Validation of the CONTEC08C oscillometric blood pressure monitor in adults according to the International Organization for Standardization 81060-2:2018 standard

This study aimed to assess the accuracy of the CONTEC08C automated oscillometric upper-arm sphygmomanometer in adults for clinical use in accordance with the ISO 81060-2:2018 standard. A total of 90 normotensive and hypertensive participants aged 18-75 years were recruited, and 85 were analyzed to evaluate the accuracy of the CONTEC08C oscillometric upper-arm sphygmomanometer using the same arm sequential validation method and a standardized protocol. The mean ± standard deviation (SD) of the differences between the test device and reference blood pressure (BP) measurements was 0.5 ± 3 mmHg for SBP and 0.4 ± 3.5 mmHg for DBP, meeting validation criterion 1. For validation criterion 2, the SD of the averaged differences between the test device and reference BP measurements per subject was 1.81/2.41 mmHg (systolic/diastolic). The CONTEC08C oscillometric upper-arm blood pressure monitor fulfilled the requirements of the ISO 81060-2:2018 standard in adults in the clinical setting and can therefore be recommended for safe clinical use.