OneTouch Select Plus Flex Owner's Booklet
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OneTouch Select Plus Flex Owner's Booklet

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Blood Glucose Monitoring System
Owner's
Booklet
Instructions for Use

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Summary of Contents for OneTouch Select Plus Flex

  • Page 1 Blood Glucose Monitoring System Owner's Booklet Instructions for Use...
  • Page 3 Blood Glucose Monitoring System Owner's Booklet...
  • Page 4 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 compatible wireless devices running software applications that let you review and graph your results, and help identify patterns.
  • Page 5 Compatible wireless devices 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. Meter symbols and icons Meter Power Low Battery...
  • Page 6 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 Sterilised by irradiation Not for general waste...
  • Page 7 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 Solution and the ® OneTouch  Delica  Plus Lancing Device.
  • Page 8 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 9 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 ®...
  • Page 10 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 31 for pairing instructions.
  • Page 11 Your meter is subject to and complies with applicable Worldwide Radio regulations and 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.
  • Page 12 WARNING: The BLUETOOTH 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.
  • Page 13 BLUETOOTH trademark ® The 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: Table Of Contents

    Table of Contents Getting to know your system ........14 Setting up your system ..........24 Setting up your meter ............24 Connecting to a compatible wireless device ....29 Turning the meter off ............35 Taking a test ............... 36 Testing your blood glucose ..........36 Testing with control solution .........
  • Page 15 Editing Your Settings ..........82 Editing time and date............82 Editing your range limits ..........83 Caring for your system ..........86 Battery ................90 Troubleshooting your system ........ 94 Detailed information about your system..108 Index ................122...

  • Page 16: Getting To Know Your System

    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...
  • Page 17 Getting to know your system NOTE: 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 Getting to know your system 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 ® OneTouch Select Plus ®...
  • Page 19 Getting to know your system *Lancets, OneTouch Select Plus Control Solution ® and Test Strips are available separately. For availability of lancets, test strips and control solution, contact Customer Service or your healthcare professional. WARNING: Keep the meter and testing supplies away from young children.
  • Page 20 Getting to know your system Getting to know your OneTouch Select Plus Flex Blood Glucose Monitoring ™ System Meter...
  • Page 21 Getting to know your system...
  • Page 22 Getting to know your system Getting to know your OneTouch Select ® Plus Test Strip Test strip...
  • Page 23 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 Colour Bar below the meter display.
  • Page 24 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 using the Range Indicator feature: • The meter comes with pre-set...
  • Page 25 Getting to know your system This page left blank intentionally.

  • Page 26: Setting Up Your System

    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. Every time you turn your meter on, a start-up screen will appear for a few seconds.
  • Page 27 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.
  • Page 28 Setting up your system Minutes will flash • If the minutes displayed is correct, press confirm. • If the minutes displayed is not correct, press to change the minutes and press to confirm. Setting the date After completing the time setup, the meter will automatically move to date setup.
  • Page 29 Setting up your system Month will flash • If the month displayed is correct, press confirm. • If the month displayed is not correct, press to change the month and press to confirm. Day will flash • If the day displayed is correct, press confirm.
  • Page 30 Setting up your system 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.

  • Page 31: Connecting To A Compatible Wireless Device

    Setting up your system Connecting to a compatible wireless device Turning the BLUETOOTH feature on or off ® In order to connect your meter with your compatible wireless device, the BLUETOOTH feature will need to be ® turned on. The symbol will appear on the meter screen when the BLUETOOTH feature is on.
  • Page 32 Setting up your system Pairing Overview Pairing allows your OneTouch Select Plus Flex Meter ™ to communicate with compatible wireless devices. The devices must be within 8 metres of each other to pair and sync. Download the OneTouch Reveal Mobile App from ®...
  • Page 33 2. The BLUETOOTH feature is turned on by pressing ® together 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 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 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 compatible wireless device using the keypad on your compatible wireless device. CAUTION: Make sure the PIN you enter on your compatible wireless device matches the PIN on your meter display.
  • Page 36 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...

  • Page 37: Turning The Meter Off

    Setting up your system After syncing, the Sync symbol will disappear, the "Syncing Data" message will disappear on the app, and the app will display a list of any new results sent from the meter. NOTE: Inserting a test strip during the transmission will cancel the transfer of all results.

