OneTouch® UltraEasy® User Guide Great Britain
Contents
1. ONE ITOUCH UltraEasy Blood Glucose Monitoring System USER GUIDE Contents Getting to know your system 1 2 Setting the time and date and coding your meter Testing your blood glucose Reviewing past results Control solution testing 18 Q Caring for your system 20 7 Error messages and details about your system Call Customer Care Freephone UK 0800 121200 Ireland 1800 535676 Or Visit us at www LifeScan co uk If you cannot reach Customer Care Freephone contact your health care professional for advice Manufactured for Distributed by LifeScan UK a Division of Ortho Clinical Diagnostics eat LifeScan Inc Johnson amp Johnson 50 100 Holmers Farm Way High Wycombe Milpitas CA 95035 USA Buckinghamshire HP12 4DP United Kingdom 0344 Se A LIFES 2009 LifeScan Inc AL afohmonsfohmon company Milpitas CA 95035 Before you begin Before using this product to test your blood glucose carefully read this User Guide and the inserts that come with the OneTouch Ultra Test Strips and OneTouch Ultra Control Solution Take note of warnings and cautions throughout this User Guide which are identified with A Many people find it helpful to practice the test with control solution before testing with blood for the first time See Section 5 Control solution testing Intended use The OneTouch UltraEasy Blood Glucose Monitoring System is intended to be used for the quantitative measu2. ERROR MESSAGES AND DETAILS ABOUT YOUR SYSTEM 28 LifeScan self test blood glucose monitoring devices conform to the following EU Directives IVDD 98 79 EC C Blood Glucose Meter Test Strips and Control Solution 0344 MDD 93 42 EEC C 4 Lancets 0120 C Blood Sampler eel LifeScan Inc Milpitas CA 95035 USA Ec rer LifeScan Regulatory Affairs Europe Division of Ortho Clinical Diagnostics France 1 rue Camille Desmoulins TSA 40007 92787 Issy les Moulineaux Cedex 09 France Electrical and safety standards The meter has been tested for immunity to Level 4 electrostatic discharge as specified in IEC 61000 4 2 This meter has been tested for immunity to radio frequency interference over the frequency range 80 MHz to 2 5 GHz at 3 V m as specified in IEC 61000 4 3 Degree of protection rating Minimum of IP2X This meter complies with CISPR 11 2003 Class B Radiated Only Emissions of the energy used are low and are not likely to cause interference in nearby electronic equipment Guarantee LifeScan guarantees that the OneTouch UltraEasy 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 purchaser and is not transferable The system described herein is covered by one or more of the following U S patents 6 284 125 and D546 216 Use of the monitoring device included herein is protected under one or more of the follow
3. e Control solution tests must be done at room temperature e if you have had repeated unexpected blood glucose results as 20 25 C Make sure your meter test strips and control solution described in Applying blood and reading results in Section 3 or are at room temperature before testing e if you drop or damage the meter A CAUTION Do Not swallow control solution it is not for human consumption Do Not apply control solution to the skin or eyes as it may cause irritation How to test with control solution Start with the meter off If you have turned the meter on to change settings or review past results turn it off Check the code on the test strip vial before inserting the test strip Insert a test strip to turn on the meter Make sure the three contact bars are facing you Push the test strip in as far as it will go Do Not bend the test strip Match the code on the meter with the code on the test strip vial If the code on the meter does not match the code on the test strip vial press A or W to match the code number on the test strip vial The new code number will flash on the display for three seconds and then stay constant for three seconds The display will advance to the screen with the flashing blood drop icon amp If the codes already match wait three seconds The display will advance to the screen with the flashing blood drop icon lt Mark the test as a control solution test Example IMPOR
4. need to be updated simply wait five seconds The meter display will automatically advance to the next setting Set the hour With the hour flashing on the display press and release A or W to go forward or backward one hour To move faster hold the A or W buttons down When the correct hour appears on the display wait five seconds Your entry will be saved and you will move to the next setting The minutes will now start flashing SETTING THE TIME AND DATE AND CODING YOUR METER 4 Set the minutes Press A or W to change the minutes When you have the correct minutes on the display wait five seconds to move to the next setting The year last two digits only month and day appear on the display and the year flashes Set the year Press A or W to change the year When you have the correct year on the display wait five seconds to move to the next setting The month will now start flashing Set the month Press A or W to change the month When you have the correct month on the display wait five seconds to move to the next setting The day will now start flashing O Set the day Press A or W to change the day When you have the correct day on the display wait five seconds to move to the next screen Your time and date settings will be displayed for five seconds After the five seconds the settings will be saved and the meter will then turn off If you want to adjust your settings press A or W while the time and date a
