Limitations Of Use - iHealth BG5S Owner's Manual

Wireless smart gluco-monitoring system
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instructions in a safe place for reference.
Misuse of the iHealth system can cause electrocution, burns, fire, and other hazards.
The meter and lancing device are for single patient use.
Do not use either item on multiple patients.
Do not share the meter or lancing device with anyone, including other family members.
Do not place the iHealth system in or near liquid.
The iHealth system can be used up to an altitude of 3276 meters (10744 feet).
Use the iHealth system only for the purpose described in the Owner's Manual.
Use only accessories that are supplied by the manufacturer.
Do not use the iHealth system if it has sustained any damage or is not working properly.
Keep the iHealth system away from heat at all times. Do not let the iHealth system come into contact
with surfaces that are hot to the touch.
Do not block test port or place the iHealth system on soft surfaces that may block the test port. Keep
test port free from lint, hair, debris, etc.
Do not place anything on top of the iHealth system.
Do not place foreign objects into any opening in the iHealth system.
Do not use the meter in a manner not specified by the manufacturer.
All parts of the iHealth system are considered biohazards and can potentially transmit infectious
diseases, even after you have performed cleaning and disinfection.
Please refer to the resources identified below for detailed information:
"FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for
Transmitting Bloodborne Pathogens: Initial Communication" (2010)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
"CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens" (2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html

LIMITATIONS OF USE

The iHealth system is not intended for use on neonates.
The iHealth system is not intended for use on artery blood, serum, and plasma.
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
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