Important safety information

Indications, contraindications, warnings and precautions

All Medtronic MiniMed^™ devices and associated components listed below 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 associated with the use of these systems.

Patients should always discuss potential risks and benefits with a healthcare professional. Please review the product manual prior to use for detailed instructions and disclosure.

For a full list of reference documents please visit our Download Library.

MiniMed^™ 780G system with SmartGuard^™ technology with Simplera Sync^™ sensor

The MiniMed™ 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at 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. The MiniMed™ 780G System includes SmartGuard™ technology, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.

The Simplera Sync™ sensor can be used one time and has a life up to 6 days, followed by a grace period of 24 hours. During the grace period, the sensor will continue to work as it did during the first 6 days, to allow the patient to change their sensor more flexibly. However, some sensors may not survive the full wear period for a variety of reasons. Please be prepared to replace the sensor during the grace period to ensure sensor glucose values continue to be monitored.

The Simplera Sync™ sensor is not intended to be used directly to make therapy adjustments while the MiniMed 780G is operating in manual mode. All therapy adjustments in Manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Simplera Sync™ sensor. The Simplera Sync™ sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Simplera Sync™ sensor in the abdomen or other body sites, including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia.

The Medtronic MiniMed™ 780G System consists of the following devices: MiniMed™ 780G Insulin Pump, Simplera Sync™ sensor, the Accu-Chek™ Guide Link blood glucose meter, and the Accu-Chek™ Guide Test Strips. The system requires a prescription from a healthcare professional.

WARNING: Do not use the SmartGuard™ feature for people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to operate in the SmartGuard™ feature.

WARNING: Do not use the MiniMed™ 780G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed™ 780G system.

WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump is in Manual Mode. When the SmartGuard™ feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if your symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the infusion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.

Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed™ 780G system has not been studied in pregnant women, persons with type 2 diabetes, or in persons using other anti-hyperglycemic therapies that do not include insulin. 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 https://www.medtronicdiabetes.com/important-safety-information#minimed-780g-simplera-sync and the appropriate user guide at https://www.medtronicdiabetes.com/download-library.

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MiniMed^™ 780G system with SmartGuard^™ technology with Guardian^™ 4 sensor

The MiniMed^™ 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at 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. The MiniMed^™ 780G system includes SmartGuard^™ technology, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values.

The Medtronic MiniMed^™ 780G system consists of the following devices: MiniMed^™ 780G insulin pump, the Guardian^™ 4 transmitter, the Guardian^™ 4 sensor, One-press serter, the Accu-Chek^™ Guide Link blood glucose meter, and the Accu-Chek^™ Guide test strips. The system requires a prescription from a healthcare professional.

The Guardian^™ 4 sensor is intended for use with the MiniMed^™ 780G system and the Guardian 4 transmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian^™ 4 sensor is indicated for up to seven days of continuous use.

The Guardian^™ 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed^™ 780G is operating in manual mode. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian^™ 4 sensor. The Guardian^™ 4 sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Guardian^™ 4 sensor in the abdomen or other body sites including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia.

WARNING: Do not use the SmartGuard^™ feature for people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to operate in the SmartGuard^™ feature.

WARNING: Do not use the MiniMed^™ 780G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed^™ 780G system.

WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump is in Manual Mode. When the SmartGuard^™ feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if your symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the infusion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.

Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed^™ 780G system has not been studied in pregnant women, persons with type 2 diabetes, or in persons using other anti-hyperglycemic therapies that do not include insulin. 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 https://www.medtronicdiabetes.com/important-safety-information#minimed-780g and the appropriate user guide at https://www.medtronicdiabetes.com/download-library

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MiniMed^™ 780G system with SmartGuard^™ technology with Guardian^™ Sensor (3)

The MiniMed^™ 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at 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. The MiniMed^™ 780G System includes SmartGuard^™ technology, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose 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^™ 780G System consists of the following devices: MiniMed^™ 780G 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 from a healthcare professional.

The Guardian^™ Sensor (3) is intended for use with the MiniMed^™ 780G system and the Guardian^™ Link (3) transmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian^™ (3) sensor is indicated for seven days of continuous use.

The Guardian^™ Sensor (3) is not intended to be used directly to make therapy adjustment while the MiniMed^™ 780G system is operating in manual mode. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian^™ Sensor (3). The Guardian^™ Sensor (3) is indicated for abdomen and buttock insertion for users ages 7-13 years, and abdomen and arm insertion for user ages 14 years and older.

Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed^™ 780G system has not been studied in pregnant women, persons with type 2 diabetes, or in persons using other anti-hyperglycemic therapies that do not include insulin. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with the system and its components, please consult https://www.medtronicdiabetes.com/important-safety-information#minimed-780g and the appropriate user guide at https://www.medtronicdiabetes.com/download-library

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MiniMed^™ 770G system with SmartGuard^™ 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 values (SG) 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 SmartGuard^™ Auto Mode for people who require less than eight units or more than 250 units of total daily insulin per day. A total daily dose of at least eight units, but no more than 250 units, is required to operate in SmartGuard^™ Auto Mode.

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 https://www.medtronicdiabetes.com/important-safety-information#minimed-770g and the appropriate user guide at http://www.medtronicdiabetes.com/download-library

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MiniMed^™ 670G system

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. 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, and the CONTOUR^®NEXT Link 2.4 Glucose Meter. The system requires a prescription.

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 fourteen 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 and requires a prescription. The Guardian^™ Sensor (3) is indicated for 7 days of continuous use.

One-press serter
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.

CONTOUR^®NEXT LINK 2.4 Glucose Meter
The CONTOUR^®NEXT LINK 2.4 Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single patient use only and should not be shared. The CONTOUR^®NEXT LINK 2.4 wireless blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. The CONTOUR^®NEXT Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The CONTOUR^®NEXT LINK 2.4 wireless blood glucose transmit glucose values to the MiniMed^™ 670G insulin pump and facilitate transfer of information to Medtronic CareLink^™Software through the use of radio frequency communication. The CONTOUR^®NEXT LINK 2.4 Wireless Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for, diabetes mellitus. It is not intended for use on neonates.

Contraindications
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.

For additional information, please consult the appropriate User Guide.

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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 system is 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.

WARNING: The SmartGuard^™ Suspend on low feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again, resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the SmartGuard^™ feature, it is important to read the SmartGuard^™ feature information in the User Guide and discuss proper use of the feature with your healthcare provider.

See https://www.medtronicdiabetes.com/important-safety-information and the appropriate user guides for additional important details.

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MiniMed^™ 530G system with SmartGuard^™ technology

Indications for use

The MiniMed^™ 530G 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 diabetes mellitus in persons, sixteen 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^™ 530G system can be programmed to automatically suspend delivery of insulin for up to two hours when the sensor glucose value falls below a predefined threshold value.

The MiniMed^™ 530G system consists of the following devices that can be used in combination or individually: MiniMed^™ 530G insulin pump, Enlite^™ sensor, Enlite^™ serter, the MiniLink^™ Real-Time transmitter, CONTOUR^®NEXT LINK wireless meter, CareLink^™ Pro therapy management software for diabetes, and CareLink^™ Personal therapy management software for diabetes. The system requires a prescription.

The MiniMed^™ 530G system 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 MiniMed^™ 530G system. The MiniMed^™ 530G system is 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 alarm to 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.

Warning

WARNING: The "SmartGuard^™ feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the Threshold Suspend feature, it is important to read the Threshold Suspend information in the Getting Started Guide and the MiniMed^™ 530G System User Guide and discuss proper use of the Threshold Suspend feature with your healthcare provider.

Contraindications

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.

See Instructions for Use (IFU) for additional details.
http://www.medtronicdiabetes.com/download-library/minimed-530g

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MiniMed^™ Paradigm^™ REAL-Time Revel^™ insulin pump

The Paradigm^™REAL-Time Revel^™ insulin pumps (MMT-523/MMT-723) are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Paradigm^™ REAL-Time Revel^™ system consists of the Paradigm^™ MMT-523/MMT-723 insulin pumps, the Enlite^™ glucose sensor (MMT-7008), and the MiniLink^™ Transmitter (MMT-7703). Use of the Paradigm^™ MMT-523/MMT-723 insulin pumps with the optional sensor and transmitter components is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes in adults (ages 18 and older).

Enlite^™ sensor

The Enlite^™ sensor (MMT-7008) is intended for use with the Paradigm^™ REAL-Time Revel^™ insulin pump systems (MMT-523/MMT-723) to continuously monitor glucose levels in persons with diabetes. Glucose values provided by the Paradigm^™ REAL-Time Revel^™ system are 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 home glucose monitor and not on the sensor glucose readings provided by the Paradigm^™ REAL-Time Revel^™ system.

