INDICATIONS, SAFETY, AND WARNINGS Diabetes

MiniMed™ 770G System

Important Safety Information: MiniMedTM 770G System with SmartGuardTM Technology

The MiniMed™ 770G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons two years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed™ 770G system includes SmartGuard™ technology, which can be programmed to automatically adjust delivery of basal insulin based on continuous glucose monitoring (CGM) sensor glucose (SG) values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.

The Medtronic MiniMed™ 770G system consists of the following devices: MiniMed™ 770G insulin pump, the Guardian™ Link (3) transmitter, the Guardian™ Sensor (3), one-press serter, the Accu-Chek® Guide Link blood glucose meter, and the Accu-Chek® Guide test strips. The system requires a prescription.

The Guardian™ Sensor (3) has not been evaluated and is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian™ Sensor (3).

All therapy adjustments should be based on measurements obtained using the Accu-Chek® Guide Link blood glucose meter and not on values provided by the Guardian™ Sensor (3). Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the Accu-Chek® Guide Link blood glucose meter. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an alternative site. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise.

WARNING: Do not use the 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

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MiniMed™ 670G System

INDICATIONS

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.

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 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.

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.

Potential Risks

Risks related to insulin pump infusion set General risks related to insulin pump infusion set may include: • Localized infection

  • Skin irritation or redness
  • Bruising
  • Discomfort or pain
  • Bleeding
  • Irritation
  • Rash
  • Occlusions that can interrupt insulin delivery and lead to hyperglycemia or Diabetic Ketoacidosis 

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.

Risks related to insulin administration and pump use

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:

  • Hypoglycemia
  • Hyperglycemia
  • Diabetic Ketoacidosis
  •  Seizure
  • Coma
  • Death

Risks related to sensor use

General risks related to sensor use may include:

  • Skin irritation or other reactions
  • Bruising
  •  Discomfort
  • Redness
  • Bleeding
  • Pain
  • Rash
  • Infection
  • Raised bump
  • Appearance of a small "freckle-like" dot where needle was inserted
  • Allergic reaction
  • Fainting secondary to anxiety or fear of needle insertion
  • Soreness or tenderness
  • Swelling at insertion site
  •  Sensor fracture, breakage or damage
  • Minimal blood splatter associated with sensor needle removal
  • Residual redness associated with adhesive, tape, or both
  • Scarring

Specific risks related to sensor use

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.

Specific risks related to meter use

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.

  • Ascorbic Acid (known as vitamin C) can interfere with your meter if you get vitamin C injections.
  • Xylose: Do not use during or soon after xylose absorption testing. Xylose in the blood will cause an interference. If you have the following conditions, always consult with your healthcare professional before using Auto Mode.
  • Liver problems, such as cirrhosis or Gilberts Syndrome resulting in bilirubin levels greater than 54 mg/dL.
  • Gout or chronic kidney disease resulting in uric acid levels greater than 59 mg/dL. Risks related to serter use General risks with serter use may include skin infection around the area where the serter is used.

RISKS RELATED TO THE MINIMED™ 670G INSULIN PUMP SYSTEM

General risks related to the MiniMed™ 670G insulin pump system may include:

  • Hypoglycemia
  • Hyperglycemia
  • Diabetic Ketoacidosis
  • Seizure
  • Coma
  • Death

GENERAL WARNINGS PUMP

  • Do not use the pump when a flammable anesthetic mixture with air, oxygen, or nitrous oxide is present. These environmental conditions can damage your pump and result in serious injury.
  • 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.
  • Do not make treatment decisions, such as determining your insulin dose for meals, using the MiniMed™ 670G continuous glucose monitor (CGM) values, as they are not intended to be used to make such treatment decisions. The MiniMed™ 670G CGM does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions. Blood glucose values may differ from sensor glucose values. Using the sensor glucose readings for treatment decisions could lead to high or low blood glucose.
  • Never rely on the pump beeps or vibrations alone to navigate through the pump screens or menus. Always check your pump screen as you navigate. The pump beeps and vibrations are intended to notify you of a condition that may require attention. Relying on the pump beeps or vibrations alone to navigate can result in incorrect menu selection or settings.
  • Do not use your pump if the screen appears broken or unreadable. In some instances, impact to the pump can damage the screen while the buttons continue to function. If the screen is broken or unreadable, do not press any buttons. Remove the pump and begin using your backup insulin plan per the direction of your healthcare professional. If the pump is accidentally programmed while the screen is broken or unreadable, this could result in high or low blood glucose levels. If your screen is damaged, contact the 24-Hour Technical Support to arrange for shipment of a replacement pump.
  • Only use rapid acting U100 insulin (Humalog® and Novolog®) that has been prescribed by your healthcare professional for use with an infusion pump. Do not put any other drugs or medications inside your reservoir for use with this pump. Other drugs or medications are not intended for use with this pump. Use of other drugs or medications can cause serious injury.
  • Always make sure the infusion set is disconnected from your body before you rewind your pump or fill the infusion set tubing. Never insert the reservoir into the pump while the tubing is connected to your body. Doing so could result in an accidental infusion of insulin.
  • Do not insert the reservoir in the pump if you did not rewind your pump. Doing so could result in an accidental infusion of insulin.
  • Do not use the MiniMed™ 670G insulin pump or additional system devices adjacent to other electrical equipment which may cause interference with the normal system operation. This includes mobile communication devices such as cell phones, GPS navigation systems, anti-theft systems, and any electrical equipment that has an output transmitter power greater than 1W. For more information about recommended separation distance guidelines between the insulin pump and common RF emitters, see Guidance and manufacturer's declaration, on page 335. The recommended separation distance between the insulin pump and common RF emitters is 12 inches. Other electrical equipment that may compromise normal system operation has been contraindicated. 
  • Do not unscrew or retighten the tubing connector on the reservoir while the infusion set is connected to your body. Doing so could result in an accidental infusion of insulin.
  • Do not use standard Luer sets with the MiniMed™ 670G insulin pump. Luer sets are not compatible with the pump. MiniMed™ reservoirs and MiniMed™ infusion sets are specifically designed for use with the MiniMed™ 670G insulin pump.
  • Do not change or modify your MiniMed™ reservoir or MiniMed™ infusion set unless expressly approved by Medtronic Diabetes. Modifying the devices can cause serious injury, interfere with your ability to operate the device, and void your warranty.
  • Do not rely on preset pump alarms or reminders alone to prompt you to check your blood glucose. This can cause you to forget to check your blood glucose. Set additional reminders on other devices, such as your cell phone.
  • Do not change or modify the internal RF transmitter or antenna unless expressly approved by Medtronic Diabetes. Doing so could interfere with your ability to operate the equipment.
  • Do not attempt to use the MiniLink™™ transmitter (MMT-7703), the Guardian™ Link transmitter (MMT-7763), or the Guardian™ Connect transmitter (MMT-7821) with the MiniMed™ 670G insulin pump. These transmitters do not communicate with this insulin pump.
  • If other devices that employ radio frequencies are in use, such as cell phones, cordless phones, and wireless networks, they may prevent communication between the transmitter and the insulin pump. This interference does not cause any incorrect data to be sent and does not cause any harm to your devices. Moving away from, or turning off, these other devices may enable communication. If you continue to experience RF interference, please contact the 24-Hour Technical Support.
  • Special Precautions regarding Electromagnetic Compatibility (EMC): This body worn device is intended to be operated within a reasonable residential, domestic, public or work environment, where common levels of radiated “E” (V/m) or “H” fields (A/m) exist; such as cellular phones, Wi-Fi®, Bluetooth®, electric can openers, microwave and induction ovens. This device generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the provided instructions, may cause harmful interference to radio communications.
  • Portable and mobile RF communications equipment can affect Medical Electrical Equipment as well. If you encounter RF interference from a mobile or stationary RF transmitter, move away from the RF transmitter that is causing the interference.
  • Do not rely on glucose sensor-enabled features when Airplane Mode is on because the pump does not receive sensor readings from the transmitter. Glucose sensor-enabled features include CGM, SmartGuard™, and Auto Mode. When using Airplane Mode, always rely on your blood glucose (BG) values when making therapy decisions to avoid hypoglycemia or hyperglycemia.
  • This device can generate, use, and radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. If the device does cause interference to radio or television reception, you are encouraged to try to correct the interference by one or more of the following measures:
  • Decrease the distance between the transmitter and the insulin pump to 6 feet (1.8 meters) or less.
  • Decrease the distance between the meter and the insulin pump to 6 feet (1.8 meters) or less. •
  • Increase the separation between the transmitter and the device that is receiving/emitting interference.

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.

  • The safety of the MiniMed™ 670G system has not been studied in people with impaired kidney function. Please let your healthcare professional know if you have kidney disease so you and your healthcare professional can determine if the potential benefits of using the system outweigh the risks.
  • The safety of the MiniMed™ 670G system has not been studied in pregnant women, people with type 2 diabetes, or in people using other antihyperglycemic therapies apart from insulin. Please let your healthcare professional know if any of these conditions apply to you so you and your healthcare professional can determine if the potential benefits of using the system outweigh the risks.
  • The safety of using Auto Mode, Suspend before low, and Suspend on low in people who have no pump experience is not known. Auto Mode, Suspend before low, and Suspend on low should not be used if insulin pump settings have not been previously established. Insulin pump settings include basal rates, insulin to carb ratio, or insulin sensitivity factors. Always discuss with your healthcare professional before using Auto Mode, Suspend before low, or Suspend on low. Reservoir and infusion sets For the most current warnings, see the user guide that came with your device.
  • Only use rapid acting U100 insulin (Humalog® and Novolog®) that has been prescribed by your healthcare professional for use with an infusion pump. Do not put any other drugs or medications inside your reservoir for use with this pump. Other drugs or medications are not intended for use with this pump, and can result in serious injury.
  • 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 hyperglycemia or hypoglycemia. If this occurs, start over with a new reservoir and infusion set.
  • Do not reinsert the introducer needle into the infusion set. Reinsertion may cause tearing of the soft cannula, which may result in unpredictable medication flow.
  • If infusing insulin, and your blood glucose level becomes unexplainably high, or an occlusion alarm occurs, check for clogs and/or leaks. • If in doubt, change the infusion set because the soft cannula may be dislodged, crimped and/or partially clogged. Should any of these problems arise, make a plan with your healthcare professional for rapidly replacing insulin. Test your blood glucose level to make sure the problem is corrected.
  • Reuse of the infusion set may cause damage to the cannula/needle and lead to infection, site irritation, and/or inaccurate medication delivery.
  • Dispose of transfer guard safely in sharps container.
  • Never prime the set or attempt to free a clogged line while the set is inserted. You may accidentally inject too much medication.
  • Do not put disinfectants, perfumes, or deodorants on the infusion set as these may affect the integrity of the set.
  • Dispose of the infusion set and introducer needle safely, in a sharps container, after a single use. Do not clean or re-sterilize.
  • Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle.
  • Only use reservoir and infusion sets manufactured or distributed by Medtronic Diabetes. The pump has undergone extensive testing to confirm appropriate operation when used with compatible reservoirs and infusion sets manufactured or distributed by Medtronic Diabetes. We cannot guarantee appropriate operation if the pump is used with reservoirs or infusion sets offered by third parties. We are not responsible for any injury or malfunctioning of the pump that may occur in association with such use.
  • Use aseptic techniques when temporarily disconnecting the set and consult your healthcare provider on how to compensate for missed medication when disconnected.
  • If infusing insulin, carefully monitor your blood glucose levels when disconnected and after reconnecting.
  • Reservoir and transfer guard are sterile, non-pyrogenic, and for single use only.
  • Do not clean or re-sterilize. Reuse of the reservoir may lead to insulin degradation, infection, inaccurate medication delivery, and/or leaks which may cause damage to the pump. • Inaccurate medication delivery, infection and/or site irritation may result from improper insertion and maintenance of the infusion site.
  • If using this infusion set for the first time, do the first set-up in the presence of your healthcare professional.
  • Do not leave air in the infusion set. Prime completely.
  • Replace the infusion set every 48 to 72 hours according to Centers for Disease Control guidelines, or per your healthcare professional’s instructions.
  • If infusing insulin, do not change the infusion set just before bedtime unless you can check your blood glucose 1 to 3 hours after insertion.
  • Do not use if package has been opened or damaged.
  • Ensure sterility by checking that the sterile paper and tamper-proof seal are not damaged.
  • This device is sterile and non-pyrogenic unless the package has been opened or damaged. Do not use if the package has been opened or damaged. Do not use the infusion set if the tubing connector needle has been damaged.
  • Do not use the infusion set for more than 3 days. Insulin is not labeled for more than three days when it is used in an infusion set. If insulin is used in the infusion set for more than three days, it may increase the risk of set occlusions and cause problems with insulin absorption, which may lead to severe hyperglycemia and DKA.
  • Before insertion, clean the insertion site with isopropyl alcohol.
  • 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.
  • Release the tubing with caution as a hard pull of the tubing can result in damage to the infusion set/introducer needle. Ensure that the infusion set is properly in place when the tubing is fully released.
  • 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.
  • Failure to remove trapped air from reservoir may result in inaccurate delivery of medication
  • Never point a loaded insertion device towards the body part, where insertion is not desired.
  • Remove the needle guard before inserting the infusion set.

Sensor and serter

For the most current warnings, see the user guide that came with your device.

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

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.

  • Do not attempt to remove the sensor yourself if you suspect that the sensor is broken. While there is no evidence of a sensor breaking in a patient’s body, sensor breakage can result in serious injury. Contact your healthcare professional for assistance in removing the sensor. • 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.
  • If bleeding continues, causes excessive pain or discomfort, or is significantly visible in the plastic base of the sensor, do the following:

        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.

  • 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.
  • Keep the needle housing within sight at all times to avoid an accidental needlestick or puncture.
  • Taking medications with acetaminophen 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.
  • Make sure the sensor is securely placed in the serter to avoid improper insertion, pain, or minor injury.
  • Watch for bleeding at the insertion site (under, around, or on top of the sensor). If bleeding occurs, do the following:

        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.

  • The sensor is designed to work with Guardian™ Link (3) transmitter 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.
  • It is not known how different conditions or medications common to the critically ill population may affect the performance of the system. Therefore, the use of this sensor in the critically ill population is not recommended.

Transmitter

For the most current warnings, see the user guide that came with your device.

  • Do not allow children to put small parts in their mouth. This product poses a choking hazard for young children.
  • Do not use the tester if it comes in contact with blood. Touching blood can cause infection. Dispose of the tester according to the local regulations for medical waste disposal or contact your healthcare professional for disposal information.
  • Bleeding may occur after inserting the sensor. Always make sure that the site is not bleeding before connecting the transmitter to the sensor. Blood can get into the transmitter connector and damage the device. Discard the device if damaged. If bleeding occurs, apply steady pressure with a sterile gauze or clean cloth at the insertion site until bleeding stops. After bleeding stops, connect the transmitter to the sensor.
  • Do not use the transmitter adjacent to other electrical equipment which may cause interference with the normal system operation. This includes mobile communication devices such as cell phones, GPS navigation systems, and other devices that have an output transmitter power greater than 1W. Other electrical equipment that may compromise normal system operation has been contraindicated.
  • Do not change or modify the device unless expressly approved by Medtronic Diabetes. Modifying the device can cause serious injury, interfere with your ability to operate the device, and void your warranty.

Meter

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.

Serious illness

  • Capillary (fingerstick or Alternative Site) blood glucose testing may not be clinically appropriate when peripheral flow is decreased. Shock, severe hypotension, hyperosmolar hyperglycemia, diabetic ketoacidosis, and occurrence of severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood. 4, 5, 6
  • Keep out of reach of children. This kit contains small parts which could cause suffocation if accidentally swallowed.

Talk to your healthcare professional

  • Before setting any Target ranges or High or Low Alerts on your meter.
  • Before changing your medication based on test results.
  • If your blood sugar reading is under 50 mg/dL, follow medical device immediately.
  • If you blood sugar reading is over 250 mg/dL, wash and dry your hands well and repeat the test with a new strip. If you get a similar result, call your healthcare professional as soon as possible.
  • About whether Alternative Site Testing (AST) is appropriate for you. Caution: Do not use Alternative Site Testing under the following conditions. Use fingertip testing in any of these cases:
  • If you think your blood glucose is low (hypoglycemia).
  • When blood glucose is changing rapidly (after a meal, insulin dose or exercise).
  • If you have hypoglycemic unawareness (lack of symptoms). • If you get alternative site blood glucose results that do not agree with how you feel.
  • During illness or times of stress.
  • If you will be driving a car or operating machinery.
  • For calibration of CGM system. AST testing should not be used for Bolus Wizard, to calibrate a device or verify a low blood glucose level. Consult your healthcare professional to determine if alternative site testing is right for you. Potential Biohazard
  • Always wash and dry your hands well with soap and water before and after testing, handling the meter, lancing device or test strips.
  • The meter, lancing device and lancets are for single person use. Do not share them with anyone including other family members. Do not use on multiple persons.7, 8
  • The lancing device provided by Ascensia is intended for self-testing by a single patient. It must not be used on more than one person due to 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 healthcare professional. All products that come in contact with human blood should be handled as if capable of transmitting infectious diseases.

Exposure to magnetic fields and radiation

  • Do not expose your pump to MRI equipment, diathermy devices, or other devices that generate strong magnetic fields (for example, x-ray, CT scan, or other types of radiation). The strong magnetic fields can cause the devices to malfunction, and result in serious injury. If your pump is exposed to a strong magnetic field, discontinue use and contact the 24-Hour Technical Support for further assistance. Magnetic fields, and direct contact with magnets, may affect the accurate functioning of your system, which may lead to health risks such as hypoglycemia or hyperglycemia.
  • Do not expose your transmitter to MRI equipment, diathermy devices, or other devices that generate strong magnetic fields. Exposure to a strong magnetic field has not been evaluated and can cause the device to malfunction, result in serious injury, or be unsafe. If your transmitter is inadvertently exposed to a strong magnetic field, discontinue use and contact the 24-Hour Technical Support for further assistance.
  • 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.
  • Always remove your pump, sensor, transmitter, and meter before entering a room that has x-ray, MRI, diathermy, or CT scan equipment. The magnetic fields and radiation in the immediate vicinity of this equipment can make your devices nonfunctional or damage the part of the pump that regulates insulin delivery, possibly resulting in over delivery and severe hypoglycemia.
  •  Do not expose your pump to a magnet, such as pump cases that have a magnetic clasp. Exposure to a magnet may interfere with the motor inside the pump. Damage to the motor can cause the device to malfunction and result in serious injury.
  • Always carry the Medical Emergency Card provided with your device when you are traveling. The Medical Emergency Card provides critical information about airport security systems, and using your pump on an airplane, that can help you and others. Not following the guidance on the Medical Emergency Card could result in serious injury.

GENERAL PRECAUTIONS

  • Always test your blood glucose levels at least four times per day. Although the pump has multiple safety alarms, it cannot notify you if the infusion set is leaking, or the insulin has lost its potency. 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.

Waterproof capabilities

  • At the time of manufacture and when the reservoir and tubing are properly inserted, your pump is waterproof. It is protected against the effects of being underwater to a depth of up to 12 feet (3.6 meters) for up to 24 hours.
  • If the pump is dropped, hit against a hard object, or otherwise damaged, the waterproof characteristics of the outer casing of the pump may be compromised. If your pump has been dropped or you suspect your pump is damaged, carefully inspect your pump to ensure there are no cracks before exposing your pump to water.
  • This waterproof capability rating applies only to your pump.
  • If you believe that water has entered your pump or you observe any other possible pump malfunction, check your blood glucose, and treat high blood glucose as necessary, using an alternative source of insulin. Contact the 24-Hour Technical Support for further assistance. Always contact your healthcare professional if you experience excessively high or low blood glucose levels or if you have any questions about your care.

Electrostatic discharge

  • Although your MiniMed™ 670G insulin pump is designed to be unaffected by typical levels of electrostatic discharge (ESD), very high levels of ESD can result in a reset of the pump's software and a pump error alarm. After clearing the alarm, verify that your pump is set to the correct date and time, and that all other settings are programmed to the desired values. The software reset could erase your previously programmed settings. Following a pump reset, Auto Mode will be unavailable for 5 hours to allow active insulin to be updated.
  • For more information on pump alarms, see Pump alarms, alerts, and messages. For more information on re-entering your pump settings, see My pump is asking me to enter my settings. If you are unable to reenter your pump settings, or otherwise believe there is a problem with your pump, contact the 24-Hour Technical Support.

Extreme temperatures

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.

Lotion, sunscreen, and insect repellent

  • Some skin care products, such as lotion, sunscreen, and insect repellents, can cause damage to plastics, which is a material used in your pump case. After using such products, be sure to wash your hands prior to handling your pump. If you get any skin care products or insect repellents on your pump, wipe them off as soon as possible with a damp cloth and mild soap. For instructions on cleaning your pump, see Cleaning your pump.

Infusion sets and sites

  • Always refer to the infusion set user guide for all precautions, warnings, and instructions relating to the infusion set and your insertion sites. Not referring to the infusion set user guide can result in minor injury or damage to the infusion set.

Sensor

  • Always refer to the sensor user guide for all precautions, warnings, and instructions relating to the sensor. Not referring to the sensor user guide can result in minor injury or damage to the sensor. Transmitter
  • Always refer to the transmitter user guide for all precautions, warnings, and instructions relating to the transmitter. Not referring to the transmitter user guide can result in minor injury or damage to the transmitter.

Meter

  • Always refer to the meter user guide for all precautions, warnings, and instructions relating to compatible meters. Not referring to the meter user guide can result in minor injury or damage to the meter.

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MiniMed™ 630G System

INDICATIONS

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.

CONTRAINDICATIONS

Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms.

Potential risks

Risks related to insulin pump infusion

General risks related to insulin pump infusion set may include:

  • Localized infection
  • Skin irritation or redness
  • Bruising • Discomfort or pain
  • Bleeding
  • Irritation
  • Rash

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.

Risks related to insulin administration and pump use

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:

  • Hypoglycemia
  • Hyperglycemia

Risks related to sensor use

General risks related to sensor use may include:

  • Skin irritation or reaction to adhesives
  • Bruising • Discomfort
  • Redness • Bleeding
  • Pain
  • Rash
  • Infection
  • Irritation from tapes used with glucose-sensing products
  • Raised bump
  • Appearance of a small "freckle-like" dot where needle was inserted
  • Allergic reaction
  • Fainting secondary to needle insertion
  • Soreness or tenderness
  • Swelling at insertion site
  • Sensor fracture, breakage or damage
  • Minimal blood splatter associated with sensor needle removal
  • Residual redness associated with adhesive and or tapes
  • Scarring

Specific risks related to sensor use

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.

Risks related to serter use

General risks with serter use may include skin infection around the area where the serter is used.

Risks related to the MiniMed™ 630G insulin pump system

General risks related to the MiniMed™ 630G insulin pump system may include:

  • Hypoglycemia
  • Hyperglycemia

Specific risks related to the MiniMed™ 630G insulin pump system

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:

  • Bruising at sensor site (1 incident reported)
  • Bleeding at sensor site (1 incident reported)
  • Urine ketones resulting from improper connection of the tubing to the insulin pump (1 incident reported)

GENERAL WARNINGS

Pump

  • Do not use the pump when a flammable anesthetic mixture with air, oxygen, or nitrous oxide is present. These environmental conditions can damage your pump and result in serious injury.
  • Never rely on the pump beeps or vibrations alone to navigate through the pump screens or menus. Always check your pump screen as you navigate.
  • The pump beeps and vibrations are intended to notify you of a condition that may require attention. Relying on the pump beeps or vibrations alone to navigate can result in incorrect menu selection or settings.
  • Do not rely on preset pump alarms or reminders alone to prompt you to check your blood glucose. This can cause you to forget to check your blood glucose. Set additional reminders on other devices, such as your cell phone.
  • Do not use standard Luer sets with the MiniMed™ 630G insulin pump. Luer sets are not compatible with the pump. MiniMed™ reservoirs and MiniMed™ infusion sets are specifically designed for use with the MiniMed™ 630G insulin pump.
  • Do not change or modify your MiniMed™ reservoir or MiniMed™ infusion set unless expressly approved by Medtronic Diabetes. Modifying the devices can cause serious injury, interfere with your ability to operate the device, and void your warranty.
  • Only use U-100 insulin that has been prescribed by your healthcare professional for use with an infusion pump. Do not put any other drugs or medications inside your reservoir for use with this pump. Other drugs or medications are not intended for use with this pump. Use of other drugs or medications can cause serious injury.
  • Always make sure the infusion set is disconnected from your body before you rewind your pump or fill the infusion set tubing. Never insert the reservoir into the pump while the tubing is connected to your body. Doing so could result in an accidental infusion of insulin.
  • Do not insert the reservoir in the pump if you did not rewind your pump. Doing so could result in an accidental infusion of insulin.
  • Do not use the MiniMed™ 630G insulin pump or additional system devices adjacent to other electrical equipment which may cause interference with the normal system operation. This includes mobile communication devices such as cell phones, GPS navigation systems, anti-theft systems, and any electrical equipment that has an output transmitter power greater than 1W. For more information about recommended separation distance guidelines between the insulin pump and common RF emitters, see Guidance and manufacturer's declaration, on page 267. The recommended separation distance between the insulin pump and common RF emitters is 12 inches. Other electrical equipment that may compromise normal system operation has been contraindicated. For more information, see Exposure to magnetic fields and radiation.
  • Do not unscrew or retighten the tubing connector on the reservoir while the infusion set is connected to your body. Doing so could result in an accidental infusion of insulin. 
  • Do not use the MiniLink™ transmitter, MMT-7703, with the MiniMed™ 630G insulin pump. This device does not communicate with this insulin pump. Use of this transmitter with this insulin pump can result in serious injury.
  • Do not use the Guardian™ Link transmitter, MMT-7763, with the Guardian™ Sensor (3), MMT-7020. They do not work together. Use of this transmitter with this sensor, causes damage.to these devices and can result in serious injury.
  • Do not use your pump if the screen appears broken or unreadable. In some instances, impact to the pump can damage the screen while the buttons continue to function. If the screen is broken or unreadable, do not press any buttons. Remove the pump and begin using your backup insulin plan per the direction of your healthcare professional. If the pump is accidentally programmed while the screen is broken or unreadable, this could result in high or low blood glucose levels. If your screen is damaged, contact the 24-Hour Technical Support to arrange for shipment of a replacement pump. 

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.

