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Important Safety Information: MiniMed™ 780G system with SmartGuard™ technology with Instinct sensor, Simplera Sync™ sensor, and Guardian™ 4 sensor
The MiniMed™ 780G system is intended for the continuous delivery of basal insulin at selectable rates and the administration of insulin boluses at selectable rates for the management of type 1 diabetes mellitus in persons 7 years of age and older using the Instinct, Simplera Sync™ or Guardian™ 4 sensor, and of type 2 diabetes mellitus in persons 18 years of age and older requiring insulin using the Simplera Sync™ or Guardian™ 4 sensor.
The MiniMed™ 780G System includes SmartGuard™ technology, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values. The system is intended for use with connected sensors, including the Simplera Sync™ and Guardian™ 4 sensors and integrated continuous glucose monitors, including the Instinct sensor, each of which has different wear-time, form factor, insertion site, and other distinguishing characteristics that relate to sensor performance. Consult the appropriate sensor user guide when using the system. Discuss treatment decisions with your HCP.
WARNING: Do not use the SmartGuard™ feature 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 the SmartGuard™ feature.
WARNING: Do not use the MiniMed™ 780G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed™ 780G system.
WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump is in Manual Mode. When the SmartGuard™ feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if your symptoms do not match the SG value, use a blood glucose (BG) meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the infusion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.
Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed™ 780G system has not been studied in pregnant women, persons with type 2 diabetes using the Instinct sensor, or in persons using other anti-hyperglycemic therapies that do not include insulin. For complete details of the system, including accessories and additional important safety information concerning indications, contraindications, warnings and precautions associated with the system and its components, please consult https://www.medtronicdiabetes.com/important-safety-information and the appropriate user guide at https://www.medtronicdiabetes.com/download-library.
Important Safety Information: InPen™
The InPen™ is a home- use reusable pen injector for single- patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self- injection of a desired dose of insulin and for calculating an insulin dose or carbohydrate intake based on user entered data. A healthcare professional must assist in dosage programming of the device prior to use, based on various patient- specific criteria and targets. The InPen™ requires a prescription. For additional product and safety information, please consult the Instructions for Use and bit.ly/InPenRisks.