Bayer HealthCare Contour User guide

BLOOD GLUCOSE MONITORING SYSTEM

USER GUIDE

Thank you for choosing the C ONTOUR

® blood glucose monitoring system! We are proud to be your partner in helping you manage your diabetes. Our goal is to make this the simplest, most accurate meter you will ever use.

The C ONTOUR blood glucose monitoring system is intended for self-testing by people with diabetes and by healthcare professionals to monitor glucose concentrations in whole blood.

Additional Materials

• C ONTOUR

® Test Strips— Use for blood glucose or control solution testing. The test strips are supplied in a handy bottle with an easy-to-open flip-top lid.

• M ICROLET

® 2 or Ascensia ® M ICROLET

® Lancing Device with Adjustable Endcap and clear Alternative Site Testing (AST) Endcap — Use the Gray Adjustable Endcap for testing on the fingertip. Use the clear AST Endcap for testing on the forearm or palm.

• Batteries— Uses two 3-volt (DL2032 or CR2032) lithium batteries. Replace when necessary.

For the Free Batteries For Life program, call 1-800-348-8100.

For short simple instructions, a quick reference guide is also provided. It can be more convenient when traveling.

Table of Contents

Your Testing Tools

Your Meter Display

Your Meter Features

Symptoms of High or Low Blood Sugar

Important Things to Know

Before You Begin Testing

Getting Ready to Test

Getting the Blood Drop

Testing Your Blood

Set-up for Basic (L-1) and Advanced (L-2) Modes

Setting the Date, Time and Sound

Setting Advanced Mode (L-2) Features

Using Advanced Mode

Viewing Stored Results

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15

18

19

24

Alternative Site Testing (Forearm or Palm)

Control Solution Testing

Transferring Results to a Computer

28

30

33

Error Codes and Symbols

Changing the Batteries

Caring for the System

Technical Information

34

37

39

40

Specifi cations 41

Warranty 42

Service and Supplies 44

8

10

11

4

5

2

3

6

7

Your

C ONTOUR

®

Meter:

Up/Down

Scroll Buttons

Test Strip Port

Your

C ONTOUR

®

Test Strip:

Gray End

Insert this end into the test strip port.

Sample Tip

Blood sample pulled in here.

M ICROLET ® 2 lancing device and lancets

(Included with some kits)

Display

Memory Button

(On/Off, Memory

Recall, Enter)

2

OR

Ascensia ® M ICROLET ® adjustable lancing device and lancets

(Included with some kits)

Please refer to the Ascensia

M ICROLET device package insert for complete instructions on using this lancing device.

Your Meter Display:

The picture below shows all the symbols that appear on your meter display. To view, with the meter off, press and hold ▲ or ▼. All display segments will appear for 10 seconds. If you need more than

10 seconds to check the display, press and hold ▲ or ▼ again.

While all characters are displayed, it is very important to verify that is fully displayed. If there are missing segments, see Error Codes and Symbols (page

34). This may affect the way you see your results.

Top area on the display presenting date and time.

Indicates sound is turned on.

or will appear if the meter is in 12 hour setup.

Pre-meal result marker.

Indicates the batteries are low and need to be changed.

Post-meal result marker.

Center area on the display that shows either your test result or any error codes.

Day/month format.

Identifies a

Logbook entry.

Indicates the meter is ready to test.

Control result marker.

Results are displayed as mg/dL or mmol/L.

The 7 appears when viewing 7 day

HI–LO summary.

Indicates an alarm has been set.

Indicates it is too cold or too hot for your meter to test accurately.

Indicates Average.

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Your Meter Features:

Easy: The C ONTOUR blood glucose monitoring system is about simplicity. You will notice its uncomplicated approach the first time you see it. Simple things like the use of three large buttons and a clear display are sure to make this your favorite meter right from the start.

Automatic: You no longer have to worry about coding* your meter or marking a control test result. The C ONTOUR meter does it automatically. It will even tell you when a test strip is under-filled.

Programmed: Your C ONTOUR meter has been preset at the factory with the standard date, time, and units of measure (mg/dL) used where you purchased your meter. To change these settings or use advanced meter features, such as meal markers or post-meal test alarm, read through the

Additional Features section of your user guide.

