Validation of the CONTEC08A upper-arm blood pressure monitor in adult Chinese.

OBJECTIVE

The aim of this study was to evaluate the accuracy of the CONTEC08A oscillometric upper-arm blood pressure (BP) monitor for BP measurement in adults according to the International Organization for Standardization (ISO) 81060-2:2018 and amendment (Amd)1:2020 standard.

METHODS

Eighty-five subjects (male 40 and female 45) were recruited to fulfill the age, sex, BP, and cuff distribution criteria of the ISO standard in the general population, and had a mean age of 40.2 years. The same arm sequential BP measurement method was used with three differently sized cuffs for the arm circumference ranging from 18 to 26 cm (small), 22-32 cm (medium), and 22-43 cm (large), respectively, for the test device, and two differently sized cuffs for the arm circumference ≤32 cm (standard) and >32 cm (large), respectively, for the mercury sphygmomanometer.

RESULTS

Two hundred and fifty-five comparison pairs were obtained for analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference SBP/DBP readings was 1.1 ± 6.7/3.0 ± 5.3 mmHg. For validation criterion 2, the SD of the averaged SBP/DBP differences between the test device and reference BP per subject was 5.63/4.68 mmHg.

CONCLUSION

The automated upper-arm BP monitor CONTEC08A has passed the requirements of the ISO Universal Standard in the general population, and can be recommended for BP measurement in adults.