Meter

The Paradigm^™ pump can be programmed to receive fingerstick blood glucose values transmitted from CONTOUR^®NEXT LINK Wireless Meter for use in the Bolus Wizard^™ calculator and for use as calibration values for the glucose sensor. Glucose values from other glucose meters must be manually entered into the pump. For additional details, including warnings, precautions, and contraindications, please consult the product user guide at https://www.medtronicdiabetes.com/download-library/minimed-revel.

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Medtronic MiniMed^™ insulin infusion pumps

This section applies to insulin infusion function of all MiniMed^™ external pumps, with or without Continuous Glucose Monitoring function, including MiniMed^™ pump model MMT-508 or older, MiniMed^™ Paradigm^™ pumps, MiniMed^™ Paradigm^™ REAL-Time pumps and MiniMed^™ Paradigm^™ REAL-Time Revel pumps.

Please refer to Medtronic MiniMed^™ REAL-Time Continuous Glucose Monitoring section for important safety information regarding Continuous Glucose Monitoring function of the MiniMed^™ Paradigm^™ REAL-Time pumps or MiniMed^™ Paradigm^™ REAL-Time Revel^™ pumps.

Indications for use

The insulin pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus. Age restrictions apply depending on pump model.

Contraindications

Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day and to maintain contact with their healthcare professional.

Successful insulin pump therapy requires sufficient vision or hearing to allow recognition of the pump signals and alarms.

Warnings/precautions

Insulin pump therapy uses only rapid-acting U100 insulin. Therefore, any interruption in insulin delivery (due to infusion set clogs, leaks, loss of insulin potency, or pump malfunction) may result in hyperglycemia (high blood glucose) within 2-to-4 hours and, subsequently, the rapid onset of diabetic ketoacidosis (DKA) within 4-to-10 hours. The onset of stress or illness (caused by infection or an emotional event) can also result in a rise of blood glucose levels and the development of DKA.

Establish a plan with your healthcare professional for rapidly identifying and treating both hypoglycemia and hyperglycemia, to prevent the onset of DKA and possible hospitalization. Act quickly to respond to out-of-target blood glucose. Notify your healthcare professional of low blood glucose requiring assistance or of high blood glucose, or of an increased frequency in low or high blood glucose.

If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately. Always carry an "emergency kit" of supplies that includes insulin, syringes or pens, blood glucose test strips and meter and urine ketone test strips, in case you develop a problem with your pump and your insulin delivery is stopped, or in case of high blood glucose. You should check for urine or blood ketones whenever your blood glucose is elevated above 250 mg/dL (13.7 mmol/L) and take an insulin injection if appropriate. For proper infusion set insertion techniques, follow the advice of your healthcare professional and the Instructions for Use included with the product. Change your infusion site every 2-to-3 days, according to your healthcare professional's suggestions, and according to the Instructions for Use that accompany the infusion sets and reservoirs. Check the amount of insulin remaining in your reservoir at least once a day. Infection at the infusion site is a risk of pump therapy. Check the infusion site often for redness, irritation and inflammation.

Bolus Wizard^™ feature

If you give yourself insulin by using a syringe, the Bolus Wizard^™ feature will not be able to correctly determine the active insulin in your system. Consult with your healthcare professional on how long you need to wait after a manual injection before you can rely on the active insulin calculation of your Bolus Wizard^™ feature.

Use only the reservoir and infusion sets specifically designed for your pump. Use of non-Medtronic MiniMed^™ reservoirs and/or infusion sets may interfere with proper pump operation. Do not modify your reservoir or infusion set.

Tubing connector

If insulin, or any liquid, gets inside the tubing connector, it can temporarily block the vents that allow the pump to properly prime the infusion set. This may result in the delivery of too little or too much insulin, which can cause hypoglycemia or hyperglycemia. To prevent liquid from getting inside the tubing connector, after you fill the reservoir make sure you hold the insulin vial upright when you remove the reservoir from the transfer guard. If you do not hold the insulin vial upright, insulin can get on the top of the reservoir and could transfer liquid into the tubing connector. If any liquid gets on the top of the reservoir or inside the tubing connector when you change your infusion set, start over with a new reservoir and infusion set.

If you are going to have an X-ray, CT scan, MRI or any other type of radiation therapy, take your pump and remote control off, and remove them from the treatment area.

The pump is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide.

Do not use any lubricants on the pump mechanism. Do not use hot air to dry your pump. This may damage your pump's internal electronics.

Although the pump has multiple safety alarms, it cannot notify you if the set is leaking or the insulin has lost its potency. It is essential; therefore, that you test your blood glucose levels at least four times per day. If your blood glucose is out of range, check the pump and the infusion set to ensure that the necessary amount of insulin is being delivered.

See Instructions for Use (IFU) for additional details.
https://www.medtronicdiabetes.com/download-library

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CareLink^™ personal therapy management software

Indications for use

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.

Contraindications

The CareLink^™ software should not be used for the treatment of medical conditions other than diabetes.

Warnings/precautions

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.
http://www.medtronicdiabetes.com/download-library/carelink

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Medtronic MiniMed^™ Professional Continuous Glucose Monitoring (CGM) system

The Professional CGM System consists of the CGMS iPro^™ Continuous Glucose Recorder and accessories, or CGMS Gold and accessories, as well as separately available glucose sensor.

Please refer to Medtronic MiniMed^™ Glucose Sensor section for important safety information regarding Sof-sensor glucose sensor.

Indications for use

The CGMS iPro^™ Digital Recorder or CGMS Gold is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using standard home glucose monitoring devices. The information collected by the CGMS iPro^™ Digital Recorder or CGMS Gold may be downloaded and displayed on a computer and reviewed by healthcare professionals. This information may allow identification of patterns of glucose-level excursions above or below the desired range, facilitating therapy adjustments which may minimize these excursions.

The CGMS iPro^™ Digital Recorder or CGMS Gold:

Will not allow readings to be made available directly to patients in real time.
Provides readings that will be available for review by physicians after the recording interval (72 hours).
Is currently intended for occasional rather than everyday use.
Is not intended to change patient management based on the numbers generated, but to guide future management of the patient based on response to trends noticed. That is, these trends or patterns may be used to suggest when to take fingerstick glucose measurements to better manage the patient.

Contraindications

Do not use magnetic mattress pads while wearing the CGMS iPro^™ Digital Recorder. The magnetic mattress pad will cause the digital recorder to frequently enter a transmission mode that will quickly drain the rechargeable battery and will temporarily disable data collection. Therefore, there will be sensor data gaps and the digital recorder is likely to not function for the entire 3-day duration. The magnetic mattress pad will not, however, affect the accuracy of the sensor readings that are collected, nor will it lead to any unsafe conditions.

Do not expose your digital recorder to MRI equipment or other devices that generate strong magnetic fields. If your digital recorder is inadvertently exposed to a strong magnetic field, discontinue use and contact your physician.

Successful operation of the CGMS System Gold requires some visual and auditory acuity. Use of the CGMS System Gold is not recommended for patients whose impaired vision or hearing does not allow full recognition of the Monitor signals and alarms, or who do not have a caregiver that can perform this function for them.

Warnings/precautions

Product contains small parts and may pose a choking hazard for young children.

Do not place the CGMS iPro^™ Magnetic Wand or any other magnet within 1.5 inches (3.8cm) of the CGMS iPro^™ Digital Recorder except while performing patient set-up and data download procedures. Premature battery discharge may occur.

Do not insert the glucose sensor with attached CGMS iPro^™ Digital Recorder closer than two to three inches (5.08 - 7.62 cm) from the insulin pump. The use of the CGMS iPro^™ Magnetic Wand may inadvertently cause incorrect operation of the pump.

If performing multiple CGMS iPro^™ Digital Recorder studies on the same patient, establish a rotation schedule for choosing new glucose sensor sites. Avoid sites that are constrained by clothing, have scar tissue, or are subject to rigorous movement during exercise.

If any blood gets inside the CGMS iPro^™ Digital Recorder connector, the CGMS iPro^™ Digital Recorder must be discarded.

CGMS System Gold users should be educated to program and operate the Monitor and respond to alarm conditions prior to attempted use of the system.

Using the CGMS Gold Monitor in close proximity to strong electromagnetic sources, such as medical imaging equipment, television and radio transmitters and high-voltage power lines, is not recommended.

The current and voltage signals shown in the CGMS Gold Monitor are to be used only for finding potential problems with the CGMS System Gold and do not indicate the current glucose value.

See Instructions for Use (IFU) for additional details.
http://www.medtronicdiabetes.com/download-library/cgm

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Medtronic MiniMed^™ REAL-Time Continuous Glucose Monitoring (CGM) system

The REAL-Time CGM System consists of the Guardian^™ REAL-Time Continuous Glucose Monitor or MiniMed^™ Paradigm^™ REAL-Time (Revel) Pump, as well as separately available glucose sensor and MiniLink^™ REAL-Time transmitter.

