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Rev. date: 07/2012

USER GUIDE

Blood Glucose Monitoring System

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Contents:

 Getting to know your system 1

 Setting the time and date, and coding your meter

 Testing your blood glucose 8

 Reviewing past results 16

 Control solution testing 18

 Caring for your system 20

 Error messages and details about your system 24

Call OneTouch® Customer Care

UK 0800 121200

Ireland 1800 535676

Or,

Visit us at www.LifeScan.co.uk

If you cannot reach OneTouch® Customer Care, contact your healthcare professional for advice.

LifeScan Europe

Division of Cilag GmbH

International

6300 Zug

Switzerland

Distributed by LifeScan UK, a Division of Ortho-Clinical Diagnostics,

Johnson & Johnson, 50-100 Holmers Farm Way, High Wycombe,

Buckinghamshire HP12 4DP, United Kingdom

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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®

Ultra® Test Strips and OneTouch® Ultra® Control Solution. Take note of warnings and cautions throughout this User Guide, 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 5, Control solution testing.

Intended use

The OneTouch® UltraEasy® Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose

(sugar) in fresh capillary whole blood. The OneTouch® UltraEasy® System is intended for self-testing outside the body (in vitro

diagnostic use) by people with diabetes at home and by healthcare 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.

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GETTING TO KNOW YOUR SYSTEM

 Getting to know your system

The OneTouch® UltraEasy® Blood Glucose Monitoring System

Included with your kit:

a. OneTouch® UltraEasy® Meter (battery included)

b. Lancing Device

c. Sterile Lancet(s)

d. Carrying Case

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

OneTouch® Customer Care 0800 121200 (UK) or

1800 535676 (Ireland).

Available separately:

e. OneTouch® Ultra® Test Strips

f. OneTouch® Ultra® Control Solution

g. Clear Cap for AST testing

For availability of control solution, call

OneTouch® Customer Care 0800 121 200 (UK) or

1800 535 676 (Ireland).

 WARNING: Keep the meter and testing

supplies away from young children. Small

items such as the battery door, battery,

test strips, lancets, protective disks on the

lancets and control solution vial cap are

choking hazards.

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GETTING TO KNOW YOUR SYSTEM

Getting to know your system

METER

Display mmol/L is the pre-

set unit of measure

Up and down buttons

Turns the meter on or o

Select or change information

Test port

Insert test strip here to

turn meter on for testing

TEST STRIP

Edge to

apply sample

Conrmation

window

Contact bars

Insert into test port

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GETTING TO KNOW YOUR SYSTEM

Turning your meter on

To perform a test, insert a test strip as far as it will go. The display will turn on and

the meter will briey perform system checks. Or, to change the time and date,

start with the meter o, then press and hold ▼ for ve seconds until the start-up

test screen appears. After the start-up test screen, the pre-set time and date will

appear on the display. Or, if you want to turn the meter on to review past results,

start with the meter o, then press and release ▼.

Every time you turn your meter on, a start-up test screen will appear for two seconds. All segments of the display should appear

briey on the start-up test screen to tell you that the meter is working properly. To check that all display segments are working, as

soon as the start-up test screen appears, press and hold ▲ to keep the start-up test screen display on. Release ▲ to proceed to the

next step. If the meter does not power on, try changing the meter battery. See Replacing the battery in Section 6.

Turning your meter o

There are several ways to turn your meter o:

• Press and hold ▼ for two seconds, when reviewing past results.

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

• Before or after completing a test, remove the test strip.

 CAUTION: If any information is missing from the

start-up test screen, there may be a problem with the

meter. Call OneTouch® Customer Care 0800 121200 (UK)

or 1800 535676 (Ireland).

Start-up Test Screen

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SETTING THE TIME AND DATE, AND CODING YOUR METER

 Setting the time and date, and coding your meter

Setting the time and date

Your OneTouch® UltraEasy® Meter comes with the time, date and unit of measurement pre-set. Before using your meter for the rst time

or if you change the meter battery, you should check and update the time and date. Make sure you complete steps 1 to 6 below to ensure

your desired settings are saved.



Turn the meter on

Press and hold ▼ for ve seconds until the start-up test screen appears. After the

start-up test screen, the pre-set time and date will appear on the display for ve

seconds. The hour will now start ashing.