5. 1800 535676 Ireland ERROR MESSAGES AND DETAILS ABOUT YOUR SYSTEM 25 Message What it means What to do One of the following may apply If you tested in a cool environment repeat You may have high glucose and have the test in a warmer environment with a tested in an environment near the new test strip see Section 3 Testing your low end of the system s operating blood glucose If this error message appears temperature range 6 44 again contact Customer Care Freephone or 0800 121200 UK or 1800 535676 Ireland There may be a problem with the test If you tested in a normal or warm strip For example it may have been environment repeat the test with a new damaged or moved during testing test strip see Section 3 Testing your blood or glucose If this error message appears again contact Customer Care Freephone 0800 121200 UK or 1800 535676 Ireland The sample was improperly applied If you applied the sample incorrectly review or blood application see Section 3 Testing your blood glucose or control solution testing see Section 5 Control solution testing and repeat the test with a new test strip If the error message appears again contact Customer Care Freephone 0800 121200 UK or 1800 535676 Ireland There may be a problem with the meter If this error message appears again contact Customer Care Freephone 0800 121200 UK or 1800 535676 Ireland The meter has detected a problem with Repeat the
6. TANT Mark all control solution tests with CtL This will stop them from being stored as blood glucose results e Control solution results marked with CtL are not stored in the meter s memory CONTROL SOLUTION TESTING 18 Press A so that the control solution test symbol CtL appears in the upper right corner of the display You must mark the test before you apply control solution Once you have completed the test you cannot change the marking The meter is now ready to perform a control solution test If you decide not to do a control solution test press again to remove CtL from the display mmol L Prepare and apply control solution Shake the control solution vial before each test Remove the cap and squeeze the vial to discard the first drop Then wipe the tip with a clean tissue or cloth Hold the vial upside down and gently squeeze a hanging drop Touch and hold the hanging drop of control solution to the narrow channel in the top edge of the test strip Make sure the confirmation window fills completely Control solution should not be applied to the flat face of the test strip Narrow Channel Apply drop here Read your result When the confirmation window is full the meter will count down from 5 to 1 Your result will then appear on the display along with CtL and the unit of measurement Confirmation Window LI mmol L Check if the result is in range Compare the result displayed on the meter to
7. at are harmful if inhaled or swallowed and may cause skin or eye irritation Insert a test strip to turn on the meter Start with the meter off If you have turned the meter on to change settings or review past results turn it off Remove a test strip from its vial With clean dry hands you may touch the test strip anywhere on its surface Do Not bend cut or modify the test strips in any way Use each test strip immediately after removing it from the vial Hold the meter as shown and insert the test strip into the test port Make sure the three contact bars are facing you Push the test strip in as far as it will go Do Not bend the test strip SETTING THE TIME AND DATE AND CODING YOUR METER 6 A CAUTION OneTouch Ultra Test Strips are for single use only Never re use a test strip that had either blood or control solution applied to it After the start up test screen appears the meter will display the code from your last test If a constant and a flashing appear instead of a code number such as when you are first using the meter follow the instructions in step 3 to change to a numerical code Match the code on the meter with the code on the test strip vial If the code on the meter does not match the code on the test strip vial press or W to match the code number on the test strip vial The new code number will flash on the display for three seconds and then stay constant for three second
8. availability of control solution call LifeScan Customer Care on Freephone 0800 121 200 UK or 1800 535 676 Ireland GETTING TO KNOW YOUR SYSTEM 1 Getting to know your system Test port Display mmol L is the Up and down buttons Insert test strip here to pre set unit of Turns the meter on or off METER es Contact bars TEST STRIP Edgeto Insert into test port apply sample Confirmation window GETTING TO KNOW YOUR SYSTEM 2 Turning your meter on To perform a test insert a test strip as far as it will go The display will turn on and the meter will briefly perform system checks Or to change the time and date start with the meter off then press and hold W for five seconds until the start up test screen appears After the start up test screen the pre set time and date will appear on the display Or if you want to turn the meter on to review past results start with the meter off then press and release W Start up Test Screen Every time you turn your meter on a start up test screen will appear for two seconds All segments of the display should appear briefly on the start up test screen to tell you that the meter is working properly To check that all display segments are working as soon as the start up test screen appears press and hold A to keep the start up test screen display on Release A to proceed to the next step If the meter does not power on try changing the meter battery See Replacing the ba