Exposure to magnetic fields and radiation

  • Do not expose your pump to MRI equipment, diathermy devices, or other devices that generate strong magnetic fields (for example, x-ray, CT scan, or other types of radiation). The strong magnetic fields can cause the devices to malfunction, and result in serious injury. If your transmitter is exposed to a strong magnetic field, discontinue use and contact the 24-Hour Technical Support for further assistance.
  • Always remove your pump, sensor, transmitter, and meter before entering a room that has x-ray, MRI, diathermy, or CT scan equipment. The magnetic fields and radiation in the immediate vicinity of this equipment can make your devices nonfunctional or damage the part of the pump that regulates insulin delivery, possibly resulting in over delivery and severe hypoglycemia.
  • Always carry the Medical emergency card provided with your device when you are traveling. The Medical emergency card provides critical information about airport security systems, and using your pump on an airplane, that can help you and others. Not carrying the Medical emergency card could result in serious injury.
  • Do not expose your pump to a magnet, such as pump cases that have a magnetic clasp. Exposure to a magnet may interfere with the motor inside the pump. Damage to the motor can cause the device to malfunction, and result in serious injury.

Reservoir and infusion sets

  • Only use reservoir and infusion sets manufactured by Medtronic Diabetes. The pump has undergone extensive testing to confirm appropriate operation when used with compatible reservoirs and infusion sets manufactured or distributed by Medtronic Diabetes. We cannot guarantee appropriate operation if the pump is used with reservoirs or infusion sets offered by third parties. We are not responsible for any injury or malfunctioning of the pump that may occur in association with such use.
  • Only use U-100 insulin that has been prescribed by your healthcare professional for use with an infusion pump. Do not put any other drugs or medications inside your reservoir for use with this pump. Other drugs or medications are not intended for use with this pump. Use of other drugs or medications can cause serious injury.
  • Always refer to the reservoir and infusion set user guides for all precautions, warnings, and instructions relating to the reservoir and infusion set. Not referring to the reservoir and infusion set user guides can result in serious injury or damage to the sensor.

Sensor

  • Do not attempt to remove the sensor yourself if you suspect that the sensor is broken. While there is no evidence of a Guardian™ Sensor (3) breaking in a patient’s body, sensor breakage can result in serious injury. Contact your healthcare professional for assistance in removing the sensor.
  • Always refer to the sensor user guide for all precautions, warnings, and instructions relating to the sensor. Not referring to the sensor user guide can result in serious injury or damage to the sensor.

Transmitter

  • Do not allow children to put small parts in their mouth. This product poses a choking hazard for young children.
  • Always refer to the transmitter user guide for all precautions, warnings, and instructions relating to the transmitter. Not referring to the transmitter user guide can result in serious injury or damage to the transmitter.

Meter

  • Always refer to the meter user guide for all precautions, warnings, and instructions relating to the CONTOUR®NEXT LINK 2.4 meter. Not referring to the meter user guide can result in serious injury or damage to the meter.

GENERAL PRECAUTIONS

  • Always test your blood glucose levels at least four times per day. Although the pump has multiple safety alarms, it cannot notify you if the infusion set is leaking, or the insulin has lost its potency. 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.

Waterproof capabilities

  • At the time of manufacture and when the reservoir and tubing are properly inserted, your pump is waterproof. It is protected against the effects of being underwater to a depth of up to 12 feet (3.6 meters) for up to 24 hours. • If the pump is dropped, hit against a hard object, or otherwise damaged, the waterproof characteristics of the outer casing of the pump may be compromised. If your pump has been dropped or you suspect your pump is damaged, carefully inspect your pump to ensure there are no cracks before exposing your pump to water.
  • This waterproof capability rating applies only to your pump.
  • If you believe that water has entered your pump or you observe any other possible pump malfunction, check your blood glucose, and treat high blood glucose as necessary, using an alternative source of insulin. Contact the 24-Hour Technical Support for further assistance. Always contact your healthcare professional if you experience excessively high or low blood glucose levels or if you have any questions about your care.

Electrostatic discharge

  • Although your MiniMed™ 630G insulin pump is designed to be unaffected by typical levels of electrostatic discharge (ESD), very high levels of ESD can result in a reset of the pump's software and a pump error alarm. After clearing the alarm, verify that your pump is set to the correct date and time, and that all other settings are programmed to the desired values. The software reset could erase your previously programmed settings.
  • For more information on pump alarms, see Pump alarms, alerts, and messages, on page 202. For more information on re-entering your pump settings, see My pump is asking me to enter my settings, on page 230. If you are unable to reenter your pump settings, or otherwise believe there is a problem with your pump, contact the 24-Hour Technical Support.

Extreme temperatures

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.

Lotion, sunscreen, and insect repellent

  • Some skin care products, such as lotion, sunscreen, and insect repellents, can cause damage to plastics, which is a material used in your pump case. Carefully inspect your pump to ensure there are no cracks. After using such products, be sure to wash your hands prior to handling your pump. If you get any skin care products or insect repellents on your pump, wipe them off as soon as possible with a damp cloth and mild soap. For instructions on cleaning your pump, see Cleaning your pump. Infusion sets and sites
  • Always refer to the infusion set user guide for all precautions, warnings, and instructions relating to the infusion set and your insertion sites. Not referring to the infusion set user guide can result in minor injury or damage to the infusion set.

Sensor

  • Always refer to the sensor user guide for all precautions, warnings, and instructions relating to the sensor. Not referring to the sensor user guide can result in minor injury or damage to the sensor.

Transmitter

  • Always refer to the transmitter user guide for all precautions, warnings, and instructions relating to the transmitter. Not referring to the transmitter user guide can result in minor injury or damage to the transmitter.

Meter

  • Always refer to the meter user guide for all precautions, warnings, and instructions relating to the CONTOUR®NEXT LINK 2.4 meter. Not referring to the meter user guide can result in minor injury or damage to the meter.

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Guardian™ Connect CGM System

INDICATIONS FOR USE

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.

Guardian™ Sensor (3)

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.

Guardian™ Connect transmitter

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.

Guardian™ Connect app

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.

Charger

The charger is used to charge your transmitter battery. For best results, recharge your transmitter between each use to ensure full transmitter battery life. 

Tester

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.

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.

Oval tape

The tape is indicated for use with Medtronic glucose sensor products. It is indicated for one-time use.

User Safety

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.

CONTRAINDICATIONS

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.

Safety Warnings

App and Mobile Device

  • Missing alerts from the Guardian™ Connect app may result in undetected low and high glucose levels. Follow the instructions and safety warnings in this user guide to make sure you receive alerts as intended.
  • You must allow notifications for the Guardian™ Connect app during setup. Also, do not turn off notifications for the Guardian™ Connect app in your mobile device settings. If notifications are off, you will not receive any alerts (including the Urgent Low glucose (alert) even if the audio override feature is on.
  • Do not use the Guardian™ Connect app unless you understand how your mobile device settings work. If your mobile device settings are not set up correctly, you may not receive sensor glucose alerts.
  • Make sure Bluetooth is on, even if your mobile device is in Airplane mode. If Bluetooth is off, you will not get sensor glucose information or alerts.
  • Do not use the Guardian™ Connect app if your mobile device screen or speakers are damaged. If your mobile device is damaged, you may not get sensor glucose alerts and sensor glucose information may not be shown correctly.
  • If you turn off the override feature in the Guardian™ Connect app, the alerts will be based on the ringer setting of your mobile device. If your ringer is set to Do Not Disturb, silent, or a low volume, you may not hear sensor glucose alerts.
  • Alerts for the Guardian™ Connect app will sound through your headphones when headphones are connected. If you leave your headphones connected when not in use, you may not hear sensor glucose alerts.
  • Do not close the Guardian™ Connect app. If the app is closed, you will not get sensor glucose information or alerts.
  • Your mobile device may close the Guardian™ Connect app automatically when you are using another app, such as a game. If the Guardian™ Connect app is closed, you will not get sensor glucose alerts. Check the Guardian™ Connect app occasionally to make sure it is running.
  • If your mobile device restarts, the Guardian™ Connect app will not restart automatically. If you do not open the app again, you will not get sensor glucose alerts. Always make sure to open the app after your mobile device restarts.
  • Do not let your mobile device shut down due to low battery, or you will not get sensor glucose alerts. Make sure you have a charger available so you can charge your battery if needed.
  • When you snooze a sensor glucose alert, you won't get that alert again during the length of the snooze time you set. Make sure to set the snooze to a short enough time so that you can be sure to get an alert again if your glucose level doesn’t improve.
  • Do not make therapy decisions based on sensor glucose values because sensor glucose and blood glucose (BG) values may be different. Confirm your glucose level with your blood glucose meter before making treatment decisions, such as dosing insulin before a meal or taking carbs to treat a low.
  • Do not root or jailbreak your mobile device. Rooting or jailbreaking means to change the software of your mobile device in a way the manufacturer did not intend. If you change your mobile device in this way, you may not get sensor glucose alerts and your sensor glucose information may not be shown correctly.

Transmitter

  • Do not use the transmitter adjacent to other electrical equipment that may cause interference with the normal system operation. For more information on other electrical equipment that may compromise normal system operation, see Exposure to magnetic fields and radiation, on page 7.
  • Do not use the device if you see any cracking, flaking, or damage to the housing. Cracking, flaking, or damage to the housing are signs of deterioration. Deterioration of the housing can affect the ability to properly clean the transmitter and result in serious injury. Call the 24-Hour Technical Support and discard the device according to local regulations for battery disposal (nonincineration), or contact your healthcare professional for disposal information.
  • Do not discard the transmitter in a medical waste container or expose it to extreme heat. The transmitter contains a battery that may ignite and result in serious injury.
  • Do not allow children to put small parts in their mouth. This product poses a choking hazard for young children.
  • Do not change or modify the device unless expressly approved by Medtronic Diabetes. Modifying the device can cause serious injury, interfere with your ability to operate the device, and void your warranty.

