title: Validation of the G.LAB MD2680 digital automatic blood pressure monitor according to international protocols.
abstract: OBJECTIVE
  The aim of this study was to validate the G.LAB MD2680 digital automatic blood pressure (BP) monitor according to major international protocols.
  
  
  METHODS
  The device was evaluated against auscultatory sphygmomanometry according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010, the British Hypertension Society (BHS), and the International Organization for Standardization (ISO) 81060-2:2013 protocols. Bland-Altman plots were completed for systolic (SBP) and diastolic blood pressures (DBP), and the mean differences and SDs between the test device and the reference device were computed for all BP values.
  
  
  RESULTS
  The G.LAB MD2680 passed the ESH-IP revision 2010 on 33 participants with a mean device-observer difference of 0.89±4.97 mmHg for SBP and 0.72±4.91 mmHg for DBP, respectively. The device achieved A/A grading for the BHS protocol among 85 participants with a device-observer difference of 0.70±6.35 mmHg for SBP and 0.62±6.41 mmHg for DBP, respectively. Furthermore, it also fulfilled the two criteria of the ISO 81060-2:2013 protocol.
  
  
  CONCLUSIONS
  The G.LAB MD2680 digital automatic BP monitor fulfilled the accuracy requirements of the ESH-IP revision 2010 and the ISO 81060-2:2013 protocols, and achieved A/A grade of the BHS protocol, and it can be recommended for self-measurement in adults.
authors.affiliation: Department of Cardiology, Cangzhou Central Hospital, Hebei Medical University, Cangzhou City, China.
authors.forename: Yan-Fen
authors.initials: YF
authors.lastname: Guo
authors.forename: Xiao-Qun
authors.initials: XQ
authors.lastname: Zhang
authors.forename: Jin-Ling
authors.initials: JL
authors.lastname: Fu
authors.forename: Xiao
authors.initials: X
authors.lastname: Zhang
authors.forename: Hou-Zhi
authors.initials: HZ
authors.lastname: Shan
authors.forename: Na
authors.initials: N
authors.lastname: Shi
authors.forename: Li-Qiu
authors.initials: LQ
authors.lastname: Yan
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001795:Blood Pressure Determination / Q000295:instrumentation* / Q000379:methods; D015924:Blood Pressure Monitors; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic