KNOW YOUR DEVICE
Principle of Operation
Testing with the Blood Glucose Monitoring is based on the measurement of electrical currents
generated by the reaction of glucose with the reagent of the strip. The blood glucose monitoring
system measures the current and converts it to the corresponding blood glucose level. The
strength of the current produced by the reaction depends on the amount of glucose in the blood
sample.
Intended use of the equipment
This device is intended to be used for:
•
Quantitative measurement of glucose in fresh capillary whole blood samples drawn from the
fingertip, palm, forearm, upper arm, calf, or thigh.
•
Single person measurement only (it should not be shared)
•
Self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an
aid to monitor the effectiveness of diabetes control.
This device should not be used for the diagnosis of or screening for diabetes, or for neonatal use.
Alternative Site Testing (AST) should be done only during steady state times when glucose levels
are not changing rapidly.
The Blood Glucose Test Strips (NGS50-24/0726) are intended for use with the Blood Glucose
Monitor (MBG10-6/0741) to quantitatively measure glucose in fresh capillary whole blood samples
drawn from the fingertips, palm, forearm, upper arm, calf or thigh.
MEDICAL DISCLAIMER: This device and manual are not meant to be a substitute for advice
provided by doctors or other medical professionals.
Contact your physician for interpretation of measurements, or if you have or suspect you have a
medical issue.
Limitation of Use
•
The Blood Glucose Monitor is not intended for use on neonates.
•
The Blood Glucose Monitor is not intended for use on artery blood, serum, plasma and
venous blood samples.
•
The Blood Glucose Monitor should be only used with the test strips (NGS50-24/0726).
•
The Blood Glucose Monitor cannot be used above an altitude of 10744 feet (3275 meters)
•
If you are taking acetaminophen containing drugs (Tylenol and other medicines containing
acetaminophen, blood concentrations >5 mg/dL) or Vitamin C (ascorbic acid, blood
concentrations >4 mg/dL) at doses higher than recommended, these may interfere with your
glucose monitor and cause you to get inaccurate results with this system
•
Not for use for patients in a hyperglycemic-hyperosmolar state, with or without ketosis.
•
Not for use on critically ill patients.
•
Not to be used for patients who are dehydrated, hypertensive, hypotensive, or in shock.
•
Do not use during or soon after xylose absorption testing.
