OneTouch Ultra ® Blood Glucose Monitoring Owner`s Booklet(BY)
Contents
1. 2 Sacks D B Carbohydrates Burtis C A and Ashwood E R ed Tietz Textbook of Clinical Chemistry Philadelphia W B Saunders Company 1994 p 959 41 42 Meter Set up You may need to update the meter settings when you first receive your meter or when you replace the battery Follow these instructions If you need assistance call LifeScan Customer Service at 1 800 227 8862 STEP 1 Enter the meter set up ONETOUCH Ultra e Start with the meter off eo e Press and continue to hold the button until ONLY the time appears on the w W bottom right of the display Release the Y button Meter on NOTE You must move through all the settings to save changes Flashing indicates setting can be changed ONETOUCH Ultra ONETOUCH Ultra If you use the 12 hour format the AM or PM will change each time you reach 12 00 Be sure the AM PM setting is correct when you set the hour STEP 2 Set the hour Press and release the amp button to change the hour If you go past the desired hour press and release the button until you scroll through to the desired hour To scroll faster hold the Y button down Press and release the W button to move to the next step STEP 3 Set the minutes Press and release the amp button to change to the desired minutes Press and release the W button to move to the next step 43 STEP 4 Set the AM PM or 24 hour time format2. If they do not code the meter correctly See pages 10 12 15 16 STEP 2 Mark this test as a control solution test This marks the test as a control solution test ctl ONETOUCH Ultra D mg dL Press and release the button so etl appears on the display NOTE Mark all control solution tests with etl to distinguish them from blood glucose tests in the meter memory Marked control solution tests will not be included in your averages STEP 3 Apply control solution to the test strip To ensure an accurate control solution test shake the vial discard the first drop and wipe the dispenser tip before you begin NARROW CHANNEL TOP EDGE Apply Drop Here Touch and hold a drop of control solution where the narrow channel meets the TOP EDGE of the test strip CONFIRMATION WINDOW ONETOUCH Ultra ef The control solution will be drawn Example into the narrow channel When the The control solution test result confirmation window is full the will appear on the display ctl meter will count down from 5 to 1 will appear above your result 18 STEP 4 Compare control solution result to the range printed on the TEST STRIP VIAL A CAUTION The control solution range printed on the test strip vial is for OneTouch CONTROL Ultra Control Solution RANGE only It is not a recommended range for your blood glucose level If the results are not within the control range printed on th
3. ONETOUCH Ultra ONETOUCH Ultra or Press and release the button to choose between AM PM and 24 hour formats Press and release the W button to move to the next step STEP 5 Niga Set the year Press and release the button to change to the desired year Press and release the button to move to the next step STEP 6 Set the month Press and release the amp button to change to the desired month ONETOUCH Ultra Press and release the button to move to the next step STEP 7 Set the day Press and release the amp button to change to the desired day ONETOUCH Ultra Press and release the Y button Continue to the next page 45 If your meter has shut off after setting the day you have completed the meter set up and saved your changes If either mg dL or mmol L is flashing on the display continue below STEP 8 Set the unit of measure to mg dL ONETOUCH Ultra Press and release the button until mg dL appears on the display Press and release the button to save your entry save your changes and shut the meter off A WARNING The mg dL unit of measure is the standard in the United States If mg dL does not appear call LifeScan Customer Service at 1 800 227 8862 46 47 48 Caring for Your OneTouch Ultra System Meter Your OneTouch Ultra Meter does not require special maintenance or cleaning Take care to avoid getting dirt dus
4. number continue to press the amp button until the correct code number appears After selecting the correct code number it will flash for three seconds and then appear solid for three seconds 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 Then the amp symbol will appear with mg dL indicating that the OneTouch Ultra System is ready for testing A WARNING If mg dL does not appear with the symbol call LifeScan Customer Service at 1 800 227 8862 12 Checking the System with Control Solution Why you should do a control solution test OneTouch Ultra Control Solution is used to check that the meter and the test strips are working together as a system and that you are performing the test correctly It is very important that you do this simple check routinely to make sure you get an accurate result When you should do a control solution test hu i 5 To practice the test process instead of using blood le Re x r4 al J gt When you open a new vial of test strips Once a week gt Whenever you suspect that the meter or test strips are not working properly If you have had repeated unexpected blood glucose test results as described on page 3 gt After dropping the meter NOTE Refer to addi
5. 0 V 2032 or equivalent lithium battery Battery Life About 1 000 tests about one year at three tests per day Glucose Units mg dL Memory 150 blood glucose and control solution tests Automatic Shutoff Two minutes after last user action Size 3 12 x 2 25 x 0 85 Approximate Weight 1 5 ounces with battery Operating Ranges Temperature 43 111 F 6 44 C Relative Humidity 10 90 Hematocrit 30 55 Guarantee The makers guarantee that the OneTouch Ultra Meter shall be free of defects in material and workmanship for a period of three years This guarantee is valid from the date of purchase The guarantee extends only to the original purchaser and is not transferable PRODUCT SAFETY INFORMATION This meter complies with the following Electrical and Safety Standards This meter complies with CISPR 11 2003 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 Level 3 electrostatic discharge as specified in IEC 61000 4 2 This meter has been tested for immunity to radio frequency interference over the frequency range 80MHz to 2 5GHz at 3V m as specified in IEC 61000 4 3 Degree of protection rating IP21 CAN CSA C22 2 61010 1 04 UL 61010 1 04 IEC 61010 1 and IEC es 61010 2 101 Updated Symbol Information Caution see Instructions for use Direct current In vitro diagnostic medical device
