Arkray Glucocard Shine - Health-Related Information and Precautions

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• The GLUCOCARD Shine Blood Glucose Monitoring System is
intended for in vitro (outside the body) diagnostic use only and for
the quantitative measurement of glucose in capillary whole blood.
• The GLUCOCARD Shine Blood Glucose Monitoring System is
intended for use by a single user only. Do not share the meter and
lancing device with another person.
• The GLUCOCARD Shine Blood Glucose Meter is designed to
minimize code related errors in monitoring by using the no-coding
function.
• The glucose in the blood sample mixes with special chemicals
on the test strip to produce a small electrical current. The
GLUCOCARD Shine Meter converts this electrical current to
glucose concentration.
• The GLUCOCARD Shine Blood Glucose Meter should be used only
with the GLUCOCARD Shine Test Strip.
• An abnormally high or low red blood cell count (hematocrit level
over 60% or below 20%) may produce inaccurate results.
• Inaccurate results may occur in severely hypotensive (having low
blood pressure) individuals or patients in shock. Inaccurate low
results may occur for individuals experiencing a hyperglycemic
(high blood sugar) or hyperosmolar state, with or without ketosis.
Critically ill patients should not be tested with blood glucose
meters.
• All parts of the kit are considered biohazardous and can potentially
transmit infectious diseases, even after you have performed
pre-cleaning and disinfection.
The GLUCOCARD Shine Blood Glucose Monitoring System is
waived under CLIA document number CR??????. To obtain further
information about this waiver, visit the FDA website at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/search.cfm
Important Health-Related Information