9. be affected by factors and conditions that do not affect laboratory results in the same way Your OneTouch UltraEasy Meter glucose value is considered accurate when it is within 20 of the laboratory measurement There are some specific situations that could cause a difference of more than 20 e You have eaten recently The blood glucose level from a fingertip can be up to 3 9 mmol L higher than blood drawn from a vein venous sample used for a lab test e Your haematocrit percentage of blood that is red blood cells is high above 55 or low below 30 e You are suffering from severe dehydration e You tested at a temperature near the low end of the operating range 6 C and you get a high glucose result i e greater than 10 0 mmol L In this situation repeat the test in a warmer environment with a new test strip as soon as possible For accuracy and precision data and for important information on limitations see the insert that comes with your test strips To maximize your chances of an accurate comparison between meter and laboratory results follow a few basic guidelines Before going to the lab While at the lab e Perform a control solution test to make sure the meter is e Conduct your meter test within 15 minutes of the lab test working properly e Use only fresh capillary blood obtained from the fingertip Do Not eat for at least eight hours before you test your blood e Follow all instructions in this User Guide for p
10. ble USB format install the software driver Interface Cable A WARNING To avoid a possible shock Do Not insert a test strip when the meter is connected to a computer with the OneTouch Interface Cable Get ready to transfer readings Connect the OneTouch Interface Cable to the COM or USB port on your computer Make sure the meter is turned off If you insert the cable while the meter is already on the meter will not respond to computer commands Then connect the other end of the OneTouch Interface Cable to the meter data port Transfer data Follow the instructions provided with OneTouch DMS to download the results from the meter Once the command to start the download is sent from the computer to the meter the meter display will show PC indicating that the meter is in communication mode You will not be able to perform a test when the meter is in communication mode REVIEWING PAST RESULTS 17 Control solution testing When to test with control solution OneTouch Ultra Control Solution contains a known amount of glucose and is used to check that the meter and the test strips are working properly Do a control solution test e to practice the test process instead of using blood NOTE e once a week e Use only OneTouch Ultra Control Solution with your OneTouch e whenever you open a new vial of test strips UltraEasy Meter e if you suspect the meter or test strips are not working properly
11. care professional without delay Repeat the test after the meter and test strips have reached a temperature within the operating range Repeat the test after the meter and test strips have reached a temperature within the operating range ERROR MESSAGES AND DETAILS ABOUT YOUR SYSTEM 24 No result in memory such as the first time use of the meter a gt D P or Your meter was unable to recall this mmol L M scl Error message indicates there is a problem with the meter Error message could be caused either by a used test strip ora problem with the meter Error message indicates that the blood or control solution sample was applied before the meter was ready You can still perform a blood glucose test and get an accurate test result Contact Customer Care Freephone 0800 121200 UK or 1800 535676 Ireland to report this occurrence if this is not your first time use of the meter Do Not use the meter Contact Customer Care Freephone 0800 121200 UK or 1800 535676 Ireland Repeat the test with a new test strip see Section 3 Testing your blood glucose If this message continues to appear contact Customer Care Freephone 0800 121200 UK or 1800 535676 Ireland Repeat the test with a new test strip Apply a blood or control solution sample only after the flashing blood drop icon amp appears on the display If this message continues to appear contact Customer Care Freephone 0800 121200 UK or
12. d date are set correctly If they are not use the and buttons to re set the meter before testing See Setting the time and date in Section 2 NOTE Removing the meter battery will not affect your stored results However you may need to re set the time and date Dispose of batteries according to your local environmental regulations Please recycle or dispose of used batteries using your local battery collection systems and in compliance with your local et environmental laws and regulations Batteries contain chemicals that if released may affect the environment and human health The crossed out wheeled bin symbol indicates the need for the separate collection for batteries CARING FOR YOUR SYSTEM 21 Caring for your system Your OneTouch UltraEasy Blood Glucose Monitoring System does not need any special maintenance Storing your system Store your meter test strips and control solution in your carrying case after each use Store each item in a cool dry place below 30 C but Do Not refrigerate Keep all items away from direct sunlight and heat Tightly close the cap on the test strip vial and or control solution vial immediately after use to avoid contamination or damage Store test strips only in their original vial Checking for expiration or damage to test strips and control solution Test strips and control solution have expiration dates printed on their vials When you first open a test strip or control solution vial
