OneTouch Select Plus Flex Instructions For Use Manual
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OneTouch Select Plus Flex Instructions For Use Manual

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Enlarged version
C4
Yellow = 5mm margin, Red = 10mm margin
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.
LifeScan self-test blood glucose monitoring devices conform to
the following EU Directives:
IVDD (98/79/EC):
Blood Glucose Meter, Test Strips, and Control Solution
MDD (93/42/EEC):
Lancing System
Distributed by:
LifeScan UK & Ireland,
A division of Johnson & Johnson
Medical Limited,
50-100 Holmers Farm Way,
High Wycombe,
Bucks,
HP12 4DP
United Kingdom
PF3130451 Rev 1
© 2015 LifeScan, Inc.
Rev. Date: 01/2015
PF3130451 Rev 1
Yellow = 5mm margin, Red = 10mm margin
Type: Project File Name: 3130451 Revision: 1
Effectivity Date: Mar 18 2015
Statement of Use: Verify status before each use
PF3130451Rev1_OTSPF_OB_C_GB_en_zug_R2.indd 4
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.
LifeScan Europe
Division of Cilag
GmbH International
Gubelstrasse 34
6300 Zug
Switzerland
Status: Current
State: Released
3/12/15 11:27 AM

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  • Page 1 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.
  • Page 2 Yellow margin, 10mm margin Blood Glucose Monitoring System Owner's Booklet Instructions for Use Yellow = margi R ed R ed 1 0m mm m argin Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use PF3130451Rev1_OTSPF_OB_C_GB_en_zug_R2.indd 1 3/12/15 11:27 AM...
  • Page 3 Yellow = 5mm margin, Red = 10mm margin Yellow = 5mm margin, Red = 10mm margin Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use PF3130451Rev1_OTSPF_OB_C_GB_en_zug_R2.indd 2 3/12/15 11:27 AM...
  • Page 4 Yellow = 5mm margin, Red = 10mm margin Yellow = 5mm margin, Red = 10mm margin Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use PF3130451Rev1_OTSPF_OB_C_GB_en_zug_R2.indd 3 3/12/15 11:27 AM...
  • Page 5 Leg1 Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use PF3130451Rev1_OTSPF_OB_C_GB_en_zug_R2.indd 1 3/12/15 11:27 AM...

  • Page 6: Type: Project File Name: 3130451 Revision

    Yellow= 5mm Red=7mm margin Select Plus Flex ™ Blood Glucose Monitoring System Owner's Booklet Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use PF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 1...
  • Page 7 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.
  • Page 8 Yellow= 5mm Red=7mm margin 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. Meter symbols and icons Meter Power...
  • Page 9 Yellow= 5mm Red=7mm margin 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...
  • Page 10 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: This meter and lancing device are for single patient use only.
  • Page 11 Yellow= 5mm Red=7mm margin 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.
  • Page 12 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.
  • Page 13 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.
  • Page 14 Yellow= 5mm Red=7mm margin 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.

  • Page 15: Table Of Contents

    Yellow= 5mm Red=7mm margin 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 ..........

  • Page 16: Table Of Contents

    Yellow= 5mm Red=7mm margin  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 Index .................

  • Page 17: Getting To Know Your System

    Yellow= 5mm Red=7mm margin  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 Type: Project File Name: 3130451 Revision: 1...
  • Page 18 Yellow= 5mm Red=7mm margin 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.
  • Page 19 Solution* Solution* (vial with blue cap) (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. Type: Project File Name: 3130451 Revision: 1...
  • Page 20 Yellow= 5mm Red=7mm margin 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®...
  • Page 21 Yellow= 5mm Red=7mm margin Getting to know your system Getting to know your OneTouch Select Plus Flex™ Blood Glucose Monitoring System Meter Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use PF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 16...
  • Page 22 Yellow= 5mm Red=7mm margin Getting to know your system Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use PF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 17 3/12/15 11:35 AM...
  • Page 23 Yellow= 5mm Red=7mm margin Getting to know your system Getting to know your OneTouch Select® Plus Test Strip Test strip Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use PF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 18...
  • Page 24 Yellow= 5mm Red=7mm margin 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...
  • Page 25 Yellow= 5mm Red=7mm margin 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. Example Things you should know before Below Range Result...
  • Page 26 Yellow= 5mm Red=7mm margin Getting to know your system This page left blank intentionally. Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use PF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 21 3/12/15 11:35 AM...

