Alpert Bruce S
Department of Pediatrics, School of Medicine, University of Tennessee, Memphis, Tennessee, USA.
Blood Press Monit. 2004 Feb;9(1):19-23. doi: 10.1097/00126097-200402000-00005.
To test the Pharma-Smart Model PS-2000 public use blood pressure monitor for compliance with the Association for the Advancement of Medical Instrumentation's Standard (AAMI) and to a modified British Hypertension Society (BHS) Protocol.
Subjects tested ranged in age from 18-74, with the average age of 40. Arm circumference ranged from 22-38 cm. Resting systolic blood pressure (BP) ranged from 91-252 mmHg, and resting diastolic pressure ranged from 57-160 mmHg. There were 44 males, and 41 females. For each subject the readings obtained by the PS-2000 were compared with auscultatory readings obtained by two clinicians, blinded to the results of each other and the device. The manual reference measurements were alternated with the readings obtained by the device.
The average differences between the reference readings (average of the two clinicians) using the AAMI analysis and the automated readings were 0.07+/-7.0 mmHg (Mean+/-SD) for systolic BP, and -0.3+/-6.6 mmHg for diastolic BP.
The device met the accuracy requirements of the AAMI standard. In addition, when the data were analyzed to assess the compliance with the current British Hypertension Society Protocol (BHS), the device earned the highest rating of 'A' for both systolic and diastolic pressure. We believe that the Pharma-Smart PS-2000 will provide valid readings when placed in non-medical public use sites.
测试Pharma-Smart Model PS-2000型公众使用的血压监测仪是否符合美国医学仪器促进协会标准（AAMI）以及修改后的英国高血压学会协议。
受试对象年龄在18至74岁之间，平均年龄为40岁。臂围在22至38厘米之间。静息收缩压范围为91至252毫米汞柱，静息舒张压范围为57至160毫米汞柱。男性44名，女性41名。对于每位受试者，将PS-2000获得的读数与两名临床医生获得的听诊读数进行比较，这两名临床医生彼此不知对方及该设备的结果。手动参考测量与设备获得的读数交替进行。
使用AAMI分析的参考读数（两名临床医生的平均值）与自动读数之间的平均差异，收缩压为0.07±7.0毫米汞柱（均值±标准差），舒张压为-0.3±6.6毫米汞柱。
该设备符合AAMI标准的准确性要求。此外，在分析数据以评估是否符合当前英国高血压学会协议（BHS）时，该设备在收缩压和舒张压方面均获得了最高等级“A”。我们认为，Pharma-Smart PS-2000放置在非医疗公共场所时将能提供有效的读数。