Customizable: The C ONTOUR meter allows you to set personal choices for some features. For more information, please see pages 14–19.

*Your C ONTOUR meter is designed with No Coding™ technology, so the meter codes itself every time you insert a test strip. This means you do not have to worry about getting inaccurate results due to miscoding or forgetting to code your meter.

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Need Help? Call toll free: 1-800-348-8100

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.

According to the American Diabetes Association, some of the most common symptoms are: 1

High blood sugar

(Hyperglycemia):

Low blood sugar

(Hypoglycemia):

• frequent urination

• excessive thirst

• blurred vision

• increased fatigue

• extreme hunger

• irritability

• shakiness

• sweating

• fast heartbeat

• blurred vision

• confusion

• passing out

• seizure

Ketones (Ketoacidosis):

• shortness of breath

• nausea and vomiting

• very dry mouth

CAUTION: If you are experiencing any of these symptoms, test your blood glucose. If your test result is below 50 mg/dL or above 250 mg/dL, contact your doctor immediately.

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

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Important Things to Know:

Always keep the test strips in the original bottle.

Tightly close the bottle immediately after removing a test strip.

The bottle is designed to keep the test strips dry. Exposure to room humidity from leaving the bottle open or not storing them in the original bottle can damage your test strips.

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.

Do not press the test strip against your finger when testing. This may block the sample tip.

Test strips are for single use only. Do not use a test strip that appears damaged or has been used.

Let the meter and test strips adjust to the temper- ature of the location where you are testing.

Whenever the meter is moved from one location to another, allow approximately 20 minutes for the meter to adjust to the temperature of that new location before performing a blood glucose test. The products have been designed to give accurate results at temperatures between 41°F and

113°F.

Check the expiration dates on your test strips and control solution.

It is important to not use the test strips or control solution if the expiration date printed on the bottle label and carton has passed or it has been six months (180 days) since you first opened the bottle. It will help to write the six month discard date on the label in the area provided when you first open the test strips or control solution.


IMPORTANT NOTE:

• Your meter has been preset and locked to display results in mg/dL (milligrams of glucose per deciliter). In some countries, the meters are preset to display units in mmol/L

(millimoles of glucose per liter);

• Results in mg/dL will never have a decimal point;

• Results in mmol/L will always have a decimal point.

Example: or

Check your display to ensure that results are being displayed in mg/dL. If they are not, contact Bayer Diabetes

Care Customer Service, 1-800-348-8100.

Before You Begin Testing:

1.

Read your user guide and all instructional materials provided in your meter kit before testing.

2.

Have all the materials you will need ready before you begin testing. This includes your C ONTOUR

® meter, the C ONTOUR ® test strips, and the M ICROLET ® 2 or

Ascensia ® M ICROLET ® lancing device with M ICROLET ® lancets. You may also need C ONTOUR ® control solution to run a quality control check.

3.

Wash your hands thoroughly with warm soapy water and dry them well before testing.


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8

The following steps (pages 8–13) are shown in the proper order for performing a blood glucose test.

Getting Ready to Test:

Your lancing device may not be the one shown here.

Please check your lancing device insert for complete instructions on its use. Read the M ICROLET 2 or the

Ascensia M ICROLET insert for complete instructions. For testing sites other than fingertip, see page 28.

Wash and dry your hands thoroughly before testing.

Remove the endcap from the

M ICROLET 2 lancing device with your thumb on the grip indent as shown.

Loosen the round protective cap on a lancet by rotating it ¼ turn, but do not remove it. Always use M ICROLET lancets for best operation.

Insert the lancet firmly into the lancing device until it comes to a full stop. This will cock the device. You can also pull and release the cocking handle.


Twist off the round protective lancet cap. Be sure to save it for disposing of the used lancet.

Replace the gray endcap prior to getting your blood drop.

Remove a test strip from the bottle. Tightly close the bottle lid immediately after you have removed the test strip.

NOTE: Check the expiration and discard dates on the bottle.

Make sure the test strip does not appear torn or damaged.

Hold the test strip with the gray end facing up.

Insert the gray 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.


