De Greeff Annemarie, Arora Jasleen, Hervey Simon, Liu Bing, Shennan Andrew H
Maternal and Fetal Research Unit, Division of Reproduction and Endocrinology, King's College London, North Wing, St Thomas' Hospital, Westminster Bridge Road, London, UK.
Blood Press Monit. 2008 Apr;13(2):111-6. doi: 10.1097/MBP.0b013e3282f3fb2e.
Noninvasive blood pressure (BP) measurement is dependent on either auscultation or oscillometry. The Tensoval duo control device uses auscultatory and/or oscillometric technology to determine BP. We evaluated the accuracy of this device in adults according to the British Hypertension Society (BHS) protocol and the International Protocol of the European Hypertension Society.
Ethical approval was obtained and participants gave written informed consent. Eighty-five participants who fulfilled the protocol criteria were recruited. Nine sequential same arm measurements were taken from each participant by two trained observers, comparing the device to mercury sphygmomanometery. Data analysis was performed according to the respective protocol guidelines.
The device achieved an A grade for both systolic and diastolic pressures with 68, 91 and 98% of systolic and 73, 91 and 98% of diastolic differences within the <or=5, <or=10 and <or=15 mmHg categories of the BHS protocol. It maintained an A/A grade throughout the low, medium and high-pressure analysis. It also achieved the requirements of the Association for the Advancement of Medical Instrumentation (ANSI/AAMI SP10 protocol) with a mean difference (SD) of -2.4 (6.0) mmHg for systolic and 0.9 (6.3) mmHg for diastolic pressure. It also passed all the phases of the International Protocol.
The Tensoval duo control can be recommended for clinical and home care use in an adult population according to the criteria of the BHS protocol and the International Protocol. It is the first fully automated BP device for self-measurement to maintain an A/A grade throughout the low, medium and high-pressure ranges.
无创血压测量依赖于听诊法或示波法。Tensoval duo control设备采用听诊和/或示波技术来测定血压。我们根据英国高血压学会（BHS）方案和欧洲高血压学会国际方案评估了该设备在成年人中的准确性。
获得伦理批准，参与者签署书面知情同意书。招募了85名符合方案标准的参与者。两名经过培训的观察者对每位参与者的同一手臂进行9次连续测量，将该设备与汞柱式血压计进行比较。根据各自的方案指南进行数据分析。
根据BHS方案，该设备在收缩压和舒张压方面均达到A级，收缩压差异在≤5、≤10和≤15 mmHg类别中的比例分别为68%、91%和98%，舒张压差异的比例分别为73%、91%和98%。在整个低、中、高压分析中，它均保持A/A级。它还达到了美国医疗仪器促进协会（ANSI/AAMI SP10方案）的要求，收缩压平均差异（标准差）为-2.4（6.0）mmHg，舒张压平均差异为0.9（6.3）mmHg。它还通过了国际方案的所有阶段。
根据BHS方案和国际方案的标准，Tensoval duo control可推荐用于成年人群的临床和家庭护理。它是首款在低、中、高压范围内均保持A/A级的全自动自我测量血压设备。
