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OneTouch Ultra Plus Flex Manual

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1
Owner's Booklet
Blood Glucose Monitoring System
Ultra
®
Plus Flex
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Thanks for choosing OneTouch®!
The OneTouchUltra Plus Flex™ Blood Glucose Monitoring
System is one of the latest product innovations from
OneTouch®.
Your OneTouchUltra Plus Flex™ Meter is designed to
connect (sync) with a variety of devices running software
applications that let you review and graph your results,
and help identify patterns. Meter results are sent to the
compatible devices either through BLUETOOTH® SMART
(wireless) or USB cable connection.
Every OneTouch® Meter is designed to help you test your
blood glucose and manage your diabetes.
This Owner's Booklet offers a complete explanation of how
to use your new meter and testing supplies. It reviews the
do's and don'ts of testing your blood glucose level. Please
keep your Owner's Booklet in a safe place; you may want
to refer to it in the future.
We hope OneTouch® products and services will continue to
be a part of your life.
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Meter symbols and icons
Meter Power
Low Battery
Battery Empty
Control Solution
Syncing
BLUETOOTH® SMART Feature On
History Mode (Past results)
Apply Sample
Range Indicator Arrow
Setting Mode
Compatible Wireless Devices
Visit www.LifeScan.co.uk for information on which wireless
devices are compatible with your OneTouchUltra Plus
Flex™ Meter, and where/how to download the software
application on your compatible wireless device.
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Other symbols and icons
Cautions and Warnings: Refer to the
Owner's Booklet and inserts that came with
your system for safety-related information.
Direct current
Consult Instructions for Use
Manufacturer
Lot Number
Serial Number
Storage Temperature Limits
In Vitro Diagnostic Device
Do Not Re-use
Sterilized by irradiation
Not for general waste
Use By Date
Contains sucient for n tests
Underwriters Laboratories certification
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5
Before you begin
Before using this product to test your blood glucose,
carefully read this Owner's Booklet, and the inserts that
come with the OneTouch Ultra® Plus Test Strips, OneTouch
Ultra® Plus Control Solutions and the OneTouch®Delica®
Lancing Device.
IMPORTANT SAFETY INSTRUCTIONS:
• This meter and lancing device are for single patient use
only. Do Not share them with anyone else, including
family members! Do Not use on multiple patients!
• After use and exposure to blood, all parts of this kit are
considered biohazardous. A used kit may potentially
transmit infectious diseases even after you have
performed cleaning and disinfection.
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Intended use
The OneTouchUltra Plus Flex™ Blood Glucose Monitoring
System is intended to be used for the quantitative
measurement of glucose (sugar) in fresh capillary whole
blood samples drawn from the fingertip. The system is
intended to be used by a single patient and should not be
shared.
The OneTouchUltra Plus Flex™ Blood Glucose Monitoring
System is intended for self-testing outside the body (in
vitro diagnostic use) by people with diabetes at home and
with their healthcare professionals in a clinical setting as
an aid to monitor the effectiveness of diabetes control.
The OneTouchUltra Plus Flex™ Blood Glucose Monitoring
System is not to be used for the diagnosis of or screening
of diabetes or for neonatal use.
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Test principle
Glucose in the blood sample mixes with the enzyme
FAD-GDH (see page100) in the test strip and a small
electric current is produced. The strength of this current
calculates your blood glucose level. It then displays the
blood glucose result and stores it in the meter memory.
Use only OneTouch Ultra® Plus Control Solutions and Test
Strips with the OneTouchUltra Plus Flex™ Meter.
BLUETOOTH® SMART wireless
technology
BLUETOOTH® SMART wireless technology is used by
some smartphones and many other devices. Your
OneTouchUltra Plus Flex™ Meter uses BLUETOOTH® SMART
wireless technology to pair and to send your glucose
results to compatible wireless devices.
The OneTouchUltra Plus Flex™ Meter is designed to work
with the OneTouchReveal® Mobile App and many other
diabetes applications on compatible wireless devices.
NOTE: Some diabetes management apps, including the
OneTouchReveal® Mobile App, may not be available in
your country. Visit www.LifeScan.co.uk to learn if the
OneTouchReveal® Mobile App is available in your country.
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Visit www.OneTouch.com for information on
which wireless devices are compatible with your
OneTouch Verio Flex™ Meter, and where/how to
download the software application on your
compatible wireless device.
When using the OneTouch Verio Flex™ System,
we suggest you pair your OneTouch Verio Flex™
Meter with a compatible wireless device and track
your results. See page 29 for pairing instructions.
Changes or modifications not expressly approved
by the party responsible for compliance could void
the user’s authority to operate the equipment.
This device complies with Part 15 of the FCC
Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful
interference and (2) this device must accept any
interference received, including interference that
may cause undesired operation.
9
These guidelines help ensure that your meter will not
affect the operation of other nearby electronic devices.
Additionally, other electronic devices should not affect the
use of your meter.
WARNING: The BLUETOOTH® SMART feature on your
meter sends test results to your compatible wireless device.
To prevent other people's results from being sent to your
compatible wireless device, Do Not let anyone else use your
meter to test their blood glucose. This meter is for single
patient use only.
WARNING: In locations where cell phone use is not
permitted, such as hospitals, some healthcare professional
oces and airplanes, you should turn the BLUETOOTH®
SMART feature o. See page27 for more information.
BLUETOOTH® SMART trademark
The BLUETOOTH® SMART word mark and logos are owned
by the Bluetooth SIG, Inc. and any use of such marks by
LifeScan Europe is under license. Other trademarks and
trade names are those of their respective owners.
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Table of Contents
 1 Getting to know your system ...................................12
 2 Setting up your system ............................................22
Setting up your meter ..................................................... 22
Connecting to a compatible wireless device ............... 27
Turning the meter off ...................................................... 33
 3 Taking a test ..............................................................34
Testing your blood glucose ............................................34
Testing with control solution..........................................58
 4 Reviewing past results ............................................68
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 5 Editing Your Settings ............................................... 74
Editing time and date ..................................................... 74
Editing your range limits ................................................ 75
 6 Caring for your system ............................................78
 7 Battery .......................................................................82
 8 Troubleshooting your system ................................. 86
 9 Detailed information about your system .............96
10 Index ........................................................................ 108
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 1 Getting to know your
system
Your OneTouchUltra Plus Flex™ Blood
Glucose Monitoring System
Included with your kit:
OneTouchUltra Plus Flex™
Meter (CR2032 lithium coin
cell battery included)
Lancing device
Lancets
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1
Getting to know your system
NOTE: If any item is missing or defective in your kit,
contact Customer Service. Call OneTouch® Customer Care
on 0800121200 (UK) or 1800535 676 (Ireland) during the
hours of 8:30am-6pm Monday-Friday, 9am-1pm Saturday.
Or visit www.LifeScan.co.uk.
NOTE: If another type of lancing device was included, see
the separate instructions for that lancing device.
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1
Getting to know your system
Available separately:
Items pictured below are required, but may not be
included in your kit:
They are sold separately. Refer to your meter carton for a
list of included items.
