The objective of this study was to validate the G.LAB MD2231 digital automatic wrist BP monitor according to multiple protocols, which included the European Society of Hypertension International Protocol (ESH-IP) revision 2010, the British Hypertension Society (BHS), and the Association for the Advancement of Medical Instrumentation (AAMI)/the International Organization for Standardization (ISO) protocols.
Participants and methods
A total of 33 participants were initially included for validation on the basis of the ESH-IP revision 2010, and then the device was further assessed on 85 participants according to the BHS and AAMI/ISO protocols. The validation procedures of the protocols were followed precisely.
The G.LAB MD2231 achieved the requirements of the ESH-IP revision 2010 with mean differences of 1.99±5.13 and −0.85±4.83 mmHg for systolic and diastolic BP, respectively. Furthermore, the A/A grade was obtained according to the BHS protocol with mean differences of 2.19±6.89 and −1.03±6.56 mmHg for systolic and diastolic BP, respectively, and the two criteria of the AAMI/ISO were also fulfilled.
The G.LAB MD2231 digital automatic wrist BP monitor fulfilled the ESH-IP revision 2010, the BHS, and the AAMI/ISO protocols, which can be recommended for BP measurement in the general population.