Blood Glucose Monitoring System Owner's Booklet Instructions for Use
Blood Glucose Monitoring System Owner's Booklet 1
Thanks for choosing OneTouch®! The OneTouch Select® Plus Blood Glucose Monitoring System is one of the latest product innovations from OneTouch®. Every OneTouch® Meter is designed to make it easy to test your blood glucose and help you 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.
Meter Symbols and Icons Low Battery Battery Empty High Above Range Note (Blood Glucose Result) In Range In Range Note (Blood Glucose Result) Low Below Range Note (Blood Glucose Result) Before Meal Tag After Meal Tag Control Solution Result Blood Glucose Result Above 33.3 mmol/L Blood Glucose Result Below 1.
Other symbols and icons Cautions and Warnings: Refer to the Owner's Booklet and inserts that came with your system for safetyrelated information.
This page left blank intentionally.
Table of Contents 1 Getting to know your system........................... 12 The OneTouch Select® Plus Blood Glucose Monitoring System.......................................................... 12 The Range Indicator Feature.........................................18 2 Set up your system......................................... 22 Turn your meter on........................................................ 22 Use the display backlight to make it easy to read results........................................
Turn Meal Tagging On/Off............................................. 87 Check the meter serial number, software version, and last meter error...................... 100 6 Care and maintenance.................................. 102 Storing your system......................................................102 Cleaning and disinfection.............................................102 7 Batteries..................................................... 108 Replacing the batteries...................................
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 and OneTouch Select® Plus Control Solutions. 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.
Intended use The OneTouch Select® Plus 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.
Test principle Glucose in the blood sample mixes with the enzyme Glucose Oxidase (see page 130) in the test strip and a small electric current is produced. The strength of this current changes with the amount of glucose in the blood sample. Your meter measures the current, calculates your blood glucose level, displays the blood glucose result, and stores it in its memory. Use only OneTouch Select® Plus Control Solutions and Test Strips with the OneTouch Select® Plus Meter.
This page left blank intentionally.
1 Getting to know your system The OneTouch Select® Plus Blood Glucose Monitoring System Included with your kit: OneTouch Select® Plus Meter (2 x CR2032 batteries included) OneTouch Delica® Lancing Device OneTouch Delica® Sterile Lancets OneTouch Select® Plus Test Strips 12
Getting to know your system 1 A carrying case is included with your system kit. NOTE: The OneTouch Delica® Lancing Device uses ONLY OneTouch Delica® Lancets. If another type of lancing device was included, see the separate instructions for that lancing device.
1 Getting to know your system Available separately: Items pictured 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* *OneTouch Select® Plus Control Solutions and Test Strips are available separately. For availability of test strips and control solutions, contact customer care or your healthcare professional.
Getting to know your system 1 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.
1 Getting to know your system Getting to know your OneTouch Select® Plus Blood Glucose Monitoring System Meter 16
Getting to know your system 1 Test strip 17
1 Getting to know your system The Range Indicator Feature The OneTouch Select® Plus Meter automatically lets you know if your current glucose result is within, below or above your range limits. It does this by displaying a Range Indicator Note with your current glucose result. The Note also points to a corresponding Range Indicator Colour Bar below the meter display. Together, the Range Indicator Note and Colour Bar can help you understand the meaning of your glucose results.
Getting to know your system 1 3 Possible Range Indicator Notes Example Below Range Result Example In Range Result Example Above Range Result A Range Indicator Note will appear with your result after each test depending upon how you set your "General" low and high range limits in the meter. Your meter will use these general settings to decide which Range Indicator Note (Low, In Range or High) will appear with your result. NOTE: These General Range Indicator Notes will apply to all your untagged tests.
1 Getting to know your system The meter also provides Meal Tagging to help identify Before or After Meal tests. If you turn Meal Tagging On, you will be asked to set up additional "Mealtime" low and high range limits. Your meter will use these mealtime settings to decide which Range Indicator Note (Low, In Range or High) will appear with your result. NOTE: These Mealtime Range Indicator Notes will apply to all your Meal Tagged tests.
Getting to know your system 1 Things you should know before using the Range Indicator feature: • Your meter knows which range limit "General" or "Mealtime" to apply depending on whether your current result is untagged or meal tagged. • Your meter comes pre-set with Meal Tagging turned Off. You will not be able to meal tag results or apply specific "Mealtime" range limits to those tagged results until you turn Meal Tagging On.
2 Set up your system Turn your meter on Press and hold until the start-up screen appears. Once the start-up screen is displayed, release . The meter will also turn on when you insert a test strip. NOTE: If you see any missing pixels within the start-up screen, there may be a problem with the meter. Call OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland) during the hours of 8:30am6pm Monday-Friday, 9am-1pm Saturday. Or visit www.LifeScan.co.uk.
Set up your system 2 First time set up Before using your meter for the first time, you should check to make sure the pre-set language, time and date, and general range limits in the meter are correct. This ensures that the correct time, date and Range Indicator Note are assigned to each of your test results. Pressing after making your selection confirms each setting and takes you to the next screen. to return to When setting up your meter you can press the previous screen to adjust a setting.
2 Set up your system NOTE: The time and date format are pre-set. These settings cannot be changed. Set time, date and general range limits 1. Set the time The Set Time screen will be displayed next. If the time is correct, press to save and continue to Step 2 to set the date. If you need to edit the time, press or to highlight Edit and press . Press press or to set the hour and . Set Time 15:45 Save Edit Step 1 of 3 Set Time Repeat this step to set the minutes.
Set up your system 2 When the time is correct, press to save. If you need to make an adjustment, press or to highlight Edit and press , then repeat Step 1. A Saved screen appears to confirm that the time displayed is now stored in the meter. OK? 16:45 Save Edit Step 1 of 3 2. Set the date The Set Date screen will be displayed next. If the date is correct, press to save and continue to Step 3 to set the general range limits. If you need to edit the date, press or to highlight Edit and press .
2 Set up your system Press press or to set the day and . Repeat this step to set the month and year. Set Date 30 Apr 2014 Step 2 of 3 When the date is correct, press to save. If you need to make an adjustment, press or to highlight Edit and press , then repeat Step 2. A Saved screen will appear to confirm that the date displayed is now stored in the meter.
Set up your system 2 3. Set the general range limits Your meter uses the low and high range limits set in your meter to tell you when a test result is within, below or above the range limits. The general range limits you set during first time set up will apply to all untagged glucose results unless Meal Tagging is turned On. CAUTION: Be sure to talk to your healthcare professional about the low and high limits that are right for you.
2 Set up your system The general range limits are pre-set in the meter with a low limit of 3.9 mmol/L and a high limit of 10.0 mmol/L. If the low and high range limits are correct, press to save. A Saved screen will appear. Continue to Setup complete. If you need to edit the pre-set limits to fit your needs, press or to highlight Edit and press . Set low/high limits for your range 3.9 - 10.0 mmol/L Save Edit Step 3 of 3 Press or to change the pre-set Low Limit to the desired value between 3.
Set up your system 2 Press or to change the pre-set High Limit to the desired value between 5.0 mmol/L and 16.7 mmol/L and press . Set Range high limit 4.2 – 10.0 mmol/L Step 3 of 3 When your low and high range limits are correct, press to save. If you need to make an adjustment, press or to highlight Edit and press , then repeat Step 3. OK? 4.2 - 9.
2 Set up your system A Saved screen will appear to confirm the low and high limits displayed are now stored in the meter. Saved. 4.2 - 9.4 mmol/L Step 3 of 3 Setup complete Setup complete appears on the screen. Your meter is now ready for use. Press to return to the Main Menu screen. See page 62. Setup complete. OK NOTE: If the meter was turned on by inserting a test strip, the Apply Blood screen appears instead of the Main Menu.
Set up your system 2 Turn the meter off after setup There are three ways to turn your meter off: • Press and hold for several seconds until the meter turns off. • Remove the test strip after a test. Or, • Your meter will turn off by itself if left alone for two minutes.
3 Take a test Test your blood glucose NOTE: Many people find it helpful to practise testing with control solution before testing with blood for the first time. See page 59.
Take a test 3 NOTE: • Use only OneTouch Select® Plus Test Strips. • Unlike some blood glucose meters, no separate step to code your OneTouch Select® Plus System is required. • 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 surface to dry before testing. • Keep test strips in a cool, dry place between 5°C and 30°C.
3 Take a test • Tightly close the cap on the vial immediately after use to avoid contamination and damage. • Store unused 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.
Take a test 3 IMPORTANT: If another person assists you with testing, the meter, lancing device and cap should always be cleaned and disinfected prior to use by that person. See page 102. NOTE: 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.
3 Take a test CAUTION: • Do Not use the OneTouch Select® Plus 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 Customer Care immediately if the test strip vial is damaged.
Take a test 3 OneTouch Delica® Lancing Device NOTE: The OneTouch Delica® Lancing Device uses ONLY OneTouch Delica® Lancets. If the lancing device shown here is different from the device included in your kit, please see the separate insert for your lancing device.
