Validation of the DBP-6279B arm-type fully automatic digital blood pressure monitor in pregnancy according to the ISO 81060-2:2018/AMD 1:2020 protocol

To evaluate the accuracy of the DBP-6279B arm-type fully automatic digital blood pressure monitor in pregnant populations according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018/AMD 1:2020) and the Recognized Consensus Standards published by the Food and Drug Administration (FR Recognized List No.056, FR Recognized No. 3-166), a total of 115 pregnant women were enrolled in this clinical trial. One participant was excluded because it met the data exclusion criteria. The arm circumference and subgroup distributions of the subjects met the requirements of the protocol. According to criterion 1, the mean difference of systolic blood pressure between the test device and the reference device was ‑0.89 mmHg, with a SD of 5.60 mmHg. The mean difference of diastolic blood pressure was ‑0.17 mmHg, with a SD of 4.65 mmHg. The mean difference in both systolic and diastolic blood pressure was less than 5.0 mmHg, and the SD was less than 8.0 mmHg. Additional analyses were also conducted in accordance with criterion 2 and the results met the requirements, too. Therefore, it is recommended for pregnant populations in home and clinical use.