OneTouch Ultra®
Plus Mid Control
Solution*
(vial with blue cap)
OneTouch Ultra®
Plus High Control
Solution*
(vial with red cap)
OneTouch Ultra®
Plus Test Strips*
*OneTouch Ultra® Plus Control Solution and Test Strips
are available separately. For availability of test strips and
control solution, contact Customer Service or ask your
pharmacist or healthcare professional.
You can use either OneTouch Ultra® Plus Mid Control
Solution or OneTouch Ultra® Plus High Control Solution
with your OneTouchUltra Plus Flex™ Meter.
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1
Getting to know your system
WARNING: Keep the meter and testing supplies away
from young children. Small items such as the battery door,
batteries, test strips, lancets, protective covers on the
lancets, and control solution vial cap are choking hazards.
Do Not ingest or swallow any items.
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1
Getting to know your system
Meter
Getting to know your
OneTouchUltra Plus Flex™ Blood
Glucose Monitoring System
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1
Getting to know your system
Meter
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1
Getting to know your system
Test strip
Getting to know your OneTouch Ultra®
Plus Test Strip
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1
Getting to know your system
The Range Indicator feature
The OneTouchUltra Plus Flex™ Meter automatically
lets you know if your current result is below, above or
within your range limits. It does this by displaying your
current result with a Range Indicator Arrow, pointing to a
corresponding Range Indicator Color Bar below the meter
display. Use the Range Indicator Arrow and Color Bar
together to interpret your results.
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1
Getting to know your system
3 Possible Range Indicator Displays
A Range Indicator Arrow will
appear just below your result
after each test depending upon
how you set your low and high
range limits in the meter.
Things you should know before
using the Range Indicator feature:
• The meter comes with pre-set
range limits. The pre-set low
range limit is 3.9mmol/L and
the pre-set high range limit is
10.0mmol/L. You can change
these limits as needed to meet
your needs. See page75 for
details on the pre-set range
limits and on editing your
range limits.
• If you decide to change
your range limits, the Range
Indicator Arrows stored with
previous results in meter
memory will not change.
However, any new tests will
display Range Indicator Arrows
which reflect your changes.
Example
Below Range Result
Example
In Range Result
Example
Above Range Result
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1
Getting to know your system
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 2 Setting up your system
Setting up your meter
Turn your meter on
To turn your meter on, press
and hold until the start-up
test screen appears. Once the
device is on, release . You
can also turn the meter on by
inserting a test strip.
CAUTION:
If you see any missing segments within the start-up
screen, there may be a problem with the meter. Contact
Customer Service. Contact OneTouch® Customer Care on
0800121200 (UK) or 1800535 676 (Ireland).
NOTE: If you turned the meter on for the first time by
inserting a test strip instead of pressing
, you will not
be able to perform a glucose test until you complete the
first time setup.
Every time you turn your meter on, a start-up screen will
appear for a few seconds. All segments of the display
should appear briefly, indicating your meter is working
properly. If the meter does not power on, check the
battery.
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2
Setting up your system
First time setup
To turn your meter on, press and hold
until the start-
up screen appears. Once the device is on, release .
The meter will now automatically prompt you to set the
time and date. The SET icon will appear on the screen to
indicate that the meter has entered setup mode.
Setting the time
Hour will flash
• If the hour displayed
is correct, press
to
confirm.
• If the hour displayed is not
correct, press
or to
change the hour and press
to confirm.
Minutes will flash
• If the minutes displayed
is correct, press
to
confirm.
• If the minutes displayed is
not correct, press
or
to change the minutes and
press to confirm.
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2
Setting up your system
Setting the date
After completing the time setup, the meter will
automatically move to date setup.
Year will flash
• If the year displayed
is correct, press
to
confirm.
• If the year displayed is not
correct, press
or to
change the year and press
to confirm.
Month will flash
• If the month displayed
is correct, press
to
confirm.
• If the month displayed is
not correct, press
or
to change the month
and press to confirm.
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2
Setting up your system
Setting the date
After completing the time setup, the meter will
automatically move to date setup.
Day will flash
• If the day displayed is
correct, press
to
confirm.
• If the day displayed is not
correct, press
or to
change the day and press
to confirm.
You are now ready to take
a test. See the section
Testing your blood glucose
in Chapter 3.
NOTE: After completing first time setup, a screen with
three dashes will appear. Once you begin testing, your last
result will appear in place of the three dashes, along with
the date and time the test was taken.
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2
Setting up your system
Adjusting the time and date settings after
first time setup
You can adjust the meter's time and date settings after
first time setup. Press and hold
to turn the meter on,
then press and hold and at the same time. The SET
screen will appear. See page74.
After adjusting the settings, your meter will exit settings
mode and your last result screen will appear.
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2
Setting up your system
Connecting to a compatible wireless
device
Turning the BLUETOOTH® SMART feature
on or o
In order to connect your meter with your compatible
wireless device, the BLUETOOTH® SMART feature will
need to be turned on. The
symbol will appear on the
meter screen when the BLUETOOTH® SMART feature is
on. When the symbol is not present on the screen the
BLUETOOTH® SMART feature is off.
• To turn the BLUETOOTH® SMART feature on press
and at the same time.
• To turn the BLUETOOTH® SMART feature off press
and at the same time.
The
symbol indicates
the BLUETOOTH® SMART
feature is on
NOTE: The BLUETOOTH® SMART feature will turn OFF
during a blood glucose test.
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2
Setting up your system
Pairing Overview
Pairing allows your OneTouchUltra Plus Flex™ Meter
to communicate with compatible wireless devices. The
devices must be within 8meters of each other to pair and
sync. Download the OneTouchReveal® Mobile App from
the appropriate app store before pairing your meter and
compatible wireless device.
NOTE: Some diabetes management apps, including the
OneTouchReveal® Mobile App, may not be available in
your country. Visit www.LifeScan.co.uk to learn if the
OneTouchReveal® Mobile App is available in your country.
Multiple OneTouchUltra Plus Flex™ Meters can be paired
with your compatible wireless device. For example, your
compatible wireless device can be paired with a meter at
home and another at work. To pair multiple meters, repeat
the pairing instructions for each meter. See page29 for
pairing instructions.
Your OneTouchUltra Plus Flex™ Meter can be paired
with multiple compatible wireless devices. To pair
multiple compatible wireless devices, repeat the pairing
instructions for each compatible wireless device.
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2
Setting up your system
Pairing Instructions
1. Start by turning your meter on using the
button
2. The BLUETOOTH® SMART feature is turned on by
pressing
and together
The
symbol will appear to
indicate that the BLUETOOTH®
SMART feature is on.
3. Open the OneTouchReveal® Mobile App and follow
instructions to pair meter with your compatible
wireless device
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2
Setting up your system
4. Look for "OneTouch" and the last 4 characters of the
meter serial number on the compatible wireless device
display to correctly identify your meter
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2
Setting up your system
5. When prompted by the OneTouchReveal® Mobile App,
the meter will display a six digit PIN number
Enter the PIN number into your wireless compatible device
using the keypad on your compatible wireless device.
Example of PIN number
display on meter
CAUTION:
Make sure the PIN you enter on your compatible device
matches the PIN on your meter display. If a PIN number
unexpectedly appears on your meter display, cancel the
PIN request by either inserting a test strip to take a test or
press the
button to enter History Mode.
