Use
only CONTOURTMTS control solutions (Normal, Low or High) with your CONTOURTMTS
blood glucose monitoring system.

Using
anything other than CONTOUR TS control solution could present incorrect results

 You should perform a control test:

When
using your meter for the first time

When
you open a new bottle or package of test strips

If
you think your meter may not be working properly

If
you have repeated unexpected blood glucose results

Normal,
Low or High control solutions are available and sold separately. Always use
CONTOUR TS control solutions. Other brands could present incorrect results. If
you need help locating CONTOUR TS control solutions, contact Customer Service.
See the back cover for contact information.

 1. Wash and dry your hands well before
testing.

2.
Remove a test strip from the bottle and firmly snap the

lid
closed

 NOTE: Check the expiry date on the test strip
bottle and the expiry and discard dates on control solution. Do not use expired
materials.

3.
Hold the test strip with the grey end facing up.

4.
Insert the grey end into the test strip port on the meter.

The
meter will turn on. An image of a test strip with a flashing blood drop will
appear letting you know the meter is ready to test.

5 . Gently
rock the control bottle before opening to ensure itis mixed well.

6 . Squeeze
a small drop of control solution on a clean, nonabsorbent surface, such as a
piece of wax paper. Do not apply control solution to your fingertip or to the
test strip directly from the bottle.

7 . Immediately touch the
tip of the test strip to the drop of control solution. The solution is pulled
into the test strip through the tip.

8.
Hold it in the drop until the meter beeps.

With
the meter off, press and release M to view stored test results. The 14 day
average will appear in the center of the display. Any control results are not
included in this 14 day average

Press
M to review previous results. Results will be shown starting with the most
recent. Each result will show the date and time the test was taken. You can
press to scroll through the results.

When
End appears on the display, you have viewed all of the results in the memory.

Press
M to turn the meter off, or it will automatically turn off after 3 minutes

NOTES

Averages
include the specified time period plus the

Current
day. The meter will hold 250 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 turn off automatically after three minutes.

 Error
Codes and Symbols:

Low
Battery – when battery symbol remains on display screen during testing

Replace
the battery as soon as battery symbol possible (see page 28)

Temperature
out-of-range.

Move
to an area that is within the operating range for the meter: 5°C-45°C. Let the
meter and test strips adjust to this temperature for twenty minutes before
testing.

The
test strip and repeat filled enough to give an accurate result

You
may have applied blood more than once on the same strip.

Blocked
sample tip…

 Blood drop too small.

·
Remove the test using a new
test strip.

·
Do not attempt to apply
blood more than once per strip

·
Do not push strip into skin
while filling strip

·
See suggested drop size
on  page 9.

   The
meter is sensing Remove the test strip

Remove
the test strip and retest a used test strip. using a new test strip. Wait until
you see the flashing blood drop in the display before adding the blood sample.

Test
strip not inserted correctly.

Remove
the test strip and insert correctly it properly (see page 7). Use only
CONTOURTMTS test strips

Potential
software or hardware issue

Remove
the test strip and retest using a new test strip.  If you continue to have problems, contact
Customer Service. See the back cover for contact information

Wrong
test strip.

Remove
the test strip and retest using only a CONTOUR TS Test Strip.

Strip
disturbed during countdown.

 Strip degraded due to long exposure out of
bottle.

 Used test strip inserted.

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 Customer Service. See the back cover for
contact information.

Changing
the Battery

The
battery should be replaced when the meter continually displays or does not turn
on. Your CONTOURTMTS meter uses one 3-volt lithium battery (DL2032 or CR2032)

1.
Turn off your meter before
changing your battery.

2.
Press firmly on the battery
cover and slide in the direction of the arrow.

NOTE: After replacing the battery you
will need to reset the time (see page 18). The date and other formatting
choices do not need to be reset. Test results stored in the memory are not
erased when the battery is changed.

3 .  Remove
the old battery by placing your finger under the top of the battery and pulling
upward. Grasp the battery and remove

4. Place new battery into the battery
compartment with the “+” side up.

5 . Slide the battery cover back into place,
lining up with the open slots, and close firmly.