  • Page 27: Setting Up Your System

    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...
  • Page 28 Yellow= 5mm Red=7mm margin 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.
  • Page 29 Yellow= 5mm Red=7mm margin 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 confirm. If the year displayed is not correct, press change the year and press to confirm.
  • Page 30 Yellow= 5mm Red=7mm margin Setting up your system Day will flash If the day displayed is correct, press confirm. If the day displayed is not correct, press change the day and press to confirm. You are now ready to take a test.
  • Page 31 Yellow= 5mm Red=7mm margin 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 at the same time.

  • Page 32: Connecting To A Compatible Wireless Device

    Yellow= 5mm Red=7mm margin Setting up your system Connecting to a compatible wireless device Turning the BLUETOOTH® SMART feature on or off 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®...
  • Page 33 Visit www.LifeScan.co.uk to learn if the OneTouch Reveal® Mobile App is available in your country. Multiple OneTouch Select Plus Flex™ Meters can be paired with your compatible wireless device. For example, your compatible wireless device can be paired with a meter at home and another at work.
  • Page 34 BLUETOOTH® SMART feature is on. 3. Open the OneTouch Reveal® Mobile App and follow instructions to pair meter with your compatible wireless device Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015...
  • Page 35 Yellow= 5mm Red=7mm margin 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 Type: Project File Name: 3130451 Revision: 1...
  • Page 36 Yellow= 5mm Red=7mm margin 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.
  • Page 37 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®...

  • Page 38: Turning The Meter Off

    Yellow= 5mm Red=7mm margin Setting up your system Turning the meter off There are three ways to turn your meter off: for several seconds until the meter Press and hold turns off. Remove the test strip. Your meter will turn off by itself if left alone for two minutes.

