Zijian Xie, Li Zhu, Xiao Zheng, Chaoya Li, Jia Hu, Xinda Wang, Hua Deng, Xiaoqin Du, Jiahui Liang, Bin Peng
{"title":"根据 ISO 81060-2:2018 + Amd.1:2020 对 TMB-2296-BT 成人血压计进行验证。","authors":"Zijian Xie, Li Zhu, Xiao Zheng, Chaoya Li, Jia Hu, Xinda Wang, Hua Deng, Xiaoqin Du, Jiahui Liang, Bin Peng","doi":"10.1097/MBP.0000000000000728","DOIUrl":null,"url":null,"abstract":"<p><p>This study aimed to validate the accuracy of the test device (TMB-2296-BT) blood pressure (BP) monitor in adults according to International Standard Organization (ISO) 81060-2:2018 + Amd.1:2020 universal standard protocol, which is a digital monitor. Three trained observers used the same arm sequential method to compare the SBPs and DBPs measured by the test device with those measured by the reference device (mercury sphygmomanometer). For the test device with cuff ranging from 22 to 32 cm, there are 88 adults, with a male-to-female ratio of 35 : 53. The mean difference and SD between reference BPs and test device BPs readings were (0.21 ± 2.59)/(0.66 ± 2.12) mmHg for SBP/DBP for criterion 1, and (0.21 ± 2.07)/(0.66 ± 1.76) mmHg for SBP/DBP for criterion 2. For the test device with cuffs ranging from 22 to 42 cm, there are 87 adults, with a male-to-female ratio of 49 : 38. The mean difference and SD between reference BPs and test device BPs readings were (-1.62 ± 2.80)/(0.12 ± 3.01) mmHg for SBP/DBP for criterion 1, and (-1.62 ± 2.35)/(0.12 ± 2.60) mmHg for SBP/ DBP for criterion 2. And for the test device with cuff arm circumference sizes of 22-32 cm and 22-42 cm fulfilled both validation criterion 1 and 2 of the ISO 81060-2:2018 + Amd.1:2020 standard and can be recommended for both clinical and self/home BP measurement in adults.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":null,"pages":null},"PeriodicalIF":1.2000,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Validation of the TMB-2296-BT blood pressure monitor in adults according to the ISO 81060-2:2018 + Amd.1:2020.\",\"authors\":\"Zijian Xie, Li Zhu, Xiao Zheng, Chaoya Li, Jia Hu, Xinda Wang, Hua Deng, Xiaoqin Du, Jiahui Liang, Bin Peng\",\"doi\":\"10.1097/MBP.0000000000000728\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>This study aimed to validate the accuracy of the test device (TMB-2296-BT) blood pressure (BP) monitor in adults according to International Standard Organization (ISO) 81060-2:2018 + Amd.1:2020 universal standard protocol, which is a digital monitor. Three trained observers used the same arm sequential method to compare the SBPs and DBPs measured by the test device with those measured by the reference device (mercury sphygmomanometer). For the test device with cuff ranging from 22 to 32 cm, there are 88 adults, with a male-to-female ratio of 35 : 53. The mean difference and SD between reference BPs and test device BPs readings were (0.21 ± 2.59)/(0.66 ± 2.12) mmHg for SBP/DBP for criterion 1, and (0.21 ± 2.07)/(0.66 ± 1.76) mmHg for SBP/DBP for criterion 2. For the test device with cuffs ranging from 22 to 42 cm, there are 87 adults, with a male-to-female ratio of 49 : 38. The mean difference and SD between reference BPs and test device BPs readings were (-1.62 ± 2.80)/(0.12 ± 3.01) mmHg for SBP/DBP for criterion 1, and (-1.62 ± 2.35)/(0.12 ± 2.60) mmHg for SBP/ DBP for criterion 2. And for the test device with cuff arm circumference sizes of 22-32 cm and 22-42 cm fulfilled both validation criterion 1 and 2 of the ISO 81060-2:2018 + Amd.1:2020 standard and can be recommended for both clinical and self/home BP measurement in adults.</p>\",\"PeriodicalId\":8950,\"journal\":{\"name\":\"Blood Pressure Monitoring\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2024-10-04\",\"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.0000000000000728\",\"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.0000000000000728","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 the TMB-2296-BT blood pressure monitor in adults according to the ISO 81060-2:2018 + Amd.1:2020.
This study aimed to validate the accuracy of the test device (TMB-2296-BT) blood pressure (BP) monitor in adults according to International Standard Organization (ISO) 81060-2:2018 + Amd.1:2020 universal standard protocol, which is a digital monitor. Three trained observers used the same arm sequential method to compare the SBPs and DBPs measured by the test device with those measured by the reference device (mercury sphygmomanometer). For the test device with cuff ranging from 22 to 32 cm, there are 88 adults, with a male-to-female ratio of 35 : 53. The mean difference and SD between reference BPs and test device BPs readings were (0.21 ± 2.59)/(0.66 ± 2.12) mmHg for SBP/DBP for criterion 1, and (0.21 ± 2.07)/(0.66 ± 1.76) mmHg for SBP/DBP for criterion 2. For the test device with cuffs ranging from 22 to 42 cm, there are 87 adults, with a male-to-female ratio of 49 : 38. The mean difference and SD between reference BPs and test device BPs readings were (-1.62 ± 2.80)/(0.12 ± 3.01) mmHg for SBP/DBP for criterion 1, and (-1.62 ± 2.35)/(0.12 ± 2.60) mmHg for SBP/ DBP for criterion 2. And for the test device with cuff arm circumference sizes of 22-32 cm and 22-42 cm fulfilled both validation criterion 1 and 2 of the ISO 81060-2:2018 + Amd.1:2020 standard and can be recommended for both clinical and self/home BP measurement in adults.
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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