Replacement Warranty

^* Program eligibility requirements and terms and conditions apply. Subject to change.
^∑ Refers to Auto Mode. Some interaction required. Individual results may vary.
Δ Continuous Glucose Monitor
^† The system is intended to complement, not replace, information obtained from standard blood glucose monitoring devices. All therapy adjustments should be based on measurements obtained from standard blood glucose monitoring devices and not on values provided by the system.

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.

1 Bergenstal RM,Tamborlane WV, Ahmann A, et al. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N EnglJ Med. 2010;363:311–320.

§ Program Terms

• Guardian^™ Connect evaluation orders are billed to insurance at the time of shipping. Any patient out-of-pocket costs are held by Medtronic until the patient decides to proceed with the purchase of Guardian^™ Connect 14 days after the shipment of their Guardian^™ Connect system, the Therapy Consultant contacts the patient to discuss her/his decision.
• Once all documentation is obtained and the edits are cleared for shipment according to the standard protocol for processing, the customer’s order will be released. The 30-day evaluation program will begin once the customer has completed training.
• Starter kit includes one Guardian^™ Connect transmitter, one charger, two universal tester, one one-press serter and one box of Guardian^™ Sensor 3.
• If the patient decides to proceed with the purchase of Guardian^™ Connect, she/he keeps the Guardian^™ Connect evaluation CGM, and Medtronic sends the patient the bill for the co-insurance amount for Guardian^™ Connect.
• If the patient decides not to proceed with the purchase of Guardian^™ Connect, Medtronic will send the patient a shipping label to return the transmitter. Once the product is returned, the patient has no further obligation to Medtronic. Medtronic also will refund the payer.
• If the patient indicates that they wish to return the CGM, but does not return the CGM within 75 days after the shipment of the Guardian^™ Connect CGM, they will receive a bill for the cash pay cost of the transmitter as outlined in their patient agreement of $620.
• MiniMed^™ CGM system has certain labeling restrictions that may exclude certain populations, including age and type of diabetes. We recommend you consult your healthcare provider.
• A valid prescription will be required to purchase. Other restrictions may apply.
• Program terms are subject to change at any time and without notice.

Important Safety Information: MiniMed^™ 770G System With SmartGuard^™ Technology
The MiniMed^™ 770G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons two years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed^™ 770G System includes SmartGuard^™ technology, which can be programmed to automatically adjust delivery of basal insulin based on continuous glucose monitoring (CGM) sensor glucose values (SG) and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.

The Medtronic MiniMed^™ 770G System consists of the following devices: MiniMed^™ 770G Insulin Pump, the Guardian^™ Link (3) Transmitter, the Guardian^™ Sensor (3), one-press serter, the Accu-Chek^® Guide Link blood glucose meter, and the AccuChek^®Guide Test Strips. The system requires a prescription.

The Guardian^™ Sensor (3) has not been evaluated and is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian^™ Sensor (3).

All therapy adjustments should be based on measurements obtained using the Accu-Chek^® Guide Link blood glucose meter and not on values provided by the Guardian^™ Sensor (3). Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the Accu-Chek^® Guide Link blood glucose meter. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an alternative site. 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.

WARNING: Do not use the SmartGuard^™ Auto Mode for people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to operate in SmartGuard^™ Auto Mode.

WARNING: Do not use the MiniMed^™ 770G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed^™ 770G system.

Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. The safety of the MiniMed^™ 770G system has not been studied in pregnant women. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult https://www.medtronicdiabetes.com/important-safetyinformation#minimed-770g and the appropriate user guide at https://www.medtronicdiabetes.com/download-library

Important Safety Information: MiniMed^™ 630G System with SmartGuard^™ Technology
The MiniMed^™ 630G system with SmartGuard™ technology requires a prescription. It is intended for continuous delivery of basal insulin and administration of insulin boluses for the management of diabetes mellitus in persons 14 years of age or older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The SmartGuard^™ feature allows one to program the pump to temporarily suspend delivery of insulin for up to two hours when the sensor glucose value falls below a predefined threshold value. The MiniMed^™ 630G system is not intended to be used directly for making therapy adjustments or preventing or treating hypoglycemia. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare professional. The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a blood glucose meter (BGM). A confirmatory finger stick test via the CONTOUR®NEXT LINK 2.4 blood glucose meter is required prior to making adjustments to diabetes therapy. Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the CONTOUR®NEXT LINK 2.4 meter. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an alternative site (palm) or from a control solution test. 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. 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. Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day, or who are unwilling or unable to maintain contact with their healthcare professional, or whose vision or hearing does not allow recognition of pump signals and alarms. Insulin pumps use U100 rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately.

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^™ Suspend on low feature, it is important to read the SmartGuard^™ Suspend on low information in the Getting Started Guide and the MiniMed^™ 630G System User Guide and discuss proper use of the SmartGuard^™ Suspend on low feature with your healthcare provider.

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 www.medtronicdiabetes.com/importantsafetyinformation for more details.

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