Abbott Freestyle PRT03831-xxx - Manual (Page 3)

Indications for Use
The FreeStyle Navigator® Continuous Glucose Monitoring System is indicated for continually
recording interstitial fluid glucose levels in people (ages 18 and older) with diabetes mellitus
for the purpose of improving diabetes management. Readings and alarms about glucose
levels from FreeStyle Navigator® Continuous Glucose Monitoring System are not intended
to replace traditional blood glucose monitoring. Before adjusting therapy for diabetes
management based on the results and alarms from the FreeStyle Navigator® Continuous
Glucose Monitoring System, traditional blood glucose tests must be performed. The FreeStyle
Navigator® Continuous Glucose Monitoring System provides a built-in blood glucose meter to
confirm the continuous glucose result.
The FreeStyle Navigator® Continuous Glucose Monitoring System provides real-time readings,
graphs, trends, and glucose alarms directly to the user. The FreeStyle Navigator® Continuous
Glucose Monitoring System is intended to be used in home settings to aid people with
diabetes in predicting and detecting episodes of hypoglycemia and hyperglycemia and in
clinical settings to aid health care professionals in evaluating glucose control. The FreeStyle
Navigator® Continuous Glucose Monitoring System is available only by prescription.
Contraindications
The FreeStyle Navigator® Continuous Glucose Monitoring System must be removed prior to
Magnetic Resonance Imaging (MRI).