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blood glucose monitoring system
IMPORTANT SAFETY INFORMATION
WARNING
If your blood glucose reading is under 2.8 mmol/L, follow
medical advice immediately.
If your blood glucose reading is over 13.9 mmol/L, or the
critical level you have established with your health care
professional:
1. Wash and dry your hands well.
2. Retest with a new strip.
If you get a similar result, call your health care professional as soon
as possible. If the blood glucose reading is 13.9 mmol/L or greater,
check your ketone levels.
1
Serious Illness
The system should not be used to test critically ill patients. Capillary
blood glucose testing may not be clinically appropriate for persons
with reduced peripheral blood flow. Shock, severe hypotension and
severe dehydration are examples of clinical conditions that may
adversely affect the measurement of glucose in peripheral blood.
2-4
Talk to Your Health Care Professional:
• Before setting any Target Ranges in your meter or in the
C
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D
iabetes
app.
• Before changing your treatment or medication based on test results.
• About whether Alternative Site Testing (AST) is appropriate for you.
• Before making any other decision of medical relevance.
Potential Biohazard
• Always wash your hands with antibacterial soap and water and
dry them well before and after testing or handling the meter,
lancing device, or test strips.
INTENDED USE
The C
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blood glucose monitoring system is intended to
be used for the measurement of blood glucose in both insulin and non-
insulin treated patients with diabetes as an aid for patients and their
HCPs in monitoring the effectiveness of the patient’s diabetes control.
The C
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blood glucose monitoring system is intended for
self-testing by persons with diabetes and health care professionals
in venous blood and in fresh capillary whole blood drawn from the
fingertip or palm. The C
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blood glucose monitoring
system is intended for self-testing outside the body (in vitro diagnostic
use).
The C
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blood glucose monitoring system should not be
used for the diagnosis of or screening for diabetes or for neonatal use.
Alternative site testing (palm) should be done only during steady state
times (when glucose is not changing rapidly). The C
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test strips are for use with the C
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blood glucose meter
to quantitatively measure glucose in venous blood and fresh capillary
whole blood drawn from the fingertips or palm.
The meter is for the quantitative measurement of glucose in whole
blood from 0.6 mmol/L–33.3 mmol/L.
The system is intended for in vitro diagnostic use only.