Guardian Technologies Glucose Monitor - Manual

Leading the way to the
first artificial pancreas
R E A L - T i me g l u co s e read i ng s a n d a l a r m s
fo r re d u c e d g l u co s e va r i a b i l i t y
1 - 4
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
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.
References:
Call 1-888-206-REAL or visit www.minimed.com/guardianrt for
additional information.
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.
1-3 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.
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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.
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.