Ascensia Diabetes Care US N1 Wireless Blood Glucose Monitoring System User Manual

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Document ID	1433126
Application ID	aRd9XHLfFbpicUZNFsAc2Q==
Document Description	Manual 2
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	210.56kB (2632033 bits)
Date Submitted	2011-03-17 00:00:00
Date Available	2011-03-18 00:00:00
Creation Date	2011-03-02 16:10:14
Producing Software	Acrobat Distiller 9.4.0 (Macintosh)
Document Lastmod	2011-03-02 16:10:14
Document Title	untitled

This option controls whether you
want to hear the “beeps” during
testing.
Your CONTOUR LINK meter can give
you the option of marking your test
results by turning this option on.
Press ▲ or ▼ to choose whether
to turn the buzzer on or off. (You
will hear a beep when you switch
screen.)
to the
(See pages 30–35 to learn how
to use these options!)
Press M to set.
Press M to set.
Setting the 12 or 24 Hour Clock:
Setting the Test Reminder Alarm Time:
12H will now flash on the display.
Press ▲ or ▼ to choose the 12H or
24H setting.
You can now select the timing for
the alarm to sound. The default set); this can be
ting is 2.0 hours (
changed to 1.0, 1.5 or 2.5 hours.
Setting the Time, Date,
and Sound
This option lets you set the meter
to display the time as a 12 hour
setting with AM and PM or as a
24 hour display (military time).
Press ▲ or ▼ to change the alarm
time.
Press M to set.
Press M to set.
Setting the Month and Day
format:
m/d will now flash on the display.
Press ▲ or ▼ to choose how you
want the date to appear (month/
day or day.month).
Press M to set.
28
Press ▲ or ▼ to turn the marker
option on or off.
Need Help ? Bayer Diabetes Care: 1-800-348-8100
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You have now completed the setup
of your meter!
The final display will remain on for
3 seconds, showing all the options
you have chosen.
If you ever want to change the
options you have chosen, simply
go back to page 26 and follow the
Setup instructions.
www.bayerdiabetes.com/us
Options
Options
The flashing bell symbol will now
appear on the display, along with
the word “ .”
Setting the Markers and Test
Reminder Alarm:
You will now see three markers
displayed on your meter, along
with the word “
.”
Setting the Markers
and Test Reminder Alarm
Setting the Sound:
29
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Options
Be sure to leave the used
test strip in the meter
until you have finished
marking the results.
Using the Markers and
Test Reminder Alarm
Pre-meal = Marks a test result that was taken before
a meal.
Post-meal = Marks a test result that was taken after
a meal.
Logbook = Marks any result as being unique or
different in some way and for which you may want
to make notes in your Clinilog® logbook. Seeing
a result with this symbol next to it in the memory
will help remind you that there is more information
recorded about this test result.
Press M or remove the used test strip to automatically save
the test result in the meter memory.
OR
Press ▲ or ▼ until all three markers disappear from the
display. Press M and remove the used test strip.
Dispose of the used test strip and lancet properly to prevent
injury or contamination to others.
If you want to mark the test result:
Press ▲ or ▼ to move to the
marker you want to set. You
will know when you have
chosen a marker when you
see the box around it flashing
on the display.
Press M to set.
If you mark a result with the ,
the
will appear with a box
flashing around it.
This allows you to set an alarm
that will go off in 2 hours (or
whatever time you have selected
in the Setup mode), to remind
you to run a post-meal test.
If you want to set the alarm,
press M.
If you do not want to set
the alarm, press ▲ or ▼. The
will disappear showing
an empty flashing box.
Options
If you have set your meter
with the marker option
on (see page 29), your
meter will display three
markers next to your
blood glucose test result.
(If the Send option is on,
the markers will not be
displayed until after the
result has been sent to
the Medtronic device and
the display stops flashing.)
If you do not want to mark the test result:
Using the Markers and
Test Reminder Alarm
Using the Markers and
Test Reminder Alarm:
Press M to set.
