* CGM uses a special sensor to measure sugar levels just below the skin known as interstitial fluid. These sensor glucose (SG) values are different from blood glucose (BG) measurements using a BG meter. Sensor glucose values should not be used to make treatment decisions. Patients should always do a BG fingerstick before they make treatment decisions.

∆ Refers to suspend on low. WARNING: Do not use the Suspend on low feature to prevent or treat low glucose. Always confirm your sensor glucose reading using your BG meter, and follow the instructions of your healthcare professional to treat low glucose. Using Suspend on low alone to prevent or treat low glucose may result in prolonged hypoglycemia.

^ Data from only the voluntary CareLink™ Personal uploads from the MiniMed™ 530G system in the U.S. available from October 15, 2013 to November 29, 2015 evaluated. Based on 3,770,311 days of data with 41,287 users (79.7% with SmartGuard™ feature on) reporting 2,239,637 SmartGuard™ events.

** The Bolus Wizard^™ calculator does not account for manual injections and could prompt you to deliver more insulin than needed. Too much insulin may cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection before you can rely on the active insulin calculation of your Bolus Wizard^™ calculator.

§ At the time of manufacture and when the reservoir and tubing are properly inserted, your pump is waterproof. It is protected against the effects of being underwater to a depth of up to 12 feet (3.6 meters) for up to 24 hours.

¶ Assumes four injections per day for 30 days and one infusion set change every three days.

IReferences

1. Battelino T, Conget I, Olsen B, et al. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomized controlled trial. Diabetologia. 2012;55:3155–3162. 2. Doyle EA, Weinzimer SA, Steffen AT, Ahern JAH, Vincent M, Tamborlane WV. A randomized prospective trial comparing the efficacy of insulin pump therapy with multiple daily injections using insulin glargine. Diabetes Care. 2004;27(7):1554–1558. 3. Bode BW, Steed RD, Davidson PC. Reduction in severe hypoglycemia with long-term continuous subcutaneous insulin infusion in type 1 diabetes. Diabetes Care. 1996;19:324–327. 4. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329:977–986. 5. Bailey T, et al. Accuracy, Precision, and User Performance Evaluation of the CONTOUR^®NEXT LINK 2.4 Blood Glucose Monitoring System. Poster presented at the 7th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD); 2014 February 5–8, Vienna, Austria.

Important Safety Information: MiniMed^™ 630G System with SmartGuard^™ Technology
Indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus. MiniMed™ 630G system is approved for ages 14 years or older with Guardian™ Sensor 3 and MiniMed™ 630G system is approved for ages 16 years or older with Enlite™ sensor. Both systems require a prescription. Insulin infusion pumps and associated components of insulin infusion systems are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks of insulin pump therapy. Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Insulin pumps use rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately. Replace the infusion set every 48–72 hours, or more frequently per your healthcare professional’s instructions. Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected. The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a blood glucose meter. A confirmatory fingerstick using a CONTOUR®NEXT LINK 2.4 meter is required prior to making adjustments to diabetes therapy. Always check the pump display when using a CONTOUR®NEXT LINK 2.4 meter, to ensure the glucose result shown agrees with the glucose results shown on the meter. Do not calibrate your CGM device or calculate a bolus using a result taken from an Alternative Site (palm) or a result from a control solution test. If a control solution test is out of range, please note that the result may be transmitted to your pump when in the “Always” send mode. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise. The MiniMed™ 630G system is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Suspend on low alarm and take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare provider.

WARNING: The SmartGuard™ Suspend on low feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again, resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the SmartGuard™ feature, it is important to read the SmartGuard™ feature information in the User Guide and discuss proper use of the feature with your healthcare provider.

See important safety information page and the appropriate user guides for additional important details.

Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected. Please visit important safety information for more details.

The CONTOUR^®NEXT LINK 2.4 Meter is used with the MiniMed^™ 630G system.

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Ascensia, the Ascensia Diabetes Care logo, and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care.

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