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

Blood Press Monit. 2017 Aug;22(4):226-229. doi: 10.1097/MBP.0000000000000256.

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.

Publication types

  • Validation Study

MeSH terms

  • Adult
  • Aged
  • Blood Pressure Monitoring, Ambulatory / instrumentation*
  • Blood Pressure Monitoring, Ambulatory / methods*
  • Blood Pressure Monitoring, Ambulatory / standards
  • Blood Pressure Monitors*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Practice Guidelines as Topic