30
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www.bayerdiabetes.com/us
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You can now run another test by placing a test strip in the
test strip port and following the testing instructions
(page 10).
Options
Using the Markers and
Test Reminder Alarm
32
When you have completed this
test and the result is shown on
the display, you may want to
symbol
mark this test with the
to identify this test result as your
post-meal result.
To Cancel a Test Reminder Alarm:
Press M to enter the
meter memory. The 14
day average will appear
along with the
Options
When the alarm sounds,
the meter will automatically turn on, the
alarm will sound, and
the display will show the
pre-meal test result you
marked when you set the
alarm. Pressing any button will silence the alarm.
For example: An alarm has been set. You decide to retest before that alarm goes off. If you mark the new test
result with a pre-meal marker ( ) and set a new alarm
( ), the old alarm setting will be ignored and only the new
setting will sound in 2 hours (or in the time you selected in
the Setup mode).
Press M again and a box
will appear and flash
around the
Press ▲ or ▼. The empty box (
alarm has been turned off.
) will now indicate the
Using the Markers and
Test Reminder Alarm
Test Reminder Alarm:
Press M to set.
If you do not want to run another test immediately after the
alarm sounds, press any button to turn your meter off.
The meter will only set one alarm. It will remember the last
alarm set. Any previous alarm setting will be lost.
Need Help ? Bayer Diabetes Care: 1-800-348-8100
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Pre-Meal
Press ▲ or ▼
TO SET
Press M
Press M
Alarm is set to go off after a
set amount of time to remind
you to run a post-meal test.
Press M
Result is marked as a
post-meal test.
Press M
Result is marked in memory
as unique. You should note
this in your Logbook.
Options
(ON)
Post-Meal
Press ▲ or ▼
Using the Markers and
Test Reminder Alarm
34
WHAT IT MEANS
Result is marked as a
pre-meal test. You can
now set an alarm.
(ON)
Alarm
Press ▲ or ▼
YOU WILL SEE
(ON)
Logbook
Press ▲ or ▼
(ON)
Need Help ? Bayer Diabetes Care: 1-800-348-8100
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www.bayerdiabetes.com/us
Options
YOU WILL SEE
Using the Markers and
Test Reminder Alarm
TO MARK RESULTS
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The 14 day average will appear
on the display with the average for
test results taken over the last 14
days. If you have set an alarm that
has not sounded yet, you will also
symbol.
see a
Options
Viewing Stored Results
36
Number of results: The number
of results included in the average
is shown at the top of the display.
Your control results are not included
in this 14 day average.
Press ▲ to view the 7 day total.
7 day total: Your meter will display
the total number of results taken
during the last seven days.
High and low results: At the top of
the display you will see the number
of high results (above 180 mg/dL)
and low results (below 72 mg/dL)
during that seven day period.
Need Help ? Bayer Diabetes Care: 1-800-348-8100
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Previous results: Results will be
shown starting with the most
recent. Each result will show the
date and time the test was taken,
as well as any symbols you chose
to mark the test result.
You can press ▲ or ▼ to scroll
forward or backward through
the results. You can press and
release the button to view stored
results one at a time or you can
hold it to move through results
continuously.
appears on the display,
When
you have viewed all of the results
in the memory.
The meter will hold 480 results in
the memory. When the maximum
is reached, the oldest test result
will be removed as a new test
is completed and saved to the
memory.
Press M to turn the meter off, or
it will automatically turn off after
three minutes.
www.bayerdiabetes.com/us
Options
With the meter off, press the M
button on the meter to view stored
test results.
Press ▼ to review previous
results.
Viewing Stored Results
Using the Memory:
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Error Codes and Symbols:
Diabetes Care Customer Service at 1-800-348-8100.
WHAT IT MEANS
Low batteries.
Replace the batteries as soon as
possible to avoid the risk of a test
result not being stored in your meter.
Call Bayer Diabetes Care Customer
Service at 1-800-348-8100 for free
replacement batteries.
