Guardian Technologies Glucose Monitor manual Real benefits for your patients

REAL benefits for your patients

and your practice

The Guardian® RT System delivers:

•REAL protection for your patients from high and low glycemic excursions.1-4

• REAL insight for your patients with REAL-Time readings of glucose values updated every five minutes, so they can intervene sooner for improved therapy management.2-4

•REAL security for your patients with REAL-Time alarms to warn against hypo- and hyperglycemia.

•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.1-3Solutions® 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 www.minimed.com

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

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 www.minimed.com/guardianrt for additional information.

References:
1.	US Patents. Sensor technologies.	8.	Steil GM, et al. Diabetes.
	Data on File Medtronic Diabetes, 2005.		2000;49(Suppl 1):510.
2.	Bode BW, et al. Diabetes Research and	9.	Gross TM, et al. DiabetesTechnol Ther.
	Clin Practice. 1999;46:183-90.		2000;2(Suppl 1):S19-26.
3.	Kaufman FR, et al. Diabetes Care.	10.	Caplin NJ, et al. Diabet Med.
	2001;24(12):2030.		2003;20:238-41.
4.	Ludvigsson J, et al. Pediatrics.	11.	Skyler JS, et al. Diabetes Technol Ther.
	2003;111(5 Pt 1):933-8.		2000;2(Suppl 1):S7-12.
5.	Bode B, et al. DiabetesTechnol Ther.	12.	ADA Diabetes Care.
	2004;6(2):105-13.		2002;25(1):S33-49.
6.	Derr R, et al. Diabetes Care.	13.	Ludvigsson J, et al. Pract Diab Int.
	2003;26(10):2728-33.		2003;20(1):7-12.
7.	DCCT. JAMA.	14.	Pilot Study. Guardian RT. Data on File
	1997;277(5):374-5.		Medtronic Diabetes 2005.

REAL - Time glucose readings and alarms

for reduced glucose variability 1 - 4