Important Safety Information

Indications, Contraindications, Warnings and Precautions

All Medtronic MiniMed devices and associated components listed below are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks associated with the use of these systems.

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

 

MiniMed® 530G System

This section applies to the MiniMed 530G system, including MiniMed 530G pump model MMT-551/751, various compatible reservoirs and infusion sets, and accessories such as Enlite® sensor model MMT-7008, MiniLink® transmitter model MMT-7703, etc.

Indications for Use

MiniMed 530G System

The MiniMed 530G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, sixteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 530G system can be programmed to automatically suspend delivery of insulin for up to two hours when the sensor glucose value falls below a predefined threshold value.

The MiniMed 530G System consists of the following devices that can be used in combination or individually: MiniMed 530G Insulin Pump, Enlite® Sensor, Enlite® Serter, the MiniLink® Real-Time System, Bayer’s CONTOUR® NEXT LINK Wireless Meter, CareLink® Pro Therapy Management Software for Diabetes, and CareLink® Personal Therapy Management Software for Diabetes. The system requires a prescription.

The MiniMed 530G System is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the MiniMed 530G System. The MiniMed 530G System is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Threshold Suspend alarm to take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare provider.

Enlite® Glucose Sensor

The Enlite sensor is intended for use with the MiniMed 530G insulin pump
(models MMT-551, MMT-751) to continuously monitor glucose levels in persons with diabetes.

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.

Warnings/Precautions

Pump

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

Never rely on the pump beeps or vibrations alone to navigate through the pump screens or menus, as this may result in incorrect menu selection or setting. You should always check your pump if you hear any unanticipated beeps or vibrations. Do not rely on preset pump alarms or reminders alone to prompt you to check your blood glucose. Set additional reminders on other devices, such as your cell phone, to avoid forgetting to check your blood glucose.

Drive Support Cap

The drive support cap should appear slightly indented at all times. If you notice that the cap is loose, or sticking out, discontinue use of the pump and contact our 24 Hour HelpLine at 1 800 646 4633 to arrange for your pump to be replaced. Do not press on the drive support cap if it is sticking out. Pushing on the drive support cap may result in unintended delivery of insulin, which can cause hypoglycemia.

Threshold Suspend Feature

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

Bolus Wizard Feature

Do not use the Bolus Wizard to calculate a bolus for a period of time after giving a manual injection by syringe or pen. The Bolus Wizard does not account for manual injections, and could prompt you to deliver more insulin than needed. Too much insulin may cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection before you can rely on the active insulin calculation of your Bolus Wizard.

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 and therefore we are not responsible for any injury or malfunctioning of the pump that may occur in association with such use.

Do not put any other drugs/medications inside your reservoir to use with this pump. Only insulin that has been prescribed by your physician can be used in this pump.

Tubing Connector

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

Transmitter

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

Sensor

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 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.

NOTE: While there is no evidence of an Enlite sensor breaking in a patient’s body, if you suspect that sensor breakage has occurred do not attempt to remove the sensor yourself. Contact your physician for assistance removing the sensor.

Exposure to magnetic fields and radiation

If you are going to have an X-ray, MRI, diathermy treatment, CT scan, or other type of exposure to radiation, take off your pump, sensor, transmitter, meter and remote control before entering a room containing any of these equipment. The magnetic fields and radiation in the immediate vicinity of these devices can make them nonfunctional or damage the part of the pump that regulates insulin delivery, possibly resulting in over delivery and severe hypoglycemia. If your pump is inadvertently exposed to a magnetic field, discontinue use and contact our 24 Hour HelpLine for further assistance.

Do not use pump cases that have a magnetic clasp. Exposure to a magnetic clasp may interfere with the motor inside the pump.

Airport security

Important information about airport security systems, and using your insulin pump on an airplane, can be found on the Emergency Card. Be sure to carry the Emergency Card provided when you are traveling.

General precautions

Avoid 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 and remote control to temperatures above 108°F (42°C) or below 34°F (1°C), as 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, sterilize or autoclave your pump or remote control. Exposure to high temperatures may damage your device.

