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.

Medtronic MiniMed Insulin Infusion Pumps

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

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

Indications for Use

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

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

If 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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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.