Important Safety Information

Medtronic Diabetes Insulin Infusion Pumps

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

Indications for use

The Guardian REAL-Time Continuous Glucose Monitoring System is indicated to record interstitial glucose levels in persons seven years of age or older who have Type 1 or Type 2 diabetes. This information is intended to supplement, not replace, blood glucose information obtained using standard home blood glucose monitoring devices. A separate pediatric model is indicated for patients ages 7-17.

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 operation of an insulin pump requires good vision and hearing. While features exist to help facilitate pump usage, Medtronic Diabetes does not recommend the use of this product by individuals whose impaired vision or hearing does not allow full recognition of the pump signals and alarms.

Warnings/Precautions/Adverse Reactions

Insulin pump therapy uses only faster-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 two-to-four hours and, subsequently, the rapid onset of diabetic ketoacidosis (DKA) within four-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.

The intensive management of diabetes has also been associated with an increased incidence of hypoglycemia (low blood glucose). Never go to bed with a blood glucose value below your target level. Blood glucose tests should be performed before driving a vehicle or operating machinery, because hypoglycemia can have serious consequences.

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 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 profession'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 Diabetes reservoirs and/or infusion sets may reduce pump accuracy and hinder occlusion detection. Do not modify your reservoir or infusion set. 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.

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.

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.

FCC Notice

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.

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Medtronic Diabetes Continuous Glucose Monitoring

Indications for Use

The Continuous Glucose Monitoring components of the MiniMed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System are indicated to record interstitial glucose levels in persons 7 years of age or older who have Type 1 or Type 2 diabetes. This information is intended to supplement, not replace, blood glucose information obtained using standard home glucose monitoring devices. A confirmatory fingerstick is required prior to treatment. Continuous Glucose Monitoring information 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 that may minimize these excursions. A version of this product is specifically designed for children is indicated for persons ages 7-17.

Contraindications

Successful operation of the Continuous Glucose Monitoring System requires adequate vision and hearing. Use of the Continuous Glucose Monitoring System 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.

Warnings/Precautions

The Continuous Glucose Monitoring System users should be educated to program and operate the monitor and respond to alarm conditions prior to attempted use of the system.

The current and voltage signals shown in the monitor are to be used only for finding potential problems with the Continuous Glucose Monitoring System and do not indicate current glucose value. Infection and/or site irritation may result from improper insertion and maintenance of insertion site.

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The Guardian^® REAL-Time System

Safety Information

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

Prescription Device Warning

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

Indications for Use

The Guardian REAL-Time Continuous Glucose Monitoring System is intended to continuously record interstitial glucose levels in persons 7 years of age or older who have Type 1 or Type 2 diabetes. This information is intended to supplement, not replace, blood glucose information obtained using standard home glucose monitoring devices. This information collected by the The Guardian REAL-Time Continuous Glucose Monitoring System 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 that may minimize these excursions. A version of the product specially designed for children is indicated for patients age 7-17.

Contraindications

Successful operation of the The Guardian REAL-Time Continuous Glucose Monitoring System requires adequate vision and hearing. Use of the The Guardian REAL-Time Continuous Glucose Monitoring System 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.

Warnings/Precautions

The Guardian REAL-Time Continuous Glucose Monitoring System users should be educated to program and operate the monitor and respond to alarm conditions prior to attempted use of the system. The current and voltage signals shown in the monitor are to be used only for finding potential problems with the The Guardian REAL-Time Continuous Glucose Monitoring System and do not indicate current glucose value. Infection and/or site irritation may result from improper insertion and maintenance of insertion site.

Read Chapter 2, "Inserting the Sensor," in your product manual, for proper preparation of site prior to insertion. Failure to follow instructions may result in pain or injury.

 

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