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Select Plus Flex
Instruction Manual
125 pgs2.64 Mb0

OneTouch Select Plus Flex Instruction Manual

©2015LifeScan, Inc.
LifeScan Europe Division of Cilag GmbH International Gubelstrasse 34 6300 Zug Switzerland
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.
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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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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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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
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No. of Covers: 4
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Inside No. of pages:
No. of sides: 1 2
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Description: Booklet, Owners, OTSPF, GB (zug)
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Owner's Booklet
Blood Glucose Monitoring System
Select Plus Flex
™
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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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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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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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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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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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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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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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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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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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 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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 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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1
Getting to know your system
NOTE: If any item is missing or defective in your kit, contact Customer Service. Call OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland) during the hours of 8:30am-6pm Monday-Friday, 9am-1pm Saturday. Or visit www.LifeScan.co.uk.
NOTE: If another type of lancing device was included, see the separate instructions for that lancing device.
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1
Getting to know your system
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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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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1
Getting to know your system
Meter
Getting to know your OneTouchSelect Plus Flex™ Blood Glucose Monitoring System
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1
Getting to know your system
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1
Getting to know your system
Test strip
Getting to know your OneTouchSelect® Plus Test Strip
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Getting to know your system
The Range Indicator feature
The OneTouchSelect Plus Flex™ Meter automatically lets you know if your current result is below, above or within your range limits. It does this by displaying your current result with a Range Indicator Arrow, pointing to a corresponding Range Indicator Color Bar below the meter display. Use the Range Indicator Arrow and Color Bar together to interpret your results.
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1
Getting to know your system
3 Possible Range Indicator Displays
A Range Indicator Arrow will appear just below your result after each test depending upon how you set your low and high range limits in the meter.
Things you should know before using the Range Indicator feature:
đƫ The meter comes with pre-set
range limits. The pre-set low range limit is 3.9mmol/L and the pre-set high range limit is
10.0mmol/L. You can change these limits as needed to meet your needs. See page77 for details on the pre-set range limits and on editing your range limits.
đƫ 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. Contact OneTouch® Customer Care on 0800121200 (UK) or 1800535 676 (Ireland).
NOTE: If you turned the meter on for the first time by inserting a test strip instead of pressing
, you will not be able to perform a glucose test until you complete the first time setup.
Every time you turn your meter on, a start-up screen will appear for a few seconds. All segments of the display should appear briefly, indicating your meter is working properly. If the meter does not power on, check the battery.
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2
Setting up your system
First time setup
To turn your meter on, press and hold
until the start-
up screen appears. Once the device is on, release
. The meter will now automatically prompt you to set the time and date. The SET icon will appear on the screen to indicate that the meter has entered setup mode.
Setting the time
Hour will flash
đƫ If the hour displayed
is correct, press
to
confirm.
đƫ If the hour displayed is not
correct, press
or to
change the hour and press
to confirm.
Minutes will flash
đƫ If the minutes displayed
is correct, press
to
confirm.
đƫ If the minutes displayed is
not correct, press
or to change the minutes and press
to confirm.
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2
Setting up your system
Setting the date
After completing the time setup, the meter will automatically move to date setup.
Year will flash
đƫ If the year displayed
is correct, press
to
confirm.
đƫ If the year displayed is not
correct, press
or to
change the year and press
to confirm.
Month will flash
đƫ If the month displayed
is correct, press
to
confirm.
đƫ If the month displayed is
not correct, press
or
to change the month
and press to confirm.
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2
Setting up your system
Day will flash
đƫ If the day displayed is
correct, press
to
confirm.
đƫ 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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