Intended Use; Important Safety Instructions - BioTel Care BGM 4 Manual Del Usuario

A. Intended Use
The BioTel Care® 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
Care® Blood Glucose Monitoring System consists of the BioTel
Care® Blood Glucose Meter, BioTel Care® Blood Glucose Test
Strips, and BioTel Care® Glucose Control Solutions. The BioTel
Care® 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
Care® Blood Glucose Meter uses cellular data transmission to
send test results to Telcare's cloud database, Telserve, and to
receive messages from Telserve. The BioTel Care® 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 Care® 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.
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