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).

Autor: Hernández Véliz D; Institute of Cardiology and Cardiovascular Surgery, 17th street 702 between A and Paseo Avenue, Havana, 10400, Cuba., Valdés González Y; Institute of Endocrinology, Zapata street and D street, Havana, 10400, Cuba. gonzalezvaldes1974@gmail.com., Armas Rojas NB; Institute of Cardiology and Cardiovascular Surgery, 17th street 702 between A and Paseo Avenue, Havana, 10400, Cuba., De la Noval García R; Institute of Cardiology and Cardiovascular Surgery, 17th street 702 between A and Paseo Avenue, Havana, 10400, Cuba., Ringrose J; University of Alberta, Edmonton, AB, Canada., Padwal R; University of Alberta, Edmonton, AB, Canada.
Jazyk: angličtina
Zdroj: Journal of human hypertension [J Hum Hypertens] 2024 Nov; Vol. 38 (11), pp. 779-785. Date of Electronic Publication: 2024 Aug 24.
DOI: 10.1038/s41371-024-00948-9
Abstrakt: 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.
(© 2024. The Author(s), under exclusive licence to Springer Nature Limited.)
Databáze: MEDLINE
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