Anwar YA, Giacco S, McCabe EJ, Tendler BE, White WB
Section of Hypertension and Clinical Pharmacology, University of Connecticut School of Medicine, Farmington, Connecticut, USA.
Blood Press Monit. 1998 Aug;3(4):261-265.
Automatic noninvasive blood pressure measuring devices should be independently validated prior to marketing by using standard guidelines such as those published by the Association for the Advancement of Medical Instrumentation and British Hypertension Society. OBJECTIVE: To assess a new noninvasive oscillometric automatic home blood pressure (Omron HEM-737 IntelliSense; Omron Healthcare Inc., Vernon Hills, Illinois, USA). METHODS: We compared the device's measurements with mercury column measurements for 90 subjects (270 measurements). In addition to calculation of the limits of agreement for the device versus observers, we also dtermined the impacts of age, level of blood pressure, body mass, and arm size on the levels of agreement. RESULTS: Observers showed that close agreement was attained, with mean differences of 0.42 +/- 3.65 mmHg for systolic blood pressure and 0.37 +/- 3.59 mmHg for diastolic blood pressure. The proportions of values agreeing to within 5, 10, and 15 mmHg were 88, 99, and 100% for systolic and 86, 100, and 100% for diastolic blood pressure for the two obsevers. The observer-device disagreement was 0.76 +/- 6.55 mmHg for systolic and 1.0 +/- 5.5 mmHg for diastolic blood pressure. The proportions of values agreeing to within 5, 10, and 15 mmHg were 71, 93, and 97% for systolic and 77, 96, and 98% for diastolic blood pressure for the observers and device. CONCLUSIONS: The Omron HEM-737 IntelliSense satisfied the Association for the Advancement of Medical Instrumentation's criteria for a general adult population across large ranges of age, blood pressure, body mass, and arm circumference. These findings support the use of this recorder for out-of-office self-monitoring of blood pressure.
自动无创血压测量设备在上市前应依据标准指南（如美国医疗仪器促进协会和英国高血压学会发布的指南）进行独立验证。目的：评估一种新型无创示波法自动家用血压计（欧姆龙HEM - 737智能型；美国伊利诺伊州弗农山的欧姆龙医疗保健公司）。方法：我们将该设备的测量结果与90名受试者（270次测量）的汞柱血压测量结果进行了比较。除了计算该设备与观察者之间的一致性界限外，我们还确定了年龄、血压水平、体重和手臂尺寸对一致性水平的影响。结果：观察者显示一致性良好，收缩压平均差异为0.42±3.65 mmHg，舒张压平均差异为0.37±3.59 mmHg。两位观察者的收缩压在5、10和15 mmHg范围内一致的比例分别为88%、99%和100%，舒张压分别为86%、100%和100%。观察者与设备之间的收缩压差异为0.76±6.55 mmHg，舒张压差异为1.0±5.5 mmHg。观察者与设备的收缩压在5、10和15 mmHg范围内一致的比例分别为71%、93%和97%，舒张压分别为77%、96%和98%。结论：欧姆龙HEM - 737智能型满足了美国医疗仪器促进协会针对广大年龄、血压、体重和臂围范围的一般成年人群的标准。这些发现支持使用该记录仪进行门诊外血压自我监测。
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