13. emia low blood glucose This may require immediate treatment according to your health care professional s recommendations Although this result could be due to a test error it is safer to treat first then do another test A CAUTION High glucose results If your test result is higher than 10 0 mmol L it may mean hyperglycaemia high blood glucose If you are uncertain about this test result consider re testing Your health care professional can work with you to determine what actions if any you should take if your results are higher than 10 0 mmol L If your meter displays HI you may have a very high blood glucose level severe hyperglycaemia exceeding 33 3 mmol L Re check your glucose level If the result is HI again this may indicate a severe problem with your blood glucose control and it is important you obtain and follow instructions from your health care professional without delay A CAUTION Repeated unexpected glucose results If you continue to get unexpected results check your system with control solution See Section 5 Control solution testing If you are experiencing symptoms that are not consistent with your blood glucose results and you have followed all instructions in this User Guide call your health care professional Never ignore symptoms or make significant changes to your diabetes control programme without speaking to your health care professional A CAUTION Unusual red blood cell count A haematocrit percen
14. erforming a e Take your meter with you to the lab blood glucose test with your meter 1 Sacks D B Carbohydrates Burtis C A and Ashwood E R ed Tietz Textbook of Clinical Chemistry Philadelphia W B Saunders Company 1994 959 Technical specifications Reported result range 1 1 33 3 mmol L Memory 500 blood glucose test results Calibration Plasma equivalent Automatic shutoff 2 minutes after last action Sample Fresh capillary whole blood Size 10 8 x 3 20 x 1 70 cm Test time 5 seconds Weight Approximately 40 grams with battery Assay method Glucose oxidase biosensor Operating ranges Temperature 6 44 C Meter power source One replaceable 3 0 Volt CR 2032 Altitude up to 3048 meters lithium battery or equivalent Relative humidity 10 90 Unit of measurement mmol L Haematocrit 30 55 Battery ratings One 3 0 V d c 3 mA one CR 2032 battery direct current ERROR MESSAGES AND DETAILS ABOUT YOUR SYSTEM 27 Symbols A Cautions and Warnings Refer to safety related notes in the User Guide and inserts that came with your meter and testing supplies Direct current t Low battery SN Serial Number LOT Lot number VD In vitro diagnostic medical device Expiration date Sterilized by irradiation Storage temperature limits C Consult instructions for use Contains sufficient for lt n gt tests Do not reuse et Separate collection of batteries Manufacturer J E lt gt n i Authorised Representative
15. esult on the meter Your blood glucose level appears on the display along with the unit of measurement and the date and time of the test Blood glucose results are ae q ag automatically stored in the meter s memory Oo a Example A CAUTION If you test at the low end of the operating range 6 44 C and your glucose is high over 10 0 mmol L the reading on your meter may be lower than your actual glucose In this situation repeat the test in a warmer environment with a new test strip as soon as possible A WARNING If mmol L does not appear with the test result call Customer Care Freephone 0800 121200 UK or 1800 535676 Ireland Use of the wrong unit of measurement may cause you to misinterpret your blood glucose level and may lead to incorrect treatment Error messages If you get an Er message on your screen rather than a result see Understanding error and other messages in Section 7 Unexpected test results Refer to these cautions Z whenever your results are lower than higher than or otherwise not what you expect TESTING YOUR BLOOD GLUCOSE 14 A CAUTION Dehydration and low glucose results Severe dehydration resulting from excessive water loss may cause false low results If you think you are suffering from severe dehydration contact your health care professional immediately A CAUTION Low glucose results If your test result is lower than 3 9 mmol L or is shown as LO it may mean hypoglyca
16. f blood forms under the cap Forearm TESTING YOUR BLOOD GLUCOSE 11 When sampling blood from your forearm or palm make sure the drop of blood is large enough approximate size before you release pressure and remove the lancing device Remove the lancing device Carefully lift the lancing device away from your skin Do Not smear the blood sample NOTE e You may need to wait a little longer to get a large enough drop of blood from the forearm or palm Do Not squeeze the site excessively e Ifthe sample drop of blood runs or spreads due to contact with hair or with a line in your palm Do Not use that sample Try puncturing again in a smoother area e Remember You may have to adjust the lancing device to a deeper setting to get a large enough drop of blood approximate size Applying blood and reading results Once you have a blood sample and your meter shows the screen with the flashing blood drop icon amp you are ready to obtain a blood glucose result If your meter does not show the screen with the flashing blood drop icon amp remove the unused test strip and re start the test process See Getting a blood sample in Section 3 Prepare to apply the sample Keeping your finger extended and steady move the meter and test strip toward the blood drop Do Not hold the meter and test strip underneath the blood drop This may cause blood to run into the test port and damage the meter Fingertip Whe
