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Resumen del manual
• REAL empowerment for your patients by enabling them to use their Guardian RT System as a diary showing how diet, exercise, medication, and lifestyle affect glycemic control.1-3 Solutions® Software for Guardian makes downloading the data easy. • REAL advantages for you to focus more on optimizing therapy and less on managing basic therapy adherence by enhancing patient understanding and self- management of glycemic control.13 Safety Information Continuous Glucose Monitoring Medtronic MiniMed Guardian RT Continuous Glucose Monitoring 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 Guardian RT Continuous Glucose Monitoring System is intended to continuously record interstitial glucose levels in persons 18 years and 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. The information collected by the Guardian RT 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. Contraindications Successful operation of the Guardian RT Continuous Glucose Monitoring System requires adequate vision and hearing. Use of the Guardian RT 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 RT 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 Guardian RT Continuous Glucose Monitoring System and do not indicate the 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. Diabetes Headquarters Medtronic Diabetes 18000 Devonshire Street Northridge, CA 91325 1-800-MINIMED (1-800-646-4633) CGMS and Guardian are registered trademarks of Medtronic MiniMed. System Gold is a trademark of Medtronic MiniMed. ©2005 Medtronic MiniMed. All rights reserved. 9197565-011 091305 and your practice Leading the way to the first artificial pancreas As the pioneer of both insulin pump therapy and continuous glucose monitoring, Medtronic Diabetes is the only company with the resources, advances and technological building blocks necessary to achieve an artificial pancreas. This has been our vision since the inception of the company more than 20 years ago. Call 1-888-206-REAL or visit for additional information. REAL-Time glucose readings an d alarms for re duce d glucose var i a b i l i t y 1-4 References: 1. US Patents. Sensor technologies. Data on File Medtronic Diabetes, 2005. 2. Bode BW, et al. Diabetes Research and Clin Practice. 1999;46:183-90. 3. Kaufman FR, et al. Diabetes Care. 2001;24(12):2030. 4. Ludvigsson J, et al. Pediatrics. 2003;111(5 Pt 1):933-8. 5. Bode B, et al. DiabetesTechnol Ther. 2004;6(2):105-13. 6. Derr R, et al. Diabetes Care. 2003;26(10):2728-33. 7. DCCT. JAMA. 1997;277(5):374-5. 8. Steil GM, et al. Diabetes. 2000;49(Suppl 1):510. 9. Gross TM, et al. DiabetesTechnol Ther. 2000;2(Suppl 1):S19-26. 10. Caplin NJ, et al. Diabet Med. 2003;20:238-41. 11. Skyler JS, et al. Diabetes Technol Ther. 2000;2(Suppl 1):S7-12. 12. ADA Diabetes Care. 2002;25(1):S33-49. 13. Ludvigsson J, et al. Pract Diab Int. 2003;20(1):7-12. 14. Pilot Study. Guardian RT. Data on File Medtronic Diabetes 2005. Continuous glucose monitoring system with REAL-Time glucose readings and alarms Now available to your patients: Continuous glucose monitoring system with REAL-Time glucose readings and alarms Now available to your patients: The Guardian® RT Continuous Glucose Monitoring System is the latest advance in diabetes management by Medtronic Diabetes, the 20-year pioneer of continuous glucose monitoring and insulin pump therapy. Medtronic Diabetes is the sensor expert and pioneered CGMS® System, the first FDA-approved continuous glucose monitoring system for physician use. Insights from the 3-day diagnostic system have been used by physicians in more than 150,000 patients worldwide to gain valua...