Validation of the fully automated Pangao PG-800B68 upper-arm device according to the European Society of Hypertension International Protocol revision 2010

ObjectiveThis study aimed to validate the fully automated Pangao PG-800B68 upper-arm device according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010.Materials and methodsSequential measurements of systolic blood pressure (SBP) and diastolic blood pressure (DBP) were obtained in 33 participants using the standard mercury sphygmomanometer and the test device. The ESH-IP revision 2010 was followed precisely and 99 pairings of test device and reference blood pressure measurements were obtained for analysis.ResultsThe number of blood pressure differences within 5, 10, and 15mmHg was 76, 95, and 98, respectively, for SBP and 79, 96, and 99, respectively, for DBP. The device achieved all the required criteria of the ESH-IP revision 2010 with a device-observer difference of -0.034.64mmHg for SBP and -0.64 +/- 4.50mmHg for DBP.ConclusionAccording to the validation results on the basis of the ESH-IP revision 2010, the Pangao PG-800B68 can be recommended for clinical use and self-measurement in adults.