6. 2032 or equivalent lithium battery The meter will alert you when the power is getting low by displaying two different messages the x symbol appears on the display with mg dL when the meter is turned on and all other display messages are functional From the time the symbol first appears there is enough power left for about 50 tests The test results will be accurate but it N time to change the battery 49 50 When the symbol appears on the display by itself it means that the battery will not provide enough power for a test You must change the battery To replace the battery make sure that the meter is turned off Turn the meter over and locate the battery compartment STEP 1 Open the Battery Compartment Push up on the tab and pull the battery compartment cover toward you STEP 2 Remove the Old Battery Pull upward on the clear plastic tab Insert one 3 0 V 2032 or equivalent lithium battery making sure the positive side of the battery is facing up STEP 3 Place the Cover Place the cover over the battery compartment Push down until you hear the tab click into place STEP 4 Check the Time Date and Unit of Measure After replacing the battery turn the meter on by inserting a test strip or pressing the button If the meter is in setting mode confirm that the time time format and date are set correctly If they are not use the Y and buttons to reset th
7. a as the first time use of the blood glucose test and get meter an accurate test result or Call LifeScan Customer Your meter was unable to Service at recall this result 1 800 227 8862 to report this occurance if this is not your first time use of the meter Average of results from the If your 14 day and 30 day I last 14 days br means test result averages are l that 64 tests were not what you expect you _ performed within the should not rely on them mg dL jy PAY Eu period The 30 day AVG average appears with a J0 before the we on the screen MESSAGE WHAT IT MEANS Error message that indicates that there is a problem with the meter Error message could be caused either by a used test strip or a problem with the meter Error message that indicates that the blood or control solution sample was applied before the amp symbol appeared on the display ACTION Do Not use the meter Call LifeScan Customer Service at 1 800 227 8862 for a replacement meter Repeat the test with a new test strip Refer to pages 8 9 for test strip information If the error message persists call LifeScan Customer Service at 1 800 227 8862 Repeat the test with a new test strip Apply blood or control solution sample only after the amp symbol appears on the display Refer to pages 29 31 for information on sample application 57 58 MESSAGE WHAT IT MEANS Error message that indic
8. and control solution test results with date and time in its memory It also provides you with 14 and 30 day averages of your blood glucose test results If your 14 day and 30 day test result averages are not what you expect you should not rely on them Review the test results in memory with these easy steps STEP 1 Enter the Memory Mode You may enter the memory mode either with the meter turned off or immediately after completing a test Press the button mem and the 14 day average will appear mg dL with the number of blood glucose tests U Ree BHn performed in this period e g 64n means that 64 tests were performed within the period After three seconds the 30 day average will appear If you are using the meter for the first time indicates there are no test results in memory These averages are calculated from the blood glucose results obtained during the last 14 mem and 30 calendar days A H1 result will be l included in your averages as 600 mg dL and a a LD result as 20 mg dL Results marked as I control solution tests will not be included in dn dann mg dL your averages If your 14 day and 30 day test B result averages are not what you expect you JU ave 148n should not rely on them STEP 2 Recall Test Results em The most recent test result with date and l time will appear Press and release the button and the next most recent test Jnl result will appear The meter
9. only OneTouch Ultra Control Solution or a blood sample to the test strip D Refer to additional information in the OneTouch Ultra Test Strip package A WARNING Do Not swallow test strips The test strip vial may contain drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation 10 Before Testing Checking the Meter Display code ctl ketones mem Each time you turn on the OneTouch Ultra Li ol LI Meter either by inserting a test strip or pressing the button all segments of the E r l E display will appear briefly This tells you that mmol evm the system is performing several self checks to j jj PAY JAAG AM confirm that the meter is working properly To check that all display segments are working with the meter off press the Q button and immediately hold the button down Coding the Meter Code numbers are used to calibrate the OneTouch Ultra Meter with OneTouch Ultra Test Strips for accurate 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 Each time you test check to be sure that the code number on the meter display matches the code number on the test strip vial 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 on the meter and the code on the test strip vi
