{"title":"验证欧姆龙 HEM-1026 (HCR-1901T2/HCR-1902T2)：根据通用协议验证家庭血压监测设备的准确性。","authors":"Hakuo Takahashi, Shingo Yamashita, Nobuki Yakura","doi":"10.2147/VHRM.S468382","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>The performance of Omron HEM-1026 (HCR-1901T2 / HCR-1902T2) for monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018+amendment (Amd)1:2020 protocol.</p><p><strong>Methods: </strong>The device was assessed in 101 participants who fulfilled the inclusion criteria, including arm circumference range and systolic and diastolic BP provided by the protocol. Data validation and analysis were performed according to the manufacturer's instructions.</p><p><strong>Results: </strong>In the ISO 81060-2:2018+Amd 1:2020 validation procedure (criterion 1), the mean ± standard deviation (SD) of the differences between the test device and reference BP was -2.1 ± 7.24/-0.6 ± 5.63 mmHg (systolic/diastolic). These data fulfilled the ISO81060-2:2018+Amd1:2020 requirement of ≤5±≤8 mmHg. The mean differences between the two observers and Omron HEM-1026 were -2.1 ± 5.71 mmHg for systolic BP and -0.6 ± 4.81 mmHg for diastolic BP, fulfilling criterion 2 with an SD of ≤ 6.62 for systolic BP and ≤ 6.91 for diastolic BP. The two ISO criteria were fulfilled.</p><p><strong>Conclusion: </strong>The Omron HEM-1026 BP monitor fulfilled the requirements of the ISO 81060-2:2018+Amd 1:2020 validation standard and can be recommended for home BP measurements in the general population.</p>","PeriodicalId":23597,"journal":{"name":"Vascular Health and Risk Management","volume":"20 ","pages":"333-339"},"PeriodicalIF":2.6000,"publicationDate":"2024-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11277893/pdf/","citationCount":"0","resultStr":"{\"title\":\"Validating the Accuracy of Omron HEM-1026 (HCR-1901T2/HCR-1902T2): Blood Pressure Monitoring Device at Home, According to the Universal Protocol.\",\"authors\":\"Hakuo Takahashi, Shingo Yamashita, Nobuki Yakura\",\"doi\":\"10.2147/VHRM.S468382\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>The performance of Omron HEM-1026 (HCR-1901T2 / HCR-1902T2) for monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018+amendment (Amd)1:2020 protocol.</p><p><strong>Methods: </strong>The device was assessed in 101 participants who fulfilled the inclusion criteria, including arm circumference range and systolic and diastolic BP provided by the protocol. Data validation and analysis were performed according to the manufacturer's instructions.</p><p><strong>Results: </strong>In the ISO 81060-2:2018+Amd 1:2020 validation procedure (criterion 1), the mean ± standard deviation (SD) of the differences between the test device and reference BP was -2.1 ± 7.24/-0.6 ± 5.63 mmHg (systolic/diastolic). These data fulfilled the ISO81060-2:2018+Amd1:2020 requirement of ≤5±≤8 mmHg. The mean differences between the two observers and Omron HEM-1026 were -2.1 ± 5.71 mmHg for systolic BP and -0.6 ± 4.81 mmHg for diastolic BP, fulfilling criterion 2 with an SD of ≤ 6.62 for systolic BP and ≤ 6.91 for diastolic BP. The two ISO criteria were fulfilled.</p><p><strong>Conclusion: </strong>The Omron HEM-1026 BP monitor fulfilled the requirements of the ISO 81060-2:2018+Amd 1:2020 validation standard and can be recommended for home BP measurements in the general population.</p>\",\"PeriodicalId\":23597,\"journal\":{\"name\":\"Vascular Health and Risk Management\",\"volume\":\"20 \",\"pages\":\"333-339\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2024-07-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11277893/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Vascular Health and Risk Management\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2147/VHRM.S468382\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Vascular Health and Risk Management","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/VHRM.S468382","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
Validating the Accuracy of Omron HEM-1026 (HCR-1901T2/HCR-1902T2): Blood Pressure Monitoring Device at Home, According to the Universal Protocol.
Purpose: The performance of Omron HEM-1026 (HCR-1901T2 / HCR-1902T2) for monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018+amendment (Amd)1:2020 protocol.
Methods: The device was assessed in 101 participants who fulfilled the inclusion criteria, including arm circumference range and systolic and diastolic BP provided by the protocol. Data validation and analysis were performed according to the manufacturer's instructions.
Results: In the ISO 81060-2:2018+Amd 1:2020 validation procedure (criterion 1), the mean ± standard deviation (SD) of the differences between the test device and reference BP was -2.1 ± 7.24/-0.6 ± 5.63 mmHg (systolic/diastolic). These data fulfilled the ISO81060-2:2018+Amd1:2020 requirement of ≤5±≤8 mmHg. The mean differences between the two observers and Omron HEM-1026 were -2.1 ± 5.71 mmHg for systolic BP and -0.6 ± 4.81 mmHg for diastolic BP, fulfilling criterion 2 with an SD of ≤ 6.62 for systolic BP and ≤ 6.91 for diastolic BP. The two ISO criteria were fulfilled.
Conclusion: The Omron HEM-1026 BP monitor fulfilled the requirements of the ISO 81060-2:2018+Amd 1:2020 validation standard and can be recommended for home BP measurements in the general population.
期刊介绍：
An international, peer-reviewed journal of therapeutics and risk management, focusing on concise rapid reporting of clinical studies on the processes involved in the maintenance of vascular health; the monitoring, prevention, and treatment of vascular disease and its sequelae; and the involvement of metabolic disorders, particularly diabetes. In addition, the journal will also seek to define drug usage in terms of ultimate uptake and acceptance by the patient and healthcare professional.
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