根据医疗器械进步协会/欧洲高血压学会/ISO 81060-2:2018协议,对JAMR F1701T(臂型)压力监测仪进行验证。

IF 16.4 1区 化学 Q1 CHEMISTRY, MULTIDISCIPLINARY
Jing Li, Li-Hong Han, Ru Feng, Li-Hao Wu, Jie Cai, Tian-Ying Zeng, Hui Liu, Ya-Wen Zeng, Li Zhou, Zhong-Qun Zhan
{"title":"根据医疗器械进步协会/欧洲高血压学会/ISO 81060-2:2018协议,对JAMR F1701T(臂型)压力监测仪进行验证。","authors":"Jing Li,&nbsp;Li-Hong Han,&nbsp;Ru Feng,&nbsp;Li-Hao Wu,&nbsp;Jie Cai,&nbsp;Tian-Ying Zeng,&nbsp;Hui Liu,&nbsp;Ya-Wen Zeng,&nbsp;Li Zhou,&nbsp;Zhong-Qun Zhan","doi":"10.1097/MBP.0000000000000643","DOIUrl":null,"url":null,"abstract":"<p><p>To validate the JAMR F1701T (arm type) blood pressure (BP) monitor according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). A total of 90 subjects (male 60 and female 30) were recruited to fulfill the criteria of the AAMI/ESH/ISO Universal Standard (the number, gender, age, limber size, and BP distribution), and sequential measurements of BP, including both SBP and DBP were obtained using the test device and the standard mercury sphygmomanometer. A total of 270 sets of comparison data (three sets of each subject) were obtained and analyzed. According to the validation criterion 1 of ISO 81060-2:2018, the mean ± SD of the differences between the JAMR F1701T and mercury sphygmomanometer BP (systolic/diastolic) readings was 2.06 ± 6.83/-4.84 ± 5.23 mmHg. For criterion 2, the SD of the averaged BP (systolic/diastolic) differences between the JAMR F1701 and reference BP (systolic/diastolic) per participant was 5.62/4.39 mmHg (the requirement was ≤6.43/5.01 mmHg by calculation). The JAMR F1701T met all the requirements of the ISO 81060-2:2018, and can be recommended for clinical and self/home use.</p>","PeriodicalId":1,"journal":{"name":"Accounts of Chemical Research","volume":null,"pages":null},"PeriodicalIF":16.4000,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6c/d2/bpmj-28-163.PMC10132453.pdf","citationCount":"0","resultStr":"{\"title\":\"Validation of the JAMR F1701T (arm type) pressure monitor according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/ISO 81060-2:2018 protocol.\",\"authors\":\"Jing Li,&nbsp;Li-Hong Han,&nbsp;Ru Feng,&nbsp;Li-Hao Wu,&nbsp;Jie Cai,&nbsp;Tian-Ying Zeng,&nbsp;Hui Liu,&nbsp;Ya-Wen Zeng,&nbsp;Li Zhou,&nbsp;Zhong-Qun Zhan\",\"doi\":\"10.1097/MBP.0000000000000643\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>To validate the JAMR F1701T (arm type) blood pressure (BP) monitor according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). A total of 90 subjects (male 60 and female 30) were recruited to fulfill the criteria of the AAMI/ESH/ISO Universal Standard (the number, gender, age, limber size, and BP distribution), and sequential measurements of BP, including both SBP and DBP were obtained using the test device and the standard mercury sphygmomanometer. A total of 270 sets of comparison data (three sets of each subject) were obtained and analyzed. According to the validation criterion 1 of ISO 81060-2:2018, the mean ± SD of the differences between the JAMR F1701T and mercury sphygmomanometer BP (systolic/diastolic) readings was 2.06 ± 6.83/-4.84 ± 5.23 mmHg. For criterion 2, the SD of the averaged BP (systolic/diastolic) differences between the JAMR F1701 and reference BP (systolic/diastolic) per participant was 5.62/4.39 mmHg (the requirement was ≤6.43/5.01 mmHg by calculation). The JAMR F1701T met all the requirements of the ISO 81060-2:2018, and can be recommended for clinical and self/home use.</p>\",\"PeriodicalId\":1,\"journal\":{\"name\":\"Accounts of Chemical Research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":16.4000,\"publicationDate\":\"2023-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6c/d2/bpmj-28-163.PMC10132453.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Accounts of Chemical Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/MBP.0000000000000643\",\"RegionNum\":1,\"RegionCategory\":\"化学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MULTIDISCIPLINARY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Accounts of Chemical Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/MBP.0000000000000643","RegionNum":1,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, MULTIDISCIPLINARY","Score":null,"Total":0}
引用次数: 0

摘要

根据医疗器械进步协会/欧洲高血压学会/国际标准化组织(AAMI/ESH/ISO)通用标准(ISO 81060-2:2018)验证JAMR F1701T(臂型)血压(BP)监测仪。共招募90名受试者(男60岁,女30岁),符合AAMI/ESH/ISO通用标准(人数、性别、年龄、肢体大小、血压分布),使用测试装置和标准水银血压计连续测量血压,包括收缩压和舒张压。共获得对比资料270组(每个受试者3组)并进行分析。根据ISO 81060-2:2018验证标准1,JAMR F1701T与汞柱血压计BP(收缩压/舒张压)读数差异的平均值±SD为2.06±6.83/-4.84±5.23 mmHg。对于标准2,每位参与者JAMR F1701与参考血压(收缩压/舒张压)之间的平均血压(收缩压/舒张压)差的SD为5.62/4.39 mmHg(计算要求≤6.43/5.01 mmHg)。JAMR F1701T符合ISO 81060-2:2018的所有要求,可推荐用于临床和自我/家庭使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Validation of the JAMR F1701T (arm type) pressure monitor according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/ISO 81060-2:2018 protocol.

Validation of the JAMR F1701T (arm type) pressure monitor according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/ISO 81060-2:2018 protocol.

Validation of the JAMR F1701T (arm type) pressure monitor according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/ISO 81060-2:2018 protocol.

To validate the JAMR F1701T (arm type) blood pressure (BP) monitor according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). A total of 90 subjects (male 60 and female 30) were recruited to fulfill the criteria of the AAMI/ESH/ISO Universal Standard (the number, gender, age, limber size, and BP distribution), and sequential measurements of BP, including both SBP and DBP were obtained using the test device and the standard mercury sphygmomanometer. A total of 270 sets of comparison data (three sets of each subject) were obtained and analyzed. According to the validation criterion 1 of ISO 81060-2:2018, the mean ± SD of the differences between the JAMR F1701T and mercury sphygmomanometer BP (systolic/diastolic) readings was 2.06 ± 6.83/-4.84 ± 5.23 mmHg. For criterion 2, the SD of the averaged BP (systolic/diastolic) differences between the JAMR F1701 and reference BP (systolic/diastolic) per participant was 5.62/4.39 mmHg (the requirement was ≤6.43/5.01 mmHg by calculation). The JAMR F1701T met all the requirements of the ISO 81060-2:2018, and can be recommended for clinical and self/home use.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Accounts of Chemical Research
Accounts of Chemical Research 化学-化学综合
CiteScore
31.40
自引率
1.10%
发文量
312
审稿时长
2 months
期刊介绍: Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信