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A. Intended Use
The BioTel CareTM Blood Glucose Monitoring system is intended
for the quantitative measurement of glucose in fresh capillary
whole blood samples drawn from the fingertips, forearm, or
palm. It is intended for lay use by persons with diabetes to aid
in diabetes management. It is indicated for use at home (over
the counter [OTC]) and should be used only by a single patient
and should not be shared. Test results are plasma-calibrated for
easy comparison to clinical laboratory methods. Testing is done
outside the body (in vitro diagnostic use). The BioTel CareTM
Blood Glucose Monitoring System consists of the BioTel Care
BGMTM Blood Glucose Meter, BioTel CareTM Blood Glucose Test
Strips, and BioTel CareTM Glucose Control Solutions. The BioTel
CareTM Blood Glucose Monitoring system is not indicated for the
diagnosis or screening of diabetes or for neonatal use. Palm and
forearm testing should be done only during steady-state times
when glucose is not changing rapidly. The BioTel CareTM Blood
Glucose Meter uses cellular data transmission to send test results
to Telcare’s remote database, Telserve, and to receive messages
from Telserve. The BioTel CareTM Blood Glucose Monitoring
System is not intended to provide automated treatment guidance
or decisions, nor is it to be used as a substitute for professional
healthcare judgment.
B. Important Safety Instructions
The
BioTel CareTM
Blood Glucose Monitoring System and lancing
device are for single patient use.
Do not share them with anyone, including family members! Do
not use on multiple patients! Do not transfer ownership.
Because all parts of the kit may come in contact with your blood,
all parts are considered biohazardous. Kit parts can potentially
transmit infectious diseases, even after cleaning and disinfection.
Dispose of in accordance with local regulations.
