Special Information For Healthcare Providers And Caregivers; Indication For Use - SD CodeFree User Instruction Manual

SD CodeFree™ BLOOD GLUCOSE MONITORING SYSTEM
2. Special Information for Healthcare
Providers and Caregivers
• Do not use this device to measure blood
glucose in people who are experiencing
cardiovascular collapse (severe shock) or
decreased peripheral blood flow.
• Hematocrit: A hematocrit (percentage of your
blood that is red blood cells) that is either very
high (above 60%) or very low (below 20%) can
cause false results.
3. Indication for use (Purpose of the
device)
Your new SD CodeFree™ meter and accessories
work together to measure the amount of
glucose (sugar) in your blood.
Your SD CodeFree™ blood glucose monitoring
system is indicated for monitoring glucose in
fresh capillary whole blood samples drawn
from the fingertip, palm, forearm or upper
arm. Your SD CodeFree™ meter must be used
with only SD CodeFree™ blood glucose test
strip. Testing is done outside the body. (in
vitro diagnostic use) This system is indicated
for home (over-the-counter or OTC) by
person with diabetes, or in clinical settings by
healthcare professionals, as an aid to monitor
the effectiveness of diabetes control. This
system should not be used for the diagnosis
of diabetes or for testing newborns. When
you put a drop of blood onto the test strip,
the meter displays a blood glucose result
in five seconds. Testing your blood glucose
regularly can make a big difference in how you
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