IMPORTANT SAFETY INFORMATION

Read the entire User's Guide before using the Seven Continuous Glucose Monitoring System. If you do not understand something or have any questions, please ask your Diabetes Management Team or another health care provider. Contraindications, warnings, precautions, cautions, and other important safety information is detailed below and is also located in the Seven System User's Guide.

CONTRAINDICATIONS

• The Seven System must be removed prior to Magnetic Resonance Imaging (MRI).
• Use of acetaminophen-containing medications while using the Seven Sensor may affect the performance of the device.

WARNINGS, PRECAUTIONS, AND CAUTIONS

WARNINGS

• This device is not designed to replace a blood glucose meter. The Seven System must be used with a blood glucose meter.
• Treatment decisions should not be based solely on results from the Seven System. You must confirm with 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 your blood glucose meter to check the Seven System results.
• Update the Seven System's calibration every 12 hours at a minimum to ensure device performance. The performance of the Seven System when calibrated less frequently than the recommendation to calibrate a minimum of every 12 hours has not been studied.

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 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 of the Sensor.
• The Sensor is sterile in its unopened, undamaged package. Do not use any Sensor if its sterile package has been previously damaged or opened.
• The Sensor has currently only been tested in adult persons with type 1 and type 2 diabetes. The device has not been tested in children or adolescents, pregnant women, or persons on dialysis.

CAUTION

U.S. federal law restricts the sale of the Seven System to sale by or on order of a physician.