E 10
Invalid date or
time.
See Setup instructions (page 27)
to set the date and time on
your meter. If you continue to
have problems, contact Bayer
Diabetes Care Customer Service:
1-800-348-8100.
(will flash for
10 seconds
then the meter
will turn off)
Dead batteries.
Replace the batteries immediately
to avoid the risk of a test result
not being stored in your meter.
E 11
Abnormal result.
Temperature out
of range.
Move to an area that is within
the operating range for the meter
(41°F – 113°F). Let the meter adjust
to this temperature for twenty
minutes before testing.
Remove the test strip and retest
using a new test strip. Carefully
follow testing instructions in your
User Guide.
If you continue to have problems,
contact Bayer Diabetes Care
Customer Service: 1-800-348-8100.
E 15
The meter has
detected an error
and cannot send
the result to your
Medtronic device.
Turn the Send option off (see
page 26), then retest using a
new test strip. (You can then
manually enter your result into
your Medtronic device.)
Then contact Bayer Diabetes
Care Customer Service. (You can
still use your meter for testing,
but results cannot be sent to
your Medtronic device.)
HI
Test result is above
600 mg/dL.
• Wash your hands and the test
site. Repeat the test using a
new test strip.
• If your result is still “HI,”
contact your physician or
healthcare professional
immediately.
Error Codes and Symbols
E1
WHAT IT MEANS
WHAT YOU SHOULD DO
E2
The test strip has
not filled with
enough blood for
an accurate test.
Remove the test strip and retest
using a new test strip.
E3
The meter is detecting a used test
strip or blood was
applied before the
meter was ready.
Remove the test strip and retest
using a new test strip. Wait until
you see the flashing blood drop
on the display before adding the
blood sample.
Test strip is not
inserted correctly.
Remove and reinsert the test strip
properly (see page 11).
Potential software
or hardware issue.
Remove the test strip and retest
using a new test strip. If you
continue to have problems,
contact Bayer Diabetes Care
Customer Service.
E4
Help
E5
E9
E6
E 12
E8
E 13
E7
Wrong test strip.
Remove the test strip and retest
using a CONTOUR test strip.
WHAT YOU SHOULD DO
Error Codes and Symbols
WHAT YOU SEE
(will remain
on the display)
WHAT YOU SEE
Help
If you do not resolve the problem, contact Bayer
WARNING: Glucose levels above 250 mg/dL may indicate
a potentially serious medical condition.
LO
Test result is
below 10 mg/dL.
• Repeat the test using a new
test strip.
• If your result is still “LO,” contact
your physician or healthcare
professional immediately.
WARNING: Glucose levels below 50 mg/dL may indicate
a potentially serious medical condition.
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WHAT IT MEANS
WHAT YOU SHOULD DO
The Medtronic
device did not
acknowledge receipt
of the test result
within 60 seconds.
• Be sure the Medtronic device
is located within 4 feet of
the CONTOUR LINK meter.
• Check that the Medtronic
device is set to accept
meter results and the meter
ID has been programmed
into the device.
• Check the Medtronic device
display to determine if the
glucose result has been
received by the device. If it
has not, you can enter the
test result manually.
If you continue to have problems, contact Bayer Diabetes
Care Customer Service.
• Test strip or control
solution is past the
expiration date or is
past the discard date.
• Test strip is deteriorated due to heat
or exposure to
moisture.
• Control solution is
not at room temperature or may not
be mixed well.
• Incorrect control
solution was used.
• Check all expiration dates
and discard dates. Do not
use expired testing materials.
• Make sure you are using
CONTOUR control solution.
• Gently rock the control
bottle to ensure the control
solution is mixed well.
• Run another control test.
• If result is still out of range,
retest with a new test strip
and new control solution.
• If result is still out of range,
call Bayer Diabetes Care
Customer Service.
Some display
segments do not
appear when the
meter initially
turns on.
Possible meter
electronics failure.
Compare meter display
with the illustration on
page 4. If the display is
not correct, contact Bayer
Diabetes Care Customer
Service.
