Validation of Combiomed Hipermax-BF model A7101 automatic oscillometric arm sphygmomanometer in general population: AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)

Abstract This study was designed to evaluate the accuracy of the Hipermax-BF model A7101 automatic oscillometric arm sphygmomanometer (Combiomed, Havana, Cuba) in general population. The research was developed according to the Universal Standard AAMI/ESH/ISO (ISO 81060-2:2018) and the ISO 81060-2:2018/DAM amendment 1 of 2020. The subjects were recruited according to the requirements of age, gender, blood pressure values and arm circumference based on the recommendations. The same arm sequential blood pressure measurement method was used. For measurements with the device under test, the 2-piece cuff was used. 92 subjects were recruited and 85 were analyzed. Mean age was 44.8 ± 14.7 years, mean 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 of the standard, for the obtained mean values of 1.23/0.84 mmHg (systolic/diastolic), the maximum allowable standard deviation had to be < 6.84 for PS and < 6.89 for PD. The Combiomed Hipermax-BF A7101 automatic sphygmomanometer meets the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in the general population.