  • Page 39: Taking A Test

    OneTouch Select® Plus Test Strips Lancing device Sterile lancets NOTE: Use only OneTouch Select® Plus Test Strips. Make sure your meter and test strips are about the same temperature before you test. Do Not test if there is condensation (water build-up) on your meter.
  • Page 40 Yellow= 5mm Red=7mm margin Taking a test 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, especially in high humidity environments. Tightly close the cap on the vial immediately after use to avoid contamination and damage.
  • Page 41 See page 100 for more information. CAUTION: Do Not use the OneTouch Select Plus Flex™ System when PAM (Pralidoxime) is known or suspected to be in the patient's whole blood sample, as it may cause inaccurate results.
  • Page 42 Yellow= 5mm Red=7mm margin Taking a test 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. Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current...
  • Page 43 Yellow= 5mm Red=7mm margin Taking a test Getting to know your OneTouch® Delica® Lancing Device Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use PF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 38...
  • Page 44 OneTouch® Delica® Lancets. If another type of lancing device was included, see the separate instructions for that lancing device. The OneTouch Select Plus Flex™ Blood Glucose Monitoring System has not been evaluated for Alternate Site Testing (AST). Use only fingertips when testing with the system.
  • Page 45 Yellow= 5mm Red=7mm margin 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.
  • Page 46 Yellow= 5mm Red=7mm margin 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. Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released...
  • Page 47 Yellow= 5mm Red=7mm margin 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.
  • Page 48 Yellow= 5mm Red=7mm margin 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. Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use...
  • Page 49 Yellow= 5mm Red=7mm margin 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.
  • Page 50 Yellow= 5mm Red=7mm margin 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 contact bars facing you. NOTE: No separate step to code the meter is required.
  • Page 51 Yellow= 5mm Red=7mm margin 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.
  • Page 52 Yellow= 5mm Red=7mm margin Taking a test 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.
  • Page 53 Yellow= 5mm Red=7mm margin Taking a test Applying blood and reading results Prepare to apply the sample Keeping your finger extended and steady, move the meter and test strip toward the blood drop. Do Not apply blood on the top of the test strip.
  • Page 54 Yellow= 5mm Red=7mm margin Taking a test Applying the sample Line up the test strip with the blood drop so that the narrow channel on the edge of the test strip is almost touching the edge of the blood drop. Gently touch the channel to the edge of the blood drop.
  • Page 55 Yellow= 5mm Red=7mm margin Taking a test Do Not press the test strip too firmly against the puncture site or the channel may be blocked from filling properly. Do Not smear or scrape the drop of blood with the test strip. Do Not apply more blood to the test strip after you have moved the drop of blood away.
  • Page 56 Yellow= 5mm Red=7mm margin Taking a test Wait for the confirmation window to fill completely. The blood drop will be drawn into the narrow channel and the confirmation window should fill completely. Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use...
  • Page 57 Yellow= 5mm Red=7mm margin Taking a test CAUTION: You may get an error message or an inaccurate result if the blood sample does not fill the confirmation window completely. Discard the used strip and re-start the test process with a new test strip. When the confirmation window is full, this means you have applied enough blood.
  • Page 58 Yellow= 5mm Red=7mm margin 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, Example the meter will also display a Range Below Range Result Indicator Arrow below your glucose result to indicate if your result is...
  • Page 59 Yellow= 5mm Red=7mm margin Taking a test Interpreting unexpected results Refer to the following cautions when your results are higher or lower than what you expect. CAUTION: Low results If your result is below 3.9 mmol/L or is shown as LO (meaning the result is less than 1.1 mmol/L), it may mean hypoglycemia (low blood glucose).
  • Page 60 Yellow= 5mm Red=7mm margin Taking a test CAUTION: High results If your result is above 10.0 mmol/L, it may mean hyperglycemia (high blood glucose) and you should consider re-testing. Talk to your healthcare professional if you are concerned about hyperglycemia. HI is displayed when your result is over 33.3 mmol/L.
  • Page 61 Yellow= 5mm Red=7mm margin 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.
  • Page 62 Yellow= 5mm Red=7mm margin Taking a test 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.
  • Page 63 Example If you are still unable to send results to the compatible wireless device, please call Customer Service. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). NOTE: Inserting a test strip during the transmission will cancel the transfer of all results. The symbol appears on the screen and you can proceed with testing.
  • Page 64 Yellow= 5mm Red=7mm margin 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.
  • Page 65 Yellow= 5mm Red=7mm margin 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.
  • Page 66 Yellow= 5mm Red=7mm margin 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.

  • Page 67: Testing With Control Solution

    (Control solution is available separately.) NOTE: 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.
  • Page 68 Yellow= 5mm Red=7mm margin Taking a test 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. Tightly close the cap on the control solution vial immediately after use to avoid contamination or damage.
  • Page 69 Yellow= 5mm Red=7mm margin Taking a test Do a control solution test Whenever 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 results.
  • Page 70 Yellow= 5mm Red=7mm margin Taking a test 2. Wait for the flashing blood drop icon ( ) to appear on the display 3. Press until the control solution icon ( appears on the display Preparing the control solution 1. Before removing the cap, shake the vial gently 2.
  • Page 71 Yellow= 5mm Red=7mm margin 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 Type: Project File Name: 3130451 Revision: 1...
  • Page 72 Yellow= 5mm Red=7mm margin Taking a test Applying the control solution 1. Hold the meter so that the narrow channel at the top edge of the test strip is at a slight angle to the drop of control solution 2. Touch the channel on the top edge of the test strip to the control solution 3.
  • Page 73 Yellow= 5mm Red=7mm margin 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.
  • Page 74 OneTouch Select® Plus Control Solution vial. If your control solution result falls outside the expected range, repeat Example Range the test with a new test OneTouch Select® Plus Mid strip. Control Solution Control Range 5.7-7.7 mmol/L OneTouch Select® Plus High Control Solution Control Range 16.5-22.4 mmol/L...
  • Page 75 Do Not use the meter, test strips, or control solution. Contact Customer Service. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). Type: Project File Name: 3130451 Revision: 1...
  • Page 76 Yellow= 5mm Red=7mm margin Taking a test Cleaning the control solution cap Clean the top of the control solution cap with a clean, damp tissue or cloth. Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use PF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 71...

