Validation of combiomed hipermax-BF model A7101 automatic oscillometric upper-arm sphygmomanometer in general population: AAMI/ESH/ISO universal standard (ISO 81060-2:2018/Amd 1:2020)

Abstract

This study evaluates the accuracy of the Hipermax-BF model A7101 (Combiomed, Havana, Cuba) automatic oscillometric upper-arm sphygmomanometer for office and home use in general population as part of the HEARTS in the Americas initiative. The research was developed according to the Universal Standard AAMI/ESH/ISO ISO 81060-2:2018/Amd 1:2020. The subjects were recruited according to the requirements of age, gender, blood pressure values and upper-arm circumference. The same upper-arm sequential blood pressure measurement method was used. For measurements with the device under test, the 2-piece cuff from 22-44 cm limb circumference range was used. 92 subjects were recruited and 85 were analyzed. Mean age was 44.8 ± 14.7 years, mean upper-arm circumference was 32.3 ± 6.2, and 56.5% were female. For Validation Criterion 1, the mean value ± standard deviation of the differences in readings between the device under test and the reference device was 1.2 ± 4.9/0.8 ± 4.9 mmHg (systolic/diastolic). For both pressures, in criterion 1 the standard requires a mean value of the differences ≤ ± 5 mmHg and a standard deviation ≤ ± 8 mmHg. For Validation Criterion 2, the standard deviation of the mean blood pressure differences per subject was 4.2/4.2 mmHg (systolic/diastolic). According to Table 1 of criterion 2, for the mean values of 1.2/0.8 mmHg (systolic/diastolic), the maximum allowable standard deviation had to be < 6.84 for systolic and < 6.89 for diastolic pressure. The Combiomed Hipermax-BF A7101 automatic sphygmomanometer meets the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018/Amd 1:2020) in the general population.