Important Information: Read This First - i-SENS GM505PAD User Manual

Important Information: Read This First!

For optimum safety and benefits, please read the entire manual
contents before using the system.
Intended use:
CareSens N Blood Glucose Monitoring System is used for the
quantitative measurement of the glucose level in capillary
whole blood as an aid in monitoring diabetes management
effectively at home or in clinical settings.
CareSens N Blood Glucose Monitoring System should be
used only for self-testing outside the body (in vitro diagnostic
use only). CareSens N Blood Glucose Monitoring System
should not be used for the diagnosis of diabetes or for testing
newborns. Testing sites include the traditional fingertip testing
along with alternate site testing on forearm and palm.
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 (unopened or opened test strip vial)
Do not discard this product with other household-type waste
Do not reuse
Consult instructions for use
Temperature limitation
Authorised representative
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Batch code
Manufacturer
Serial number
• G lucose in blood samples reacts with the chemical in
the test strip to produce a small electrical current. The
CareSens N meter detects this electrical current and
measures the amount of glucose in the blood sample.
• T he CareSens N Blood Glucose Meter is designed to
minimise code related errors in monitoring by using the
no-coding function.
• T he CareSens N Blood Glucose Meter should be used only
with the CareSens N Test Strips.
• A n abnormally high or low red blood cell count (hematocrit
level over 65% or below 15%) may produce inaccurate
results.
• I f your test result is below 3.3 mmol/L or above 13.3 mmol/L,
consult a healthcare professional immediately.
• I naccurate results may occur in severely hypotensive
individuals or patients in shock. Inaccurate low results
may occur for individuals experiencing a hyperglycemic-
hyperosmolar state, with or without ketosis. Critically ill
patients should not be tested with blood glucose meters.
• I naccurate results may occur in patients undergoing
oxygen therapy.
If you need assistance, please contact your authorised i-SENS
sales representative or visit www.i-sens.com for more information.
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