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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 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. The REAL-Time 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 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.

For information on proper sharps disposal, please visit: http://sharpsdisposal.medtronic.com/

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.

For information on proper sharps disposal, please visit: http://sharpsdisposal.medtronic.com/

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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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Continuous Glucose Monitoring Medtronic Diabetes CGMS® System
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: U.S. law restricts this device to sale by or on the order of a licensed physician.

Indications for Use
The CGMS System 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 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. The CGMS System:

  • Is intended for prescription-use only.
  • Will not allow readings to be made available directly to patients in real time.
  • Provides readings that will be available for review by physicians only after the entire recording interval (72 hours).
  • Is currently intended for occasional rather than everyday use.
  • Is to be used only as a supplement to, and not a replacement for, standard invasive measurement.
  • 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.
The monitor, sensor, cable and test plug are intended for use with the Medtronic Diabetes CGMS System.

The Sen-serter® is indicated only for insertion of the Medtronic Diabetes glucose sensor.

Contraindications
Successful operation of the CGMS System requires adequate vision and hearing. Use of the CGMS 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 who can perform this function for them.

Warnings
Sensor/Sen-Serter
Infection and/or site irritation may result from improper insertion and maintenance of insertion site.

The sensor is sterile unless package has been opened or damaged. Do not use if package has been opened or damaged.

Read Chapter 3, "The Sensor," in the product manual for proper preparation of site prior to insertion. Failure to follow instructions may result in pain or injury.

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

Discard the sensor on the first day of the month indicated on the "Use Before" date on label.

Do not use sensor if temperature-limit indicator on box is black (not clear).

Never point the loaded Sen-serter toward any body part where insertion is not desired.

Monitor
CGMS 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 System and do not indicate the current glucose value.

Precautions
Sensor

Always wash hands with soap and water before opening the sensor package. After opening the package, avoid touching any sensor surfaces that will come in contact with the body (i.e., sensor, needle, connector adhesive surfaces and bandage).

Before inserting the sensor, always clean the skin at the sensor insertion location with a topical antimicrobial solution, such as isopropyl alcohol.

Avoid inserting sensor in locations that are constrained by clothing or accessories, or are subjected to rigorous movement during exercise.

For users who wear an insulin pump, make sure that the sensor insertion site is at least two (2) inches away from the insulin infusion site. Users who inject insulin should be instructed to administer injections at least three (3) inches away from the Sensor insertion site.

When replacing sensor, select new insertion site at least two inches (5 cm) from previous site. Dispose of introducer needle safely in sharps container after single use. Do not clean or re-sterilize.

Dispose of sensor in biohazard container.

After sensor insertion, the insertion location should be checked often for redness, bleeding, pain, tenderness and swelling, especially before going to bed and after waking up. The presence of these symptoms may result in sensor removal.

The sensor should be checked periodically to ensure that it remains in place. If the sensor is disconnected and then reconnected, the signals it sends to the monitor may not be stable or accurate. The sensor may need to be recalibrated (See section titled, "Perform the Initial Calibration" in the product manual) before returning to normal operation.

Monitor
Using the 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.

Contact sports or other activities that may damage the monitor should be avoided. Prior to exercising, CGMS System users should make sure that the sensor and monitor are securely fastened to their bodies.

Monitors should be placed in a Shower-Pak™ prior to taking a shower or engaging in other activities in which the monitor would be expected to get wet. Do not submerge the monitor.

Keep the monitor in its leather case to protect it against moisture, dirt, and debris.

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