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Important Safety Information: MiniMedTM 770G System with SmartGuardTM Technology
The MiniMed™ 770G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons two years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed™ 770G system includes SmartGuard™ technology, which can be programmed to automatically adjust delivery of basal insulin based on continuous glucose monitoring (CGM) sensor glucose (SG) values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.
The Medtronic MiniMed™ 770G system consists of the following devices: MiniMed™ 770G insulin pump, the Guardian™ Link (3) transmitter, the Guardian™ Sensor (3), one-press serter, the Accu-Chek® Guide Link blood glucose meter, and the Accu-Chek® Guide test strips. The system requires a prescription.
The Guardian™ Sensor (3) has not been evaluated and is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian™ Sensor (3).
All therapy adjustments should be based on measurements obtained using the Accu-Chek® Guide Link blood glucose meter and not on values provided by the Guardian™ Sensor (3). Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the Accu-Chek® Guide Link blood glucose meter. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an alternative site. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise.
WARNING: Do not use the SmartGuard™ Auto Mode 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 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 http://www.medtronicdiabetes.com/important-safety-information#minimed-770g and the appropriate user guide at http://www.medtronicdiabetes.com/download-library
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.
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 seven 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.
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.
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.
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.
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.
Risks related to insulin pump infusion set General risks related to insulin pump infusion set may include: • Localized infection
Patients should be instructed to follow the provided user guides for insertions and care of infusion sets. If an infusion site becomes irritated or inflamed, the infusion set should be removed and another placed in a new location.
Due to the use of insulin, there is risk related to the infusion of insulin and the potential interruptions of insulin delivery. These general risks may include:
General risks related to sensor use may include:
Taking medications with acetaminophen, including, but not limited to 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 use BG meter readings to verify your glucose level before making therapy decisions, including when you could have acetaminophen active in your body. Avoid taking medications with acetaminophen while in Auto Mode. If acetaminophen is taken, use additional BG meter readings to verify your glucose levels, and consider exiting Auto Mode. Do not use these additional BG meter readings to calibrate the sensor. Always check the label of any medications to confirm whether acetaminophen is an active ingredient. Sensor placement and insertion has been studied in the belly (abdomen) only and is not approved for other sites.
Some types of medication or chronic medical conditions may affect BG meter readings and cause you to get inaccurate results. The level of inaccuracy depends on the amount of certain substances that are active in your body and may be different for each person. If you have taken the following medications, do not use your BG meter readings to calibrate the sensor and exit Auto Mode.
Note: Harmful interference is defined by the FCC as follows. Any emission, radiation or induction that endangers the functioning of a radio navigation service or of other safety services or seriously degrades, obstructs or repeatedly interrupts a radio communications service operating in accordance with FCC rules.
For the most current warnings, see the user guide that came with your device.
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.
a. Remove the sensor and continue to apply steady pressure until the bleeding stops. Discard the sensor in a sharps container .
b. Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation. Treat based on instructions from your healthcare professional.
c. Insert a new sensor in a different location.
a. 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.
b. If bleeding stops, connect the transmitter (or recorder) 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.
For the most current warnings, see the user guide that came with your device.
For the most current warnings, see the user guide that came with your device. Always use the fingertip for blood samples used for calibrating the sensor while in Auto Mode. The fingertip was the only site studied for use with Auto Mode. Do not use blood samples from the palm to calibrate the sensor as this site was not studied for use with Auto Mode and the performance of the system is not known.
Exposure to magnetic fields and radiation
Exposure to extreme temperatures can damage your device, which can adversely affect safety and effectiveness of your device. Avoid the following conditions:
1. Avoid exposing your pump to temperatures above 104 °F (40 °C) or below 41 °F (5 °C). This may damage your device.
2. Insulin solutions freeze near 32 °F (0 °C) and degrade at high temperatures. If you are outside in cold weather, wear your pump close to your body and cover it with warm clothing. If you are in a warm environment, take measures to keep your pump and insulin cool.
3. Do not steam, heat, sterilize, or autoclave your pump. Exposure to high temperatures may damage your device.
Infusion sets and sites
Sensor
Meter
The MiniMed™ 630G system with SmartGuard™ technology 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, fourteen 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™ 630G system includes SmartGuard™ technology, which can be programmed to temporarily suspend delivery of insulin for up to two hours when the sensor glucose value falls below a predefined threshold value. The MiniMed™ 630G system consists of the following devices: MiniMed™ 630G Insulin Pump, Guardian™ Sensor (3), one-press serter, the Guardian™ Link (3) transmitter system, CareLink USB, CONTOUR®NEXT LINK 2.4 Wireless Meter, and CONTOUR®NEXT Test Strips. The system requires a prescription. The MiniMed™ 630G 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™ 630G system. 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 SmartGuard™ Suspend on low 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 professional.
