iHealth Align - Manual (Page 18)

• 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
SYSTEM TROUBLESHOOTING
If you follow the recommended action but the problem persists, or error messages other than the
ones below appear, please call iHealth Labs Customer Service at 1-855-816-7705. Do not attempt to
repair the meter by yourself and never try to disassemble the meter under any circumstances.
Problems
The meter does not respond
after the test strip has been
inserted into the glucose
meter.
Possible Causes Solution(s)
1. The meter is not correctly
connected to a mobile device.
2. Too much time has passed between
inserting the test strip and performing
the test.
3. Test strip has not been fully inserted
into the glucose meter.
1.Remove the meter from the mobile
device and reconnect.
2. Remove and reinsert the test strip
into the glucose meter.
3. Reinsert the test strip into the
glucose meter.
Test results are inconsistent
or control solution test results
are not within the specified
range.
1. Not enough blood sample in the
test strip.
2. Test strip or control solution has
expired.
3. Test strip has been damaged due to
heat or humidity.
1. Retest with a new test strip and
make sure that enough sample has
been applied.
2. Retest with a new test strip or new
control solution.
3. Perform a control solution test using
a new test strip. If results are still out
of range, replace with new vial of test
strips.
4. iHealth System is not performing
due to the environment being above or
below room temperature.
4. Bring the iHealth System to room
temperature environment and wait
approximately 30 minutes before
performing a new test.
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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.