NOTE: If a setting does not need to be updated, simply wait ve seconds.

The meter display will automatically advance to the next setting.



Set the hour

With the hour ashing on the display, press and release ▲ or ▼ to go forward or

backward one hour. To move faster, hold the ▲ or ▼ buttons down.

When the correct hour appears on the display, wait ve seconds. Your entry will be saved

and you will move to the next setting. The minutes will now start ashing.



WARNING: If your display shows mg/dL rather than mmol/L, contact OneTouch® Customer Care 0800 121200 (UK)

or 1800 535676 (Ireland). You cannot change the unit of measurement. Use of the wrong unit of measurement may

cause you to misinterpret your blood glucose level, and may lead to incorrect treatment.

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SETTING THE TIME AND DATE, AND CODING YOUR METER



Set the minutes

Press ▲ or ▼ to change the minutes. When you have the correct minutes on the display,

wait ve seconds to move to the next setting. The year (last two digits only), month and day

appear on the display and the year ashes.



Set the year

Press ▲ or ▼ to change the year. When you have the correct year on the display, wait

ve seconds to move to the next setting. The month will now start ashing.



Set the month

Press ▲ or ▼ to change the month. When you have the correct month on the display, wait

ve seconds to move to the next setting. The day will now start ashing.



Set the day

Press ▲ or ▼ to change the day. When you have the correct day on the display, wait ve

seconds to move to the next screen.

Your time and date settings will be displayed for ve seconds. After the ve seconds, the

settings will be saved and the meter will then turn o. If you want to adjust your settings,

press ▲ or ▼ while the time and date are still on the display. You will be returned to the

rst set-up screen where you can begin with the hour.

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SETTING THE TIME AND DATE, AND CODING YOUR METER

Coding your meter

Have these things ready when you test your blood glucose level:

NOTE:

• Use only OneTouch® Ultra® Test Strips with your OneTouch® UltraEasy® Meter.

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

• Testing must be done within the operating temperature range (6–44°C). For the most accurate results, try to test as close to room

temperature (20–25°C) as you can.



Insert a test strip to turn on the meter

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

Remove a test strip from its vial. 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.

Hold the meter as shown and insert the test strip into the test port. Make sure the three contact bars are facing

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

 CAUTION: The test strip vial contains drying agents that are harmful if inhaled or swallowed

and may cause skin or eye irritation.

 CAUTION: If you cannot test due to a problem with your testing supplies, contact your healthcare professional or OneTouch® Customer

Care 0800 121200 (UK) or 1800 535676 (Ireland). Failure to test could delay treatment decisions and lead to a serious medical condition.



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 to obtain accurate test results.

You must code the meter before using it for the rst time and then every time you change to another vial of

test strips.

• OneTouch® UltraEasy® Meter

• OneTouch® Ultra® Test Strips

• Lancing device

• Sterile lancets with protective disks

• OneTouch® Ultra® Control Solution

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SETTING THE TIME AND DATE, AND CODING YOUR METER

 CAUTION: OneTouch® Ultra® Test Strips are for single use only. Never re-use a test strip that had either blood or control

solution applied to it.

After the start-up test screen appears, the meter will display the code from your

last test. If a constant

and a ashing “––” appear 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 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 ▲ or ▼ to match the

code number on the test strip vial. The new code number will ash on the display for three seconds,

and then stay constant for three seconds. The display will advance to the screen with the ashing blood

drop icon

If the codes already match, wait three seconds. The display will advance to the

screen with the ashing blood drop icon

. The meter is now ready to perform a

blood glucose test.

NOTE:

• If the screen with the ashing blood drop icon

appears before you are sure the codes match, remove the test strip, wait until

the meter turns o, then re-start from step 1 in Coding your meter.

• If you press ▲ by mistake so that the control solution test symbol CtL appears on the display, press ▲ again to change it back to

the screen with the ashing blood drop icon

 CAUTION: Matching the code on the meter and the code on the test strip vial is essential to obtain accurate results. Each

time you test, check to make sure the code numbers match.

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TESTING YOUR BLOOD GLUCOSE

 Testing your blood glucose

 CAUTION: To reduce the chance of infection:

• Make sure to wash the puncture site with soap and water before

sampling.