3 Take a test NOTE: • The OneTouch Select® Plus Blood Glucose Monitoring System has not been evaluated for Alternate site testing (AST). Use only fingertips when testing with the system. • The OneTouch Delica® Lancing System does not include the materials needed to perform Alternate site testing (AST). The OneTouch Delica® Lancing System should not be used on the forearm or palm with the OneTouch Select® Plus Blood Glucose Monitoring System.
Take a test 3 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. • Always use a new, sterile lancet each time you test. • Always keep your meter and lancing device clean (see page 102). • The meter and lancing device are for single patient use only.
3 Take 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. Rinse and dry completely. 1. Remove the lancing device cap Remove the cap by turning it counterclockwise and then pulling it straight off of the device.
Take a test 3 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. Save the protective cover for lancet removal and disposal. See page 52.
3 Take a test 3. Replace the lancing device cap Place the cap back onto the device; turn clockwise to secure the cap. Do Not overtighten.
Take a test 3 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. Deeper punctures work well for people with thick or callused skin. Turn the depth wheel to choose the setting. NOTE: A shallower fingertip puncture may be less painful.
3 Take a test 6. Insert a test strip to turn the meter on Insert a test strip into the test strip port with the contact bars facing you. No separate step to code the meter is required. When the Apply Blood screen appears on the display, you can apply your blood sample to the test strip.
Take a test 3 7. 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. 8. Get a round drop of blood Gently squeeze and/or massage your fingertip until a round drop of blood forms on your fingertip. 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.
3 Take a test Applying blood and reading results 1. 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. This may cause blood to run into the test strip port and damage the meter. Do Not allow blood to enter the Data Port.
Take a test 3 2. Apply 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.
3 Take a test Gently touch the channel to the edge of the blood drop. • 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. • 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.
Take a test 3 CAUTION: You may get an ERROR 5 message if the blood sample does not fill the confirmation window completely. See page 119. Discard the test strip and re-start the test process. 3. 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.
3 Take a test 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 blood drop and wait for the meter to count down (about 5 seconds). Countdown screen CAUTION: Do Not make immediate treatment decisions on the Range Indicator Notes that appear with your test results.
Take a test 3 Know whether your glucose test result is within, below or above your general range limits When your glucose result is displayed after a test along with the date and time, the meter will display a Range Indicator Note. The Note tells you if your result is within range, below or above your general range limits set in the meter (see page 85). The Range Indicator Note will also point to the appropriate Range Indicator Colour Bar on the meter as a visual reminder.
3 Take a test After getting a blood glucose result Once you have your blood glucose result, you may: • Press and hold to return to the Main Menu. • Press and hold for several seconds until the meter turns off. The meter will also automatically turn off if left alone for two minutes. Or, • Remove the test strip and the meter will turn off. Removing the used lancet NOTE: This lancing device has an ejection feature, so you do not have to pull out the used lancet. 1.
Take a test 3 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 cupped side of the cover. 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, prime the device again and then slide the ejection control forward until the lancet comes out.
3 Take 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. This will help prevent infection and sore fingertips.
Take a test 3 Disposing of the used lancet and test strip Discard the used lancet carefully after each use to avoid unintended lancet stick injuries. Used lancets and test strips may be considered biohazardous waste in your area. Be sure to follow your 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.
3 Take a test Interpreting unexpected test results Refer to the following cautions whenever your blood glucose results are higher or lower than what you expect. CAUTION: Low blood glucose results If your blood glucose result is below 3.9 mmol/L or is shown as EXTREME LOW GLUCOSE, (meaning the result is less than 1.1 mmol/L), it may mean hypoglycaemia (low blood glucose). This may require immediate treatment according to your healthcare professional's recommendations.
Take a test 3 CAUTION: High blood glucose results If your blood glucose result is above 10.0 mmol/L, it may mean hyperglycaemia (high blood glucose) and you should consider re-testing. Talk to your healthcare professional if you are concerned about hyperglycaemia. EXTREME HIGH GLUCOSE is displayed when your blood glucose result is over 33.3 mmol/L. You may have severe hyperglycaemia (very high blood glucose). Re-test your blood glucose level.
3 Take a test CAUTION: Repeated unexpected blood glucose results If you continue to get unexpected results, check your system with control solution. See page 59. If you are experiencing symptoms that are not consistent with your blood glucose results 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.
Take a test 3 Test with control solution 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. (Control solution is available separately.) 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.
3 Take 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. • 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.
Take a test 3 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. • If you drop or damage the meter.
3 Take a test Performing a control solution test 1. Press and hold to turn the meter on and display the Main Menu 2. Highlight Settings on the Main Menu and press 30 Apr Results Log Averages Settings 3.
