Zijian Xie, Bin Peng, Jia Hu, Xinda Wang, Xiaoqin Du, Chaoya Li, Jiahui Liang
{"title":"根据 ISO 81060-2:2018 + Amd.1:2020 协议对 TMB-2285-BT 普通人群腕式血压计进行验证。","authors":"Zijian Xie, Bin Peng, Jia Hu, Xinda Wang, Xiaoqin Du, Chaoya Li, Jiahui Liang","doi":"10.1097/MBP.0000000000000724","DOIUrl":null,"url":null,"abstract":"<p><p>The objective of this study is to evaluate the accuracy of the wrist blood pressure (BP) monitor (TMB-2285-BT) in general population according to international standard of ISO 81060-2:2018+Amd.1:2020. The TMB-2285-BT BP monitor is an oscillometric device measuring BP from wrist. A single cuff for wrist sizes of 13.5-21.5 cm was used for the test device. The study was performed according to the 'International Standard (ISO 81060-2:2018 + Amd.1:2020) protocol' using the same-arm sequential BP measurement method. Subjects (n ≥ 85) fulfilling the age, gender, BP, and cuff distribution criteria of the protocol were enrolled. For criterion 1, the mean difference of SBP and DBP between the test device and the reference device was -0.27 mmHg and -0.80 mmHg, respectively. For criterion 2, the SD of the averaged paired determinations of SBP and DBP for the test device and the reference device was 2.60 and 2.06 mmHg, respectively, both of which were less than 6.95 and 6.89 mmHg. The accuracy of the test device fulfilled the requirements of the criterion 1 and 2 of ISO 81060-2:2018 + Amd.1:2020. The TMB-2285-BT wrist BP monitor can be recommended for home BP measurement for general population.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":null,"pages":null},"PeriodicalIF":1.2000,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Validation of TMB-2285-BT wrist blood pressure monitor in general population according to the ISO 81060-2:2018 + Amd.1:2020 Protocol.\",\"authors\":\"Zijian Xie, Bin Peng, Jia Hu, Xinda Wang, Xiaoqin Du, Chaoya Li, Jiahui Liang\",\"doi\":\"10.1097/MBP.0000000000000724\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The objective of this study is to evaluate the accuracy of the wrist blood pressure (BP) monitor (TMB-2285-BT) in general population according to international standard of ISO 81060-2:2018+Amd.1:2020. The TMB-2285-BT BP monitor is an oscillometric device measuring BP from wrist. A single cuff for wrist sizes of 13.5-21.5 cm was used for the test device. The study was performed according to the 'International Standard (ISO 81060-2:2018 + Amd.1:2020) protocol' using the same-arm sequential BP measurement method. Subjects (n ≥ 85) fulfilling the age, gender, BP, and cuff distribution criteria of the protocol were enrolled. For criterion 1, the mean difference of SBP and DBP between the test device and the reference device was -0.27 mmHg and -0.80 mmHg, respectively. For criterion 2, the SD of the averaged paired determinations of SBP and DBP for the test device and the reference device was 2.60 and 2.06 mmHg, respectively, both of which were less than 6.95 and 6.89 mmHg. The accuracy of the test device fulfilled the requirements of the criterion 1 and 2 of ISO 81060-2:2018 + Amd.1:2020. The TMB-2285-BT wrist BP monitor can be recommended for home BP measurement for general population.</p>\",\"PeriodicalId\":8950,\"journal\":{\"name\":\"Blood Pressure Monitoring\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2024-09-13\",\"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.0000000000000724\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"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.0000000000000724","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
Validation of TMB-2285-BT wrist blood pressure monitor in general population according to the ISO 81060-2:2018 + Amd.1:2020 Protocol.
The objective of this study is to evaluate the accuracy of the wrist blood pressure (BP) monitor (TMB-2285-BT) in general population according to international standard of ISO 81060-2:2018+Amd.1:2020. The TMB-2285-BT BP monitor is an oscillometric device measuring BP from wrist. A single cuff for wrist sizes of 13.5-21.5 cm was used for the test device. The study was performed according to the 'International Standard (ISO 81060-2:2018 + Amd.1:2020) protocol' using the same-arm sequential BP measurement method. Subjects (n ≥ 85) fulfilling the age, gender, BP, and cuff distribution criteria of the protocol were enrolled. For criterion 1, the mean difference of SBP and DBP between the test device and the reference device was -0.27 mmHg and -0.80 mmHg, respectively. For criterion 2, the SD of the averaged paired determinations of SBP and DBP for the test device and the reference device was 2.60 and 2.06 mmHg, respectively, both of which were less than 6.95 and 6.89 mmHg. The accuracy of the test device fulfilled the requirements of the criterion 1 and 2 of ISO 81060-2:2018 + Amd.1:2020. The TMB-2285-BT wrist BP monitor can be recommended for home BP measurement for 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.