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


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.


CONCLUSIONS
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.
aDepartment of Neurology bPrenatal Diagnosis Laboratory, Weifang People's Hospital, Weifang cDepartment of Cardiology, Mizhou Health Center, Zhucheng City, Shandong, China.
Yinghui
Y
Jiao
Qingfen
Q
Guan
Lili
L
Wu
Chengdong
C
Wang
Lingyun
L
Cao
D000328:Adult; D000368:Aged; D018660:Blood Pressure Monitoring, Ambulatory / Q000295:instrumentation* / Q000379:methods* / Q000592:standards; D015924:Blood Pressure Monitors; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic