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Warranty Information
Manufacturer’s Warranty
i-SENS, Inc. warrants that the CareSens Dual Meter shall be free
of defects in material and workmanship in normal use for a
period of five (5) years. The meter must have been subjected to
normal use. The warranty does not cover improper handling,
tampering, use, or service of the meter. Any claim must be
made within the warranty period.
i-SENS will, at its discretion, repair or replace a defective meter
or meter part that is covered by this warranty. As a matter
of warranty policy, i-SENS will not reimburse the consumer’s
purchase price.
Obtaining Warranty Service
To obtain warranty service, you must return the defective
meter or meter part along with proof of purchase to your
nearest i-SENS sales or customer service representative.
β-Ketone
Accuracy:
The accuracy of the CareSens Dual Blood Glucose/
Blood
β
-Ketone System(Model: GM01HAC) was assessed
by comparing blood
β
-ketone results obtained by patients
with those obtained using a Randox Monaco, a laboratory
instrument.
Slope
1.012
Y-intercept
-0.0223
Correlation coefficient (r)
0.996
Number of tests
100
Range tested
0.015–7.2 mmol/L
Within Run Precision
Blood avg.
0.5 mmol/L
SD = 0.04 mmol/L
Blood avg.
1.4 mmol/L
SD = 0.05 mmol/L
Blood avg.
3.2 mmol/L
CV = 2.9%
Blood avg.
5.5 mmol/L
CV = 3.1%
Blood avg.
7.2 mmol/L
CV = 3.8%
Precision:
Precision studies were performed in a laboratory
using the CareSens Dual Blood
β
-Ketone Monitoring Systems.
Between Run Precision
Control avg. 0.7 mmol/L
SD = 0.05 mmol/L
Control avg. 2.4 mmol/L
CV = 4.0%
Control avg. 4.7 mmol/L
CV = 4.4%
This study shows that there could be a variation of up to 4.4%.
