iHealth Align User Manual

Page 4

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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)

http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html

CONTENTS OF THE iHealth Align GLUCO-MONITORING SYSTEM

Package contents may vary according to geographic markets. Please refer to the package

contents listed on the package you purchased.

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