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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)

Journal of Human Hypertension volume 38, pages 779–785 (2024)Cite this article

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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.

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Data availability

The data analyzed during this study are available in the Cuban Public Registry of Clinical Trials. https://rpcec.sld.cu/.

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Acknowledgements

We would like to acknowledge the collaboration of the Group for the conduct of clinical validation studies of automatic sphygmomanometers in Cuba: Amarilys Jimenez Chiquet and Lizette Pérez Perea from the Public Health Ministry, Jorge Enrique Aguiar Pérez, Sandra Quintana Estévez, Mary Leivys Herrera Giró, Judith Castellanos Almeida and Dania Fernández Rodríguez from the Institute of Cardiology and Cardiovascular Surgery, Elaine Hernández Morales, Zuleidys Gourneo Álvarez, Emelina Despaigne Carrión and Yadira Drake Pérez from the University Hospital “General Calixto García”, Katherine Bancroft Sánchez from the Obstetric Hospital “América Arias”, Mario César Muñiz Ferrer, Ernesto Alcolea González and Dorian Alonso Martínez from the State Center for the Control of Medicines, Equipment and Devices (CECMED), Irma Millán Marrero and Edilberto González Ortiz from BioCubaFarma, as well as Peter Wood from the University of Alberta, Canada, Norm Campbell from University of Calgary, Canada, James E. Sharman from University of Tasmania, Australia and Cintia Lombardi. Thanks to the Panamerican Health Organization (PAHO) and the World Hypertension League (WHL) for joint work in the formation of technical capabilities in low and middle-income countries.

Funding

This study was funded by the Cuban Ministry of Public Health.

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Author notes

  1. These authors contributed equally: Damaris Hernández Véliz, Yamilé Valdés González.

Authors and Affiliations

  1. Institute of Cardiology and Cardiovascular Surgery, 17th street 702 between A and Paseo Avenue, Havana, 10400, Cuba

    Damaris Hernández Véliz, Nurys Bárbara Armas Rojas & Reinaldo De la Noval García

  2. Institute of Endocrinology, Zapata street and D street, Havana, 10400, Cuba

    Yamilé Valdés González

  3. University of Alberta, Edmonton, AB, Canada

    Jennifer Ringrose & Raj Padwal

Authors
  1. Damaris Hernández Véliz
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  2. Yamilé Valdés González
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  4. Reinaldo De la Noval García
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  5. Jennifer Ringrose
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  6. Raj Padwal
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Contributions

DHV conceived the original idea, designed the procedures according to the standard, collected data, helped write the manuscript. YVG conceived the original idea, designed the procedures according to the standard, collected data, helped write the manuscript. NAR designed the procedures according to the standard, participated in data extraction and processing, provided comments on the report. RDLNG designed the procedures according to the standard, collected data, helped write the manuscript. JR provided comments on the Clinical Investigation Plan design and experimental issues according to the standard, advised data collection/processing and provided comments on the report. RP provided comments on the Clinical Investigation Plan design and experimental issues according to the standard, advised data collection/processing and provided comments on the report.

Corresponding author

Correspondence to Yamilé Valdés González.

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The authors declare no competing interests.

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In all cases, the ethical principles of the Declaration of Helsinki were respected and the informed consent of the participants was obtained.

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Hernández Véliz, D., Valdés González, Y., Armas Rojas, N.B. et al. 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). J Hum Hypertens 38, 779–785 (2024). https://doi.org/10.1038/s41371-024-00948-9

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