Cilag Z ONE TOUCH Verio Flex / Blood Glucose Monitoring System User Manual

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Document ID	2510367
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Document Description	User Manual
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Permanent Confidential	No
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Document Type	User Manual
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Date Submitted	2015-01-22 00:00:00
Date Available	2015-07-21 00:00:00
Creation Date	2015-01-12 10:52:51
Producing Software	Adobe PDF Library 10.0.1
Document Lastmod	2015-01-13 16:24:50
Document Title	User Manual
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Contents covered by one or more of the following U.S. patents: 6,179,979,
6,193,873, 6,284,125, 6,716,577, 6,749,887, 6,797,150, 6,863,801, 6,872,298,
7,045,046, 7,498,132, 7,846,312, 8,449,740, 8,529,751 and 8,398,664. Use of the
monitoring device included herein is protected under one or more of the following
U.S. patents: 6,413,410, 6,890,421, 8,163,162, 7,749,371, 8,449,740 and 8,529,751.
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 Verio®
Test Strip. 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.
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As your partner in diabetes care, we welcome you to contact us
(7 days a week, 8 a.m. - 10 p.m. Eastern Time) at 1 888 567-3003
(English), 1 888 567-3010 (Español), or www.OneTouch.com.
PF 3125983 Rev 1
© 2015 LifeScan, Inc.
Rev. Date: 10/2014
PF 3125983 Rev 1
Manufactured by:
LifeScan Europe
Division of Cilag
GmbH International
Gubelstrasse 34
6300 Zug
Switzerland
Meter made in China.
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Blood Glucose Monitoring System
Owner's
Booklet
Instructions
for Use
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PMS
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Language Sequence: English
CMYK
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Process Colors
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CPS Reference No.: Refer to References Section in Enable for CPS No.
PF No./Rev.: 3125983 Rev 1
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Description: Booklet, Owners, OTVF, US (zug)
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Special Instructions
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No. of sides: 1
Inside No. of pages:
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Rev. Date: 12-Jan-15
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No. of Covers: 4
JDE Item No.: N/A
LFS Contact: Susan Cabral
Art Agency: ForeignExchange Translations Job No.: 25677
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Blood Glucose Monitoring System
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Owner's Booklet
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Thanks for choosing OneTouch®!
The OneTouch Verio Flex™ Blood Glucose Monitoring
System is one of the latest product innovations from
OneTouch®.
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Your OneTouch Verio 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.
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Every OneTouch® Meter is designed to help you test your
blood glucose and manage your diabetes.
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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.
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We hope OneTouch® products and services will continue to
be a part of your life.
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Compatible Wireless Devices
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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.
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Meter Power
Meter symbols and icons
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Low Battery
Battery Empty
Control Solution
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Syncing
BLUETOOTH® SMART Feature On
History Mode (Past results)
Apply Sample
Range Indicator Arrow
Setting Mode
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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.
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Direct current
Before you begin
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Before using this product to test your blood
glucose, carefully read this Owner's Booklet, and
the inserts that come with the OneTouch Verio® Test
Strips, OneTouch Verio® Control Solution and the
OneTouch® Delica® Lancing Device.
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IMPORTANT SAFETY INSTRUCTIONS:
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• 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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For more information see: FDA Public Health Notification:
"Use of Fingerstick Devices on More than One Person
Poses Risk for Transmitting Bloodborne Pathogens:
Initial Communication" (2010) http://www.fda.gov/
MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
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CDC Clinical Reminder: "Use of Fingerstick Devices
on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens" (2010) http://www.cdc.gov/
injectionsafety/Fingerstick-DevicesBGM.html.
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Intended use
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The OneTouch Verio 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.
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The OneTouch Verio Flex™ Blood Glucose Monitoring
System is intended for self-testing outside the body
(in vitro diagnostic use) by people with diabetes at home
as an aid to monitor effectiveness of diabetes control. The
OneTouch Verio 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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The OneTouch Verio Flex™ Blood Glucose Monitoring
System is not for use on critically ill patients, patients in
shock, dehydrated patients or hyperosmolar patients.
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Test principle
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Glucose in the blood sample mixes with the enzyme
FAD-GDH (see page 103) 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.
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Use only OneTouch Verio® Control Solution and Test
Strips with the OneTouch Verio Flex™ Meter.
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BLUETOOTH® SMART wireless
technology
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BLUETOOTH® SMART wireless technology is used by
some smartphones and many other devices. Your
OneTouch Verio Flex™ Meter uses BLUETOOTH® SMART
wireless technology to pair and to send your glucose
results to compatible wireless devices.
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The OneTouch Verio Flex™ Meter is designed to work with
the OneTouch Reveal® Mobile App.