Indications for use

The REAL-Time CGM Device, with the separately available glucose sensor and transmitter, are indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes in adults (age 18 or older).

Information provided by the REAL-Time CGM devices is intended to supplement, not replace, blood glucose information obtained using standard home glucose monitoring devices. Glucose values provided by the REAL-Time CGM device are 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 home glucose monitor and not on the sensor glucose readings provided by the REAL-Time CGM devices.

The MiniLink^™ REAL-Time transmitter is indicated for use as a component of select Medtronic continuous glucose sensing systems and Medtronic MiniMed^™ sensor-enabled pump systems.

Contraindications

Glucose monitoring therapy is not recommended for people who are unwilling or unable to perform a minimum of four meter blood glucose tests per day and to maintain contact with their healthcare professional. Use of a glucose monitoring system and requires sufficient vision or hearing to allow recognition of the monitor signals and alarms.

Do not expose your MiniLink^™ REAL-Time transmitter to MRI equipment or other devices that generate strong magnetic fields. If your MiniLink^™ Real-Time transmitter is inadvertently exposed to a strong magnetic field, discontinue use and contact your physician.

Warnings/precautions

Although the CGM device has multiple safety alarms, it cannot tell you about all potential problems. You must test your blood glucose levels at least two times per day. Check your blood glucose using your blood glucose meter before making any therapy changes.

Blood glucose measurements taken when your glucose levels change rapidly should not be used to calibrate your system.

Product contains small parts and may pose a choking hazard for young children. Do not use the MiniLink Real-Time transmitter to send glucose readings to the monitor while onboard an aircraft. Disconnect the MiniLink^™ REAL-Time transmitter from the sensor while travelling on an aircraft or if interference with other transmitting devices occurs.

See Instructions for Use (IFU) for additional details.
http://www.medtronicdiabetes.com/download-library/guardian-real-time

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iPro^™2 Professional Continuous Glucose Monitoring (CGM)

The iPro2^™ digital recorder is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using standard home glucose monitoring devices. The information collected by the iPro2^™ digital recorder may be uploaded to a computer (with Internet access) and reviewed by healthcare professionals. The information may allow identification of patterns of glucose-level excursions above and below a desired range, facilitating therapy adjustments, which may minimize these excursions.

The iPro2^™ system is intended for prescription use only.
Does not allow data to me made available directly to patients in real time
Provides data that will be available for review by physicians after the recording interval (up to72 hours for Sof-sensor glucose sensor; 144 hours for Enlite^™ sensor)
Is intended for occasional rather than everyday use
Is to be only used as a supplement to, not a replacement for, standard invasive measurement

See Instructions for Use (IFU) for additional details.
http://www.medtronicdiabetes.com/download-library/ipro-2

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MiniMed^™ Sof-sensor^™ glucose sensor

The glucose sensor (Sof-sensor) can be used either with a REAL-Time CGM System, or with a Professional CGM System.

Please refer to Medtronic MiniMed^™ REAL-Time CGM System, or Medtronic MiniMed^™ Professional CGM System sections for important safety information regarding the REAL-Time CGM System (including MiniLink REAL-Time Transmitter) and Professional CGM System, respectively.

Indications for use

The Sof-sensor glucose sensor is intended for use with Medtronic MiniMed^™ glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

Warnings/precautions

Failure to follow instructions may result in pain or injury.

Bleeding, swelling, irritation or infection at the insertion site are possible risks associated with inserting the sensor and may result from improper insertion and maintenance of insertion site.

After insertion, wait 5 minutes before attaching the transmitter to watch for bleeding at the insertion site. If bleeding occurs, apply steady pressure using a sterile gauze or clean cloth for up to 3 minutes.

If bleeding stops:

Attach the sensor to the transmitter.

If bleeding does NOT stop:

CAUTION: DO NOT attach the sensor to the transmitter.

Remove the sensor and discard.
Check the site for redness, bleeding, irritation, pain, tenderness or inflammation and treat accordingly.
Insert a new sensor in a different location.

The sensor is sterile and non-pyrogenic, unless the package has been opened or damaged. Do not use any glucose sensor if its sterile package has been previously opened or damaged. Always inspect packaging for damage prior to use.

If sensor is not securely placed in Sen-serter^™ prior to insertion, pain or minor injury may occur.

Remove needle guard before inserting sensor. If you develop inflammation, redness, soreness or tenderness at insertion site, or if you experience unexplained fevers, remove sensor. Check site often for these conditions and to ensure sensor is still in place, especially before going to bed and upon waking.

For single patient, one time use only. Reuse of the sensor may cause damage to the sensor surface, and lead to inaccurate glucose values, site irritation and/or infection.

See Instructions for Use (IFU) for additional details.
http://www.medtronicdiabetes.com/download-library/sof-sensor

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Guardian^™ sensor 3

Indications for use

The Guardian^™ Sensor (3) is intended for use with the Medtronic MiniMed^™ 630G, MiniMed^™ 670G, and Guardian^™ Connect systems to continuously monitor glucose levels in persons with diabetes. It is intended to be used for detecting trends and tracking patterns in persons aged fourteen years and older. It is also intended to be used by the MiniMed^™ 670G system to automatically adjust basal insulin levels. It is indicated for use - 2 - as an adjunctive device to complement, not replace, information obtained from standard blood glucose monitoring devices. The sensor is intended for single use and requires a prescription. The Guardian^™ Sensor (3) is indicated for 7 days of continuous use.

Contraindications

None known

General warnings

Read this entire user guide before attempting to insert the sensor. The one-press serter (MMT-7512) does not work the same as other Medtronic^™ insertion devices. Failure to follow directions or using a different serter may result in improper insertion, pain, or injury. The Guardian^™ Sensor (3) was developed, and its performance evaluated, for use with the approved system only. The sensor should not be used as part of unapproved systems, as it may provide inaccurate sensor glucose readings.

The sensor is designed to work with approved transmitters only. It is not interchangeable with transmitters and recorders that are not compatible with the sensor. Connecting your sensor to a transmitter or recorder that is not approved for use with the sensor may cause damage to the components or inaccurate sensor glucose values.

Do not make therapy decisions based on sensor glucose values because sensor glucose (SG) and blood glucose (BG) values may differ. If your sensor glucose reading is low or high, or if you feel symptoms of low or high glucose, confirm your blood glucose with your meter using a fingerstick blood sample prior to making therapy decisions.

Taking medications with acetaminophen, such as Tylenol^™*, fever reducers, or cold medicine, while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person. Always check the label of any medications to confirm whether acetaminophen is an active ingredient.

Do not expose your sensor to MRI equipment, diathermy devices, or other devices that generate strong magnetic fields as the performance of the sensor has not been evaluated under those conditions and may be unsafe. If your sensor is inadvertently exposed to a strong magnetic field, discontinue use and contact the 24-Hour Technical Support for further assistance.

A retractable needle is attached to the sensor, and minimal blood splatter may occur. If you are a healthcare professional or caregiver, wrap sterile gauze around the sensor to minimize contact with blood. Keep as much distance as possible between you and the patient when removing the needle.

Keep the needle housing within sight at all times to avoid an accidental needlestick or puncture. Always inspect the packaging for damage prior to use. Sensors are sterile and non-pyrogenic, unless the package has been opened or damaged. Do not use the sensor if the sterile package has been opened or damaged. Use of an unsterile sensor can cause site infection. This product contains small parts and may pose a choking hazard for children. Watch for bleeding at the insertion site (under, around, or on top of the sensor).

If bleeding occurs, do the following:

Apply steady pressure, using sterile gauze or a clean cloth placed on top of the sensor, for up to three minutes. The use of unsterile gauze can cause site infection.
If bleeding stops, connect the transmitter to the sensor. If bleeding does not stop, do not connect the transmitter to the sensor. This can allow blood to get into the transmitter connector and could damage the device.

If bleeding continues, causes excessive pain or discomfort, or is significantly visible in the plastic base of the sensor, do the following:

Remove the sensor and continue to apply steady pressure until the bleeding stops. Discard the sensor in a sharps container.
Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation. Treat based on instructions from your healthcare professional.
Insert a new sensor in a different location.

General precautions

Wash your hands with soap and water before inserting the sensor to help prevent site infection.
Wear gloves when inserting the sensor into someone other than yourself to avoid contact with patient blood.
Do not insert the sensor through tape. Inserting the sensor through tape may cause improper sensor insertion and function.
Only use alcohol to prepare the insertion site, to ensure that residue is not left on the skin. Rotate the sensor insertion site so that sites do not become overused.
Discard used sensors and needle housings in a sharps container after each use to avoid accidental needlestick or puncture.
Do not clean, resterilize, or try to extract the needle from the needle housing. An accidental needlestick or puncture may occur.
Do not reuse sensors. Reuse of a sensor may cause damage to the sensor surface and lead to inaccurate glucose values, site irritation, or infection.

