Coleman Andrew, Steel Stephen, deGreeff Annemarie, Shennan Andrew
Medical Physics Department, Guy's & St Thomas' NHS Foundation Trust.
Blood Press Monit. 2010 Jun;15(3):163-6. doi: 10.1097/MBP.0b013e32833713cf.
The BP11 is currently one of the lowest-cost blood pressure (BP) monitors available in the UK and has sold approximately 1.5 million units since its launch in 2006. As access to home-use BP monitoring increases, it is important that such devices are validated so that consumers and clinicians can be confident of their accuracy.
The device was validated using the European Society of Hypertension International Protocol. Data collection and analysis were carried out under the laboratory standard ISO17025. Adherence to the standard and protocol was audited on-site by the United Kingdom Accreditation Service. Nine sequential same-arm measurements were taken alternating between trained observers and the test device. Minor variations from the protocol are reported.
The device passed both phases of the European Society of Hypertension International Protocol. The mean (standard deviation) of the difference between the observers and the device measurements was -1.2 (6.4) mmHg for systolic and 2.1 (6.8) mmHg for diastolic pressures, respectively.
The BP11 BP monitor can be recommended for home and professional use in an adult population.
BP11是目前英国市场上成本最低的血压监测仪之一，自2006年推出以来已售出约150万台。随着家用血压监测的普及，确保此类设备的准确性对于消费者和临床医生至关重要。
该设备依据欧洲高血压学会国际协议进行验证。数据收集和分析按照实验室标准ISO17025开展。英国认可服务局对标准和协议的遵循情况进行现场审核。由经过培训的观察员和测试设备交替进行九次连续的同侧测量。报告了与协议的细微差异。
该设备通过了欧洲高血压学会国际协议的两个阶段。观察者与设备测量值之间差异的平均值（标准差），收缩压为-1.2（6.4）mmHg，舒张压为2.1（6.8）mmHg。
BP11血压监测仪可推荐用于成人家庭和专业使用。
