Editors Note: Due to overwhelming demand, we’ve been able to extend this program to customers through January 31, 2017!
Important Safety Information
The MiniMed 530G and 630G systems with SmartGuard technology are intended for the delivery of insulin and continuous glucose (CGM) monitoring for the management of diabetes mellitus in persons 16 years of age or older who require insulin. 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. The systems are 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 Threshold suspend (530G) or Suspend on low (630G) alarm and take measures to prevent or treat hypoglycemia themselves. The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a blood glucose meter. A confirmatory fingerstick via a CONTOUR®NEXT LINK portfolio meter*, is required prior to making adjustments to diabetes therapy. Always check the pump display when using a CONTOUR®NEXT LINK portfolio meter*, to ensure the glucose result shown agrees with the glucose results shown on the meter. Additional, warnings, precautions and contraindications apply. See www.medtronicdiabetes.com/support/download-library/user-guides and www.medtronicdiabetes.com/importantsafetyinformation for details.
MiniMed® 670G System
The Medtronic MiniMed 670G system requires a prescription and 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, fourteen 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 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.
Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Do not use the 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 therapy 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 therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional.
The safety of the 670G system has not been studied in people with impaired kidney function. Please let your healthcare professional know if you have kidney disease so you and your healthcare professional can determine if the potential benefits of using the system outweigh the risks. The safety of the 670G system has not been studied in pregnant women, people with type 2 diabetes, or in people using other anti-hyperglycemic therapies apart from insulin. Please let your healthcare professional know if any of these conditions apply to you so you and your healthcare professional can determine if the potential benefits of using the system outweigh the risks.
For complete safety information, please consult the appropriate User Guide.
*The CONTOUR®NEXT LINK 2.4 Meter is used with the MiniMed 630G system. The CONTOUR®NEXT LINK Meter is used with the MiniMed 530G system.
At Medtronic Diabetes our vision is to transform diabetes care together for greater freedom and better health. Each word in that statement is important – including the one “together”. We’re a group of passionate people working hard to make a big positive impact on the lives of those with diabetes. But we can’t do it alone. Collaboration is key. With healthcare providers, academic institutions, non-profits and other companies. And, most importantly, with you – the people who live with diabetes every day.