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Enlite^™ sensor

Indications for use

The sensor is intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

Contraindications

None known

General warnings

Do not make therapy treatment decisions based on sensor glucose values because sensor glucose and blood glucose values may differ. If your sensor glucose reading is high or low, or if you feel symptoms of high or low glucose, confirm your blood glucose with your BG meter prior to making therapy decisions to avoid severe high or low glucose conditions.

Keep an arm’s length between you and the patient when removing the needle. A retractable needle is attached to the sensor and minimal blood splatter may occur.

Keep the needle housing within sight at all times to avoid accidental needle stick injury.

Always inspect the packaging for damage prior to use. Sensors are sterile and nonpyrogenic, unless the package has been opened or damaged. Do not use any of the sensors if the sterile package has been opened or damaged. Use of an unsterile sensor can cause site infection.

Watch for bleeding at the insertion site (under, around, or on top of the sensor). Apply steady pressure using sterile gauze or a clean cloth placed on top of the sensor for up to three minutes, if bleeding occurs. The use of unsterile gauze can cause an infection.

Do not attach the transmitter to the sensor, if bleeding does not stop. Blood can get into the transmitter’s connector, which can damage the device. Remove the sensor and continue to apply steady pressure until the bleeding stops.

Remove the sensor and discard.
Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation and treat accordingly.
Insert a new sensor in a different location.

Keep the sensor away from children. This product contains small parts and may pose a choking hazard.

General precautions

Wash your hands with soap and water before inserting the sensor to help prevent site infection.

Wear gloves when inserting the sensor into someone other than yourself to avoid contact with patient blood.

Do not insert the sensor through tape to ensure proper sensor function and insertion.

Only use alcohol to prepare the insertion site to ensure that residue is not left on the skin.

Rotate the sensor insertion site so that sites do not become overused.

Discard used sensors and needle housings in a sharps container after each use to avoid accidental needle stick injury.

Do not clean, resterilize, or try to extract the needle from the needle housing. An accidental needle stick may occur.

Do not reuse sensors. Reuse of the sensor may cause damage to the sensor surface and lead to inaccurate glucose values, site irritation, or infection

See Instructions for Use (IFU) for additional details.
http://www.medtronicdiabetes.com/download-library/enlite-sensor

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One-press serter

Indications for use

The serter is used as an aid for inserting the Enlite^™ sensor. It is indicated for single-patient use and is not intended for multiple patient use.

Contraindications

Do not use the serter on products other than the Enlite^™ sensor. Medtronic cannot guarantee the safety or efficacy of this product if used with other products.

General warnings

Read this entire user guide before attempting to insert the sensor. The serter does not work the same as other Medtronic insertion devices. Failure to follow directions may result in improper insertion, pain, or injury.

Contact the 24-Hour Technical Support or your local representative, if you have questions or concerns. Do not make therapy decisions based on sensor glucose values because sensor glucose and blood glucose values may differ. If your sensor glucose reading is low or high, or if you feel symptoms of low or high glucose, do the following prior to making therapy decisions. Confirm your blood glucose with your BG meter using a fingerstick blood sample.

A retractable needle is attached to the sensor and minimal blood splatter may occur. If you are a healthcare professional or caregiver, wrap sterile gauze around the sensor to minimize contact with blood. Keep as much distance as possible between you and the patient when removing the needle.

Keep the needle housing within sight at all times to avoid an accidental needlestick or puncture.

Always inspect the sensor packaging for damage before use. Sensors are sterile and non-pyrogenic, unless the package has been opened or damaged. Do not use the sensor if the sterile package has been opened or damaged. Use of an unsterile sensor can cause site infection.

Watch for bleeding at the insertion site (under, around, or on top of the sensor).

If bleeding occurs, do the following:

Apply steady pressure using sterile gauze or a clean cloth, placed on top of the sensor for up to three minutes. The use of unsterile gauze can cause site infection.
If bleeding stops, connect the transmitter to the sensor. If bleeding does not stop, do not connect the transmitter to the sensor because blood can get into the transmitter connector, and could damage the device.

If bleeding continues, do the following:

Remove the sensor and continue to apply steady pressure until the bleeding stops. Discard the sensor in a sharps container.
Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation. Treat based on instructions from your healthcare professional.
Insert a new sensor in a different location.

Make sure the sensor is securely placed in the serter to avoid improper insertion, pain, or minor injury.

Keep the serter away from children. This product contains small parts and may pose a choking hazard.

Refer to the Enlite^™ User Guide for additional sensor related warnings.

General precautions

Wash your hands with soap and water before inserting the sensor to help prevent site infection.

If you are a healthcare professional or caregiver, wear gloves when inserting the sensor into someone other than yourself to avoid contact with patient blood.

Do not insert the sensor through tape. Inserting the sensor through tape may cause improper sensor insertion and function.

Only use alcohol to prepare the insertion site, to ensure that residue is not left on the skin.

Rotate the sensor insertion sites so that they do not become overused.

Discard used sensors and needle housings in a sharps container after each use to avoid accidental needlestick or puncture.

Do not clean, resterilize, or try to extract the needle from the needle housing. An accidental needlestick or puncture may occur.

Do not reuse sensors. Reuse of a sensor may cause damage to the sensor surface and lead to inaccurate glucose values, site irritation, or infection.

Always make sure the sensor is firmly attached so that it does not come out of your body. Factors that may increase the likelihood of the sensor falling off include increased physical activity (particularly for younger patients) and improper taping technique.

See Instructions for Use (IFU) for additional details.
http://www.medtronicdiabetes.com/download-library/enlite-sensor

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Enlite^™ serter

Indications for use

The Enlite^™ serter is indicated for use for a single patient as an aid to insert the Enlite^™ glucose sensor (sensor).

Contraindications

Do not use the Enlite^™ serter on products other than the Enlite^™ sensor. Medtronic cannot guarantee this product’s safety or efficacy if used on other products.

General warnings

Read this entire user guide before attempting to insert the sensor. The Enlite^™ serter does not work the same as other Medtronic insertion devices. The serter injects the sensor into the insertion site when the button is released, not when the button is pressed.

Failure to follow directions may result in pain or injury.

Do not make therapy treatment decisions based on sensor glucose values because sensor glucose and blood glucose values may differ. If your sensor glucose reading is low or high, or if you feel symptoms of low or high glucose, confirm your blood glucose with your BG meter prior to making therapy decisions to avoid severe low or high glucose conditions.

Keep an arm’s length between you and the patient when removing the needle. A retractable needle is attached to the sensor and minimal blood splatter may occur.

Keep the needle housing within sight at all times to avoid accidental needle stick injury.

Always inspect the sensor packaging for damage prior to use. Sensors are sterile and nonpyrogenic, unless the package has been opened or damaged. Do not use any of the sensors if the sterile package has been opened or damaged. Use of an unsterile sensor can cause site infection.

Do not attach the transmitter to the sensor, if bleeding does not stop. Blood can get into the transmitter connector, which may damage the device. Remove the sensor and continue to apply steady pressure until the bleeding stops.

Remove the sensor and discard in a sharps container.
Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation and treat accordingly.
Insert a new sensor in a different location.

Make sure the sensor is securely placed in the serter to avoid pain or minor injury.

Keep the serter away from children. This product contains small parts and may pose a choking hazard.

Refer to the Enlite^™ Glucose Sensor User Guide for additional sensor related warnings.

General precautions

Wash your hands with soap and water before inserting the sensor to help prevent site infection.

Wear gloves when inserting the sensor into someone other than yourself to avoid contact with patient blood.

Do not insert the sensor through tape to ensure proper sensor function and insertion.

Only use alcohol to prepare the insertion site to ensure that residue is not left on the skin.

Rotate the sensor insertion site so that sites do not become overused.

Discard used sensors and needle housings in a sharps container after each use to avoid accidental needle stick injury.

Do not clean, resterilize, or try to extract the needle from the needle housing. An accidental needle stick may occur.

Do not reuse sensors. Reuse of the sensor may cause damage to the sensor surface and lead to inaccurate glucose values, site irritation, or infection.

See Instructions for Use (IFU) for additional details.
http://www.medtronicdiabetes.com/download-library/enlite-serter

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Roche Accu-Chek^® Guide Link blood glucose monitoring system

The Accu-Chek^® Guide Link Blood Glucose Monitoring System is comprised of the Accu-Chek^® Guide Link meter and the Accu-Chek^® Guide test strips.

The Accu-Chek^® Guide Link Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.

The Accu-Chek^® Guide Link Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes

The Accu-Chek^® Guide Link Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

This system is not for use in diagnosing or screening for diabetes mellitus and not for neonatal use.

Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Accu-Chek^® Guide Link Blood Glucose Monitoring System is intended to be used to wirelessly transmit glucose values to the MiniMed 770G system with Bluetooth wireless technology through the use of Bluetooth low energy communication.