Infusion sets and sites

Avoid using an infusion set insertion site that will be irritated by clothing and accessories, or by rigorous stretching and exercise.

Sensor

Prior to exercising, make sure the sensor is firmly attached, so it does not come out of your body.

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

Insulin pump and RF accessories

The pump, meter, transmitter and remote control comply with the United States Federal Communications Commission and international standards for electromagnetic compatibility.

These devices comply with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesirable operation. It does not interfere with any RF signals transmitted from outside sources.

These standards are designed to provide reasonable protection against excessive radio frequency interference and prevent undesirable operation of the device from unwanted electromagnetic interference. Operation is subject to the following two conditions:

  1. This device has been tested and found to comply with the regulationsgoverning such devices in your area. For the specific regulation and testresults for your area, please contact our 24 Hour HelpLine.
  2. This device generates, uses, and can radiate radio frequency energy and, if installed and used in accordance with the instruction, 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:
    • Reorient or relocate the insulin pump/remote control/transmitter/meter
    • Increase the separation between the insulin pump/remote control/transmitter/meter and the device that is receiving/emitting interference

    The meter and the transmitter send information to the pump using radio frequency. If other devices that use radio frequency are in use, such as cell phones, cordless phones and wireless networks, they may prevent communication between the pump and the meter. This interference will not cause any incorrect data to be sent and will not cause any harm to your pump or meter. Moving away from or turning off these other devices may allow communication. Refer to Troubleshooting, on page 223 to correct interference problems you may have.

    Wireless transmission between the pump and transmitter within the 6 feet (1.8 meters) operating range may be interrupted due to the transmitter orientation and the pump position on the body. Move the pump closer to the transmitter or to another position. If a Lost Sensor alarm has occurred retry:

    Main > Sensor > Link to Sensor > Find Lost Sensor

    If you have questions, please contact the 24 Hour HelpLine.

RF interference from other devices

Common consumer electronic devices that transmit in the same frequency band used by the MMT-7703 MiniLink transmitter may prevent the pump from receiving the glucose information sent by the transmitter. Most cellular (mobile) phones and 900 MHz cordless phones, when transmitting or receiving, may cause significant interruption of transmitter-receiver communication. It is likely that other devices operating in similar frequency ranges will have a similar effect. This interference, however, will not cause any incorrect data to be sent and will not cause any harm to your transmitter.

The pump includes a programmable WEAK SIGNAL alert that notifies you when one or more expected transmissions were not received as expected by the pump. The pump will also issue a LOST SENSOR alert if communication is interrupted for an extended period of time. If you receive a LOST SENSOR alert, please see the I want to find a lost sensor section in the Troubleshooting chapter.

Communication problems can usually be resolved by:

  • ensuring that there is less than 6 feet (1.8 meters) between the receiving device and transmitter, to include RF glucose meters;
  • turning off or moving away from other RF transmitting devices; or
  • reorienting or relocating the transmitter or receiving device, or both.

Communications problems may also occur due to cellular telephone interference. Testing conducted with several different cellular telephones indicates that, while a glucose value is being transmitted, using a cell phone within 12 inches (31 cm) of receiving devices, transmitters or RF glucose meters can interfere with reception of the transmitted values. In the event of such interference, normal communication can be re-established by:

  • turning the cell phone off; or
  • keeping the cell phone at least 12 inches (31 cm) away from the receiving device, transmitter or glucose meter when a glucose measurement is being transmitted.

    Tip: If you are experiencing communication problems, try wearing your pump on one side of your body and the cell phone on the other. This normally resolves communication problems.

    If you have questions, please contact the 24 Hour HelpLine.

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Medtronic MiniMed Insulin Infusion Pumps Generally

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

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

 

Indications for Use

The insulin pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons of all ages requiring insulin.

