Guardian Glucose Monitor User Manual

REAL benefits for your patients
and your practice
The Guardian®RT System delivers:
• REAL protection for your patients from high and
1
low glycemic excursions.
-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
1
affect glycemic control.
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Solutions®Software for
Guardian makes downloading the data easy.
• REAL advantages for you to focus more on optimizing
ther
apy an
ss on mana
d le
ging basic therapy adherence by enhancing patient understanding and self­management of glycemic control.
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 GuardianRT 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
vel excursions above or below the desired range, facilitating therapy adjustments that
e-le
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gluc
ay minimize these excursions.
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Contraindications
Successful operation of the GuardianRT Continuous Glucose Monitoring System requires adequate vision and hearing. Use of the GuardianRT Continuous Glucose Monitoring System is not recommended for patients whose impaired vision or hearing does not allow full recognition
nitor signals and alarms, or who do not have a caregiver that can perform this function
f the mo
o for them.
Warnings/Precautions
dianRT Continuous Glucose Monitoring System users should be educated to program
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The Gua 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 GuardianRT 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.
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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
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Leading the way to the
first artificial pancreas
As the pioneer of both insulin pump therapy
and continuous glucose monitoring,
onic Diabetes is the only company with
Medtr
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.
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Call 1-888-206-REAL or visit www.minim additional information.
References:
tents. Sensor technologies.
a
US P
1. Data on File Medtronic Diabetes, 2005.
2. Bode BW, et al.
Clin Practice.
3. Kaufman FR, et al. 2001;24(12):2030.
4. Ludvigsson J, et al. 2003;111(5 Pt 1):933-8.
5. Bode B, et al. 2004;6(2):105-13.
6. Derr R, et al. 2003;26(10):2728-33.
7. DCCT. 1997;277(5):374-5.
Diabetes Research and
1999;46:183-90.
Diabetes Care.
Pediatrics.
DiabetesTechnol Ther.
Diabetes Care.
JAMA.
e
il GM, et al.
e
St
8. 2000;49(Suppl 1):510.
9. Gross TM, et al. 2000;2(Suppl 1):S19-26.
10. Caplin NJ, et al. 2003;20:238-41.
11. Skyler JS, et al. 2000;2(Suppl 1):S7-12.
Diabetes Care.
12. ADA 2002;25(1):S33-49.
13. Ludvigsson J, et al. 2003;20(1):7-12.
14. Pilot Study. Guardian RT. Data on File Medtronic Diabetes 2005.
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Diabe
DiabetesTechnol Ther.
Diabet Med.
Diabetes Technol Ther.
Pract Diab Int.
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REAL-Time glucose readings and alarms
for reduced glucose variability
or
1-4
Now available to your patients:
Continuous glucose monitoring system
with REAL-Time glucose readings and alarms
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
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 valuable insights into their glycemic control.
Now Medtronic Diabetes proudly brings the benefits of continuous glucose monitoring directly to
patients with the Guardian RT system. This new technology gives patients access to REAL-Time
glucose readings and alarms, around the clock, so they can intervene in ways never before
possible, reducing their glucose variability and achieving improved diabetes management.
The Guar
a continuous glucose sensor,
radiofrequency transmitter, and
the Guardian RT monitor to give
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information around the clock
dian RT system includes
atients R
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EAL-Time gluc
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®
System,
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2
2-5
REAL-Time Glucose Readings
are viewable at the push of a button. An updated glucose value is available every five minutes — 288 times per day — at work, during mealtime, when exercising and overnight, to help patients take action before they experience a problem. You can also view previous glucose values during the last 8 hours.
wareness of glucose variability is important because even brief fluctuations
A in glucose levels can lead to long-term diabetes complications like eye, nerve, kidney and heart disease.
6,7
REAL-Time Alarms
warn patients of hypoglycemia and hyperglycemia, day or night, that may not
d by fingersticks alone and HbA1c testing.
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sound or vibrate. The sound volume of the alarms can also be adjusted to suit
tient’s unique needs. Patient response to REAL-Time alarms resulted
a
our p
y in a significant re
duction in the duration of hypoglycemic excursions.
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t to
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REAL-Time system components help your patients
manage their diabetes like never before
The Guardian RT Transmitter — Communicates wirelessly
through radio frequency (RF) to the Guardian RT monitor
REAL-Time Glucose Readings
REAL-Time Alarms
®
tware for Guardian —
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Solutio
n kn
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a
t
s easily download historical information from the Guardian RT
tem to a computer.
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So
wn as the Com-Station™, you and your patients can
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g a special docking
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Continuous Glucose Sensor provides REAL insights This tiny REAL-Time sensor
inserts easily under the skin in a virtually painless process. It measures current glucose levels in interstitial fluid. The accuracy of continuous glucose monitoring is proven in numerous published studies. required prior to adjusting insulin delivery and when calibrating the glucose sensor.
an RT mo
The Guar
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include on-screen REAL-Time glucose readings an into the control and improve their diabetes management.
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ound the clock
n ar
o give patients meaningful insights
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Fingersticks are
EAL-Time
ws R
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Inno
ing them to take
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tio
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reports show the effect of meals, exercise and medication
tient’s glycemic control
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n a p
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Includes Historical Trend Graphs — Up to 21 days of information are available for downloading glucose trends to make it easier for you to optimize your patient’s therapy
the
omizable Treatment Reports —
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