OneTouch Select Plus Flex, Owner'S Booklet

Page 1: ...Blood Glucose Monitoring System Owner s Booklet Instructions for Use ...

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Page 3: ...1 Owner s Booklet Blood Glucose Monitoring System ...

Page 4: ...y patterns Meter results are sent to the compatible devices either through BLUETOOTH 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 Own...

Page 5: ...le 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 Low Battery Battery Empty Control Solution Syncing BLUETOOTH Feature On History Mode Past results Apply Sample Range Indicator Arrow Setting Mode ...

Page 6: ...em 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 Sterilised by irradiation Not for general waste Use By Date Contains sufficient for n tests Underwriters Laboratories certification ...

Page 7: ... the OneTouch Delica Plus Lancing Device 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 cleanin...

Page 8: ...ing 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 ...

Page 9: ...ays the result and stores it in its memory Use only OneTouch Select Plus Control Solution and Test Strips with the OneTouch Select Plus Flex Meter Use of OneTouch Select Plus Test Strips with meters for which they are not intended may yield inaccurate results BLUETOOTH wireless technology BLUETOOTH wireless technology is used by some smartphones and many other devices Your OneTouch Select Plus Fle...

Page 10: ...uchMEA com to learn if the OneTouch Reveal Mobile App is available in your country Visit www OneTouchMEA com 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 w...

Page 11: ...erence received including interference that may cause undesirable operation 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 If you experience meter interference problems try moving your meter away from the source of the interference You can also move the elect...

Page 12: ... single patient use only WARNING In locations where cell phone use is not permitted such as hospitals some healthcare professional offices and airplanes you should turn the BLUETOOTH feature off See page 29 for more information Do Not leave your meter unattended or in a public place so that others may change your personal parameters or make physical connections to it The meter has been designed de...

Page 13: ...e BLUETOOTH word mark and logos are registered trademarks owned by the Bluetooth SIG Inc and any use of such marks by LifeScan Scotland Ltd is under licence Other trademarks and trade names are those of their respective owners ...

Page 14: ... 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 68 4 Reviewing past results 78 ...

Page 15: ...iting Your Settings 82 Editing time and date 82 Editing your range limits 83 6 Caring for your system 86 7 Battery 90 8 Troubleshooting your system 94 9 Detailed information about your system 108 10 Index 122 ...

Page 16: ...tting 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 ...

Page 17: ...If any item is missing or defective in your kit contact Customer Service Contact LifeScan Customer Service at service LifeScanMEA com NOTE If another type of lancing device was included see the separate instructions for that lancing device ...

Page 18: ... 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 Mid Control Solution OneTouch Select Plus Test Strips Lancets ...

Page 19: ...ts test strips and control solution contact Customer Service or your healthcare professional 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 ...

Page 20: ...18 1 Getting to know your system Meter Getting to know your OneTouch Select Plus Flex Blood Glucose Monitoring System ...

Page 21: ...19 1 Getting to know your system ...

Page 22: ...20 1 Getting to know your system Getting to know your OneTouch Select Plus Test Strip Test strip ...

Page 23: ...ets 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 Colour Bar below the meter display Use the Range Indicator Arrow and Colour Bar together to interpret your results ...

Page 24: ... 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 83 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 ...

Page 25: ...23 1 Getting to know your system This page left blank intentionally ...

Page 26: ...problem with the meter Contact Customer Service Contact LifeScan Customer Service at service LifeScanMEA com 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 displ...

Page 27: ...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 ...

Page 28: ...not correct press or to change the year and press to confirm Setting the date After completing the time setup the meter will automatically move to date setup 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 ...

Page 29: ...ed 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 ...

Page 30: ... The SET screen will appear See page 82 After adjusting the settings your meter will exit settings mode and your last result screen will appear 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 wi...

Page 31: ...eed to be turned on The symbol will appear on the meter screen when the BLUETOOTH feature is on When the symbol is not present on the screen the BLUETOOTH feature is off To turn the BLUETOOTH feature on press and at the same time To turn the BLUETOOTH feature off press and at the same time The symbol indicates the BLUETOOTH feature is on NOTE The BLUETOOTH feature will turn OFF during a blood gluc...