17. ill appear After each test and when reviewing past results the battery icon will now flash to remind you to change the battery as soon as possible When the battery icon is flashing by itself on the display you cannot perform a test You must install a new battery before using your meter Replacing the battery Remove the old battery Start with the meter off Open the battery door and pull up on the battery ribbon CARING FOR YOUR SYSTEM 20 A WARNING To avoid a possible shock Do Not change the battery while the meter is connected to a computer with the OneTouch Interface Cable Insert the new battery With the side facing up toward you place the battery in the compartment within the fold of the ribbon Push the battery until it sna into place Insert the two battery door tabs into the matching holes and push down until you hear the door click into place If the meter does not power on after you have replaced the battery check that the battery is correctly installed with the side up If the meter still does not power on call Customer Care Freephone 0800 121200 UK or 1800 535676 Ireland Check the time and date After replacing the battery turn the meter on by pressing and holding the W button for five seconds to access the set up mode The start up test screen will be briefly displayed then the date and time will appear in the top right corner of the display Check that the time an
18. ing U S patents 7 250 105 6 413 410 6 733 655 7 468 125 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 Onelouch Ultra Test Strips No test strip supplier other than LifeScan is authorized to grant such a license The accuracy of results generated with LifeScan meters using test strips manufactured by anyone other than LifeScan has not been evaluated by LifeScan Notes ERROR MESSAGES AND DETAILS ABOUT YOUR SYSTEM 29
19. it clicks If it does not click it may have been cocked when you inserted the lancet 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 Get a round drop of blood Gently squeeze and or massage your fingertip until a round drop of blood approximate size forms on your fingertip If the blood smears or runs Do Not use that sample Wipe the area and gently squeeze another drop of blood or puncture a new site TESTING YOUR BLOOD GLUCOSE 9 Choosing the right sampling site at the right time The OneTouch UltraEasy Meter allows you to sample blood from your fingertip forearm or palm Forearm and palm sampling is also referred to as Alternate Site Testing AST At times results obtained at the forearm or palm may be different from a fingertip measurement Talk to your health care professional before you begin using your forearm or palm for sampling If you are testing Use blood sample from your Routinely before meals Prior to or more than two hours after a meal Fingertip forearm or palm e a rapid acting insulin injection or insulin pump bolus e exercise When your blood glucose is changing rapidly such as e within two hours after a meal e within two hours after a rapid acting insulin injection or insulin pump bolus or e during or within two hours after exercise When you are concerned about the possibility
20. n applying a drop of blood from your forearm or palm keep your palm or forearm steady and bring the top edge of the test strip to the drop of blood with your other hand Forearm TESTING YOUR BLOOD GLUCOSE 12 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 A Narrow Channel Gently touch the channel to the edge of the blood drop Be careful not to push the test strip against your fingertip or the test strip may not fill completely NOTE e Do Not smear or scrape the drop of blood with the test strip e Do Not apply more blood to the test strip after you have moved the drop of blood away e Do Not move the test strip in the meter during a test A CAUTION You may get an Er 5 message or an inaccurate result if the blood sample does not fill the confirmation window completely See Understanding error and other messages in Section 7 Discard the test strip and re start the test process 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 When the confirmation window is full this means you have applied enough blood Now you can move the test strip away from the blood drop and wait for the meter to count down from 5 to 1 Full Not Full TESTING YOUR BLOOD GLUCOSE 13 Read your r
21. o turn it on After the start up test screen your most recent test result will appear on the display M also appears to indicate memory mode If you have just completed a test leave the test strip in the meter and press W to enter the memory mode Your most recent blood glucose test result appears along with M LL mmol L Press W to move to the previous result stored in the meter Then press A or V to move forward or backward through all of your results When you re finished reviewing past results press and hold W for two seconds until the meter turns off NOTE lf no results are currently stored in the meter will appear on the display REVIEWING PAST RESULTS 16 Downloading results to a computer You can use your meter with OneTouch Diabetes Management Software DMS for storing your records and to help you spot patterns for planning meals exercise and medication OneTouch DMS puts information downloaded from the meter into charts and graphs If you are a current OneTouch DMS user additional software updates may be required for use with the OneTouch UltraEasy Meter Please visit www LifeScan co uk Obtain the required software and cable For order information and to learn more about OneTouch Diabetes Management Software visit www LifeScan co uk Install the software on a computer Follow the installation instructions provided with the Software If using a OneTouch Interface Ca
