Accuracy of the COMBEI BP118A Device for Self-Blood Pressure Measurements in General Population - Validation According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.

Background: Electronic devices for blood pressure (BP) measurements must undergo independent clinical validation as recommended by various authorities and scientific societies.

Objective: To assess the accuracy of the Combei BP118A device in the general population according to the Universal Standard Validation Protocol.

Methods: The new-developed Combei BP118A device measures BP at the brachial level using the oscillometric method. The study was performed according to the "AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) protocol". Subjects (n = 88) were recruited to fulfill the age, gender, BP and cuff distribution criteria according to the protocol requirements using the same arm sequential BP measurement method. Differences between observers' mercury sphygmomanometer reference measurements and device BP values (test versus reference) and their standard deviation (SD) were calculated.

Results: Ninety-one subjects were selected, 88 of whom were included. The mean BP differences between the simultaneous observers' reference measurements were -0.2 ± 1.7 mmHg for systolic BP (SBP) and -0.2 ± 1.7 mmHg for diastolic BP (DBP). For validation criterion 1, the mean difference ± SD between the reference and device BP values were 3.6 ± 5.5 mmHg for SBP and 1.4 ± 4.5 mmHg for DBP. For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 5/4.1 mmHg for SBP/DBP (≤5.9/6.8). These results fulfilled the protocol requirements.

Conclusion: The Combei BP118A oscillometric device for home BP measurement fulfilled all of the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and consequently can be recommended for home BP measurements.