 

CAUTION

Keep
battery cover and battery out of reach of children. Accidental swallowing could
cause suffocation. Lithium batteries are poisonous. If swallowed, immediately
contact your doctor or poison control center. Discard batteries according to
your local environmental regulations.

Changing
the Battery

Caring
for Your Meter

Store
meter in the carrying case provided whenever

possible.

 Wash and dry hands well before handling to
keep

the
meter and test strips free of water, oils and other contaminants. Handle the
meter carefully to avoid damaging the

electronics
or causing other malfunctions.

Avoid
exposing meter and test strips to excessive humidity, heat, cold, dust, or
dirt.

Clean
your meter as recommended on page 13.

 

 Symptoms
of High or Low Blood Glucose

Symptoms
of High or Low Blood Glucose

You
can better understand your test results by being aware of the symptoms of high
or low blood glucose. According to the American Diabetes Association, some of
the most common symptoms are

Low
blood glucose (Hypoglycaemia):

 shakiness

sweating

fast
heartbeat

blurred
vision

confusion

passing
out

seizure

irritability

extreme
hunger

dizziness

High
blood glucose (Hyperglycaemia):

frequent
urination

excessive
thirst

blurred
vision

increased
fatigue

hunger

Ketones
(Ketoacidosis)

shortness
of breath

 nausea or vomiting

 very dry mouth

Information
For Safety

If
you are experiencing any of these symptoms, test your blood glucose. If your
test result is under 50 mg/dL or above 250 mg/dL, contact your health care
professional immediately.

For
additional information and a complete list of symptoms, contact your health
care professional.

System
Specifications

Test
Sample: Venous, arterial or capillary whole blood

Test
Result: Referenced to plasma/serum glucose

Sample
Volume: 0.6 uL

Measuring
Range: 10-600 mg/dL

Results:
5-second countdown

Memory
Feature: Stores most recent 250 test results

Battery
Type: One 3-volt lithium battery, 225 mAh capacity

(DL2032 or CR2032)

Battery
Life: Approximately 1000 tests (1 yr. average use)

Operating
Temperature Range: r*

Humidity:
10% – 93% RH 5°C

Dimensions:
71 mm (H) x 60 mm (W) x 19 mm (T)

Weight:
56.7 grams

Sound:
A beep sounds whenever a test strip is inserted into the

meter,
when the test strip is filled with blood or control solution, or when a test
result appears on the display screen. Two beeps will sound for an error. To
turn off the sound, see Setting the Sound on page 19

 Electromagnetic Compatibility (EMC): The
CONTOURTMTS meter complies with the electromagnetic requirement specified in
ISO 15197:2013. Electromagnetic emissions are low and unlikely to interfere
with other nearby electronic equipment, nor are emissions from nearby
electronic equipment likely to interfere with the CONTOUR TS meter. The CONTOUR
TS meter meets the requirements of IEC 61000-4-2 for immunity to electrostatic
discharge. Avoid use of electronic devices in very dry environments, especially
if synthetic materials are present. The CONTOUR TS meter meets the requirements
of IEC 61326-1 for radio frequency interference. To avoid radio frequency
interference, do not use the CONTOURTMTS meter near electrical or electronic
equipment that are sources of electromagnetic radiation, as these may interfere
with the proper operation of the meter.

 Principles
of the Procedure: The CONTOURTMTS blood glucose test is based on
measurement of electrical current caused by the reaction of the glucose with
the reagent 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 generated, 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.

Comparison
Options: The CONTOURTMTS system is designed for use with venous and
capillary whole blood. Comparison to a laboratory method must be done
simultaneously with aliquots of the same sample. Note: Glucose concentrations
drop rapidly due to glycolysis (approximately 5% – 7% per hour).

The
following symbols are used throughout the product labeling for the CONTOURTMTS
blood glucose monitoring system (meter packaging and labeling, and test strip
and control solution packaging and labeling).