22. of hypoglycaemia low blood sugar Fingertip A CAUTION Do Not test on your forearm or palm when e You think your blood glucose is rapidly falling such as within two hours of exercise or a rapid acting insulin injection or insulin pump bolus Testing with a fingertip sample may identify hypoglycaemia or an insulin reaction sooner than testing with a forearm or palm sample e It has been less than two hours after a meal a rapid acting insulin injection or insulin pump bolus physical exercise or you think your glucose level is changing rapidly e You are concerned about the possibility of hypoglycaemia or an insulin reaction such as when driving a car This is especially important if you suffer from hypoglycaemia unawareness lack of symptoms to indicate an insulin reaction Remember Consult with your health care professional before using your forearm or palm for testing Choose a different puncture site each time you test Repeated punctures in the same spot may cause soreness and calluses If bruising occurs at an alternate site or you have difficulty getting a sample consider sampling from a fingertip instead You may want to review the choice of sites with your health care professional Lancing and sampling from an alternate site Sampling from your palm or forearm allows you to use your fingertips less often You may find that obtaining a blood sample from an alternate site is less painful than using a fingertip Getting a blood
23. re still on the display You will be returned to the first set up screen where you can begin with the hour SETTING THE TIME AND DATE AND CODING YOUR METER 5 N am vs ae a I N 1 c OEY ene a ti 7 Coding your meter Have these things ready when you test your blood glucose level e OneTouch UltraEasy Meter e Lancing device e OneTouch Ultra Control Solution e OneTouch Ultra Test Strips e Sterile lancets with protective disks NOTE e Use only OneTouch Ultra Test Strips with your OneTouch UltraEasy Meter e Make sure your meter and test strips are about the same temperature before you test e Testing must be done within the operating temperature range 6 44 C For the most accurate results try to test as close to room temperature 20 25 C as you can A CAUTION If you cannot test due to a problem with your testing supplies contact your health care professional or Customer Care Freephone 0800 121200 UK or 1800 535676 Ireland Failure to test could delay treatment decisions and lead to a serious medical condition Check the code on the test strip vial before inserting the test strip Code numbers are used to calibrate your meter with the test strips you are using to obtain accurate test results You must code the meter before using it for the first time and then every time you change to another vial of test strips A CAUTION The test strip vial contains drying agents th
24. rement of glucose sugar in fresh capillary whole blood The OneTouch UltraEasy System is intended for self testing outside the body in vitro diagnostic use by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control It should not be used for the diagnosis of diabetes or for testing newborns Test principle Glucose in the blood sample mixes with special chemicals in the test strip and a small electric current is produced The strength of this current changes with the amount of glucose in the blood sample Your meter measures the current calculates your blood glucose level displays the result and stores it in its memory Getting to know your system The OneTouch UltraEasy Blood Glucose Monitoring System Included with your kit a OneTouch UltraEasy Meter battery included b Lancing Device c Sterile Lancet s d Carrying Case If any of these items are missing from your kit call Customer Care Freephone 0800 121200 UK or 1800 535676 Ireland Available separately g e OneTouch Ultra Test Strips f OneTouch Ultra Control Solution g Clear Cap for AST testing A WARNING Keep the meter and testing me Fa supplies away from young children Small ka items such as the battery door battery test strips lancets protective disks on the lancets and control solution vial cap are choking hazards For
25. s The display will advance to the screen with the flashing blood drop icon amp If the codes already match wait three seconds The display will advance to the screen with the flashing blood drop icon lt amp The meter is now ready to perform a blood glucose test NOTE e If the screen with the flashing blood drop icon amp appears before you are sure the codes match remove the test strip wait until the meter turns off then re start from step 1 in Coding your meter e lf you press A by mistake so that the control solution test symbol CtL appears on the display press again to change it back to the screen with the flashing blood drop icon A CAUTION Matching the code on the meter and the code on the test strip vial is essential to obtain accurate results Each time you test check to make sure the code numbers match SETTING THE TIME AND DATE AND CODING YOUR METER 7 Testing your blood glucose Getting a blood sample Overview of the Lancing Device Clear Cap for alternate site sampling Release button Cocking control Blue or black cap har for fingertip sampling Sterile lancet Lancet point The blue or black cap and clear cap are also used for depth adjustment NOTE f you do not have a lancing device please refer to the instructions that came with your lancing device A CAUTION To reduce the chance of infection Make sure to wash the puncture site with soap and
