Limitations of use – iHealth Align User Manual

Page 17

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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

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

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comparison of the iHealth system to another monitoring system known to be well maintained and

monitored by a healthcare provider.

• The meter will automatically adjust for the current time zone when the testing takes place. When

traveling across time zones, living on or near a time zone boundary, you need to be aware that the

logged glucose measurement times may not be synchronized to your normal day-to-day regime.

• If you take insulin and will be traveling across time zones, talk to your health care professional before

your trip.

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