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

• Always use a new, sterile lancet—lancets are for single use only.

• Keep your meter and lancing device clean. See Caring for your

system in Section 6.

NOTE: If you do not have a lancing device, please refer to the instructions that came with your lancing device.

*The blue (or black) cap and clear cap are also used for depth adjustment

Getting a blood sample

Overview of the Lancing Device

Cocking control

Blue (or black) cap*

(for ngertip sampling)

Sterile lancet

Lancet point

Protective disk

Release button

Depth indicator

Clear Cap*

(for alternate site sampling)

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TESTING YOUR BLOOD GLUCOSE

Preparing your sample site

Before you test your blood glucose, wash your hands and forearm (if applicable)

thoroughly with warm, soapy water. Rinse and dry.

Lancing and sampling from your ngertip



Remove the blue (or black) cap by snapping it o



Insert a sterile lancet into the lancing device

Insert the lancet into the holder and push in rmly. Twist the protective disk until it

separates from the lancet and save the disk for later use.

Do Not twist the lancet.



Replace the blue (or black) cap by snapping it back on



Adjust the depth setting

The lancing device has nine puncture depth settings, numbered 1 through 9. The smaller numbers are for a

shallower puncture, and the larger numbers are for a deeper puncture. Shallower punctures work for children and

most adults. Deeper punctures work well for people with thick or callused skin. Twist the blue (or black) cap until

the correct setting appears.

NOTE: A shallower puncture may be less painful. Try a shallower setting rst and increase the depth until you nd

the one deep enough to get a large enough drop of blood ( approximate size).



Cock the lancing device

Slide the cocking control back until it clicks. If it does not click, it may have been cocked when you inserted

the lancet.



Puncture your nger

Hold the lancing device rmly against the side of your nger. Press the release button. Remove the lancing device

from your nger.



Get a round drop of blood

Gently squeeze and/or massage your ngertip until a round drop of blood

( approximate size) forms on your ngertip. 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.

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TESTING YOUR BLOOD GLUCOSE

Lancing and sampling from an alternate site

Sampling from your palm or forearm allows you to use your ngertips less often. You may nd that obtaining a blood sample from an

alternate site is less painful than using a ngertip. Getting a blood sample from your forearm or palm is dierent than getting a sample from

your ngertips.

 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 hypoglycaemia 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 hypoglycaemia or an insulin reaction, such as when driving a car. This is especially important

if you suer from hypoglycaemia unawareness (lack of symptoms to indicate an insulin reaction).

Remember: Consult with your healthcare professional before using your forearm or palm for testing.

Choose a dierent puncture site each time you test. Repeated punctures in the same spot may cause soreness and calluses. 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 healthcare professional.

Choosing the right sampling site at the right time

The OneTouch® UltraEasy® Meter allows you to sample blood from your ngertip, forearm or palm. Forearm and palm sampling is also referred

to as “Alternate Site Testing” (AST). At times, results obtained at the forearm or palm may be dierent from a ngertip measurement. Talk to

your healthcare professional before you begin using your forearm or palm for sampling.

If you are testing: Use blood sample from your:

Routinely before meals

Prior to or more than two hours after:

• a meal

• a rapid-acting insulin injection or insulin pump bolus

• exercise

When your blood glucose is changing rapidly, such as:

• within two hours after a meal

• within two hours after a rapid-acting insulin injection or insulin pump bolus, or

• during or within two hours after exercise

When you are concerned about the possibility of hypoglycaemia (low blood sugar)

Fingertip

Fingertip, forearm, or palm

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TESTING YOUR BLOOD GLUCOSE



Insert a sterile lancet and snap on the clear cap



Adjust the depth setting

You may have to adjust the lancing device to a deeper setting to get a large enough

drop of blood from your forearm or palm. Twist the clear cap toward the larger

numbers to increase the depth.

Be sure to cock the lancing device.



Puncture 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 colour

(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.

Forearm sampling

Choose a eshy area of the forearm away from bone, visible veins and hair.

Sometimes there is less blood ow to the forearm than to the ngertips. To help you

get a large enough drop of blood, you may gently massage or apply warmth to the

site to increase blood ow.

Palm sampling

Choose a eshy area on the palm below your thumb or little nger. Select a spot

with no visible veins and away from deep lines, which may cause your blood

sample to smear.

