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. MiniMed™ 630G system is approved for ages 14 years or older with Guardian™ Sensor 3 and MiniMed™ 630G system is approved for ages 16 years or older with Enlite™ sensor. Indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus. Important Safety Information: MiniMed™ 630G System with SmartGuard™ Technology įor proper instructions on inserting the Guardian™ Sensor 3, visit the support webpage for inserting your sensor. For complete details of the system and its components, including warnings, contraindications, and precautions, please consult the user guide at and. If the mobile device is not set up or used correctly, you may not receive sensor glucose information or alerts. The system requires a functioning mobile electronic device with correct settings. The system is intended to complement, not replace, information obtained from standard blood glucose monitoring devices, and is not recommended for people who are unwilling or unable to perform a minimum of two meter blood glucose tests per day, or for people who are unable or unwilling to maintain contact with their healthcare professional. The Guardian™ Connect system requires a prescription and is indicated for continuous or periodic monitoring of glucose levels in the interstitial fluid under the skin, in patients (14 to 75 years of age) with diabetes mellitus. Important Safety Information: Guardian™ Connect CGM System 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 and the appropriate user guide at The safety of the MiniMed™ 770G system has not been studied in pregnant women. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Training is essential to ensure the safe use of the MiniMed™ 770G system. WARNING: Do not use the MiniMed™ 770G system until appropriate training has been received from a healthcare professional. 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 SmartGuard™ Auto Mode for people who require less than 8 units or more than 250 units of total daily insulin per day. 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. 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. All therapy adjustments should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian™ Sensor (3).Īll 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). 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.
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 Accu-Chek® Guide test strips. 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 (SG) values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values. 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.
Important Safety Information: MiniMed TM 770G System with SmartGuard TM Technology
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