Bayer HealthCare CONTOUR NEXT User manual

®
®
10/13/12
mmol/L
5.2
Before Meal
12:24 PM
See Options
Blood Glucose Monitoring System
USER GUIDE
Uses only CONTOUR®NEXT blood glucose test strips from Bayer
DATE:
CLIENT:
DESCRIPTION:
SCHAWK JOB#:
SKU#:
DIMENSIONS:
PRINTER SPEC:
RELEASE: V-1 LANGUAGE(S): ENGLISH INTERNAL: R-X
18211 NE 68th Street, E120
Redmond, WA 98052
T: 425-881-5454
BAN#: 84671533 Rev. 04/15
Contour Next User Guide Canada
Alt#1 - 04/28/15 Copy Changes
April 28, 2015
Bayer HealthCare
Contour Next User Guide mmol/L - English
916961
Multi Parent BAN# Multi
6.0" (H) x 4.5" (W)
PUSG0494 REV G
FONTS: Helvetica, Helvetica Neue, Zapf Dingbats, Skinny Mini, Mini Micra
COLORS: Cyan Magenta Yellow Black 281 Process Build: 100C 79M 10Y 42K
NOTE: THIS COLOR PROOF INDICATES COLOR BREAK ONLY AND MAY NOT ACCURATELY REFLECT ACTUAL PRODUCTION COLOR.
Regional English Master No: XXXXXXX
Clinical Trial / Global Master Template No: M-UG-0054-R0003
FC: 21 mm BC: 8 mm
Footer: 7.5 mm
1/3rd of the Cross clear
space has been applied.
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i®
IMPORTANT SAFETY INFORMATION
WARNINGS
Serious Illness
• Capillary (fingerstick or Alternative Site) blood glucose testing may
not be clinically appropriate when peripheral flow is decreased.
Shock, severe hypotension, hyperosmolar hyperglycemia, diabetic
ketoacidosis, and occurrence of severe dehydration are examples
INTENDED USE
The CONTOUR®NEXT blood glucose monitoring system from Bayer
(meter, test strips and control solution) is intended for use by persons
with diabetes for self-testing and by health care professionals for
use on a single patient. The CONTOUR NEXT system is intended
for the quantitative measurement of glucose (from 0.6mmol/L to
33.3mmol/L) in fresh capillary whole blood samples drawn from the
fingertip or palm. Venous whole blood samples may also be used by
health care professionals.
The CONTOUR NEXT blood glucose monitoring system may also
be used by health care professionals to monitor hypoglycemia in
neonates. The system should not be used for diagnosis or screening.
Diagnosis of neonatal hypoglycemia should be performed using a
laboratory glucose method. For neonates exhibiting hypoglycemic
symptoms, provide appropriate medical care to treat symptoms and
monitor patients. If symptoms are inconsistent with meter results,
obtain a laboratory blood glucose test. The CONTOUR NEXT blood
glucose monitoring system has not been evaluated specifically with
pre-term neonates.
The CONTOUR NEXT blood glucose monitoring system may be used
as an aid to monitor the effectiveness of an individual’s personal
blood glucose control program. The CONTOUR NEXT blood glucose
monitoring system is not intended for the diagnosis of or screening
for diabetes mellitus.
The CONTOUR NEXT blood glucose monitoring system is intended
for in vitro diagnostic use only.
The CONTOUR NEXT blood glucose monitoring system is
intended for single-patient use only and should not be shared.
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ii
of clinical conditions that may adversely affect the measurement
of glucose in peripheral blood.1-3
Talk to Your Health Care Professional
• Before setting any Target ranges on your meter,
• Before changing your medication based on test results,
• If your blood sugar reading is under 2.8 mmol/L follow medical
advice immediately,
• If your blood sugar reading is over 13.9 mmol/L, wash and dry
your hands well and repeat the test with a new strip. If you
get a similar result, call your health care professional as soon
as possible,
• About whether Alternative Site Testing (AST) is appropriate for you.