Warning:

Do not use Alternative Site Testing to calibrate a continuous glucose monitoring system.
Do not use Alternative Site Testing to make insulin dosing calculations.

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CONTOUR^®NEXT LINK 2.4 meter

Indications for use:

The CONTOUR^®NEXT LINK 2.4 wireless blood glucose monitoring system is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR^®NEXT LINK 2.4 wireless blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. The system consists of a CONTOUR^®NEXT LINK 2.4 wireless blood glucose meter, CONTOUR^®NEXT test strips and CONTOUR^®NEXT control solutions.

CONTOUR^®NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.

The CONTOUR^®NEXT control solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check.

The CONTOUR^®NEXT LINK 2.4 wireless blood glucose monitoring system is intended to be used to transmit glucose values to MiniMed^™ 630G Pump and facilitate transfer of information to Medtronic CareLink^™ Software through use of radio frequency communication.

The CONTOUR^®NEXT LINK 2.4 wireless blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

Warnings/precautions:

Meter

Do not calibrate your continuous glucose monitoring device from an Alternative Site Testing (AST) or control solution test result.
Do not calculate a bolus based on an AST or control solution test result.
Do not send an out of range control solution test result to your pump. If the control solution test result is out of range, the result may be transmitted to your pump when in “Always” send mode.
Always check the display on your pump to ensure that the glucose result shown agrees with the glucose result shown on the meter.

General warnings:

Meter

Serious Illness
- Capillary (fingerstick or Alternative Site) blood glucose testing may not be clinically appropriate when peripheral flow is decreased. Shock, severe hypotension, hyperosmolar hyperglycemia, diabetic ketoacidosis, and occurrence of severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood.^1,2,3
- Keep out of reach of children. This kit contains small parts which could cause suffocation if accidentally swallowed.
Talk to Your Health Care Professional
- Before setting any Target ranges or High or Low Alerts on your meter.
- Before changing your medication based on test results.
- If your blood sugar reading is under 50 mg/dL, follow medical advice immediately.
- If your blood sugar reading is over 250 mg/dL, wash and dry your hands well and repeat the test with a new strip. If you get a similar result, call your health care professional as soon as possible.
- About whether Alternative Site Testing (AST) is appropriate for you.
Potential Biohazard
- Always wash and dry your hands well with soap and water before and after testing, handling the meter, lancing device or test strips.
- The meter, lancing device and lancets are for single person use. Do not share them with anyone including other family members. Do not use on multiple persons.^4,5
- All parts of this kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection. For Cleaning and Disinfection instructions, please refer to the meter’s user guide.
- The lancing device provided by Ascensia Diabetes Care is intended for self-testing by a single patient. It must not be used on more than one person due to the risk of infection.
- Use a new lancet each time you test because it is no longer sterile after use.
- Always dispose of test strips and lancets as medical waste or as advised by your health care professional. All products that come in contact with human blood should be handled as if capable of transmitting infectious diseases.

Precautions:

Read your CONTOUR^®NEXT LINK 2.4 user guide, the lancing device package insert, your Medtronic device user guide and all instructional materials provided in your meter kit before testing.
Please follow all instructions for use and care exactly as described to help avoid inaccurate results.
Examine product for missing, damaged, or broken parts. If the test strip bottle is open inside a new box of strips, do not use those strips. For replacement parts, contact Ascensia Diabetes Care Customer Service at 1.800.848.8100.
The CONTOUR^®NEXT LINK 2.4 meter from Ascensia Diabetes Care only works with CONTOUR^®NEXT test strips and CONTOUR^®NEXT control solutions.
Always keep the CONTOUR^®NEXT test strips in their original bottle. Tightly close the bottle immediately after removing a test strip. The bottle is designed to keep the test strips dry. Avoid exposing meter and test strips to excessive humidity, heat, cold, dust, and dirt. Exposure to room humidity from leaving the bottle open or not storing the strips in their original bottle can damage your test strips. This could lead to inaccurate results. Do not use a test strip that appears damaged or has been used.
Check the expiration dates on your test strips and control solution. Do not use the test strips or control solution if the expiration date printed on the bottle label and carton has passed. This can cause inaccurate results. For the control solution, do not use if it has been 6 months since you first opened the bottle. After first opening the bottle, write the 6-month discard date on the control solution label.
If your control solution test result is out of range, contact Ascensia Diabetes Care Customer Service at 1.800.848.8100. Do not use the meter for blood glucose testing until you resolve this issue.
The meter has been designed to give accurate results at temperatures between 41° to 113°F. If you are outside this range, you should not test. Whenever the meter is moved from one location to another, allow approximately 20 minutes for the meter to adjust to the temperature of the new location before performing a blood glucose test.
Do not perform a blood glucose test when the CONTOUR^®NEXT LINK 2.4 meter is connected to a computer.
Use only approved cables or wall charger from the manufacturer or a 5V charger approved by a certified body such as UL or TUV.
The CONTOUR^®NEXT LINK 2.4 meter from Ascensia Diabetes Care has been preset and locked to display results in mg/dL (milligrams of glucose per deciliter of blood).
- Results in m g/dL will never have a decimal point;
- Results in m mol/L will always have a decimal point.
- Example: 93 mg/dL or 5.2 mmol/L
Check your display screen to be sure the results are shown the right way. If not, please contact Ascensia Diabetes Care Customer Service at 1.800.848.8100.
The CONTOUR^®NEXT LINK 2.4 wireless blood glucose monitoring system from Ascensia Diabetes Care has a measuring range of 20 mg/dL to 600 mg/dL.

For results under 20 mg/dL or over 600 mg/dL:

If your blood sugar reading is under 20 mg/dL, the “Follow Medical Advice Immediately” screen will display and the meter will beep twice. Contact your health care professional.
If your blood sugar reading is over 600 mg/dL the next screen will tell you to retest. The meter will beep twice. If results are still over 600 mg/dL, “Follow Medical Advice Immediately” is displayed.
Please be aware that USB ports in some computers and self-powered USB hubs can become much warmer than the room. A USB extension cable is available. If you wish to test immediately after disconnecting from your computer, please use the USB cable to protect the meter from exposure to heat created by the computer.

For more information, please visit http://www.medtronicdiabetes.com/download-library/glucose-meters

¹Wickham NWR, Achar KN, Cove DH. Unreliability of capillary blood glucose in peripheral vascular disease. Practical Diabetes. 1986;3(2):100.
² Atkin, S. et al. Fingerstick Glucose Determination in Shock. Ann Intern Med.1991;114:1020-1024.
³ Desachy A, Vuagnat AC, et al. Accuracy of bedside glucometry in critically ill patients: influence of clinical characteristics and perfusion index. Mayo Clin Proc. 2008;83(4): 400-405.
⁴ FDA Public Health Notification: Use of fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication: Update 11/20/2010. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
⁵ CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens (2010). http://www.cdc.gov/injectionsafety/FIngerstick-DevicesBGM.html

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Medtronic infusion sets

Infusion sets require a prescription and are indicated for the subcutaneous infusion of insulin from an infusion pump. Infusion sets are indicated for single use. Refer to the Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.

Infusion sets are contraindicated for intravenous (IV) infusion and the infusion of blood or blood products.

Do not use the infusion sets beyond the Use-by date, or if the package is opened or damaged, as sterility may be compromised.

Inaccurate medication delivery, infection and/or site irritation may result from improper insertion and maintenance of the infusion site. Before insertion, clean the insertion site with isopropyl alcohol. Remove the needle guard before inserting the infusion set.

Fill the tubing completely with insulin before insertion. Do not leave air in the tubing. An uncontrolled amount of insulin may be delivered if air is present.

For sets that make use of a soft canula (all but Sure-T), check frequently to make sure the soft cannula remains firmly in place as you may not feel pain if it pulls out. The soft cannula must always be completely inserted to receive the full amount of medication.

If the infusion site becomes inflamed, replace the set, and use a new site until the first site has healed.

Replace the infusion set if the tape becomes loose, or if the soft cannula becomes fully or partially dislodged from the skin.

If using this infusion set for the first time, do the first set-up in the presence of your healthcare professional.

Follow the instructions provided and replace as indicated in those instructions.

The Extended infusion may be worn for a maximum of seven days, or according to the insulin labeling, whichever duration is shorter. Other sets may only be worn for a maximum of 48 or 72 hours, depending on set type. Consult the instructions for the set of interest at https://www.medtronicdiabetes.com/support/download-library/user-guides.

