User's Manual
8 | Continuous Glucose Monitoring System
WARNINGS
•
This device is not designed to replace a blood glucose meter. The G4-Global
System must be used with a blood glucose meter.
•
Treatment decisions should not be based solely on results from the G4-Global
System. You must confi rm results with fi ngerstick readings from a blood
glucose meter before making therapeutic adjustments.
•
Symptoms related to low or high blood glucose levels should not be ignored. If
you have symptoms of low or high glucose, use fi ngerstick readings from your
blood glucose meter to check the G4-Global System results.
•
You should update the G4-Global System calibration every 12 hours at a
minimum. The performance of the G4-Global System when calibrated less
frequently than every 12 hours has not been studied.
• Sensors may fracture on rare occasions. If a Sensor breaks and no portion of it
is visible above the skin, do not attempt to remove it. Seek professional medical
help if you have symptoms of infection or infl ammation—redness, swelling or
pain—at the insertion site. If you experience a broken Sensor, please report
this to our Technical Support department.
• The G4-Global System is not approved for use in children or adolescents,
pregnant women or persons on dialysis.
• The safety and effectiveness of the G4-Global System has not been evaluated
for Sensor Probe insertion sites other than the skin of the abdomen.
PRECAUTIONS
•
Always wash hands with soap and water before opening the Sensor package.
After opening the package, avoid touching the adhesive area.
•
Before inserting the Sensor, always clean the skin at the Sensor insertion
location with a topical antimicrobial solution, such as isopropyl alcohol. Do not
apply the Sensor until the cleaned area is dry.
•
Establish a rotation schedule for choosing each new Sensor location. Avoid
Sensor locations that are constrained by clothing, accessories, or subjected to
rigorous movement during exercise.
•
Avoid injecting insulin or placing an insulin pump infusion set within 3 inches
(7.62 centimeters) of the Sensor.