  • Page 38: Taking A Test

    NOTE: Many people find it helpful to practise testing with control solution before testing with blood for the first time. See page 68. Preparing for a test Have these things ready when you test: OneTouch Select Plus Flex Meter ™ OneTouch Select Plus Test Strips ®...
  • Page 39 Taking a test • Keep test strips in a cool, dry place between 5°C and 30°C. • 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.
  • Page 40 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.
  • Page 41 Taking a test • If you cannot test due to a problem with your testing supplies, contact your healthcare professional. Failure to test could delay treatment decisions and lead to a serious medical condition. • The test strip vial contains drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation.
  • Page 42 Taking a test Getting to know your OneTouch  Delica  Plus ® ™ Lancing Device Release button Slider control Depth indicator Depth wheel Lancing device cap Protective cover...
  • Page 43 ™ 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 44 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 45 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 Taking a test 2. Insert a sterile lancet into the lancing device Align the lancet as shown here, so that the lancet fits into the lancet holder. Push the lancet into the device until it snaps into place and is fully seated in the holder. Twist the protective cover one full turn until it separates from the lancet.
  • Page 47 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 Taking a test 4. Adjust the depth setting The device has 13 puncture depth settings (each dot shown between numbers 1 to 7 on 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.
  • Page 49 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 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. The flashing blood drop icon ( ) appears on the display.
  • Page 51 Taking a test Sampling blood 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 and the sample site with warm, soapy water. Rinse and dry completely. Contaminants on the skin may affect results.
  • Page 52 Taking a test 2. Get a round 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 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. Do Not hold the meter and test strip underneath the blood drop.
  • Page 54 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 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 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 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 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 Below Range Result Range Indicator Arrow below your glucose result to indicate if your result is below, above...
  • Page 59 Taking a test CAUTION: Do Not make immediate treatment decisions based on the Range Indicator feature. Treatment decisions should be based on the numerical result and healthcare professional recommendation and not solely on where your result falls within your range limits. WARNING: Confirm that the unit of measure mg/dL is displayed.
  • Page 60 Taking a test Interpreting unexpected results Refer to the following cautions when your results are higher or lower than what you expect. CAUTION: Low results If your result is below 70 mg/dL or is shown as LO (meaning the result is less than 20 mg/dL), it may mean hypoglycaemia (low blood glucose).
  • Page 61 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 Taking a test CAUTION: High results • If your result is above 180 mg/dL, it may mean hyperglycaemia (high blood glucose) and you should consider re-testing. Talk to your healthcare professional if you are concerned about hyperglycaemia. • HI is displayed when your result is over 600 mg/dL.
  • Page 63 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 64 Taking a test Sending your results to the app If the BLUETOOTH feature on the meter is turned on, ® indicated by the BLUETOOTH symbol ( ), the meter ® will automatically send the latest result to any paired compatible wireless device. The compatible wireless device must have the app running and have already been paired to the meter before sending a result.
  • Page 65 Taking a test To ensure that glucose test results are successfully sent to the app, turn on the BLUETOOTH feature and check ® the following: • The compatible wireless device and meter are both turned on, and the app is running. • The meter is correctly paired with your compatible wireless device.
  • Page 66 Taking a test If you are still unable to send results to the compatible wireless device, please call Customer Service. Contact LifeScan Customer Service at: service@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.
  • Page 67 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 rotating it and then pulling it straight off the device.
  • Page 68 Taking a test 3. Eject the lancet 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 Taking a test 4. Replace the lancing device cap Place the cap back onto the 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.