Results are
not displayed in
expected units of
measure mg/dL.
This may affect
the way you see
your results.
Contact Bayer Diabetes Care
Customer Service.
Test result continues to flash
for 60 seconds,
then stops.
Error Codes and Symbols
Help
40
Control test
result is out-ofrange (too high
or too low).
Need Help ? Bayer Diabetes Care: 1-800-348-8100
CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 40-41
You can better understand your test results by being aware
of the symptoms of high or low blood glucose; this will also
help you decide what to do if your results seem unusual.
Some of the most common symptoms are:*
High blood glucose
(Hyperglycemia):
• frequent urination
• excessive thirst
• blurred vision
• increased fatigue
• extreme hunger
• irritability
Low blood glucose
(Hypoglycemia):
• shakiness
• sweating
• fast heartbeat
• blurred vision
• confusion
• passing out
• seizure
Ketones (Ketoacidosis):
• shortness of breath
• nausea and vomiting
• very dry mouth
*For additional information and a complete list of symptoms,
contact your healthcare professional or refer to the website
for the American Diabetes Association: www.diabetes.org
www.bayerdiabetes.com/us
Symptoms of High or Low Blood Glucose
WHAT YOU SEE
Symptoms of High or Low Blood Glucose
Help
If you do not resolve the problem, contact Bayer
Diabetes Care Customer Service at 1-800-348-8100.
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Changing the Batteries:
WARNING: When a low battery warning displays on the
meter, replace the battery as soon as possible to avoid a
test result not being stored in the meter memory.
Slide the battery cover back into
place, lining up with the open slots,
and close firmly.
Batteries should be replaced
when the meter continually
displays or the meter briefly
shows and then turns off (See
Error Codes and Symbols,
page 38).
WARNING: Keep batteries away from children.
Lithium batteries are poisonous. If swallowed,
immediately contact your physician or poison control
center. Discard batteries according to your local
environmental regulations.
Changing the Batteries
NOTE: If you put the new
batteries in the meter within
5 minutes of taking the old
ones out, all your settings and
results will be saved. If you take
more than 5 minutes, you will
need to reset the date and time
although your other settings
and results will be saved.
Remove the old batteries by
pressing the top of the battery
which will raise the bottom of the
battery up.
Extras
Place new batteries under the
prongs and into the battery
compartment with the “+” side up.
(Battery part numbers are DL2032
or CR2032.)
42
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Bayer offers the Free Batteries for Life program.
When your batteries are low, please call
1-800-348-8100 for your free batteries.
Caring for the System:
• When a low battery warning displays on the meter,
replace the battery as soon as possible to avoid a test
result not being stored in the meter memory.
• Store the meter in the carrying case provided whenever
possible.
• Wash your hands and dry thoroughly before handling
to keep the meter and test strips free of oils and other
contaminants.
• Handle the meter carefully to avoid damaging the electronics or causing other malfunctions.
Caring for the System
Press firmly on the battery cover
and slide in the direction of the
arrow.
• Avoid exposing the meter and test strips to excessive
humidity, heat, cold, dust, or dirt.
Please see page 18 for details on cleaning and disinfecting
your meter.
www.bayerdiabetes.com/us
Extras
Turn off your meter before changing your batteries.
43
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Transferring Results to a Computer:
Transferring Results to a Computer
You can easily transfer test
results from the CONTOUR LINK
meter to a computer that
includes the Bayer's
GLUCOFACTS® DELUXE
Diabetes Management
Software or Medtronic
CareLink® Therapy Management
Software. The results can then
be summarized into easy-to-read reports
that you can share with your physician.
A Bayer data cable is required to use this feature.
IMPORTANT: The CONTOUR LINK meter has not been
tested or certified by Bayer for use with any software
other than Bayer's G LUCOFACTS ® D ELUXE diabetes
management software or CareLink Software. Bayer is
not responsible for any erroneous results from the
use of other software.
