Dexcom SEVEN User Manual page 18

Continuous glucose monitoring system
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WARNINGS
Sensors 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 inflammation—redness, swelling or pain—at the
insertion site. If you experience a broken sensor, please report this to our Technical
Support department.
e SEVEN System is not approved for use in children or adolescents, pregnant
women or persons on dialysis.
e safety and effectiveness of the SEVEN 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 SEVEN 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
SEVEN Sensor until the cleaned area is dry.
Establish a rotation schedule for choosing each new SEVEN 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 of a Sensor.
e Sensor is sterile in its unopened, undamaged package. Do not use any Sensor if
its sterile package has been previously damaged or opened.
For OpenChoice Calibration you must enter the exact fingerstick reading that your
blood glucose meter displays. Enter all fingerstick readings for calibration within 5
minutes. Entering incorrect fingerstick readings that occurred more than 5 minutes
ago will affect device performance.
CAUTION
U.S. federal law restricts the sale of the Seven System to sale by or on order of a physician.
14 | SEVEN
CONTINUOUS GLUCOSE MONITORING SYSTEM

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