Page 32: ...available in your country Visit www OneTouchMEA com 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 To pair multiple meters repeat the pairing instructions for each meter See page 31 f...

Page 33: ...ur meter on using the button 2 The BLUETOOTH feature is turned on by pressing and together The symbol will appear to indicate that the BLUETOOTH feature is on 3 Open the OneTouch Reveal Mobile App and follow instructions to pair meter with your compatible wireless device ...

Page 34: ...32 2 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 ...

Page 35: ...e Example of PIN number display on meter CAUTION Make sure the PIN you enter on your compatible wireless 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 com...

Page 36: ...veal 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 feature is ON as indicated by If needed press and at the same time to turn the BLUETOOTH 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 Synci...

Page 37: ...cel the transfer of all results The flashing symbol appears on the screen and you can proceed with testing Turning the meter off 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 c...

Page 38: ...dy when you test OneTouch Select Plus Flex Meter OneTouch Select Plus Test Strips Lancing device Sterile lancets 3 Taking a test 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 Move your meter and test strips to a cool dry spot and wait for the meter ...

Page 39: ...nused 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 or control solution applied to it Test strips are for single use only Do Not test with a test strip that is bent or damaged With clean dry hands you may touch the test strip anywhere on its surface Do Not bend cut or modify the test strip in ...

Page 40: ... your meter results to those obtained from a lab See page 108 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 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 Custo...

Page 41: ...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 expiry date printed on the vial ...

Page 42: ...40 3 Taking a test Getting to know your OneTouch Delica Plus Lancing Device 1 Release button 2 Slider control 3 Depth indicator 4 Depth wheel 5 Lancing device cap 6 Protective cover ...

Page 43: ...neTouch Select Plus 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 Plus Lancing System does not include the materials needed to perform Alternate Site Testing AST The OneTouch Delica Plus Lancing System should not be used on the forearm or palm with the OneTouch Select Plus Flex Blood G...

Page 44: ...use a new sterile lancet each time you test Always keep your meter and lancing device clean See page 86 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 pe...

Page 45: ...43 3 Taking a test Preparing your lancing device 1 Remove the lancing device cap Remove the cap by rotating it and then pulling it straight off the device ...

Page 46: ...own 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 65 ...

Page 47: ...45 3 Taking a test 3 Replace the lancing device cap Place the cap back onto the device turn the cap or push the cap straight on to secure it Ensure the cap is aligned as shown in the image ...

Page 48: ...n the Depth Wheel indicates an additional available depth setting Adjust the depth by turning the depth wheel Smaller numbers are for a shallower puncture and larger numbers for a deeper puncture NOTE 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 ...

Page 49: ...47 3 Taking a test 5 Cock the lancing device Pull the slider back until it clicks If it does not click it may already have been cocked when you inserted the lancet ...

Page 50: ...ip 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 The flashing blood drop icon appears on the display You can now apply your blood sample to the test strip ...

Page 51: ...me spot may cause soreness and calluses Before testing wash your hands and the sample site with warm soapy water Rinse and dry completely Contaminants on the skin may affect results 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 ...

Page 52: ...ound drop of blood Gently squeeze and or massage your fingertip until a round drop of blood forms 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: ...er extended and steady move the meter and test strip toward the blood drop Do Not apply blood on the top of the test strip Do Not hold the meter and test strip underneath the blood drop This may cause blood to run into the test strip port and damage the meter Do Not allow blood to enter the Data Port ...

Page 54: ...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: ...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 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 ...

Page 56: ...54 3 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 ...

Page 57: ...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 The Countdown screen will appear Now you can move the test strip away from the drop of blood and wait for the meter to count down about 5 seconds Countdown Screen ...

Page 58: ...se 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 Colour Bar on the meter as a visual reminder Example Below Range Result Example In Range Result Example Above Range Result ...

Page 59: ... 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 ...

Page 60: ... as LO meaning the result is less than 20 mg dL it may mean hypoglycaemia 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...