WARNING: Do not use the Suspend on low feature to prevent or treat low glucose. The Suspend on low feature is designed to suspend insulin delivery when you are unable to respond to the Suspend on low alarm. Always confirm your sensor glucose reading using your BG meter, and follow the instructions of your healthcare professional. Using Suspend on low to prevent or treat low glucose may result in prolonged hypoglycemia.
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.
General risks related to insulin pump infusion set may include:
Patients should be instructed to follow the provided user guides for insertions and care of infusion sets. If an infusion site becomes irritated or inflamed, the infusion set should be removed and another placed in a new location.
Due to the use of insulin, there is risk related to the infusion of insulin and the potential interruptions of insulin delivery. These general risks may include:
General risks related to sensor use may include:
Taking medications with acetaminophen, including, but not limited to 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 use BG meter readings to verify your glucose level before making therapy decisions, including when you could have acetaminophen active in your body.
Always check the label of any medications to confirm whether acetaminophen is an active ingredient.
Sensor placement and insertion has been studied in the belly (abdomen) and back of upper arm only and is not approved for other sites.
General risks with serter use may include skin infection around the area where the serter is used.
General risks related to the MiniMed™ 630G insulin pump system may include:
During the conduct of the In-Clinic, Randomized, Cross-Over Study to Assess the Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed™ Paradigm X54 System with Hypoglycemic Induction from Exercise 1, the following specific system risks were identified:
Pursuant to IEC60601-1-2:2007; subclause 5.2.2:
The MiniMed™ 630G insulin pump should not be used adjacent to other electrical equipment. If adjacent use becomes necessary, the MiniMed™ 630G insulin pump should be observed to verify normal system operation.
Sensor
Transmitter
Meter
Exposure to extreme temperatures can damage your device, which can adversely affect safety and effectiveness of your device. Avoid the following conditions:
Sensor
Transmitter
Meter
The Guardian™ Connect system 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 Guardian™ Connect system provides real-time glucose values and trends through a Guardian™ Connect app installed on a compatible consumer electronic mobile device. It allows users to detect trends and track patterns in glucose concentrations. The Guardian™ Connect app alerts if a Guardian™ Sensor (3) glucose level reaches, falls below, rises above or is predicted to surpass set values. The Guardian™ Sensor (3) glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a 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). The Guardian™ Connect system is comprised of the following devices: Guardian™ Connect app, Guardian™ Sensor (3), and the Guardian™ Connect transmitter.
The Guardian™ Sensor (3) is intended for use with Medtronic Diabetes glucose-sensing systems, to continuously monitor glucose levels in persons with diabetes. The Guardian™ Sensor (3) is indicated for 7 days of continuous use. 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™ Connect transmitter is intended for use with the Guardian™ Connect system. The Guardian™ Connect transmitter powers the glucose sensor, collects and calculates sensor data, and sends the data via Bluetooth version 4.0 to the Guardian™ Connect app installed on a compatible mobile device. The transmitter is only compatible with the Guardian™ Sensor (3). The transmitter is indicated for multiple uses on a single patient as a component of the Guardian™ Connect system. The Guardian™ Connect transmitter requires a prescription.
The Guardian™ Connect app is intended for use only by patients using a compatible mobile device, and who have sufficient experience to adjust mobile device audio and notification settings. The app displays sensor glucose data, and also provides a user interface for sensor calibration, entering data such as exercise and meals, and uploading information to the CareLink Personal website. It allows users to detect trends and track patterns in glucose concentrations. The Guardian™ Connect app provides alerts if a Guardian™ Sensor (3) glucose level reaches, falls below, rises above, or is predicted to surpass set values. The Guardian™ Connect app is available over-the-counter (OTC) but requires the Guardian™ Sensor (3) and Guardian™ Connect transmitter to function.
The charger is used to charge your transmitter battery. For best results, recharge your transmitter between each use to ensure full transmitter battery life.
The tester is intended for use with the Guardian™ Connect transmitter. It is a device used as a watertight cleaning plug during transmitter cleaning. It is also used for simulating a sensor to test that the transmitter is working properly.
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.
The tape is indicated for use with Medtronic glucose sensor products. It is indicated for one-time use.
This section includes important safety information such as indications, contraindications, safety warnings, potential adverse reactions, and how to protect the system from radiation exposure damage.
Continuous glucose monitoring 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. Successful CGM use requires sufficient vision or hearing to allow recognition of the alerts generated by the Guardian™ Connect app. Do not use 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.
App and Mobile Device
1. 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.
