Arkray Glucocard SHINE XL, User Manual

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Precision: Precision studies were performed in a
laboratory using the GLUCOCARD Shine XL Blood
Glucose Monitoring System
This study shows that there could be variation of up to 4.1 %.
Within Run Precision
Total Precision
SD = 1.2 mg/dL
CV = 2.4 %
CV = 2.3 %
SD = 1.9 mg/dL
SD = 3.2 mg/dL
CV = 4.1 %
CV = 2.6 %
CV = 2.8 %
35 mg/dL
116 mg/dL
324 mg/dL
38 mg/dL
86 mg/dL
125 mg/dL
189 mg/dL
334 mg/dL Blood avg.
Blood avg.
Blood avg.
Blood avg.
Blood avg.
Control avg.
Control avg.
Control avg.
Alternate Sites Testing Evaluation
Comparison of results using various AST sites with the results
of YSI measurements.
• Alternate site test results for glucose concentration
< 75 mg/dL
Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL
Fingertip
Forearm
Palm
Thigh
Calf 1/2 (50 %)
1/2 (50 %)
2/2 (100 %)
1/2 (50 %)
1/2 (50 %)
2/2 (100 %)
2/2 (100 %)
2/2 (100 %)
2/2 (100 %)
2/2 (100 %) 2/2 (100 %)
2/2 (100 %)
2/2 (100 %)
2/2 (100 %)
2/2 (100 %)
Test site