Take a test 3 Wait for the Insert Strip screen to appear on the display. 4. Insert a test strip Make sure the contact bars are facing you.
3 Take a test Wait for the Apply Control Solution screen to appear on the display. 5. Prepare the control solution Before removing the cap, shake the vial gently. Remove the vial cap and place it on a flat surface with the top of the cap pointing up. Squeeze the vial to discard the first drop.
Take a test 3 Wipe both the tip of the control solution vial and the top of the cap with a clean, damp tissue or cloth. Then, squeeze a drop into the small well on the top of the cap or onto another clean, non-absorbent surface.
3 Take a test 6. Apply the control solution 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. Touch the channel on the top edge of the test strip to the control solution. Wait for the channel to fill completely.
Take a test 3 7. Read your result The meter will count down and display your result along with the date, time, unit of measure, and Control Solution. Because Control Test was selected, the meter marks the result as a control solution test. CAUTION: Make sure you select Control Test from the Settings screen before you begin a control solution test. An Error 6 screen may appear if you applied control solution to the test strip without following the steps beginning on page 62.
3 Take a test 8. Check if the result is in range Each vial of test strips has the OneTouch Select® Plus Mid Control Solution range printed on its label. Compare the result Example range displayed on the meter to OneTouch Select® Plus Mid the range printed on the Control Solution Control Range test strip vial. 5.7-7.
Take a test 3 Out-of-range results may be due to: • Not following the instructions beginning on page page 62. • Control solution is contaminated, expired, or past its discard date. • Test strip or test strip vial is damaged or expired. • Meter, test strips and/or control solution were not all at the same temperature when the control solution test was performed. • Control solution was not at room temperature (20-25°C). • A problem with the meter.
3 Take 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 Care. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland) 800 62253 (Malta) or 800 9074 (Iceland). • The control solution ranges printed on the test strip vial are for control solution tests only and are not recommended ranges for your blood glucose level. 9.
Take a test 3 This page left blank intentionally.
4 Review past results and averages Review your past results Your meter stores your most recent 500 blood glucose and control solution test results and displays them in several ways. 1. Get to the Results Log From the Main Menu, press or to highlight Results Log and press . Up to four results are displayed on the screen, starting with the most recent.
Review past results and averages 4 2. Scroll through your results Result Detail Press to move backward and to move forward through your results. Pressing and holding or allows you to move more quickly. 30 Apr To display the details of a particular result, press with that result highlighted.
4 Review past results and averages The following symbols may appear with your result. Some of these symbols may only appear when displaying results in the Results Log. if the blood glucose result was above 33.3 mmol/L if the blood glucose result was below 1.
Review past results and averages 4 View your averages Get to the Averages screen From the Main Menu, press or to highlight Averages and press . 30 Apr 09:45 Results Log Averages Settings For each of the 7, 14, 30 and 90 day periods leading up to the current date, the meter displays the averages of those results. These averages include ALL your results, including Meal Tagged and untagged results. Averages 7 Days 14 Days 30 Days 90 Days Page 1 of 3 75 6.4 mmol/L 6.8 mmol/L 6.7 mmol/L 6.
4 Review past results and averages If Meal Tagging is turned On, you can view your Before Meal and After Meal Averages for the same time periods. Press or to display your Before Meal and After Meal Averages. Only those results tagged Before Meal or After Meal will be included in these averages. Press to return to the Main Menu screen. Before Meal Avgs 6.4 7 Days mmol/L 6.2 14 Days mmol/L 6.2 30 Days mmol/L 5.6 90 Days mmol/L Page 2 of 3 After Meal Avgs 6.4 7 Days mmol/L 14 Days 10.
Review past results and averages 4 NOTE: • Averages are calculated only when there are at least 2 glucose results for the time period being averaged. • An EXTREME HIGH GLUCOSE result is always counted as 33.3 mmol/L, and an EXTREME LOW GLUCOSE result is always counted as 1.1 mmol/L. • The meter calculates averages based on the 7, 14, 30 and 90 day periods ending on the current date setting. If you change your date setting, your averages may change too.
4 Review past results and averages Result averages provide information from past results. Do Not use result averages to make immediate treatment decisions. Always consult your healthcare professional before making significant changes to your diabetes care plan. CAUTION: Do Not allow other people to use your meter as it may affect your averages.
Review past results and averages 4 To transfer meter data, follow the instructions provided with the OneTouch® Diabetes Management Software to download the results from the meter. You will need a standard micro USB interface cable to connect your OneTouch Select® Plus Meter to a computer to download results (not included). Once the meter has been connected to the computer, the meter display will show PC Connected indicating that the meter is in communication mode.
