Validation of the Wellvii VitalDetect blood pressure monitor in general population according to the International Standardization Organization 81060-2:2018

Abstract

Objective To evaluate the accuracy of the Wellvii VitalDetect automated oscillometric finger blood pressure monitor (single cuff size) for self/home blood pressure measurement according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018). Methods According to the universal standard, a total of 92 participants were recruited and finally blood pressure of 85 eligible participants was sequentially measured and compared with a standard mercury sphygmomanometer. Results A total of 255 comparison pairs were obtained and analyzed based on the universal standard. For the validation criterion 1 of the ISO 81060-2:2018 universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 1.66 ± 7.67 and 1.04 ± 6.45 mmHg for systolic and diastolic blood pressure, respectively. For criterion 2, the SD of the averaged blood pressure differences between the test device and reference blood pressure per subject was ± 6.49 mmHg (pass ≤ 6.73 mmHg) and ± 5.67 mmHg (pass ≤ 6.86 mmHg) for systolic and diastolic blood pressure, respectively. Conclusion The Wellvii VitalDetect automated finger blood pressure monitor passed all the requirements for validation by the ISO 81060-2:2018 universal standard and can be recommended for self/home blood pressure measurement in general population.