10. results If you believe you are suffering from severe dehydration consult a health care professional immediately D Low glucose results If your test result is lower than 70 mg dL or is shown as LO it may mean hypoglycemia 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 and then repeat the test D High glucose results If your test result is greater than 180 mg dL or is shown as HI it may mean hyperglycemia high blood glucose If you do not have symptoms first repeat the test Your health care professional can work with you to decide what actions if any you should take if you continue to get results higher than 180 mg dL or if you have symptoms D Repeated unexpected results If you continue to get unexpected results check your system with control solution See Checking the System with Control Solution on pages 13 19 You can also check averages and previous results including date and time to determine the validity of your results If you are experiencing symptoms that are not consistent with your blood glucose results and you have followed all instructions in this booklet call your health care professional Never ignore symptoms or make significant changes to your diabetes control program without speaking to your health care professional D Hematocrit A hematocrit percentage of y
11. than forearm samples When your blood glucose is falling testing with a fingertip sample may identify a hypoglycemic low blood sugar level sooner than a test with a forearm sample D Use forearm samples only for testing prior to or more than two hours after meals insulin doses or physical exercise D Testing performed within two hours after meals insulin doses or physical exercise or whenever you feel that your glucose levels may be changing rapidly should be done with a fingertip sample You should also use fingertip testing whenever you have a concern about hypoglycemia insulin reactions such as when driving a car particularly if you suffer from hypoglycemic unawareness lack of symptoms to indicate an insulin reaction as forearm testing may fail to detect hypoglycemia What you should do Use forearm or fingertip samples for testing prior to or more than two hours after meals insulin doses or physical exercise D Routine testing before meals can be done either at the fingertip or the forearm P Consult your health care professional before you begin using the forearm for testing 27 28 Step by Step Test Procedure Insert This End STEP 1 Insert Test Strip Insert a test strip contact bars end first and facing up into the test port Push it in until it will go no further The meter will turn on and the display check will appear briefly Then the code number will appear followed by the sym
12. will appear after the meter counts down from 5 to 1 Blood glucose test results are automatically stored in the meter memory You may also record them in the logbook provided with your system Turn the meter off by removing the test strip Dispose of used test strip in a sealed container Example Plasma Calibrated Result A WARNING If mg dL does not appear with the test result call LifeScan Customer Service at 1 800 227 8862 A CAUTION If you tested at the low end of the operating range 43 F 6 C and your glucose is high over 180 mg dL 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 Discarding Used Test Strips and Lancets 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 health care professional s recommendations or your local regulations for proper disposal STEP 1 Remove the Cap from the Lancing Device Twist the cap counterclockwise Optional Replace the protective cover on the used lancet by placing it on a hard surface and pushing the lancet tip into the cover STEP 2 Eject the Lancet Point the lancing device down and away Push the release button to ensure that the lancing device is not cocked Push forward on th
13. will recall mg dL up to your last 150 test results in order nn 4g AM from the most recent to the oldest If memory is not full will appear for memory locations that are empty When the memory is full the oldest result is dropped and the newest is added To move through the tests more quickly press and hold the amp button Marked control solution tests will appear as ctl STEP 3 ONE TOUCH Exit the Memory Mode Press the Y button to turn off the meter 37 38 Downloading Test Results to a Personal Computer Transferring test results with date and time from the meter memory to your personal computer requires OneTouch Diabetes Management Software with the accompanying OneTouch Interface Cable OneTouch Diabetes Management Software is available separately Note to users of OneTouch Diabetes Management Software Do Not transfer data from a meter that has experienced a loss of power Call LifeScan Customer Service at 1 800 227 8862 for more information STEP 1 Install OneTouch Diabetes Management Software Follow the instructions provided in the OneTouch Diabetes Management Software User s Manual STEP 2 Connect the OneTouch Interface Cable Make sure the meter is turned off Connect the OneTouch Interface Cable to your computer and with the meter ae off to the meter data port NOTE While in the communication mode you will be unable to perform a blood glucose t
14. Lot number Serial number Expiration date Sterilized by irradiation Do not reuse Manufacturer Additional Operating Ranges and Ratings Information Altitude Up to 10 000 feet 3048 meters Equipment rating 3 0v 2mA 64 36 47 56 40 59 62 Checking the Meter Display Checking the System with Control Solution Coding the Meter Control Solution Before you begin Control Solution Checking the System with Control Solution OneTouch Ultra Control Solution Out of range results Data Downloading Discarding Used Test Strips and Lancets Display Messages Problem Solving Guide Fingertip Blood Sampling Forearm Blood Sampling Hyperglycemia Hypoglycemia Important Information about Forearm Testing Intended Use Lancet Disposal Lancing Device Cleaning Lancing Device Preparing Lancing Device Using Low Glucose M Button Memory Using Messages Special Meter Display E Meter Display Checkin i ku in ar EnA 10 Meter Maintenance Meter Memory Meter Set up Meter Specifications OneTouch Diabetes Management Software OneTouch Interface Cable OneTouch Ultra Blood Glucose Meter OneTouch Ultra Blood Glucose Monitoring System OneTouch Ultra Control Solution OneTouch Ultra Test Strips OneTouch Ultra Test Strips Code OneTouch Ultra Test Strips Expiration Plasma Calibration Pro