Potential Biohazard
• Always wash and dry your hands well with soap and water before
and after testing, handling the meter, lancing device or test strips.
• The meter, lancing device and lancets provided by Bayer are for
single-patient use. Do not share them with anyone including other
family members. Do not use on multiple patients.
• All parts of this kit are considered biohazardous and can
potentially transmit infectious diseases, even after you have
performed cleaning and disinfection. For instructions, please
see Cleaning and Disinfection, page 22.
• The lancing device provided by Bayer should not be used for
assisted blood draws by health care professionals or at health
care provision sites.
• Use a new lancet each time you test because it is no longer sterile
after use.
• Always dispose of test strips and lancets as medical waste or as
advised by your health care professional. All products that come
in contact with human blood should be handled as if capable of
transmitting infectious diseases.
• Keep out of reach of children. This kit contains small parts which
could cause suffocation if accidentally swallowed.
• Keep batteries away from children. Lithium batteries are
poisonous. If swallowed, immediately contact your poison
controlcenter.
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iii ®
PRECAUTIONS
• Read your CONTOUR®NEXT user guide, the lancing device
package insert and all instructional materials provided in your
meter kit before testing. Please follow all instructions for use and
care exactly as described to help avoid inaccurate results.
• Examine product for missing, damaged, or broken parts. If
the test strip bottle is open inside a new box of strips, do not
use those strips. Contact Bayer Diabetes Care Helpline at
1-800-268-7200 for replacement parts.
• The CONTOUR®NEXT meter from Bayer only works with
CONTOUR®NEXT test strips and CONTOUR®NEXT control solution.
• Always keep the CONTOUR NEXT test strips in their original bottle.
Tightly close the bottle immediately after removing a test strip.
The bottle is designed to keep the test strips dry. Avoid exposing
meter and test strips to excessive humidity, heat, cold, dust, or
dirt. Exposure to room humidity by leaving the bottle open or not
storing the strips in their original bottle can damage your test
strips. This could lead to inaccurate results. Do not use a test
strip that appears damaged or has been used.
• Check the expiration dates on your test strips and control
solution. Do not use the test strips or control solution if the
expiration date printed on the bottle label and carton has passed.
This can cause inaccurate results. For the control solution, do not
use if it has been six months since you first opened the bottle.
It will help to write the six month discard date on the control
solution label.
• If your control solution test result is out of range, call Bayer
Diabetes Care Helpline at 1-800-268-7200. Do not use the meter
for blood glucose testing until you resolve this issue.
• The meter has been designed to give accurate results at
temperatures between 5°C and 45°C. If you are outside this
range, you should not test. Whenever the meter is moved from
one location to another, allow approximately 20 minutes for the
meter to adjust to the temperature of the new location before
performing a blood glucose test.
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iv
• Do not perform a blood glucose test when the CONTOUR®NEXT
meter is connected to a computer.
• Use only approved equipment from the manufacturer or certified
body such as UL or TUV.
• It is advisable to avoid use of electronic devices in very dry
environments, especially if synthetic materials are present.
• Your CONTOUR NEXT meter from Bayer has been preset and
locked to display results in mmol/L (millimoles of glucose per liter
of blood).
OResults in mmol/L will always have a decimal point;
OResults in mg/dL will never have a decimal point.
Example: or
OCheck your display screen to be sure the results are shown
the right way. If not, contact Bayer Diabetes Care Helpline
at 1-800-268-7200.
• The CONTOUR NEXT blood glucose monitoring system from Bayer
has a measuring range of 0.6 mmol/L to 33.3 mmol/L.
OFor results over 33.3 mmol/L or under 0.6 mmol/L:
о If your blood sugar reading is under 0.6 mmol/L, the “Result
Under 0.6 mmol/L” screen will instruct you to “Follow Medical
Advice Immediately.” Contact your health care professional.
