Accuracy Evaluation of One Glucose Monitoring System ... | 合法醫療器材資訊網
由KJeon著作·2017·被引用1次—Inthisstudy,theB.BraunOmnitest®3BloodGlucoseMonitoringSystem(BGMS,InfopiaCo,Ltd,Anyang,RepublicofKorea)hasbeenevaluatedforaccuracyin ...
In this study, the B.Braun Omnitest® 3 Blood Glucose Monitoring System (BGMS, Infopia Co, Ltd, Anyang, Republic of Korea) has been evaluated for accuracy in accordance with ISO 15197:2013 standard.1 From October to November in 2015, this BGMS was evaluated at the Hanil General Hospital in a study conducted by the Institutional Review Board (approval KMC-2015-ME-003) and the notified authority. One hundred capillary blood samples measured by the BGMS were compared to plasma-equivalent glucose values of the fingertip blood samples measured by the YSI 2300 STAT Plus™ (YSI Life Sciences, Yellow Springs, OH, USA) glucose analyzer. Three lots of test strips were repeatedly tested by meters complying with ISO 15197:2013, and assessed the comparison of the results with the respective mean values of the reference measurements. Two meters per lot were tested with capillary whole blood collected from a finger...
Accuracy Evaluation of One Glucose Monitoring System ... | 合法醫療器材資訊網
Article as PDF | 合法醫療器材資訊網
B. Braun Omnitest Set of 3 Blood Glucose Monitor mg Black 1 ... | 合法醫療器材資訊網
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