For more information, call our Bayer Diabetes Care
Customer Service (1-800-348-8100), or visit our website
at www.bayerdiabetes.com/us.
For CareLink information, visit www.medtronicdiabetes.com.
Extras
NOTE: If the cable is connected to the data port (even if
the cable is not connected to a PC), results will NOT be
sent to the Medtronic device.
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Accuracy
Diabetes experts have suggested that glucose meters
should agree within 15 mg/dL of a laboratory method
when the glucose concentration is lower than 75 mg/dL,
and within 20% of a laboratory method when the glucose
concentration is 75 mg/dL or higher. The chart below
displays how often the CONTOUR LINK meter achieves this
goal. The chart is based on a study done on 100 patients
to see how well the CONTOUR LINK compared to laboratory
results.
For glucose results lower than 75 mg/dL, the
percent (and number) of meter results that
match the laboratory method within 15 mg/dL :
For glucose results at 75 mg/dL or higher, the
percent (and number) of meter results that
match the laboratory method within 20%:
98.7%
(75/76)
98.5%
(319/324)
Note: When meter results are compared to the laboratory results, results
below 75 mg/dL are compared in mg/dL.
Precision
A study was conducted with the CONTOUR LINK blood
glucose monitoring system with five heparinized whole
blood specimens with glucose levels from 44 to 332 mg/dL.
Multiple replicates (n=100) were tested using multiple
C ONTOUR L INK blood glucose meters and one lot of
CONTOUR blood glucose test strips. The following precision
results were obtained:
Plasma/Serum
Mean
SD
Coefficient of variation
41.8 mg/dL
1.26 mg/dL
3.02%
78.1 mg/dL
1.99 mg/dL
2.55%
125.7mg/dL
2.67 mg/dL
2.12%
198.0 mg/dL
4.32 mg/dL
2.18%
312.3 mg/dL
5.01 mg/dL
1.60%
www.bayerdiabetes.com/us
Technical Information
WARNING: Do not allow solution to run down into
the test strip port or around the buttons. Doing so
may cause a malfunction.
Technical Information:
Extras
For complete instructions on disinfecting and cleaning
your meter and lancing device, please see page 18.
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Specifications:
Test Sample: Whole blood
Operating Temperature Range: 41°F–113°F
Test Result: Referenced to plasma/serum glucose
Humidity: 10–93% RH
Sample Volume: 0.6 µL
Dimensions: 77 mm (H) x 57 mm (W) x 23 mm (T)
Measuring Range: 20- 600 mg/dL
Weight: 1.85 ounces
Measuring Time: 5 seconds
Alarm: “Beeps” whenever a test strip is inserted into
or removed from the meter, when the test strip is
filled with blood or control solution, and when a test
result appears in the display. Two beeps will sound
for an error. Twenty beeps will sound when a programmed alarm goes off.
Memory Feature: Stores most recent 480 test
results
Radio Frequency: 916.5 MHz
Battery Type: Two 3-volt lithium batteries
(DL2032 or CR2032)
Specifications
Extras
Extras
Specifications
Battery Life:
Send option off: About 1000 tests (1 yr.
average use).
Send option on: About 244 tests (2 months at
4 transmitted results per day).
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Warranty:
Limitations of Warranty: This warranty is subject to the
following exceptions and limitations:
1. A 90-day warranty only will be extended for consumable
parts and/or accessories.
5. Bayer HealthCare makes no warranty of the performance
of the C ONTOUR ® LINK meter or test results when used
with any control solution other than C ONTOUR control
solution.
BAYER HEALTHCARE MAKES NO OTHER EXPRESS WARRANTY
FOR THIS PRODUCT. THE OPTION OF REPLACEMENT, DESCRIBED
ABOVE, IS BAYER HEALTHCARE’S ONLY OBLIGATION UNDER
THIS WARRANTY. IN NO EVENT SHALL BAYER BE LIABLE FOR
INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES, EVEN IF
BAYER HEALTHCARE HAS BEEN ADVISED OF THE POSSIBILITY
OF SUCH DAMAGES.