15. ONE TOUCH Oa Monitoring System Owner s Booklet Important Safety Information To be sure your meter is working properly EVERY time you turn it on confirm that D All segments are visible in the display check code ctl ketones mem Ii fet I Li LI mmol L mg dL display check 1B B8 ave HH Pm Example D The unit of measure is correct mg dL D The date and time are correct ONETOUCH Ultra unit of measure date time Example OneTouch Ultra System Owner s Booklet Read this first O Each time you turn on your meter the unit of measure will appear on the display with the amp symbol The unit of measure will also appear under every test result You may misunderstand your blood glucose results if your meter is set to the incorrect unit of measure Your meter s unit of measure should be set to mg dL CORRECT If your meter is set to the correct unit of measure mg dL will appear on the display Your test result will not include a decimal point Fig 1 Do Not change this setting this is the correct unit of measure for the United States Fig 1 mg dL milligrams deciliter no decimal point INCORRECT Fig 2 mmol L millimoles liter decimal point If your meter is set to the other unit of measure mmol L will appear on the display The test result will include a decimal point Fig 2 Unless your health care professional has told yo
16. U S patents 6 045 567 6 156 051 6 197 040 6 284 125 and D428 150 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 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 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 2008 LifeScan Inc Rev date 02 2011 amp AW 06405105B Distributed by LifeScan Inc Milpitas CA 95035 For LifeScan Europe Division of Cilag GmbH International 6300 Zug Switzerland Y TIFESCAN
17. aced CODE Appears with the code number of the test strips Check your code every time you test DAY AVG AVG displayed when 14 or 30 day average is shown NOTE mmol L and decimal point appear in display but are not used in this meter when displaying glucose results If your meter is set to the correct unit of measure mg dL will appear on the display Your test result will not include a decimal point You cannot change this setting this is the correct unit of measure for the United States KETONES Appears when a test result is above 240 mg dL to suggest ketone testing MEM Indicates a test result stored in memory code ctl ketones mem q py TEST RESULT AREA Test results are displayed here xan A VA mg dL This is the unit of measure Be sure this appears with the amp symbol before applying sample to the test strip ZAX WARNING If mg dL does not MONTH DAY appear with the amp symbol call LifeScan AM PM SYMBOL Customer Service at AM PM displayed when set to 12 hour time format 1 800 227 8862 HOUR MINUTES OneTouch Ultra Test Strips The OneTouch Ultra System measures the amount of glucose in whole blood Blood is applied in the TOP EDGE of the OneTouch Ultra Test Strip and is automatically drawn into the reaction cell where the reaction takes place TOP EDGE Apply a drop of blood to the narrow channel here in the top edge of the test str
18. al match STEP 1 Enter the Code Mode Insert a test strip Vy l to turn on the meter Push it all the way in until 10 30 45 it will go no further Avoid Example bending the test strip The display check will NOTE Date and time appear Then the code number is displayed for three seconds will flash briefly The first time you use the meter three dashes will flash meaning that there is no code stored in the memory Follow Step 3 to code the meter If three dashes appear any other time see page 56 of Display Messages and Problem Solving Guide STEP 2 Match the Code Numbers Compare the code number on the meter display with the code number on the test strip vial If the two code numbers match you may begin testing If they do not match follow Step 3 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 11 STEP 3 Code the Meter Immediately press the button while the code number is displayed on the meter to select the correct code Each time you press and release the amp button the number will increase by one To move more quickly press and hold the button NOTE If the apply blood symbol is displayed before the meter is coded correctly remove the test strip and repeat steps 1 through 3 NOTE If you scrolled past the desired code
19. ancing device with anyone Always use a new sterile lancet Lancets are for single use only D Keep the OneTouch Ultra Meter and lancing device clean D Make sure to wash the puncture site with soap and water before testing 21 STEP 1 Insert a Lancet Turn the Lancing Device Cap counterclockwise to remove it Insert the lancet into the lancet holder and push down firmly until it is fully seated Do Not twist the lancet Remove the protective cover from the lancet see instructions for your lancets Replace the Lancing Device Cap Turn it clockwise until it is snug Adjust the puncture depth setting if necessary Twist the depth adjustment knob toward the smaller bumps for a shallower puncture or toward the larger bumps for a deeper puncture 22 A STEP 2 Cock the Lancing Device Slide the ejection cocking control back until it clicks If it does not click the lancing device may have been cocked when the lancet was inserted The lancing device is now ready for use ku STEP 3 Wash Your Hands and the Puncture Site To reduce the chance of infection use warm soapy water Rinse and dry thoroughly 23 24 Fingertip Blood Sampling The OneTouch Ultra System requires a very small blood drop to perform a test You may obtain it from a fingertip or forearm See page 25 for information on obtaining a blood sample from the forearm Choose a different puncture s