  • Page 77: Reviewing Past Results

    Yellow= 5mm Red=7mm margin  4 Reviewing past 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.
  • Page 78 You will need a standard micro USB interface cable to connect your OneTouch Select Plus Flex™ Meter to a computer to download results (not included). Type: Project File Name: 3130451 Revision: 1...
  • Page 79 Do Not insert a test strip while the meter is connected to a computer. If you are unable to download your results to a computer, please call Customer Service. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). Type: Project File Name: 3130451 Revision: 1...
  • Page 80 Yellow= 5mm Red=7mm margin Reviewing past results This page left blank intentionally. Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use PF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 75 3/12/15 11:36 AM...

  • Page 81: Editing Your Settings

    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.

  • Page 82: Editing Your Range Limits

    Yellow= 5mm Red=7mm margin 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.
  • Page 83 Yellow= 5mm Red=7mm margin 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 to change the value between 3.3 mmol/L-6.1 mmol/L, and then press 2.
  • Page 84 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.

  • Page 85: Caring For Your System

    Yellow= 5mm Red=7mm margin  6 Caring for your system Storing your system Store your meter, test strips, control solution and other items in your carrying case. Keep in a cool, dry place between 5°C and 30°C. Do Not refrigerate. Keep all items away from direct sunlight and heat.
  • Page 86 Yellow= 5mm Red=7mm margin Caring for your system Do Not use alcohol or any other solvent. Do Not allow liquids, dirt, dust, blood or control solution to enter the test strip port or the data port. (See page 16.) Do Not spray cleaning solution on the meter or immerse it in any liquid.
  • Page 87 Yellow= 5mm Red=7mm margin Caring for your system 2. Wipe dry with a clean, soft cloth Disinfecting your meter, lancing device and cap The meter, lancing device and cap should be disinfected periodically. Clean your meter, lancing device and cap prior to disinfecting.
  • Page 88 If you see signs of wear, please contact Customer Service. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015...

  • Page 89: Battery

    Yellow= 5mm Red=7mm margin  7 Battery Replacing the battery Your OneTouch Select Plus Flex™ Meter uses one CR2032 lithium coin cell battery. IMPORTANT: Use only one CR2032 lithium coin cell battery with your meter. Do Not use rechargeable batteries. Use of an incorrect battery type may result in your meter providing fewer tests than normal.
  • Page 90 If the meter does not power on after you have replaced the meter battery, check that the battery is correctly installed. If the meter still does not power on, contact Customer Service. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). Type: Project File Name: 3130451 Revision: 1...
  • Page 91 Yellow= 5mm Red=7mm margin Battery 3. Replace battery cover by sliding it upwards onto the meter 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.
  • Page 92 Yellow= 5mm Red=7mm margin Battery This page left blank intentionally. Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use PF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 87 3/12/15 11:36 AM...

