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Limitations of GLUCOCARD Shine Express Blood
Glucose Monitoring System
• An abnormally high or low red blood cell count (hematocrit
level over 65% or below 15%) may produce inaccurate results.
• Inaccurate results may occur in severely hypotensive
individuals or patients in shock.
• Inaccurate low results may occur for individuals experiencing a
hypoglycemic hyperosmolar state, with or without ketosis.
• Severe dehydration (excessive water loss) may cause false
low results. If you believe you are suffering from severe
dehydration, consult your healthcare professional immediately.
• Altitudes of higher than 10,000 ft. (3,048 m) above sea level
may have an effect on the performance of the test strip.
• This single-patient use system is for single-patient use only
and should
not
be shared.
•
Not
for neonatal use.
•
Do not use
for diagnosis of or screening for diabetes mellitus.
•
Not for use
on critically ill patients.
•
Not for use
on anyone undergoing oxygen therapy.
This device is not intended for use in healthcare or assisted-
use settings such as hospitals, physician offices, or long-term
care facilities because it has not been cleared by FDA for use
in these settings, including for routine assisted testing or as
part of glycemic control procedures.
Use of this device on multiple patients may lead to
transmission of Human Immunodeficiency Virus (HIV),
Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other
bloodborne pathogens.
Summary of Contents for Gluocard Shine Express
Page 1: ...User Manual For single user home use only ...
Page 4: ......