5 Adjust meter settings after first time set up You can adjust the meter settings at any time. When you turn your meter on, the Main Menu is displayed after the start-up screen. A shaded bar highlights the current selection on the meter display. From the Main Menu, press or to highlight Settings and press . 30 Apr Results Log Averages Settings Select the specific setting you want to modify and press .
Adjust meter settings 5 after first time set up Set time and date 1. Edit the time Time / Date Highlight Time/Date on the Settings screen and press . Next, highlight Time and press . The current time set in the meter is displayed. Press or to change the hour and press . Repeat this step to change the minutes. A Saved screen appears to confirm that the time displayed is now stored in the meter.
5 Adjust meter settings after first time set up 2. Edit the date Time / Date Highlight Date on the Time/Date screen and press . Time: 15:45 Date: 30 May 2014 The current date set in the meter is displayed. Press or to change the day and press . Repeat this step to change the month and year. A Saved screen appears to confirm that the date displayed is now stored in the meter.
Adjust meter settings 5 after first time set up NOTE: To help ensure that the time and date in your meter are set correctly, once every 6 months, and every time you change the batteries, a screen will prompt you to confirm the time and date set in the meter. If they are correct, press . See page 108 for information on changing the batteries. Please verify. 09 Jun 16:00 Is this time/date correct? Yes Edit If not correct, press or to highlight Edit and press .
5 Adjust meter settings after first time set up Set range limits Range limits are defined by a low and high limit and are set by you in the meter. Your meter uses the low and high range limits to tell you when a test result is within, below or above the range limits. When you select Range on the Settings screen, you will be able to edit your "General" range limits. CAUTION: Be sure to talk to your healthcare professional about the low and high limits that are right for you.
Adjust meter settings 5 after first time set up Edit your general range limits Highlight Range on the Settings screen and press . Settings Time / Date Language Range Meal Tagging Control Test The current general range limits set in the meter are displayed. Range Press or to change the Low Limit to the desired value between 3.3 mmol/L and 6.1 mmol/L. Then press . 85 low limit 3.9 mmol/L – 10.
5 Adjust meter settings after first time set up Press or to change the High Limit to the desired value between 5.0 mmol/L and 16.7 mmol/L. Then press . Range high limit 4.2 – 10.0 mmol/L A Saved screen will appear to confirm the low and high limits displayed are now stored in the meter. Saved. 4.2 – 10.
Adjust meter settings 5 after first time set up Turn Meal Tagging On/Off Your OneTouch Select® Plus Meter lets you attach a Before Meal or After Meal tag to your current glucose result. To add tags, Meal Tagging must be turned On. • A Before Meal glucose test is taken just before the start of your meal. • An After Meal glucose test is typically taken one or two hours after the start of your meal. We suggest you talk to your healthcare professional to see how meal tags may help you manage your diabetes.
5 Adjust meter settings after first time set up Highlight Meal Tagging on the Settings screen and press . Settings Time / Date Language Range Meal Tagging Control Test A check mark will indicate whether Meal Tagging is currently turned Off or On. Meal Tagging On Off Turn Meal Tagging On to label glucose results Before Meal or After Meal.
Adjust meter settings 5 after first time set up When you turn Meal Tagging On, you will be prompted to check your Before Meal and After Meal range limits that will apply only to those glucose results that are tagged Before Meal and After Meal. Press to continue and make any adjustments to your Before Meal or After Meal limits. The pre-set Before Meal range limits are 3.9 mmol/L and 7.2 mmol/L (Low and High Limits), and the pre-set After Meal range limits are 6.7 mmol/L and 10.
5 Adjust meter settings after first time set up Press or to change the Low Limit to the desired value between 3.3 mmol/L and 6.1 mmol/L. Then press . Before Meal Range low limit 3.9 – 7.2 mmol/L Step 1 of 2 Press or to change the High Limit to the desired value between 5.0 mmol/L and 12.0 mmol/L. Then press . Before Meal Range high limit 4.0 – 7.
Adjust meter settings 5 after first time set up A Saved screen appears to confirm that your Before Meal range limits are stored in the meter. Saved. Before Meal Range 3.9 – 7.2 mmol/L Step 1 of 2 If the After Meal range limits are correct, press to save. If you need to make adjustments, press or to highlight Edit and press . Then follow the previous steps above for setting and saving the After Meal range limits. After Meal: set low/high range limits 6.7 - 10.
5 Adjust meter settings after first time set up When you are finished setting and saving your mealtime range limits, a Saved screen appears to confirm that Meal Tagging is On. Saved. Meal Tagging On NOTE: If Meal Tagging is turned On and you choose to turn it Off, you will be prompted to confirm or edit your general range limits that will apply to all untagged glucose results. Follow the instructions on page 85 to edit your general range limits. 92 Meal Tagging Take note.