NOTE: Some diabetes management apps, including the
OneTouch Reveal® Mobile App, may not be available in
your country. Visit www.OneTouch.com 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.
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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 31 for pairing instructions.
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Changes or modifications not expressly approved by the
party responsible for compliance could void the user’s
authority to operate the equipment.
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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.
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For Canada - IC:
Statement acc. RSS Gen Issue 3, Sect. 7.1.3
This device complies with Part 15 of the FCC Rules and with Industry Canada
license-exempt RSS standard(s). 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.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux
appareils radio exempts de licence. L'exploitation est autorisée aux deux
conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2)
l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi,
même si le brouillage est susceptible d'en compromettre le fonctionnement
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NOTE: This equipment has been tested and found to
comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful
interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio
communications. However, there is no guarantee that
interference will not occur in a particular installation. If
this equipment does cause harmful interference to radio or
television reception, which can be determined by turning
the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following
measures:
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• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and
receiver.
• Connect the equipment into an outlet on a circuit
different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/ TV
technician for help.
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If you experience meter interference problems, try moving
your meter away from the source of the interference.
You can also move the electronic device or its antenna to
another location to solve the problem.
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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.
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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.
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WARNING: In locations where cell phone use is not
permitted, such as hospitals, some healthcare professional
offices and airplanes, you should turn the BLUETOOTH®
SMART feature off. See page 29 for more information.
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BLUETOOTH® SMART trademark
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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
Getting to know your system....................................14
Setting up your system.............................................24
Setting up your meter...................................................... 24
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Connecting to a compatible wireless device ................ 29
Taking a test............................................................... 36
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Turning the meter off....................................................... 35
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Testing your blood glucose............................................. 36
Reviewing past results.............................................70
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Testing with control solution..........................................60
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Editing Your Settings................................................ 76
Editing time and date...................................................... 76
Editing your range limits................................................. 77
Caring for your system.............................................80
Battery........................................................................86
Troubleshooting your system..................................90
Detailed information about your system............ 100
10
Index.......................................................................... 110
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Getting to know your
system
Your OneTouch Verio Flex™ Blood
Glucose Monitoring System
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Included with your kit:
Lancing device
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OneTouch Verio Flex™ Meter
(CR2032 lithium coin cell
battery included)
Lancets
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OneTouch Verio®
Test Strips*
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Getting to know your system 1
NOTE: If any item is missing or defective in your kit,
contact Customer Service. As your partner in diabetes
care, we welcome you to contact us (7 days a week,
8 a.m. - 10 p.m. Eastern Time) at 1 888 567-3003 (English),
1 888 567-3010 (Español), or www.OneTouch.com.
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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:
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OneTouch Verio®
Level 4 Control
Solution*
(vial with
red cap)
OneTouch Verio®
Test Strips*
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OneTouch Verio®
Level 3 Control
Solution*
(vial with
blue cap)
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They are sold separately. Refer to your meter carton for a
list of included items.
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*OneTouch Verio® 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 Verio® Level 3 Control
Solution or OneTouch Verio® Level 4 Control Solution
with your OneTouch Verio Flex™ Meter.
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Getting to know your system 1
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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
Getting to know your
OneTouch Verio Flex™ Blood Glucose
Monitoring System
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Meter
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Getting to know your system 1
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1 Getting to know your system
Getting to know your OneTouch Verio®
Test Strip
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Test strip
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Getting to know your system 1
The Range Indicator feature
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The OneTouch Verio 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
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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.
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Example
Below Range Result
Things you should know before
using the Range Indicator feature:
Example
In Range Result
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• The meter comes with pre-set
range limits. The pre-set low
range limit is 70 mg/dL and
the pre-set high range limit
is 180 mg/dL. You can change
these limits as needed to meet
your needs. See page 77 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.
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Example
Above Range Result
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Getting to know your system 1
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Setting up your system
Setting up your meter
Turn your meter on
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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.
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CAUTION:
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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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If you see any missing segments within the start-up
screen, there may be a problem with the meter. Contact
Customer Service. 1 888 567-3003.
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.
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Setting up your system 2
First time setup
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until the startTo turn your meter on, press and hold
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
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• 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.
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Minutes will flash
• If the minutes displayed
to
is correct, press
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
AM/PM will flash
Setting the date
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• If the AM/PM displayed
to
is correct, press
confirm.
• If the AM/PM displayed is
not correct, press
or
to change AM/PM and
press
to confirm.
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Year will flash
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After completing the time setup, the meter will
automatically move to date setup.
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• If the year displayed
to
is correct, press
confirm.
• If the year displayed is not
correct, press
or
to
change the year and press
to confirm.
