A. Menarini Diagnostics GlucoMen Day Meter, Руководство пользователя

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/ 10 Performance Characteristics
The performance of GlucoMen
®
Day METER Blood Glucose Monito-
ring System has been evaluated in laboratory and in clinical tests
following ISO 15197:2013 (EN ISO 15197:2015).
System accuracy results for glucose concentration
< 5.55 mmol/L
/ 10.1 Accuracy
The accuracy of the GlucoMen
®
Day METER system was assessed
by comparing blood glucose results obtained by patients with those
obtained using a YSI Model 2300 Glucose Analyzer, a laboratory
instrument. The following results were obtained by diabetic patients
at clinic centres.
Within ± 0.28 mmol/L Within ± 0.56 mmol/L Within ± 0.83 mmol/L
117/186 (62.9 %) 181/186 (97.3 %) 186/186 (100 %)
System accuracy results for glucose concentration
≥ 5.55 mmol/L
Within ± 5 % Within ± 10 % Within ± 15 %
207/414 (50 %) 375/414 (90.6 %) 413/414 (99.8 %)
System accuracy results for glucose concentrations between
2.1 mmol/L and 29.5 mmol/L
Within ± 0.83 mmol/L and Within ± 15 %
599/600 (99.8%)
/ 10.2 Packed Cell Volume (Haematocrit)
The haematocrit levels (15-65 %) were successfully tested to eva-
luate the effect of haematocrit level on measurement of glucose
concentration.
/ 10.3 Precision
The precision studies were performed in a laboratory using Gluco-
Men
®
Day METER system.
Within Run Precision
*Bloodav 2.1 mmol/L SD = 0.1 mmol/L
*Bloodav 4.2 mmol/L SD = 0.1 mmol/L
*Bloodav 7.2 mmol/L CV = 3.4 %
*Bloodav 11.4 mmol/L CV = 3.2 %
*Bloodav 17.9 mmol/L CV = 3.0 %
This study shows that there could be variation of up to 3.4 %.
Between Run Precision
*Controlav 2.2 mmol/L SD = 0.1 mmol/L
*Controlav 6.4 mmol/L CV = 2.9 %
*Controlav 19.3 mmol/L CV = 3.0 %