  • Page 93: Troubleshooting Your System

    Troubleshooting your system Error and other messages The OneTouch Select Plus Flex™ Meter displays messages when there are problems with the test strip, with the meter or when your glucose levels are above 33.3 mmol/L or below 1.1 mmol/L. Improper use may cause an inaccurate result without producing an error message.
  • Page 94 Yellow= 5mm Red=7mm margin Troubleshooting your system What it means You may have a very high blood glucose level (severe hyperglycemia), over 33.3 mmol/L. NOTE: When your glucose result is above 33.3 mmol/L, both the HI and the Range Indicator Arrow will flash on the meter screen.
  • Page 95 (10-44°C). If you do not get another HI .t message, you can proceed with testing. If this message continues to appear, contact Customer Service. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). Type: Project File Name: 3130451 Revision: 1...
  • Page 96 (10-44°C). If you do not get another LO.t message, you can proceed with testing. If this message continues to appear, contact Customer Service. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). Type: Project File Name: 3130451 Revision: 1...
  • Page 97 If you cannot resolve the error with your meter, contact Customer Service. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). They will refer to the error number and code to help troubleshoot the problem.
  • Page 98 There is a problem with the meter. What to do Do Not use the meter. Contact Customer Service. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). What it means Error message could be caused either by a used test strip or a problem with the meter or test strip.
  • Page 99 Repeat the test with a new test strip. Apply a blood or control solution sample only after the flashing symbol appears on the display. If this message continues to appear, contact Customer Service. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). Type: Project File Name: 3130451 Revision: 1...
  • Page 100 If the error message appears again, contact Customer Service. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). Type: Project File Name: 3130451 Revision: 1...
  • Page 101 If the error message appears again, contact Customer Service. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). Type: Project File Name: 3130451 Revision: 1...
  • Page 102 If the error message appears again, contact Customer Service. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). Type: Project File Name: 3130451 Revision: 1...
  • Page 103 Yellow= 5mm Red=7mm margin 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.
  • Page 104 You can still perform a blood glucose test or control solution test and get an accurate result. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland). Type: Project File Name: 3130451 Revision: 1...

  • Page 105: Detailed Information About Your System

    However, your meter result may differ from your lab result due to normal variation. A result from your OneTouch Select Plus Flex™ Meter is considered accurate when it is within 0.83 mmol/L of a laboratory method when the glucose concentration is lower than 5.55 mmol/L and within 15% of laboratory method when...
  • Page 106 Yellow= 5mm Red=7mm margin 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.
  • Page 107 Yellow= 5mm Red=7mm margin Detailed information about your system Testing with your OneTouch Select Plus Flex™ Meter at the lab: Test within 15 minutes of the lab test. Use only a fresh, capillary blood sample from your fingertip. Follow all instructions in this Owner's Booklet for performing a blood glucose test.
  • Page 108 Yellow= 5mm Red=7mm margin Detailed information about your system Technical Specifications Assay method Glucose Oxidase biosensor Automatic shutoff Two minutes after last action 3.0 V d.c. (CR2032 lithium coin cell Battery ratings battery) Battery type One replaceable 3.0 Volt CR2032 lithium coin cell battery (or equivalent) Biological source Aspergillus Niger...
  • Page 109 Yellow= 5mm Red=7mm margin Detailed information about your system Operating ranges Temperature: 10-44°C Relative humidity: non-condensing 10-90% Altitude: up to 3048 meters Hematocrit: 30-55% Reported result range 1.1-33.3 mmol/L Fresh capillary whole blood Sample Sample volume 1.0 μL Size 52(W) x 86(L) x 16(T) millimeters Test time Average test time is 5 seconds Unit of measure...
  • Page 110 5.55 mmol/L, and within 15% of a laboratory method when the glucose concentration is 5.55 mmol/L or higher. Samples from 100 patients were tested using both the OneTouch Select Plus Flex™ System and the YSI 2300 Glucose Analyzer laboratory instrument. System Accuracy Results for Glucose Concentrations <5.55 mmol/L...
  • Page 111 Yellow= 5mm Red=7mm margin Detailed information about your system System Accuracy Results for Glucose Concentrations *5.55 mmol/L Percent (and number) of meter results that match the laboratory test Within ±5% Within ±10% Within ±15% 63.3% 95.5% 99.8% (266/420) (401/420) (419/420) System Accuracy Results for Glucose Concentrations between 1.5 mmol/L and 26.8 mmol/L Percent (and number) of meter results that match the...
  • Page 112 Yellow= 5mm Red=7mm margin Detailed information about your system User Performance Accuracy A study evaluating glucose values from fingertip capillary blood samples obtained by 174 lay persons showed the following results: 100.0% within ±0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.55 mmol/L, and 95.9% within ±15% of the medical laboratory values at glucose concentrations at or above 5.55 mmol/L.
  • Page 113 Yellow= 5mm Red=7mm margin Detailed information about your system Regression Statistics Samples were tested in duplicate on each of three test strip lots. Results indicate that the OneTouch Select Plus Flex™ System compares well with a laboratory method. # of Subjects # of Tests...
  • Page 114 Yellow= 5mm Red=7mm margin Detailed information about your system Precision Within Run Precision (300 Venous Blood Samples Tested per Glucose Level) Data generated using the OneTouch Select Plus Flex™ Meter. Target Mean Standard Coefficient Glucose Glucose Deviation of Variation (mmol/L) (mmol/L) (mmol/L) 2.22...
  • Page 115 Yellow= 5mm Red=7mm margin Detailed information about your system Total Precision (600 Control Solution Tests per Glucose Level) Data generated using the OneTouch Select Plus Flex™ Meter. Glucose Mean Standard Coefficient Level Ranges Glucose Deviation of Variation (mmol/L) (mmol/L) (mmol/L) 2.52 0.07...
  • Page 116 Software Updates LifeScan will periodically notify you about software and feature upgrades to your meter. The OneTouch  Select Plus Flex™ Meter software can be upgraded by connecting to a PC via USB cable connection and visiting www.LifeScan.co.uk and following the step-by-step instructions.
  • Page 117 Yellow= 5mm Red=7mm margin Detailed information about your system 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.
  • Page 118 Yellow= 5mm Red=7mm margin Detailed information about your system This page left blank intentionally. Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use PF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 113 3/12/15 11:36 AM...