  • Page 70: Testing With Control Solution

    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 performing correctly.
  • Page 71 Taking a test NOTE: • 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 72 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 73 Taking a test 2. Wait for the flashing blood drop icon ( ) to appear on the display 3. Press and hold until the control solution icon ( ) appears on the display Preparing the control solution 1. Before removing the cap, shake the vial gently 2.
  • Page 74 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...
  • Page 75 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 76 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, (for control solution) and stored in the meter. Control solution results can be seen when reviewing past results on the meter.
  • Page 77 OneTouch Select ® Plus Mid Control Solution range printed on its label. Compare the result displayed on the meter to the OneTouch Select ® Plus Mid Control Solution Example Range range printed on the test OneTouch Select Plus Mid ®...
  • Page 78 Taking a test CAUTION: The control solution range printed on the test strip vial is for control solution tests only and is not a recommended range for your blood glucose level. Causes of out-of-range results Out-of-range results may be due to: • Not following the instructions for performing a control solution test.
  • Page 79 Taking a test CAUTION: If you continue to get control solution results that fall outside the range printed on the test strip vial, Do Not use the meter, test strips, or control solution. Contact Customer Service. Contact LifeScan Customer Service at: service@LifeScanMEA.com.

  • Page 80: Reviewing Past Results

    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. 1.
  • Page 81 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 computer to ™ download results (not included).
  • Page 82 Reviewing past results Once the command to start the download is sent from the computer to the meter, the meter display will show the flashing Sync symbol ) indicating that the meter is in communication mode. Do Not insert a test strip while the meter is connected to a computer.
  • Page 83 Reviewing past results This page left blank intentionally.

  • Page 84: 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.

  • Page 85: Editing Your Range Limits

    Editing Your Settings Editing your range limits Your meter uses low and high range limits to tell you when your result is below, above or within your set range. The meter comes with pre-set range limits that can be changed. The pre-set low range limit is 70 mg/dL and the pre-set high range limit is 180 mg/dL.
  • Page 86 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 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...
  • Page 87 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.

  • Page 88: Caring For Your System

    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. Cleaning and disinfection Cleaning and disinfection are different and both should be performed.
  • Page 89 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 18.) • Do Not spray cleaning solution on the meter or immerse it in any liquid.
  • Page 90 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. For disinfecting, obtain regular household bleach (containing a minimum of 5.5% sodium hypochlorite as the active ingredient)*.
  • Page 91 Caring for your system 1. Hold the meter with the test strip port pointed down Use a soft cloth dampened with this solution to wipe the outside of the meter and lancing device until the surface is damp. Be sure to squeeze out any excess liquid before you wipe the meter.

  • Page 92: Battery

    Battery Replacing the battery Your OneTouch Select Plus Flex Meter uses one CR2032 ™ lithium coin cell battery. WARNING: CHEMICAL BURN HAZARD. DO NOT INGEST BATTERY. This product contains a coin/button cell battery. If swallowed, it can quickly cause severe internal burns and can lead to death.
  • Page 93 Battery 1. Remove the old battery 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 Battery 2. Insert the new battery Insert one CR2032 lithium coin cell battery on top of the battery ribbon, with the plus (+) side up. If the meter does not power on after you have replaced the meter battery, check that the battery is correctly installed.
  • Page 95 Battery 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. 5. Dispose of battery Dispose of the battery according to your local environmental regulations.

  • Page 96: 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 600 mg/dL or below 20 mg/dL. Improper use may cause an inaccurate result without producing an error message.
  • Page 97 Troubleshooting your system What it means You may have a very low blood glucose level (severe hypoglycaemia), below 20 mg/dL. NOTE: When your glucose result is below 20 mg/dL, both the LO and the Range Indicator Arrow will flash on the meter screen. What to do This may require immediate treatment.
  • Page 98 Troubleshooting your system What it means You may have a very high blood glucose level (severe 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.
  • Page 99 Troubleshooting your system What it means Meter is too hot (above 44°C) to perform a test. What to do Move the meter and test strips to a cooler area. Insert a new test strip when the meter and test strips are within the operating range (10-44°C).
  • Page 100 Troubleshooting your system What it means Meter is too cold (below 10°C) to perform a test. What to do Move the meter and test strips to a warmer area. Insert a new test strip when the meter and test strips are within the operating range (10-44°C).
  • Page 101 Troubleshooting your system Error Screens If there is a problem with your meter, there are six possible error screens that may appear. Along with an error number, there is also an error code in the upper left corner of your meter screen. If you cannot resolve the error with your meter, contact Customer Service.
  • Page 102 Troubleshooting your system What it means There is a problem with the meter. What to do Do Not use the meter. Contact Customer Service. Contact LifeScan 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.
  • Page 103 Troubleshooting your system What it means The sample was applied before the meter was ready. What to do Repeat the test with a new test strip. Apply a blood or control solution sample only after the flashing symbol appears on the display. If this message continues to appear, contact Customer Service.
  • Page 104 Troubleshooting your system What it means The meter has detected a problem with the test strip. Possible cause is test strip damage. What to do Repeat the test with a new test strip. See page 36 for taking a blood glucose test, or page 70 for taking a control solution test.
  • Page 105 Troubleshooting your system What it means One of the following may apply: • Not enough blood or control solution was applied or was added after the meter began to count down. • The test strip may have been damaged or moved during testing.
  • Page 106 Troubleshooting your system What it means The meter has detected a problem with the test strip. Possible cause is that you did not apply the correct sample type to the test strip when prompted by the meter for a blood or control solution sample.
  • Page 107 Troubleshooting your system What it means Meter battery power is low but there is still enough battery power to perform a test. The flashing low battery ) icon will continue to appear until the battery is replaced. What to do Replace the meter battery soon.
  • Page 108 Troubleshooting your system What it means No result in memory, such as the first time use or when you have chosen to delete all the results after downloading to a computer. What to do Contact Customer Service to report this occurrence, unless this is your first use of the meter.
  • Page 109 Troubleshooting your system This page left blank intentionally.

