Validation of the G.LAB MD2231 digital automatic wrist blood pressure monitor according to multiple protocols

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Abstract

Objective

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.

Results

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.

Conclusion

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.

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