20. appears on the display by itself The power is too low to perform a test ACTION 4 If the error message appears again call LifeScan Customer Service at 1 800 227 8862 Repeat the test with a new test strip Refer to pages 29 31 for information on sample application Test results will still be accurate but replace the battery as soon as possible Replace the battery at once The meter will not operate 59 60 MESSAGE WHAT IT MEANS Flashing time means the meter has lost power and entered the setting mode 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 43 111 F 644 C 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 43 111 F 6 44 C ACTION You must reset the time time format and date See Meter Set up pages 42 47 Confirm that your meter is set in mg dL If not call LifeScan Customer Service at 1 800 227 8862 Note to users of OneTouch Diabetes Management Software Do Not transfer data from a meter that has experienced a loss of power Call LifeScan Customer Service at 1 800 227 8862 for more information Repeat the test after the meter and test strips have reached a temperature within the o
21. ates one of the following conditions may be present 1 bS 2 You may have high glucose and have tested in an environment near the low end of the system s operating temperature range 43 111 F 644 C There may be a problem with the test strip For example it may have been damaged or moved during testing The sample was improperly applied ACTION 1 If you tested in a cool environment repeat the test in a warmer environment with a new test strip If the error message appears again call LifeScan Customer Service at 1 800 227 8862 2 If you were testing in a normal or warm environment repeat the test with a new test strip See pages 8 9 for test strip information If the error message appears again call LifeScan Customer Service at 1 800 227 8862 If you applied the blood incorrectly review pages 29 31 on blood application and repeat the test with a new test strip If the error message appears again call LifeScan Customer Service at 1 800 227 8862 V MESSAGE Error 4 continued WHAT IT MEANS 4 There may be a problem with the meter Error message that indicates that the meter has detected a problem with the test strip Possible causes are test strip damage or an incompletely filled confirmation window The 25 symbol appears on the display with the unit of measure The power is getting low It is time to change your battery 3 The 2 symbol
22. blems Solving Reduce Chance of Infection Repeated Unexpected Results Set the Unit of Measure to mg dL Step by Step Test Procedure Temperature Range Blood Testing Temperature Range Control Solution Testing Test Port Test Procedure Step by Step Test Strip Information Important Test Strips OneTouch Ultra Time Changing Unexpected Results Unit of Measure mg dL sssecssescssecsssssscssscscsssesssnseessesseesess 65 66 Notes Glucose Ranges Times of Day for People Without Diabetes mg dL Your Target Ranges mg dL Before breakfast Before lunch 1 hour 2 hours Between Source Krall L P and Beaser R S Joslin Diabetes Manual Philadelphia Lea and Febiger 1989 p 138 Meter Serial No Important phone numbers LifeScan Customer Service 7 days a week 8 a m 10 p m 1 800 227 8862 English 1 800 381 7226 Espa ol Health Care Professional Pharmacist Diabetes Educator Other As your partner in diabetes care we offer valuable diabetes related knowledge tools and special offers online www OneTouchDiabetes com www OneTouchEnEspanol com We welcome you to contact us 7 days a week 8 a m 10 p m Eastern Time 1 800 227 8862 English 1 800 381 7226 Espa ol For assistance outside of these hours please contact your health care professional The system described herein is covered by one or more of the following
23. bol with mg dL Check to make sure the code number on the meter display matches the code number on the test strip vial Always confirm that the unit of measure is mg dL when you test your blood glucose level A WARNING If mg dL does not appear with the symbol call LifeScan Customer Service at 1 800 227 8862 Use of the wrong unit of measure may cause you to misinterpret your blood glucose level and may lead to incorrect treatment Be sure the meter and test strip codes match If they do not code the meter correctly See pages 10 12 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 STEP 2 Get a Blood Sample Obtain a round drop of blood using the lancing device The blood sample must be large enough sample size to fill the confirmation window Keeping your finger extended and steady move the meter and test strip toward the 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 29 30 When applying a drop of blood from your forearm keep your forearm steady and bring the top edge of the test strip to the drop of blood with your other hand Forearm STEP 4 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 tou
24. ching the edge of the blood drop 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 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 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 page 59 Discard the test strip and re start the test process STEP 5 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 j 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 Confirmation Window If the confirmation window is not full you may get an error message or an inaccurate test result Full Not Full 31 32 NOTE If you do not apply a blood sample within two minutes after the symbol appears the meter will turn itself off You must remove the test strip and insert it back into the meter to restart the test procedure STEP 6 Accurate Results in Just 5 Seconds Your blood glucose test result