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Medtronic Extended^™ infusion set

The Extended^™ Infusion Set is indicated for up to 7 days of wear for the subcutaneous infusion of insulin from an infusion pump. It is NOT indicated for intravenous (IV) infusion or the infusion of blood or blood products. Inaccurate medication delivery, infection and/or site irritation may result from improper insertion and maintenance of the infusion site. Before insertion, clean the insertion site with isopropyl alcohol. Remove the needle guard before inserting the infusion set. If using this infusion set for the first time, do the first set-up in the presence of your healthcare professional. Do not leave air in the infusion set. Prime completely. Check frequently to make sure the soft cannula remains firmly in place as you may not feel pain if it pulls out. The soft cannula must always be completely inserted to receive the full amount of medication. If the infusion site becomes inflamed, replace the set, and use a new site until the first site has healed. Replace the infusion set if the tape becomes loose, or if the soft cannula becomes fully or partially dislodged from the skin. Regularly replace the infusion set as indicated in the instructions for use, or per the insulin labeling, whichever duration is shorter. For more details, see https://www.medtronicdiabetes.com/important-safety-information.

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Medtronic reservoirs

MiniMed reservoirs are indicated for the subcutaneous infusion of insulin from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.

MiniMed reservoirs are contraindicated for the infusion of blood or blood products.

Do not use the reservoir longer than indicated, as this may result in the delivery of too little insulin, which may cause hyperglycemia.

The reservoir and transfer guard are sterile, nonpyrogenic, and for single use only. Do not clean or resterilize. Reuse of the reservoir may lead to any one of the following: insulin degradation, infection, inaccurate medication delivery, or leaks, which may cause damage to the pump.

Do not use if the package has been opened or damaged.

Read all instructions carefully before using the MiniMed™ Reservoir. Conduct the first setup in the presence of a healthcare professional.

Use the Extended reservoir for a maximum of 7 days, or according to the insulin labeling, whichever duration is shorter. Do not use with two- or three-day infusion sets. The Extended reservoir may only be used for up to seven days with use of the Medtronic Extended infusion set. Use of the reservoir with two- or three-day infusion sets may lead to hyperglycemia or diabetic ketoacidosis.

Consult https://www.medtronicdiabetes.com/support/download-library/user-guides for full details.

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i-Port Advance^™ injection port

Indications for use

i-Port Advance^™ injection port is indicated for patients who administer or receive multiple daily subcutaneous injections of physician prescribed medications, including insulin. The device may remain in place for up to 72 hours to accommodate multiple injections without the discomfort of additional needle sticks. i-Port Advance^™ injection port may be used on a wide range of patients, including adults and children.

Contraindications

Do not use the same i-Port Advance^™ injection port for longer than 72 hours.

Do not attempt to reapply the i-Port Advance^™ injection port after use.

The i-Port Advance^™ injection port is neither intended nor indicated for use with blood or blood products.

Do not use the i-Port^™ Advance injection port for any purpose other than the indications specified by your healthcare provider.

Do not use a needle longer than 5/16 in. (8 mm) or thicker than 28 gauge when injecting into the i-Port Advance^™ injection port.

Warnings/precautions

The i-Port Advance^™ injection port is only sterile and nonpyrogenic if the insertion device is unopened or undamaged. Do not use if the package is already open or is damaged, or if the protective liner has fallen off. Ensure the sterility by checking the sterile paper and tamper-proof seal.

Carefully read through instructions prior to using the i-Port^™ Advance injection port. Failure to follow instructions may result in pain or injury.

If the i-Port Advance^™ injection port is not securely placed in the inserter with the needle pointing straight ahead prior to insertion, pain or injury may occur.

Be sure that the needle guard is removed before insertion.

Do not use if introducer needle is bent or broken.

Do not use a needle longer than 5/16 in. (8 mm). Do not attempt to use a 1/2 in. (12 mm) injection needle with the i-Port Advance^™ injection port. Doing so may damage the device causing unnecessary punctures of the skin, or tearing or puncturing of the soft cannula which may result in unpredictable medication delivery.

Do not use a needle shorter than 3/16 in. (5 mm) when injecting into the i-Port Advance^™ injection port.

Do not inject multiple drugs contraindicated for subcutaneous administration into the same site.

The i-Port Advance^™ injection port is a single use device. Reuse of the port may damage the cannula in the device and increases the risk of the tape becoming loose. Reuse of the port may result in infection or site irritation and inaccurate medication delivery.

Incorrect medication absorption, infection, or site irritation may result from improper application to the body or maintenance of the i-Port Advance^™ injection port insertion site, or both. If the insertion site becomes irritated or inflamed, remove and discard the device and apply a new device to a different location on the body.

The soft cannula may crimp or bend when applying or while wearing. A crimped or bent cannula may limit or prevent medication delivery through the i-Port Advance^™ injection port. You should remove and discard the device immediately if you suspect a crimped or bent cannula. Indications that your i-Port Advance^™ injection port has a crimped or bent cannula include:

difficulty pressing down on the plunger of the syringe when injecting
Injected medication escaping from the device onto the top of the septum
injected medication leaking onto the skin or saturating the tape
moisture present inside the transparent body of the device

Do not reinsert the introducer needle into the i-Port Advance^™ injection port. Reinsertion could cause puncturing or tearing of the soft cannula which would result in unpredictable medication delivery or injury.

Replace the i-Port Advance^™ injection port if the tape becomes loose or is displaced from its original site. Since the cannula is soft, it may not cause pain if it slips out, and this may occur without you noticing it. The soft cannula must always be completely inserted to receive the full amount of medication from the injection.

Wash your hands and swab skin with alcohol or similar disinfectant where you intend to apply the i-Port Advance injection port. Let skin surface dry completely prior to applying the device to the disinfected area.

Ensure the septum is clean before every use (use pure water).

Do not put perfumes or deodorants on the i-Port Advance injection port as these may affect the integrity of the device.

Do not inject into the i-Port Advance injection port through clothing.

Never point the loaded inserter toward any body part where insertion is not desired.

Store i-Port Advance at room temperature. Do not store or leave the device in direct sunlight.

Avoid applying the i-Port Advance injection port to sites that contain scar tissue, lipodystrophy, or stretch marks. Avoid sites that are constrained by clothing or accessories, or that are subjected to rigorous movement during exercise. Avoid sites that are under a belt or on the waistline.

Do not inject more than 75 times through a single device.

The device has a residual volume up to 2.60 μL (0.0026 mL or 0.26 units). It is not known if the residual drug remains in the cannula or is absorbed into the subcutaneous tissue over time. The prescribing healthcare provider should consider if the retention of, or delay in delivery of small doses of a drug (such as 1 international unit or 10 μL of U100 insulin) may adversely affect the therapeutic goals in some patients such as infants or small children.

See Instructions for Use (IFU) for additional details.
http://www.medtronicdiabetes.com/download-library/i-port-advance

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Guardian^™ Connect CGM system

Indications for use

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/important-safety-information.

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Simplera^™ System

Indications for use

The Simplera system is a real-time continuous glucose monitoring (CGM) system indicated for the management of diabetes in persons ages 18 years and older.

The Simplera system does not require calibration and is designed to replace fingerstick BG testing for diabetes treatment decisions, unless otherwise indicated. The instances during which BG testing must be performed include (1) during the first 12 hours of wear, (2) if the medication taken contains paracetamol or acetaminophen, (3) when the most recent sensor glucose (SG) reading is unavailable, and (4) when symptoms do not match the SG value.

Interpretation of the Simplera system results should otherwise be based on the glucose trends and several sequential sensor readings over time as described in the instructions.

Contraindications

The Simplera system has no known contraindications.

Warnings

General

CGM is not recommended for people who are unwilling or unable to perform blood glucose tests as required or for people who are unwilling or unable to maintain contact with their healthcare professional.

Always consult a healthcare professional before using sensor glucose values to make treatment decisions if a medication that contains acetaminophen or paracetamol is taken while wearing the sensor. Medications that contain acetaminophen or paracetamol can falsely raise sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in the body and can differ for each person. Falsely elevated sensor readings can result in over-administration of insulin, which can cause hypoglycemia. Medications that contain acetaminophen or paracetamol include, but are not limited to, cold medicines and fever reducers. Check the label of any medications being taken to see if acetaminophen or paracetamol is an active ingredient. Use additional blood glucose meter readings to confirm blood glucose levels.

Do not use continuous glucose monitoring if hydroxyurea, also known as hydroxycarbamide, is taken. Hydroxyurea is used to treat certain diseases, such as cancer and sickle cell anemia.

Hydroxyurea use results in higher sensor glucose readings compared to blood glucose readings. Taking hydroxyurea while using continuous glucose monitoring can result in inaccurate or missed alerts, and substantially higher sensor glucose readings in reports than actual blood glucose readings.

Always check the label of any medication being taken to confirm if hydroxyurea or hydroxycarbamide is an active ingredient. If hydroxyurea is taken, consult a healthcare professional. Use additional blood glucose meter readings to verify glucose levels.

If a serious incident related to the device occurs, immediately report the incident to Medtronic and to the applicable competent authority having jurisdiction in their locale.