Charger

  • Dispose of the charger according to the local regulations for battery disposal, or contact your healthcare professional for disposal information. The charger may ignite upon incineration.

Tester

  • Do not use the tester if it comes in contact with blood. Touching blood can cause infection. Dispose of the tester according to the local regulations for medical waste disposal, or contact your healthcare professional for disposal information.

Serter

  • 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.
  • Wear gloves when inserting the sensor into someone other than yourself to avoid contact with patient blood. Minimal bleeding may occur. Contact with patient blood can cause infection.
  • Never point a loaded serter toward any body part where insertion is not desired. An accidental button-push may cause the needle to inject the sensor in an undesired location, causing minor injury.

Sensor

  • Taking medications with acetaminophen or paracetamol including but not limited to Tylenol®, fever reducers, cold medicine while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen or paracetamol active in your body and may be different for each person. Always use blood glucose meter readings to verify your glucose level before making therapy decisions.
  • The Guardian™ Sensor (3) should only be used with the one-press serter. Medtronic cannot guarantee the safety or effectiveness of this product if used with other products.
  • The Guardian™ Sensor (3) was developed for use with and the performance evaluated 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.
  • 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.
  • Watch for bleeding at the insertion site (under, around, or on top of the sensor). If bleeding occurs, do the following:

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. 

Exposure to magnetic fields and radiation

  • Do not expose your sensor or transmitter to Magnetic Resonance Imaging (MRI) equipment, diathermy devices, or other devices that generate strong magnetic fields (for example, x-ray, CT scan, or other types of radiation). Always remove your sensor and transmitter before entering a room that has x-ray, MRI, diathermy, or CT scan equipment. Exposure to a strong magnetic field has not been evaluated and can cause the device to malfunction, result in serious injury or be unsafe. If your sensor or transmitter is exposed to a strong magnetic field, discontinue use and contact the 24-Hour Technical Support for further assistance.

PRECAUTIONS

  • You must test your blood glucose levels at least two times per day, or as indicated by the system. If the app indicates that your sensor glucose is not within your glucose target range, check your blood glucose using your blood glucose meter.
  • Do not use any other sensor. Other sensors are not intended for use with the transmitter, and will damage the transmitter and the sensor.
  • Only use the green colored tester (MMT-7736L) with the transmitter. Do not use any other tester. Other testers are not intended for use with the transmitter, and will damage the transmitter and the tester.
  • Always use the tester when cleaning the transmitter. Do not use any other tester with the transmitter. Use of another tester can allow water to get into the transmitter or can prevent proper cleaning. Water can damage the transmitter.
  • Do not twist the tester or sensor while attached to the transmitter. Twisting the tester or sensor will damage the transmitter.
  • Do not allow the tester to come in contact with any liquid when not connected to the transmitter. A wet tester can damage the transmitter.
  • Do not allow the transmitter to come in contact with any liquid when not connected to a sensor or to the tester. Moisture will damage the transmitter and a wet transmitter can damage the sensor.
  • Do not clean the o-rings on the tester with any substances. Cleaning the o-rings can damage the tester.
  •  Wash your hands with soap and water before inserting the sensor to help prevent site infection.
  • Wear gloves when inserting the sensor into someone other than yourself to avoid contact with patient blood.
  • Do not insert the sensor through tape. Inserting the sensor through tape may cause improper sensor insertion and function.
  • Only use alcohol to prepare the insertion site, to ensure that residue is not left on the skin.
  • Rotate the sensor insertion site so that sites do not become overused.
  • Discard used sensors and needle housings in a sharps container after each use to avoid accidental needlestick or puncture.
  • Do not clean, resterilize, or try to extract the needle from the needle housing. An accidental needlestick or puncture may occur.
  • Do not reuse sensors. Reuse of a sensor may cause damage to the sensor surface and lead to inaccurate glucose values, site irritation, or infection.

Where to insert the sensor

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.

Potential risks related to sensor use

General risks with sensor use include:

  • Skin irritation or other reactions
  • Bruising
  • Discomfort
  • Redness
  • Bleeding
  • Pain
  • Rash
  • Infection
  • Raised bump
  • Appearance of a small “freckle-like” dot where needle was inserted
  • Allergic reaction
  • Fainting secondary to anxiety or fear of needle insertion
  • Soreness or tenderness
  • Swelling at insertion site
  • Sensor fracture, breakage or damage
  • Minimal blood splatter associated with sensor needle removal
  • Residual redness associated with adhesive or tapes or both
  • Scarring

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iPRO™2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM)

INDICATIONS FOR USE

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.

THE iPRO™2 SYSTEM:

  • is intended for prescription use only.
  • does not allow data to be made available directly to patients in real time.
  • provides data that will be available for review by physicians after the recording interval (up to 144 hours).
  • is intended for occasional rather than everyday use.
  •  is to be used only as a supplement to, and not a replacement for, standard invasive measurement.

CONTRAINDICATIONS

None known.

WARNINGS

  • This product contains small parts and may pose a choking hazard for young children.
  • The glucose sensor should be removed if redness, bleeding, pain, tenderness, irritation, or inflammation develops at the sensor insertion site, or if the patient experiences unexplained fever.
  • An optional occlusive adhesive dressing should be removed if irritation or reaction to the tape develops.
  • The glucose sensor may create special needs regarding your patients' medical conditions or medications. Bleeding, swelling, irritation or infection at the insertion site are possible risks associated with inserting the sensor and sometimes result from improper insertion and maintenance of insertion site. Taking medications with acetaminophen 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. Healthcare professionals should discuss this with their patients before they use the glucose sensor.
  • Do not modify this product, as modification could result in a safety hazard.
  • The iPro™2 must be disinfected after every use on a patient. Users must adhere to universal precautions when handling or using this device to prevent transmission of diseases. For more information, refer to "Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007." www.cdc.gov/hicpac/2007ip/ 2007isolationprecautions.html. For more information on cleaning and disinfection, see Cleaning and disinfecting the iPro2™ system.
  • Do not expose your iPro2 or sensor to Magnetic Resonance Imaging (MRI) equipment, x-ray equipment, Computed Tomography (CT) scanners, Intensity-Modulated Radiation Therapy (IMRT), diathermy devices, or other devices that generate strong magnetic fields or ionizing radiation. This equipment has strong magnetic fields or ionizing radiation that can cause the device to malfunction. If the iPro2 or sensor is inadvertently exposed to a strong magnetic field, discontinue use and contact the 24-Hour Technical Support for further assistance.

Precautions

  • If performing multiple iPro™2 studies on the same patient, establish a rotation schedule for choosing new sensor sites.
  • Avoid inserting a sensor in areas on the body that are constrained by clothing, have scar tissue, or are subject to rigorous movement during exercise.
  • Before connecting the iPro™2, do the following:

        - 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.

  • If body fluid comes into contact with the cleaning plug's connector or the Dock's connector, the contaminated device must be discarded to prevent contamination of the iPro™2.
  •  Do not allow fluids (including water, cleaning fluids, and disinfectants) on the iPro™2's connector opening or connector pins. Fluids can cause the connector pins to corrode and may affect the iPro™2's performance.

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CareLink™ System Software

Indications for Use

The CareLink™ software is intended for use as a tool to help manage diabetes. The purpose of the software is to take information transmitted from insulin pumps, glucose meters and continuous glucose monitoring systems, and turn it into CareLink™ reports. The reports provide information that can be used to identify trends and track daily activities-such as carbohydrates consumed, meal times, insulin delivery, and glucose readings. There are two versions of Medtronic MiniMed CareLink™ Therapy Management Software available: CareLink™ Personal and CareLink™ Pro.

Contraindications

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

Warnings/Precautions

  • The software is intended to be used by or with advice from a healthcare professional familiar with the management of diabetes.
  • System results are not intended to produce medical advice and should not be relied upon for such purpose.
  • Patients should monitor their blood glucose levels at least 4 - 6 times a day.
  • Patients should not make any changes to their treatment without consulting their healthcare professional first.

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

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Enlite™ Sensor

INDICATIONS FOR USE

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

CONTRAINDICATIONS

None known

GENERAL WARNINGS

  • Do not make therapy treatment decisions based on sensor glucose values because sensor glucose and blood glucose values may differ. If your sensor glucose reading is high or low, or if you feel symptoms of high or low glucose, confirm your blood glucose with your BG meter prior to making therapy decisions to avoid severe high or low glucose conditions.
  • Keep an arm’s length between you and the patient when removing the needle. A retractable needle is attached to the sensor and minimal blood splatter may occur.
  • Keep the needle housing within sight at all times to avoid accidental needle stick injury.
  •  Always inspect the packaging for damage prior to use. Sensors are sterile and nonpyrogenic, unless the package has been opened or damaged. Do not use any of the sensors if the sterile package has been opened or damaged. Use of an unsterile sensor can cause site infection.
  • Watch for bleeding at the insertion site (under, around, or on top of the sensor). Apply steady pressure using sterile gauze or a clean cloth placed on top of the sensor for up to three minutes, if bleeding occurs. The use of unsterile gauze can cause an infection.
  • Do not attach the transmitter to the sensor, if bleeding does not stop. Blood can get into the transmitter’s connector, which can damage the device. Remove the sensor and continue to apply steady pressure until the bleeding stops.

