i-SENS CareSens N Pop, Руководство владельца

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Precision: The precision studies were performed in a laboratory
using CareSens N POP Blood Glucose Monitoring Systems.
Within Run Precision
*Blood avg. 2.1 mmol/L SD = 0.1 mmol/L
*Blood avg. 4.6 mmol/L SD = 0.2 mmol/L
*Blood avg. 6.9 mmol/L CV = 3.0%
*Blood avg. 11.7 mmol/L CV = 3.2%
*Blood avg. 17.1 mmol/L CV = 2.6%
Total Precision
*Control avg. 2.1 mmol/L SD = 0.1 mmol/L
*Control avg. 6.6 mmol/L CV = 3.8%
*Control avg. 17.4 mmol/L CV = 3.3%
This study shows that there could be variation of up to 3.8%.
Packed Cell Volume (Hematocrit)
The hematocrit levels (15–65%) were tested to evaluate
the effect of hematocrit level on measurement of glucose
concentration.
Range (mmol/L) Average of difference (Hct 15–65%)
1.7 to 2.8 -0.2–0.1 mmol/L
5.3 to 8.0 -1.5–7.1%
15.5 to 23.3 -5.4–1.1%
Difference Averages
No. Interferent
1 Acetaminophen -0.1 mmol/L -3.3%
2 Ascorbic acid 0.4 mmol/L -0.9%
3 Bilirubin (unconjugated) -0.01 mmol/L 1.4%
4 Ceftriaxone 0.1 mmol/L 2.4%
5 Cholesterol -0.1 mmol/L -1.8%
6 Creatinine 0.01 mmol/L 0.7%
7 Dopamine 0.1 mmol/L 0.4%
8 EDTA 0.1 mmol/L 1.4%
9 Galactose -0.1 mmol/L -0.1%
10
Gentisic acid -0.1 mmol/L -4.4%
11 Glutathione (Red) -0.2 mmol/L 0.6%
12 Hemoglobin -0.01 mmol/L -0.5%
13 Heparin 0.1 mmol/L 2.8%
14 Hydrocortisone 0.02 mmol/L 1.9%
15 Ibuprofen -0.1 mmol/L 2.8%
16 Icodextrin -0.2 mmol/L -0.5%
Interval1 Interval 2
(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.