Do not use the Simplera system if you are pregnant or critically ill. Since the system has not been studied in these populations, the impact of medications common to these conditions on system performance is unknown and the system may be inaccurate in these populations.

Android users

Allow Do Not Disturb Permissions and Notifications for the Simplera app. If Do Not Disturb Permissions or Notifications are turned off, the app will not send any alerts, including Urgent Low Alert.

The Digital Wellbeing feature is intended to reduce alerts. If this feature is enabled, the Simplera app will not send alerts. If the app timer is set in the Digital Wellbeing feature for the Simplera app, the app will shut down and will not send any sensor glucose alerts when the timer expires.

Do not lower the vibration level to the lowest setting in the Android Vibration intensity menu. If vibration is lowered to the lowest setting, the app will not send any vibrations with the alerts, including Urgent Low Alert.

iOS users

Allow Critical Alerts and Notifications for the Simplera app. If Critical Alerts or Notifications are turned off, the app will not send any alerts, including Urgent Low Alert.

The Downtime setting within the Screen Time feature is intended to prevent alerts during the Downtime period. If this setting is enabled, the Simplera app will be prevented from sending alerts.

Do not modify settings in the Accessibility menu. Do not turn off vibration settings. If vibration is turned off, the app will not send any vibrations with the alerts, including Urgent Low Alert. Do not enable the Assistive Access feature. The Assistive Access feature may prevent the Simplera app from pairing with the sensor or displaying alerts.

Vibrate on silent must be turned on in the iOS phone settings or the alerts, including Urgent Low, will not vibrate during Mute alerts.

Apple Watch users

To receive sensor glucose information or alerts on the Apple Watch, ensure Bluetooth is enabled and the watch is within range of the mobile device.

If the mobile device is damaged, the watch may not receive sensor glucose alerts. Do not use the watch if the screen or speakers are damaged.

The Apple Watch will not vibrate for alerts from the Simplera app if Haptic Alerts are disabled.

Do not disable the mirror feature for the Simplera app in the Apple Watch settings. If the mirror feature is disabled, the watch will not display any alerts, including Urgent Low Alert.

When the watch enters Power Reserve mode or Low Battery mode, it no longer provides glucose alerts or sensor glucose information.

If the mobile device is unlocked, sensor glucose alerts are not sent to the Apple Watch. Refer to the Simplera app on the mobile device for sensor glucose alerts.

The Apple Watch may display connection requests. Do not accept connection requests from unknown devices.

Always protect the Apple Watch with a passcode. Sharing the passcode could compromise the security of the device.

Sensor

Read entire user guide before attempting to insert the Simplera sensor. The inserter portion of the sensor does not work the same way as other Medtronic insertion devices. The sensor is not inserted the same way as other Medtronic sensors. Failure to follow directions may result in improper insertion, pain, or injury.

Always examine the Simplera sensor box for damage. If the sensor box is open or damaged, examine the sensor for damage. If the sensor is visibly damaged, discard the device to avoid possible contamination.

Do not use the Simplera sensor if any part of the device is damaged. If the device is damaged, discard the device to avoid possible contamination.

Do not use the Simplera sensor if the tamper band is broken, damaged, or is missing from the device. The sensor is sterile and non-pyrogenic unless the device is damaged. If the tamper band is broken, damaged, or is missing from the device, the sensor and needle can be exposed to contamination. A sensor and needle exposed to contamination can cause insertion site infection if inserted into the body.

Do not use the Simplera sensor if the cap label is broken, damaged or missing from the device.

The sensor is sterile and non-pyrogenic unless the device is damaged. If the cap label is broken, damaged, or missing from the device, the sensor and the needle can be exposed to contamination. A sensor and needle exposed to contamination can cause insertion site infection if inserted into the body.

Do not unscrew or remove the Simplera sensor cap until the device is ready to be used. Do not remove the cap and store the device for future use. The sensor is sterile and non-pyrogenic unless the cap is removed from the device or the tamper band is broken. If the cap is not on the device or the tamper band is broken, the sensor and the needle can be exposed to contamination. A sensor and needle exposed to contamination can cause insertion site infection if inserted into the body.

Do not remove the cap and place it back on the device. Placing the cap back on the device could cause damage to the needle, prevent a successful insertion, and cause injury.

Do not change or modify the Simplera sensor. Changing or modifying the sensor can result in improper insertion, pain, or injury.

Do not let children hold the Simplera sensor without adult supervision. Do not let children put any part of the Simplera sensor in their mouth. This product poses a choking hazard for young children that can result in serious injury or death.

Watch for bleeding at the insertion site on top of the Simplera sensor. If bleeding occurs, apply steady pressure with a sterile gauze pad or clean cloth placed on top of the sensor for up to three minutes. If bleeding continues, is significantly visible on top of the sensor, or if there is excessive pain or discomfort after insertion, follow these steps:

Remove the Simplera sensor and continue to apply steady pressure until the bleeding stops.

Dispose of the Simplera sensor according to instructions.

Check the insertion site for redness, bleeding, irritation, pain, tenderness, or inflammation. If there is redness, bleeding, irritation, pain, tenderness, or inflammation, contact a healthcare professional.

Insert a new Simplera sensor in a different location.

Report any adverse reactions associated with the Simplera sensor to 24-Hour Technical Support. Adverse reactions can cause serious injury.

Precautions

Diabetes treatment decisions should be made based on a combination of SG readings, trend arrows, glucose target ranges, active alerts, and recent events (such as insulin doses, exercise, meals, and medications).

Using CGM information to make treatment decisions

After becoming familiar with CGM, treatment decisions should be made based on all the information available, including the following:

SG readings
Trend arrows
Active SG alerts
Recent events such as insulin doses, medication, meals, exercise, etc.

Consult a healthcare professional to determine the right glucose target ranges.

Sensor

Do not use the Simplera sensor adjacent to other electrical equipment that may cause interference with normal system operation. For more information on electrical equipment that may cause interference with normal system operation, see Exposure to magnetic fields and radiation, instructions.

Some skin care products, such as sunscreens and insect repellents, can damage the Simplera sensor. Do not allow skin care products to touch the sensor. Wash hands after using skin care products before touching the sensor. If any skin care products touch the sensor, immediately wipe the sensor with a clean cloth.

Exposure to magnetic fields and radiation

Do not expose the Simplera sensor to Magnetic Resonance Imaging (MRI) equipment, diathermy devices, or other devices that generate strong magnetic fields (for example, CT scan, or other types of radiation). Exposure to strong magnetic fields can cause the sensor to malfunction, result in serious injury, or be unsafe.

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InPen

Indications for use

The InPen requires a prescription. It is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog^® U-100 3.0 mL cartridges, Novo Nordisk Novolog^® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp^® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.

For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use.

For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.

Contraindications

The InPen system is not intended for anyone unable or unwilling to:

Test blood glucose (BG) levels as recommended by a healthcare provider
Maintain sufficient diabetes self-care skills
Visit a healthcare provider regularly

InPen is not recommended for the blind or visually impaired without the assistance of a sighted individual trained to use it. Always carry a spare insulin delivery device in case your InPen is lost or damaged.

Warnings, cautions and other important notes

Pediatric Patients

Younger children may inadvertently play with the pen injector or the app, leading to unintentional logging or delivery of insulin. It is the responsibility of the healthcare provider and the caregiver to determine if the patient is appropriate for treatment with the InPen system.

Do not allow small children to chew on or ingest parts, such as the pen cap and cartridge components. Small parts could pose a choking hazard. If ingested or swallowed, these component pieces may cause internal injury or infection. For patients who do not self-manage their disease, the smart device should always be under the supervision of a caregiver. Inadvertent button presses may lead to unintentional dose logging or changes to therapy settings. These changes can potentially lead to hypoglycemic or hyperglycemic events which could result in serious injury or death.

Supported devices, connecting, settings and security

The InPen App is compatible with:

iOS 10 or later
Android 6 or later

Check the Companion Medical website to make sure the app is compatible before updating your smart device.

CAUTION: You must first pair your InPen with a smart device and the InPen App. This will ensurethat doses from your InPen are sent wirelessly to the App on your smart device.

IMPORTANT: Your smart device must be set up correctly to work properly and safely with theInPen System. Your device’s internal settings override any InPen App setting. If the settings on your device are incorrect your InPen System may not function properly.

WARNING: If your InPen is out of range of the smart device the Dose Calculator may not have all of your recent insulin logged and may result in unsafe recommendations, which could lead to severe hyperglycemia, hypoglycemia, or injury.

IMPORTANT: Enable the security features of your smart device to prevent unauthorized access toyour data and settings.

WARNING: The Bluetooth^® feature on your InPen sends dose information to your smart device. To prevent other people’s doses from being sent to the smart device, do not let anyone else use your InPen to dose insulin. The InPen is for single patient use only.

