1. Validation of the G.LAB MD2680 digital automatic blood pressure monitor according to international protocols
- Author
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Xiao Zhang, Jin-Ling Fu, Yan-Fen Guo, Hou-Zhi Shan, Na Shi, Li-Qiu Yan, and Xiao-Qun Zhang
- Subjects
Male ,medicine.medical_specialty ,Validation study ,020205 medical informatics ,02 engineering and technology ,030204 cardiovascular system & hematology ,Assessment and Diagnosis ,03 medical and health sciences ,0302 clinical medicine ,0202 electrical engineering, electronic engineering, information engineering ,Internal Medicine ,Humans ,Medicine ,Aged ,Aged, 80 and over ,Advanced and Specialized Nursing ,Blood pressure monitors ,business.industry ,Automatic blood pressure monitor ,Blood Pressure Determination ,General Medicine ,Middle Aged ,Blood Pressure Monitors ,Blood pressure ,Practice Guidelines as Topic ,Emergency medicine ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
The aim of this study was to validate the G.LAB MD2680 digital automatic blood pressure (BP) monitor according to major international protocols.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.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.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.
- Published
- 2017