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Contraindications

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

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

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Warnings/Precautions

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

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

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

Drive Support Cap

The drive support cap should appear slightly indented at all times. If you notice that the cap is loose, or sticking out, discontinue use of the pump and contact our 24 Hour HelpLine at 1 800 646 4633 to arrange for your pump to be replaced. Do not press on the drive support cap if it is sticking out. Pushing on the drive support cap may result in unintended delivery of insulin, which can cause hypoglycemia.

Bolus Wizard Feature

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

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

Tubing Connector

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

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

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

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

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

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Medtronic MiniMed mySentry Remote Glucose Monitor

Prescription Device Warning

Caution: US law restricts this device to sale by, or on the order of, a licensed physician.

 

Indications for Use

The mySentry system is indicated for the remote monitoring, within your home, of a single Paradigm
REAL-Time Revel insulin pump (MMT-523/-723/MMT-523K/-723K).The REAL-Time glucose values provided by the monitor, as received from the Paradigm REAL-Time Revel insulin pump, are not intended to be used directly for making therapy adjustments. Rather, they provide an indication that may require a confirmation fingerstick measurement. All therapy adjustments should be based on measurements obtained using a blood glucose meter and not based on the value displayed by the monitor or Paradigm REAL-Time Revel insulin pump.

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Contraindications

None known.

 

Warnings/Precautions

The mySentry monitor only displays the information from the pump and is a way to monitor a pump wearer from another room. Once you turn off an alarm on the mySentry monitor, you need to attend to the alarm on the pump itself. You cannot respond to pump alarms directly through the mySentry monitor.

The mySentry system is not a replacement for personal blood glucose monitoring as directed by your physician. As such, it is very important that you continue your own personal blood glucose monitoring program. Failure to monitor your blood glucose independently of the real-time glucose values provided by the mySentry monitor, as received from the Paradigm REAL-Time Revel insulin pump, may result in hyperglycemia or hypoglycemia and significant physical injury, including death.

Although the mySentry system has been designed and tested to meet or exceed the latest industry standards as required by the Food and Drug Administration (FDA), the mySentry system transmits/receives information wirelessly by radio frequency (RF) transmission (unencrypted) and therefore can be susceptible to RF or electrical interference, or possible interception. If there is RF interference or if the pump is out of range of the monitor, it will not transmit data. Take care to pay attention to the Historical vs. Real-Time Data icons for accurate interpretation of data. See Historical Data and Real-Time Data icons in the Basics chapter for more information.

Transmission of all data or alarms cannot be guaranteed with the mySentry system. This product does not provide any medical advice and should not be relied upon for such purpose. Please refer to the Paradigm REAL-Time Revel insulin pump before making therapy decisions.

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Medtronic MiniMed REAL-Time Continuous Glucose Monitoring (CGM) System

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

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

 

Indications for Use

The REAL-Time CGM Device, with the separately available glucose sensor and transmitter, are indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes in adults (age 18 or older). A version of this product specifically designed for children is indicated for persons ages 7-17.

Information provided by the REAL-Time CGM devices is intended to supplement, not replace, blood glucose information obtained using standard home glucose monitoring devices. Glucose values provided by the REAL-Time CGM device are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on the sensor glucose readings provided by the REAL-Time CGM devices.

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

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Contraindications

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

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

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Warnings/Precautions

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

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

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

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Medtronic MiniMed Professional Continuous Glucose Monitoring (CGM) System

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

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

 

Indications for Use

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

The CGMS iPro Digital Recorder or CGMS Gold:

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

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Contraindications

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

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

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

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Warnings/Precautions

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

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

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

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

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

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

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

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

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Medtronic MiniMed Glucose Sensor

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

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

 

Indications for Use

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

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Warnings/Precautions

Failure to follow instructions may result in pain or injury.

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

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

If bleeding stops:

  1. Attach the sensor to the transmitter.

If bleeding does NOT stop:

CAUTION: DO NOT attach the sensor to the transmitter.

  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.

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

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

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

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

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Medtronic MiniMed CareLink Therapy Management Software

Indications for Use

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

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Contraindications

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

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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.

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*This Important Safety Information was updated on October 31, 2011.