Manage glucose levels with a smart continuous glucose monitoring (CGM) system, powered by Guardian™ Sensor 3.WATCH VIDEO
BENEFITS OF CGM
Real-time glucose readings to compatible devices
Early notification of oncoming lows and highs throughout the day and night
Visibility to the direction your patients' glucose levels are going
Visibility of time spent high, low, and within a glucose range of 70–180 mg/dL
Insights into how food, physical activity, medication, and illness impacts your patients' diabetes1
GUARDIANTM SENSOR 3 POWERS OUR PUMP AND CGM SYSTEMS
Integrated with our latest advancement in insulin pump therapy, the Guardian™ Sensor 3 enables different levels of automation that fit your lifestyle:
Patients can better manage their highs and lows with smart CGM powered by Guardian™ Connect CGM and Guardian™ Sensor 3, the only CGM system that can predict a high or low up to an hour in advance.†
GUARDIANTM SENSOR 3
|Conditions||Abdomen MARD||Buttocks MARD|
|Conditions||Abdomen MARD||Arm MARD|
Refers to Auto Mode. Some user interaction required. Individual results may vary.
Smart CGM predicts future high and low sensor glucose events up to 60 minutes in advance.
MARD is the Mean Absolute Relative Difference between finger-stick measurements and CGM sensor glucose values.
The system is intended to complement, not replace, information obtained from standard blood glucose monitoring devices. All therapy adjustments should be based on measurements obtained from standard blood glucose monitoring devices and not on values provided by the system.
Important Safety Information: MiniMedTM 770G System with SmartGuardTM Technology
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. 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 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 system requires a prescription.
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. All therapy adjustments should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian™ Sensor (3).
All 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). 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. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an alternative site. 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.
WARNING: Do not use the MiniMed™ 770G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed™ 770G system.
Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. The safety of the MiniMed™ 770G system has not been studied in pregnant women. 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 http://www.medtronicdiabetes.com/important-safety-information#minimed-770g and the appropriate user guide at http://www.medtronicdiabetes.com/download-library
Important Safety Information: Guardian™ Connect CGM System
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. 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 system requires a functioning mobile electronic device with correct settings. If the mobile device is not set up or used correctly, you may not receive sensor glucose information or alerts. For complete details of the system and its components, including warnings, contraindications, and precautions, please consult the user guide at http://www.medtronicdiabetes.com/support/download-library/user-guides and http://www.medtronicdiabetes.com/importantsafetyinformation.
For proper instructions on inserting the Guardian™ Sensor 3, visit the support webpage for inserting your sensor.
Important Safety Information: MiniMed™ 630G System with SmartGuard™ Technology
Indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus. 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. Both systems require a prescription. 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. Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day. 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. Insulin pumps use rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately. Replace the infusion set every 48–72 hours, or more frequently per your healthcare professional’s instructions. Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected. The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a blood glucose meter. A confirmatory fingerstick using a CONTOUR®NEXT LINK 2.4 meter is required prior to making adjustments to diabetes therapy. Always check the pump display when using a CONTOUR®NEXT LINK 2.4 meter, to ensure the glucose result shown agrees with the glucose results shown on the meter. Do not calibrate your CGM device or calculate a bolus using a result taken from an Alternative Site (palm) or a result from a control solution test. 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. The MiniMed™ 630G or MiniMed™ 530G system 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 Suspend on low alarm and take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare provider.
See www.medtronicdiabetes.com/importantsafetyinformation and the appropriate user guides for additional important.
Important Safety Information: CareLink™ Personal Therapy Management Software
The CareLink™ software is intended for use as a tool to help manage diabetes. The purpose of the software is to take information transmitted from insulin pumps, glucose meters and continuous glucose monitoring systems, and turn it into CareLink™ reports. The reports provide information that can be used to identify trends and track daily activities-such as carbohydrates consumed, meal times, insulin delivery, and glucose readings. There are two versions of Medtronic MiniMed™ CareLink™ Therapy Management Software available - CareLink™ Personal and CareLink™ Pro.
The CareLink™ software should not be used for the treatment of medical conditions other than diabetes.
The software is intended to be used by or with advice from a healthcare professional familiar with the management of diabetes.
System results are not intended to produce medical advice and should not be relied upon for such purpose.
Patients should monitor their blood glucose levels at least 4 - 6 times a day.
Patients should not make any changes to their treatment without consulting their healthcare professional first.
See Instructions for Use (IFU) for additional details.
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