2. If bleeding stops, connect the transmitter (or recorder) 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, causes excessive pain or discomfort, or is significantly visible in the plastic base of the sensor, do the following:
3. Remove the sensor and continue to apply steady pressure until the bleeding stops. Discard the sensor in a sharps container.
4. Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation. Treat based on instructions from your healthcare professional.
5. Insert a new sensor in a different location. Contact the 24-Hour Technical Support if you experience any adverse reactions associated with the transmitter or sensor. Adverse reactions can cause serious injury.
CAUTION: Avoid the 2 inch (5.0 cm) area around the navel to help ensure a comfortable insertion site and to help with sensor adhesion. Choose an insertion site that has an adequate amount of subcutaneous fat. Shown here are the best body areas (shaded) for sensor insertion.
Note: Assistance may be needed for sensor insertion into the back of the upper arm. Some users found it difficult to insert the sensor into their arm by themselves. Do not insert the sensor in muscle or areas constrained by clothing or accessories, areas with tough skin or scar tissue, sites subjected to rigorous movement during exercise, or in sites under a belt or on the waistline for best sensor performance and to avoid accidental sensor removal.
General risks with sensor use include:
The iPro2™ Recorder is to be used with either Enlite™ sensor or Sof-sensor and 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.
None known.
- Make sure that the sensor insertion site is not bleeding before connection. If you find blood on top of the sensor adhesive, do not connect the iPro™2. This is to prevent body fluids from getting into the iPro™2 connector opening. If blood gets inside the iPro™2's connector opening, it may not be properly cleaned and disinfected without damaging the connector pins. So the iPro™2 will have to be discarded.
- If bleeding occurs, apply steady pressure with a sterile gauze or cloth at the insertion site until bleeding stops. After bleeding stops, attach the iPro™2 to the sensor.
- If bleeding persists after three minutes, remove the sensor and discard. Insert a new sensor in a different location.
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.
See Instructions for Use (IFU) for additional details: http://www.medtronicdiabetes.com/download-library/carelink.
IMPORTANT SAFETY INFORMATION FOR INPENTM SMART INSULIN PEN:
The InPenTM 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 InPenTM dose calculator, a component of the InPenTM 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, insulin sensitivity parameters, and duration of insulin action to be programmed into the software prior to use as it is required for set up.
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.
For additional product and important safety considerations, see User Guide and http://bit.ly/InPenSafety.
The sensor is intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
None known
1. Remove the sensor and discard.
2. Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation and treat accordingly.
3. Insert a new sensor in a different location.
See Instructions for Use (IFU) for additional details: http://www.medtronicdiabetes.com/download-library/enlite-sensor.
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.
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.
See Instructions for Use (IFU) for additional details: http://www.medtronicdiabetes.com/download-library/enlite-serter.
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).
1. 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.
2. 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.
1. Remove the sensor and continue to apply steady pressure until the bleeding stops. Discard the sensor in a sharps container.
2. Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation. Treat based on instructions from your healthcare professional.
3. Insert a new sensor in a different location.
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).
1. 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.
2. 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.
1. Remove the sensor and continue to apply steady pressure until the bleeding stops. Discard the sensor in a sharps container.
2. Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation. Treat based on instructions from your healthcare professional.
3. Insert a new sensor in a different location.
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.
- 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.
- 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
For results under 20 mg/dL or over 600 mg/dL:
For more information, please visit http://www.medtronicdiabetes.com/download-library/glucose-meters.
The 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. The i-Port Advance™ injection port may be used on a wide range of patients, including adults and children.
This product is indicated for the subcutaneous infusion of insulin from an infusion pump.
Infusion sets are indicated for subcutaneous use only and not for intravenous (IV) infusion or the infusion of blood or blood products.
This product is indicated for the subcutaneous infusion of insulin from an infusion pump.
This product is neither intended nor indicated for intravenous (IV) infusion or the infusion of blood or blood products.
The MiniMed™ Mio™ Advance infusion set is indicated for subcutaneous infusion of medication administered by an external pump.
This infusion set is indicated for subcutaneous use only. Do not use the infusion set for intravenous infusion. Do not use the infusion set with blood or blood products.
This product is indicated for the subcutaneous infusion of insulin from an infusion pump.
Infusion sets are indicated for subcutaneous use only and not for intravenous (IV) infusion or the infusion of blood or blood products.
This product is indicated for the subcutaneous infusion of insulin from an infusion pump.
Infusion sets are indicated for subcutaneous use only and not for intravenous (IV) infusion or the infusion of blood or blood products.
Wickham NWR, Achar KN, Cove DH. Unreliability of capillary blood glucose in peripheral vascular disease. Practical Diabetes. 1986;3(2):100.
Atkin, S. et al. Fingerstick Glucose Determination in Shock. Ann Intern Med.1991;114:1020-1024.
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.
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/
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