9

Getting the Blood Drop:

The puncture depth depends on the endcap setting and the amount of pressure applied to the puncture site. You will determine which combination works best for you.

Use the

Gray endcap

Shallow

Puncture

Deep

Puncture

Press the endcap firmly against the puncture site and press the blue release button with your thumb.

Stroke your hand and finger towards the puncture site to form a drop of blood. Do not squeeze around the puncture site.

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Test immediately after a good blood drop has formed.

Suggested drop size


Testing Your Blood:

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.

After a beep, you will see the meter count down 5 seconds.

Your test result will appear and will be automatically stored in the meter memory.

Remove the test strip to turn your meter off.

Fingertip Testing www.bayerdiabetes.com/us

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You can set your meter to use special marker options by using Advanced Mode (L-2). See pages 18–23.

Expected Values: Blood glucose values will vary depending on food intake, medication dosages, health, stress, or exercise. Consult your healthcare professional for the target value that is appropriate for you. According to the American

Diabetes Association standard medical practice goals for a non-pregnant individual with diabetes: 2

• Before a meal: 90 to 130 mg/dL

• 2 hours after a meal: less than 180 mg/dL

CAUTION

250 mg/dL, or you see “ ” or “ ” on the meter display, call your physician or healthcare professional immediately.

• ONTOUR blood glucose results without the advice of your physician or healthcare professional.

NOTE: If you want to mark your result (Advanced Mode), you will need to do it before removing the test strip.

To turn your meter off, simply remove the test strip. Carefully dispose of the used test strip.


Removing the used lancet:

In one hand, hold the lancing device with your thumb on the grip indent, with your other hand, hold the gray endcap dial as shown, and gently snap off the endcap.

Place the round protective lancet cap on a flat surface with the Bayer logo facing down.

With the used lancet still in the lancing device, push the lancet needle completely into the middle of the exposed side of the cap.

While (a) pressing the blue release button, (b) pull the blue cocking handle, and the lancet will drop into the container you have selected.

Dispose of the used lancet carefully to prevent injury or contamination to others.

Do not reuse lancets. Use a new M ICROLET lancet each time you test.


13

Set-up for Basic (L-1) and Advanced (L-2) Modes:

Your new C ONTOUR meter is pre-set for the Basic Mode and offers the same easy test procedure in either the Basic or Advanced Mode.

BASIC MODE (L-1)

• 7 day HI and LO summary

• 14 day average

• 480 test result memory

ADVANCED MODE (L-2)

• 7 day HI and LO summary

• 7, 14, and 30 day averages

• 480 test result memory

• Pre- and post-meal markers

• 30 day pre- and post-meal averages

• Selectable post-meal alarms

(2.5, 2.0, 1.5, 1.0 hours)

• Personal HI and LO test settings

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Your meter is pre-set to Basic

Mode. If you have set your meter to the Advanced Mode, and want to return to Basic

Mode:

1. Press M to turn your meter on. Wait to see the

2. Press and hold ▲ or ▼

3.

4.

5. flashing test strip.

for 3 seconds.

L-2 will flash.

Press ▲ or ▼ to change to L-1.

Press M to set.

To set your meter to Advanced

Mode, and take advantage of meal markers and other functions available to you:

1. Press M to turn your meter on. Wait to see the flashing test strip.

2. Press and hold ▲ or ▼ for 3 seconds.

3. L-1 will flash.

4. Press ▲ or ▼ to change to L-2.

5. Press M to set.

Please see page 18 for more details.


Setting the Date, Time and Sound:

Your C ONTOUR meter allows you to set the date, time, and sound as you like them.

• You can view 12 or 24 hour time;

• month/day or day.month, and;

• choose to have your meter beep or not.

To get into set-up mode when the meter is off, press and hold M for 3 seconds. A complete display will briefly appear, then numbers will flash in the top left corner of the display.

Setting the Time:

With the 12H flashing on the display, press ▲ or ▼ to select the 12H (with AM and PM) or

24H setting (military time).

Press M to set.

The number in the hour position will now flash. Press ▲ or ▼ until you reach the current hour.

Press M to set.

The minute will now flash.