Adjust meter settings 5 after first time set up Edit your mealtime range limits Meal Tagging must be turned On to be able to edit mealtime range limits. See page 87. Settings Highlight Range on the Settings screen and press . Language Time / Date Range Meal Tagging Control Test NOTE: If you decide to change your "Mealtime" range limits, your previous Range Indicator Notes in the Results Log will not change. However, any new tests will display Range Indicator Notes which reflect your changes.
5 Adjust meter settings after first time set up Edit your Before Meal and After Meal range limits. Highlight Before Meal on the Range screen and press . Range mmol/L The current Before Meal range limits set in the meter are displayed. Press or to change the Low Limit to the desired value between 3.3 mmol/L and 6.1 mmol/L. Then press . Before Meal: 3.9 - 7.2 After Meal: 6.7 - 10.0 Before Meal Range low limit 3.9 mmol/L 94 – 7.
Adjust meter settings 5 after first time set up Press or to change the High Limit to the desired value between 5.0 mmol/L and 12.0 mmol/L. Then press . Before Meal Range high limit 4.2 – 7.2 mmol/L A Saved screen appears to confirm that the Before Meal range limits displayed are now stored in the meter. Saved. Before Meal Range 3.9 – 7.
5 Adjust meter settings after first time set up Highlight Range on the Settings screen and press . Next, highlight After Meal on the Range screen and press . Follow the previous steps for changing the After Meal range limits. Range mmol/L Before Meal: 4.2 - 7.2 After Meal: 6.7 - 10.0 NOTE: The After Meal Low limit can be set between 4.4 mmol/L and 6.7 mmol/L. The After Meal High limit can be set between 6.6 mmol/L and 16.7 mmol/L.
Adjust meter settings 5 after first time set up Attaching tags to your glucose results When Meal Tagging is turned On, you can tag your glucose results. After your glucose result appears on the display after a test, your tagging options appear below your result (Before Meal, After Meal, and No Tag). Press or to highlight Before Meal ( ) or After Meal ( ) and press . If you do not want to tag this result, highlight No Tag and press , or press to return to the Result screen.
5 Adjust meter settings after first time set up NOTE: • You can edit the meal tag that appears below your result while your result is still displayed (see next page). Simply press to return to the Meal Tagging screen above and repeat the instructions for tagging your result. • You can tag an EXTREME HIGH result but not an EXTREME LOW result. • You cannot edit a meal tag while reviewing the result in the Results Log.
Adjust meter settings 5 after first time set up The selected Before Meal ( ) or After Meal ( ) icon will appear below your result. The Range Indicator feature on your meter automatically displays the appropriate Range Indicator Note and points to the corresponding Range Indicator Colour Bar. Your meter applies either Before Meal or After Meal range limits to your result, depending on whether you attached a Before Meal or After Meal tag.
5 Adjust meter settings after first time set up Check the meter serial number, software version, and last meter error The meter serial number, software version, and information about the last meter error are stored in your meter. You can check this information at any time and use it for troubleshooting. 1. Press or to scroll to and highlight Meter Info on the Settings screen Settings Language Range Meal Tagging Control Test Meter Info 2.
Adjust meter settings 5 after first time set up Press to scroll down and display information about the last error that occurred on the meter.
6 Care and maintenance 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. Cleaning is part of your normal care and maintenance and should be performed prior to disinfection, but cleaning does not kill germs.
Care and maintenance 6 Cleaning your meter, lancing device and cap The meter, lancing device and cap should be cleaned when they are visibly dirty and before disinfection. Clean your meter at least once per week. The meter and lancing device should be cleaned whenever they are visibly dirty. For cleaning obtain regular strength liquid dish soap and a soft cloth. Prepare a mild detergent solution by stirring 2.5 mL of regular strength liquid dish soap into 250 mL of water.
6 Care and maintenance 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. 2.
Care and maintenance 6 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)*. Prepare a solution of 1 part household bleach and 9 parts water. *Follow manufacturer's instruction for handling and storage of bleach. 1.
6 Care and maintenance 2. After wiping, cover the surface you are disinfecting with the soft cloth dampened with the bleach solution for 1 minute Wash hands thoroughly with soap and water after handling the meter, lancing device and cap. If you see signs of wear, please contact Customer Care. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland) 800 62253 (Malta) or 800 9074 (Iceland).
Care and maintenance 6 This page left blank intentionally.
