Academic Journal
Validation of Combiomed Hipermax-BF model A7101 automatic oscillometric arm sphygmomanometer in general population: AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)
| Title: | Validation of Combiomed Hipermax-BF model A7101 automatic oscillometric arm sphygmomanometer in general population: AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) |
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| Authors: | Yamilé Valdés González, Damaris Hernández Véliz, Nurys B. Armas Rojas, Reinaldo de la Noval García, Jennifer Ringrose, Raj Padwal |
| Publisher Information: | Springer Science and Business Media LLC, 2024. |
| Publication Year: | 2024 |
| Subject Terms: | 2. Zero hunger, Radiology, Nuclear Medicine and Imaging, Social Psychology, Ergonomics and Human Factors in Technology Use, Non-contact Physiological Monitoring Technology, Population, Biomedical Engineering, Social Sciences, FOS: Medical engineering, Pulse Oximetry, FOS: Psychology, Engineering, Continuous Blood Pressure Estimation, Environmental health, Medical Applications of Infrared Thermography, Physical Sciences, Health Sciences, Sphygmomanometer, Blood pressure, Psychology, Medicine, Internal medicine |
| Description: | 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. |
| Document Type: | Article Other literature type |
| DOI: | 10.21203/rs.3.rs-3883748/v1 |
| DOI: | 10.60692/7t7my-meg51 |
| DOI: | 10.60692/d5ba4-hyf81 |
| Rights: | CC BY |
| Accession Number: | edsair.doi.dedup.....3ab77fe8778a0fecc4e8b6a209f8823f |
| Database: | OpenAIRE |
| DOI: | 10.21203/rs.3.rs-3883748/v1 |
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