25. e ejection cocking control and eject the lancet directly into a container for sharp objects Return the ejection cocking control to the middle position Replace the cap u Special Messages The OneTouch Ultra Meter displays results between 20 and 600 mg dL If your blood glucose test result is lower than 20 mg dL LD will appear on the meter display This may mean severe hypoglycemia low blood glucose that requires 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 repeat the test ketones If your blood glucose test result is above 600 mg dL H will appear on the meter display This may mean severe hyperglycemia high blood glucose You should recheck your blood glucose level If Hi again appears on the display call your health care professional immediately When your blood glucose test result is above 240 mg dL or reads Hi ketones will appear on the meter display This message does not mean that the system detected ketones but that testing with a ketone test strip may be advisable Consult your health care professional about when and how to test for ketones NOTE Do Not use a ketone strip with the OneTouch Ultra Meter Me _ 35 36 Using the Meter Memory Your OneTouch Ultra Meter stores the 150 most recent blood glucose
26. e meter before testing See Meter Set up pages 42 47 Also be sure to confirm the unit of measure is mg dL STEP 5 Dispose of Batteries This product contains a lithium ion battery ies which contains perchlorate material special handling may apply see www dtsc ca gow hazardouswaste perchlorate As always please dispose of battery ies according to your local environmental regulations California Code of Regulations Title 22 Section 67384 4 A WARNING The mg dL unit of measure is the standard in the United States If mg dL does not appear call LifeScan Customer Service at 1 800 227 8862 NOTE Replacing the battery does not affect previous test results stored in memory However the time and date settings may need to be updated Always confirm the unit of measure is mg dL 51 52 Display Messages and Problem Solving Guide Following is a summary of all display messages These messages help to identify certain problems but do not appear in all cases when a problem has occurred Improper use may cause an inaccurate result without producing an error message or a symbol In the event of a problem refer to the information under ACTION Assistance is available from LifeScan Customer Service 7 days a week 8 a m 10 p m Eastern Time Call LifeScan Customer Service at 1 800 227 8862 MESSAGE WHAT IT MEANS ACTION code cti ketones mem Display check Appears If segments are r fel r whenever the meter is turned
27. e test strip vial the meter and test strips may not be working properly Repeat the control solution test Control solution out of range results may be due to gt Incorrect unit of measure gt Failure to discard the first drop gt Error in performing the test of control solution and wipe the gt Failure to shake the control dispenser tip clean solution vial well gt Expired or contaminated gt Improper meter coding control solution gt Test strip deterioration gt The meter test strips or con Meter malfunction trol solution are too warm or too cold AXCAUTION If you continue to get control solution test results that fall outside of the range printed on the vial the system may not be working properly Do Not use the meter Call LifeScan Customer Service at 1 800 227 8862 19 Testing Your Blood ev this section and the test strip package insert carefully a before testing Make sure you have all items needed to test OneTouch Ultra Meter gt OneTouch Ultra Test Strips Lancing Device gt Sterile Lancets with protective covers Preparing the Lancing Device Depth Adjustment Knob Clear Cap Depth Indicator For Forearm Samplin Aiection Cocking Control pling Release Button Lancet with Protective Cover Puncture Settings a f _ Lancet Point Protective Cover Lancing Device Cap ACAUTION To reduce the chance of infection Never share a lancet or the l
28. est If the meter is in either memory or setting mode it will not respond to computer commands 2 STEP 3 Transfer Data Follow the instructions in the OneTouch Diabetes Management Software User s Manual to initiate the data transfer command PL will appear on the meter display when the first command is received indicating that the meter is in the communication mode If the command is not received within two minutes the meter will turn itself off Pressing the Q button will also turn the meter off ai Ultra To learn more about OneTouch Diabetes Management Software or to obtain a OneTouch Interface Cable separately call LifeScan Data Management Line at 1 800 382 7226 or visit us at www OneTouchDiabetes com 39 40 Comparing Meter and Laboratory Results OneTouch Ultra Meter test results and laboratory test results are both expressed in plasma equivalent units However your meter result may differ somewhat from your laboratory result due to normal variation Meter results can be affected by factors and conditions that do not affect laboratory results in the same way Your OneTouch Ultra Meter glucose value should agree with a laboratory measurement within 20 most of the time under normal conditions A result within that range is considered accurate when testing with the OneTouch Ultra Meter However results can differ by more than 20 in some situations See the OneTouch Ultra Te
