Limitations Of Use - iHealth BG1 Owner's Manual

LIMITATIONS OF USE

• The iHealth Align Gluco-Monitoring System is not intended for use on neonates.
• The iHealth Align Gluco-Monitoring System is not intended for use on artery blood, serum, plasma
and venous blood samples.
• The iHealth Align Gluco-Monitoring System should only be used with iHealth test strips
(AGS-1000I).
• The iHealth Align Gluco-Monitoring System can be used up to an altitude of 10,744 feet (3,276
meters).
• The following substances at levels greater than normal or therapeutic levels may cause significant
interference (affect the result by greater than 10%), resulting in an inaccurate result: ascorbic acid,
uric acid, acetaminophen, dopamine, L-dopa. These substances do not affect test results in normal
concentrations but may affect test results in high concentrations. Do not use haemolysis samples,
icterus samples, or high lipemia samples.
• Patients undergoing oxygen therapy may show results lower than actual levels.
• Not for use for patients in a hyperglycemic-hyperosmolar state, with or without ketosis.
• Not for use on critically ill patients.
• Not for patients who are dehydrated, hypertensive, hypotensive, or in shock.
• Red blood cell count (hematocrit) extent 20%-60% can lead to incorrect test results.If you do not
Compounds
Ascorbic acid
Uric acid
Acetaminophen
Bilirubin
Dopamine
L-dopa
Methyldopa
Tolbutamide
Triglycerides
Hemoglobin
Limitation
2mg/dL
＞10mg/dL
＞5mg/dL
＞15mg/dL
＞0.03mg/dL
＞0.45mg/dL
＞0.75mg/dL
＞24mg/dL
＞2000mg/dL
＞250mg/dL
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