The Medtronic MiniMed 670G 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, 7 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 670G System includes SmartGuard technology, which can be programmed to automatically adjust delivery of basal insulin based on Continuous Glucose Monitor sensor glucose values, and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.
The Medtronic MiniMed 670G System consists of the following devices: MiniMed 670G Insulin Pump, the Guardian Link (3) Transmitter, the Guardian Sensor (3), One-press Serter.
The Guardian Sensor (3) is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the Guardian Sensor (3).
WARNING: Medtronic performed an evaluation of the MiniMed 670G system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore this device should not be used in anyone under the age of 7 years old. This device should also not be used in patients who require less than a total daily insulin dose of 8 units per day because the device requires a minimum of 8 units per day to operate safely.
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.
WARNING: Do not use Auto Mode for a period of time after giving a manual injection of insulin by syringe or pen. Manual injections are not accounted for in Auto Mode. Therefore, Auto Mode could deliver too much insulin. Too much insulin may cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection of insulin before you resume Auto Mode.
WARNING: Do not use the Bolus Wizard to calculate a bolus for a period of time after giving a manual injection of insulin by syringe or pen. Manual injections are not accounted for in the active insulin amount. Therefore, the Bolus Wizard could prompt you to deliver more insulin than needed. Too much insulin can cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection of insulin before you can rely on the active insulin calculation of your Bolus Wizard.
Guardian Sensor (3) The Guardian Sensor (3) is intended for use with the MiniMed 670G system to continuously monitor glucose levels in persons with diabetes. It is intended to be used for detecting trends and tracking patterns in persons aged 7 years and older, and to be used by the MiniMed 670G system to automatically adjust basal insulin levels. It is indicated for use as an adjunctive device to complement, not replace, information obtained from standard blood glucose monitoring devices. The sensor is intended for single use. The Guardian Sensor (3) is indicated for up to 7 days of continuous use.
The serter is used as an aid for inserting the sensor. It is indicated for single-patient use and is not intended for multiple patient use.
Guardian Link (3) Transmitter
The Guardian Link (3) Transmitter is intended for use with MiniMed 670G System. The Guardian Link (3) Transmitter powers the glucose sensor, collects and calculates sensor data, and wirelessly sends the data to the MiniMed 670G insulin pump. The Transmitter is intended for single-patient multi-use.
Pump technology is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Do not use the one-press serter on products other than the Enlite sensor or Guardian Sensor (3). Medtronic cannot guarantee the safety or efficacy of this product if used with other products. The reservoir is contraindicated for the infusion of blood or blood products. Infusion sets are indicated for subcutaneous use only and not for intravenous (IV) infusion or the infusion of blood or blood products. Insulin pump technology is not recommended for those who are unwilling to perform at least four blood glucose tests per day. As insulin pumps use rapid acting insulin only, BG testing is required to help identify rapid glycemic deterioration due to insulin infusion occlusion, infusion site problems, insulin stability issues, user error, or a combination of these. Pump technology is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional.
For additional information, please consult the appropriate User Guide.