About Your New System; Welcome; Intended Use; Application - Infopia Element compact User Manual

About Your New System

Welcome

Thank you for selecting the Element Compact Blood Glucose Monitoring
System. This user manual is designed to provide the information that you are
looking for, when you need it. Follow steps for using the system in this manual.
Before using your monitoring system for the first time, please read this manual
carefully. If you have any questions, please contact Customer Service at 1 888-
446-3246, anytime-24 hours a day. You can also obtain information at
www.infopiausa.com.

Intended Use

The system is intended for the quantitative measurement of the concentration
of glucose in whole blood drawn from fingertip, palm, and forearm by a single
patient(lay user) as an aid in the management of diabetes, is intended for self
testing by persons at home, is for single patient use only, and should not be
shared.
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It is intended for use the outside of body(in vitro diagnostic use) and not for
diagnosis of or screening for diabetes, nor for use on neonates.
The alternative site testing (palm and forearm) in this system can only be used
during steady state blood glucose conditions.

Application

Element Compact Blood Glucose Test Strips are for in vitro diagnostic use and
for self testing only. The Element Compact Blood Glucose Meter is not a
substitute for your physician or healthcare professional. Use the Element
Compact Blood Glucose Meter in conjunction with your healthcare program.

Test Principle

Glucose in the blood sample reacts with glucose oxidase on the test strip and a
harmless electrical current is produced. The strength of these currents change
with the amount of glucose in the blood sample and the Element Compact
Blood Glucose Meter automatically interprets this reaction.
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