Press ▲ or ▼ to select the current minute.

Press M to set.

If you selected a 12 hour time setting, the AM or PM will now flash. Press ▲ or ▼ to select AM or PM.

Press M to set.


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Setting the Month and Day Format:

m/d will now flash on the display. Press ▲ or ▼ to select the format you wish

(m/d for month/day format or d.m for day.month format).

Press M to set.

Setting the Date:

The year will be flashing.

Press ▲ or ▼ to select the current year.

Press M to set.

The month will now flash.

Press ▲ or ▼ to select the month.

Press M to set.

The day will now flash. Press

▲ or ▼ to select the day.

Press M to set.


Setting the Sound:

The flashing bell symbol will now appear on the display along with the word “ ”.

This option controls whether you want to hear the beep sound during testing.

To turn the beep sound off during testing, press ▲ or ▼ to display “ ”.

Press M to set.

After setting the sound,

“ ” will flash. To keep your meter in Basic Mode, press

M to set. To change your meter to Advanced Mode, press

▲ or ▼ to change to “ ”, and press M to set.

If you are using Basic Mode

(L-1 will appear on your display), you have completed your meter set-up.


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18

Setting Advanced Mode (L-2) Features:

If you selected Advanced

Mode (L-2 on your display) you can change your meter’s personal low and high blood glucose settings. By personalizing these settings, your

C ONTOUR meter will help you track these HI and LO results.

The LO setting will flash

(default 72). To change this setting, press ▲ or ▼ until you reach your desired LO setting, and then press M to set. (The range of values for

LO is 60-90 mg/dL.)

Your HI blood glucose setting will now flash (default 180).

To change, press ▲ or ▼ until you reach your desired

HI setting. Press M to set.

(The range of values for HI is 100–250 mg/dL.)

Post-Meal Test Alarm Set-up:

To change the alarm time for post-meal testing, press ▲ or ▼ to display the options available. Select 2.5, 2.0,

1.5, or 1.0 hour(s) to set your post-meal alarm (default is

2.0 hours). Press M to set.


You have now completed your

C ONTOUR meter set-up for

Advanced Mode!

Using the Markers:

If you have set-up your meter in Advanced Mode, your meter will display three markers after you test your blood.

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 = The logbook marker can be used to mark 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.

Please see the following pages to use these options.


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If you do not want to mark the test result:

Remove the used test strip to automatically save the test result in the meter memory with no markers. Dispose of the used test strip and lancet properly. This will also turn the meter off.

If you want to mark the test result:

Before you remove your test strip, press ▲ or ▼ to select the marker you want to set. The marker will flash.

To mark a result with the pre-meal marker, press M when the flashes.

The will then flash.

This feature allows you to set an alarm to remind you to run a post-meal test.

The alarm is available only after setting a pre-meal marker.

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If you want to set the alarm, press M. The will appear and stop flashing.

If you do not want to set the alarm, press ▲ or ▼ and the

will disappear. Press M to set.

To mark a result with the post-meal marker, press ▲ or ▼ until the flashes. Press M to set.

To mark a result with the logbook, press ▲ or ▼ until the

flashes. Press M to set.


Using the Alarm:

When the alarm sounds, the meter will automatically turn on. The alarm will beep 20 times, and the display will show the pre-meal test result you marked when you set the alarm. Pressing any button will silence the alarm.

You can now run another test by placing a test strip in the test strip port and following the testing instructions (page 8).

When you have completed this test and the result is shown on the display, will flash. To mark this test as a post-meal result, press M. If you do not want to mark this test, remove the test strip to turn the meter off.

If you decide not to test after the alarm sounds, press any button to turn your meter off.

The meter will only set one alarm at a time. It will remember the last alarm set. www.bayerdiabetes.com/us

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To Cancel an Alarm:

When the meter is off, press

M to turn on the meter. The date and time will appear along with the .

Press ▲ or ▼ two times and the alarm icon will disappear.

Press M to cancel the alarm.

