1-6
StatStrip Glucose Hospital Meter
It is not intended for use with neonate cord blood specimens.
It is not intended for the screening or diagnosis of diabetes
mellitus but is indicated for use in determining dysglycemia.
1.4 Capillary Precautions
• Caution should be exercised when testing capillary
whole blood due to potential pre-analytical variability
in capillary specimen collection.
• A capillary whole blood specimen relies upon an
adequate,non-compromisedcapillarybloodow.
The healthcare provider must be aware that a
capillary whole blood specimen glucose result may
not always be the same as an arterial or a venous
whole blood glucose result, especially when the
patient's condition is rapidly changing.
• If a capillary whole blood glucose result is not con-
sistent with a patient’s clinical signs and symptoms,
glucose testing should be repeated with either an
arterial or venous specimen on the StatStrip Glucose
Hospital Meter System.
1.5 Limitations
• The system has not been evaluated for use with
neonate venous blood.
• Blood source - Use only whole blood. Do not use
serum or plasma.
• Temperature and humidity extremes - Test results
may be inaccurate when test strips are stored out-
side of the storage and handling conditions.
• Altitudes above 15,000 feet (4500 meters) above
sea level have not been evaluated.
• Specimens - Only fresh whole blood or whole blood
collected in lithium heparin collection devices should
be used for arterial and venous specimens.
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 6 9/13/18 8:29 AM
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