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.

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

GENERAL PRECAUTIONS

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

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

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Enlite™ Serter

Indications for use

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

Contraindications

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

General warnings

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

  • Failure to follow directions may result in pain or injury.
  • Do not make therapy treatment decisions based on sensor glucose values because sensor glucose and blood glucose values may differ. If your sensor glucose reading is low or high, or if you feel symptoms of low or high glucose, confirm your blood glucose with your BG meter prior to making therapy decisions to avoid severe low or high glucose conditions.
  • Keep an arm’s length between you and the patient when removing the needle. A retractable needle is attached to the sensor and minimal blood splatter may occur.
  • Keep the needle housing within sight at all times to avoid accidental needle stick injury.
  • Always inspect the sensor packaging for damage prior to use. Sensors are sterile and nonpyrogenic, unless the package has been opened or damaged. Do not use any of the sensors if the sterile package has been opened or damaged. Use of an unsterile sensor can cause site infection.
  • 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.

  1. Remove the sensor and discard in a sharps container.
  2. Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation and treat accordingly.
  3. Insert a new sensor in a different location.
  • Make sure the sensor is securely placed in the serter to avoid pain or minor injury.
  • Keep the serter away from children. This product contains small parts and may pose a choking hazard.
  • Refer to the Enlite Glucose Sensor User Guide for additional sensor related warnings.

General Precautions

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

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

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GUARDIAN™ SENSOR (3)

INDICATIONS FOR USE

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

CONTRAINDICATIONS

None known.

GENERAL WARNINGS

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

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

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

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

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

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

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

If bleeding occurs, do the following:

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.

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

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.

GENERAL PRECAUTIONS

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

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One-press Serter

Indications for use

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

Contraindications

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

General warnings

Read this entire user guide before attempting to insert the sensor. The serter does not work the same as other Medtronic insertion devices. Failure to follow directions may result in improper insertion, pain, or injury. Contact the 24-Hour Technical Support or your local representative, if you have questions or concerns. Do not make therapy decisions based on sensor glucose values because sensor glucose and blood glucose values may differ. If your sensor glucose reading is low or high, or if you feel symptoms of low or high glucose, do the following prior to making therapy decisions. Confirm your blood glucose with your BG meter using a fingerstick blood sample. A retractable needle is attached to the sensor and minimal blood splatter may occur. If you are a healthcare professional or caregiver, wrap sterile gauze around the sensor to minimize contact with blood. Keep as much distance as possible between you and the patient when removing the needle. Keep the needle housing within sight at all times to avoid an accidental needlestick or puncture. Always inspect the sensor packaging for damage before use. Sensors are sterile and non-pyrogenic, unless the package has been opened or damaged. Do not use the sensor if the sterile package has been opened or damaged. Use of an unsterile sensor can cause site infection. Watch for bleeding at the insertion site (under, around, or on top of the sensor).

 If bleeding occurs, do the following:

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.

If bleeding continues, do the following:

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.

  • Make sure the sensor is securely placed in the serter to avoid improper insertion, pain, or minor injury
  • Keep the serter away from children. This product contains small parts and may pose a choking hazard.
  • Refer to the Enlite User Guide for additional sensor related warnings.

General precautions

  • Wash your hands with soap and water before inserting the sensor to help prevent site infection.
  • If you are a healthcare professional or caregiver, wear gloves when inserting the sensor into someone other than yourself to avoid contact with patient blood.
  • Do not insert the sensor through tape. Inserting the sensor through tape may cause improper sensor insertion and function.
  • Only use alcohol to prepare the insertion site, to ensure that residue is not left on the skin.
  • Rotate the sensor insertion sites so that they do not become overused.
  • Discard used sensors and needle housings in a sharps container after each use to avoid accidental needlestick or puncture.
  • Do not clean, resterilize, or try to extract the needle from the needle housing. An accidental needlestick or puncture may occur.
  • Do not reuse sensors. Reuse of a sensor may cause damage to the sensor surface and lead to inaccurate glucose values, site irritation, or infection.
  • Always make sure the sensor is firmly attached so that it does not come out of your body. Factors that may increase the likelihood of the sensor falling off include increased physical activity (particularly for younger patients) and improper taping technique.

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CONTOUR®NEXT LINK 2.4 meter

Indications for Use

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

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

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

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

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

Warnings/Precautions

Meter

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

General Warnings

Meter

Serious Illness

  • Capillary (fingerstick or Alternative Site) blood glucose testing may not be clinically appropriate when peripheral flow is decreased. Shock, severe hypotension, hyperosmolar hyperglycemia, diabetic ketoacidosis, and occurrence of severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood.1,2,3
  • Keep out of reach of children. This kit contains small parts which could cause suffocation if accidentally swallowed.

Talk to Your Health Care Professional

  • Before setting any Target ranges or High or Low Alerts on your meter.
  • Before changing your medication based on test results.
  • If your blood sugar reading is under 50 mg/dL, follow medical advice immediately.
  • If your blood sugar reading is over 250 mg/dL, wash and dry your hands well and repeat the test with a new strip. If you get a similar result, call your health care professional as soon as possible.
  • About whether Alternative Site Testing (AST) is appropriate for you.
  • Potential Biohazard

        - Always wash and dry your hands well with soap and water before and after testing, handling the meter, lancing device or test strips.

        - The meter, lancing device and lancets are for single person use. Do not share them with anyone including other family members. Do not use on multiple persons.4,5

        - All parts of this kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection. For Cleaning and Disinfection instructions, please refer to the meter’s user guide.

        - The lancing device provided by Ascensia Diabetes Care is intended for self-testing by a single patient. It must not be used on more than one person due to the risk of infection.

        - Use a new lancet each time you test because it is no longer sterile after use.

        - Always dispose of test strips and lancets as medical waste or as advised by your health care professional. All products that come in contact with human blood should be handled as if capable of transmitting infectious diseases.

Precautions

  •  Read your CONTOUR®NEXT LINK 2.4 user guide, the lancing device package insert, your Medtronic device user guide and all instructional materials provided in your meter kit before testing.
  • Please follow all instructions for use and care exactly as described to help avoid inaccurate results.
  • Examine product for missing, damaged, or broken parts. If the test strip bottle is open inside a new box of strips, do not use those strips. For replacement parts, contact Ascensia Diabetes Care Customer Service at 1.800.848.8100.
  • The CONTOUR®NEXT LINK 2.4 meter from Ascensia Diabetes Care only works with CONTOUR®NEXT test strips and CONTOUR®NEXT control solutions.
  • Always keep the CONTOUR®NEXT test strips in their original bottle. Tightly close the bottle immediately after removing a test strip. The bottle is designed to keep the test strips dry. Avoid exposing meter and test strips to excessive humidity, heat, cold, dust, and dirt. Exposure to room humidity from leaving the bottle open or not storing the strips in their original bottle can damage your test strips. This could lead to inaccurate results. Do not use a test strip that appears damaged or has been used.
  • Check the expiration dates on your test strips and control solution. Do not use the test strips or control solution if the expiration date printed on the bottle label and carton has passed. This can cause inaccurate results. For the control solution, do not use if it has been 6 months since you first opened the bottle. After first opening the bottle, write the 6-month discard date on the control solution label.
  • If your control solution test result is out of range, contact Ascensia Diabetes Care Customer Service at 1.800.848.8100. Do not use the meter for blood glucose testing until you resolve this issue.
  • The meter has been designed to give accurate results at temperatures between 41° to 113°F. If you are outside this range, you should not test. Whenever the meter is moved from one location to another, allow approximately 20 minutes for the meter to adjust to the temperature of the new location before performing a blood glucose test.
  • Do not perform a blood glucose test when the CONTOUR®NEXT LINK 2.4 meter is connected to a computer.
  • Use only approved cables or wall charger from the manufacturer or a 5V charger approved by a certified body such as UL or TUV.
  • The CONTOUR®NEXT LINK 2.4 meter from Ascensia Diabetes Care has been preset and locked to display results in mg/dL (milligrams of glucose per deciliter of blood).

        - Results in m g/dL will never have a decimal point;

        - Results in m mol/L will always have a decimal point.

        - Example: 93 mg/dL or 5.2 mmol/L

  • Check your display screen to be sure the results are shown the right way. If not, please contact Ascensia Diabetes Care Customer Service at 1.800.848.8100.
  • The CONTOUR®NEXT LINK 2.4 wireless blood glucose monitoring system from Ascensia Diabetes Care has a measuring range of 20 mg/dL to 600 mg/dL.

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

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

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

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i-PORT ADVANCE™ INJECTION PORT

INDICATIONS FOR USE

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.