6. Wait for your compatible wireless device to indicate
that your meter and compatible wireless device are
paired
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2
Setting up your system
Syncing to send results wirelessly to the
OneTouchReveal® Mobile App
After pairing the meter with your compatible
wireless device, you are ready to send results to the
OneTouchReveal® Mobile App.
1. Open the OneTouchReveal® Mobile App on your
compatible wireless device
2. Press and hold
to turn the meter on and make sure
the BLUETOOTH® SMART feature is ON as indicated by ( )
If needed, press
and at the same time to turn the
BLUETOOTH® SMART feature on.
The Sync symbol (
)
flashes on the meter display.
"Syncing Data" will appear
on the app to notify you that
the meter is communicating
with the app.
Syncing Data
After syncing, the Sync symbol will disappear, the
"Syncing Data" message will disappear on the app, and
the app will display a list of any new results sent from the
meter.
NOTE: Inserting a test strip during the transmission will
cancel the transfer of all results. The flashing
symbol
appears on the screen and you can proceed with testing.
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2
Setting up your system
Turning the meter o
There are three ways to turn your meter off:
• Press and hold
for several seconds until the meter
turns off.
• Remove the test strip.
• Your meter will turn off by itself if left alone for two
minutes.
NOTE: Following a glucose test, the meter will still be
available for BLUETOOTH® SMART connection for up to
4 hours. See page69 for more details.
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Testing your blood glucose
Preparing for a blood glucose test
NOTE: Many people find it helpful to practice testing with
control solution before testing with blood for the first
time. See page58.
Have these things ready when you test:
OneTouchUltra Plus Flex™ Meter
OneTouch Ultra® Plus Test Strips
Lancing device
Sterile lancets
 3 Taking a test
NOTE:
• Use only OneTouch Ultra® Plus Test Strips.
• Unlike some blood glucose meters, no separate step
to code your OneTouchUltra Plus Flex™ System is
required.
• Testing must be done within operating temperature
range (6-44°C).
• Make sure your meter and test strips are about the
same temperature before you test.
• Keep test strips in a cool, dry place between 5°C and
30°C.
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3
Taking a test
• Do Not test if there is condensation (water build-up)
on your meter. Move your meter and test strips to a
cool, dry spot and wait for the meter surface to dry
before testing.
• 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.
• 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 return the used test strip to the vial after
performing a test.
• Do Not re-use a test strip that had blood, control
solution, or any contaminants applied to it. Test strips
are for single use only.
• With clean, dry hands, you may touch the test strip
anywhere on its surface. Do Not bend, cut or modify
the test strip in any way.
• When you first open a vial of test strips, record the
discard date on the label. Refer to the test strip insert
or vial label for instructions on determining the
discard date.
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3
Taking a test
• Comparing your blood glucose test results taken with
this meter to your results taken from a different meter
is not recommended. Results may differ between
meters and are not a useful measure of whether
your meter is working properly. To check your meter
accuracy, you should periodically compare your meter
results to those obtained from a lab. See page96 for
more information.
IMPORTANT: If another person assists you with testing,
the meter should always be cleaned prior to use by that
person. See page78.
CAUTION:
• The OneTouchUltra Plus Flex™ Blood Glucose
Monitoring System should not be used for patients
within 24 hours of receiving a D-xylose absorption test
as it may cause inaccurately high results.
• Do Not use the OneTouch Ultra Plus Flex™ Family of
Meters when PAM (Pralidoxime) is known or suspected
to be in the patient's whole blood sample.
• 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. Contact
OneTouch® Customer Care on 0800121200 (UK) or
1800535 676 (Ireland).
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3
Taking a test
• If you cannot test due to a problem with your testing
supplies, contact your healthcare 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 first,
or your results may be inaccurate.
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3
Taking a test
Getting to know your OneTouch®Delica®
Lancing Device
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3
Taking a test
NOTE:
• The OneTouch®Delica® Lancing Device uses ONLY
OneTouch®Delica® Lancets.
• If another type of lancing device was included, see the
separate instructions for that lancing device.
• The OneTouchUltra Plus Flex™ Blood Glucose
Monitoring System has not been evaluated for Alternate
Site Testing (AST). Use only fingertips when testing
with the system.
• The OneTouch®Delica® Lancing System does not
include the materials needed to perform Alternate Site
Testing (AST). The OneTouch®Delica® Lancing System
should not be used on the forearm or palm with the
OneTouchUltra Plus Flex™ Blood Glucose Monitoring
System.
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3
Taking a test
Lancing precautions
CAUTION:
To reduce the chance of infection and disease spread by
blood:
• Make sure to wash the sample site with soap and warm
water, rinse and dry before sampling.
• The lancing device is intended for a single user. Never
share a lancet or lancing device with anyone.
• Always use a new, sterile lancet each time you test.
• Always keep your meter and lancing device clean (See
page78).
• The meter and lancing device are for single patient use
only. Do Not share them with anyone, including family
members! Do Not use on multiple patients!
• After use and exposure to blood, all parts of this kit
are considered biohazardous. A used kit may transmit
infectious diseases even after you have performed
cleaning and disinfection.
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3
Taking a test
Preparing the lancing device
1. Remove the lancing device cap
Remove the cap by turning
it counterclockwise and then
pulling it straight off of the
device.
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3
Taking a test
2. Insert a sterile lancet into the lancing device
Align the lancet as shown
here, so that the lancet fits
into the lancet holder. Push
the lancet into the device
until it snaps into place and
is fully seated in the holder.
Twist the protective
cover one full turn until it
separates from the lancet.
Save the protective cover
for lancet removal and
disposal. See page55.
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3
Taking a test
3. Replace the lancing device cap
Place the cap back onto the device; turn clockwise to
secure the cap.
Do Not overtighten.
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3
Taking a test
4. Adjust the depth setting
The lancing device has seven
puncture depth settings,
numbered 1 through 7.
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.
Turn the depth wheel to choose the setting.
NOTE: A shallower fingertip puncture may be less painful.
Try a shallower setting first and increase the depth until
you find the one deep enough to get a blood sample of
the proper size.
5. Cock the lancing device
Slide the cocking control
back until it clicks. If it does
not click, it may already
have been cocked when you
inserted the lancet.
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3
Taking a test
Preparing the meter
1. Insert a test strip to turn the meter on
Insert a test strip into the test strip port with the gold side
of the test strip and the two silver prongs facing you.
NOTE: No separate step to
code the meter is required.
The flashing blood drop icon
(
) appears on the display.
You can now apply your
blood sample to the test
strip.
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3
Taking a test
Getting a blood sample from the fingertip
Choose a different puncture site each time you test.
Repeated punctures in the same spot may cause soreness
and calluses.
Before testing, wash your hands thoroughly with warm,
soapy water. Rinse and dry completely.
1. Puncture your finger
Hold the lancing device
firmly against the side of
your finger. Press the release
button. Remove the lancing
device from your finger.
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3
Taking a test
Getting a blood sample from the fingertip
Choose a different puncture site each time you test.
Repeated punctures in the same spot may cause soreness
and calluses.
Before testing, wash your hands thoroughly with warm,
soapy water. Rinse and dry completely.
