Evaluation of the overall efficacy of the Omron office digital blood pressure HEM-907 monitor in adults
Evaluation of the overall efficacy of the Omron office digital blood pressure HEM-907 monitor in adults
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DOI：
10.1097/00126097-200104000-00007
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发表时间：
2001-04-01
影响因子：
1.3
通讯作者：
Anwar, YA
中科院分区：
文献类型：
--
作者：
White, WB;Anwar, YA
背景无创自我血压监测已越来越受到人们的欢迎。为了确保用于此目的的设备的准确性，所有设备都需要在上市前进行独立验证。本研究的目的是评估HEM-907血压监测仪的准确性。HEM-907是一种新型的半自动、无创、示波血压监测仪，专门用于临床或医生办公室。方法将使用该仪器测量的血压与两名有经验的观察者使用汞血压计对100名受试者和患者进行测量(384次测量)进行比较。结果两位观察者对收缩压和舒张压的一致性分别为-0.36+/-2.32 mm Hg和0.02+/-2.42 mm Hg。该仪器与观察者对收缩压和舒张压的一致性分别为1.56+/-4.42 mm Hg和3.49+/-4.61 mm Hg。结论欧姆龙HEM-907符合美国医学会无创性血压监测仪的准确性标准。血压计Monit 6：107-110(C)2001 Lippincott Williams&Wilkins.
Background Non-invasive self blood pressure monitoring has become increasingly popular. To assure the accuracy of devices used for this purpose, all need to be validated independently prior to marketing. The objective of this study was to assess the accuracy of the HEM-907, a new semi-automatic, non-invasive, osciliometric blood pressure monitoring device specifically designed to be used in the clinic or physician's office setting.Methods Blood pressure measurements taken employing this device were compared with the results obtained by two experienced observers using a mercury sphygmomanometer on 100 subjects and patients (384 measurements). The limits of agreement were calculated for the device compared with the results of the two observers according to the standards of the Association for the Advancement of Medical instrumentation (AAMI).Results The agreement between the two observers was -0.36 +/- 2.32 mmHg for systolic blood pressure and 0.02 +/- 2.42 mmHg for diastolic blood pressure. The agreement between the device and the observers was 1.56 +/- 4.42 mmHg and 3.49 +/- 4.61 mmHg for systolic and diastolic blood pressure respectively.Conclusions The Omron HEM-907 satisfied the AAMI criteria for accuracy for a non-invasive blood pressure monitoring device. Blood Press Monit 6:107-110 (C) 2001 Lippincott Williams & Wilkins.