Page 61: ... 3 Taking a test 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 ...

Page 62: ...a HI is displayed when your result is over 600 mg dL You may have severe hyperglycaemia 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 Arr...

Page 63: ...ults 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 programme without speaking to your healthcare professional Unusual red blood cell count A haematocrit percentage of your blood that is red blood cells that is either very high above 55 or very low below 30 can cause fals...

Page 64: ...nding 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 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 ne...

Page 65: ...rned 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 8 metres 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 symbol remaining on the meter screen Example ...

Page 66: ...e LifeScanMEA com 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 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 ...

Page 67: ...t have to pull out the used lancet 1 Remove the lancing device cap Remove the cap by rotating it and then pulling it straight off 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 flat side of the disk ...

Page 68: ...t Holding the lancing device directed downwards push the slider forward until the lancet comes out of the lancing device If the lancet fails to eject properly cock the device then push the slider control forward until the lancet comes out ...

Page 69: ...e device turn the cap or push the cap straight in to secure it Ensure the cap is aligned as shown in the image 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 ...

Page 70: ...our 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 Select Plus Control Solution is used to check that the meter and test strips are working together properly and that the test is perform...

Page 71: ...remove a test strip and perform a test Use the test strip immediately after removing it from the vial especially in high humidity environments Control solution tests must be done at room temperature 20 25 C Make sure your meter test strips and control solutions are at room temperature before testing CAUTION Do Not swallow or ingest control solution Do Not apply control solution to the skin or eyes...

Page 72: ...at the meter or test strips are not working properly If you have had repeated unexpected blood glucose results 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 Insert the test strip with the test strip port and contact bars facing you ...

Page 73: ... 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 and hold or until the control solution icon appears on the display ...

Page 74: ... 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 ...

Page 75: ...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 3 Wait for the channel to fill completely 2 Touch the channel on the top edge of the test strip to the control solution ...

Page 76: ...easure 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 and hold or until the control solution icon appears before you begin a control solution test An screen may appear if you applied control solution to the test strip without following the steps beginning on page 70 See page 104 for more inf...

Page 77: ... printed on its label Compare the result displayed on the meter to the OneTouch Select Plus Mid Control Solution range printed on the test strip vial If your control solution result falls outside the expected range repeat the test with a new test strip Example Range OneTouch Select Plus Mid Control Solution Control Range 102 138 mg dL ...

Page 78: ...e 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 w...

Page 79: ...de the range printed on the test strip vial Do Not use the meter test strips or control solution Contact Customer Service Contact LifeScan Customer Service at service LifeScanMEA com Cleaning the control solution cap Clean the top of the control solution cap with a clean damp tissue or cloth ...

Page 80: ...lood 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 off 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 co...

Page 81: ... available to you contact Customer Service Contact LifeScan Customer Service at service LifeScanMEA 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 Select Plus Flex Meter to a ...

Page 82: ...ter 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 Contact LifeScan Customer Service at service LifeScanMEA com ...

Page 83: ...81 4 Reviewing past results This page left blank intentionally ...

Page 84: ...gs 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 me...

Page 85: ...rent 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 fo...

Page 86: ...imit 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 ...

Page 87: ...mits 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 ...

Page 88: ...ge 88 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 Cleaning your meter lancing device and cap The meter lancing device and cap should be cleaned whenever they are visibly dirty and before disinfection Clean your meter at least...

Page 89: ...the data port See page 18 Do Not spray cleaning solution on the meter or immerse it in any liquid 1 Holding the meter with the test strip port pointed down use a soft cloth dampened with water and mild detergent to wipe the outside of the meter and lancing device Be sure to squeeze out any excess liquid before you wipe the meter Wipe the outside of the cap ...

Page 90: ...an your meter lancing device and cap prior to disinfecting For disinfecting obtain regular household bleach containing a minimum of 5 5 sodium hypochlorite as the active ingredient Prepare a solution of 1 part household bleach and 9 parts water Follow manufacturer s instruction for handling and storage of bleach 2 Wipe dry with a clean soft cloth ...

