Important Safety Instructions; Contents Of The Ihealth Align Gluco-Monitoring System - iHealth BG1 Owner's Manual

IMPORTANT SAFETY INSTRUCTIONS

Please read the following information carefully before using the iHealth system. Always keep
these instructions in a safe place for reference.
• Misuse of the iHealth system can cause electrocution, burns, fire, and other hazards.
• The glucose meter and lancing device are for single patient use. Do not use either item on
multiple patients.
• Do not share the glucose meter or lancing device with anyone, including other family members.
• Do not place the iHealth system in or near liquid.
• Use the iHealth system only for the purpose described in the Owner's Manual.
• Use only iHealth branded accessories.
• 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 glucose meter 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 glucose meter.
• Do not place foreign objects into any opening in the glucose meter.
• Do not use the glucose meter in a manner not specified by the manufacturer.
• When not in use, please disconnect the glucose meter from the mobile device.
• 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)
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