OneTouch Select Plus Flex User manual

©2015LifeScan, Inc.
LifeScan Europe
Division of Cilag
GmbH International
Gubelstrasse 34
6300 Zug
Switzerland
Distributed by:
LifeScan UK & Ireland,
A division of Johnson & Johnson
Medical Limited,
50-100 Holmers Farm Way,
High Wycombe,
Bucks,
HP12 4DP
United Kingdom
Call OneTouch® Customer
Care on 0800121200 (UK)
or 1800535 676 (Ireland)
during the hours of
8:30am-6pm Monday-Friday,
9am-1pm Saturday. Or visit
www.LifeScan.co.uk.
C4
Contents covered by one or more of the following U.S. patents: 5,708,247,
5,951,836, 6,241,862, 6,284,125, 7,112,265, 7,462,265, 7,807,031, 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, 6,733,655, 7,250,105, 7,468,125, 8,066,866 and
8,093,903. Purchase of this device does not act to grant a use license under these
patents. Such a license is granted only when the device is used with OneTouch®
Select® Plus 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.
Blood Glucose Meter, Test Strips, and Control Solution
Lancing System
LifeScan self-test blood glucose monitoring devices conform to
the following EU Directives:
IVDD (98/79/EC):
MDD (93/42/EEC):
PF3130451 Rev 1
Rev. Date: 01/2015
PF3130451 Rev 1
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Statement of Use: Verify status before each use
Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

Blood Glucose Monitoring System
Instructions
for Use
Owner's
Booklet
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Statement of Use: Verify status before each use
Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

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Statement of Use: Verify status before each use
Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

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Statement of Use: Verify status before each use
Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

PF No./Rev.: 3130451 Rev 1
CPS Reference No.: Refer to References Section in Enable for CPS No.
LFS Contact: Andrew Mark
Rev. Date: 12-Mar-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 Instructions Dieline
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Description: Booklet, Owners, OTSPF, GB (zug) Art Agency: ForeignExchange Translations Job No.: 28801
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Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

1
Owner's Booklet
Blood Glucose Monitoring System
Select Plus Flex™
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Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

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Thanks for choosing OneTouch®!
The OneTouchSelect Plus Flex™ Blood Glucose Monitoring
System is one of the latest product innovations from
OneTouch®.
Your OneTouchSelect Plus Flex™ Meter is designed to
connect (sync) with a variety of devices running software
applications that let you review and graph your results,
and help identify patterns. Meter results are sent to the
compatible devices either through BLUETOOTH® SMART
(wireless) or USB cable connection.
Every OneTouch® Meter is designed to help you test your
blood glucose and manage your diabetes.
This Owner's Booklet offers a complete explanation of how
to use your new meter and testing supplies. It reviews the
do's and don'ts of testing your blood glucose level. Please
keep your Owner's Booklet in a safe place; you may want
to refer to it in the future.
We hope OneTouch® products and services will continue to
be a part of your life.
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Statement of Use: Verify status before each use
Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

3
Meter symbols and icons
Meter Power
Low Battery
Battery Empty
Control Solution
Syncing
BLUETOOTH® SMART Feature On
History Mode (Past results)
Apply Sample
Range Indicator Arrow
Setting Mode
Compatible Wireless Devices
Visit www.LifeScan.co.uk for information on which wireless
devices are compatible with your OneTouchSelect Plus
Flex™ Meter, and where/how to download the software
application on your compatible wireless device.
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Statement of Use: Verify status before each use
Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

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Other symbols and icons
Cautions and Warnings: Refer to the Owner's
Booklet and inserts that came with your system
for safety-related information.
Direct current
Consult Instructions for Use
Manufacturer
Lot Number
Serial Number
Storage Temperature Limits
In Vitro Diagnostic Device
Do Not Re-use
Sterilized by irradiation
Not for general waste
Use By Date
Contains sucient for n tests
Underwriters Laboratories certification
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Statement of Use: Verify status before each use
Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

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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Select® Plus Test Strips,
OneTouchSelect® Plus Control Solutions and the
OneTouch®Delica® Lancing Device.
IMPORTANT SAFETY INSTRUCTIONS:
đƫ 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!
đƫ 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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Statement of Use: Verify status before each use
Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

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Intended use
The OneTouchSelect Plus Flex™ Blood Glucose Monitoring
System is intended to be used for the quantitative
measurement of glucose (sugar) in fresh capillary whole
blood samples drawn from the fingertip. The system is
intended to be used by a single patient and should not be
shared.
The OneTouchSelect Plus Flex™ Blood Glucose Monitoring
System is intended for self-testing outside the body (in
vitro diagnostic use) by people with diabetes at home and
with their healthcare professionals in a clinical setting as
an aid to monitor the effectiveness of diabetes control.
The OneTouchSelect Plus Flex™ Blood Glucose Monitoring
System is not to be used for the diagnosis of or screening
of diabetes or for neonatal use.
The OneTouchSelect Plus 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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Statement of Use: Verify status before each use
Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