CONTRAINDICATIONS

  • Do not use the same i-Port Advance™ injection port for longer than 72 hours.
  • Do not attempt to reapply the i-Port Advance™ injection port after use.
  • The i-Port Advance™ injection port is neither intended nor indicated for use with blood or blood products.
  • Do not use the i-Port Advance™ injection port for any purpose other than the indications specified by your healthcare professional.
  • Do not use needles with a gauge smaller than 28 or greater than 32. Doing so may damage the septum and may cause incorrect medication delivery.
  • Do not use a needle longer than 5/16 in. (8 mm) when injecting into the i-Port Advance™ injection port. Longer needles 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. Shorter needles may not pass through the port septum, which may prevent the medication from properly entering the body.

WARNINGS AND PRECAUTIONS

  • The i-Port Advance™ injection port is only sterile and non-pyrogenic 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 tamperproof 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 inject multiple medications contraindicated for subcutaneous administration into the same site.
  • The i-Port Advance™ injection port is a one time, single patient use device. Reuse of the port may damage the cannula in the device and increases the risk of the tape becoming loose. Reuse of the port may result in infection or site irritation and inaccurate medication delivery.
  • Incorrect medication absorption, infection, or site irritation may result from improper application to the body or maintenance of the i-Port Advance™ injection port insertion site, or both. If the insertion site becomes irritated or inflamed, remove and discard the device and apply a new device to a different location on the body.
  • The soft cannula may crimp or bend when applying or while wearing. A crimped or bent cannula may limit or prevent medication delivery through the i-Port Advance™ injection port. You should remove and discard the device immediately if you suspect a crimped or bent cannula. Indications that your i-Port Advance™ injection port has a crimped or bent cannula include: - difficulty pressing down on the plunger of the syringe when injecting - injected medication escaping from the device onto the top of the septum - injected medication leaking onto the skin or saturating the tape - moisture present inside the transparent body of the device.
  • Make sure that the soft cannula does not extend beyond the introducer needle. If it does, do not use the device. This may result in improper insertion, causing a bent cannula and incorrect medication delivery.
  • 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.
  • Refer to your healthcare professional for instructions about site rotation. Improper site rotation can result in incorrect medication delivery, infection or site irritation.
  • 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 purified 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 the i-Port Advance™ injection port 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 i-Port Advance™ injection port may have up to 2.60 µL or 0.26 units of medication that remain in the port. This can delay or prevent your medication from entering your body. Consult with the healthcare professional of your prescribed medication to determine if this impacts your therapy management.

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MINIMED™ QUICK-SET™ INFUSION SET

INDICATIONS FOR USE

This product is indicated for the subcutaneous infusion of insulin from an infusion pump.

CONTRAINDICATIONS

Infusion sets are indicated for subcutaneous use only and not for intravenous (IV) infusion or the infusion of blood or blood products.

WARNINGS

  • Inaccurate medication delivery, infection and/or site irritation may result from improper insertion and maintenance of the infusion site.
  • Before insertion, clean the insertion site with isopropyl alcohol.
  • Remove the needle guard before inserting the infusion set.
  •  If using this infusion set for the first time, do the first set-up in the presence of your healthcare professional. Do not leave air in the infusion set. Prime completely.
  • Check frequently to make sure the soft cannula remains firmly in place as you may not feel pain if it pulls out. The soft cannula must always be completely inserted to receive the full amount of medication.
  • If the infusion site becomes inflamed, replace the set, and use a new site until the first site has healed. Replace the infusion set if the tape becomes loose, or if the soft cannula becomes fully or partially dislodged from the skin.
  • Replace the infusion set every 48- 72 hours, or per your healthcare professional’s instructions.
  • Do not reinsert the introducer needle into the infusion set. Re-insertion may cause tearing of the soft cannula, which may result in unpredictable medication flow.
  • Never prime the set or attempt to free a clogged line while the set is inserted. You may accidentally inject too much medication.
  • Do not put disinfectants, perfumes, or deodorants on the infusion set as these may affect the integrity of the set.
  • Dispose of the infusion set and introducer needle safely, in a sharps container, after a single use. Do not clean or re-sterilize.
  • This device is sterile and non-pyrogenic unless the package has been opened or damaged. Do not use if the package has been opened or damaged. (For Paradigm users, do not use the infusion set if the tubing connector needle has been damaged.)
  • Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle.
  • Use aseptic techniques when temporarily disconnecting the set and consult your healthcare provider on how to compensate for missed medication when disconnected.
  • If infusing insulin, carefully monitor your blood glucose levels when disconnected and after reconnecting.
  • If infusing insulin, and your blood glucose level becomes unexplainably high, or an occlusion alarm occurs, check for clogs and/or leaks. If in doubt, change the infusion set because the soft cannula may be dislodged, crimped and/or partially clogged. Should any of these problems arise, make a plan with your healthcare professional for rapidly replacing insulin. Test your blood glucose level to make sure the problem is corrected.
  • If infusing insulin, do not change the infusion set just before bedtime unless you can check your blood glucose 1-3 hours after insertion. Reuse of the infusion set may cause damage to the cannula/needle and lead to infection, site irritation, and/or inaccurate medication delivery.
  • 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 hyperglycemia or hypoglycemia. If this occurs, start over with a new reservoir and infusion set

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MINIMED™ MIO™ INFUSION SET

INDICATIONS FOR USE

This product is indicated for the subcutaneous infusion of insulin from an infusion pump.

CONTRAINDICATIONS

This product is neither intended nor indicated for intravenous (IV) infusion or the infusion of blood or blood products.

WARNINGS

  •  Inaccurate medication delivery, infection and/or site irritation may result from improper insertion and maintenance of the infusion site.
  • Ensure sterility by checking that the sterile paper and tamper-proof seal are not damaged.
  • Before insertion, clean the insertion site with isopropyl alcohol.
  • Remove the needle guard before inserting the infusion set.
  • If using this infusion set for the first time, do the first set-up in the presence of your healthcare professional.
  •  Do not leave air in the infusion set. Prime completely.
  • Check frequently to make sure the soft cannula remains firmly in place as you may not feel pain if it pulls out. The soft cannula must always be completely inserted to receive the full amount of medication.
  • Release the tubing with caution as a hard pull of the tubing can result in damage to the infusion set/introducer needle. Ensure that the infusion set is properly in place when the tubing is fully released.
  • 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.
  • Replace the infusion set every 48-72 hours, or per your healthcare professional’s instructions.
  • Do not reinsert the introducer needle into the infusion set. Re-insertion may cause tearing of the soft cannula, which may result in unpredictable medication flow.
  • Never prime the set or attempt to free a clogged line while the set is inserted. You may accidentally inject too much medication.
  • Do not put disinfectants, perfumes, or deodorants on the infusion set as these may affect the integrity of the set.
  • Dispose of the infusion set and introducer needle safely, in a sharps container, after a single use. Do not clean or re-sterilize.
  • This device is sterile and non-pyrogenic unless the package has been opened or damaged. Do not use if the package has been opened or damaged.
  • For Paradigm users, do not use the infusion set if the tubing connector needle has been damaged.
  • Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle.
  • Use aseptic techniques when temporarily disconnecting the set and consult your healthcare professional on how to compensate for missed medication when disconnected.
  • If infusing insulin, carefully monitor your blood glucose levels when disconnected and after reconnecting.
  • If infusing insulin, and your blood glucose level becomes unexplainably high, or an occlusion alarm occurs, check for clogs and/or leaks.
  • If in doubt, change the infusion set because the soft cannula may be dislodged, crimped and/or partially clogged. Should any of these problems arise, make a plan with your healthcare professional for rapidly replacing insulin. Test your blood glucose level make sure the problem is corrected.
  • Never point a loaded insertion device towards any body part, where insertion is not desired.
  • If infusing insulin, do not change the infusion set just before bedtime unless you can check your blood glucose 1-3 hours after insertion.
  • Reuse of the infusion set may cause damage to the cannula/needle and lead to infection, site irritation, and/or inaccurate medication delivery

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MINIMED™ MIO™ ADVANCE INFUSION SET

INDICATIONS FOR USE

The MiniMed™ Mio™ Advance infusion set is indicated for subcutaneous infusion of medication administered by an external pump.

CONTRAINDICATIONS

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.

GENERAL INSTRUCTIONS

  • You can wear the infusion set for a maximum of 72 hours, or per your healthcare professional’s instructions.
  •  If you are using the infusion set for the first time, do the first set–up in the presence of your healthcare professional.