Page 91: ...ueeze out any excess liquid before you wipe the meter 2 After wiping cover the surface you are disinfecting with the soft cloth dampened with the bleach solution for 1 minute Then wipe with a clean damp soft cloth Wash hands thoroughly with soap and water after handling the meter lancing device and cap If you see signs of wear please contact Customer Service Contact LifeScan Customer Service at se...

Page 92: ...te medical attention 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 batt...

Page 93: ...ry Start with the meter turned off Remove the battery cover by pressing and sliding it downward 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 ...

Page 94: ...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 Contact LifeScan Customer Service at service LifeScanMEA com ...

Page 95: ...attery 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 ...

Page 96: ...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 Contact LifeScan Customer Service at service LifeScanMEA com ...

Page 97: ...n 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 ...

Page 98: ...e hyperglycaemia 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 ...

Page 99: ...r and test strips to a cooler area Insert a new test strip when the meter and test strips are within the operating range 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 LifeScan Customer Service at service LifeScanMEA com ...

Page 100: ...er and test strips to a warmer area Insert a new test strip when the meter and test strips are within the operating range 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 LifeScan Customer Service at service LifeScanMEA com ...

Page 101: ... 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 Contact LifeScan Customer Service at service LifeScanMEA com They will refer to the error number and code to help troubleshoot the problem Example Error Screen Code ...

Page 102: ...an Customer Service at service LifeScanMEA com 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 Repeat the test with a new test strip see page 52 or page 73 If this message continues to appear contact Customer Service Contact LifeScan Customer Service at service LifeScanMEA com ...

Page 103: ... 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 Contact LifeScan Customer Service at service LifeScanMEA com ...

Page 104: ...rip Possible cause is test strip damage What to do Repeat the test with a new test strip See page 36 for taking a blood glucose test or page 70 for taking a control solution test If the error message appears again contact Customer Service Contact LifeScan Customer Service at service LifeScanMEA com ...

Page 105: ...t 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 36 for taking a blood glucose test or page 70 for taking a control solution test If the error message appears again contact Customer Service Contact LifeScan Customer Service at service LifeScanMEA com ...

Page 106: ...sample type to the test strip when prompted by the meter for a blood or control solution sample What to do Repeat the test with a new test strip See page 36 for taking a blood glucose test or page 70 for taking a control solution test If the error message appears again contact Customer Service Contact LifeScan Customer Service at service LifeScanMEA com ...

Page 107: ...e 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 There is not enough battery power to perform a test What to do Replace the battery immediately ...

Page 108: ... 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 Contact LifeScan Customer Service at service LifeScanMEA com ...

Page 109: ...107 Troubleshooting your system 8 This page left blank intentionally ...

Page 110: ...ed in plasma equivalent units 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 15 mg dL of a laboratory method when the glucose concentration is lower than 100 mg dL and within 15 of a laboratory method when the glucose concentration is 100 mg dL or higher ...

Page 111: ...u 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 haematocrit is above 55 or below 30 You are severely dehydrated For additional information refer to the OneTouch Select Plus Test Strip Insert 1 Sacks D B Carbohydrates Burtis C A and Ashwood E R ed Tietz Textbook of Clinical Chemistry Philadelphia W...

Page 112: ...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 ...

Page 113: ...our fingertip Follow all instructions in this Owner s Booklet for performing a blood glucose test 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 ...

Page 114: ...thium coin cell battery Battery type One replaceable 3 0 Volt CR2032 lithium coin cell battery or equivalent Biological source Aspergillus Niger BLUETOOTH Technology Frequency band 2 4 2 4835 GHz Maximum power 0 4 mW Operating Range Distance minimum 8 metres unobstructed Operating Channels 40 Channels Security Encryption 128 bit AES Advanced Encryption Standard Calibration Plasma equivalent ...

Page 115: ...ranges Temperature 10 44 C Relative humidity non condensing 10 90 Altitude up to 3048 metres Haematocrit 30 55 Reported result range 20 600 mg dL Sample Fresh capillary whole blood Sample volume 1 0 µL Size 52 W x 86 L x 16 T millimetres Test time Average test time is 5 seconds Unit of measure mg dL Weight Approximately 50 grams ...

