Limitations
• The system should not be used to test neonates.
• Do not test samples other than fresh capillary whole blood
obtained from the fingertip.
• Do not use the system at altitudes above 10,000 feet
(3000 meters).
• Do not use when hematocrit is outside the acceptable
hematocrit range for testing of 20% to 55%.
• Severe dehydration (excessive water loss) may cause
inaccurate results. If you believe you are suffering from severe
dehydration, consult your healthcare professional immediately.
• For in vitro diagnostic use only
• Critically ill patients should not be tested with this device.
• Inaccurate results may occur in severely hypotensive
individuals or patients in shock.
• Incorrect result may occur in individuals who are dehydrated.
• The meter and lancing device are for single patient use. Do
not share these items with anyone, including other family
members! Do not use on multiple patients!
• Do not reuse; each test strip is for single use only.
• Do not use when humidity is higher than 90% and lower than
10%, as extremes in humidity may affect results.
• For single patient use only.
• For over-the counter use
6 www.i-sens.com
•
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 the electrical current which
reflects 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 55% or below 20%) may produce inaccurate
results.
•
Critically ill patients should not be tested with this device.
If you need assistance, please contact Customer Service:
1-800-429-5001 Mon–Sat, 9 am–9 pm EST. At all other times or
in case of emergency, contact your healthcare professional or
emergency medical response.
www.i-sens.com 7