 WARNINGS

  • Do not use if the package is opened or damaged. An opened or damaged package may be contaminated. This can cause an infection. This is a single use product.
  • Do not use if the disconnect cover is removed. Use a new infusion set instead. One purpose of the disconnect cover is as a safety feature against accidental firing of the insertion device which could cause injury.
  • Do not change the infusion set just before bedtime unless you can check your blood glucose one to three hours afterwards.
  • Do not put alcohol, disinfectants, perfumes, deodorants, cosmetics, or other substances with solvents on the infusion set. These substances may damage the infusion set. High or low blood glucose can result if the infusion set is damaged.
  •  Never point the insertion device toward any body part where insertion is not desired.
  • Always rotate your insertion site when changing the infusion set. Reusing an insertion site too often may cause scarring and inaccurate insulin delivery. Review your pump user guide on how to rotate insertion sites.
  • Check the insertion site often through the clear window. Improper insertion and maintenance of the insertion site can cause inaccurate insulin delivery, infection, or site irritation. Replace the infusion set at a new site if the soft cannula is not properly inserted.
  • Check the cannula housing and tubing for blood. Blood could cause insufficient insulin delivery. This may result in high blood glucose. Replace the infusion set at a new site if there is blood.
  • Fill 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.
  • Check the tubing for clogs or leaks if your blood glucose reading is high. Clogs or leaks may restrict insulin delivery and result in high blood glucose. Replace the infusion set even if you are not sure if there is a clog or leak.
  • Do not attempt to clear air or an occlusion in the tubing while it is connected to your body. An uncontrolled amount of insulin may be delivered. This can cause high or low blood glucose. Disconnect the tubing before adjusting it.
  • Reuse of the infusion set may cause damage to the cannula or needle and lead to infection, site irritation, or inaccurate medication delivery.
  • For the MiniMed tubing connector: If insulin or any liquid gets inside the tubing connector, it can temporarily block the vents that allow the pump to properly fill the infusion set. This may result in the delivery of too little or too much insulin, which can cause hyperglycemia or hypoglycemia. If this occurs, start over with a new reservoir and infusion set.
  • For No Delivery Alarms, refer to your pump user guide.

Precautions

  • Do not change to a product you have not used before without consulting a healthcare professional for correct handling. The infusion set product is closely related to insertion location. Therefore, your healthcare professional should always be included when choosing an infusion set product.
  • An inaccurate insertion site or inappropriate site management can result in physical pain, influence insulin absorption or cause damage to the product. Other site issues may also occur.
  • Use an insertion site as recommended by your healthcare professional. The choice of site depends on treatment and patient–specific factors. Check that the insertion site is free of skin irritation such as redness, scar tissue, bleeding, and so forth. Do not insert into muscle or over bone. Doing so can cause pain or damage to the product. Replace the infusion set and use a new insertion site if this happens.
  • If needed, remove body hair around the insertion site to ensure that the adhesive sticks to the skin.
  • To avoid stopping insulin delivery that could result in high blood glucose, do not use an insertion site where clothing can push or pull on the infusion set. An insertion site such as under the waistband of your pants may cause various set problems including (but not limited to) disconnecting the tubing, pulling out the cannula, or kinking the tubing, any of which could interrupt insulin delivery.
  • Do not reposition the infusion set on your body. Repositioning the infusion set may damage the adhesive. Replace the infusion set if the adhesive is damaged.
  • Dispose of the insertion device in a proper sharps container according to local laws.
  • The insertion device has a needle. Improper disposal may cause an accidental needle stick.
  • Avoid touching a used soft cannula. A used infusion set is infectious waste. Dispose of a used infusion set in a proper container according to local laws.
  • Check your blood glucose while disconnected from the pump. Consult your healthcare professional on how to correct for missed insulin and for how much time the pump can remain disconnected.
  • Always check your blood glucose one to three hours after inserting a new infusion set. This is to confirm accurate insulin delivery. High or low blood glucose can result if insulin delivery is not accurate.
  • Check your blood glucose several times throughout the day or as recommended by your healthcare professional.
  • Carefully monitor your blood glucose level when disconnected and after reconnecting your infusion set.
  • Store and handle insulin according to the manufacturer’s instructions.

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MINIMED™ SILHOUETTE™ INFUSION SET

INDICATIONS FOR USE

This product is indicated for the subcutaneous infusion of insulin from an infusion pump. 

CONTRAINDICATIONS

Infusion sets are indicated for subcutaneous use only and not for intravenous (IV) infusion or the infusion of blood or blood products. 

WARNINGS

  • Inaccurate medication delivery, infection and/or site irritation may result from improper insertion and maintenance of the infusion site.
  • Before insertion, clean the insertion site with isopropyl alcohol.
  • Remove the needle guard before inserting the infusion set.
  • If using this infusion set for the first time, do the first setup in the presence of your healthcare professional.
  • Do not leave air in the infusion set. Prime completely.
  • Check frequently to make sure the soft cannula remains firmly in place as you may not feel pain if it pulls out. The soft cannula must always be completely inserted to receive the full amount of medication.
  • If the infusion site becomes inflamed, replace the set, and use a new site until the first site has healed. Replace the infusion set if the tape becomes loose, or if the soft cannula becomes fully or partially dislodged from the skin.
  • Replace the infusion set every 48-72 hours, or per your healthcare professional’s instructions.
  • Do not reinsert the introducer needle into the infusion set. Re-insertion may cause tearing of the soft cannula, which may result in unpredictable medication flow.
  • Never prime the set or attempt to free a clogged line while the set is inserted. You may accidentally inject too much medication.
  • Do not put disinfectants, perfumes, or deodorants on the infusion set as these may affect the integrity of the set. Dispose of the infusion set and introducer needle safely, in a sharps container, after a single use.
  • Do not clean or re-sterilize. This device is sterile and non-pyrogenic unless the package has been opened or damaged.
  •  Do not use if the package has been opened or damaged. (For Paradigm users, do not use the infusion set if the tubing connector needle has been damaged.)
  • Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle.
  • Use aseptic techniques when temporarily disconnecting the set and consult your healthcare provider on how to compensate for missed medication when disconnected.
  • If infusing insulin, carefully monitor your blood glucose levels when disconnected and after reconnecting. If infusing insulin, and your blood glucose level becomes unexplainably high, or an occlusion alarm occurs, check for clogs and/ or leaks.
  • If in doubt, change the infusion set, because the soft cannula may be dislodged, crimped and/or partially clogged. Should any of these problems arise, make a plan with your healthcare professional for rapidly replacing insulin. Test your blood glucose level to make sure the problem is corrected.
  • If infusing insulin, do not change the infusion set just before bedtime unless you can check your blood glucose 1-3 hours after insertion.
  • Reuse of the infusion set may cause damage to the cannula/needle and lead to infection, site irritation, and/or inaccurate medication delivery.

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MINIMED™ SURE-T™ INFUSION SET

INDICATIONS FOR USE

This product is indicated for the subcutaneous infusion of insulin from an infusion pump. 

CONTRAINDICATIONS

Infusion sets are indicated for subcutaneous use only and not for intravenous (IV) infusion or the infusion of blood or blood products. 

WARNINGS

  • 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.
  • Carefully remove the needle guard before inserting the infusion set. Do not bend the needle prior to insertion, and do not use the infusion set if the needle is bent or has been damaged.
  • If using this infusion set for the first time, do the first setup in the presence of your healthcare professional.
  • Do not leave air in the infusion set. Prime completely.
  • Check frequently to make sure the needle remains firmly in place as you may not feel pain if it pulls out. The needle 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 needle becomes fully or partially dislodged from the skin.
  • Replace the infusion set every 48 hours, or per your healthcare professional’s instructions.
  • Never prime the set or attempt to free a clogged line while the set is inserted. You may accidentally inject too much medication.
  • Do not put disinfectants, perfumes, or deodorants on the infusion set as these may affect the integrity of the set.
  • Dispose of the infusion set and needle safely, in a sharps container, after a single use. Do not clean or re-sterilize.
  • This device is sterile and non-pyrogenic unless the package has been opened or damaged. Do not use if the package has been opened or damaged. (For Paradigm users, do not use the infusion set if the tubing connector needle has been damaged.)
  • Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle.
  • Use aseptic techniques when temporarily disconnecting the set and consult your healthcare provider on how to compensate for missed medication when disconnected.
  • If infusing insulin, carefully monitor your blood glucose levels when disconnected and after reconnecting.
  • If infusing insulin, and your blood glucose level becomes unexplainably high, or an occlusion alarm occurs, check for clogs and/or leaks.
  • If in doubt, change the infusion set because the needle may be dislodged, and/or partially clogged. Should any of these problems arise, make a plan with your healthcare professional for rapidly replacing insulin. Test your blood glucose level to make sure the problem is corrected.
  • If infusing insulin, do not change the infusion set just before bedtime unless you can check your blood glucose 1-3 hours after insertion.
  • Reuse of the infusion set may cause damage to the cannula/needle and lead to infection, site irritation, and/or inaccurate medication delivery.

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1

Wickham NWR, Achar KN, Cove DH. Unreliability of capillary blood glucose in peripheral vascular disease. Practical Diabetes. 1986;3(2):100.

2

Atkin, S. et al. Fingerstick Glucose Determination in Shock. Ann Intern Med.1991;114:1020-1024.

3

Desachy A, Vuagnat AC, et al. Accuracy of bedside glucometry in critically ill patients: influence of clinical characteristics and perfusion index. Mayo Clin Proc. 2008;83(4): 400-405.

4

FDA Public Health Notification: Use of fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication: Update 11/20/2010. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/

5

CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens (2010). http://www.cdc.gov/injectionsafety/FIngerstick-DevicesBGM.html