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Important Information: Read This First!
For optimum safety and benefits, please read the entire manual
contents before using the system. Please note the following
instructions:
Intended use:
KetoSens Blood
β
-Ketone Monitoring System is used for the
quantitative measurement of the
β
-Ketone level in capillary/
venous whole blood as an aid in monitoring diabetic ketoacidosis
management effectively at home or in clinical settings.
Fresh venous whole blood may be used only if drawn by healthcare
professionals.
KetoSens Blood
β
-Ketone Monitoring System should be used only
for self-testing outside the body (
in vitro
diagnostic use only). Test
blood
β
-Ketone in fresh capillary/venous whole blood samples
from the traditional fingertip testing.
•
The KetoSens Blood
β
-Ketone Monitoring System is
intended for self-testing outside the body (
in vitro
diagnostic use).
•
β
-Ketone in blood samples reacts with the chemical
in the test strip to produce a small electrical current.
The KetoSens meter detects this electrical current and
measures the amount of
β
-Ketone in the blood sample.
•
The KetoSens Blood
β
-Ketone Meter is designed to
minimise code related errors in monitoring by using the
no-coding function.
•
The KetoSens Blood
β
-Ketone Meter should be used only
with the KetoSens Test Strips.
• An abnormally high or low red blood cell count (hematocrit
level over 60 % or below 30 %) may produce inaccurate
results.
• Critically ill patients should not be tested with blood
β
-Ketone meters.
If you need assistance, please contact your authorised i-SENS
sales representative or visit www.i-sens.com for more information.
Meaning of Symbols Used:
For
in vitro
diagnostic use
This product fulfills the requirements for Directive 98/79/EC
on
in vitro
diagnostic medical devices
Cautions for safety and optimum product use
Use by
Do not discard this product with other household-type waste
Do not reuse
Batch code
Consult instruction for use
Manufacturer
Temperature limitations
Serial number
Authorised representative
Summary of Contents for KetoSens
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