IMPORTANT: Bluetooth^® performance varies due to differences in phone hardware and operating systems. The InPen App is not recommended on Jailbroken or Rooted devices.

IMPORTANT: Your smart device must have enough memory storage or the InPen App will not be able to be installed or log dose. You may need to delete files or apps from your smart device.

IMPORTANT: To ensure a secure connection, pair your InPen and smart device in a secure area with limited Bluetooth^® devices in range.

CAUTION: Make sure you know which InPen you are pairing with your smart device.

IMPORTANT: The use of a security code on your mobile device is recommended.

Therapy setup, insulin and insulin dose calculation

IMPORTANT: Your Therapy Settings must be set correctly before using the Dose Calculator. Do not use the Dose Calculator if you have guessed settings or believe they may be set incorrectly.

IMPORTANT: All insulin you have recently taken must be entered to ensure that Active Insulin is correct. If you have taken any Rapid-acting or mealtime insulin from a device other than InPen, it must be logged manually.

NOTE: Long-acting insulin is not considered part of Active Insulin. Active Insulin applies to Rapid-acting or mealtime insulin only.

IMPORTANT: If you do not enter a current glucose value, Active Insulin will not be subtracted from the dose recommendation.

WARNING: Using the Dose Calculator with incorrect Therapy Settings or without all of your recent insulin logged may result in unsafe recommendations, which could lead to severe hyperglycemia, hypoglycemia, or injury.

IMPORTANT: To use the dose calculator safely, it is extremely important that Therapy Settingsare correct. Proceed only after talking to your health care provider.

IMPORTANT: Once selected and confirmed, your Meal Therapy cannot be changed. Verify withyour doctor if you are unsure of your Meal Therapy. If you choose the wrong meal therapy contactCustomer Service by tapping Settings from the Home screen and selecting Help and Support.

IMPORTANT: Before changing Meal Therapy Mode, you will need your current Meal Therapy settings from your healthcare provider. Previous Meal Therapy settings may be lost when you change to a new Meal Therapy type.

IMPORTANT: An updated prescription is required to increase the precision of your Meal Therapymode.

IMPORTANT: The calculated dose is a suggestion. You decide whether to follow the suggestion or rely on your own judgment. The dose calculator cannot account for other factors like activity, illness, alcohol use, etc.

IMPORTANT: Therapy doses and Prime doses must be correctly identified, because only therapeutic doses are included in Active Insulin and used by the Dose Calculator.

WARNING: Log all insulin from all sources into the Logbook. The Dose Calculator does not account for manual injections that you do not enter and could recommend more insulin than needed. Too much insulin may cause hypoglycemia.

IMPORTANT: Your mobile device must be set to the current time to ensure that manual doses are logged correctly and your Active Insulin is correct. Incorrect time settings could result in unsafe recommendations, which could lead to severe hyperglycemia, hypoglycemia, or injury.

IMPORTANT: The Insights by InPen report is intended to supplement, not replace, medical expertise in the self-administration of insulin for the treatment of diabetes. The report provides information that can be used to identify trends to inform treatment decisions. Reports are not intended to produce medical advice and should not be relied upon for such purpose.

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MiniMed^™ Mobile app

The MiniMed^™ Mobile app is intended to provide a secondary display for a compatible MiniMed^™ insulin pump system on a suitable consumer electronic device for passive monitoring and to sync data to CareLink^™ system. The MiniMed^™ Mobile app is not intended to replace the real-time display of Continuous glucose monitoring or insulin pump data on the primary display device (i.e., the insulin pump). All therapy decisions should be based on the primary display device. The MiniMed^™ Mobile app is not intended to analyze or modify the continuous glucose monitoring data or insulin pump data that it receives. Nor is it intended to control any function of the connected continuous glucose monitoring system or insulin pump. The MiniMed^™ Mobile app is not intended to receive information directly from the sensor or transmitter of a continuous glucose monitoring system.

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CareLink^™ Connect app

The CareLink^™ Connect app is intended to provide a secondary display of insulin pump and CGM (Continuous Glucose Monitor) data on a supported mobile device. CareLink^™ Connect app is not intended to replace the real-time display of insulin pump or CGM data on the primary display device. All therapy decisions should be based on the primary display device. CareLink^™ Connect app is not intended to analyze or modify the insulin pump and CGM data that it receives. Nor is it intended to control any function of the insulin pump or CGM system to which it is connected. CareLink^™ Connect app is not intended to receive information directly from the insulin pump or CGM system.

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Medtronic Diabetes Updater app

The Medtronic Diabetes Updater app is intended for use on a suitable consumer electronic device to wirelessly update software of a MiniMed^™ insulin pump with smart device connectivity. The Medtronic Diabetes Updater app is not intended to analyze or modify the continuous glucose monitor data or insulin pump data, nor is it intended to control any function of the connected continuous glucose monitoring system or insulin pump. The Medtronic Diabetes Updater app is not intended to receive information directly from the sensor or transmitter of a continuous glucose monitoring system. The Medtronic Diabetes Updater app is not intended to be used without a CareLink^™ account. Log into an existing CareLink^™ account or create a new account during the update process.

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*This Important Safety Information page was updated on April 21, 2023.

Important safety information

Indications, contraindications, warnings and precautions

Insulin pumps

Continuous Glucose Monitor (CGM)

Smart pen system

Sensors and serters

Meters

Infusion sets

Reservoirs

Injection port

CareLink™ therapy management software

Apps

MiniMed™ 780G system with SmartGuard™ technology with Simplera Sync™ sensor

MiniMed™ 780G system with SmartGuard™ technology with Guardian™ 4 sensor

MiniMed™ 780G system with SmartGuard™ technology with Guardian™ Sensor (3)

MiniMed™ 770G system with SmartGuard™ technology

MiniMed™ 670G system

MiniMed™ 630G system with SmartGuard™ technology

MiniMed™ 530G system with SmartGuard™ technology

Indications for use

Warning

Contraindications

MiniMed™ Paradigm™ REAL-Time Revel™ insulin pump

Enlite™ sensor

Meter

Medtronic MiniMed™ insulin infusion pumps

Indications for use

Contraindications

Warnings/precautions

Bolus Wizard™ feature

Tubing connector

CareLink™ personal therapy management software

Indications for use

Contraindications

Warnings/precautions

Medtronic MiniMed™ Professional Continuous Glucose Monitoring (CGM) system

Indications for use

Contraindications

Warnings/precautions

Medtronic MiniMed™ REAL-Time Continuous Glucose Monitoring (CGM) system

Indications for use

Contraindications

Warnings/precautions

iPro™2 Professional Continuous Glucose Monitoring (CGM)

MiniMed™ Sof-sensor™ glucose sensor

Indications for use

Warnings/precautions

Guardian™ sensor 3

Indications for use

Contraindications

General warnings

General precautions

Enlite™ sensor

Indications for use

Contraindications

General warnings

General precautions

One-press serter

Indications for use

Contraindications

General warnings

General precautions

Enlite™ serter

Indications for use

Contraindications

General warnings

General precautions

Roche Accu-Chek® Guide Link blood glucose monitoring system

Warning:

CONTOUR®NEXT LINK 2.4 meter

Indications for use:

Warnings/precautions:

Meter

General warnings:

Meter

Precautions:

Medtronic infusion sets

Medtronic Extended™ infusion set

Medtronic reservoirs

i-Port Advance™ injection port

CareLink^™ therapy management software

MiniMed^™ 780G system with SmartGuard^™ technology with Simplera Sync^™ sensor

MiniMed^™ 780G system with SmartGuard^™ technology with Guardian^™ 4 sensor

MiniMed^™ 780G system with SmartGuard^™ technology with Guardian^™ Sensor (3)

MiniMed^™ 770G system with SmartGuard^™ technology

MiniMed^™ 670G system

MiniMed^™ 630G system with SmartGuard^™ technology

MiniMed^™ 530G system with SmartGuard^™ technology

MiniMed^™ Paradigm^™ REAL-Time Revel^™ insulin pump

Enlite^™ sensor

Medtronic MiniMed^™ insulin infusion pumps

Bolus Wizard^™ feature

CareLink^™ personal therapy management software

Medtronic MiniMed^™ Professional Continuous Glucose Monitoring (CGM) system

Medtronic MiniMed^™ REAL-Time Continuous Glucose Monitoring (CGM) system

iPro^™2 Professional Continuous Glucose Monitoring (CGM)

MiniMed^™ Sof-sensor^™ glucose sensor

Guardian^™ sensor 3

Enlite^™ sensor

Enlite^™ serter

Roche Accu-Chek^® Guide Link blood glucose monitoring system

CONTOUR^®NEXT LINK 2.4 meter

Medtronic Extended^™ infusion set

i-Port Advance^™ injection port

Guardian^™ Connect CGM system

Simplera^™ System

MiniMed^™ Mobile app

CareLink^™ Connect app