{"title":"根据ISO 81060-2:2018/AMD 1:2020协议，在普通人群中验证U60EH腕戴式电子血压计。","authors":"Sicong Mu, Min Zhu, Liping Ma, Lixiu Fang","doi":"10.1097/MBP.0000000000000659","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the accuracy of the U60EH Wrist Electronic Blood Pressure Monitor in general population according to the Universal Standard (ISO 81060-2:2018/AMD 1:2020).</p><p><strong>Methods: </strong>Subjects were recruited to fulfill the age, gender, blood pressure (BP) and cuff distribution criteria of the Universal Standard in a general population using the same arm sequential BP measurement method. A single cuff for wrist sizes 13.5-21.5 cm was used on this test device.</p><p><strong>Results: </strong>According to Criterion 1, the mean difference of SBP between the test device and the reference device was 1.51 mmHg, with an SD of 6.48 mmHg. The mean difference of DBP was -0.44 mmHg, with an SD of 5.98 mmHg. The mean difference of both SBP and DBP was less than 5 mmHg, and the SD was less than 8 mmHg, which met the requirements. According to Criterion 2, the mean difference of SBP between the test device and the reference device was 1.51 mmHg, and the SD was 5.88 mmHg, which was less than 6.78 mmHg and met the requirements. The mean difference of DBP was -0.44 mmHg, and the SD was 5.22 mmHg, which was less than 6.93 mmHg and met the requirements.</p><p><strong>Conclusion: </strong>All results passed the Standard (ISO 81060-2:2018/AMD 1:2020) requirements. The U60EH Wrist Electronic Blood Pressure Monitor can be recommended for home and clinical use.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":"28 5","pages":"280-283"},"PeriodicalIF":1.2000,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/46/13/bpmj-28-280.PMC10484183.pdf","citationCount":"0","resultStr":"{\"title\":\"Validation of the U60EH Wrist Electronic Blood Pressure Monitor in general population according to the ISO 81060-2:2018/AMD 1:2020 Protocol.\",\"authors\":\"Sicong Mu, Min Zhu, Liping Ma, Lixiu Fang\",\"doi\":\"10.1097/MBP.0000000000000659\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To evaluate the accuracy of the U60EH Wrist Electronic Blood Pressure Monitor in general population according to the Universal Standard (ISO 81060-2:2018/AMD 1:2020).</p><p><strong>Methods: </strong>Subjects were recruited to fulfill the age, gender, blood pressure (BP) and cuff distribution criteria of the Universal Standard in a general population using the same arm sequential BP measurement method. A single cuff for wrist sizes 13.5-21.5 cm was used on this test device.</p><p><strong>Results: </strong>According to Criterion 1, the mean difference of SBP between the test device and the reference device was 1.51 mmHg, with an SD of 6.48 mmHg. The mean difference of DBP was -0.44 mmHg, with an SD of 5.98 mmHg. The mean difference of both SBP and DBP was less than 5 mmHg, and the SD was less than 8 mmHg, which met the requirements. According to Criterion 2, the mean difference of SBP between the test device and the reference device was 1.51 mmHg, and the SD was 5.88 mmHg, which was less than 6.78 mmHg and met the requirements. The mean difference of DBP was -0.44 mmHg, and the SD was 5.22 mmHg, which was less than 6.93 mmHg and met the requirements.</p><p><strong>Conclusion: </strong>All results passed the Standard (ISO 81060-2:2018/AMD 1:2020) requirements. The U60EH Wrist Electronic Blood Pressure Monitor can be recommended for home and clinical use.</p>\",\"PeriodicalId\":8950,\"journal\":{\"name\":\"Blood Pressure Monitoring\",\"volume\":\"28 5\",\"pages\":\"280-283\"},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2023-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/46/13/bpmj-28-280.PMC10484183.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Blood Pressure Monitoring\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/MBP.0000000000000659\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/7/19 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.0000000000000659","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/7/19 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
Validation of the U60EH Wrist Electronic Blood Pressure Monitor in general population according to the ISO 81060-2:2018/AMD 1:2020 Protocol.
Objective: To evaluate the accuracy of the U60EH Wrist Electronic Blood Pressure Monitor in general population according to the Universal Standard (ISO 81060-2:2018/AMD 1:2020).
Methods: Subjects were recruited to fulfill the age, gender, blood pressure (BP) and cuff distribution criteria of the Universal Standard in a general population using the same arm sequential BP measurement method. A single cuff for wrist sizes 13.5-21.5 cm was used on this test device.
Results: According to Criterion 1, the mean difference of SBP between the test device and the reference device was 1.51 mmHg, with an SD of 6.48 mmHg. The mean difference of DBP was -0.44 mmHg, with an SD of 5.98 mmHg. The mean difference of both SBP and DBP was less than 5 mmHg, and the SD was less than 8 mmHg, which met the requirements. According to Criterion 2, the mean difference of SBP between the test device and the reference device was 1.51 mmHg, and the SD was 5.88 mmHg, which was less than 6.78 mmHg and met the requirements. The mean difference of DBP was -0.44 mmHg, and the SD was 5.22 mmHg, which was less than 6.93 mmHg and met the requirements.
Conclusion: All results passed the Standard (ISO 81060-2:2018/AMD 1:2020) requirements. The U60EH Wrist Electronic Blood Pressure Monitor can be recommended for home and clinical use.
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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