1. Puncture your finger
Hold the lancing device
firmly against the side of
your finger. Press the release
button. Remove the lancing
device from your finger.
2. Get a round drop of blood
Gently squeeze and/or
massage your fingertip until
a round drop of blood forms
on your fingertip.
NOTE: If the blood smears or
runs, Do Not use that sample.
Dry the area and gently squeeze
another drop of blood or
puncture a new site.
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3
Taking a test
Applying blood and reading results
Applying the sample
1. Apply the sample to the test strip
You can apply blood to either side of the test strip.
Apply your sample to the opening of the channel.
Be sure to apply your sample immediately after you get a
drop of blood.
Holding the meter at a
slight angle, guide the
channel to the blood drop.
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3
Taking a test
Applying blood and reading results
Applying the sample
1. Apply the sample to the test strip
You can apply blood to either side of the test strip.
Apply your sample to the opening of the channel.
Be sure to apply your sample immediately after you get a
drop of blood.
When it touches your
sample, the test strip wicks
blood into the channel.
2. Wait for the channel to fill completely
The blood drop will be drawn into the narrow channel. The
channel should fill completely.
The channel turns red and the meter will count down from
5 to 1.
Blood should not be applied on the top of the test strip or
to the top edge of the test strip.
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3
Taking a test
NOTE:
• Do Not smear or scrape the sample with the test strip.
• Do Not press the test strip too firmly against the
puncture site or the channel may be blocked from filling
properly.
• 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 or
you may get an error message or the meter may turn
off.
• Do Not remove the test strip until the result is
displayed or the meter will turn off.
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3
Taking a test
Viewing your result
Your result appears on the display,
along with the unit of measure,
and the date and time of the test.
After your glucose result appears,
the meter will also display a Range
Indicator Arrow below your glucose
result to indicate if your result is
below, above or within your range
limits (see page19). The arrow
will point to the appropriate Range
Indicator Color Bar on the meter as
a visual reminder.
Example
Below Range Result
Example
In Range Result
Example
Above Range Result
CAUTION:
Do Not make immediate treatment
decisions based on the Range
Indicator feature. Treatment
decisions should be based on the
numerical result and healthcare
professional recommendation and
not solely on where your result
falls within your range limits.
WARNING: Confirm that the unit of measure mmol/L is
displayed. If your display shows mg/dL rather than mmol/L,
stop using the meter and contact Customer Service.
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3
Taking a test
Interpreting unexpected results
Refer to the following cautions when your results are
higher or lower than what you expect.
CAUTION:
Low results
If your result is below
3.9mmol/L or is shown as
LO (meaning the result is
less than 1.1mmol/L), it may
mean hypoglycemia (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 first, then do
another test.
NOTE: When your glucose result is below 1.1mmol/L, both
the LO and the Range Indicator Arrow will flash on the
meter screen.
CAUTION:
Dehydration and low results
You may get false low results if you are severely
dehydrated. If you think you are severely dehydrated,
contact your healthcare professional immediately.
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3
Taking a test
Interpreting unexpected results
Refer to the following cautions when your results are
higher or lower than what you expect.
CAUTION:
High results
• If your result is above 10.0mmol/L, it may mean
hyperglycemia (high blood glucose) and you should
consider re-testing. Talk to your healthcare professional
if you are concerned about hyperglycemia.
• HI is displayed when your
result is over 33.3mmol/L.
You may have severe
hyperglycemia (very high
blood glucose). Re-
test your blood glucose
level. If the result is HI again, this indicates a severe
problem with your blood glucose control. Obtain and
follow instructions from your healthcare professional
immediately.
NOTE: When your glucose result is above 33.3mmol/L,
both the HI and the Range Indicator Arrow will flash on
the meter screen.
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3
Taking a test
CAUTION:
Repeated unexpected results
• If you continue to get unexpected results, check your
system with control solution.
• If you are experiencing symptoms that are not
consistent with your results and you have followed
all instructions in this Owner's Booklet, call your
healthcare professional. Never ignore symptoms or
make significant changes to your diabetes management
program without speaking to your healthcare
professional.
Unusual red blood cell count
A hematocrit (percentage of your blood that is red blood
cells) that is either very high (above 60%) or very low
(below 20%) can cause false results.
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3
Taking a test
Removing the used lancet
NOTE: This lancing device has an ejection feature, so you
do not have to pull out the used lancet.
1. Remove the lancing device cap
Remove the cap by turning
it counterclockwise and then
pulling it straight off of the
device.
2. Cover the exposed lancet tip
Before removing the lancet, place the lancet protective
cover on a hard surface then push the lancet tip into the
cupped side of the cover.
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3
Taking a test
3. Eject the lancet
Slide the ejection control
forward until the lancet
comes out of the lancing
device. Return the ejection
control to its back position.
If the lancet fails to eject
properly, cock the device
again and then slide the
ejection control forward until
the lancet comes out.
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3
Taking a test
4. Replace the lancing device cap
Place the cap back onto the device; turn clockwise to
secure the cap.
Do Not overtighten.
It is important to use a new lancet each time you obtain a
blood sample. Do Not leave a lancet in the lancing device.
This will help prevent infection and sore fingertips.
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3
Taking a test
Disposing of the used lancet and test strip
Discard the used lancet carefully after each use to avoid
unintended lancet stick injuries. Used lancets and test
strips may be considered biohazardous waste in your
area. Be sure to follow your healthcare professional's
recommendations or local regulations for proper disposal.
Wash hands thoroughly with soap and water after
handling the meter, test strips, lancing device and cap.
Testing with control solution
Control solution testing precautions
OneTouch Ultra® Plus Control Solution is used to check that
the meter and test strips are working together properly
and that the test is performing correctly. (Control solution
is available separately.)
NOTE:
• Use only OneTouch Ultra® Plus Mid Control Solution or
OneTouch Ultra® Plus High Control Solution with your
OneTouchUltra Plus Flex™ Meter. Either level can be
used to check your system.
• When you first open a new vial of control solution,
record the discard date on the vial label. Refer to the
control solution insert or vial label for instructions on
determining the discard date.
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3
Taking a test
• Tightly close the cap on the control solution vial
immediately after use to avoid contamination or
damage.
See page34 for more information on testing.
CAUTION:
• Do Not swallow or ingest control solution.
• Do Not apply control solution to the skin, eyes, ears or
nose as it may cause irritation.
• Do Not use control solution after the expiration
date (printed on the vial label) or the discard date,
whichever comes first, or your results may be
inaccurate.
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3
Taking a test
When to do a control solution test
• When you open a new vial of test strips.
• If you suspect that the meter or test strips are not
working properly.
• If you have had repeated unexpected blood glucose
readings.
• If you drop or damage the meter.
Preparing your meter for a control solution
test
1. Insert a test strip to turn the meter on
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3
Taking a test
Preparing your meter for a control solution
test
1. Insert a test strip to turn the meter on
Preparing the control solution
1. Before removing the cap, shake the vial gently
2. Remove the vial cap and place it on a flat surface with
the top of the cap pointing up
3. Squeeze the vial to discard
the first drop
2. Wait for the flashing blood
drop icon (
) to appear on
the display
3. Press
or until the
control solution icon ( )
appears on the display
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3
Taking a test
4. Wipe both the tip of the
control solution vial and the
top of the cap with a clean,
damp tissue or cloth
5. Squeeze a drop into the
small well on the top of the
cap or onto another clean,
non-absorbent surface
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3
Taking a test
Applying the control solution
1. Hold the meter so that the
side edge of the test strip is
at a slight angle to the drop
of control solution
3. Wait for the channel to fill
completely
2. Touch the channel on the side of the test strip to the
control solution
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3
Taking a test
Viewing your control solution result
After the control solution
is applied, the meter will
count down until the test
is complete. Your result is
displayed along with the date,
time, unit of measure, and
(for control solution) and stored in the meter.
Control solution results can be seen when reviewing past
results on the meter.
CAUTION: Make sure you press or until the control
solution icon
appears before you begin a control solution
test. Invalid results may be logged into your history if you
applied control solution to the test strip without following the
steps beginning on page60.
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3
Taking a test
Checking if the result is in range
Example range
OneTouch Ultra® Plus Mid
Control Solution Control
Range 5.7-7.7mmol/L
OneTouch Ultra® Plus High
Control Solution Control
Range 16.5-22.4mmol/L
Compare the result
displayed on the meter to
the range printed on your
OneTouch Ultra® Plus
Control Solution vial.
If your control solution
result falls outside the
expected range, repeat
the test with a new test
strip.
CAUTION:
The range printed on the control solution vial is for control
solution tests only and is not a recommended range for
your blood glucose level.
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3
Taking a test
Causes of out-of-range results
Out-of-range results may be due to:
• Not following the instructions for performing a control
solution test.
• Control solution is contaminated, expired, or past its
discard date.
• Test strip or test strip vial is damaged, expired, or past
its discard date.
• Meter, test strips and/or control solution were not all at
the same temperature when the control solution test
was performed.
• A problem with the meter.
• Dirt or contamination in the small well on the top of the
control solution cap.
CAUTION:
If you continue to get control solution results that fall
outside the range printed on the control solution vial, Do
Not use the meter, test strips, or control solution. Contact
Customer Service. Contact OneTouch® Customer Care on
0800121200 (UK) or 1800535 676 (Ireland).
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3
Taking a test
Cleaning the control solution cap
Clean the top of the control solution cap with a clean,
damp tissue or cloth.
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 4 Reviewing past results
2. Scroll through your results by pressing to move
backwards and to move forward through your results
Reviewing past results on your meter
Your meter stores your most recent 500 blood glucose and
control solution test results and displays them in the order
the tests were taken. The ( ) symbol will appear on your
screen when in History Mode.
1. When the meter is o, press and hold to turn
History Mode on
The (
) symbol indicates you are viewing your past
results.
The (
) symbol indicates if the result was below,
above or within range at the time of the test, by pointing
to the appropriate color bar.
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4
Reviewing past results
Using the meter without syncing to
an app
The meter can be used without a compatible wireless
device or the app. You can still test your blood glucose
and review up to 500 results on the meter.
Sending your results to the app
If the BLUETOOTH® SMART feature on the meter is turned
on, indicated by the BLUETOOTH® SMART symbol ( ),
the meter will automatically send the latest result to
any paired wireless compatible device. The compatible
wireless device must have the app running and have
already been paired to the meter before sending a result.
NOTE: The compatible wireless device must have the app
open and have already been paired to the meter before
sending a result. See page28.
NOTE: If the BLUETOOTH® SMART feature on the meter is
turned off, or the meter is out of range, the result is not
sent to the compatible wireless device. The result is saved
in the meter memory with the current date and time, and
will be sent to the app the next time you sync. The sent
results are also stored in the meter. To sync, the app must
be open and running on your compatible wireless device.
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4
Reviewing past results
To ensure that glucose test results are successfully sent
to the app, turn on the BLUETOOTH® SMART feature and
check the following:
• The compatible wireless device and meter are both
turned on, and the app is running.
• The meter is correctly paired with your compatible
wireless device.
• The Bluetooth feature on both devices is running
(indicated by
) and the devices are within 8meters of
each other.
• The meter will attempt to transmit results up to 4 hours
after a test, even if the meter appears to be off. This
is indicated by the BLUETOOTH® SMART symbol (
)
remaining on the meter screen.
Example
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4
Reviewing past results
If you are still unable to send results to the compatible
wireless device, please call Customer Service. Contact
OneTouch® Customer Care on 0800121200 (UK) or
1800535 676 (Ireland).
NOTE: Inserting a test strip during the transmission will
cancel the transfer of all results. The
symbol appears on
the screen and you can proceed with testing.
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4
Reviewing past results
Downloading results to a computer
Your meter can work with diabetes management software,
which provides a visual way to track key factors that
affect your blood sugar. To learn more about diabetes
management tools available to you, contact Customer
Service. Call OneTouch® Customer Care on 0800121200
(UK) or 1800535 676 (Ireland) during the hours of
8:30am-6pm Monday-Friday, 9am-1pm Saturday. Or visit
www.LifeScan.co.uk.
Connect only to a computer certified to UL 60950-1 (
).
To transfer meter data, follow the instructions provided
with the diabetes management software product to
download the results from the meter. You will need a
standard micro USB interface cable to connect your
OneTouchUltra Plus Flex™ Meter to a computer to
download results (not included).
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4
Reviewing past results
Downloading results to a computer
Your meter can work with diabetes management software,
which provides a visual way to track key factors that
affect your blood sugar. To learn more about diabetes
management tools available to you, contact Customer
Service. Call OneTouch® Customer Care on 0800121200
(UK) or 1800535 676 (Ireland) during the hours of
8:30am-6pm Monday-Friday, 9am-1pm Saturday. Or visit
www.LifeScan.co.uk.
Connect only to a computer certified to UL 60950-1 (
).
To transfer meter data, follow the instructions provided
with the diabetes management software product to
download the results from the meter. You will need a
standard micro USB interface cable to connect your
OneTouchUltra Plus Flex™ Meter to a computer to
download results (not included).
Once the command to start
the download is sent from the
computer to the meter, the
meter display will show the
flashing Sync symbol ( )
indicating that the meter is in
communication mode.
Do Not insert a test strip while the meter is connected to
a computer.
If you are unable to download your results to a computer,
please call Customer Service. Contact OneTouch® Customer
Care on 0800121200 (UK) or 1800535 676 (Ireland).
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 5 Editing Your Settings
Editing time and date
You can adjust the meter's time and date settings after
first time setup. Press and hold to turn the meter on,
then press and hold and at the same time. The SET
screen will appear, and the hour will flash.
For instructions on adjusting the time and date, see
page23.
After adjusting the settings, you will exit settings mode
and your last glucose result screen will appear. The
adjusted time and date will be displayed once a new
glucose test has been completed and the result appears on
the screen.
NOTE: You will not be able to perform a blood glucose test
until you finish editing the time and date.
NOTE: The OneTouchReveal® Mobile App on your
compatible wireless device checks and updates the time
and date in your meter each time you sync. Check the time
and date often on your compatible wireless device to be
sure they are correct. See the App instructions for more
information.
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5
Editing Your Settings
Editing your range limits
Your meter uses low and high range limits to tell you
when your result is below, above or within your set range.
The meter comes with pre-set range limits that can be
changed. The pre-set low range limit is 3.9mmol/L and
the pre-set high range limit is 10.0mmol/L. To edit the
pre-set range limits press and hold and at the
same time. The SET screen will appear with the current
low range limit displayed, and the number and range
indicator arrow will flash.
NOTE: The low and high range limits you set apply to
all glucose test results. This includes tests taken before
or after mealtimes, medications and around any other
activities that may affect your blood glucose.
CAUTION:
Be sure to talk to your healthcare professional about the
low and high range limits that are right for you. When
selecting or changing your limits, you should consider
factors such as your lifestyle and diabetes therapy. Never
make significant changes to your diabetes care plan
without consulting your healthcare professional.
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5
Editing Your Settings
1. Review the pre-set low range limit displayed
• To accept the pre-set low
range limit, press
.
• To edit the pre-set
low range limit, press
or to change
the value between
3.3mmol/L-6.1mmol/L, and
then press .
2. Review the pre-set high range limit displayed
• To accept the pre-set high
range limit, press
.
• To edit the pre-set
high range limit, press
or to change
the value between
5.0mmol/L-16.7mmol/L,
and then press .
Your meter will exit settings mode and your last result
screen will appear.
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5
Editing Your Settings
NOTE: If you change your range limits, this will only affect
whether future test results are displayed as below, above
or within your range limits. Changing your range limits
does not affect how past results are displayed.
NOTE: You will not be able to perform a glucose test until
you finish editing the range limits.
NOTE: You can use the OneTouchReveal® Mobile App on
your compatible wireless device to change the range limits
stored in your meter. See the instructions that came with
the app for more information.
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 6 Caring for your system
Cleaning and disinfection
Cleaning and disinfection are different and both should
be performed. Cleaning is part of your normal care
and maintenance and should be performed prior to
disinfection, but cleaning does not kill germs. Disinfection
is the only way to reduce your exposure to disease. For
cleaning information, see page78 and for disinfecting
information, see page80.
Storing your system
Store your meter, test strips, control solution and other
items in your carrying case. Keep in a cool, dry place
between 5°C and 30°C. Do Not refrigerate. Keep all items
away from direct sunlight and heat.
Cleaning your meter, lancing device
and cap
The meter, lancing device and cap should be cleaned
whenever they are visibly dirty and before disinfection.
Clean your meter at least once per week. For cleaning
obtain regular strength liquid dish soap and a soft cloth.
Prepare a mild detergent solution by stirring 2.5mL of
regular strength liquid dish soap into 250mL of water.
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6
Caring for your system
Cleaning your meter, lancing device
and cap
The meter, lancing device and cap should be cleaned
whenever they are visibly dirty and before disinfection.
Clean your meter at least once per week. For cleaning
obtain regular strength liquid dish soap and a soft cloth.
Prepare a mild detergent solution by stirring 2.5mL of
regular strength liquid dish soap into 250mL of water.
• Do Not use alcohol or any other solvent.
• Do Not allow liquids, dirt, dust, blood or control
solution to enter the test strip port or the data port.
(See page16.)
• Do Not spray cleaning solution
on the meter or immerse it in
any liquid.
1. Holding the meter with the test strip port pointed
down, use a soft cloth dampened with water and mild
detergent to wipe the outside of the meter and lancing
device
Be sure to squeeze out any
excess liquid before you wipe
the meter. Wipe the outside of
the cap.
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6
Caring for your system
Disinfecting your meter, lancing device
and cap
The meter, lancing device and cap should be disinfected
periodically. Clean your meter, lancing device and cap
prior to disinfecting. For disinfecting, obtain regular
household bleach (containing a minimum of 5.5% sodium
hypochlorite as the active ingredient)*. Prepare a solution
of 1 part household bleach and 9 parts water.
*Follow manufacturer’s instruction for handling and
storage of bleach.
2. Wipe dry with a clean,
soft cloth
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6
Caring for your system
Disinfecting your meter, lancing device
and cap
The meter, lancing device and cap should be disinfected
periodically. Clean your meter, lancing device and cap
prior to disinfecting. For disinfecting, obtain regular
household bleach (containing a minimum of 5.5% sodium
hypochlorite as the active ingredient)*. Prepare a solution
of 1 part household bleach and 9 parts water.
*Follow manufacturer’s instruction for handling and
storage of bleach.
1. Hold the meter with the test strip port pointed down
Use a soft cloth dampened
with this solution to wipe
the outside of the meter
and lancing device until the
surface is damp. Be sure to
squeeze out any excess liquid
before you wipe the meter.
2. After wiping, cover the surface you are disinfecting
with the soft cloth dampened with the bleach solution
for 1 minute
Wash hands thoroughly with
soap and water after handling
the meter, lancing device and
cap.
If you see signs of wear, please contact Customer Service.
Contact OneTouch® Customer Care on 0800121200 (UK)
or 1800535 676 (Ireland).
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 7 Battery
Replacing the battery
Your OneTouchUltra Plus Flex™ Meter uses one CR2032
lithium coin cell battery.
IMPORTANT: Use only one CR2032 lithium coin cell battery
with your meter. Do Not use rechargeable batteries. Use
of an incorrect battery type may result in your meter
providing fewer tests than normal.
If the meter does not turn on, you may need to replace the
battery. See below for instructions.
WARNING: Certain batteries may cause leaking which can
damage the meter or cause the battery to lose power sooner
than normal. Replace leaking battery immediately.
NOTE: After replacing the battery, you will be prompted
to set time and date, as if you are turning the meter on for
the first time.
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7
Battery
Replacing the battery
Your OneTouchUltra Plus Flex™ Meter uses one CR2032
lithium coin cell battery.
IMPORTANT: Use only one CR2032 lithium coin cell battery
with your meter. Do Not use rechargeable batteries. Use
of an incorrect battery type may result in your meter
providing fewer tests than normal.
If the meter does not turn on, you may need to replace the
battery. See below for instructions.
1. Remove the old battery
Start with the meter turned off.
Remove the battery cover by
sliding it downward.
Pull up on the battery ribbon
to lift the battery out of the
compartment.
Do Not remove the battery while
the meter is connected to a
computer.
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7
Battery
3. Replace battery cover by
sliding it upwards onto the meter
2. Insert the new battery
Insert one CR2032 lithium coin
cell battery on top of the battery
ribbon, with the plus (+) side up.
If the meter does not power on after you have replaced
the meter battery, check that the battery is correctly
installed. If the meter still does not power on, contact
Customer Service. Contact OneTouch® Customer Care on
0800121200 (UK) or 1800535 676 (Ireland).
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7
Battery
5. Dispose of battery
Dispose of the battery according to your local
environmental regulations.
4. Check your meter settings
Removing the meter battery will not affect your stored
results. However, you will need to check your date and
time settings.
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 8 Troubleshooting your
system
Error and other messages
The OneTouchUltra Plus Flex™ Meter displays messages
when there are problems with the test strip, with the
meter or when your glucose levels are above 33.3mmol/L
or below 1.1mmol/L. Improper use may cause an
inaccurate result without producing an error message.
NOTE: If the meter is on but does not operate (locks-up),
contact Customer Service. Contact OneTouch® Customer
Care on 0800121200 (UK) or 1800535 676 (Ireland).
What it means
You may have a very
low blood glucose level
(severe hypoglycemia),
below 1.1mmol/L.
NOTE: When your glucose result is below 1.1mmol/L, both
the LO and the Range Indicator Arrow will flash on the
meter screen.
What to do
This may require immediate treatment. Although this
message could be due to a test error, it is safer to treat
first and then do another test. Always treat according to
your healthcare professional’s recommendations.
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Troubleshooting your system
8
What it means
You may have a very
high blood glucose level
(severe hyperglycemia),
over 33.3mmol/L.
NOTE: When your glucose result is above 33.3mmol/L,
both the HI and the Range Indicator Arrow will flash on
the meter screen.
What to do
Re-test your blood glucose level. If the result is HI
again, obtain and follow instructions from your healthcare
professional right away.
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What it means
Meter is too hot (above 44°C)
to perform a test.
What to do
Move the meter and test strips to a cooler area. Insert a
new test strip when the meter and test strips are within
the operating range (6-44°C). If you do not get another
HI .t message, you can proceed with testing.
If this message continues to appear, contact Customer
Service. Contact OneTouch® Customer Care on
0800121200 (UK) or 1800535 676 (Ireland).
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What it means
Meter is too cold (below 6°C)
to perform a test.
What to do
Move the meter and test strips to a warmer area. Insert a
new test strip when the meter and test strips are within
the operating range (6-44°C). If you do not get another
LO.t message, you can proceed with testing.
If this message continues to appear, contact Customer
Service. Contact OneTouch® Customer Care on
0800121200 (UK) or 1800535 676 (Ireland).
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Troubleshooting your system
8
Example Error
Screen Code
Error Screens
If there is a problem with your meter, there are six possible
error screens that may appear. Along with an error
number, there is also an error code in the upper left corner
of your meter screen. If you cannot resolve the error with
your meter, contact Customer Service. Contact OneTouch®
Customer Care on 0800121200 (UK) or 1800535 676
(Ireland). They will refer to the error number and code to
help troubleshoot the problem.
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What it means
There is a problem with
the meter.
What it means
Error message could be
caused either by a used test
strip or a problem with the
meter or test strip.
What to do
Do Not use the meter. Contact Customer Service. Contact
OneTouch® Customer Care on 0800121200 (UK) or
1800535 676 (Ireland).
What to do
Repeat the test with a new test strip; see page48 or
page63. If this message continues to appear, contact
Customer Service. Contact OneTouch® Customer Care on
0800121200 (UK) or 1800535 676 (Ireland).
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What it means
The sample was applied
before the meter was ready.
What to do
Repeat the test with a new test strip. Apply a blood or
control solution sample only after the flashing
symbol
appears on the display. If this message continues to
appear, contact Customer Service. Contact OneTouch®
Customer Care on 0800121200 (UK) or 1800535 676
(Ireland).
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8
What it means
One of the following may
apply:
• Not enough blood or
control solution was
applied or more was added
after the meter began to
count down.
• The test strip may have been damaged or moved
during testing.
• The sample was improperly applied.
• There may be a problem with the meter.
What to do
Repeat the test with a new test strip; see page48 or
page63. If the error message appears again, contact
Customer Service. Contact OneTouch® Customer Care on
0800121200 (UK) or 1800535 676 (Ireland).
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What it means
Meter battery power is low
but there is still enough
battery power to perform
a test. The flashing low
battery (
) icon will
continue to appear until the
battery is replaced.
What to do
Replace the meter battery soon.
What it means
The meter has detected a
problem with the test strip.
Possible cause is test strip
damage.
What to do
Repeat the test with a new test strip; see page48 or
page63. If the error message appears again, contact
Customer Service. Contact OneTouch® Customer Care on
0800121200 (UK) or 1800535 676 (Ireland).
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8
What it means
There is not enough battery
power to perform a test.
What to do
Replace the battery immediately.
What it means
No result in memory, such
as the first time use or when
you have chosen to delete all
the results after downloading
to a computer.
What to do
Contact Customer Service to report this occurrence,
unless this is your first use of the meter. You can still
perform a blood glucose test or control solution test and
get an accurate result. Contact OneTouch® Customer Care
on 0800121200 (UK) or 1800535 676 (Ireland).
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 9 Detailed information
about your system
Comparing meter results to laboratory
results
Results obtained from the OneTouchUltra Plus Flex™
Meter and laboratory tests are reported in plasma-
equivalent units. However, your meter result may differ
from your lab result due to normal variation. A result
from your OneTouchUltra Plus Flex™ Meter is considered
accurate when it is within TBDmmol/L of a laboratory
method when the glucose concentration is lower than
TBDmmol/L and within TBD of laboratory method when
the glucose concentration is TBDmmol/L or higher.
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9
Meter results can be affected by factors that do not affect
lab results in the same way. Specific factors that may
cause your meter result to vary from your lab result may
include:
• You have eaten recently. This can cause a result from
fingertip testing to be up to 3.9mmol/L higher than a
lab test using blood drawn from a vein.
1
• Your hematocrit is above 60% or below 20%.
• You are severely dehydrated.
For additional information, refer to the OneTouch Ultra®
Plus Test Strip Insert.
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.
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Guidelines for obtaining an accurate
meter to lab comparison
Before going to the lab:
• Perform a control solution test to make sure your meter
is working properly.
• Do Not eat for at least 8 hours before you test your
blood.
• Take your meter and testing supplies with you to the
lab.
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Testing with your OneTouchUltra Plus
Flex™ Meter at the lab:
• Test within 15 minutes of the lab test.
• Use only a fresh, capillary blood sample from your
fingertip.
• Follow all instructions in this Owner's Booklet for
performing a blood glucose test.
Comparing your meter results to those
taken from another meter
Comparing your blood glucose test results taken with this
meter to your results taken from a different meter is not
recommended. Results may differ between meters and are
not a useful measure of whether your meter is working
properly.
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Technical specifications
Assay method FAD-GDH (flavin adenine dinucleotide
dependent glucose dehydrogenase)
Automatic shuto Two minutes after last action
Battery ratings 3.0 V d.c. (CR2032 lithium coin cell
battery),
Battery type One replaceable 3.0 Volt CR2032
lithium coin cell battery (or equivalent)
BLUETOOTH® SMART
Technology
Frequency range: 2.4-2.4835 GHz
Operating Range Distance: minimum
8meters (unobstructed)
Operating Channels: 40 Channels
Security Encryption: 128-bit AES
(Advanced Encryption Standard)
Calibration Plasma-equivalent
Data port type Compatible with USB 2.0
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Memory 500 test results
Operating ranges Temperature: 6-44°C
Relative humidity: non-condensing
10-90%
Altitude: up to 3048meters
Hematocrit: 20-60%
Reported result range 1.1-33.3mmol/L
Sample Fresh capillary whole blood
Sample volume 0.4µL
Size 52.0(W) x 86.0(L) x 16.0(T)mm
Test time 5 seconds
Unit of measure mmol/L
Weight Approximately 50grams
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9
System Accuracy
Diabetes experts have suggested that glucose meters
should agree within TBDmmol/L of a laboratory method
when the glucose concentration is lower than TBDmmol/L,
and within TBD of a laboratory method when the glucose
concentration is TBDmmol/L or higher.
Samples from TBD patients were tested using both the
OneTouchUltra Plus Flex™ System and the YSI 2300
Glucose Analyzer laboratory instrument.
System Accuracy Results for Glucose
Concentrations <TBDmmol/L
Percent (and number) of meter results that match the
laboratory test
Within
±TBDmmol/L
Within
±TBDmmol/L
Within
±TBDmmol/L
TBD TBD TBD
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System Accuracy Results for Glucose
Concentrations ≥TBDmmol/L
Percent (and number) of meter results that match the
laboratory test
Within ±TBD Within ±TBD Within ±TBD
TBD TBD TBD
System Accuracy Results for Glucose
Concentrations between TBDmmol/L
and TBDmmol/L
Within ±TBDmmol/L or ±TBD
TBD
NOTE: Where TBDmmol/L represents the lowest glucose
reference value and TBDmmol/L represents the highest
glucose reference value (YSI value).
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9
Regression Statistics
Samples were tested in duplicate on each of three test
strip lots. Results indicate that the OneTouchUltra Plus
Flex™ System compares well with a laboratory method.
# of Subjects # of Tests Slope Intercept
(mmol/L)
TBD TBD TBD TBD
95% CI
Slope
95% CI
Intercept
(mmol/L)
Std. Error
(S
y.x
)
(mmol/L)
R
2
TBD TBD TBD TBD
User Performance Accuracy
A study evaluating glucose values from fingertip capillary
blood samples obtained by TBD lay persons showed the
following results:
TBD% within ±TBDmmol/L of the medical laboratory
values at glucose concentrations below TBDmmol/L, and
TBD% within ±TBD% of the medical laboratory values at
glucose concentrations at or above TBDmmol/L.
TBD% of the total number of samples were within
±TBDmmol/L or ±TBD% of the medical laboratory values.
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Precision
Within Run Precision (TBD Venous Blood Samples Tested
per Glucose Level)
Data generated using the OneTouchUltra Plus Flex™ Meter.
Target
Glucose
(mmol/L)
Mean
Glucose
(mmol/L)
Standard
Deviation
(mmol/L)
Coecient
of Variation
(%)
TBD TBD TBD TBD
TBD TBD TBD TBD
TBD TBD TBD TBD
TBD TBD TBD TBD
TBD TBD TBD TBD
Results show that the greatest variability observed
between test strips when tested with blood is TBDmmol/L
SD or less at glucose levels less than TBDmmol/L, or
TBD% CV or less at glucose levels at TBDmmol/L or above.
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106
Detailed information about your system
9
Total Precision (TBD Control Solution Tests per Glucose
Level)
Data generated using the OneTouchUltra Plus Flex™ Meter.
Glucose
Level Ranges
(mmol/L)
Mean
Glucose
(mmol/L)
Standard
Deviation
(mmol/L)
Coecient
of Variation
(%)
Low
(TBD)
TBD TBD TBD
Mid
(TBD)
TBD TBD TBD
High
(TBD)
TBD TBD TBD
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Yellow= 5mm Red=7mm margin
05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 106 1/27/15 4:35 PM
107
Detailed information about your system
9
Guarantee
LifeScan guarantees that the OneTouchUltra Plus Flex™
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.
Electrical and safety standards
This meter complies with CISPR 11: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 electrostatic
discharge as specified in IEC 61326-2-6. This meter
complies with immunity to radio frequency interference as
specified in IEC 61326-1 and 61326-2-6.
The meter meets the requirements for immunity to
electrical interference at the frequency range and test level
specified in international standard ISO 15197.
Do Not use the equipment where aerosol sprays are being
used, or when oxygen is being administered.
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Yellow= 5mm Red=7mm margin
05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 107 1/27/15 4:35 PM
108
AST 39
Batteries 82
Batteries, replacing 82
Battery empty icon 3
Battery empty warning 95
Battery low icon 3, 94
BLUETOOTH SMART feature 9, 12, 27, 69
BLUETOOTH® SMART feature 7
Buttons on meter 18
Cleaning your meter, lancing device and cap 78
Comparing meter results to laboratory results 96
Compatible wireless devices 3
Control solution 60
Control solution, discard and expiration dates 58, 59
Control solution, testing 58, 64, 66
Data port 18
Date setting 24, 26
Dehydration 52, 97
Disinfecting your meter, lancing device and cap 80
Display check 22
Disposal, lancets and test strips 58
Downloading results to a computer 72
Edit date 74
Edit range limits 75
10 Index
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Yellow= 5mm Red=7mm margin
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109
Index
10
Edit time 74
Error messages 86
EXTREME HIGH GLUCOSE message 53, 87
EXTREME LOW GLUCOSE message 52, 86
Fingertip testing procedure 34
First time setup 23, 28
Guarantee 107
Hyperglycemia 53, 87
Hypoglycemia 52, 86
Icons 3, 4
Infection, reduce the chance 40
Intended use 6
Kit components 12
Lancing device 12, 39, 41, 78
mmol/L 18, 101
Pairing 28, 29
PIN 31
Plasma calibration 96, 100
Range Indicator feature 19
Range limits setting 75
Results, reviewing past 68
Serial number 31
Settings 23, 26, 74
Software, diabetes management 72
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Yellow= 5mm Red=7mm margin
05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 109 1/27/15 4:35 PM
110
Index
10
Start-up screen 22
Storing your system 78
Symbols 3, 4
Syncing 32, 69
Technical specifications 102
Temperature 34, 66, 78, 88, 89, 101
Test principle 7
Test strip 19, 45, 60
Test strip, applying drop of blood 48
Test strip, discard and expiration dates 35
Test strip, silver prongs 19
Time setting 23, 26
Turning meter off 33
Turning meter on 22, 45, 60
Unexpected results 52, 54
Unit of measure 18, 101
Unusual red blood cell count (hematocrit) 97, 101
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Yellow= 5mm Red=7mm margin
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111
Notes
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Yellow= 5mm Red=7mm margin
05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 111 1/27/15 4:35 PM
112
Notes
Yellow= 5mm Red=7mm margin
05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 112 1/27/15 4:35 PM
Template, OneTouch Ultra Plus Flex, Owner's Booklet, 1L
AW 05983201A
GC 059832
ADS-03 / LCB-01a
01/27/15
R. Muolic
28696
4
GC AW Template Title:
GC AW Template Number:
GC Document Number:
ADS Reference Number:
Rev. Date:
LifeScan Contact:
Job No:
Number of Colors:
FXT Desktop
Round
Two SStein
- 01-27-15
- SStein
Notes:
Font size ranges from 9pt to 15pt
CMYK
N/A
ForeignExchange Translations
ForeignExchange Translations
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05983201A_OT_UPF_OB_mmolL_Inside_R2.indd 1 1/27/15 4:35 PM
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  • How to restart this product after changging the battery. Submitted on 27-12-2022 at 12:03

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