After performing a test:

TO MARK RESULTS YOU WILL SEE

Pre-Meal

Press ▲ or ▼ (Flashing)

Alarm

Press ▲ or ▼

Post-Meal

Press ▲ or ▼

Logbook

Press ▲ or ▼

(Flashing)

(Flashing)

(Flashing)

TO SET

Press M

Press M

Press M

Press M


YOU WILL SEE WHAT IT MEANS

Result is marked as a pre-meal test.

You can now set an alarm.

Alarm is set to go off in the amount of time you have set (1.0 –2.5 hours) to remind you to run a post-meal test.

Result is marked as a post-meal test.

Result is marked in memory as unique. You should note this in your

Clinilog ® logbook.


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Viewing Basic Mode Results:

Press M to turn your meter on. Press M again to view the memory.

The 14 day average will appear in the center of the display with the number of results shown at the top of the display. Any control results are not included in this 14 day average.

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Press ▲ to view the 7 day high and low summary.

At the top of the display you will see the number of HI results (above 180 mg/dL) and

LO results (below 72 mg/dL) during the preceding 7 day period and the total number of results during that period.

Press ▼ two times 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 ▲ or ▼ to scroll forward or backward through the results.


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

NOTES:

•

Averages include the specified time period plus the current day.

•

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 3 minutes.

• represents the number of test results.


25

Viewing Advanced Mode Results:

In Advanced Mode (L-2), you have all of the options described in Basic Mode plus additional items available.

Press M to turn your meter on. Briefly press M again to view the 14 day average including the number of results used to obtain the average.

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Press ▼ 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 ▲ or ▼ to scroll forward or backward through the results.

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

Viewing Advanced Mode Averages:

Press M to turn your meter on. Press M again to view the

14 day average including the number of results used to obtain the average.

Press ▲ to view the 7 day high and low summary.

At the top of the display you will see the number of HI and

LO results. In the center of the display is the total number of results.


Press ▲ to view the 7 day average.

You will see the average in the center of the display and the number of results along the top.

Press ▲ to view the 30 day average.

This will display the average in the center and the number of readings along the top.

Press ▲ again to view the 30 day average of results marked with a pre-meal marker.

Press ▲ again to view the 30 day average of results marked with a post-meal marker.

Press ▲ again and you will see .

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


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Alternative Site Testing (AST):

Use AST only when it has been more than two hours after any one of the following: a meal, diabetes medication, or exercise.

Use the

Clear endcap

IMPORTANT: Do not use Alternative Site Testing under the following conditions. Use fingertip testing in any of these cases: insulin dose or exercise). agree with how you feel.

Consult your healthcare professional to determine if alternative site testing is right for you.

Attach the clear AST endcap to the M ICROLET 2 lancing device.

Select a puncture site from a fleshy area on forearm or palm. Avoid veins, hair, moles, bones, and tendons.


For palm testing, it is not necessary to rub the skin or pump the device.

Press the clear endcap firmly against the puncture site and then press the blue release button.

For forearm testing only, rub the testing area vigorously until it feels warm to increase blood flow. Press the clear endcap firmly against the puncture site and then press the blue release button. Keep the device in constant contact with the skin and pump (apply and release pressure) up and down 2–3 times without lifting the device away from the skin.

Maintain steady pressure until the blood drop reaches the suggested size (0.6 μL).

Suggested drop size

Lift the device away from the skin without smearing the blood.

Do not test the blood sample if you get: Smeared blood •

Clotted blood • Runny blood • Clear fluid mixed with the blood.


29

Control Solution Testing:

Use only Bayer’s C ONTOUR control solutions (Normal,

Low, or High) to practice on the system or to run a check to make sure the meter and the test strips are working properly.

Using anything other than C ONTOUR control solution could present incorrect results.

Remove a test strip from the bottle. Tightly close the bottle lid immediately after you have removed the test strip.

NOTE: Check the expiration and discard dates. Make sure the test strip does not appear torn or damaged.

Hold the test strip with the gray end facing up.

Insert the gray 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.

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NOTE: Gently rock the control bottle before opening to ensure it is mixed well.

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 the test strip directly from the bottle.

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. Hold it in the drop until the meter beeps.

After a beep, you will see the meter count down 5 seconds until the test is complete and your control test result is displayed.

The meter will automatically recognize and mark the control result for you.

