Validation of the Omron M7 (HEM-780-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol
Validation of the Omron M7 (HEM-780-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol
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DOI：
10.1097/mbp.0b013e3282cb57b6
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发表时间：
2008-02-01
影响因子：
1.3
通讯作者：
Shennan, Andrew
中科院分区：
文献类型：
--
作者：
Coleman, Andrew;Steel, Stephen;Shennan, Andrew
背景Omron M7（HEM-780-E）是一款用于专业和家用市场的自动血压计式上臂血压监测仪。本研究的目的是验证该设备的准确性，根据英国高血压协会（BHS）和协会的促进医疗器械（AAMI）SP10 validation criteria.Methods参与者被招募，直到获得了85个，填补了血压范围指定的BHS协议。本研究的招募对象来自普通医疗和专科诊所以及英国伦敦盖伊和圣托马斯医院的工作人员。由两名受过训练的观察员从每位参与者身上连续取9个同臂血压读数，在汞参考血压计和Omron M7（HEM-780-E）之间交替。收缩压和舒张压的参考和测试设备读数之间的差异，与BHS和AAMI标准进行比较，以确定研究的结果。结果欧姆龙M7（HEM-780-E）是分级为'A'的收缩压和'A'的舒张压根据BHS标准。观察者和器械测量值之间的差异的平均值（标准差）为收缩压0.75 +/- 6.5 mmHg，舒张压1.33 +/- 5 mmHg。因此，该设备也满足AAMI SP10标准的研究人群，这需要的差异< +/- 5（8）mmHg.Conclusion欧姆龙M7（HEM-780-E）达到了“A/A”的BHS标准下的性能分类，并通过了AAMI要求的研究人群。它可以被推荐用于专业和家庭使用在这个人群中。
Background The Omron M7 (HEM-780-E) is an automated oscillometric upper arm blood pressure monitor for the professional and home use markets. The aim of this study was to validate the accuracy of this device according to the British Hypertension Society (BHS) and the Association for the Advancement of Medical Instrumentation (AAMI) SP10 validation criteria.Methods Participants were recruited until a total of 85 were obtained that filled the blood pressure ranges specified by the BHS protocol. Recruitment to the study was from the general medical and specialist clinics and from the staff at Guy's and St Thomas' Hospital in London, UK. Nine sequential same-arm blood pressure readings were taken from each participant by two trained observers, alternating between a mercury reference sphygmomanometer and the Omron M7 (HEM-780-E). The differences between the reference and test device readings, for both systolic and diastolic pressures, were compared with BHS and AAMI criteria to determine the outcome of the study.Results The Omron M7 (HEM-780-E) is graded 'A' for systolic and 'A' for diastolic blood pressures according to the BHS criteria. The mean (standard deviation) of the difference between the observer and the device measurements was 0.75 +/- 6.5) mmHg for systolic and 1.33 +/- 5 mmHg for diastolic pressures. The device, therefore, also satisfies the AAMI SP10 standard for the study population, which requires differences of < +/- 5 (8) mmHg.Conclusion The Omron M7 (HEM-780-E) achieved an 'A/A' performance classification under the BHS criteria and passed the AAMI requirements for the study population. It can be recommended for professional and home-use in this population.