о If your blood sugar reading is over 33.3 mmol/L the “Result
Over 33.3 mmol/L” screen will instruct you to “Wash hands or
test site. Repeat test with new strip”. If results are still over
33.3 mmol/L, “Follow Medical Advice Immediately”
is displayed.
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v®
Your Meter Features
Easy: The CONTOUR®NEXT blood glucose monitoring system is
about simplicity. You will notice this the first time you use it.
Automatic: The CONTOUR NEXT meter from Bayer is designed with
No Coding technology, to automatically code itself every time
you insert a test strip. It will also automatically mark a control
solution test.
Enough Blood: The CONTOUR NEXT meter alerts you when a test
strip is under-filled and allows you to add more blood. Your test strip
is designed to easily "sip" the blood into the sample tip. Do not drop
blood directly on the flat surface of the test strip.
Thank you for choosing the CONTOUR NEXT blood glucose monitoring
system from Bayer. We are proud to be your partner in helping you
manage your diabetes.
CAUTION: Your CONTOUR®NEXT meter ONLY works with
CONTOUR®NEXT test strips and CONTOUR®NEXT control solution.
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GETTING
STARTED
TESTING FEATURES HELP TECHNICAL
INFORMATION
Getting Ready to Test............................................................6
Getting the Blood Drop – Fingertip Testing .........................10
Test Results .........................................................................13
Alternative Site Testing (AST) - Palm...................................16
Expected Test Result Values ...............................................26
Control Solution Testing ......................................................27
Intended Use, Important Safety Information ..........................i
Your CONTOUR®NEXT Meter...................................................2
Initial Setup............................................................................5
Test Reminders....................................................................30
Logbook ..............................................................................33
Notes ...................................................................................34
Trends (Averages and Summaries)......................................35
Setup ...................................................................................39
AutoLog...............................................................................45
Caring for Your Meter ..........................................................54
Transferring Results to a Computer ....................................55
Batteries ..............................................................................55
Error Detection Displays......................................................57
System Support Information ...............................................59
Technical Information ..........................................................60
Symptoms of High or Low Blood Glucose..........................62
Specifications......................................................................63
Warranty ..............................................................................66
Index....................................................................................68
Table of Contents
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GETTING
STARTED
2®
Your CONTOUR®NEXT Meter
Your CONTOUR®NEXT Meter
Using the Meter Buttons
• Press and hold the OK button until the meter turns on.
• Press and hold the OK button until the meter turns off.
• The or scroll buttons on the meter allow you to scroll
through the menus. You can hold the or button to
scroll continuously through a list.
• Press the OK button to select the highlighted option.
• To exit from the Logbook or Trends and return to the Main
Menu, press the OK button.
• To exit from Setup and return to the Main Menu, scroll
down to Main Menu and press the OK button.
Press to scroll up
Press and hold
to keep scrolling
Press to
scroll down
Press and hold
to keep scrolling
Press and hold to
turn the meter On
or Off
Press to accept a
highlighted selection
OK Button
Up/Down
Scroll Buttons
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3
GETTING
STARTED
Language:
Continue
English
OK
No
13.10.12
mmol/L
5.2
Before Meal
12:24
See Options
Your CONTOUR®NEXT Meter
Symbol What it Means
When you select More Information.
On confirmation screens and when blood sugar test
result is in Target range.
On error screens and when blood sugar test result is
either below 0.6 mmol/L or above 33.3 mmol/L.
When blood sugar test result is above Target.
When blood sugar test result is below Target.
Listed below are symbols that appear on the CONTOUR®NEXT
meter screen. These symbols will appear in the left side of
the screen, as shown here:
Example of Language
confirmation screen
AutoLog
Meal Marker
Date
Test Result
In Target
Time
Test Strip Port
Data Port
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GETTING
STARTED
4®
Your CONTOUR®NEXT Test Strip
Your CONTOUR®NEXT Test Strip
Grey Square End
Insert this end into the test
strip port
Sample Tip
Blood sample pulled in here
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5
GETTING
STARTED
LANGUAGE
English
Français
Español
Português
Italiano
Language:
Continue
English
OK
No
Initial Setup
Initial Setup
1. Press and hold the OK button until the meter turns on.
After a welcome screen, you will see the Select
Language screen.
2. Press the button if needed to
select your desired language. Press
the button to scroll down to see
more language choices.
4. A screen confirms your language.
5. Press the OK button to complete setup. Your meter is
now ready to test your blood sugar.
You can also change your language, time and date by going
to the Main Menu and selecting Setup. See page 39.
3. When your language is highlighted, press the OK button.
This screen example shows the language selections. The
language order may differ depending on your country.
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TESTING
6®
Getting Ready to Test
Getting Ready to Test
WARNING
Always wash your hands well with soap and water
and dry them well before and after testing, handling
the meter, lancing device or used test strips.
Read your CONTOUR®NEXT user guide, the lancing
device insert and all instructional materials provided
in your meter kit before testing. Please follow all
instructions for use and care exactly as described.
Examine product for missing, damaged, or broken
parts. If the test strip bottle is open inside a new box
of strips, do not use those strips. Contact Bayer
Diabetes Care Helpline at 1-800-268-7200 for
replacement parts.
CAUTION: Your CONTOUR®NEXT meter only works
with CONTOUR®NEXT test strips and CONTOUR®NEXT
control solutions.
Have all the materials you will need ready before
you begin testing. This includes your CONTOURNEXT
meter, CONTOUR NEXT test strips, and the lancing
device and lancets from Bayer. You may also need
CONTOURNEXTcontrol solution to perform a quality
control check. CONTOUR NEXT test strips and
CONTOURNEXT control solutions are sold separately
if not included in the meter kit.
WARNING
• Dispose of the used lancet as medical waste or as
advised by your health care professional.
• Do not reuse lancets. Use a new lancet each
time you test.
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TESTING
7
1. Remove the endcap
from the lancing device.
Hold the endcap dial
and gently snap off
the endcap from top
to bottom.
WARNING: Potential Biohazard
The lancing device provided by Bayer is intended for
single patient use only. The lancing device should
not be used for assisted blood draws by health
care providers or at health care provision sites, and
should never be shared with anyone else, even a
family member, due to risk of infection. Use a new
lancet each time you test because it is no longer
sterile after use.
Preparing the Lancing Device
2. Loosen the round
protective cap on a
lancet by rotating it
¼turn, but do not
remove it.
Preparing the Lancing Device
The lancing device graphics are for illustration purposes
only. Your lancing device may look different. Refer to
your lancing device insert for detailed instructions on
preparing the lancing device.
For Alternative Site Testing instructions, see page 16.
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TESTING
8®
5. Replace the endcap.
3. Insert the lancet firmly
into the lancing device
until it comes to a
fullstop.
4. Twist off the round
protective lancet cap.
Save it for disposing of
the used lancet.
6. Rotate the endcap dial
to adjust the puncture
depth. The amount of
pressure applied to the
puncture site also affects
puncture depth.
Preparing the Lancing Device
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TESTING
9
Apply Blood
Inserting the Test Strip
1. Remove a CONTOUR®NEXT test strip from
the bottle. Tightly close the bottle lid
immediately after you have removed the
test strip.
HINT: After the test strip is inserted, if you do not apply
blood to the test strip within 3 minutes, the meter will
turn off. Remove the test strip and reinsert it to begin
a test.
You will see the Apply Blood screen. The
meter is now ready to test a blood drop.
2. Hold the test strip with
the grey square end
facing toward the meter.
stri
p
f
rom
o
ttle lid
e
moved the
3. Insert the grey square
end firmly into the test
strip port until the meter
beeps.
