Validation of the Pangao PG-800B11 blood pressure monitor according to the European Society of Hypertension and the British Hypertension Society protocols.

Objective 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. Materials and methods 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. Results 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). Conclusion 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. Blood Press Monit 19: 366-369 (C) 2014 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.