Symbols
Used

Use
by date (last day of month)

Do
not reuse

Batch
code

Temperature
limitations

In
Vitro Diagnostic Medical Device

Manufacturer

Caution

Catalogue
number

CONTROL
number

Control
Range Normal

Control
Range Low

Control
Range High

Control
Discard Date

Sterilized
using irradiation

Batteries
must be disposed of in accordance with laws in your country. Contact your
competent local authority for information on the relevant laws regarding
disposal and recycling in your area. The meter should be treated as
contaminated and disposed of according to local safety rules. It should not be
disposed of with waste electronic equipment. Contact your health care
professional or local waste disposal authority for medical waste disposal guidelines.

 Technical
Information

 Accuracy

The
CONTOURTMTS blood glucose monitoring system was tested in 100 capillary blood
samples using 600 CONTOURT

MTS
test strips. Two replicates were tested with each of 3 lots of CONTOUR TS test
strips for a total of 600 readings. Results were compared to the YSI® glucose
analyzer, which is traceable to the CDC hexokinase method. The tables below
compare the performance of the 2 methods.

Table
1 – System accuracy results for glucose concentration < 100 mg/dL

Difference range in values between YSI laboratory reference method and CONTOUR TS meter	Within + 5 mg/dL	Within + 10 mg/dL	Within + 15 mg/dL

Table
2 – System accuracy results for glucose concentration – 100 mg/dL

Difference range in values between YSI laboratory reference method and CONTOUR TS meter	Within + 5%	Within + 10%	Within + 15%
Number (and percent) of samples within specified range	297 of 420 (70.7%)	399 of 420 (95.0%)	| 416 of 420 (99.0%)

Table
3 – System accuracy results for glucose concentrations between 36 and 443 mg/dL

Within 15 mg/dL or +15%

586 of 600 (97.7%)

Acceptance
criteria in ISO 15197: 2013 are that 95% of the measured glucose values shall
fall within either +15 mg/dL of the average measured values of the reference
measurement procedure at glucose concentrations <100 mg/dL or within +15 %
at glucose concentrations 2 100 mg/dL

 User Accuracy A study evaluating
glucose values from fingertip capillary blood samples obtained by 132 lay
persons showed the following results: 100% within +15 mg/dL of the medical
laboratory values at glucose concentrations below 100 mg/dL and 95.6% within
+15% of the medical laboratory glucose concentrations at or above 100 mg/dL.

Precision

A
repeatability study was conducted with the CONTOURTMTS blood glucose monitoring
system using 5 venous whole blood specimens with glucose levels from 40 to 329
mg/dL. Multiple replicates (n=300) were tested using multiple CONTOUR TS blood
glucose meters and 3 lots of CONTOUR TS blood glucose test strips. The
following precision results were obtained.

 

 Technical
Information Precision

Table
4 – System repeatability results for CONTOURTMTS meter using CONTOURTMTS test
strips

Mean, mg/dL	Pooled Standard Deviation mg/dL	95% Confidence Interval of Standard Deviation, mg/dL	Coefficient of Variation, %
39.6	1.4	1.31 – 1.55	3.6
76.1	1.8	1.70 – 2.01	2.4
131.8	2.8	2.58 – 3.06	2.1
199.4	3.4	3.10 – 3.67	1.7
326.9	4.8	4.47 – 5.30	1.5

Intermediate
precision (which includes variability across multiple days) was evaluated using
3 control solutions. With each of 3 lots of CONTOUR TS test strips, each
control was tested once on each of 10 instruments on 10 separate days for a
total of 300 readings.

Table
5 – System intermediate precision results for CONTOUR TS meter using CONTOUR TS
test strips

Control Level	Mean, mg/dl	Standard Deviation, mg/dL	95% Confidence Interval of Standard Deviation, mg/dL	Coefficient of Variation,   %
Low	39.9	0.06	0.57 – 0.67	1.5
Normal	122.4	1.6	1.49 – 1.76	1.3
high	358.1	4.5	4.15 – 4.91	1.3

Service
Information If you have a problem and none of the problem solving steps in this
user guide help, contact Customer Service. See the back cover for contact
information. We have trained specialists to help you

 Important

Speak
to a Customer Service 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 CONTOURTMTS blood glucose meter and
CONTOURTMTS test strips available when you phone. It would also be helpful to
have a bottle of CONTOURTMTS control solution nearby.

