Abstract
Objective
To evaluate the clinical accuracy of the AViTA BPM636 oscillometric upper-arm blood pressure monitor in the tested pediatric and adult population, including children aged 5–12 years and adults aged 21–82 years with arm circumferences ranging from 15 to 42 cm, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) Universal Standard (ISO 81060-2:2018/Amd2:2024).
Methods
The AViTA BPM636 was evaluated in 85 participants (including 35 pediatric and 50 adult subjects) with upper-arm circumferences ranging from 15 to 42 cm, and two cuffs of different sizes (15 to 22 and 22 to 42 cm) were used in this study. The recruitment fulfilled the requirements of the ANSI/AAMI/ISO Universal Standard (ISO 81060-2:2018/Amd2:2024) for a combined pediatric and adult population using the same arm sequential blood pressure measurement method.
Results
For criterion 1, the mean ± SD of the differences between the test device and reference blood pressure measurements was 0.93 ± 6.11 mmHg for SBP and −0.20 ± 5.64 mmHg for DBP. For criterion 2, the SD of individual mean differences for SBP (5.44 mmHg) and DBP (4.98 mmHg) remained well within the maximum permissible limits of 6.88 and 6.95 mmHg, respectively, thereby satisfying the validation criteria.
Conclusion
The AViTA BPM636 passed the criteria of the ANSI/AAMI/ISO Universal Standard (ISO 81060-2:2018/Amd2:2024) protocol. It can be recommended for home-based blood pressure measurements in the tested population, including children aged 5–12 years and adults aged 21–82 years, with arm circumferences ranging from 15 to 42 cm.