Validation of the Omron 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol
Validation of the Omron 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol
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DOI：
10.1097/01.mbp.0000189788.05736.5f
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发表时间：
2006-02-01
影响因子：
1.3
通讯作者：
Shennan, A
中科院分区：
文献类型：
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作者：
Coleman, A;Freeman, P;Shennan, A
背景Omron 705 IT（HEM-759-E，Omron Corporation，京都，日本）是一种用于专业和家用市场的自动血压计式上臂血压监测器。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和协会的促进医疗仪器SP10 validation criteria.Methods研究参与者被招募，直到获得了85个，填补了血压类别指定的英国高血压协会协议。该研究的招募对象来自普通医疗和专科诊所以及英国伦敦的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获取9个同臂血压读数，在汞参考血压计和Omron 705 IT（HEM-759-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，与英国高血压协会和协会的医疗仪器的标准，以确定的outcome of the study.Results的进步欧姆龙705 IT（HEM-759-E）被评为“A”收缩压和“A”舒张压根据英国高血压协会的标准。观察者和器械测量值之间的差异平均值（标准差）分别为收缩压0.60（6-0）mmHg和舒张压-3.15（6.6）mmHg。该设备，因此，也满足协会的医疗器械SP10标准，要求小于+/- 5（8）mmHg.Conclusions的差异欧姆龙705 IT（HEM-759-E）实现了“A/A”的英国高血压协会的标准下的性能分类，并通过了协会的医疗器械的要求，为研究人群的进步。它可以推荐给成年人的专业和家庭使用。
Background The Omron 705IT (HEM-759-E, Omron Corporation, Kyoto, Japan) 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 and the Association for the Advancement of Medical Instrumentation SP10 validation criteria.Methods Study participants were recruited until a total of 85 were obtained that filled the blood pressure categories specified by the British Hypertension Society protocol. Recruitment to the study was from the general medical and specialist clinics and from the staff at Guy's & St Thomas' Hospital in London, UK. Nine sequential same-arm blood pressure readings were taken from each participant by two trained observers, alternating between mercury reference sphygmomanometers and the Omron 705IT (HEM-759-E). The differences between the reference and test device readings, for both systolic and diastolic pressures, were compared with British Hypertension Society and Association for the Advancement of Medical Instrumentation criteria to determine the outcome of the study.Results The Omron 705IT (HEM-759-E) is graded 'A' for systolic and 'A' for diastolic blood pressures according to the British Hypertension Society criteria. The mean (standard deviation) of the difference between the observer and the device measurements was 0.60 (6-0) mmHg for systolic and -3.15 (6.6) mmHg for diastolic pressures, respectively. The device, therefore, also satisfies the Association for the Advancement of Medical Instrumentation SP10 standard, that requires differences of less than +/- 5 (8) mmHg.Conclusions The Omron 705IT (HEM-759-E) achieved an 'A/A' performance classification under the British Hypertension Society criteria and passes the Association for the Advancement of Medical Instrumentation requirements for the study population. It can be recommended for professional and home-use in an adult population.