NOTE: The does not indicate the control test result is within the specified range. It only marks it as a control solution test.

It will not be included in your averages.


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Compare your control test result with the Normal Control

Range printed on the test strip bottle label or on the bottom of the test strip box.

NOTE: Low and High control range values can be found on the bottom of the test strip box.

If your control test result is out-of-range, see the

“What You Should Do” recommendations on page 36.

To turn your meter off, simply remove the test strip. The result will be automatically

marked and stored in the meter memory. Control results will not be included in your blood glucose averages or in the 7 day HI-LO summary.

Carefully dispose of the used test strip.

IMPORTANT: To ensure accuracy of your blood glucose test results and accuracy of your control test results, use only C ONTOUR control solution.


Transferring Results to a Computer:

You can transfer test results from the C ONTOUR meter to a computer, where they can be summarized in a report with graphs and tables. To make use of this feature, you need

Bayer’s diabetes management software and a data cable from Bayer.

For a free download of the software go to www.bayerdiabetes.com/us

IMPORTANT: The C ONTOUR meter has not been tested or certified by Bayer for use with any software other than Bayer’s diabetes management software. Bayer is not responsible for any erroneous results from the use of other software.

For more information, call our Customer Service

Department (1-800-348-8100), or visit our website at www.bayerdiabetes.com/us www.bayerdiabetes.com/us

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Error Codes and Symbols:

If you do not resolve the problem, contact Bayer

WHAT YOU SEE WHAT IT MEANS WHAT YOU SHOULD DO

Dead batteries.

Replace the batteries.

(will flash for 10 seconds and then the meter will turn off)

Call Bayer Diabetes Care Customer Service at 1-800-348-8100 for the Free Batteries for Life program.

(will remain on the display)

Low batteries.

Replace the batteries as soon as possible.

E1

E2

E3

Temperature out of range.

The test strip has not filled enough for an accurate test. Insufficient blood drop.

The meter is sensing a used test strip.

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 20 minutes before performing a test.

Remove the test strip and retest using a new test strip. Wait until you see the flashing blood drop on the display before testing.

Remove the test strip and retest using a new test strip. Wait until you see the flashing blood drop on the display before testing.

E4 Test strip not inserted correctly.

Remove and reinsert the test strip properly (see page 9).

E5 E9

E6 E12

E8 E13

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.

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Diabetes Care Customer Service at 1-800-348-8100.


E7 Incorrect sensor type.

Remove the test strip and retest using a new test strip. Make certain that you are using a C ONTOUR test strip from Bayer.

E10 Invalid date or time.

E11 Abnormal result.

This error occurs only in

Communication mode. See page

15 to reset the date or time.

If you continue to see this error, please contact Bayer Diabetes

Care Customer Service.

Remove the test strip and retest using a new test strip. Be sure you wash your hands and carefully follow instructions in this user guide.

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 still flashes “HI”, contact your physician or healthcare professional immediately.

CAUTION: 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 still flashes “LO”, contact your physician or healthcare professional immediately.

CAUTION: Glucose levels below 50 mg/dL may indicate a potentially serious medical condition.


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If you do not resolve the problem, contact Bayer

Diabetes Care Customer Service at 1-800-348-8100.


Control test result is out of range

(too high or too low).

• 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.

• Meter could be damaged.

• Check all expiration dates and discard dates. Do not use expired testing materials.

• Run another control test with a new test strip and control solution.

• Gently rock the control bottle to ensure the control solution is mixed well.

• Make sure you are using Bayer’s

C

ONTOUR

control solution.

• If result is still out of range, contact Bayer Diabetes Care

Customer Service.

Some display segments do not appear when the meter initially turns on.

Results are not displayed in expected units of measure (mg/dL or mmol/L).

Possible meter electronics failure.

This may affect the way you see your results.

Compare meter display with the illustration on page 3.

If the display is not correct, contact Bayer Diabetes Care

Customer Service.

Contact Bayer Diabetes

Care Customer Service,

1-800-348-8100.

36


Changing the Batteries:

Batteries should be replaced when the meter continually displays or the meter briefly shows and then turns off (See Error Codes and Symbols, page 34).

Turn off your meter before changing your batteries.

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

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.


37

Place new batteries under the prongs and into the battery compartment with the “+” side up.

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

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.

Bayer offers the Free Batteries For Life program. When your batteries are low, please call

1-800-348-8100 for your free batteries.

38


Caring for the System:

• Store meter in the carrying case provided whenever possible.

• Wash hands and dry them 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.

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

• The exterior of the meter can be cleaned using a moist

(not wet) lint-free tissue with a mild detergent or disinfectant solution, such as 1 part bleach mixed with 9 parts water. Wipe dry with lint-free tissue after cleaning.

CAUTION: Do not allow cleaning solution to run in or around the buttons or battery cover. Doing so may cause a malfunction.


39

Technical Information:

Accuracy: The accuracy of the C ONTOUR blood glucose monitoring system has been assessed in a correlation study conducted by healthcare professionals. In this study, 108 fresh capillary blood specimens were tested with the C ONTOUR blood glucose monitoring system by

108 untrained people with diabetes using three test strip lots. The reference measurement was done on the YSI Glucose Analyzer.

C ONTOUR data compare well with the results from the YSI method.

Regression Statistics (Plasma/Serum Reference): plasma reference glucose range: 75 to 397 mg/dL

Lot y =

Correlation

Coeffi cient (r)

1 1.02x – 0.12 mg/dL 0.972

2

3

1.03x – 4.34 mg/dL

0.95x – 0.41 mg/dL

0.963

0.974

Precision: A study was conducted with the C ONTOUR blood glucose monitoring system with five heparinized whole blood specimens with glucose levels from 40 to 325 mg/dL. Multiple replicates (n=100) were tested using multiple C ONTOUR blood glucose meters and one lot of C ONTOUR blood glucose test strips. The following precision results were obtained:

Plasma/Serum:

Mean SD

Coeffi cient of variation

38 mg/dL 1.9 mg/dL 4.8%

101 mg/dL

118 mg/dL

205 mg/dL

326 mg/dL

5.1 mg/dL

4.4 mg/dL

6.8 mg/dL

11.7 mg/dL

5.1%

3.7%

3.3%

3.6%

Your C ONTOUR blood glucose meter is specific for glucose and has been referenced to plasma/serum values. Methods calibrated to plasma/serum can be 9 to 15% higher than the results of whole blood glucose assay methods.

40


Potential Biohazard

Healthcare professionals or persons using this system on multiple patients should follow the infection control procedure approved by their facility. All products or objects which come in contact with human blood, even after cleaning, should be handled as if capable of transmitting viral diseases.

3

Specifi cations:

Test Sample: Whole blood

Test Result: Referenced to plasma/serum glucose

Sample Volume: 0.6 μL

Measuring Range: 10–600 mg/dL

Measuring Time: 5 seconds

Memory Feature: Stores most recent 480 test results

Battery Type: Two 3-volt lithium batteries

(DL2032 or CR2032)

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

Operating Temperature Range: 41º–113ºF

Humidity: 10–93% RH

Dimensions: 77 mm (H) x 57 mm (W) x 19 mm (T)

Weight: 1.7 oz. (47.5 grams)

Alarm: A beep sounds when the meter is turned on, a test strip is inserted, when a test strip is filled with blood, or when a test result appears on the display. Two beeps sound when the meter turns off or to indicate an error. Twenty beeps will sound when a programmed alarm goes off.


41

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.

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. 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., C ONTOUR

® test strips) manufactured or recommended by Bayer HealthCare.

3.

Bayer HealthCare reserves the right to make changes in design of this instrument without obligation to incorporate such changes into previously manufactured instruments.

4.

Bayer HealthCare has no knowledge of the performance of the C ONTOUR

® blood glucose meter when used with any test strips other than C ONTOUR test strips, and therefore makes no warranty of the performance of the C ONTOUR meter when used with any test strips other than C ONTOUR test strips or when the

C ONTOUR test strip is altered or modified in any manner.

42


5.

Bayer HealthCare makes no warranty of the performance of the

C ONTOUR

® meter or test results when used with any control solution other than C ONTOUR control solution.