29. ip CONFIRMATION WINDOW Check here to confirm if enough blood has been applied CONTACT BARS Insert this end of the test strip contact bars facing up into the meter Push it all the way in until it will go no further Important Test Strip Information D Store test strip vials in a cool dry place below 86 F 30 C Keep away from direct sunlight and heat Do Not refrigerate D Store test strips in their original vial only To avoid damage or contamination Do Not transfer test strips to any other place D After removing a test strip from the vial replace the vial cap immediately and close it tightly D Use each test strip immediately after removing it from the vial Do Not use test strips from any vial that is damaged or left open to air D Write the discard date 6 months after first opening the vial on the vial label when you first open it Discard the remaining OneTouch Ultra Test Strips on the discard date Do Not use test strips beyond the expiration printed on package or discard date whichever comes first because they may cause inaccurate results D Avoid getting dirt food or liquids on the test strip With clean dry hands you may touch the test strip anywhere on its surface Do Not bend cut or alter a OneTouch Ultra Test Strip in any way D OneTouch Ultra Test Strips are for single use only Never reuse a test strip that has had either blood or control solution applied to it D Apply
30. ite each time you test Repeated punctures in the same spot may cause soreness and calluses STEP 1 Position the Lancing Device Hold the lancing device firmly against the side of your finger Press the release button NOTE Do Not use the Clear Cap on your finger STEP 2 Massage the Fingertip Gently squeeze and or massage your fingertip until a round drop of blood sample size forms on your fingertip Do Not squeeze excessively on the puncture site The Z blood sample must be large enough or you may get an E 5 message see page 59 or an inaccurate test result Do Not smear the blood sample Proceed with your blood glucose test N Forearm Blood Sampling The forearm has fewer nerve endings than the fingertip so you may find that obtaining a blood sample from the forearm may be much less painful than using the fingertip The technique for forearm sampling is different from fingertip sampling Also there are differences between forearm samples and fingertip samples that you should understand Please read the important information on page 27 carefully STEP 1 Install the Clear Cap To aid in obtaining a blood sample from the forearm replace the Lancing Device Cap on the lancing device with the Clear Cap If necessary set the lancing device for a deeper puncture STEP 2 Choose the Puncture Site Select a soft fleshy area on your forearm that is clean and dry away from bone and free of visible vein
31. missing call LifeScan _ i J on To verify that all segments Customer Service at E BIE are present on the display with 1 800 227 8862 for mmol mgd the meter off press the further action Missing B BB ave dBGem button and immediately hold segments can lead to the amp button down Compare _ misinterpretation of test the meter display with page 10 results 1 This message appears 1 See Coding the immediately after the Meter pages 10 12 display check if your meter 2 Do Not rely on the has not been coded 14 and 30 day 2 If this message appears at averages It is any time after the first time important to call the meter was coded the LifeScan Customer code number has been lost Service at 1 800 The test results stored in the 227 8862 meter memory may be out of order MESSAGE Q 30 tsa Example mg dL WHAT IT MEANS This is the code number stored in the meter The system is ready to accept a blood sample The system is ready to accept a control solution test sample Five second countdown The meter is calculating the result After the countdown the meter will display the test result ACTION Make sure that this code number matches the code number on the vial of the test strips you are using 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 Yo
32. nsists of the OneTouch Ultra Blood Glucose Meter OneTouch Ultra Test Strips may be sold separately and OneTouch Ultra Control Solution may be sold separately These products have been designed tested and proven to work together to produce accurate blood glucose results Use only OneTouch Ultra brand test strips and control solution with your meter A CAUTION If you cannot test due to a problem with your testing supplies contact your health care professional or LifeScan Customer Service at 1 800 227 8862 Failure to test could delay treatment decisions and lead to a serious medical condition The OneTouch Ultra System is intended for use outside the body in vitro diagnostic use It should be used only for testing fresh capillary whole blood samples for glucose sugar It should not be used for the diagnosis of diabetes or for testing newborns CTD Petre using any product to test your blood glucose read all instructions and practice the test Do all quality control checks as directed and consult with a diabetes health care professional These recommendations apply to all blood glucose monitoring systems and are supported by the American Association of Diabetes Educators the American Diabetes Association the U S Food and Drug Administration and the Advanced Medical Technology Association Important Information D Dehydration Severe dehydration resulting from excessive water loss may cause false low
33. our blood that is red blood cells that is either very high above 55 or very low below 30 can cause false results ZA WARNING Keep the meter and testing supplies away from small children The battery door test strips lancets protective covers on the lancets and control solution vial cap are choking hazards The Complete OneTouch Ultra Blood Glucose Monitoring System OneTouch Ultra Meter OneTouch Ultra Control Solution may be sold separately Owner s Booklet OneTouch Ultra Test Strips Lancing Device may be sold separately If another type of lancing device was included see the separate instructions Carrying Case that came with that lancing device Warranty Registration Card Optional Clear Cap Logbook Sterile Lancets OneTouch Ultra Blood Glucose Meter DISPLAY Symbols simple messages and test results appear here TEST PORT The meter turns on when you insert the OneTouch Ultra Test Strip here WLS M BUTTON Used to enter into gt set up mode memory mode C BUTTON Used to change time date and code number mark control solution tests review test results in memory DATA PORT Used to download your test results to a computer OneTouch Ultra Meter Display cerr CTL Indicates a control solution test result BLOOD DROP SYMBOL Tells you when to apply the sample BATTERY SYMBOL Warns when the battery is low or must be repl
