department, AViTA Corporation, New Taipei City, Taiwan
Abstract
Objective
To determine the accuracy of the AViTA BP636 upper-arm home blood pressure (BP) monitor in general populations with small to extra-large arms according to the ANSI/AAMI/ISO Universal Standard (ISO 81060-2 : 2018/Amd1 : 2020).
Methods
The AViTA BPM636 was utilized on 85 adult participants with upper-arm circumferences ranging from 15 to 52 cm, and four cuffs of different sizes (small: 15–22 cm, normal: 22–33 cm, large: 33–42 cm, and extra large: 42–52 cm) were used in this study. The recruitment fulfills the criteria of the ANSI/AAMI/ISO Universal Standard 81060-2 : 2018/Amd1 : 2020 in the general population using the same arm sequential BP measurement method.
Results
For validation criterion 1, the mean ± SD of the differences between the test device and reference blood pressure readings was −0.35 ± 4.68/0.56 ± 3.93 mmHg (systolic/diastolic) for adults. The mean difference of SBP between the test device and the reference device was −0.35 mmHg with a SD of 3.50 mmHg, wh{ich was within the acceptable range for criterion 2 (i.e. less than 6.93 mmHg) Similarly, the mean difference in DBP was 0.56 mmHg with a SD of 3.38 mmHg, which also met the criterion 2 (i.e. within 6.91 mmHg).
Conclusion
AViTA BPM636 passed the criteria of the ANSI/AAMI/ISO 81060-2 : 2018/Amd 1 : 2020 protocol. It can be recommended for home-based BP measurements in the general population and people with extra-large arms ranging from 42 to 52 cm.
Publisher
Ovid Technologies (Wolters Kluwer Health)