Indications, Safety, and Warnings
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 Revel 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 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 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.
Medtronic Diabetes Continuous Glucose Monitoring
Indications for Use
The Continuous Glucose Monitoring components of the MiniMed Paradigm REAL-Time Revel 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 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.
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.
Professional Continuous Glucose Monitoring Medtronic Diabetes iPro CGM
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 iPro digital recorder 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 digital recorder 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:
- 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 after the 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 glucose sensor, tester, charger, and CGMS iPro Wand are intended for use with the CGMS iPro digital recorder. The Sen-serter® device is indicated only for insertion of the Medtronic MiniMed glucose sensor.
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.
Warnings
Product contains small parts and may pose a choking hazard for young children.
Sensor
The glucose sensor should be removed if redness, bleeding, pain, tenderness, irritation, or inflammation develops at the insertion site, or if you experience unexplained fever. An optional occlusive 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. Healthcare professionals should discuss this with their patients before they use the glucose sensor.
Wait five minutes after glucose sensor insertion before setting up the CGMS iPro digital recorder with the Solutions CGMS iPro.
- Make sure that the site is not bleeding before connection. If any blood gets inside the digital recorder connector, the digital recorder must be discarded.
- If bleeding occurs, apply steady pressure with a sterile gauze or clean cloth at the insertion site until bleeding stops. After bleeding stops, attach the digital recorder to the glucose sensor.
- If bleeding persists after three minutes, remove the glucose sensor and discard. Insert a new glucose sensor in a different location.
Contact your local country representative or the 24-Hour HelpLine (US) if you experience any adverse reactions associated with the digital recorder or glucose sensor.
CGMS iPro Magnetic Wand Interference
Do not store the CGMS iPro Magnetic Wand or any other magnet within 1.5 inches (3.8 cm) of the CGMS iPro digital recorder. Premature battery discharge may occur.
Do not place the CGMS iPro Magnetic Wand or any other magnet within 1.5 inches (3.8 cm) of the CGMS iPro digital recorder except while performing patient set-up and data download procedures. Premature battery discharge may occur.
CGMS iPro Magnetic Wand Interference With Insulin Pumps
Do not place the CGMS iPro Magnetic Wand directly on any insulin pump. Incorrect pump operation 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.
CGMS iPro Interference With PC Hard Drives
Do not place the CGMS iPro Magnetic Wand on your PC or external hard drives, as the magnetic field may impact the integrity of the data files stored there.
Other Electromagnetic Interference
The CGMS iPro digital recorder is designed to withstand common electromagnetic interference, including airport security systems.