7 Batteries Your OneTouch Select® Plus Meter uses 2x CR2032 lithium batteries. One battery powers the meter only and the other powers the backlight. See page 123, for information on when to change the meter batteries. If the meter does not turn on, check the batteries. Do Not change the batteries when connected to a PC. IMPORTANT: Use only CR2032 lithium batteries with your meter. Do Not use rechargeable batteries.
Batteries 7 Replacing the batteries 1. Remove the old batteries Start with the meter turned off. Remove the battery cover by sliding it downward. Pull up firmly on the plastic battery ribbons. The plastic battery ribbon with the symbol is for the meter battery, and the plastic tab with the symbol is for the backlight battery.
7 Batteries 2. Insert the new batteries With the "+" side facing up toward you, place each battery in the compartment within the fold of the plastic battery tab. Push each battery in until it snaps into the battery clasp. Replace the battery cover by sliding it upwards onto the meter. If the meter does not power on after you have replaced the meter battery, check that the battery is correctly installed with the "+" side up. If the meter still does not power on, contact Customer Care.
Batteries 7 3. Check your meter settings You will be prompted to set the time and date whenever you change the batteries. See page 24. 4. Dispose of batteries Dispose of batteries according to your local environmental regulations.
8 Troubleshooting The OneTouch Select® Plus 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. NOTE: If the meter is on but does not operate (locks-up), contact Customer Care. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland) 800 62253 (Malta) or 800 9074 (Iceland).
Troubleshooting 8 Warning EXTREME HIGH GLUCOSE (above 33.3 mmol/L) What it means You may have a very high blood glucose level (severe hyperglycaemia), over 33.3 mmol/L. What to do Re-test your blood glucose level. If the result is EXTREME HIGH GLUCOSE again, obtain and follow instructions from your healthcare professional right away.
8 Troubleshooting Warning Temperature too high. Out of operating range. See Owner’s Booklet. What it means Meter is too hot (above 44°C) to work correctly. 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). If you do not get another Temperature too high message, you can proceed with testing.
Troubleshooting 8 Warning Temperature too low. Out of operating range. See Owner’s Booklet. What it means Meter is too cold (below 10°C) to work correctly. 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). If you do not get another Temperature too low message, you can proceed with testing.
8 Troubleshooting Error 1 Meter problem. Contact Customer Care. Error 2 Meter or strip problem. Retest with a new strip. What it means There is a problem with the meter. What to do Do Not use the meter. Contact Customer Care. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland) 800 62253 (Malta) or 800 9074 (Iceland). What it means Error message could be caused either by a used test strip or a problem with the meter.
Troubleshooting 8 Error 3 Meter was not ready. Retest with a new strip. 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 Apply Blood or Apply Control Solution appears on the display. If this message continues to appear, contact Customer Care. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland) 800 62253 (Malta) or 800 9074 (Iceland).
8 Troubleshooting Error 4 Strip problem. Retest with a new strip. 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 32 or page 59. If the error message appears again, contact Customer Care. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland) 800 62253 (Malta) or 800 9074 (Iceland).
Troubleshooting 8 Error 5 Strip fill problem. Retest with a new strip. What it means One of the following may apply: • Not enough blood or control solution was applied or more was added after the meter began to count down. • The test 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 32 or page 59. If the error message appears again, contact Customer Care.
8 Troubleshooting There are two Error 6 screens: Error 6 Perform blood test again with a new strip. What it means The meter has detected a problem with the test strip. Possible cause is that you did not apply a blood sample to the test strip when prompted by the meter. What to do Repeat the test with a new test strip; see page 32. If the error message appears again, contact Customer Care.
Troubleshooting 8 Error 6 Perform control solution test again with a new strip. What it means The meter has detected a problem with the test strip. Possible cause is that you did not apply a control solution sample to the test strip when prompted by the meter. What to do Repeat the test with a new test strip; see page 59. If the error message appears again, contact Customer Care. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland) 800 62253 (Malta) or 800 9074 (Iceland).
8 Troubleshooting 15 Apr 09:45 mmol/L What it means Meter battery power is low but there is still enough power to perform a test. What to do In Range Once the meter Low Battery icon is displayed, it will continue to appear until you replace the meter battery. Test results will still be accurate, but replace the batteries as soon as possible (see page 108).
Troubleshooting 8 What it means Low Battery Replace soon. (Type CR2032) OK Warning Battery Empty Replace now. (Type CR2032) Meter battery power is low but there is still enough power to perform a test. What to do Press to continue but replace the meter battery as soon as possible. What it means There is not enough meter battery power to perform a test. What to do Replace the meter battery immediately.