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Setting up your system 2
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• If the month displayed
to
is correct, press
confirm.
• If the month displayed is
not correct, press
or
to change the month
and press
to confirm.
Month will flash
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Day will flash
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• If the day displayed is
to
correct, press
confirm.
• If the day displayed is not
correct, press
or
to
change the day and press
to confirm.
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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
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You can adjust the meter's time and date settings after
to turn the meter on,
first time setup. Press and hold
then press and hold
and
at the same time. The SET
screen will appear. See page 76.
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After adjusting the settings, your meter will exit settings
mode and your last result screen will appear.
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Setting up your system 2
Connecting to a compatible wireless
device
Turning the BLUETOOTH® SMART feature
on or off
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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.
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• 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
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Pairing allows your OneTouch Verio Flex™ Meter to
communicate with compatible wireless devices. The
devices must be within 26 feet 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.
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NOTE: Some diabetes management apps, including the
OneTouch Reveal® Mobile App, may not be available in
your country. Visit www.OneTouch.com to learn if the
OneTouch Reveal® Mobile App is available in your country.
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Multiple OneTouch Verio 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 31 for
pairing instructions.
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Your OneTouch Verio 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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Setting up your system 2
Pairing Instructions
1. Start by turning your meter on using the
button
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The symbol will appear to
indicate that the BLUETOOTH®
SMART feature is on.
2. The BLUETOOTH® SMART feature is turned on by
and
together
pressing
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51
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
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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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Setting up your system 2
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.
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CAUTION:
in
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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
button to enter History Mode.
press the
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nd
Example of PIN number
display on meter
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
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After pairing the meter with your compatible
wireless device, you are ready to send results to the
OneTouch Reveal® Mobile App.
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1. Open the OneTouch Reveal® Mobile App on your
compatible wireless device
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to turn the meter on and make sure
2. Press and hold
the BLUETOOTH® SMART feature is ON as indicated by ( )
51
and
at the same time to turn the
If needed, press
BLUETOOTH® SMART feature on.
nd
in
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.
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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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Setting up your system 2
Turning the meter off
There are three ways to turn your meter off:
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for several seconds until the meter
• Press and hold
turns off.
• Remove the test strip.
• Your meter will turn off by itself if left alone for two
minutes.
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NOTE: Following a glucose test, the meter will still be
available for BLUETOOTH® SMART connection for up to
4 hours. See page 71 for more details.
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Taking a test
Testing your blood glucose
Preparing for a blood glucose test
51
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OneTouch Verio Flex™ Meter
OneTouch Verio® Test Strips
Lancing device
Sterile lancets
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Have these things ready when you test:
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NOTE: Many people find it helpful to practice testing with
control solution before testing with blood for the first
time. See page 60.
NOTE:
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nd
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• Use only OneTouch Verio® Test Strips.
• Unlike some blood glucose meters, no separate step to
code your OneTouch Verio Flex™ System is required.
• Testing must be done within operating temperature
range (50-104°F).
• Make sure your meter and test strips are about the
same temperature before you test.
• Keep test strips in a cool, dry place between 41°F
and 86°F.
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Taking a test 3
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• 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
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• 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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IMPORTANT: If another person assists you with testing,
the meter should always be cleaned prior to use by that
person. See page 80.
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CAUTION:
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51
• The OneTouch Verio 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 Verio® 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.
1 888 567-3003.
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Taking a test 3
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• 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
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Getting to know your OneTouch® Delica®
Lancing Device
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Taking a test 3
NOTE:
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• 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 Verio 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 Verio 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:
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• 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 80).
• 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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Taking a test 3
Preparing the lancing device
1. Remove the lancing device cap
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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
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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.
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51
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Twist the protective
cover one full turn until it
separates from the lancet.
Save the protective cover
for lancet removal and
disposal. See page 57.
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Taking a test 3
3. Replace the lancing device cap
51
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Place the cap back onto the device; turn clockwise to
secure the cap.
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nd
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Do Not overtighten.
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3 Taking a test
4. Adjust the depth setting
51
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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.
nd
in
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
Pe
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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Taking a test 3
Preparing the meter
1. Insert a test strip to turn the meter on
in
51
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Insert a test strip into the test strip port with the gold side
of the test strip and the two silver prongs facing you.
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nd
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.
1. Puncture your finger
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nd
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51
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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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Before testing, wash your hands thoroughly with warm,
soapy water. Rinse and dry completely.
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2. Get a round drop of blood
ss
Gently squeeze and/or
massage your fingertip until
a round drop of blood forms
on your fingertip.
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51
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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Taking a test 3
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3 Taking a test
Applying blood and reading results
Applying the sample
1. Apply the sample to the test strip
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You can apply blood to either side of the test strip.
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Apply your sample to the opening of the channel.
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in
51
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Be sure to apply your sample immediately after you get a
drop of blood.
Pe
Holding the meter at a
slight angle, guide the
channel to the blood drop.
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Taking a test 3
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When it touches your
sample, the test strip wicks
blood into the channel.
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2. Wait for the channel to fill completely
51
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.
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nd
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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:
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51
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• 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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Taking a test 3
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Example
Below Range Result
Example
In Range Result
CAUTION:
51
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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 21). The arrow
will point to the appropriate Range
Indicator Color Bar on the meter as
a visual reminder.
Viewing your result
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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.
Example
Above Range Result
WARNING: Confirm that the unit of measure mg/dL is
displayed. If your display shows mmol/L rather than mg/dL,
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.
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CAUTION:
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Low results
in
51
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If your result is below
70 mg/dL or is shown as LO
(meaning the result is less
than 20 mg/dL), 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.
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NOTE: When your glucose result is below 20 mg/dL, 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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Taking a test 3
CAUTION:
High results
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• If your result is above 180 mg/dL, it may mean
hyperglycemia (high blood glucose) and you should
consider re-testing. Talk to your healthcare professional
if you are concerned about hyperglycemia.
in
51
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• HI is displayed when
your result is over
600 mg/dL. 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.
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NOTE: When your glucose result is above 600 mg/dL, 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
51
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ev
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• 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
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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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Taking a test 3
Removing the used lancet
NOTE: This lancing device has an ejection feature, so you
do not have to pull out the used lancet.
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51
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Remove the cap by turning
it counterclockwise and then
pulling it straight off of the
device.
1. Remove the lancing device cap
2. Cover the exposed lancet tip
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nd
in
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
ie
Slide the ejection control
forward until the lancet
comes out of the lancing
device. Return the ejection
control to its back position.
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nd
in
51
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ev
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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Taking a test 3
4. Replace the lancing device cap
51
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Place the cap back onto the device; turn clockwise to
secure the cap.
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nd
in
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
ie
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.
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Wash hands thoroughly with soap and water after
handling the meter, test strips, lancing device and cap.
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Testing with control solution
51
Control solution testing precautions
nd
in
OneTouch Verio® 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:
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• Use only OneTouch Verio® Level 3 Control Solution or
OneTouch Verio® Level 4 Control Solution with your
OneTouch Verio 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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Taking a test 3
• Tightly close the cap on the control solution vial
immediately after use to avoid contamination or
damage.
See page 36 for more information on testing.
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CAUTION:
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nd
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51
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• 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
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• 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.
51
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Preparing your meter for a control solution
test
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nd
in
1. Insert a test strip to turn the meter on
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Taking a test 3
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or
until the
3. Press
control solution icon ( )
appears on the display
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2. Wait for the flashing blood
drop icon ( ) to appear on
the display
51
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on
Preparing the control solution
in
1. Before removing the cap, shake the vial gently
Pe
nd
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
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3 Taking a test
in
51
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4. Wipe both the tip of the
control solution vial and the
top of the cap with a clean,
damp tissue or cloth
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nd
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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Taking a test 3
Applying the control solution
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1. Hold the meter so that the
side edge of the test strip is
at a slight angle to the drop
of control solution
51
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2. Touch the channel on the side of the test strip to the
control solution
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nd
in
3. Wait for the channel to fill
completely
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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.
Viewing your control solution result
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Control solution results can be seen when reviewing past
results on the meter.
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nd
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51
CAUTION: Make sure you press
or
until the control
appears before you begin a control solution
solution icon
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 62.
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Taking a test 3
Checking if the result is in range
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Each vial of test strips has
both OneTouch Verio®
Level 3 Control Solution
and OneTouch Verio®
Level 4 Control Solution
ranges printed on its
label. Compare the result
displayed on the meter
to either the OneTouch
Verio® Level 3 Control
Solution or OneTouch
Verio® Level 4 Control
Solution range printed
on the test strip vial,
depending on the type of
control solution you used.
OneTouch Verio® Level 4
Control Solution Control
Range 298-403 mg/dL
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in
51
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Example range
OneTouch Verio® Level 3
Control Solution Control
Range 102-138 mg/dL
Pe
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:
in
51
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• 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.
nd
CAUTION:
Pe
If you continue to get control solution results that fall
outside the range printed on the test strip vial, Do Not
use the meter, test strips, or control solution. Contact
Customer Service. 1 888 567-3003.
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Taking a test 3
Cleaning the control solution cap
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nd
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Clean the top of the control solution cap with a clean,
damp tissue or cloth.
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Reviewing past results
Reviewing past results on your meter
to turn
ev
1. When the meter is off, press and hold
History Mode on
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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.
0k
The ( ) symbol indicates you are viewing your past
results.
51
) symbol indicates if the result was below,
The (
above or within range at the time of the test, by pointing
to the appropriate color bar.
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nd
in
2. Scroll through your results by pressing
to move
backwards and
to move forward through your results
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Reviewing past results 4
Using the meter without syncing to
an app
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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
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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.
nd
in
NOTE: The compatible wireless device must have the app
open and have already been paired to the meter before
sending a result. See page 30.
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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:
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nd
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51
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• 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 26 feet 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.
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Example
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Reviewing past results 4
If you are still unable to send results to the compatible
wireless device, please call Customer Service.
1 888 567-3003.
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nd
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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
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ie
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. As your partner in diabetes care, we welcome
you to contact us (7 days a week, 8 a.m. - 10 p.m. Eastern
Time) at 1 888 567-3003 (English), 1 888 567-3010
(Español), or www.OneTouch.com.
0k
Connect only to a computer certified to UL 60950-1 (
).
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nd
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51
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 Verio Flex™ Meter to a computer to download
results (not included).
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Reviewing past results 4
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If you are unable to download your results to a computer,
please call Customer Service. 1 888 567-3003.
in
).
Do Not insert a test strip while the meter is connected to
a computer.
nd
rn
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are,
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.
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Editing Your Settings
Editing time and date
ie
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.
ev
For instructions on adjusting the time and date, see
page 25.
51
0k
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.
in
NOTE: You will not be able to perform a blood glucose test
until you finish editing the time and date.
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nd
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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Editing Your Settings 5
Editing your range limits
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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 70 mg/dL and the
pre-set high range limit is 180 mg/dL. 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.
51
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.
in
CAUTION:
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nd
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
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• To accept the pre-set low
range limit, press .
• To edit the pre-set low range
limit, press
or
to
change the value between
60 mg/dL-110 mg/dL, and
then press .
1. Review the pre-set low range limit displayed
2. Review the pre-set high range limit displayed
Pe
nd
in
51
• To accept the pre-set high
range limit, press .
• To edit the pre-set high
range limit, press
or
to change the value between
90 mg/dL-300 mg/dL, and
then press .
Your meter will exit settings mode and your last result
screen will appear.
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Editing Your Settings 5
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.
ie
NOTE: You will not be able to perform a glucose test until
you finish editing the range limits.
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nd
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51
0k
ev
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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Caring for your system
Storing your system
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Cleaning and disinfection
ie
Store your meter, test strips, control solution and other
items in your carrying case. Keep in a cool, dry place
between 41°F and 86°F. Keep all items away from direct
sunlight and heat.
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nd
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51
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Cleaning and disinfection are different. Both should be
performed at least once per week. Cleaning is part of your
normal care and maintenance, but does not kill germs. You
should clean your meter, lancing device and cap before
disinfecting. After use and exposure to blood, all parts of
this kit may transmit infectious diseases. Disinfection is
the only way to reduce your exposure to disease.
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Caring for your system 6
For cleaning information, see page 82 and for
disinfecting information, see page 83.
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For cleaning and disinfecting, Clorox® Germicidal Wipes*
containing 0.55% sodium hypochlorite as the active
ingredient have been shown to be safe for use with
the OneTouch Verio Flex™ System and can be obtained
from retail websites offering disinfection products, e.g.,
www.officedepot.com. For more information on purchase
options, visit www.onetouch.com/disinfection, or contact
Customer Service. 1 888 567-3003.
in
51
*Other products, such as Clorox® Disinfecting Wipes, have
not been tested and should not be used. Only Clorox®
Germicidal Wipes should be used. Follow manufacturer's
instruction for handling and storage of wipes. Clorox® is a
registered trademark of the Clorox Company.
Pe
nd
IMPORTANT: If another person assists you with testing,
the meter, lancing device and cap should always be
cleaned and then disinfected prior to use by that person.
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6 Caring for your system
Cleaning your meter, lancing device
and cap
1. Use a Clorox® Germicidal Wipe
to wipe the outside of the meter
and lancing device
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ie
The meter, lancing device and cap should be cleaned at
least once per week. Be sure to clean the meter, lancing
device and cap before disinfecting.
51
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To clean your meter, hold it with
the test strip port pointed down.
Be sure to squeeze out any excess
liquid before you wipe the meter.
nd
in
Wipe the outside of the lancing
device cap.
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2. Wipe dry with a clean,
sterile gauze
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Caring for your system 6
Disinfecting your meter, lancing device
and cap
ie
The meter, lancing device and cap should be disinfected
at least once per week. Be sure to clean the meter, lancing
device and cap before disinfecting.
ev
1. First, clean your meter, lancing device and cap prior to
disinfecting
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Follow step 1 of page 82.
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51
2. Use a new Clorox®
Germicidal Wipe to wipe the
outside of the meter, lancing
device and cap until the
surface is damp
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nd
Be sure to squeeze out any
excess liquid before you
wipe the meter. Hold the
meter with the test strip port
pointed down.
Allow the surface of the
meter, lancing device and cap
to remain damp for 1 minute.
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6 Caring for your system
3. Wipe dry with a clean, sterile gauze
Wash hands thoroughly with soap and water after
handling the meter, lancing device and cap.
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51
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• 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.
• Do Not squeeze the germicidal
wipe into test strip port.
• Do Not spray cleaning solution
on the meter and lancing device.
• Do Not immerse the meter and lancing device in any
liquid.
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nd
The OneTouch Verio Flex™ System withstood cleaning
and disinfection cycles well in excess of LifeScan's
recommendation. See page 85 for more details.
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Caring for your system 6
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Examples of damage to the meter may include fogged
display, cracked housing or lens, illegible labels, button
not working or meter malfunction (such as repeated error
messages). Examples of damage to the lancing device and
cap may include cracking, illegible depth setting numbers
and lancing device malfunction (such as failure to load,
cock or release).
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51
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Do Not use your meter or lancing device if you see
evidence of such damage. If you have questions about
cleaning or disinfecting, or if you see evidence of
physical damage, contact Customer Service. As your
partner in diabetes care, we welcome you to contact
us (7 days a week, 8 a.m. - 10 p.m. Eastern Time) at
1 888 567-3003 (English), 1 888 567-3010 (Español), or
www.OneTouch.com.
nd
Cleaning and Disinfecting Cycles
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The meter, lancing device and cap can be cleaned daily for
3 years and have been tested up to 2879 cleaning cycles.
The meter, lancing device and cap can be disinfected
weekly for 3 years, and have been tested up to
412 cleaning and disinfection cycles.
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Battery
Replacing the battery
Your OneTouch Verio Flex™ Meter uses one CR2032 lithium
coin cell battery.
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ie
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.
0k
If the meter does not turn on, you may need to replace the
battery. See below for instructions.
51
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.
nd
in
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.
1. Remove the old battery
Pe
Start with the meter turned off.
Remove the battery cover by
sliding it downward.
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Pull up on the battery ribbon
to lift the battery out of the
compartment.
the
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2. Insert the new battery
nd
in
51
Insert one CR2032 lithium coin
cell battery on top of the battery
ribbon, with the plus (+) side up.
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can
oner
Do Not remove the battery while
the meter is connected to a
computer.
ie
tery
Battery 7
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um
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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. 1 888 567-3003.
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7 Battery
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3. Replace battery cover by
sliding it upwards onto the meter
51
4. Check your meter settings
in
Removing the meter battery will not affect your stored
results. However, you will need to check your date and
time settings.
nd
5. Dispose of battery
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Dispose of the battery according to your local
environmental regulations.
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Battery 7
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This page left blank intentionally.
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Troubleshooting your
system
Error and other messages
ie
The OneTouch Verio Flex™ Meter displays messages when
there are problems with the test strip, with the meter or
when your glucose levels are above 600 mg/dL or below
20 mg/dL. Improper use may cause an inaccurate result
without producing an error message.
What it means
in
51
You may have a very
low blood glucose level
(severe hypoglycemia),
below 20 mg/dL.
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NOTE: If the meter is on but does not operate (locks-up),
contact Customer Service. 1 888 567-3003.
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nd
NOTE: When your glucose result is below 20 mg/dL, 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
ie
You may have a very
high blood glucose level
(severe hyperglycemia),
over 600 mg/dL.
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NOTE: When your glucose result is above 600 mg/dL, both
the HI and the Range Indicator Arrow will flash on the
meter screen.
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What to do
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nd
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51
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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8 Troubleshooting your system
What it means
Meter is too hot (above
104°F) to perform a test.
ie
What to do
ev
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 (50-104°F). If you do not get another
HI .t message, you can proceed with testing.
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nd
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51
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If this message continues to appear, contact Customer
Service. 1 888 567-3003.
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Troubleshooting your system 8
What it means
Meter is too cold (below 50°F)
to perform a test.
ie
What to do
ev
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 (50-104°F). If you do not get another
LO.t message, you can proceed with testing.
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nd
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51
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If this message continues to appear, contact Customer
Service. 1 888 567-3003.
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8 Troubleshooting your system
Error Screens
51
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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. 1 888 567-3003.
They will refer to the error number and code to help
troubleshoot the problem.
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nd
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Example Error
Screen Code
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Troubleshooting your system 8
What it means
There is a problem with
the meter.
ie
What to do
51
What it means
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Do Not use the meter. Contact Customer Service.
1 888 567-3003.
nd
in
Error message could be
caused either by a used test
strip or a problem with the
meter or test strip.
Pe
What to do
Repeat the test with a new test strip; see page 50 or
page 65. If this message continues to appear, contact
Customer Service. 1 888 567-3003.
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8 Troubleshooting your system
What it means
The sample was applied
before the meter was ready.
ie
What to do
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nd
in
51
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ev
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. 1 888 567-3003.
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Troubleshooting your system 8
What it means
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• Not enough blood or
control solution was
applied or more was added
after the meter began to
count down.
One of the following may
apply:
51
0k
• The test strip may have been damaged or moved
during testing.
• The sample was improperly applied.
• There may be a problem with the meter.
in
What to do
Pe
nd
Repeat the test with a new test strip; see page 50 or
page 65. If the error message appears again, contact
Customer Service. 1 888 567-3003.
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8 Troubleshooting your system
What it means
ie
The meter has detected a
problem with the test strip.
Possible cause is test strip
damage.
ev
What to do
51
0k
Repeat the test with a new test strip; see page 50 or
page 65. If the error message appears again, contact
Customer Service. 1 888 567-3003.
in
What it means
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nd
Meter battery power is low
but there is still enough
battery power to perform
a test. The flashing low
) icon will
battery (
continue to appear until the
battery is replaced.
What to do
Replace the meter battery soon.
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Troubleshooting your system 8
What it means
There is not enough battery
power to perform a test.
What it means
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Replace the battery immediately.
ie
What to do
nd
in
51
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
Pe
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. 1 888 567-3003.
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Detailed information
about your system
Comparing meter results to laboratory
results
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Results obtained from the OneTouch Verio 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 Verio Flex™ Meter is considered accurate when
it is within 15 mg/dL of a laboratory method when the
glucose concentration is lower than 75 mg/dL and within
15% of laboratory method when the glucose concentration
is 75 mg/dL or higher.
in
51
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:
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nd
• You have eaten recently. This can cause a result from
fingertip testing to be up to 70 mg/dL 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 Verio®
Test Strip Insert.
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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Detailed information about your system 9
Guidelines for obtaining an accurate
meter to lab comparison
Before going to the lab:
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• 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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9 Detailed information about your system
Testing with your OneTouch Verio Flex™
Meter at the lab:
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• 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.
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Comparing your meter results to those
taken from another meter
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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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Detailed information about your system 9
Technical specifications
FAD-GDH (flavin adenine dinucleotide
dependent glucose dehydrogenase)
Automatic shutoff
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
26.25 feet (unobstructed)
Operating Channels: 40 Channels
Security Encryption: 128-bit AES
(Advanced Encryption Standard)
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Calibration
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Assay method
Plasma-equivalent
Compatible with USB 2.0
Memory
500 test results
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Data port type
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9 Detailed information about your system
Temperature: 50-104°F
Relative humidity: non-condensing
10-90%
Altitude: up to 10,000 feet
Hematocrit: 20-60%
Reported result range
20-600 mg/dL
Sample
Fresh capillary whole blood
Sample volume
0.4 µL
Size
2.05(W) x 3.38(L) x 0.63(T) inches
Test time
5 seconds
Unit of measure
mg/dL
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Operating ranges
Weight
in
Approximately 1.76 ounces
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Lay User Accuracy
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User Accuracy of the system was assessed at 3 clinical
sites. 172 patients tested their blood using the
OneTouch Verio Flex™ System where results were
compared to the YSI 2300 Glucose Analyzer laboratory
Instrument.
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Detailed information about your system 9
Fingertip Results for Glucose
Concentrations <75 mg/dL
Within ±10 mg/dL Within ±15 mg/dL
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Within ±5 mg/dL
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Percent (and number) of meter results that match the
laboratory test
95.2% (20/21)
95.2% (20/21)
76.2% (16/21)
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Fingertip Results for Glucose
Concentrations ≥75 mg/dL
Percent (and number) of meter results that match the
laboratory test
Within ±10%
Within ±15%
58.3% (88/151)
88.7% (134/151)
98.0% (148/151)
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Within ±5%
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Number and percentage of all results falling within
±15 mg/dL or ±15%
Within 15 mg/dL or ±15%
97.7% (168/172)
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9 Detailed information about your system
Regression Statistics
Samples were tested on each of three test strip lots.
Results indicate that the OneTouch Verio Flex™ System
compares well with a laboratory method.
# of Tests
Slope
Intercept
(mg/dL)
172
172
0.99
95% CI Slope
95% CI
Intercept
(mg/dL)
Std. Error
(Sy.x)
(mg/dL)
R2
0.97 to 1.01
-1.59 to 7.55
14.0
0.98
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# of Subjects
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2.98
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Detailed information about your system 9
Precision
Within Run Precision (300 Venous Blood Samples Tested
per Glucose Level)
Mean
Glucose
(mg/dL)
40
36.5
0.83
2.26
90
88.5
1.72
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127.9
2.50
1.95
199.3
3.94
1.98
344.6
6.18
1.79
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130
200
Coefficient
of Variation
(%)
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Target
Glucose
(mg/dL)
350
Standard
Deviation
(mg/dL)
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Data generated using the OneTouch Verio Flex™ Meter.
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Results show that the greatest variability observed
between test strips when tested with blood is 0.83 mg/dL
SD or less at glucose levels less than 75 mg/dL or 1.98%
CV or less at glucose levels at 75 mg/dL or above.
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9 Detailed information about your system
Total Precision (600 Control Solution Tests per Glucose
Level)
Standard
Deviation
(mg/dL)
Level 1
(25-49)
37.14
0.92
Level 2
(102-138)
117.68
Level 3
(298-403)
348.99
Coefficient
of Variation
(%)
ie
Mean
Glucose
(mg/dL)
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Glucose
Level Ranges
(mg/dL)
Data generated using the OneTouch Verio Flex™ Meter.
2.05
8.31
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2.41
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2.48
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Detailed information about your system 9
Guarantee
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LifeScan guarantees that the OneTouch Verio 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
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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.
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The meter meets the requirements for immunity to
electrical interference at the frequency range and test
level specified in international standard ISO 15197.
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Do Not use the equipment where aerosol sprays are
being used, or when oxygen is being administered.
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10
Index
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AST
41
Batteries
86
86
Batteries, replacing
Battery empty icon
Battery empty warning
99
Battery low icon
3, 98
BLUETOOTH® SMART feature
7, 11, 29, 71
18
Buttons on meter
82
Cleaning your meter, lancing device and cap
Comparing meter results to laboratory results
100
Compatible wireless devices
62
Control solution
Control solution, discard and expiration dates
60, 61
Control solution, testing
60, 66, 68
Data port
18
Date setting
26, 28
Dehydration
54, 100
Disinfecting your meter, lancing device and cap
83
Display check
24
Disposal, lancets and test strips
60
Downloading results to a computer
74
Edit date
76
77
Edit range limits
Edit time
76
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Index 10
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90
55, 91
54, 90
36
25, 30
109
55, 91
54, 90
3, 4
42
14
14, 41, 43
18, 104
30, 31
33
100, 103
21
77
70
33
25, 28, 76
74
24
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Error messages
EXTREME HIGH GLUCOSE message
EXTREME LOW GLUCOSE message
Fingertip testing procedure
First time setup
Guarantee
Hyperglycemia
Hypoglycemia
Icons
Infection, reduce the chance
Intended use
Kit components
Lancing device
mg/dL
Pairing
PIN
Plasma calibration
Range Indicator feature
Range limits setting
Results, reviewing past
Serial number
Settings
Software, diabetes management
Start-up screen
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10 Index
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Storing your system
80
Symbols
3, 4
34, 71
Syncing
Technical specifications
103
Temperature
36, 68, 80, 92, 93, 104
Test principle
Test strip
20, 47, 62
50
Test strip, applying drop of blood
37
Test strip, discard and expiration dates
Test strip, silver prongs
20
25, 28
Time setting
35
Turning meter off
Turning meter on
24, 47, 62
Unexpected results
54, 56
Unit of measure
18, 104
Unusual red blood cell count (hematocrit)
100, 104
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PF3125983Rev1_OTVF_OB_I_US_en_zug_R4.indd 1
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in
PMS
Spot Colors
N/A
Language Sequence: English
CMYK
Black
Process Colors
N/A
CPS Reference No.: Refer to References Section in Enable for CPS No.
PF No./Rev.: 3125983 Rev 1
Description: Booklet, Owners, OTVF, US (zug)
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Uncoated Area
N/A
Uncoated Area
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Special Instructions
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N/A
N/A
Inside No. of pages: 112
No. of sides: 1
N/A
No. of Covers:
JDE Item No.: N/A
Dieline
N/A
Dieline
Rev. Date: 12-Jan-15
Art Agency: ForeignExchange Translations Job No.: 25677
LFS Contact: Susan Cabral
= CUT
= SCORE
= PERF

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