OneTouch Select User Manual

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™

AW 06659902A

Select

Blood Glucose Monitoring System

USER GUIDE

Replaces Owner’s Booklet

AW 06659902A Rev. date: 05/2012

Page 2

Contents:

0120

 Getting to know your system 1

 Setting up your meter 4

 Testing your blood glucose 8

 Attaching meal ﬂags to your results 16

 Reviewing past results and averages 18

 Control solution testing 20

 Caring for your system 22

8 Troubleshooting and detailed

information about your system 24

LifeScan self-test blood glucose monitoring devices conform to the following EU Directives:

IVDD (98/79/EC):

Blood Glucose Meter, Test Strips, and Control Solution

MDD (93/42/EEC):

Lancets

LifeScan Europe

Blood Sampler

For further information, please contact your authorized local LifeScan representative. You may also visit us at www.LifeScanMEA.com.

Division of Cilag GmbH International 6300 Zug Switzerland

Meter Made in China

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Before you begin

Before using this product to test your blood glucose, carefully read this User Guide and the inserts that come with the OneTouch® Select™ Test Strips and OneTouch® Select™ Control Solution. Take note of warnings and cautions throughout this booklet, which are identied with . Many people nd it helpful to practice the test with control solution before testing with blood for the rst time. See Section 6, Control solution testing.

Intended use

The OneTouch® Select™ Meter Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The OneTouch® Select™ Meter System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the eectiveness of diabetes control. It should not be used for the diagnosis of diabetes or for testing newborns.

Test principle

Glucose in the blood sample mixes with special chemicals in the test strip and a small electric current is produced. The strength of this current changes with the amount of glucose in the blood sample. Your meter measures the current, calculates your blood glucose level, displays the result, and stores it in its memory.

NOTE: If you have questions about your OneTouch® Select™ Meter Blood Glucose Monitoring System, contact Customer Service.

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 Getting to know your system

The OneTouch® Select™ Meter Blood Glucose Monitoring System

INCLUDED WITH YOUR KIT:

a. OneTouch® Select™ Meter (battery included) b. OneTouch® Lancing Device

If another type of lancing device was included,

see the separate instructions that came with that lancing device.

c. Sterile Lancet d. Carrying Case e. OneTouch® Select™ Test Strips

If any of these items are missing from your kit, call Customer Service.

AVAILABLE SEPARATELY:

f. Clear Cap g. OneTouch® Select™ Control Solution

For availability of control solution,

call Customer Service. You may also visit us at www.LifeScanMEA.com or ask for control solution where you obtain your test strips.

 WARNING: Keep the meter and testing supplies away from young children. Small items such as the battery door, battery, test strips, lancets, protective covers on the lancets, and control solution vial cap are choking hazards. Do Not ingest or swallow any items.

GETTING TO KNOW YOUR SYSTEM

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Getting to know your system

METER

Display

Up and down buttons

Select or change information

Test port

Insert test strip here to turn meter on for testing

mg/dL is the pre-set unit of measure

▲▼ indicates selection

available using up or down button

OK button

Turns the meter on/o

Conrms menu selections

TEST STRIP

Edge to apply sample

Conrmation window

Contact bars

Insert into test port

GETTING TO KNOW YOUR SYSTEM

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Turning your meter on

There are two ways to turn your meter on: To perform a test, insert a test strip as far as it will go. The meter will briey perform system checks, then the display will turn on. or,

 CAUTION: If you see any light areas within the black start-up screen, there may be a problem with the meter. Call Customer Service.

With the meter turned o, press and hold for two seconds to access MAIN MENU.

Check that the screen shows solid black for two seconds. If it does, the display is working properly. If the meter does not power on, try changing the meter battery. See Replacing the battery in Section 7.

Turning your meter o

There are several ways to turn your meter o:

• Press and hold for three seconds.

• Your meter will turn o by itself if left alone for two minutes.

• Go to MAIN MENU and press

or to highlight METER OFF, then press .

• Before or after completing a test, remove the test strip. If you advance from the test result screen to the MAIN MENU by

pressing , removing the test strip will not turn the meter o. Use one of the three methods above.

GETTING TO KNOW YOUR SYSTEM

Page 7

 Setting up your meter

Setting the meter language, date and time

You can change many of the settings that came pre-set with your meter. Before using your meter for the rst time or if you change the meter battery, you should check and update these settings. Make sure you complete steps 1 through 6 below to ensure your desired settings are saved.



Turn the meter on

With the meter turned o, press and hold



Get to the SETTINGS screen

When using the meter for the rst time, or after changing the meter battery, you will automatically start in the SETTINGS screen.

In other cases, from the MAIN MENU, press

or to select METER SETTINGS. To conrm your selection, press .

You may also select MENU and press to return to the MAIN MENU. See Section 4, Attaching meal ags to your results for information on the FLAGS/COMMENTS feature.

The pre-set language, date, time and unit of measure appear on the display. If they are correct, press to return to the MAIN MENU.

If the language, date, or time are not correct, select CHANGE and press .



Choose a language

Now press

or to highlight the language of your choice and press .

NOTE: If you select the wrong language, press Then, turn the meter back on and re-start from step 1.

for two seconds to access MAIN MENU.

or to select SETTINGS and press . Then, press

and hold for three seconds to turn the meter o.