8 Troubleshooting Results Log What it means No Results No result in memory, such as the first time use of the meter. What to do Contact Customer Care to report this occurrence, unless this is your first use of the meter. Contact OneTouch® Customer Care on 0800 121 200 (UK) or 1800 535 676 (Ireland) 800 62253 (Malta) or 800 9074 (Iceland). You can still perform a blood glucose test and get an accurate result.
Troubleshooting 8 This page left blank intentionally.
9 Detailed information about your system Comparing meter results to laboratory results Results obtained from the OneTouch Select® Plus 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 Meter is considered accurate when it is within 0.83 mmol/L of a laboratory method when the glucose concentration is lower than 5.
Detailed information 9 about your system 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. Sacks, D.B.: "Carbohydrates." Burtis, C.A., and Ashwood E.R. (ed.),Tietz Textbook of Clinical Chemistry, Philadelphia: W.B. Saunders Company (1994), 959.
9 Detailed information about your system Guidelines for obtaining accurate meter to lab comparisons: 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.
Detailed information 9 about your system Testing with your OneTouch Select® Plus 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.
9 Detailed information about your system Technical Specifications Assay method Glucose oxidase biosensor Automatic shutoff Two minutes after last action Battery ratings Two 3.0 V d.c., (2x CR2032 batteries), Battery type 2 replaceable 3.
Detailed information 9 about your system System Accuracy Diabetes experts have suggested that glucose meters should agree within 0.83 mmol/L of a laboratory method when the glucose concentration is lower than 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 System and the YSI 2300 Glucose Analyser laboratory instrument. System Accuracy Results for Glucose Concentrations <5.
9 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% 72.7% (314/432) 98.6% (426/432) 100.0% (432/432) System Accuracy Results for Glucose Concentrations between 1.2 mmol/L and 25.9 mmol/L Within ±0.83 mmol/L or ±15% 99.5% (597/600) NOTE: Where 1.2 mmol/L represents the lowest glucose reference value and 25.
Detailed information 9 about your system Regression Statistics Samples were tested in duplicate on each of three test strip lots. Results indicate that the OneTouch Select® Plus System compares well with a laboratory method. # of Subjects # of Tests Slope Intercept (mmol/L) 100 600 0.97 0.12 95% CI Slope 95% CI Intercept (mmol/L) Std. Error (Sy.x) (mmol/L) R2 0.97 to 0.98 0.05 to 0.19 0.45 0.
9 Detailed information about your system Precision Within Run Precision (300 Venous Blood Samples Tested per Glucose Level) Data generated using the OneTouch Select® Plus Meter. Target Glucose (mmol/L) Mean Glucose (mmol/L) Standard Deviation (mmol/L) Coefficient of Variation (%) 2.2 2.50 0.09 3.59 3.6 3.90 0.10 2.56 6.7 7.06 0.16 2.25 11.1 11.57 0.29 2.52 19.4 19.55 0.40 2.07 Results show that the greatest variability observed between test strips when tested with blood is 0.
Detailed information 9 about your system Total Precision (600 Control Solution Tests per Glucose Level) Data generated using the OneTouch Select® Plus Meter. Glucose Level Ranges (mmol/L) Mean Glucose (mmol/L) Standard Deviation (mmol/L) Coefficient of Variation (%) Low (1.67-2.78) 2.61 0.06 2.49 Mid (5.33-7.99) 6.15 0.11 1.83 High (15.54-23.31) 20.40 0.31 1.
9 Detailed information about your system User Accuracy A study evaluating glucose values from fingertip capillary blood samples obtained by 165 lay persons showed the following results: • 100% within ±0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.55 mmol/L, and 97.7% within ±15% of the medical, laboratory values at glucose concentrations at or above 5.55 mmol/L 98.2% of the total number of samples were within ±0.
Detailed information 9 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. This meter complies with immunity to radio frequency interference as specified in IEC 61326-1 or 61326-2.
10 Index After meal range limits.....................................................94 AST...................................................................................... 38 Averages............................................................................. 75 Backlight............................................................................ 22 Batteries, replacing......................................................... 109 Battery empty warning................................................
Index 10 General range setting........................................................ 85 Guarantee..........................................................................136 Hyperglycaemia........................................................... 57, 113 Hypoglycaemia........................................................... 56, 112 Icons............................................................................ 3, 4, 74 Infection, reduce the chance............................................
10 Index Storing your system.........................................................102 Symbols...................................................................... 3, 4, 74 Technical specifications...................................................130 Temperature............................. 32, 33, 60, 102, 114, 115, 130 Test strip, applying drop of blood...................................46 Test strip, contact bars.......................................... 18, 44, 63 Time setting......................
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.