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Test principle
Glucose in the blood sample mixes with the enzyme
Glucose Oxidase (see page103) in the test strip and
a small electric current is produced. The strength of this
current changes with the amount of glucose in the blood
sample. Your meter measures the current, calculates your
blood glucose level, displays the result, and stores it in its
memory.
Use only OneTouchSelect® Plus Control Solutions and Test
Strips with the OneTouchSelect Plus Flex™ Meter.
BLUETOOTH® SMART wireless
technology
BLUETOOTH® SMART wireless technology is used by
some smartphones and many other devices. Your
OneTouchSelect Plus Flex™ Meter uses BLUETOOTH®
SMART wireless technology to pair and to send your
glucose results to compatible wireless devices.
The OneTouchSelect Plus Flex™ Meter is designed to work
with the OneTouchReveal® Mobile App and many other
diabetes applications on compatible wireless devices.
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Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

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NOTE: Some diabetes management apps, including the
OneTouchReveal® Mobile App, may not be available in
your country. Visit www.LifeScan.co.uk to learn if the
OneTouchReveal® Mobile App is available in your country.
Visit www.LifeScan.co.uk for information on which wireless
devices are compatible with your OneTouchSelect Plus
Flex™ Meter, and where/how to download the software
application on your compatible wireless device.
When using the OneTouchSelect Plus Flex™ System, we
suggest you pair your OneTouchSelect Plus Flex™ Meter
with a compatible wireless device and track your results.
See page29 for pairing instructions.
Your meter is subject to and complies with applicable
Worldwide Radio regulation guidelines. Generally, these
rules state two conditions specific to the operation of the
device:
1. This device may not cause harmful interference.
2. This device must accept any interference received,
including interference that may cause undesirable
operation.
LifeScan Europe declares that this equipment is in
compliance with the applicable essential requirements and
other relevant provisions of Directive 1999/5/EC.
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Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

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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.
WARNING: In locations where cell phone use is not
permitted, such as hospitals, some healthcare professional
oces and airplanes, you should turn the BLUETOOTH®
SMART feature o. See page27 for more information.
BLUETOOTH® SMART trademark
The BLUETOOTH® SMART word mark and logos are owned
by the Bluetooth SIG, Inc. and any use of such marks by
LifeScan Europe is under license. Other trademarks and
trade names are those of their respective owners.
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Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

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Table of Contents
1Getting to know your system...................................12
2Setting up your system............................................ 22
Setting up your meter..................................................... 22
Connecting to a compatible wireless device ............... 27
Turning the meter off...................................................... 33
3Taking a test ..............................................................34
Testing your blood glucose ............................................ 34
Testing with control solution..........................................62
4Reviewing past results ............................................ 72
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Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

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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 .......................................................................84
8Troubleshooting your system.................................88
9Detailed information about your system ...........100
10Index .........................................................................114
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Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

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1Getting to know your
system
Your OneTouchSelect Plus Flex™ Blood
Glucose Monitoring System
Included with your kit:
OneTouchSelect Plus Flex™
Meter (CR2032 lithium coin
cell battery included)
Lancing device Lancets
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Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

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1
Getting to know your system
NOTE: If any item is missing or defective in your kit,
contact Customer Service. Call OneTouch® Customer Care
on 0800121200 (UK) or 1800535 676 (Ireland) during the
hours of 8:30am-6pm Monday-Friday, 9am-1pm Saturday.
Or visit www.LifeScan.co.uk.
NOTE: If another type of lancing device was included, see
the separate instructions for that lancing device.
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Statement of Use: Verify status before each use
Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

14
1Getting to know your system
OneTouchSelect®
Plus Mid Control
Solution*
(vial with blue cap)
OneTouchSelect®
Plus High Control
Solution*
(vial with red cap)
*OneTouchSelect® Plus Control Solution and Test Strips
are available separately. For availability of test strips
and control solution, contact customer service or your
healthcare professional.
Available separately:
Items listed 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Select®
Plus Test Strips*
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Statement of Use: Verify status before each use
Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1

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1
Getting to know your system
OneTouchSelect® Plus High Control Solution (vial with
red cap) can be used in addition to OneTouchSelect®
Plus Mid Control Solution (vial with blue cap). If you test
with OneTouchSelect® Plus High Control Solution, you
should always test with OneTouchSelect® Plus Mid Control
Solution first.
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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Statement of Use: Verify status before each use
Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1