  • Page 110: Detailed Information About Your System

    Detailed information about your system Comparing meter results to laboratory results Results obtained from the OneTouch Select Plus Flex ™ Meter and laboratory tests are reported in plasma- equivalent units. However, your meter result may differ from your lab result due to normal variation. A result from your OneTouch Select Plus Flex...
  • Page 111 • Your haematocrit is above 55% or below 30%. • You are severely dehydrated. For additional information, refer to the OneTouch Select ® Plus Test Strip Insert. Sacks, D.B.: "Carbohydrates. " Burtis, C.A., and Ashwood E.R.
  • Page 112 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 113 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 114 Detailed information about your system Technical Specifications Assay method Glucose Oxidase biosensor Automatic shutoff Two minutes after last action Battery ratings 3.0 V d.c. (CR2032 lithium coin cell battery) Battery type One replaceable 3.0 Volt CR2032 lithium coin cell battery (or equivalent) Biological source Aspergillus Niger...
  • Page 115 Detailed information about your system Data port type Micro USB Compatible with USB 2.0 Memory 500 test results Operating 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...
  • Page 116 100 mg/dL, and within 15% 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.
  • Page 117 Detailed information about your system System Accuracy Results for Glucose Concentrations ≥100 mg/dL 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 26.6 mg/dL and 482.0 mg/dL Percent (and number) of meter results that match the...
  • Page 118 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 ±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.
  • Page 119 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 120 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 (mg/dL) (mg/dL) (mg/dL) 46.21 1.66 3.58...
  • Page 121 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 (mg/dL) (mg/dL) (mg/dL) 45.45 1.23 2.71 (30-50) 110.44...
  • Page 122 Detailed information about your system 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.OneTouchMEA.com and following the step-by-...
  • Page 123 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 124: Index

    Index Batteries Batteries, replacing Battery empty icon Battery empty warning Battery low icon 3, 105 Blood glucose, testing BLUETOOTH feature 7, 10, 11, 29, 62 ® 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 expiry dates...
  • Page 125 Index Edit time Error messages 94, 95 EXTREME HIGH GLUCOSE message 60, 96 EXTREME LOW GLUCOSE message 58, 95 Fingertip testing procedure First time setup 25, 30 Guarantee Hyperglycaemia 60, 96 Hypoglycaemia 58, 95 Icons 3, 4 Infection, reduce the chance Intended use Kit components Lancet...
  • Page 126 Index Settings 25, 28, 82 Software, diabetes management Start-up screen Storing your system Symbols 3, 4 Syncing 34, 62 Technical specifications 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 Time setting...
  • Page 128 Contents covered by one or more of the following U.S. patents: 6,733,655, 7,462,265, 7,468,125, 8,066,866, 8,093,903, 6,602,191, 6,976,958, and 7,156,809. Purchase of this device does not act to grant a use licence under these patents. Such a licence is granted only when the device is used with OneTouch Select Plus ®...

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