Bayer HealthCare Contour TS User manual

USER GUIDE
BLOOD GLUCOSE MONITORING SYSTEM
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RELEASE: V-2 LANGUAGE(S): ENGLISH INTERNAL: R-X
18211 NE 68th Street, E120
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T: 425-881-5454
BAN#:81656517 Rev. 12/13
Contour TS User Guide - SA, Serbia, Bosnia,
Russia
Alt#2 - 12/10/13 copy changes
December 10, 2013
Bayer HealthCare
Contour TS User Guide - English and
Russian
912577
N/A Parent BAN# 82020234, 83920181
6.0" (H) 4.5" (W)
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Regional Master Template No: XXXX
Clinical Trial / Global Master Template No: XXXX
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December 18, 2013

Welcome to Accuracy
and Convenience Your CONTOUR TS System 2
CONTOUR TS Meter Display 3
Meter Features 4
System Information 5
Symptoms of High or Low Blood Sugar 7
Important Things to Know 8
Before You Begin 9
Error Codes and Symbols 24
Setting the Date, Time and Sound 20
Replacing the Battery 28
Caring for the System 29
Transferring Results to a Computer 30
Specifications 31
Symbols Used 32
Service Information 33
Warranty 34
Supplies 36
Table of Contents
Important
Testing
Setup
Solving
Problems
Care and
Extras
Preparing the Lancing Device 10
Inserting the Test Strip 11
Getting the Blood Drop 12
Testing Your Blood 13
Alternative Site Testing 15
Viewing Stored Test Results 16
Testing with a Control Solution 17
The CONTOUR TS Meter balances science and simplicity for ease and
accuracy you can depend on. We’re proud to be your partner in helping
you manage your diabetes.
Unlike many meters, the CONTOUR TS Meter does not require you to enter
a numeric code or put in a coding chip; therefore it eliminates coding
steps and inaccurate results due to miscoding.
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Important
Important
CONTOUR TS Meter Display:
A full display, as shown below, indicates that all characters in the
display are working properly. You will briefly see this display each
time you turn the meter on. You can see the complete display when
the meter is off by pressing and holding the button. Compare your
meter to the display shown below.
While all characters are displayed, it is most important to
verify that is fully displayed. If there is a difference,
see Error Codes and Symbols (page 27). This may affect the
way you see your results.
or
Displays the
date format.
or will
appear if the meter
is in 12 hour setup.
Your CONTOUR TS System
CONTOUR TS Meter Display
Your CONTOUR TS Meter:
Grey Electrode End:
This end (with the
grey end facing up) is in-
serted into the orange test
strip port on the meter.
Sample Tip: The
end of the test strip
where the blood is
drawn in.
Orange Test
Strip Port
Button
(Scroll)
Display
Your CONTOUR TS
Test Strip : 14 day
average.
Control result
marker.
Indicates
the meter is
ready to test.
Indicates the
battery is low
and needs to be
changed.
Results are
displayed as
either mg/dL
or mmol/L.
Beeper on/off
indicator.
Indicates it is too cold or
too hot for your meter
to test accurately.
Center area on the display
that shows either your test
result or any error codes.
Bottom area on
the display show-
ing date and time.
NOTE: Your CONTOUR TS Meter only works with
CONTOUR TS Test Strips!
Button
(On/Off,
Memory
Recall, Enter)
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www.diabetes.bayer.comNeed Help? Call your local Bayer Diabetes Care Customer Service
Important
Important
Meter Features
Meter Features
Your New CONTOUR TS Monitoring System is the
Perfect Balance of Science and Simplicity
The CONTOUR®TS Blood Glucose Monitoring System from
Bayer Diabetes Care is designed to make testing your blood
glucose levels easier.
Essential Features for Testing
The CONTOUR TS System requires No Coding
for ease and reliability. This means that the
CONTOUR TS Test Strips automatically code
the meter, so you don’t have to. It provides
accurate results in just 8 seconds, while only requiring 0.6 µL
of blood. The alternate site testing capability allows for more
options— test on your fingertip, palm or forearm.
Designed for Simplicity
The CONTOUR TS Meter is easy to learn and use. The two
large buttons enable simple navigation, while the large
LCD display is easy to read. The orange test strip port
makes for easy test strip insertion.