Page 116: ...5 of a laboratory method when the glucose concentration is 100 mg dL 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 100 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 67 2...

Page 117: ...ithin 10 Within 15 63 3 266 420 95 5 401 420 99 8 419 420 System Accuracy Results for Glucose Concentrations between 26 6 mg dL and 482 0 mg dL Percent and number of meter results that match the laboratory test Within 15 mg dLor 15 98 8 593 600 NOTE Where 26 6 mg dL represents the lowest glucose reference value and 482 0 mg dL represents the highest glucose reference value YSI value ...

Page 118: ...tained by 174 lay persons showed the following results 100 0 within 15 mg dL of the medical laboratory values at glucose concentrations below 100 mg dL and 95 9 within 15 of the medical laboratory values at glucose concentrations at or above 100 mg dL 96 6 of the total number of samples were within 15 mg dL or 15 of the medical laboratory values ...

Page 119: ...uplicate on each of three test strip lots Results indicate that the OneTouch Select Plus Flex System compares well with a laboratory method of Subjects ofTests Slope Intercept mg dL 100 600 0 98 0 13 95 CI Slope 95 CI Intercept mg dL Std Error Sy x mg dL R2 0 97 to 0 98 1 48 to 1 21 9 02 0 99 ...

Page 120: ...ose mg dL Mean Glucose mg dL Standard Deviation mg dL Coefficient ofVariation 40 46 21 1 66 3 58 65 70 39 1 89 2 69 120 123 56 2 65 2 15 200 193 22 3 54 1 83 350 350 02 7 41 2 12 Results show that the greatest variability observed between test strips when tested with blood is 1 89 mg dL SD or less at glucose levels less than 100 mg dL or 2 15 CV or less at glucose levels at 100 mg dL or above ...

Page 121: ...ol Solution Tests per Glucose Level Data generated using the OneTouch Select Plus Flex Meter Glucose Level Ranges mg dL Mean Glucose mg dL Standard Deviation mg dL Coefficient ofVariation Low 30 50 45 45 1 23 2 71 Mid 96 144 110 44 2 01 1 82 High 280 420 365 84 6 04 1 65 ...

Page 122: ...C via USB cable connection and visiting www OneTouchMEA com and following the step by step instructions Software updates will not affect your settings and historical data in your meter Guarantee LifeScan guarantees that the OneTouch Select Plus 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 p...

Page 123: ... 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 Use of this meter near electrical or electronic equipment that are sources of electromagnetic radiation may interfere with proper operation of this meter It is advisable t...

Page 124: ...ice and cap 86 Comparing meter results to laboratory results 108 Compatible wireless devices 3 Control solution 70 Control solution discard and expiry dates 69 Control solution testing 68 74 76 Data port 18 Date setting 26 28 Dehydration 59 109 Disinfecting your meter lancing device and cap 88 Display check 24 Disposal lancets and test strips 68 Downloading results to a computer 79 Edit date 82 Ed...

Page 125: ... setup 25 30 Guarantee 120 Hyperglycaemia 60 96 Hypoglycaemia 58 95 Icons 3 4 Infection reduce the chance 42 Intended use 6 Kit components 14 Lancet 40 43 Lancet expiry date 42 Lancing device 14 40 43 86 mg dL 18 113 Pairing 30 31 PIN 33 Plasma calibration 108 112 Range Indicator feature 21 Range limits setting 83 Results reviewing past 78 Serial number 32 ...

Page 126: ... 34 62 Technical specifications 112 Temperature 36 37 69 76 86 97 98 113 Test strip 20 48 70 Test strip applying drop of blood 51 52 Test strip contact bars 20 Time setting 25 28 Turning meter off 35 Turning meter on 24 48 70 Unexpected results 58 61 Unit of measure 18 113 Unusual red blood cell count haematocrit 61 109 113 ...

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Page 128: ...curacy 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 Lancets Lancing Device RED 2014 53 EU Rev Date 02 2020 Blood Glucose Meter LifeScan...