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. 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.
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. Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the CONTOUR®NEXT LINK 2.4 blood glucose meter. All therapy adjustments should be based on measurements obtained using the CONTOUR®NEXT LINK 2.4 blood glucose meter and not on values provided by the Guardian™ Sensor (3). A confirmatory finger stick test via the CONTOUR®NEXT LINK 2.4 blood glucose meter is required prior to making adjustments to diabetes therapy. The Guardian™ Sensor (3) glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. 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 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, seven 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.
Important Safety Information: MiniMed™ 670G System
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