26. sample from your forearm or palm is different than getting a sample from your fingertips TESTING YOUR BLOOD GLUCOSE 10 Forearm sampling Choose a fleshy area of the forearm away from bone visible veins and hair Sometimes there is less blood flow to the forearm than to the fingertips To help you get a large enough drop of blood you may gently massage or apply warmth to the site to increase blood flow Palm sampling Choose a fleshy area on the palm below your thumb or little finger Select a spot with no visible veins and away from deep lines which may cause your blood sample to smear Forearm The clear cap is used for forearm and palm sampling only Replace the blue or black cap with the clear cap Insert a sterile lancet and snap on the clear cap Adjust the depth setting You may have to adjust the lancing device to a deeper setting to get a large enough drop of blood from your forearm or palm Twist the clear cap toward the larger numbers to increase the depth Be sure to cock the lancing device Puncture your forearm or palm Firmly press and hold the lancing device against your forearm or palm for a few seconds Wait until the skin surface under the clear cap changes colour as blood collects beneath the skin This tells you there is enough blood flow for a good sample Then press the release button while continuing to apply pressure Keep holding the lancing device against your skin until a round drop o
27. tage of your blood that is red blood cells that is either very high above 55 or very low below 30 can cause false results After getting a result Once you have read your result you may e Review your meter memory by pressing W to enter memory mode see Section 4 Reviewing past results or e Turn the meter off by removing the test strip Removing the used lancet Remove the lancing device cap by snapping it off Cover the exposed lancet tip before removing the lancet Place the lancet protective disk on a hard surface Push the lancet tip into the disk Remove the lancet and place it in a container for sharp objects Replace the cap Disposing of the used lancet and test strip It is important to discard the used lancet carefully after each use to avoid unintended lancet stick injuries Used test strips and lancets may be considered biohazardous waste in your area Be sure to follow your local regulations or your health care professional s recommendations for proper disposal TESTING YOUR BLOOD GLUCOSE 15 Reviewing past results Reviewing past results The meter stores a maximum of 500 blood glucose test results When the meter memory is full the oldest result is dropped as the newest is added Results are stored automatically when you test along with the time date and unit of measurement You can review the results stored in the meter memory starting with the most recent If your meter is off press and release W t
28. test with a new test strip the test strip Possible causes are test Refer to blood application see Section strip damage or an incompletely filled 3 Testing your blood glucose or control confirmation window solution testing see Section 5 Control solution testing Meter battery is low but there is enough When the flashing battery icon first N f I im power to perform a test appears there is enough power for a com gt aw i l minimum of 100 more tests Test results mmol L will still be accurate but replace the CD E battery as soon as possible The icon flashes on the display by itself Replace the meter battery when there is not enough battery power to perform a test or view previous results ERROR MESSAGES AND DETAILS ABOUT YOUR SYSTEM 26 Detailed information about your system Comparing meter and laboratory results Test results with the OneTouch UltraEasy Meter are plasma calibrated This helps you and your health care professional to compare your meter results with laboratory tests If you have been using another type of meter one that provides whole blood calibrated results you may notice that your test results with the OneTouch UltraEasy Meter are approximately 12 higher OneTouch UltraEasy Meter test results and laboratory test results both are expressed in plasma equivalent units However your meter result may differ from your laboratory result due to normal variation Meter results can
29. the control solution range printed on the test strip vial Each vial of test strips may have a different control solution range If the results you get are not within this range the meter and test strips may not be working properly Repeat the control solution test Out of range results may be due to e not following the instructions detailed in steps 1 7 e expired or contaminated control solution e expired or damaged test strip Example e use of a test strip or control solution past its discard date or e a problem with the meter A CAUTION The control solution range printed on the test strip vial is for OneTouch Ultra Control Solution only It is not a recommended range for your blood glucose level A 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 the test strips or the control solution Call Customer Care Freephone 0800 121200 UK or 1800 535676 Ireland CONTROL SOLUTION TESTING 19 Q Caring for your system Replacing the battery Your OneTouch UltraEasy Meter uses one 3 0 Volt CR 2032 lithium battery or equivalent Replacement batteries can be found in most stores where batteries are sold Your meter comes with the battery already installed A battery icon appears in the far right hand side of the meter display to indicate low battery When there is enough power for a minimum of 100 more tests the battery icon w