Some states do not allow the exclusion or limitation
of incidental or consequential damages, so the above
limitation or exclusion may not apply to you. This warranty
gives you specific legal rights and you may also have other
rights which vary from state to state.
For warranty service: Purchaser must contact the Customer
Service Department of Bayer Diabetes Care, by calling toll
free 1-800-348-8100, for assistance and/or instructions for
obtaining service of this instrument.
3. Bayer HealthCare reserves the right to make changes
in design of this instrument without obligation to
incorporate such changes into previously manufactured
instruments.
Extras
4. Bayer HealthCare has no knowledge of the performance
of the CONTOUR LINK blood glucose meter when used
with any test strips other than CONTOUR test strips, and
therefore makes no warranty of the performance of
the CONTOUR LINK meter when used with any test strips
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Extras
Warranty
2. This warranty is limited to replacement due to defects
in parts or workmanship. Bayer HealthCare shall not be
required to replace any units which malfunction or are
damaged due to abuse, accidents, alteration, misuse,
neglect, maintenance by someone other than Bayer
HealthCare, or failure to operate the instrument in
accordance with instructions. Further, Bayer HealthCare
assumes no liability for malfunction or damage to
Bayer HealthCare instruments caused by the use of
reagents other than reagents (i.e., CONTOUR® test strips)
manufactured or recommended by Bayer HealthCare.
other than CONTOUR test strips or when the CONTOUR
test strip is altered or modified in any manner.
Warranty
Manufacturer’s Warranty: Bayer HealthCare warrants to
the original purchaser that this instrument will be free from
defects in materials and workmanship for 5 years from the
date of original purchase (except as noted below). During the stated 5-year period, Bayer HealthCare shall, at no
charge, replace a unit found to be defective with an equivalent or current version of the owner’s model.
www.bayerdiabetes.com/us
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Service Information:
Supplies:
If you have a problem and none of the problem-solving
steps in the User Guide help, call a Bayer HealthCare
Representative. We have trained specialists to help you.
When calling or writing for supplies, be sure to include
the number with the name of the replacement part or
accessory item.
Important:
Speak to a Bayer HealthCare Representative before
returning your meter for any reason. He/she will give
you the information needed to get your problem
handled correctly and efficiently.
Have your C ONTOUR L INK blood glucose meter and
CONTOUR test strips available when you phone. It would
also be helpful to have a bottle of C ONTOUR control
solution nearby.
Replacement Parts
Part
Number*
40030030
CTS-103
40453291
Item
3-volt Lithium Battery (DL2032 or CR2032) — 2
(Free Batteries for Life program. Call 1-800-348-8100.)
CONTOUR ® LINK User Guide
Bayer’s USB Data Cable
* Part numbers are subject to change without notice
FDA Public Health Notification: Use of Fingerstick Devices
on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens: Initial Communication" (2010)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
ucm224025.htm
CDC Clinical Reminder: Use of Fingerstick Devices on More than One
Person Poses Risk for Transmitting Bloodborne Pathogens" (2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
American Diabetes Association. Standards of Medical Care in
Diabetes - 2011. Diabetes Care 2011; 34 (1):S11-S61.
Extras
Extras
Service and Supplies
Service and Supplies
REFERENCES
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CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 52-53
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Bayer HealthCare LLC
Mishawaka, IN 46544 USA
www.bayerdiabetes.com/us
Bayer, the Bayer Cross, CONTOUR, MICROLET, Clinilog, GLUCOFACTS
and the No Coding logo are registered trademarks of Bayer. No Coding
is a trademark of Bayer.
Paradigm, Guardian, CareLink and Bolus Wizard are registered
trademarks of Medtronic MiniMed, Inc.
CTS-103
© 2010 Bayer. All rights reserved.
CTS-103_CntrLINK_UG_Master_FpB4_v7.indd obc54
Rev. 11/10
2/7/11 4:00:45 PM

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