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, and
plasma.
• The iHealth Align Gluco-Monitoring System should only be used with iHealth test strips (AGS1000I).
• 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.
• Very low or very high red blood cell count (hematocrit) can lead to incorrect test results. If you do not
know your hematocrit level, please consult your healthcare provider. We recommend periodic
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
15