User's Manual

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Limitation
• This system is only for in vitro diagnostics use and for self-testing.
• This system is NOT designed for use with arterial, serum or plasma samples. Do NOT put urine on the
test strip.
• This system is NOT designed for use with neonatal.
• This system is NOT for screening or diagnosis of diabetes mellitus.
• Blood β-ketone testing must NOT use the forearm or palm site. Only use the fingertip for blood β-
ketone testing.
• Hematocrit is the percentage of red blood cells in the blood. Testing outside of the Hematocrit level
range of 20~60% may cause inaccurate result. If you do NOT know your hematocrit level, consult with
your healthcare professional.
• Inaccurate results may occur if used at altitudes above 3,500m.
• This system is NOT for use on patients who are in shock, hyperosmolar state or dehydrated patients.
• Inaccurate results may occur in severely hypotensive individuals.
• Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with
or without ketosis.
• This system is NOT for use on critically ill patients.
• Xylose: Do NOT use during or soon after xylose absorption testing. Xylose in the blood will cause an
interference.
• If you are taking acetaminophen containing drugs (e.g. Tylenol, certain cold and flu remedies etc.) in
excess of the recommended levels (>20 mg/dL) then you may get inaccurate blood glucose results with
this system. If you are unsure, then ask your doctor.
• If you are taking vitamin C (ascorbic acid) in excess of the recommended levels >3 mg/dL, then your
blood glucose results may be inaccurate with this system. If you are unsure, then ask your doctor.
• If you have certain conditions that may cause your blood level of uric acid to rise (>10 mg/dL), such as
gout or kidney disease then your blood glucose results may be inaccurate. If you are unsure, then ask
your healthcare professional.
• Alternative site testing should be performed only during steady-state (when glucose is NOT changing
rapidly).
• Alternative site measurements should NEVER be used to calibrate continuous glucose monitoring
(CGMs).
• Alternative site measurements should NEVER be used for insulin dosing calculations.