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

Validation of Combiomed Hipermax-BF model A7101 automatic oscillometric arm sphygmomanometer in general population: AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Validation of Combiomed Hipermax-BF model A7101 automatic oscillometric arm sphygmomanometer in general population: AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) Yamile Valdes Gonzalez, Damaris Hernández Véliz, Nurys Armas Rojas, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3883748/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 24 Aug, 2024 Read the published version in Journal of Human Hypertension → Version 1 posted 8 You are reading this latest preprint version 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. Health sciences/Medical research/Clinical trial design/Clinical trials Biological sciences/Physiology/Cardiovascular biology/Cardiovascular diseases/Hypertension Figures Figure 1 Figure 2 Figure 3 Figure 4 Full Text Additional Declarations There is NO conflict of interest to disclose. Supplementary Files JHHTablesSummary123y4.xlsx Table 1. Participants recruited and excluded from the analysis. Characteristics of the participants (n=85) Table 2. Distribution of baseline blood pressure measurements (Step 1-5, n=255) Table 3. Compliance with the amendment of the standard on the distribution of arm diameters Table 4. Results of the validation study. Cite Share Download PDF Status: Published Journal Publication published 24 Aug, 2024 Read the published version in Journal of Human Hypertension → Version 1 posted Editorial decision: revise 07 Mar, 2024 Review # 1 received at journal 04 Mar, 2024 Reviewer # 1 agreed at journal 19 Feb, 2024 Reviewers invited by journal 12 Feb, 2024 Editor assigned by journal 11 Feb, 2024 Submission checks completed at journal 24 Jan, 2024 First submitted to journal 23 Jan, 2024 Unknown event 22 Jan, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3883748","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":272541260,"identity":"200fc27a-2200-4f0f-860e-a6ae6cef1abc","order_by":0,"name":"Yamile Valdes Gonzalez","email":"data:image/png;base64,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","orcid":"","institution":"University Hospital \"General Calixto García\"","correspondingAuthor":true,"prefix":"","firstName":"Yamile","middleName":"Valdes","lastName":"Gonzalez","suffix":""},{"id":272541261,"identity":"ea5f836f-6990-4b03-848d-a49b72e68012","order_by":1,"name":"Damaris Hernández Véliz","email":"","orcid":"","institution":"Institute of Cardiology and Cardiovascular Surgery","correspondingAuthor":false,"prefix":"","firstName":"Damaris","middleName":"Hernández","lastName":"Véliz","suffix":""},{"id":272541262,"identity":"ea45a320-0673-4348-9ae4-189deb7af1b3","order_by":2,"name":"Nurys Armas Rojas","email":"","orcid":"","institution":"Institute of Cardiology and Cardiovascular Surgery","correspondingAuthor":false,"prefix":"","firstName":"Nurys","middleName":"Armas","lastName":"Rojas","suffix":""},{"id":272541263,"identity":"ee0c0a87-ddb4-4614-837e-a3d92b28f444","order_by":3,"name":"Reinaldo De la Noval García","email":"","orcid":"","institution":"Institute of Cardiology and Cardiovascular Surgery","correspondingAuthor":false,"prefix":"","firstName":"Reinaldo","middleName":"De la Noval","lastName":"García","suffix":""},{"id":272541264,"identity":"ea8ed64c-6072-4087-9bfd-b7e43277de69","order_by":4,"name":"Jennifer Ringrose","email":"","orcid":"","institution":"University of Alberta","correspondingAuthor":false,"prefix":"","firstName":"Jennifer","middleName":"","lastName":"Ringrose","suffix":""},{"id":272541265,"identity":"fe3fc1e0-f9f4-4451-90eb-03a58f3ef0ff","order_by":5,"name":"Raj Padwal","email":"","orcid":"https://orcid.org/0000-0003-3541-2817","institution":"University of Alberta","correspondingAuthor":false,"prefix":"","firstName":"Raj","middleName":"","lastName":"Padwal","suffix":""}],"badges":[],"createdAt":"2024-01-21 06:00:18","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3883748/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3883748/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1038/s41371-024-00948-9","type":"published","date":"2024-08-24T04:00:00+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":51096894,"identity":"64fe5e3a-1075-4b8d-a973-124adcf7345e","added_by":"auto","created_at":"2024-02-14 04:36:55","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":195695,"visible":true,"origin":"","legend":"\u003cp\u003eStandardized scatter plots of the differences in measurement and arm circumference for Systolic Pressure\u003c/p\u003e","description":"","filename":"Fig1.png","url":"https://assets-eu.researchsquare.com/files/rs-3883748/v1/16d950931bfbec8486eb7ae1.png"},{"id":51097191,"identity":"3891421e-8655-4c21-b9a8-fedbbdb1e822","added_by":"auto","created_at":"2024-02-14 04:44:55","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":194601,"visible":true,"origin":"","legend":"\u003cp\u003eStandardized scatter plots of the differences in measurement and arm circumference for Diastolic Pressure\u003c/p\u003e","description":"","filename":"Fig2.png","url":"https://assets-eu.researchsquare.com/files/rs-3883748/v1/430d625b1a8ef735891527e4.png"},{"id":51096892,"identity":"7fc05020-104b-41cf-80c4-3bfe30ac1db9","added_by":"auto","created_at":"2024-02-14 04:36:55","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":139260,"visible":true,"origin":"","legend":"\u003cp\u003eStandardized Bland-Altman scatter diagrams of the differences in Systolic BP of the Equipment - Reference against its average\u003c/p\u003e","description":"","filename":"Fig3.png","url":"https://assets-eu.researchsquare.com/files/rs-3883748/v1/1f3853a239da3aa0d8bdc069.png"},{"id":51096895,"identity":"96614d44-d58c-40e2-ab6e-031565e0c637","added_by":"auto","created_at":"2024-02-14 04:36:55","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":141684,"visible":true,"origin":"","legend":"\u003cp\u003eStandardized Bland-Altman scatter plots of the differences in Diastolic BP of the Equipment - Reference against its average\u003c/p\u003e","description":"","filename":"Fig4.png","url":"https://assets-eu.researchsquare.com/files/rs-3883748/v1/ccf0d8d86e85457cdcf87fb2.png"},{"id":63205971,"identity":"91796e68-dbd9-46f4-8116-4bffefa553cd","added_by":"auto","created_at":"2024-08-25 07:06:23","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":767857,"visible":true,"origin":"","legend":"","description":"","filename":"JHHTextValidationofHipermaxBFA7101reportV2.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3883748/v1_covered_ec25f3c0-a16d-4e91-a66d-d53f32606e6b.pdf"},{"id":51096891,"identity":"8cca5fec-edda-44aa-b8d3-f2877be22d01","added_by":"auto","created_at":"2024-02-14 04:36:55","extension":"xlsx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":19217,"visible":true,"origin":"","legend":"\u003cp\u003eTable 1. Participants recruited and excluded from the analysis. Characteristics of the participants (n=85)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 2. Distribution of baseline blood pressure measurements (Step 1-5, n=255)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 3. Compliance with the amendment of the standard on the distribution of arm diameters\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 4. 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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 \u003c 6.84 for PS and \u003c 6.89 for PD. 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