Table of Contents
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Important Safety Instructions
The Centers for Disease Control and Prevention(CDC) and the US Food
and Drug Administration (FDA) have become increasingly concerned
about the risks for transmitting hepatitis B virus (HBV) and other blood
borne pathogens to people undergoing finger stick procedures for blood
sample. For instance, people with diabetes who require assistance
monitoring their blood glucose levels.
Reports of HBV infection outbreaks linked to diabetes care have been
increasing. This notice serves as a reminder that finger stick devices
should never be used for more than one person.
Warning:
• Element™ Plus meter and reusable lancing device are for single patient use
only. Do not share them with anyone including other family members! Do
not use on multiple patients!
• All parts of the kit are considered biohazardous and can potentially transmit
infectious diseases, even after you have performed cleaning and disinfec-
tion.
• Always use a new, sterile lancet. Lancets are for single use only.
• Avoiding getting hands lotions, oil, dirt or debris in or on the lancets and
reusable lancing device.
• Please refer to page 40-45 for cleaning and disinfecting Element™ Plus
system.
"FDA Public Health Notification: Use of Fingerstick Devices on More
than One Person Poses Risk for Transmitting Blood borne Pathogens
:lnitial
Communication"(2010)
"CDC Clinical Reminder: Use of Fingerstick Devices on More than One
Person Poses Risk for Transmitting Blood borne Pathogens" (2010)
http://www.cdc.gov/injectionsafey/Fingerstick-DevicesBGM.htm
6 / 7
www.infopiausa.com
http://www.fda.gov/MedicalDevices/
Table of contents
Element™ Plus KIT contents
Before you test:
Setting the meter
Performing a blood test with your fingertip
Performing a blood test with an alternate site
Caring for your Element™ Plus meter:
Cleaning and Disinfecting your system
Storage of your system
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Call toll free : 1-888-446-3246
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