30. ting rinse briefly with water and allow both to air dry CARING FOR YOUR SYSTEM 23 7 Error messages and details about your system Understanding error and other messages The OneTouch UltraEasy Meter displays messages when there are problems with the test strip with the meter or when your blood glucose levels are higher than 33 3 mmol L or lower than 1 1 mmol L Messages do not appear in all cases when a problem has occurred Improper use may cause an inaccurate result without producing a warning message Message What it means You may have a very low blood glucose level severe hypoglycaemia lower than 1 1 mmol L You may have a very high blood glucose level severe hyperglycaemia over 33 3 mmol L The meter has detected that the temperature is above the system operating range Do Not perform a test until the meter and test strips reach a temperature within the operating range of 6 44 C The meter has detected that the temperature is below the system operating range Do Not perform a test until the meter and test strips reach a temperature within the operating range of 6 44 C What to do This may require immediate treatment according to your health care professional s recommendations Although this message could be due to a test error it is safer to treat first and then do another test Re check your glucose level If the result is Hl again obtain and follow instructions from your health
31. ttery in Section 6 Turning your meter off There are several ways to turn your meter off e Press and hold W for two seconds when reviewing past results e Your meter will turn off by itself if left alone for two minutes meter Call Customer Care Freephone 0800 121200 UK e Before or after completing a test remove the test strip or 1800 535676 Ireland A CAUTION If any information is missing from the Start up test screen there may be a problem with the GETTING TO KNOW YOUR SYSTEM 3 Setting the time and date and coding your meter Setting the time and date Your OneTouch UltraEasy Meter comes with the time date and unit of measurement pre set Before using your meter for the first time or if you change the meter battery you should check and update the time and date Make sure you complete steps 1 to 6 below to ensure your desired settings are saved A WARNING If your display shows mg dL rather than mmol L contact Customer Care Freephone 0800 121200 UK or 1800 535676 Ireland You cannot change the unit of measurement Use of the wrong unit of measurement may cause you to misinterpret your blood glucose level and may lead to incorrect treatment Turn the meter on Press and hold for five seconds until the start up test screen appears After the Start up test screen the pre set time and date will appear on the display for five seconds The hour will now start flashing NOTE lf a setting does not
32. water before e Always use a new sterile lancet lancets are for single use only sampling e Keep your meter and lancing device clean See Caring for your e Never share a lancet or a lancing device with anyone system in Section 6 TESTING YOUR BLOOD GLUCOSE 8 Preparing your sample site Before you test your blood glucose wash your hands and forearm if applicable thoroughly with warm soapy water Rinse and dry Lancing and sampling from your fingertip Remove the blue or black cap by snapping it off Insert a sterile lancet into the lancing device Insert the lancet into the holder and push in firmly Twist the protective disk until it separates from the lancet and save the disk for later use Do Not twist the lancet Replace the blue or black cap by snapping it back on Adjust the depth setting The lancing device has nine puncture depth settings numbered 1 through 9 The 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 Twist the blue or black cap until the correct setting appears NOTE A shallower puncture may be less painful Try a shallower setting first and increase the depth until you find the one deep enough to get a large enough drop of blood approximate size Cock the lancing device Slide the cocking control back until
33. you must record the discard date in the space provided on the label e Test Strips date opened plus six 6 months e Control Solution date opened plus three 3 months A CAUTION Do Not use the test strips or control solution after the expiration date printed on the vial or the discard date whichever comes first or your results may be inaccurate A CAUTION Do Not use your test strips if your vial is damaged or left open to air This could lead to error messages or tests that read higher than the actual value Call OneTouch Customer Care Freephone 0800 121200 UK or 1800 535676 Ireland immediately if the test strip vial is damaged CARING FOR YOUR SYSTEM 22 Cleaning your meter To clean your meter wipe the outside with a soft cloth dampened with water and mild detergent Do Not use alcohol or another solvent to clean your meter Do Not get any liquids dirt dust blood or control solution inside the meter through the test port or the data port Never spray cleaning solution on the meter or immerse it in any liquid Cleaning your lancing device and clear cap To clean these items wipe them with a soft cloth dampened with water and mild detergent Do Not immerse the lancing device in any liquid To disinfect these items prepare a solution of one part household bleach to ten parts water Wipe the lancing device with a soft cloth dampened with this solution Immerse the caps only in this solution for 30 minutes After disinfec
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