  • Page 119: Index

    Yellow= 5mm Red=7mm margin Index Batteries Batteries, replacing Battery empty icon Battery empty warning Battery low icon 3, 98 Blood glucose, testing BLUETOOTH® SMART feature 7, 9, 27, 57 Buttons on meter Cleaning your meter, lancing device and cap Comparing meter results to laboratory results Compatible wireless devices Control solution Control solution, discard and expiration dates...
  • Page 120 Yellow= 5mm Red=7mm margin Index Edit time Error messages EXTREME HIGH GLUCOSE message 55, 89 EXTREME LOW GLUCOSE message 54, 88 Fingertip testing procedure First time setup 23, 28 Guarantee Hyperglycemia 55, 89 Hypoglycemia 54, 88 Icons 3, 4 Infection, reduce the chance Intended use Kit components Lancing device...
  • Page 121 Yellow= 5mm Red=7mm margin Index Start-up screen Storing your system Symbols 3, 4 Syncing 32, 57 Technical specifications Temperature 34, 63, 70, 80, 90, 91, 104 Test strip 18, 45, 64 Test strip, applying drop of blood 48, 49 Test strip, contact bars Time setting 23, 26 Turning meter off...
  • Page 122 Type: Project File Name: 3130451 Revision: 1 Effectivity Date: Mar 18 2015 Status: Current State: Released Statement of Use: Verify status before each use PF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 1 3/12/15 11:36 AM...
  • Page 123 •••••••••••••••••••••••••••Approver List Approver: David Latham (GPL) Approval Date: 3/16/2015 6:54:46 AM Approver: Ken Armstrong (Packaging) Approval Date: 3/17/2015 6:33:15 AM Approver: Laura Avancena (Marketing) Approval Date: 3/18/2015 8:05:56 PM Approver: Paul Fisher (Quality) Approval Date: 3/16/2015 9:06:47 AM Approver: Brian Guthrie (RnD) Approval Date: 3/16/2015 10:07:35 AM Approver: Ray Amphlett (Regulatory) Approval Date: 3/16/2015 1:00:24 PM Approver: Martin ONeill (OPS) Approval Date: 3/13/2015 11:55:17 AM Sites Impacted: Inverness...
  • Page 124 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.

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