I-SENS CARESENS DUAL Owner's Booklet - page 5
6 www.i-sens.com
www.i-sens.com 7
Important Information: Read This First!
For optimum safety and benefits, please read the entire manual
contents before using the system.
Intended use:
CareSens Dual Blood Glucose/Blood β-Ketone Monitoring
System is used for the quantitative measurement of the glucose/
β-ketone level in capillary whole blood as an aid in monitoring
diabetes management effectively at home or in clinical settings.
Fresh venous whole blood drawn by healthcare professionals
can be used only for testing blood glucose. CareSens Dual Blood
Glucose/Blood β-Ketone Monitoring System should be used
only for self-testing outside the body (in vitro diagnostic use
only). CareSens Dual Blood Glucose/Blood β-Ketone Monitoring
System should not be used for the diagnosis of diabetes or for
the diagnosis of diabetic ketoacidosis. Blood glucose testing
sites include the traditional fingertip testing along with alternate
sites testing on forearm and palm.
• Glucose/β-Ketone in blood samples reacts with the chemical
in the test strip to produce a small electrical current. The
CareSens Dual meter detects this electrical current and
measures the amount of glucose/β-ketone in the blood
sample.
• The CareSens Dual Blood Glucose/Blood β-Ketone Meter is
designed to minimise code related errors in monitoring by
using the no-coding function.
• The CareSens Dual Blood Glucose/Blood β-Ketone Meter
should only be used with CareSens PRO blood glucose and
KetoSens β-ketone test strips.
• An abnormally high or low red blood cell count (hematocrit
level over 65% or below 15% for blood glucose and
hematocrit level over 60% or below 30% for blood β-ketone)
may produce inaccurate results.
• If your blood glucose test result is below 3.3 mmol/L or
above 13.3 mmol/L, consult a healthcare professional
immediately.
• Inaccurate blood glucose results may occur in severely
hypotensive individuals or patients in shock. Inaccurate low
blood glucose results may occur for individuals experiencing
a hyperglycemic- hyperosmolar state, with or without
ketosis. Critically ill patients should not be tested with blood
glucose/blood β-ketone meters.
• Do not use during or within 24 hours of receiving xylose
absorption testing as it may cause inaccurate results.
If you need assistance, please contact your authorised i-SENS
sales representative or visit www.i-sens.com for more information.
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
Do not discard this product with other household-type
waste
Use by
Authorised representative
Do not reuse
Batch code
Consult instructions for use
Manufacturer
Temperature limitation
Serial number
Meaning of Symbols Used: