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

Cilag GmbH International ONE TOUCH Verio Flex / Blood Glucose Monitoring System

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User Manual

©2015LifeScan, Inc.

Manufactured by:

LifeScan Europe

Division of Cilag

GmbH International

Gubelstrasse 34

6300 Zug

Switzerland

Meter made in China.

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.

Rev. Date:

PF 3125983 Rev 1

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.

10/2014

PF 3125983 Rev 1

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Blood Glucose Monitoring System

Instructions

for Use

Owner's

Booklet

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PF No./Rev.: 3125983 Rev 1

CPS Reference No.: Refer to References Section in Enable for CPS No.

LFS Contact: Susan Cabral

Rev. Date: 12-Jan-15

Language Sequence: English

JDE Item No.: N/A

No. of Covers: 4

PMS N/A N/A

Inside No. of pages:

No. of sides: 1 2

Process Colors

Uncoated Area

Spot Colors Uncoated Area Special Instruction

ieline

N/A

Dieline

Description: Booklet, Owners, OTVF, US (zug) Art Agency: ForeignExchange Translations Job No.: 25677

= CUT

= SCORE

= PERF

N/A

C M Y KBlack

N/A

Leg1

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Owner's Booklet

Blood Glucose Monitoring System

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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®.

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.

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.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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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

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Verio® Test

Strips, OneTouchVerio® Control Solution and the

OneTouch®Delica® Lancing Device.

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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.

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.

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

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.

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.

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

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.

Use only OneTouchVerio® Control Solution and Test

Strips with the OneTouchVerioFlex™ Meter.

BLUETOOTH® SMART wireless

technology

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.

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.

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.

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.

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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

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:

• 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.

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.

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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.

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29 for more information.

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Table of Contents

1 Getting to know your system ...................................14

2 Setting up your system ............................................24

Setting up your meter .....................................................24

Connecting to a compatible wireless device ...............29

Turning the meter off ...................................................... 35

3 Taking a test ..............................................................36

Testing your blood glucose ............................................36

Testing with control solution..........................................60

4 Reviewing past results ............................................70

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5 Editing Your Settings ............................................... 76

Editing time and date ..................................................... 76

Editing your range limits ................................................ 77

6 Caring for your system ............................................80

7 Battery .......................................................................86

8 Troubleshooting your system .................................90

9 Detailed information about your system ...........100

10 Index .........................................................................110

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1 Getting to know your

system

Your OneTouchVerioFlex™ Blood

Glucose Monitoring System

Included with your kit:

OneTouchVerioFlex™ Meter

(CR2032 lithium coin cell

battery included)

Lancing device

Lancets OneTouchVerio®

Test Strips*

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Getting to know your system

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.

NOTE: If another type of lancing device was included, see

the separate instructions for that lancing device.

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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Verio®

Level 3 Control

Solution*

(vial with

blue cap)

OneTouchVerio®

Test Strips*

*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.

OneTouchVerio®

Level 4 Control

Solution*

(vial with

red cap)

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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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Getting to know your system

Meter

Getting to know your

OneTouchVerioFlex™ Blood Glucose

Monitoring System

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Getting to know your system

Meter

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Getting to know your system

Test strip

Getting to know your OneTouchVerio®

Test Strip

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Getting to know your system

The Range Indicator feature

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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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 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.

Example

Below Range Result

Example

In Range Result

Example

Above Range Result

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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. 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.

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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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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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.

AM/PM will ﬂash

• If the AM/PM displayed

is correct, press to

confirm.

• If the AM/PM displayed is

not correct, press or

to change AM/PM and

press to confirm.

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Setting up your system

Setting the date

After completing the time setup, the meter will

automatically move to date setup.

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.

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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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76.

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

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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Setting up your system

Pairing Overview

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.

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.

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.

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

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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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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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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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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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71 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60.

Have these things ready when you test:

OneTouchVerioFlex™ Meter

OneTouchVerio® Test Strips

Lancing device

Sterile lancets

3 Taking a test

NOTE:

• 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

• 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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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.

IMPORTANT: If another person assists you with testing,

the meter should always be cleaned prior to use by that

person. See page80.

CAUTION:

• 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

• 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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Taking a test

Getting to know your OneTouch®Delica®

Lancing Device

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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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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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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

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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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57.

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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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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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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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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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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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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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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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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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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21). 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 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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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

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.

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

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 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.

• 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.

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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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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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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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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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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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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:

• 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

• 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.

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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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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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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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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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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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62.

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Taking a test

Checking if the result is in range

Example range

OneTouch Verio® Level 3

Control Solution Control

Range 102-138 mg/dL

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.

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.

OneTouch Verio® Level 4

Control Solution Control

Range 298-403 mg/dL

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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 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

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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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30.

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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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 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.

Example

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Reviewing past results

If you are still unable to send results to the compatible

wireless device, please call Customer Service.

1888567-3003.

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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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. 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.

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VerioFlex™ Meter to a computer to download

results (not included).

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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. 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.

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Verio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. 1888567-3003.

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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25.

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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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 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.

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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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

60mg/dL-110mg/dL, 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

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

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. 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.

Storing your system

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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Caring for your system

For cleaning information, see page82 and for

disinfecting information, see page83.

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.

*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.

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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Caring for your system

2. Wipe dry with a clean,

sterile gauze

Cleaning your meter, lancing device

and cap

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.

1. Use a Clorox® Germicidal Wipe

to wipe the outside of the meter

and lancing device

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.

Wipe the outside of the lancing

device cap.

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Caring for your system

Disinfecting your meter, lancing device

and cap

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.

1. First, clean your meter, lancing device and cap prior to

disinfecting

Follow step 1 of page82.

2. Use a new Clorox®

Germicidal Wipe to wipe the

outside of the meter, lancing

device and cap until the

surface is damp

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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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.

• 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.

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

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).

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.

Cleaning and Disinfecting Cycles

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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7 Battery

Replacing the battery

Your OneTouchVerio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.

1. Remove the old battery

Start with the meter turned off.

Remove the battery cover by

sliding it downward.

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Battery

Replacing the battery

Your OneTouchVerio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.

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.

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. 1888567-3003.

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Battery

3. Replace battery cover by

sliding it upwards onto the meter

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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Battery

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8 Troubleshooting your

system

Error and other messages

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.

NOTE: If the meter is on but does not operate (locks-up),

contact Customer Service. 1888567-3003.

What it means

You may have a very

low blood glucose level

(severe hypoglycemia),

below 20mg/dL.

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

What it means

You may have a very

high blood glucose level

(severe hyperglycemia),

over 600mg/dL.

NOTE: When your glucose result is above 600mg/dL, 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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Troubleshooting your system

What it means

Meter is too hot (above

104°F) 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 (50-104°F). If you do not get another

HI .t message, you can proceed with testing.

If this message continues to appear, contact Customer

Service. 1888567-3003.

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Troubleshooting your system

What it means

Meter is too cold (below 50°F)

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 (50-104°F). If you do not get another

LO.t message, you can proceed with testing.

If this message continues to appear, contact Customer

Service. 1888567-3003.

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Troubleshooting your system

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. 1888567-3003.

They will refer to the error number and code to help

troubleshoot the problem.

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Troubleshooting your system

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.

1888567-3003.

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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Troubleshooting your system

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. 1888567-3003.

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Troubleshooting your system

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50 or

page65. If the error message appears again, contact

Customer Service. 1888567-3003.

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Troubleshooting your system

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50 or

page65. If the error message appears again, contact

Customer Service. 1888567-3003.

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Troubleshooting your system

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. 1888567-3003.

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100

9 Detailed information

about your system

Comparing meter results to laboratory

results

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.

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 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.

1Sacks, 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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101

Detailed information about your system

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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102

Detailed information about your system

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.

Testing with your OneTouchVerio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.

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103

Detailed information about your system

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

26.25feet (unobstructed)

Operating Channels: 40 Channels

Security Encryption: 128-bit AES

(Advanced Encryption Standard)

Calibration Plasma-equivalent

Data port type Compatible with USB 2.0

Memory 500 test results

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104

Detailed information about your system

Operating ranges 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

Weight Approximately 1.76ounces

Lay User Accuracy

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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Fingertip Results for Glucose

Concentrations <75mg/dL

Percent (and number) of meter results that match the

laboratory test

Within ±5mg/dL Within ±10mg/dL Within ±15mg/dL

76.2% (16/21) 95.2% (20/21) 95.2% (20/21)

Fingertip Results for Glucose

Concentrations ≥75mg/dL

Percent (and number) of meter results that match the

laboratory test

Within ±5% Within ±10% Within ±15%

58.3% (88/151) 88.7% (134/151) 98.0% (148/151)

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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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 Subjects # of Tests Slope Intercept

(mg/dL)

172 172 0.99 2.98

95% CI Slope 95% CI

Intercept

(mg/dL)

Std. Error

(Sy.x)

(mg/dL)

0.97 to 1.01 -1.59 to 7.55 14.0 0.98

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Precision

Within Run Precision (300 Venous Blood Samples Tested

per Glucose Level)

Data generated using the OneTouchVerioFlex™ Meter.

Target

Glucose

(mg/dL)

Mean

Glucose

(mg/dL)

Standard

Deviation

(mg/dL)

Coecient

of Variation

(%)

40 36.5 0.83 2.26

90 88.5 1.72 1.95

130 127.9 2.50 1.95

200 199.3 3.94 1.98

350 344.6 6.18 1.79

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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Total Precision (600 Control Solution Tests per Glucose

Level)

Data generated using the OneTouchVerioFlex™ Meter.

Glucose

Level Ranges

(mg/dL)

Mean

Glucose

(mg/dL)

Standard

Deviation

(mg/dL)

Coecient

of Variation

(%)

Level 1

(25-49)

37.14 0.92 2.48

Level 2

(102-138)

117.68 2.41 2.05

Level 3

(298-403)

348.99 8.31 2.38

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Guarantee

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

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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AST 41

Batteries 86

Batteries, replacing 86

Battery empty icon 3

Battery empty warning 99

Battery low icon 3, 98

BLUETOOTH® SMART feature 7, 11, 29, 71

Buttons on meter 18

Cleaning your meter, lancing device and cap 82

Comparing meter results to laboratory results 100

Compatible wireless devices 3

Control solution 62

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

Edit range limits 77

Edit time 76

10 Index

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Index 10

Error messages 90

EXTREME HIGH GLUCOSE message 55, 91

EXTREME LOW GLUCOSE message 54, 90

Fingertip testing procedure 36

First time setup 25, 30

Guarantee 109

Hyperglycemia 55, 91

Hypoglycemia 54, 90

Icons 3, 4

Infection, reduce the chance 42

Intended use 6

Kit components 14

Lancing device 14, 41, 43

mg/dL 18, 104

Pairing 30, 31

PIN 33

Plasma calibration 100, 103

Range Indicator feature 21

Range limits setting 77

Results, reviewing past 70

Serial number 33

Settings 25, 28, 76

Software, diabetes management 74

Start-up screen 24

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Index

Storing your system 80

Symbols 3, 4

Syncing 34, 71

Technical specifications 103

Temperature 36, 68, 80, 92, 93, 104

Test principle 7

Test strip 20, 47, 62

Test strip, applying drop of blood 50

Test strip, discard and expiration dates 37

Test strip, silver prongs 20

Time setting 25, 28

Turning meter off 35

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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PF No./Rev.: 3125983 Rev 1

CPS Reference No.: Refer to References Section in Enable for CPS No.

LFS Contact: Susan Cabral

Rev. Date: 12-Jan-15

Language Sequence: English

JDE Item No.: N/A

No. of Covers:

PMS N/A N/A

Inside No. of pages: 112

No. of sides: 1 2

Process Colors

Uncoated Area

Spot Colors Uncoated Area Special Instruction

ieline

N/A

Dieline

Description: Booklet, Owners, OTVF, US (zug) Art Agency: ForeignExchange Translations Job No.: 25677

= CUT

= SCORE

= PERF

N/A

Black

N/A

C M Y K

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

Cilag GmbH International ONE TOUCH Verio Flex / Blood Glucose Monitoring System

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