MAIN MENU

LAST RESULT ALL RESULTS

AVERAGES

SETTINGS

METER OFF

SETTINGS

METER SETTINGS

MEAL FLAGS

SETTINGS

ENGLISH

18/OCT/07

11:48 AM

mg/dL

CHANGE

LANGUAGE

FRANÇAIS

ENGLISH

SETTING UP YOUR METER

Page 8



Set the date

In the DATE AND TIME screen, press

Press

or to change the month and press .

Press

or to change the day and press



Set the time of day

Press

or to set the hour and press .

or to change the year and press .

DATE AND TIME

DATE:

18 / OCT / 2007

TIME:

11 : 48 AM

DATE AND TIME

DATE:

18 / OCT / 2007

Press or to set the minutes and press .

TIME:

11 : 48 AM

Press or to set AM or PM and press .

NOTE: The date and time formats have been pre-set. You cannot change these settings.

SETTINGS



Confirm your settings

OK will be highlighted near the bottom of the screen. If your settings are correct, press to conrm and save the settings and return to the MAIN MENU.

ENGLISH

18/OCT/07

11:48 AM

mg/dL

CHANGE

 WARNING: The unit of measure mg/dL must be displayed here. If your display shows mmol/L rather than mg/dL, contact Customer Service. You cannot change the unit of measure. Use of the wrong unit of measure may cause you to misinterpret your blood glucose level, and may lead to incorrect treatment.

If you want to cancel your settings and start the settings process over again, press

or to highlight CHANGE and press . You will be

returned to the LANGUAGE screen.

SETTING UP YOUR METER

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Coding your meter



Check the code on the test strip vial before inserting the test strip

Code numbers are used to calibrate your meter with the test strips you are using.



Insert a test strip to turn on the meter Remove a test strip from its vial and recap the vial immediately. With clean, dry hands, you may touch the test strip anywhere on its surface. Do Not bend, cut or modify the test strips in any way. Use each test strip immediately after removing it from the vial. Insert the test strip into the test port as shown. Make sure the

three contact bars are facing you and the arrow is pointing down. Push the test strip in as far as it will go.

After the black start-up screen appears, the meter will display the code from your last test. If a ashing “– –” appears instead of a code number, such as when you are rst using the meter, follow the instructions in Step 3 to change to a numerical code.

MATCH CODE

SETTING UP YOUR METER

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

Match the code on the meter with the code on the test strip vial

If the code on the meter does not match the code on the test strip vial, press match the code number on the test strip vial. The new code number will ash on the display

for three seconds, then briey stop ashing, after which the display will advance to the

APPLY SAMPLE screen.

If the codes already match, press to go to the APPLY SAMPLE screen. When you do not

make a change after ve seconds, the display will advance to the APPLY SAMPLE screen.

APPLY SAMPLE

The meter is now ready to perform a blood glucose test.

NOTE:

• If the APPLY SAMPLE screen appears before you are sure the codes match, remove the test strip, and re-start from step 1.

• If you change APPLY SAMPLE to APPLY CONTROL by mistake, press

to change it back to APPLY SAMPLE.

 CAUTION: Matching the code on the meter and the code on the test strip vial is essential to obtaining accurate results. Each time you test, check to make sure the code numbers match.

▲

SETTING UP YOUR METER

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 Testing your blood glucose

Testing with a ngertip sample

Preparing for a test

Have these things ready when you test: OneTouch® Select™ Meter OneTouch® Select™ Test Strips Lancing device Sterile lancets

NOTE:

• Use only OneTouch® Select™ Test Strips.

• Make sure your meter and test strips are about the same temperature before you test.

• Testing must be done within the operating temperature range (10–44°C). For the most accurate results, try to test as close to

room temperature (20–25°C) as you can. (see Detailed information about your system in Section 8).

• Tightly close the cap on the vial immediately after use to avoid contamination and damage.

• Store unused test strips only in their original vial.

• Do Not open the test strip vial until you are ready to remove a test strip and perform a test. Use the test strip immediately after

removing it from the vial.

• Do Not return the used test strip to the vial after performing a test.

• Do Not re-use a test strip that had blood or control solution applied to it. Test strips are for single use only.

• Write the discard date (3 months after rst opening the vial) on the vial label when you rst open it.

 CAUTION:

• DoNot use your test strips if your vial is damaged or left open to air. This could lead to error messages or inaccurate results. Contact Customer Service immediately if the test strip vial is damaged.

• If you cannot test due to a problem with your testing supplies, contact your health care professional. Failure to test could delay

treatment decisions and lead to a serious medical condition.

• The test strip vial contains drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation.

• Do Not use test strips after the expiration date (printed on the vial) or the discard date, whichever comes rst, or your results may

be inaccurate.

TESTING YOUR BLOOD GLUCOSE

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Cocking control Lancing

LANCING DEVICE

Sterile lancet

If the lancing device shown here is not included with your kit, see the user instructions for that lancing device.

 CAUTION: To reduce the chance of infection:

• Never share a lancet or a lancing device with anyone.

• Always use a new, sterile lancet each time you test–lancets are for single use only.

• Always keep your meter and lancing device clean (see Caring for your system in Section 7).

Release button

Lancet point

Depth indicator

Protective cover

device cap

(for ngertip sampling)

Getting a blood sample from the ngertip

Before testing, wash your hands thoroughly with warm, soapy water. Rinse and dry.

Clear cap

(for forearm and palm testing) See Testing

with a forearm or palm sample in Section 3.



Snap o the lancing

device cap



Insert a sterile lancet

Firmly push the lancet into the holder.



Adjust the depth setting

Twist the lancing device cap until the desired setting appears. Smaller numbers are for shallower punctures, which may be less painful.

Shallower punctures work for children and most adults. Deeper punctures work well for people with thick or callused skin.



Cock the lancing device

Slide the cocking control back until it clicks.

If it does not click, that’s okay. It may have been cocked when you inserted the lancet.



Twist o the protective

cover and save it for later use

Replace the lancing device cap.

TESTING YOUR BLOOD GLUCOSE

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

Insert a test strip to turn the meter on

Insert a test strip into the test strip port as shown, with the three contact bars facing you.

If the code on the meter does not match the code on the test strip vial, see Coding your meter in Section 2.

APPLY SAMPLE

When the APPLY SAMPLE screen appears on the display, you can apply your blood sample.

▲



Lance your finger

Hold the lancing device firmly against the side of your finger. Press the release button.

Approximate size

Get a round drop of blood

Gently squeeze your nger until you get a round drop of blood. If the blood smears or runs, Do Not use that sample. Wipe the area and gently squeeze another drop of blood or puncture a new site.

TESTING YOUR BLOOD GLUCOSE

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Applying blood and reading results

Once you have a blood sample and your meter shows the APPLY SAMPLE screen, you are ready to obtain a blood glucose result. If your meter does not show the APPLY SAMPLE screen, remove the unused test strip and re-start the test process. See Getting a blood sample from the

fingertip in Section 3.



Prepare to apply the sample

Keeping your nger extended and steady, move the meter and test strip toward the blood drop.

Fingertip

Do Not apply blood on the top of the test strip.

Do Not hold the meter and test strip underneath the blood drop. This may cause blood to run into the test port and

damage the meter.



Apply the sample

Line up the test strip with the blood drop so that the narrow channel on the edge of the test strip is almost touching the edge of the blood drop.

Narrow channel

Gently touch the channel to the edge of the blood drop.

Be careful not to push the test strip against your ngertip or the test strip may not ll completely.

• Do Not smear or scrape the drop of blood with the test strip.

• Do Not apply more blood to the test strip after you have moved the drop of blood away.

• Do Not move the test strip in the meter during a test.

 CAUTION: You may get an ERROR 5 message or an inaccurate result if the blood sample does not ll the conrmation window completely. See Troubleshooting in Section 8. Discard the test strip and re-start the test process.



Wait for the confirmation window to fill completely

The blood drop will be drawn into the narrow channel and the conrmation window should ll completely.

When the conrmation window is full, this means you have applied enough blood. Now you can move the test strip away from the blood drop and wait for the meter to count down from 5 to 1.

Full Not full

Conrmation

window full

TESTING YOUR BLOOD GLUCOSE

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

Read your result on the meter

Your blood glucose level appears on the display, along with the unit of measure, and the date and time of the test. Blood glucose results are automatically stored in the meter’s memory.

 WARNING: If mg/dL does not appear with the test result, contact Customer Service. Use of the wrong unit of measure may cause you to misinterpret your blood glucose level, and may lead to incorrect treatment.

 CAUTION: If you test at the low end of the operating range (10°C) and your glucose is high (over

180mg/dL), the reading on your meter may be lower than your actual glucose. In this situation, repeat the test in a warmer environment with a new test strip as soon as possible.

Error messages

If you get an ERROR message on your screen rather than a result, see Troubleshooting in Section 8.

After getting a result

Once you have read your result, you may:

• Attach a meal ag to this result if the meal ags feature is on, see Section 4, Attaching meal ags to your results, or

• Review your meter memory by pressing to go to MAIN MENU, see Section 5, Reviewing past results and averages, or

• Turn the meter o by removing the test strip.

Removing the used lancet Remove the lancing device cap. Place the lancet protective cover on a hard surface and push the lancet tip into the cover. Remove the lancet and place it in a container for sharp objects. Replace the

lancing device cap.

Disposing of the used lancet and test strip

It is important to discard the used lancet carefully after each use to avoid unintended lancet stick injuries. Used test strips and lancets may be considered biohazardous waste in your area. Be sure to follow your health care professional’s recommendations or local regulations for proper disposal.

(Example)

TESTING YOUR BLOOD GLUCOSE

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Interpreting unexpected test results

Refer to the following cautions whenever your test results are lower or higher than what you expect.

 CAUTION: Low glucose results

• If your test result is lower than 70 mg/dL or is shown as LOW GLUCOSE, it may mean hypoglycemia (low blood glucose). Treat this condition immediately, according to your health care professional's recommendations. Although this result could be due to a test error, it is safer to treat rst, then do another test.

• If you test at the low end of the operating range 6°C and your blood glucose is high, you may get an inaccurate low result. Re-test in a warmer environment with a new test strip.

Dehydration and low glucose results

• You may get false low glucose results if you are severely dehydrated. If you think you are severely dehydrated, contact your

health care professional immediately.

High glucose results

• If your test result is higher than 180 mg/dL, it may mean hyperglycemia (high blood glucose) and you should consider re-testing.

Talk to your health care professional if you are concerned about hyperglycemia.

• HIGH GLUCOSE is displayed when your blood glucose level is higher than 600 mg/dL . You may have severe hyperglycemia (very high blood glucose). Re-test your blood glucose. If the result is HIGH GLUCOSE again, this indicates a severe problem with your blood glucose control. Obtain and follow instructions from your health care professional immediately.

Repeated unexpected glucose results

• If you continue to get unexpected results, check your system with control solution. See Section 6, Control solution testing.

• If you are experiencing symptoms that are not consistent with your blood glucose results and you have followed all instructions

in this User Guide, call your health care professional. Never ignore symptoms or make signicant changes to your diabetes control program without speaking to your health care professional.

Unusual red blood cell count

• A hematocrit (percentage of your blood that is red blood cells) that is either very high (above 55%) or very low (below 30%) can

cause false results.

Testing with a forearm or palm sample

The OneTouch® Select™ Meter lets you obtain a blood sample from your forearm or palm. Getting a drop of blood from these ”alternate sites” may be less painful than a ngertip sample.

If you are testing:

Before or more than two hours after:

• a meal

• a rapid-acting insulin injection or insulin pump bolus

• exercise

 CAUTION: Talk to your health care professional before you begin using your forearm or palm for sampling.

Use blood sample from your:

Fingertip, forearm, or palm

TESTING YOUR BLOOD GLUCOSE

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 CAUTION: Do Not test on your forearm or palm when:

• You think your blood glucose is rapidly falling, such as within two hours of exercise or a rapid-acting insulin injection

or insulin pump bolus. Testing with a ngertip sample may identify hypoglycemia or an insulin reaction sooner than testing with a forearm or palm sample.

• It has been less than two hours after a meal, a rapid-acting insulin injection or insulin pump bolus, physical exercise, or you think your glucose level is changing rapidly.

• You are ill or during times of stress.

• You are concerned about the possibility of hypoglycemia or an insulin reaction, such as when driving a car. This is

especially important if you suer from hypoglycemia unawareness (lack of symptoms to indicate an insulin reaction).

Getting a blood sample

Getting a blood sample from your forearm or palm is dierent than getting a sample from your ngertips. Follow these instructions to get a sucient blood drop for testing.

 CAUTION: Before testing, make sure to wash the puncture site with soap and water.

Rinse and dry thoroughly.

The clear cap is for forearm and palm sampling only. Replace the blue cap with the clear cap.



Insert a lancet and snap on clear cap

Carefully insert a new, sterile lancet. Snap on the clear cap.



Adjust the depth setting

You may need a deeper setting to get a sucient sample for testing.

Twist the clear cap toward the larger numbers to increase the depth.

Be sure to cock the lancing device.



Choose a sample site

• Choose a spot away from bone, veins, and hair. Massage the site to increase blood ow.

• Select a spot with no visible veins and avoid deep lines, which may cause your blood sample to smear.

Forearm

Palm

TESTING YOUR BLOOD GLUCOSE

Page 18



Lance your forearm or palm

• Firmly press and hold the lancing device against your forearm or palm for a few seconds.

• Wait until the skin surface under the clear cap changes color (as blood collects

beneath the skin). This tells you there is enough blood ow for a good sample.

• Then press the release button while continuing to apply pressure.

• Keep holding the lancing device against your skin until a round drop of blood forms

under the cap.

• When sampling from your forearm or palm, make sure the drop of blood is sucient

Forearm or Palm



Remove the lancing device

( approximate size) before you release pressure and remove the lancing device.

Carefully lift the lancing device away from your skin. Do Not smear the blood sample.

Forearm or Palm

PalmForearm

If the drop of blood runs or spreads due to contact with hair or a line in your palm, Do Not use the sample. Try lancing again in a smoother area.

If bruising occurs at an alternate site or you have diculty getting a sample, consider sampling from a ngertip instead. You may want to review the choice of sites with your health care professional.



Apply the sample to the test strip

Keep your forearm or palm steady and use your other hand to bring the top edge of the test strip to the drop of blood.

• See Testing with a ngertip sample in Section 3 for more information on applying the blood sample to the test strip.

• See Interpreting unexpected test results in Section 3 for more information on unexpected test results.

• See Testing with a ngertip sample in Section 3 for information

Forearm

Palm

on disposing the used lancet.

TESTING YOUR BLOOD GLUCOSE

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 Attaching meal ﬂags to your results

Attaching meal ags to your results

Your OneTouch® Select™ Meter allows you to attach meal ags to your blood glucose result.

Recommendation Benet

Meal Flag Add a meal ag to every blood glucose

result.

Allows you to link the eects of food to your blood glucose results.

Provides you with separate averages for before-meal and

after-meal tests.

We suggest you talk to your health care professional to see how meal ags may help you manage your diabetes.

You can attach meal ags just after a blood glucose test before you remove your used test strip from your meter. You can also modify meal ags when reviewing a past result.

You will not be able to add a meal ag to a result marked as a control solution test.

This feature can be turned on or o. It needs to be turned on before you can use it. See Turning the ags/comments feature o or on in this section for instructions.

Turning the ags/comments feature o or on

To turn the meal ags feature o or on:



From MAIN MENU, press or to select SETTINGS

To conrm your selection, press .



From the SETTINGS screen, select MEAL FLAGS

To conrm your selection, press .

SETTINGS

METER SETTINGS

MEAL FLAGS



Press or to highlight your response

Select YES if you wish to change the setting, or NO if you wish to leave it as it is.

Press to conrm your selection and return to MAIN MENU.

ATTACHING MEAL FLAGS TO YOUR RESULTS

MEAL FLAGS

NOW SET TO: ON

CHANGE TO OFF?

YES

Page 20

Add or change a meal ag

If the meal ags feature is turned on, the up arrow at the bottom right corner of the result screen will ash when a result is rst displayed to remind you to enter a meal ag. To add or change a meal ag:



While viewing a result, press to display the MEAL FLAGS screen



Press or to highlight BEFORE MEAL or AFTER MEAL

If you decide not to assign a ag to this result, select NO FLAG.



To confirm your selection, press

The meal ag you chose will appear below the result on the result screen.

MEAL FLAGS

BEFORE MEAL

AFTER MEAL

NO FLAG

18/OCT/07 11:49AM

104

mg/dL

AFTER MEAL

NOTE: Testing after a meal can show how the food you ate aects your blood glucose. These results can be agged as AFTER MEAL and are usually obtained two hours after the start of the meal. Your health care professional may suggest another time period or other use for this feature.

ATTACHING MEAL FLAGS TO YOUR RESULTS

Page 21

 Reviewing past results and averages

Reviewing past results and averages

If you have just completed a test, press to get to the MAIN MENU screen. If your meter is o, press and hold to turn it on. From the MAIN MENU screen you can choose:

• LAST RESULT to view your most recent result,

• ALL RESULTS to review up to 350 of your most recent results four at a time, or

• AVERAGES to select one of three types of result averages.

MAIN MENU

LAST RESULT

ALL RESULTS

AVERAGES

SETTINGS

Press or to highlight LAST RESULT, ALL RESULTS, or AVERAGES. To conrm your selection, press .

METER OFF

Date Time

18/OCT/07 11:49AM

Last result

The meter will display your most recent result. Press to return to MAIN MENU.

If you wish to add or change a meal ag for this result, see Section 4, Attaching meal ags to your results.

104

mg/dL

AFTER MEAL

Unit of measure

All results

The meter will display four results at a time, in the order the tests were done, starting with the most recent. For each test result, the meter will display the date and time of the test. Results may also contain the following symbols:

HI if the result was above 600 mg/dL LO if the result was below 20 mg/dL C if the result is from a control solution test – if the result is agged BEFORE MEAL + if the result is agged AFTER MEAL

ALL RESULTS

08/DEC

07/DEC 06/DEC 05/DEC

10:01AM

5:21PM 2:08PM 8:33AM

The meter stores a maximum of 350 blood glucose or control solution test results. When the memory is full, the oldest result is dropped as the newest is added.

mg/dL

128

119

124

To view details of an individual result, press meal ag for this result, see Section 4, Attaching meal ags to your results. To return to the list of all results from an individual result, press .

To view more recent results, continue to press

To view older results, press after MENU is highlighted. Pressing and holding the results. To return to the main menu, highlight MENU, then press .

Averages

If the meal ags feature is on, the meter will display three types of averages you can access:

• the average of all test results,

• the average of before-meal results, and

• the average of after-meal results.

To select the type of result average you want to see, press or to highlight your choice, then press .

REVIEWING PAST RESULTS AND AVERAGES

or to highlight the result you want, then press . If you wish to add or change a

after the top result on the display is highlighted.

or allows you to move more quickly through

ALL RESULTS AVG

LAST 7 DAYS LAST 14 DAYS LAST 30 DAYS

mg/dL

120 138 194

Page 22

If you have turned the meal ags feature o, selecting AVERAGES from the MAIN MENU will lead directly to the ALL RESULTS AVG screen.

The meter will display your averages for each of the 7-, 14-, and 30-day periods leading up to the current date. The top of the display shows which type of average you are looking at. In result averages, a HIGH GLUCOSE result is counted as 600 mg/dL, and a LOW GLUCOSE result as 20 mg/dL. Control solution results are not part of your averages.

From any screen showing averages, press

to go back to the previous screen. To return to the main

menu, highlight MENU, then press .

AVERAGES

ALL RESULTS AV G

BEFORE MEAL AVG

AFTER MEAL AVG

BEFORE MEAL AVG

LAST 7 DAYS LAST 14 DAYS LAST 30 DAYS

mg/dL

120 138 194

NOTE:

• Result averages provide information from past results. Do Not use result averages to make immediate treatment decisions.

• If you change your date setting, your averages may change too. The meter calculates averages based on the 7-, 14-, and 30-day periods

ending on the current date setting.

To see averages for dierent parts of the day or over a dierent number of days, you can use OneTouch® Diabetes Management Software and your home computer. See Downloading results to a computer in this section.

Downloading results to a computer

You can use your meter with OneTouch® Diabetes Management Software (DMS) for storing your records and to help you spot patterns for planning meals, exercise, and medication. OneTouch® DMS puts information downloaded from the meter into charts and graphs. If you are a current OneTouch® DMS user, additional software updates may be required for use with the OneTouch® Select™ Meter. Please visit www.OneTouchDiabetesSoftware.com.



Obtain the required software and cable

For order information and to learn more about OneTouch® Diabetes Management Software, visit www.OneTouchDiabetesSoftware.com.



Install the software on a computer

Follow the installation instructions provided with OneTouch® DMS and the OneTouch® Interface Cable.

 WARNING: To avoid a possible shock, Do Not insert a test strip when the meter is connected to a computer with the OneTouch® Interface Cable.



Get ready to transfer readings

Make sure that the meter is turned o. Connect the OneTouch® Interface Cable to the COM or USB port on your computer. Then connect the other end of the cable to the meter data port.

Interface Cable



Transfer data

Follow the instructions provided with the OneTouch® DMS software to download the results from the meter.

Once the command to start the download is sent from the computer to the meter, the meter display will show “PC” indicating that the

meter is in communication mode. You will not be able to perform a test when the meter is in communication mode.

REVIEWING PAST RESULTS AND AVERAGES

Page 23

 Control solution testing

When to test with control solution

You may check your meter and test strips using the OneTouch® Select™ Control Solution.

OneTouch® Select™ Control Solution contains a known amount of glucose and is used to check that the meter and the test strips are working properly. Remember which control solution you used.

Do a control solution test: – whenever you open a new vial of test strips – if you suspect the meter or test strips are not working

properly

– if you have had repeated unexpected blood glucose

results

– if you drop or damage the meter

 CAUTION: Do Not swallow control solution; it is not for human consumption. Do Not apply control solution to the skin or eyes as it may cause irritation.

NOTE:

• Use only OneTouch® Select™ Control Solution with your

OneTouch® Select™ Meter.

• Control solution tests must be done at room temperature (20–25°C). Make sure your meter, test strips, and control

solution are at room temperature before testing.

• Write the discard date (3 months after rst opening the

vial) on the vial when you rst open it.

How to test with control solution

Start with the meter o. If you have turned the meter on to change settings or review past results, turn it o.



Check the code on the test strip vial before inserting the test strip



Insert a test strip to turn on the meter

Make sure the three contact bars are facing you and the arrow is pointing down. Push the test

strip in as far as it will go. Do Not bend the test strip.



Match the code on the meter with the code on the test strip vial

If the code on the meter does not match the code on the test strip vial, press match the code number on the test strip vial. The new code number will ash on the display for three seconds, then briey stop ashing, after which the display will advance to the

APPLY SAMPLE screen.

If the codes already match, press to go to the APPLY SAMPLE screen. When you do not make

a change after ve seconds, the display will advance to the APPLY SAMPLE screen.

APPLY CONTROL

▲

or to



Mark the test as a control solution test

Press

apply control solution. Once you have completed the test, you cannot change the marking.

The meter is now ready to perform a control solution test.

to change APPLY SAMPLE to APPLY CONTROL. You must mark the test before you

CONTROL SOLUTION TESTING

Page 24



Prepare and apply control solution

Shake the control solution vial before each test. Remove the cap and squeeze the vial to discard the rst drop. Then wipe the tip with a clean tissue or cloth. Hold the vial upside down and gently squeeze out a hanging drop.

Touch and hold the hanging drop of control solution to the narrow channel in the top edge of the test strip. Make sure the conrmation window lls completely. Control solution should not be applied to the at face of the test strip.



Read your result

When the conrmation window is full, the meter will count down from 5 to 1.

Your control solution result will then appear on the display, along with the date, time, unit of measure, and the words CONTROL TEST. The control solution results can be viewed in the list of past results, but are not counted in your result averages.



Check if the result is in range

Each vial of test strips has a OneTouch® Select™ Control Solution range printed on its label. Compare the result displayed on the meter to the OneTouch® Select™ Control Solution range printed on the test strip vial.

If the results you get are not within this range, the meter and test strips may not be working properly. Repeat the control solution test.

Out-of-range results may be due to:

• not following the instructions detailed in steps 1–7,

• expired or contaminated control solution,

• expired or damaged test strip,

• use of a test strip or control solution past its discard date, or

• a problem with the meter.

TOP EDGE

NARROW CHANNEL

Apply drop here

CONFIRMATION

WINDOW

18/OCT/07 11:49AM

104

mg/dL

CONTROL TEST

NOTE: It is important to compare your control solution result with the correct control range printed on the test strip vial or your result may appear to be out of range.

 CAUTION: The control solution range printed on the test strip vial is for OneTouch® Select™ Control Solution only. It is not a recommended range for your blood glucose level.

 CAUTION: If you continue to get control solution test results that fall outside the range printed on the test strip vial, Do Not use the meter, the test strips, or the control solution. Call Customer Service.

CONTROL SOLUTION TESTING

OneTouch®

Select™

(Example range)

105–158 mg/dL

Page 25

 Caring for your system

Replacing the battery

Your OneTouch® Select™ Meter uses one 3.0 Volt CR 2032 lithium battery (or equivalent).

Replacement batteries can be found in most stores where batteries are sold. Your meter comes with the battery already installed.

See Troubleshooting in Section 8 for information on when to change the meter battery.



Remove the old battery

Start with the meter o. Open the battery door and pull up on the battery ribbon.

 WARNING: To avoid a possible shock, Do Not change the battery while the meter is connected to a computer with the OneTouch® Interface Cable.

Meter battery



Insert the new battery

With the “+” side facing up toward you, place the battery in the compartment within the fold of the ribbon.

Push the battery until it snaps into the battery clasp. Insert the two battery door tabs into the matching holes

on the meter, and push down until you hear the door click into place.

If the meter does not power on after you have replaced the meter battery, check that the battery is correctly installed with the “+” side up. If the meter still does not power on, call Customer Service.



Check your meter settings

Removing the meter battery will not aect your stored results. However, you may need to re-set your meter settings. See Setting the meter language, date and time in Section 2.



Dispose of the battery

Dispose of batteries according to your local environmental regulations.

CARING FOR YOUR SYSTEM

Page 26

Caring for your system

Your OneTouch® Select™ Blood Glucose Monitoring System does not need any special maintenance.

Storing your system

Store your meter, test strips, control solution and other items in your carrying case after each use. Store each item in a cool, dry place below 30°C, but Do Not refrigerate. Keep all items away from direct sunlight and heat.

Tightly close the cap on the test strip vial and/or control solution vial immediately after use to avoid contamination or damage. Store test strips only in their original vial. Do Not open the test strip vial until you are ready to test.

Checking for expiration or damage to test strips and control solution

Test strips and control solution have expiration dates printed on their vials. When you rst open a test strip or control solution vial, you must record the discard date (date opened plus three months) in the space provided on the label.

 CAUTION: Do Not use the test strips or control solution after the expiration date printed on the vial or the discard date, whichever comes rst, or your results may be inaccurate.

Cleaning your meter

To clean your meter, wipe the outside with a soft cloth dampened with water and mild detergent. Do Not use alcohol or another solvent to clean your meter.

Do Not get any liquids, dirt, dust, blood, or control solution inside the meter through the test port or the data port. Never spray cleaning solution on the meter or immerse it in any liquid.

Cleaning your lancing device and clear cap

To clean these items, wipe them with a soft cloth dampened with water and mild detergent. Do Not immerse the lancing device in any liquid.

To disinfect these items, prepare a solution of one part household bleach to ten parts water. Wipe the lancing device with a soft cloth dampened with this solution. Immerse the caps only in this solution for 30 minutes. After disinfecting, rinse briey with water and allow both to air dry.

CARING FOR YOUR SYSTEM

Page 27

8 Troubleshooting and detailed information about your system

Troubleshooting

The OneTouch® Select™ Meter displays messages when there are problems with the test strip, with the meter, or when your blood glucose levels are higher than 600 mg/dL or lower than 20 mg/dL . Messages do not appear in all cases when a problem has occurred. Improper use may cause an inaccurate result without producing an error message.

NOTE: In this Section, screens that display ”SEE OWNER'S BOOKLET“ means you should refer to this User Guide.

Message What it means What to do

WARNING

LOW GLUCOSE

BELOW 20 mg/dL

You may have a very low blood glucose level (severe hypoglycemia), lower than 20 mg/dL.

This may require immediate treatment according to your health care professional’s recommendations. Although this

message could be due to a test error, it is safer to treat rst and then do another test.

WARNING

HIGH GLUCOSE

ABOVE 600 mg/dL

WARNING

LOW GLUCOSE

BELOW 20 mg/dL

CONTROL TEST

WARNING

HIGH GLUCOSE

ABOVE 600 mg/dL

CONTROL TEST

WARNING

TEMPERATURE

ERROR

TEMPERATURE

TOO HIGH

SEE OWNER’S BOOKLET

You may have a very high blood glucose level (severe hyperglycemia), over 600 mg/dL.

Your control solution test result is below 20 mg/dL.

Your control solution test result is above 600 mg/dL.

Meter is too hot (above 44°C) to work

correctly.

Re-check your glucose level. If the result is HIGH GLUCOSE again, obtain and follow instructions from your health care professional without delay.

Test again with control solution and a new test strip. If the result is LOW GLUCOSE again, Do Not use the meter.

Test again with control solution and a new test strip. If the result is HIGH GLUCOSE again, Do Not use the meter.

Wait a few minutes and insert a new test strip. If you do not get

another TEMPERATURE ERROR

message, the meter is now within the operating range.

WARNING

TEMPERATURE

ERROR

TEMPERATURE

TOO LOW

SEE OWNER’S BOOKLET

WARNING

ERROR 1

METER PROBLEM

CALL CUSTOMER

SERVICE

TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM

Meter is too cold (below 10°C) to work

correctly.

Wait a few minutes and insert a new test strip. If you do not get

another TEMPERATURE ERROR

message, the meter is now within the operating range.

There is a problem with the meter. Do Not use the meter.

Page 28

Message What it means What to do

WARNING

ERROR 2

METER OR STRIP

PROBLEM

RETEST WITH A

NEW STRIP

WARNING

ERROR 3

METER WAS NOT

READY

RETEST WITH A

NEW STRIP

WARNING

ERROR 4

STRIP PROBLEM

SEE OWNER’S BOOKLET

Error message could be caused either by a used test strip or a problem with the meter.

The sample was applied before the meter was ready.

One of the following may apply:

You may have high glucose and have tested in an environment near the low end of the system’s operating temperature range

(10–44°C).

or,

There may be a problem with the test strip. For example, it may have been damaged or moved during testing.

or,

Repeat the test with a new test strip; see Section 3, Testing your blood glucose.

Repeat the test with a new test strip. Apply a blood or control solution sample only after APPLY SAMPLE or APPLY CONTROL appears on the display.

If you tested in a cool environment, repeat the test in a warmer environment with a new test strip; see Section 3, Testing your blood glucose.

If you tested in a normal or warm environment, repeat the test with a new test strip; see Section 3, Testing your blood glucose.

WARNING

ERROR 5

STRIP PROBLEM OR SAMPLE TOO SMALL

RETEST WITH A

NEW STRIP

WARNING

LOW BATTERY

REPLACE BATTERY

SOON

SEE OWNER’S BOOKLET

The sample was improperly applied. or,

There may be a problem with the meter.

The meter has detected a problem with the

test strip. Possible causes are test strip damage

or an incompletely lled conrmation window.

Meter battery is low but still has enough power to perform a test.

If you applied the sample incorrectly, review blood application (see Section 3, Testing your blood glucose) or control solution testing (see

Section 6, Control solution testing) and repeat the test with a new test strip.

Repeat the test with a new test strip. Refer to information on blood application (see Section3, Testing your blood glucose) or control solution testing (see Section 6, Control solution testing).

This message will appear when you rst turn the meter on and there is enough power

for a minimum of 100 more tests. Press

to continue, but replace the battery as soon as possible.

TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM

Page 29

Message What it means What to do

18/OCT/07 11:49AM

104

mg/dL

WARNING

LOW BATTERY

REPLACE BATTERY

NOW!

SEE OWNER’S BOOKLET

–––

ALL RESULTS

04/DEC 03/DEC

01/DEC

9:44AM 12:23PM

10:12AM

mg/dL

- - -

–

Meter battery is low but still has enough power to perform a test.

Meter battery does not have enough power to perform a test.

No result in memory, such as the rst time use of the meter or after a download of all data to a computer.

or,

Your meter was unable to recall this result. This result will not be included in result averages.

Once the LOW BATTERY/REPLACE BATTERY SOON

message is displayed, this icon will continue to appear on screens until you replace the battery. When the battery icon rst appears, there is enough power for a minimum of 100 more tests. Test results will still be accurate, but replace the battery as soon as possible.

Replace meter battery.

You can still perform a blood glucose test and get an accurate result. Contact Customer Service to report this occurrence if this is not:

1. Your rst time use of the meter, or

2. After you just downloaded results from your meter.

You can still perform a blood glucose test and get an accurate result, but contact Customer Service to report this occurrence.

Detailed information about your system

Comparing meter and laboratory results

Test results with the OneTouch® Select™ Meter are plasma-calibrated. This helps you and your health care professional to compare your meter results with laboratory tests. If you have been using another type of meter—one that provides whole blood-calibrated results—you may

notice that your test results with the OneTouch® Select™ Meter are approximately 12% higher.

OneTouch® Select™ Meter test results and laboratory test results both are expressed in plasma-equivalent units. However, your meter result may dier from your laboratory result due to normal variation. Meter results can be aected by factors and conditions that do not aect laboratory results in the same way.

Your OneTouch® Select™ Meter glucose value is considered accurate when it is within ±20% of the laboratory measurement. There are some specic situations that could cause a dierence of more than ±20%:

• You have eaten recently. The blood glucose level from blood obtained from a ngertip can be up to 70 mg/dL higher than blood drawn from

a vein (venous sample) used for a lab test.

• Your hematocrit (percentage of your blood that is red blood cells) is high (above 55%) or low (below 30%).

• You are severely dehydrated.

• You tested at a temperature near the low end of the operating range (10°C) and you get a high glucose result (i.e., greater than 180 mg/dL).

In this situation, repeat the test in a warmer environment with a new test strip as soon as possible.

For accuracy and precision data and for important information on limitations, see the insert that comes with your test strips.

1. Sacks, D.B.: “Carbohydrates.” Burtis, C.A., and Ashwood, E.R. (ed.), Tietz Textbook of Clinical Chemistry. Philadelphia: W.B. Saunders Company (1994), 959.

TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM

Page 30

To maximize your chances of an accurate comparison between meter and laboratory results, follow a few basic guidelines:

Before going to the lab

• Perform a control solution test to make sure the meter is working properly.

• Do Not eat for at least eight hours before you test your blood.

• Take your meter with you to the lab.

While at the lab

• Conduct your meter test within 15 minutes of the lab test.

• Use only fresh, capillary blood obtained from the ngertip.

• Follow all instructions in this User Guide for performing a blood glucose test with your meter.

Technical specications

Reported result range 20–600 mg/dL

Calibration Plasma-equivalent

Sample Fresh capillary whole blood

Test time 5 seconds

Assay method Glucose oxidase biosensor

Meter power source One replaceable 3.0 Volt CR 2032

lithium battery (or equivalent)

Unit of measure mg/dL

Memory 350 blood glucose or control

solution test results

Electrical and safety standards

This meter complies with CISPR 11: 2003, Class B (Radiated Only). Emissions of the energy used are low and not likely to cause interference

in nearby electronic equipment. The meter has been tested for immunity to Level 3 electrostatic discharge as specied in IEC 61000-4-2. This meter has been tested for immunity to radio frequency interference over the frequency range 80 MHz to 2.5 GHz at 3 V/m as specied in IEC 61000-4-3.

Automatic shuto 2 minutes after last action

Size 90 mm x 55.54 mm x 21.7 mm

Weight Approximately 52.21 g,

with battery

Operating ranges Temperature: 10–44°C

Relative humidity: 10–90%

Altitude: up to 3048 meters

Hematocrit: 30–55%

Battery ratings 1 x 3.0 V d.c., 60 mA

(1 x CR 2032 batteries) direct current

Degree of protection rating: IP31

Guarantee

LifeScan guarantees that the OneTouch® Select™ Meter will be free of defects in material and workmanship for three years, valid from the date of purchase. The guarantee extends only to the original purchaser and is not transferable.

Symbols

Cautions and Warnings. Refer to safety-related notes in this User Guide and inserts that came with your meter and testing supplies.

Low battery

Direct Current

Manufacturer

Serial number symbol

Lot Number

Do not re-use

In Vitro Diagnostic Medical Device

The system described herein is covered by one or more of the following U.S. patents: 5,708,247, 5,951,836, 6,241,862, 6,284,125, and 7,112,265. Use of the monitoring device included herein is protected under one or more of the following U.S. patents: 6,413,410, 6,733,655,

7,250,105, 7,468,125. Purchase of this device does not act to grant a use license under these patents. Such a license is granted only when the

device is used with OneTouch® Select™ Test Strips. No test strip supplier other than LifeScan is authorized to grant such a license. The accuracy of results generated with LifeScan meters using test strips manufactured by anyone other than LifeScan has not been evaluated by LifeScan.

Expiration Date

Sterilized by irradiation

Consult Instructions for Use

Contains sucient for <n> tests

Storage temperature limits

Recycle

TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM