User Manual

8
Important Safety Instructions
The meter and lancing device are for single-patient use. Do not share them
with anyone, including other family members. Do not use on multiple patients.
All parts of the kit are considered bio-hazardous and can potentially transmit
infectious diseases even after you have performed disinfection.
This device is not intended for use in healthcare or assisted-use settings such
as hospitals, physician offices, or long-term care facilities because it has not
been cleared by FDA for use in these settings, including for routine assisted
testing or as part of glycemic control procedures. Use of this device on
multiple patients may lead to transmission of Human Immunodeficiency Virus
(HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne
pathogens.
For important instructions for disinfecting your meter and lancing device, refer
to CHAPTER 5 CLEANING AND MAINTENANCE on page 55.
The U.S. Food and Drug Administration (FDA) and the Centers for Disease
Control and Prevention (CDC) have issued warnings and notifications regarding
the risk of bloodborne pathogen transmission when blood glucose monitoring
systems have been used by more than one individual. Refer to the following
documents for more information:
• “FDA Public Health Notification: Use of Fingerstick Devices on More
than One Person Poses Risk for Transmitting Bloodborne
Pathogens: Initial Communication” (2010). You can find this
document at www.fda.gov.
• “CDC Clinical Reminder: Use of Fingerstick Devices on More than
One Person Poses Risk for Transmitting Bloodborne Pathogens”
(2010). You can find this document at www.cdc.gov.
CAUTION: To ensure accurate results, wash your hands with
warm, soapy water and dry them before and after every test.
Unwashed hands may lead to inaccurate results. Make sure there
is no grease, oil, lotion or alcohol on the fingertip. Use lancets
only once. Do not use any lancet or lancing device that has been
used by another person.