Inserting the Test Strip
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TESTING
10 ®
Getting the Blood Drop – Fingertip Testing
1. Press the lancing
device firmly against
the puncture site and
press the release button.
Getting the Blood Drop – Fingertip Testing
2. Stroke your hand
and finger toward the
puncture site to form a
drop of blood. Do not
squeeze around the
puncture site.
3. Test immediately after
you have formed a
small, round blood
drop as shown.
4. Immediately touch the
tip of the test strip to the
drop of blood. The blood
is pulled into the test
strip through the tip.
Hold the tip of the test
strip in the blood drop
until the meter beeps.
Do not press the tip against the skin or place the blood on
top of the test strip because this could lead to inaccurate
results or errors.
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TESTING
11
Apply More Blood
to continue testing.
(E01)
Too Little Blood
Remove used strip.
Repeat test with new
strip.
Apply More Blood
If the first blood drop is not enough,
the meter will beep twice and display
“Apply More Blood to continue testing.”
You have about 30 seconds to apply
more blood onto the same strip.
If you do not re-apply enough blood
within about 30 seconds, you will see
a screen telling you to remove the strip
and start with a new strip.
Apply More Blood
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TESTING
12 ®
AUTOLOG
Testing...
Fasting
Before Meal
After Meal
No Mark
AutoLog
AutoLog
Your meter comes with an AutoLog feature that lets you
mark your test result as Fasting, Before Meal, After Meal and
No Mark.
Fasting – The Fasting marker is used when testing blood
sugar levels after going without food or drink for at least
8 hours.
Before Meal - The Before Meal marker is used when
testing blood sugar levels within 1 hour before a meal.
After Meal – The After Meal marker is used when testing
blood sugar levels within 2 hours after the first bite of a meal.
No Mark - No Mark can be selected if you are testing at other
times than before or after a meal or fasting.
Your meter comes with AutoLog turned on. You will get
the most information from each result if you keep this
feature turned on.
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TESTING
13
AUTOLOG
Select Mark
Fasting
Before Meal
After Meal
No Mark
5
Testing...
Test Results with AutoLog On
Test Results
Test Results with AutoLog On
• Your CONTOUR®NEXT meter comes with AutoLog on.
You can turn AutoLog off using the Setup menu
(see page 45).
After you place blood on the test strip,
your test result will not display until you
make an AutoLog selection. Use the
or button to select Fasting, Before
Meal, After Meal, or No Mark, and then
press the OK button.
If your result is outside your Target range
setting, you will see your result without
pushing a button.
To get the most from your AutoLog
feature, mark your test result right away.
If you make your AutoLog selection very
quickly, you may see the remainder of
the testing countdown.
If you have not made your AutoLog selection within 1 minute,
the screen will dim. Press any button to turn the screen back
on and make your choice. If you have not made your choice
within 3 minutes, the meter turns off. Your blood sugar result
will not be lost — it will be stored in Logbook as No Mark.
CAUTION: If your result is above or below your set
Target ranges, you will always see your result without
pushing a button.
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TESTING
14 ®
13.10.12 10:20
mmol/L
3.3
After Meal
See Options
BELOW TARGET
13.10.12 10:20
mmol/L
10.3
After Meal
See Options
ABOVE TARGET
10/13/12 10:20 PM
mmol/L
8.2
After Meal
See Options
OPTIONS
Main Menu
Add Note
Add Reminder
Test Results with AutoLog On
After making your selection, your test
result appears. Press the OK button to
move to See Options.
Leave the test strip in the meter to add
a note related to this result or set a
reminder. Press the OK button and you
can select Main Menu, Add Reminder (see
page 30) or Add Note (see page 34).
To turn the meter off if you do not want to set a reminder or
add a note, remove the test strip.
HINT: The screen above shows a result that is within
the Target Range you set for an After Meal result. The
screens below show an After Meal result that is Below
Target and an After Meal result that is Above Target.
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