i-SENS NoCoding1 Plus, Руководство владельца

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Within Run Precision
*Bloodav 36 mg/dL (2.0 mmol/L) SD = 2.9 mg/dL (0.2 mmo/L)
*Bloodav 74 mg/dL (4.1 mmol/L) SD = 2.2 mg/dL (0.1 mmo/L)
*Bloodav 140 mg/dL (7.8 mmol/L) CV = 3.3%
*Bloodav 210 mg/dL (11.7 mmol/L) CV = 2.6%
*Bloodav 313 mg/dL (17.4 mmol/L) CV = 2.2%
Precision: The precision studies were performed in a laboratory
using NoCoding1 Plus BGM Systems.
Between Run Precision
*Controlav 35 mg/dL (2.2 mmol/L) SD = 1.5 mg/dL (0.1 mmol/L)
*Controlav 118 mg/dL (6.7 mmol/L) CV = 2.9%
*Controlav 328 mg/dL (17.7 mmol/L) CV = 3.3%
This study shows that there could be variation of up to 3.3%
Within ± 15 mg/dL (Within ± 0.83 mmol/L) and Within ± 15%
598/600 (99.7%)
System accuracy results for glucose concentrations between
28.7 mg/dL (1.6 mmol/L) and 486 mg/dL (27.0 mmol/L)
Packed Cell Volume (Hematocrit)
The hematocrit levels (15-65%) were tested to evaluate the effect of
hematocrit level on measurement of glucose concentration.
Range mg/dL (mmol/L) Average of difference (Hct 15-65%)
30 to 50 (1.7 to 2.8) -3.1 to 1.9 mg/dL (-0.2 to 0.1 mmol/L)
96 to 144 (5.3 to 8.0) -1.5 to 7.1%
280 to 420 (15.5 to 23.3) -5.4 to 1.1%
Difference Averages
NO Interferent
1 Acetaminophen -2.3 mg/dL (-0.1 mmo/L) -3.3%
2 Ascorbic acid 7.3 mg/dL (0.4 mmol/L) -0.9%
3 Bilirubin (unconjugated) -0.1 mg/dL (-0.01 mmol/L) 1.4%
4 Ceftriaxone 2.1 mg/dL (0.1 mmol/L) 2.4%
5 Cholesterol -1.3 mg/dL (-0.1 mmol/L) -1.8%
6 Creatinine 0.1 mg/dL (0.01 mmol/L) 0.7%
7
Dopamine 1.0 mg/dL (0.1 mmol/L) 0.4%
8 EDTA 1.1 mg/dL (0.1 mmol/L) 1.4%
9 Galactose -1.0 mg/dL (-0.1 mmol/L) -0.1%
10 Gentisic acid -1.0 mg/dL (-0.1 mmol/L) -4.4%
11 Glutathione(Red) -4.1 mg/dL (-0.2 mmol/L) 0.6%
12 Hemoglobin -0.1 mg/dL (-0.01 mmol/L) -0.5%
13 Heparin 1.1 mg/dL (0.1 mmol/L) 2.8%
14 Hydrocortisone 0.4 mg/dL (0.02 mmol/L) 1.9%
15 Ibuprofen -1.5 mg/dL (-0.1 mmol/L) 2.8%
16 Icodextrin -2.7 mg/dL (-0.2 mmol/L) -0.5%
Interval 1 Interval 2
50-100 mg/dL 250-350 mg/dL
(2.8-5.5 mmol/L) (13.9-19.4 mmol/L)
Interferences
The effect of various interfering substances was evaluated in
whole blood samples on glucose measurements.