Check
List

This
check list may be helpful when speaking with Customer Service

1.
Locate the serial number (A)
and model number (B) on the back of the meter.

3 . Check the battery
icon on the display. (See page 28,

Changing
the Battery)

 Warranty

Manufacturer’s
Warranty Diabetes Care 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,

Ascensia
Diabetes Care shall, at no charge, replace a unit found to be defective with an
equivalent or current version of the owner’s model. 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.

2.
This warranty is limited to replacement due to defects

in
parts or workmanship. Ascensia Diabetes Care shall not be required to replace
any units that malfunction or are damaged due to abuse, accidents, alteration,
misuse, neglect, maintenance by someone other than Ascensia Diabetes Care, or
failure to operate the instrument in accordance with instructions. Further,
Ascensia Diabetes Care assumes no liability for malfunction of or damage to
Ascensia Diabetes Care instruments caused by the use of test strips or control
solution other than the appropriate products recommended by Ascensia Diabetes
Care (i.e., CONTOURTMTS test strips and CONTOURTMTS control

Solutions).

3.
Ascensia Diabetes Care reserves the right to make

Changes
in the design of this instrument without obligation to incorporate such changes
into previously manufactured instruments.

4.
Ascensia Diabetes Care has no knowledge of the

performance
of the CONTOURTMTS blood glucose meter when used with any test strips other
than CONTOUR TS test strips, and therefore does not warrant

CONTOURTMTS
meter CONTOURTMTS test strips

the
performance of the CONTOURTMTS meter when used with any test strips other than
CONTOURTMTS test strips or when the CONTOUR TS test strip is altered or
modified

in
any manner.

5.
Ascensia Diabetes Care makes no warranty regarding

the
performance of the CONTOUR TS meter or test results when used with any control
solution other than

CONTOURTMTS
control solution.

6.
Ascensia Diabetes Care makes no warranty regarding

the
performance of the CONTOUR TS meter or test results when used with any software
other than the CONTOUR DIABETES APP (where supported) or the GLUCOSE FACTS DELUXE
diabetes management software

(where supported) from
ASCENSIA DIABETES CARE. ASCENSIA DIABETES CARE MAKES NO OTHER EXPRESS WARRANTY
FOR THIS PRODUCT. THE OPTION OF REPLACEMENT, DESCRIBED ABOVE, IS THE ONLY
OBLIGATION OF ASCENSIA DIABETES CARE UNDER THIS WARRANTY. IN NO EVENT SHALL
ASCENSIA DIABETES CARE BE LIABLE FOR INDIRECT, SPECIAL OR CONSEQUENTIAL
DAMAGES, EVEN IF ASCENSIA DIABETES CARE 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 Ascensia Diabetes Care Customer Service for assistance and/or
instructions for obtaining service of this instrument. See the back cover for
contact information.

 Supplies

You
can contact Customer Service for supplies. See the back cover for contact
information.

REPLACEMENT
PARTS

 Item

One
3-volt lithium battery DL2032 or CR2032

CONTOURTMTS
user guide

CONTOURTMTS
test strips

CONTOURTMTS
control solution, Normal

CONTOURTMTS
control solution, Low

CONTOURTMTS
control solution, High

REFERENCES

1.
 Sewell
DL. Protection of Laboratory Workers From Occupationally Acquired Infections;
Approved Guideline, 3rd Edition. Clinical and Laboratory Standards Institute.
CLSI document M29-A3; ISBN 156238-567-4. March 2005.

2.
Cryer PE, Davis SN.
Hypoglycemia. In: Kasper D, et al, editors. Harrison’s Principles of Internal
Medicine. 19th edition. New York, NY: McGraw Hill; 2015

 http://accessmedicine.mhmedical.

com/content.aspx?bookid=1130&sectionid=79753191

3.
American Diabetes Association. http://www.diabetes.org

4.
Burtis CA, Ashwood ER, editors. Tietz Fundamentals of Clinical

Chemistry.
5th edition. Philadelphia, PA: WB Saunders Co; 2001;444.