The clear cap is used for forearm and palm sampling only. Replace the blue (or black) cap with the clear cap.

Palm

Forearm

PalmForearm

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TESTING YOUR BLOOD GLUCOSE

Applying blood and reading results

Once you have a blood sample and your meter shows the screen with the ashing blood drop icon

, you are ready to obtain a blood

glucose result. If your meter does not show the screen with the ashing blood drop icon

, remove the unused test strip. Reinsert the test

strip to re-start the meter and test process. See Getting a blood sample in Section 3.



Prepare to apply the sample

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

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.

When applying a drop of blood from your forearm or palm, keep your palm or

forearm steady and bring the top edge of the test strip to the drop of blood with your

other hand.

Fingertip

Palm

Forearm

When sampling blood from your forearm or palm, make sure the drop of blood is large enough (

approximate size) before you release

pressure and remove the lancing device.



Remove the lancing device

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

NOTE:

• You may need to wait a little longer to get a large enough drop of blood from the forearm or palm. Do Not squeeze the site excessively.

• If the sample drop of blood runs or spreads due to contact with hair or with a line in your palm, Do Not use that sample. Try puncturing

again in a smoother area.

• Remember: You may have to adjust the lancing device to a deeper setting to get a large enough drop of blood ( approximate size).

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TESTING YOUR BLOOD GLUCOSE



Wait for the confirmation window to fill completely

The blood drop will be drawn into the narrow channel and the confirmation

window should fill completely.

When the confirmation 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.

Conrmation Window

Full Not Full

 CAUTION: You may get an Er 5 message or an inaccurate result if the blood sample does not ll the conrmation window

completely. See Understanding error and other messages in Section 7. Discard the test strip and re-start the test process.

NOTE:

• 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.



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.

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.

Narrow Channel

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TESTING YOUR BLOOD GLUCOSE

Error messages

If you get an Er message on your screen rather than a result, see Understanding error and other messages in Section 7.

Unexpected test results

Refer to these cautions  whenever your results are lower than, higher than, or otherwise not what you expect.



Read your result on the meter

Your blood glucose level appears on the display, along with the unit of

measurement, and the date and time of the test. Blood glucose results are

automatically stored in the meter’s memory.

 CAUTION: If you test at the low end of the operating range (6–44°C) and your glucose is high (over 10.0 mmol/L), 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.

 WARNING: If mmol/L does not appear with the test result, call OneTouch® Customer Care 0800 121200 (UK)

or 1800 535676 (Ireland). Use of the wrong unit of measurement may cause you to misinterpret your blood

glucose level, and may lead to incorrect treatment.

(Example)

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TESTING YOUR BLOOD GLUCOSE

 CAUTION: Dehydration and low glucose results

Severe dehydration resulting from excessive water loss may cause false low results. If you think you are suering from severe

dehydration, contact your healthcare professional immediately.

 CAUTION: Low glucose results

If your test result is lower than 3.9 mmol/L or is shown as LO, it may mean hypoglycaemia (low blood glucose). This may

require immediate treatment according to your healthcare professional’s recommendations. Although this result could be

due to a test error, it is safer to treat rst, then do another test.

 CAUTION: High glucose results

If your test result is higher than 10.0 mmol/L, it may mean hyperglycaemia (high blood glucose). If you are uncertain about

this test result, consider re-testing. Your healthcare professional can work with you to determine what actions, if any, you

should take if your results are higher than 10.0 mmol/L.

If your meter displays HI, you may have a very high blood glucose level (severe hyperglycaemia) exceeding 33.3 mmol/L.

Re-check your glucose level. If the result is HI again, this may indicate a severe problem with your blood glucose control and

it is important you obtain and follow instructions from your healthcare professional without delay.

 CAUTION: Repeated unexpected glucose results

If you continue to get unexpected results, check your system with control solution. See Section 5, 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 healthcare professional. Never ignore symptoms or make signicant changes to your

diabetes control programme without speaking to your healthcare professional.

 CAUTION: Unusual red blood cell count

A haematocrit (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.

After getting a result

Once you have read your result, you may:

• Review your meter memory by pressing ▼ to enter memory mode, see Section 4, Reviewing past results, or

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

Removing the used lancet

Remove the lancing device cap by snapping it o. Cover the exposed lancet tip before removing

the lancet. Place the lancet protective disk on a hard surface. Push the lancet tip into the disk. Remove

the lancet and place it in a container for sharp objects. Replace the 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 local regulations or your healthcare professional's recommendations for proper disposal.

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REVIEWING PAST RESULTS

 Reviewing past results

Reviewing past results

The meter stores a maximum of 500 blood glucose test results. When the meter memory is full, the oldest result is dropped as the

newest is added. Results are stored automatically when you test, along with the time, date and unit of measurement. You can

review the results stored in the meter memory, starting with the most recent.

If your meter is o, press and release ▼ to turn it on. After the start-up test

screen, your most recent test result will appear on the display. “M” also appears

to indicate memory mode.

If you have just completed a test, leave the test strip in the meter and press ▼

to enter the memory mode. Your most recent blood glucose test result appears

along with “M”.

Press ▼ to move to the previous result stored in the meter. Then, press ▲ or ▼

to move forward or backward through all of your results. When you’re nished

reviewing past results, press and hold ▼ for two seconds until the meter

turns o.

NOTE: If no results are currently stored in the meter, “–––” will appear on the display.

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REVIEWING PAST RESULTS



Get ready to transfer readings

Connect the OneTouch® Interface Cable to the COM or USB port on your computer. Make sure the meter is turned o. If you insert the

cable while the meter is already on, the meter will not respond to computer commands. Then connect the other end of the OneTouch®

Interface Cable to the meter data port.



Transfer data

Follow the instructions provided with OneTouch® DMS 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.

 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.

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® UltraEasy® Meter. Please

visit www.LifeScan.co.uk.



Obtain the required software and cable

For order information and to learn more about OneTouch® Diabetes Management

Software visit www.LifeScan.co.uk.



Install the software on a computer

Follow the installation instructions provided with the Software. If using a

OneTouch® Interface Cable (USB format), install the software driver.

Interface Cable

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CONTROL SOLUTION TESTING

 Control solution testing

When to test with control solution

OneTouch® Ultra® Control Solution contains a known amount of glucose and is used to check that the meter and the test strips are

working properly.

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. 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 ▲ or ▼ to match the code

number on the test strip vial. The new code number will ash on the display for three seconds, and then stay

constant for three seconds. The display will advance to the screen with the ashing blood drop icon

If the codes already match, wait three seconds. The display will advance to the screen with the ashing blood

drop icon



Mark the test as a control solution test

IMPORTANT: • Mark all control solution tests with CtL. This will stop them from being

stored as blood glucose results.

• Control solution results marked with CtL are not stored in the meter’s

memory.

 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.

Do a control solution test:

• to practice the test process instead of using blood,

• once a week,

• 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 (as

described in Applying blood and reading results in Section 3), or

• if you drop or damage the meter.

NOTE:

• Use only OneTouch® Ultra® Control Solution with your OneTouch®

UltraEasy® 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.

(Example)

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CONTROL SOLUTION TESTING

Press ▲ so that the control solution test symbol CtL appears in the upper right corner of the

display. You must mark the test before you 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. If you decide not to do a control solution test, press ▲ again to remove CtL from

the display.



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 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 result will then appear on the display, along with CtL and the unit of measurement.



Check if the result is in range

Compare the result displayed on the meter to the control solution range printed on the test strip vial. Each vial of

test strips may have a dierent control solution range. 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.

 CAUTION: The control solution range printed on the test strip vial is for OneTouch® Ultra® Control Solution only. It is not a

recommended range for your blood glucose level.

 CAUTION: If you continue to get control solution 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 OneTouch® Customer Care 0800 121200 (UK) or 1800 535676 (Ireland).

Conrmation

Window

5.5–7.4 mmol/L

(Example)

Top

Edge

Narrow Channel

Apply drop here

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CARING FOR YOUR SYSTEM

 Caring for your system

Replacing the battery

Your OneTouch® UltraEasy® 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. A battery icon appears in the far right-

hand side of the meter display to indicate low battery.

When there is enough power for a minimum of 100 more tests, the battery icon

will appear.

After each test and when reviewing past results, the battery icon will now ash to

remind you to change the battery as soon as possible.

When the battery icon is ashing by itself on the display, you cannot perform a

test. You must install a new battery before using your meter.

Replacing the battery



Remove the old battery

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

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CARING FOR YOUR SYSTEM

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

OneTouch® Interface Cable.



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 place. Insert the two battery door tabs into the matching holes, and push

down until you hear the door click into place.

If the meter does not power on after you have replaced the battery, check that the battery is correctly

installed with the “+” side up. If the meter still does not power on, call OneTouch® Customer Care

0800 121200 (UK) or 1800 535676 (Ireland).



Check the time and date

After replacing the battery, turn the meter on by pressing and holding the ▼ button for ve seconds to access the set-up mode. The start-up

test screen will be briey displayed; then the date and time will appear in the top right corner of the display. Check that the time and date

are set correctly. If they are not, use the ▲ and ▼ buttons to re-set the meter before testing. See Setting the time and date in Section 2.

NOTE: Removing the meter battery will not aect your stored results. However, you may need to re-set the time and date.



Dispose of batteries according to your local environmental regulations

Please recycle or dispose of used batteries using your local battery collection systems and in compliance with your local

environmental laws and regulations. Batteries contain chemicals that, if released, may aect the environment and human health.

The crossed-out wheeled-bin symbol indicates the need for the separate collection for batteries.

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CARING FOR YOUR SYSTEM

 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.

 CAUTION: Do Not use your test strips if your vial is damaged or left open to air. This could lead to error messages or tests that

read higher than the actual value. Call OneTouch® Customer Care 0800 121200 (UK) or 1800 535676 (Ireland) immediately if the

test strip vial is damaged.

Caring for your system

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

Storing your system

Store your meter, test strips and control solution 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.

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 in the space provided on the label:

• Test Strips: date opened plus six (6) months

• Control Solution: date opened plus three (3) months

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CARING FOR YOUR SYSTEM

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 nine 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.

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ERROR MESSAGES AND DETAILS ABOUT YOUR SYSTEM

 Error messages and details about your system

Understanding error and other messages

The OneTouch® UltraEasy® Meter displays messages when there are problems with the test strip, with the meter, or when your

blood glucose levels are higher than 33.3 mmol/L or lower than 1.1 mmol/L. Messages do not appear in all cases when a problem

has occurred. Improper use may cause an inaccurate result without producing a warning message.

Message What it means What to do

You may have a very low

blood glucose level (severe

hypoglycaemia), lower than

1.1 mmol/L.

This may require immediate

treatment according to your

healthcare professional’s

recommendations. Although this

message could be due to a test error, it is

safer to treat rst and then do another test.

You may have a very high

blood glucose level (severe

hyperglycaemia), over

33.3mmol/L.

Re-check your glucose level. If the result

is HI again, obtain and follow instructions

from your healthcare professional without

delay.

The meter has detected that the

temperature is above the system

operating range. Do Not perform a

test until the meter and test strips

reach a temperature within the

operating range of 6–44°C.

Repeat the test after the meter and test

strips have reached a temperature within

the operating range.

The meter has detected that the

temperature is below the system

operating range. Do Not perform a

test until the meter and test strips

reach a temperature within the

operating range of 6–44°C.

Repeat the test after the meter and test

strips have reached a temperature within

the operating range.

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ERROR MESSAGES AND DETAILS ABOUT YOUR SYSTEM

Message What it means What to do

No result in memory, such as the

rst time use of the meter.

or,

Your meter was unable to recall this

result.

You can still perform a blood glucose test

and get an accurate test result. Contact

OneTouch® Customer Care 0800 121200 (UK)

or 1800 535676 (Ireland) to report this

occurrence if this is not your rst time use

of the meter.

Error message indicates there is a

problem with the meter.

Do Not use the meter.

Contact OneTouch® Customer Care

0800 121200 (UK) or

1800 535676 (Ireland).

Error message could be caused

either by a used test strip or a

problem with the meter.

Repeat the test with a new test strip; see

Section 3, Testing your blood glucose. If

this message continues to appear, contact

OneTouch® Customer Care 0800 121200 (UK)

or 1800 535676 (Ireland).

Error message indicates that the

blood or control solution sample

was applied before the meter was

ready.

Repeat the test with a new test strip.

Apply a blood or control solution sample

only after the ashing blood drop icon

appears on the display. If this message

continues to appear, contact OneTouch®

Customer Care 0800 121200 (UK) or

1800 535676 (Ireland).

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ERROR MESSAGES AND DETAILS ABOUT YOUR SYSTEM

The meter has detected a problem with

the test strip. Possible causes are test

strip damage or an incompletely lled

conrmation window.

Repeat the test with a new test strip.

Refer to blood application (see Section

3, Testing your blood glucose) or control

solution testing (see Section 5, Control

solution testing).

Meter battery is low but there is enough

power to perform a test.

When the ashing 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.

The

icon ashes on the display by itself

when there is not enough battery power

to perform a test or view previous results.

Replace the meter battery.

Message What it means What to do

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 (6–44°C).

or,

There may be a problem with the test

strip. For example, it may have been

damaged or moved during testing.

or,

The sample was improperly applied.

or,

There may be a problem with the meter.

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 this error message appears

again, contact OneTouch® Customer Care

0800 121200 (UK) or 1800 535676 (Ireland).

If you tested in a normal or warm

environment, repeat the test with a new

test strip; see Section 3, Testing your blood

glucose. If this error message appears again,

contact OneTouch® Customer Care

0800 121200 (UK) or 1800 535676 (Ireland).

If you applied the sample incorrectly, review

blood application (see Section 3, Testing

your blood glucose) or control solution

testing (see Section 5, Control solution

testing) and repeat the test with a new test

strip. If the error message appears again,

contact OneTouch® Customer Care

0800 121200 (UK) or 1800 535676 (Ireland).

If this error message appears again, contact

OneTouch® Customer Care 0800 121200 (UK)

or 1800 535676 (Ireland).

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ERROR MESSAGES AND DETAILS ABOUT YOUR SYSTEM

Detailed information about your system

Comparing meter and laboratory results

Test results with the OneTouch® UltraEasy® Meter are plasma-calibrated. This helps you and your healthcare 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® UltraEasy® Meter are approximately 12% higher. OneTouch® UltraEasy® 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® UltraEasy® 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 a ngertip can be up to 3.9 mmol/L higher than blood drawn from a vein (venous

sample) used for a lab test.

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

• You are suering from severe dehydration.

• You tested at a temperature near the low end of the operating range (6°C) and you get a high glucose result (i.e., greater than 10.0mmol/L).

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. 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.

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.

Technical specications

Reported result range 1.1–33.3 mmol/L

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 measurement mmol/L

Memory 500 blood glucose test results

Automatic shuto 2 minutes after last action

Size 10.8 x 3.20 x 1.70 cm

Weight Approximately 40 grams, with battery

Operating ranges

Temperature: 6–44°C

Altitude: up to 3048 meters

Relative humidity: 10–90%

Haematocrit: 30–55%

Battery ratings One 3.0 V d.c., 3 mA

(one CR 2032 battery)

direct current

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ERROR MESSAGES AND DETAILS ABOUT YOUR SYSTEM

Symbols

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

Direct current Low battery

Serial Number

LOT

Lot number

IVD

In vitro diagnostic medical device Expiration date

Sterilized by irradiation Storage temperature limits

Consult instructions for use

∑

Contains sucient for <n> tests

Do not reuse Manufacturer

Separate collection of batteries Recycle

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ERROR MESSAGES AND DETAILS ABOUT YOUR SYSTEM

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

Blood Sampler

LifeScan Europe

Division of Cilag GmbH

International

6300 Zug

Switzerland

Electrical and safety standards

The meter has been tested for immunity to Level 4 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. Degree of protection rating:

Minimum of IP2X. This meter complies with CISPR 11:2003, Class B (Radiated Only). Emissions of the energy used are low and are not likely to

cause interference in nearby electronic equipment.

Guarantee

LifeScan guarantees that the OneTouch® UltraEasy® 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.

The system described herein is covered by one or more of the following U.S. patents: 6,284,125, and D546,216. Use of the monitoring device

included herein is protected under one or more of the following U.S. patents: 7,250,105, 6,413,410, 6,733,655, 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® Ultra® 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.

Notes

0120

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OneTouch Ultra Easy Handleiding

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