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Safety Information

INDICATIONS FOR USE

The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking patterns in persons (age 2 and older) with diabetes. The system is intended for use by patients at home and in healthcare facilities.

The Dexcom G4 PLATINUM System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.

The Dexcom G4 PLATINUM System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the Dexcom G4 PLATINUM System results should be based on the trends and patterns seen with several sequential readings over time.

IMPORTANT USER INFORMATION

Please review your product instructions before using your continuous glucose monitoring system. Contraindications, warnings, precautions, cautions, and other important user information can be found in your product instructions. Discuss with your healthcare professional how you should use your sensor trend information to help manage your diabetes. Your product instructions contain important information on troubleshooting your system and on the performance characteristics of the device.

CONTRAINDICATIONS

  • The blood glucose value from your blood glucose meter should be used for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM System does not replace a blood glucose meter.
  • The Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver must be removed prior to Magnetic Resonance Imaging (MRI), CT scan, or diathermy treatment. The Dexcom G4 PLATINUM System has not been tested during MRI or CT scans or with diathermy treatment, and it is unknown if there are safety or performance issues.
  • Taking acetaminophen (paracetamol) containing products (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen (paracetamol) active in your body.

WARNINGS

  • Do not use the Dexcom G4 PLATINUM CGM System until after you have been trained or viewed the training materials included with your CGM system.
  • The blood glucose value from your blood glucose meter should be used for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM System does not replace a blood glucose meter. Blood glucose values may differ from sensor glucose readings. The direction, rate of glucose change, and trend graph on your Dexcom G4 PLATINUM System provide additional information to help with your diabetes management decisions.
  • Symptoms of high and low glucose should not be ignored. If your sensor glucose readings do not fit with your symptoms, you should measure your blood glucose with a blood glucose meter.
  • Your sensor glucose readings may be inaccurate if you calibrate less than every 12 hours.
  • 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 inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to your local distributor
  • The Dexcom G4 PLATINUM System is not approved for use in pregnant women or persons on dialysis.
  • Sensor placement is not approved for sites other than under the skin of the belly (abdomen) or, in the case of patients between the ages of 2 and 17, the belly or upper buttocks.
  • If your transmitter or receiver case is damaged/cracked, do not use them, as this could create an electrical safety hazard or malfunction.
  • The sensor and transmitter include small parts that may pose a choking hazard. Keep the transmitter kit box away from young children; it contains a magnet that should not be swallowed.

PRECAUTIONS

  • Before opening the sensor package, wash your hands with soap and water and dry them to avoid contamination.
  • Before inserting the sensor, always clean the skin at the sensor insertion location with a topical antimicrobial solution, such as isopropyl alcohol. This may help prevent infection. Do not apply the sensor until the cleaned area is dry so that it will stick better.
  • Change the site where you place your sensor with each insertion to allow your skin to heal.
  • Avoid areas that are likely to be bumped, pushed or compressed or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose.
  • Avoid injecting insulin or placing an insulin pump infusion set within 7.62 cm of the sensor in case the insulin affects the sensor glucose readings.
  • The sensor is sterile in its unopened, undamaged package. Do not use any sensor if its sterile package has been previously damaged or opened.
  • To calibrate the system, you must enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement. Entering incorrect blood glucose values or blood glucose values from more than 5 minutes ago could result in inaccurate sensor glucose readings.
  • The transmission range from the transmitter to the receiver is up to 6 meters without obstruction. Wireless communication does not work well through water so the range is much less if you are in a pool, bathtub, water bed, etc.
  • Sensors should be stored at temperatures between 2° C - 25° C for the length of the shelf life. You may store your sensors in the refrigerator if it is within this temperature range. Sensors should not be stored in a freezer.
  • Keep the USB port cover on the receiver closed whenever the USB cable is not attached. The receiver may malfunction if water gets into the USB port.