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.