BAYER HEALTHCARE MAKES NO OTHER EXPRESS WAR-

RANTY FOR THIS PRODUCT. THE OPTION OF REPLACE-

MENT, 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.

PATENTS

The system described herein is covered by one or more of the following

U.S. patents: 5,120,420, 5,582,697, 5,266,179, 5,723,284, 5,954,738,

6,451,040, 6,599,406, 6,827,829, 6,911,131, and 7,232,510, as well as pending applications and international equivalents.


43

Service Information:

If you have a problem and none of the problem solving steps in this user guide help, call Bayer Diabetes Care Customer

Service. In the U.S.A., call toll free: 1-800-348-8100 (7 days a week/24 hours a day). We have trained specialists to help you.

Important:

Speak to a Bayer Diabetes Care 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 C ONTOUR blood glucose meter and

C ONTOUR test strips available when you phone. It would also be helpful to have a bottle of C ONTOUR control solution nearby.

Check List

This check list may be helpful when speaking with Bayer

Diabetes Care Customer Service:

1.

Locate the serial number

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

_______________________

_______________________

A

SN

PR00059

B

7151G mg/dL

2.

Locate the C ONTOUR test strips’ expiration date on the bottle.

_______________________

3.

Check the battery icon on the display. (See page 37,

Changing the Batteries.)

44


Supplies:

When calling or writing for supplies be sure to include the number with the name of the replacement part or accessory item.

REPLACEMENT PARTS

Part Number* Item

99C71519

40453276

40453291

CR2032 (Free Batteries For Life program.

Call 1-800-348-8100.)

C ONTOUR ® User Guide

Bayer’s Serial Data Cable

Bayer’s USB Data Cable

* Part numbers are subject to change without notice.

These parts are available in the United States from:

Bayer HealthCare LLC

Customer Service Department

Order Entry P.O. Box 2004

Mishawaka, Indiana 46546 or call 1-800-348-8100 to order

REFERENCES

1

American Diabetes Association, www.diabetes.org

2 American Diabetes Association: Standards of Medical

Care in Diabetes (Position Statement). Diabetes Care 29

(Suppl. 1):S10, 2006.

3

Protection of Laboratory Workers from Occupationally

Acquired Infections; Approved Guideline–Third Edition. Clinical and Laboratory Standards Institute (CLSI), document M29-A3,

(ISBN 1-56238-567-4). CLSI, 940 West Valley Road, Suite

1400, Wayne, Pennsylvania 19087-1898, USA 2005.


Bayer HealthCare LLC

Mishawaka, IN 46544 USA www.bayerdiabetes.com/us

Bayer, the Bayer Cross, C ONTOUR , M ICROLET ,

Clinilog, No Coding and the No Coding logo are trademarks of Bayer.

Bayer HealthCare Contour User guide

USER GUIDE

Table of Contents

Your

Meter:

Your

Test Strip:

Your Meter Display:

Your Meter Features:

Symptoms of High or Low Blood Sugar:

Important Things to Know:

IMPORTANT NOTE:

Before You Begin Testing:

Getting Ready to Test:

Getting the Blood Drop:

Testing Your Blood:

Removing the used lancet:

Set-up for Basic (L-1) and Advanced (L-2) Modes:

Setting the Date, Time and Sound:

Setting the Time:

Setting the Month and Day Format:

Setting the Date:

Setting the Sound:

Setting Advanced Mode (L-2) Features:

Post-Meal Test Alarm Set-up:

Using the Markers:

If you do not want to mark the test result:

If you want to mark the test result:

Using the Alarm:

To Cancel an Alarm:

After performing a test:

Viewing Basic Mode Results:

Viewing Advanced Mode Results:

Viewing Advanced Mode Averages:

Alternative Site Testing (AST):

Control Solution Testing:

Transferring Results to a Computer:

Error Codes and Symbols:

If you do not resolve the problem, contact Bayer

Diabetes Care Customer Service at 1-800-348-8100.

If you do not resolve the problem, contact Bayer

Diabetes Care Customer Service at 1-800-348-8100.

Changing the Batteries:

Caring for the System:

Technical Information:

Speciﬁ cations:

Warranty:

Service Information:

Supplies:

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