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Intended Use
The ACCU-CHEK Aviva Expert System is indicated as an aid in the treatment of insulin-requiring diabetes. The
ACCU-CHEK Aviva Expert System consists of the ACCU-CHEK Aviva Expert Meter, ACCU-CHEK Aviva Plus test
strips, ACCU-CHEK Aviva control solutions, and ACCU-CHEK Bolus Advisor. The ACCU-CHEK Aviva Expert
system is intended to facilitate the optimization of glycemic control in patients who are trained in multiple
daily insulin injection therapy and are under the supervision of healthcare professionals experienced in
managing insulin treated patients.
The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used for the quantitative
measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK
Aviva Expert blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic
use) by people with diabetes. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be
used by a single person and should not be shared. The ACCU-CHEK Aviva Expert blood glucose monitoring
system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site
testing should NOT be used with the ACCU-CHEK Aviva Expert blood glucose monitoring system. The
ACCU-CHEK Aviva Expert System is intended for prescription home use only.
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