{"title":"根据 AAMI/ESH/ISO 通用标准（ISO 81060-2:2018+AMD1:2020），验证 iHealth Track 上臂式血压计 KN-550BT 在普通人群中的应用。","authors":"Lei Shi, Xin-Yi Zhang, Jia-Yi Sun, Jin-Feng Chen, Yi-Fei Ma, Kai-Yuan Zhou","doi":"10.1097/MBP.0000000000000678","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To validate the iHealth Track KN-550BT oscillometric upper-arm blood pressure monitor in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020).</p><p><strong>Methods: </strong>Participants were recruited and the same left-arm sequential method was used for blood pressure measurement according to the ISO 81060-2:2018+AMD1:2020. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference results.</p><p><strong>Results: </strong>A total of 89 qualified participants were included in the final analysis. For the validation Criterion 1, the mean ± SD of the differences between the test device and reference readings was -1.22 ± 5.76 mmHg and -0.08 ± 4.40 mmHg for systolic and diastolic blood pressure, respectively. For Criterion 2, the mean ± SD of the differences between the test device and reference readings per participant was -1.22 ± 5.06 mmHg and -0.08 ± 3.84 mmHg for systolic and diastolic blood pressure, respectively.</p><p><strong>Conclusion: </strong>The iHealth Track KN-550BT upper-arm blood pressure monitor passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020) and can be recommended for clinical use and self-measurement in general population.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":null,"pages":null},"PeriodicalIF":1.2000,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Validation of the iHealth Track upper-arm blood pressure monitor KN-550BT in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020).\",\"authors\":\"Lei Shi, Xin-Yi Zhang, Jia-Yi Sun, Jin-Feng Chen, Yi-Fei Ma, Kai-Yuan Zhou\",\"doi\":\"10.1097/MBP.0000000000000678\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To validate the iHealth Track KN-550BT oscillometric upper-arm blood pressure monitor in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020).</p><p><strong>Methods: </strong>Participants were recruited and the same left-arm sequential method was used for blood pressure measurement according to the ISO 81060-2:2018+AMD1:2020. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference results.</p><p><strong>Results: </strong>A total of 89 qualified participants were included in the final analysis. For the validation Criterion 1, the mean ± SD of the differences between the test device and reference readings was -1.22 ± 5.76 mmHg and -0.08 ± 4.40 mmHg for systolic and diastolic blood pressure, respectively. For Criterion 2, the mean ± SD of the differences between the test device and reference readings per participant was -1.22 ± 5.06 mmHg and -0.08 ± 3.84 mmHg for systolic and diastolic blood pressure, respectively.</p><p><strong>Conclusion: </strong>The iHealth Track KN-550BT upper-arm blood pressure monitor passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020) and can be recommended for clinical use and self-measurement in general population.</p>\",\"PeriodicalId\":8950,\"journal\":{\"name\":\"Blood Pressure Monitoring\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2024-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Blood Pressure Monitoring\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/MBP.0000000000000678\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/9/14 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Blood Pressure Monitoring","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/MBP.0000000000000678","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/9/14 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
Validation of the iHealth Track upper-arm blood pressure monitor KN-550BT in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020).
Objective: To validate the iHealth Track KN-550BT oscillometric upper-arm blood pressure monitor in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020).
Methods: Participants were recruited and the same left-arm sequential method was used for blood pressure measurement according to the ISO 81060-2:2018+AMD1:2020. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference results.
Results: A total of 89 qualified participants were included in the final analysis. For the validation Criterion 1, the mean ± SD of the differences between the test device and reference readings was -1.22 ± 5.76 mmHg and -0.08 ± 4.40 mmHg for systolic and diastolic blood pressure, respectively. For Criterion 2, the mean ± SD of the differences between the test device and reference readings per participant was -1.22 ± 5.06 mmHg and -0.08 ± 3.84 mmHg for systolic and diastolic blood pressure, respectively.
Conclusion: The iHealth Track KN-550BT upper-arm blood pressure monitor passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020) and can be recommended for clinical use and self-measurement in general population.
期刊介绍：
Blood Pressure Monitoring is devoted to original research in blood pressure measurement and blood pressure variability. It includes device technology, analytical methodology of blood pressure over time and its variability, clinical trials - including, but not limited to, pharmacology - involving blood pressure monitoring, blood pressure reactivity, patient evaluation, and outcomes and effectiveness research.
This innovative journal contains papers dealing with all aspects of manual, automated, and ambulatory monitoring. Basic and clinical science papers are considered although the emphasis is on clinical medicine.
Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.
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