Validation of the ANDON KD-7920 wrist blood pressure monitor in general population according to the ISO 81060-2:2018+AMD1:2020 protocol

Objective: This study aimed to evaluate the accuracy of the ANDON KD-7920 oscillometric wrist blood pressure monitor in general population according to the ISO 81060-2:2018+AMD1:2020.

Methods: The same arm sequential method was used for blood pressure measurement among qualified participants according to the ISO 81060-2:2018+AMD1:2020. The validation results were assessed following the criteria of the protocol, and the Bland-Altman scatter plot was used to present the difference between the test device and reference results.

Results: A total of 90 participants were included in the study. According to criterion 1 of the validation protocol, the mean ± SD of the differences between the test device and reference readings was 0.76 ± 6.23 mmHg and -0.13 ± 5.57 mmHg for systolic and diastolic blood pressure, respectively, which met the requirements of less than 5 ± 8 mmHg. According to the criterion 2, the average differences between the test device and reference readings per participant were 0.76 ± 5.56 mmHg and -0.13 ± 5.27 mmHg for systolic and diastolic blood pressure, respectively, which also met the requirements.

Conclusion: The ANDON KD-7920 wrist blood pressure monitor passed all the requirements of the ISO 81060-2:2018+AMD1:2020 and can be recommended for clinical use and self-measurement in general population.