EPS Bio Technology EASYMAX Tag User Manual page 52

In comparison to the YSI, the EASYMAX® Tag met the ISO 15197:2013 (EN ISO 15197:2015)
standard, whereby 95% of the blood glucose values measured have to fall within the following
zones: either ±0.83 mmol/L (±15 mg/dL) of the measured average value when using the
reference measuring procedure for blood glucose concentrations <100 mg/dL (<5.55 mmol/L) or
±15% for blood glucose concentrations of ≧100 mg/dL (≧5.55 mmol/L). 99% of the individual
measured blood glucose values must fall within zones A and B of the Consensus Error Grid
(CEG) for diabetes type 1.
Performance evaluation by the user
A study to assess the glucose values of blood samples of capillary blood from the fingertips,
which were obtained from 103 individuals that had no special training, produced the following
results: 96.7% within ±15mg/dL (± 0.83 mmol/L) and 95.9% within ± 15% of the values obtained
in the medical laboratory with glucose concentrations of at least 100 mg/dL (5.55 mmol/L).
You will find further details and information regarding blood glucose results and various
technologies in generally relevant specialist medical literature.
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