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.
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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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.
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 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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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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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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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/importantsafetyinformation and the appropriate user guides for additional important details.
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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: 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.
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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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).
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.
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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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.
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.
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.
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.
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.
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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The CareLink™ software is intended for use as a tool to help manage diabetes. The purpose of the software is to take information transmitted from insulin pumps, glucose meters and continuous glucose monitoring systems, and turn it into CareLink™ reports. The reports provide information that can be used to identify trends and track daily activities-such as carbohydrates consumed, meal times, insulin delivery, and glucose readings. There are two versions of Medtronic MiniMed™ CareLink™ Therapy Management Software available - CareLink Personal and CareLink Pro.
The CareLink™ software should not be used for the treatment of medical conditions other than diabetes.
The software is intended to be used by or with advice from a healthcare professional familiar with the management of diabetes.
System results are not intended to produce medical advice and should not be relied upon for such purpose.
Patients should monitor their blood glucose levels at least 4 - 6 times a day.
Patients should not make any changes to their treatment without consulting their healthcare professional first.
See Instructions for Use (IFU) for additional details.
http://www.medtronicdiabetes.com/download-library/carelink
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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.
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:
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.
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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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.
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.
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.
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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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.
See Instructions for Use (IFU) for additional details.
http://www.medtronicdiabetes.com/download-library/ipro-2
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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.
The Sof-sensor glucose sensor is intended for use with Medtronic MiniMed™ glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
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:
If bleeding does NOT stop:
CAUTION: DO NOT attach the sensor to the transmitter.
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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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.
None known
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:
If bleeding continues, causes excessive pain or discomfort, or is significantly visible in the plastic base of the sensor, do the following:
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The sensor is intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
None known
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.
Keep the sensor away from children. This product contains small parts and may pose a choking hazard.
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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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.
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.
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:
If bleeding continues, do the following:
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.
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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The Enlite™ serter is indicated for use for a single patient as an aid to insert the Enlite™ glucose sensor (sensor).
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.
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.
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 connector, which may damage the device. Remove the sensor and continue to apply steady pressure until the bleeding stops.
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.
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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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.
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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.
For results under 20 mg/dL or over 600 mg/dL:
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.> TOP
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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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 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.
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.
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:
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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The Guardian™ Connect system requires a prescription and is indicated for continuous or periodic monitoring of glucose levels in the interstitial fluid under the skin, in patients (14 to 75 years of age) with diabetes mellitus. The system is intended to complement, not replace, information obtained from standard blood glucose monitoring devices, and is not recommended for people who are unwilling or unable to perform a minimum of two meter blood glucose tests per day, or for people who are unable or unwilling to maintain contact with their healthcare professional. The system requires a functioning mobile electronic device with correct settings. If the mobile device is not set up or used correctly, you may not receive sensor glucose information or alerts. For complete details of the system and its components, including warnings, contraindications, and precautions, please consult the user guide at http://www.medtronicdiabetes.com/support/download-library/user-guides and http://www.medtronicdiabetes.com/importantsafetyinformation.
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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.
The InPen system is not intended for anyone unable or unwilling to:
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.
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.
The InPen App is compatible with:
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.
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.
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: 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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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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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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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.