Bing Sen, Zhang Cunhai, Wang Liping, Li Linyi, Wan Yi
aDepartment of Cardiology, Second Hospital of Xi'an City bDepartment of Cardiology, Xi'an Honghui Hospital cDepartment of Cardiology, Xijing Hospital dSchool of Undergraduate eSchool of Public Health, Fourth Military Medical University, Xi'an fDepartment of Cardiology, 117 Hospital of PLA, Hangzhou, China.
Blood Press Monit. 2014 Dec;19(6):366-9. doi: 10.1097/MBP.0000000000000078.
The study aimed to determine the accuracy of the fully automated oscillometric upper-arm blood pressure (BP) monitor Pangao PG-800B11 according to the European Society of Hypertension-International Protocol (ESH-IP) revision 2010 and the British Hypertension Society (BHS) protocol 1993.
Data from 33 participants were initially examined according to the ESH-IP revision 2010. Furthermore, 52 participants were then enrolled to fulfill the BHS protocol requirements. In all participants, sequential left arm measurements were performed by two trained observers using a mercury sphygmomanometer and one supervisor using the device. The protocols' requirements were followed precisely.
The device passed all parts of the ESH protocol for systolic blood pressure (SBP) and diastolic blood pressure (DBP) and was graded A according to the criteria of the BHS protocol for both SBP and DBP. The A/A grade was achieved in low (<130/80 mmHg), medium (130-160/80-100 mmHg), and high (>160/100 mmHg) BP categories. The mean BP difference between PG-800B11 and observers in the 85 participants was -0.6±5.0 mmHg for SBP and -0.6±4.5 mmHg for DBP; thus, the device also fulfilled the requirements of the Association for the Advancement of Medical Instrumentation (AAMI).
The Pangao PG-800B11 passed all requirements of the ESH-IP revision 2010 and achieved A/A grade of the BHS protocol across a wide range of BPs.
本研究旨在根据2010年修订的欧洲高血压学会国际协议（ESH-IP）和1993年英国高血压学会（BHS）协议，确定全自动振荡式上臂血压计Pangao PG-800B11的准确性。
最初根据2010年修订的ESH-IP对33名参与者的数据进行了检查。此外，随后招募了52名参与者以满足BHS协议的要求。在所有参与者中，由两名经过培训的观察者使用汞柱式血压计依次测量左臂血压，一名监督者使用该设备进行测量。严格遵循协议要求。
该设备通过了ESH协议中收缩压（SBP）和舒张压（DBP）的所有部分，并且根据BHS协议的标准，SBP和DBP均被评为A级。在低（<130/80 mmHg）、中（130-160/80-100 mmHg）和高（>160/100 mmHg）血压类别中均达到了A/A级。85名参与者中，PG-800B11与观察者之间的平均血压差异为SBP -0.6±5.0 mmHg，DBP -0.6±4.5 mmHg；因此，该设备也满足了美国医疗仪器促进协会（AAMI）的要求。
Pangao PG-800B11通过了2010年修订的ESH-IP的所有要求，并在广泛的血压范围内达到了BHS协议的A/A级。