Overall Convenience
With its optimal size, the CONTOUR TS Meter fits well in the
palm of your hand. It is compact and portable. It provides
the accuracy you need with the ease of use you want.
System Information
Intended Use
The CONTOUR TS system (meter, test strips, controls) is intended
for self-testing by people with diabetes and by healthcare
professionals to monitor glucose concentrations in whole
blood. Capillary samples may be drawn from alternate site
testing locations. In clinical settings, the CONTOUR TS system
may also be used with fresh venous and arterial whole blood.
CAUTION
• For in vitro diagnostic use only. External use, do not
swallow test strips.
• Potential Biohazard: Healthcare professionals using
this system on multiple patients should be aware that
all products or objects that come in contact with human
blood, even after cleaning, should be handled as if
capable of transmitting viral diseases.1
• The MICROLET
®2lancing device included in the kit is not
suitable for use by healthcare professionals. It must not
be used on more than one person due to the risk of
infection.
Principles of the Procedure
The CONTOUR TS blood glucose test is based on measurement
of electrical current caused by the reaction of glucose with
the reagents on the electrode of the strip. The blood sample
is drawn into the tip of the test strip through capillary action.
Glucose in the sample reacts with FAD glucose dehydrogenase
(FAD-GDH) and potassium ferricyanide. Electrons are gener-
ated, producing a current that is proportional to the glucose in
the sample. After the reaction time, the glucose concentration
in the sample is displayed. No calculation is required.
System Information
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Important
Important
Symptoms of High or Low Blood Sugar:
You can better understand your test results by being aware of
the symptoms of high or low blood sugar; this will also help you
decide what to do if your results seem unusual.
Some of the most common symptoms are:3
High blood sugar
(Hyperglycemia):
•frequent urination
•excessive thirst
•blurred vision
•increased fatigue
•extreme hunger
•irritability
Ketones (Ketoacidosis) from
untreated Hyperglycemia:
•shortness of breath
•nausea and vomiting
•very dry mouth
If you are experiencing any of these symptoms,
test your blood glucose. If your result is displayed
as LO or HI, contact your doctor immediately.
For additional information and symptoms, contact a healthcare
professional or refer to the website for the American Diabetes
Association: www.diabetes.org
Symptoms of High or Low Blood Sugar
Low blood sugar
(Hypoglycemia):
•shakiness
•sweating
•fast heartbeat
•blurred vision
•strange behavior
•confusion
•passing out
•seizure
Limitations
1. Preservatives: Blood may be collected by healthcare pro-
fessionals into test tubes containing heparin. Do not use other
anticoagulants or preservatives.
2. Altitude: Up to 3048 meters does not significantly affect results.
3. Lipemic Specimen: Cholesterol concentrations >13.0 mmol/L or
triglyceride concentrations >33.9 mmol/L may produce elevated
readings.
4. Peritoneal dialysis solutions: Icodextrin does not interfere
with CONTOUR TS Test Strips.
5. Xylose: Do not use during or soon after xylose absorption test-
ing. Xylose in the blood will cause an interference.
6. Contraindications: Capillary blood glucose testing may not be
clinically appropriate for persons with reduced peripheral blood
flow. Shock, severe hypotension, hyperosmolar hyperglycemia and
severe dehydration are examples of clinical conditions that may
adversely affect the measurement of glucose in peripheral blood.2
7. Interference: Reducing substances occurring in the blood
naturally (uric acid, bilirubin) or from therapeutic treatments
(ascorbic acid, acetaminophen) will not significantly affect re-
sults. The limiting concentrations of these compounds are listed
in your test strip insert.
The CONTOUR TS System is not intended for use in neonatal care.
Performance Data Summary
The international standard, ISO 15197, requires that at least 95%
of the results from blood glucose meters should be within 20% of
laboratory results when equal to or above 4.2 mmol/L and within
0.8 mmol/L when below 4.2 mmol/L. The CONTOUR TS System
exceeded this goal. A study was conducted on 105 untrained
users with diabetes, testing fingertip blood, to see how well the
CONTOUR TS System compared to laboratory results. The study
demonstrated that 97.9% of the CONTOUR TS System results were
within the accuracy standard.
System Information
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