34. perating range Repeat the test after the meter and test strips have reached a temperature within the operating range If the meter does not display a message after inserting a test strip POSSIBLE CAUSE WHAT TO DO No power Replace the battery No battery or battery Check that the battery is incorrectly installed correctly installed with the positive side up Test strip inserted incorrectly or incompletely Insert the test strip correctly with the contact bars end first and facing up Push it in until it will go no further Defective meter or test strip Call LifeScan Customer Service at 1 800 227 8862 If the test does not start after applying the sample POSSIBLE CAUSE WHAT TO DO Insufficient blood sample Repeat the test with a new test strip and a larger sample making sure blood is placed to the narrow channel in the top edge of the test strip Defective test strip Sample applied after automatic shutoff two minutes after last user action Repeat the test with a new test strip Repeat the test with a new test strip apply sample only when the amp symbol appears on the display Defective meter Call LifeScan Customer Service at 1 800 227 8862 61 62 Specifications Result Range 20 to 600 mg dL Calibration Plasma equivalent Sample Fresh capillary whole blood Test Time 5 seconds Assay Method Glucose oxidase biosensor Power Source One replaceable 3
35. r 5 OneTouch Ultra Meter Display 6 OneTouch Ultra Test Strips 8 ST Before Testing 10 Checking the Meter Display 10 Coding the Meter 10 Checking the System with Control Solution 13 SSS Testing Your Blood 20 Preparing the Lancing Device 21 Fingertip Blood Sampling 24 Forearm Blood Sampling 25 Step by Step Test Procedure 28 Discarding Used Test Strips and Lancets 33 Special Messages 34 aE Using the Meter Memory 36 Downloading Test Results to a Personal Computer 38 E Comparing Meter and Laboratory Results 40 pE Meter Set up 42 Caring for Your OneTouch Ultra System 48 Meter 48 Lancing Device 48 Test Strips and Control Solutions 49 Battery 49 ZH Display Messages and Problem Solving Guide 52 o Specifications 62 E Guarantee 63 Index vi About Your New System gt The OneTouch Ultra System uses the latest blood glucose monitoring technology It measures the glucose content of a blood sample by means of an electrical current produced in the test strip and measured by the meter Test results are plasma calibrated This makes it easier for you and your diabetes care team to compare your meter results with laboratory tests If you have been using another type of meter one that provides whole blood results you may notice that your test results with the OneTouch Ultra System are about 12 higher The OneTouch Ultra Blood Glucose Monitoring System co
36. s and hair STEP 3 Massage the Area To increase blood flow to the puncture site massage the area gently For individuals who experience difficulty in getting sufficient blood for a test rubbing the area more vigorously or applying heat briefly may be helpful STEP 4 Position the Lancing Device Press and hold the lancing device against the forearm for a few seconds Press the release button STEP 5 Allow Blood Drop to Form Continue holding the lancing device against the skin for a few seconds until the blood drop forms Allow enough blood to form under the Clear Cap until you have a blood sample sample size that is sufficient to fill the confirmation window of the test strip If you must massage the area to obtain more 26 blood Do Not squeeze the site excessively If bruising occurs you may choose to lance a fingertip instead If you are having difficulty obtaining blood from the forearm call LifeScan Customer Service at 1 800 227 8862 Important information about forearm testing Under certain conditions blood glucose test results obtained using samples taken from your forearm may differ significantly from fingertip samples D The conditions in which these differences are more likely to occur are when your blood glucose is changing rapidly such as following a meal an insulin dose or physical exercise When blood glucose is changing rapidly fingertip samples show these changes more quickly
37. st Strip package insert for typical accuracy and precision data and for important information on Limitations of Procedure To make an accurate comparison between meter and laboratory results follow these guidelines Before going to the lab Perform a control solution test to make sure the meter is working properly It is best to fast for at least eight hours before doing comparison tests Take your meter with you to the lab While at the lab Make sure that the meter test and the lab test are performed within 15 minutes of each other gt Wash your hands before obtaining a blood sample Use only fresh capillary blood obtained from the fingertip You may still have a variation from the laboratory result because blood glucose levels can change significantly over short periods especially if you have recently eaten exercised taken medication or experienced stress In addition if you have eaten recently the blood glucose level from a fingerstick can be up to 70 mg dL higher than blood drawn from a vein venous sample used for a lab test Therefore it is best to fast for eight hours before doing comparison tests Factors such as the percentage of red blood cells in the blood a high or low hematocrit or the loss of body fluid severe dehydration may also cause a meter result to be different from a laboratory result References 1 Surwit R S and Feinglos M N Diabetes Forecast 1988 April p 49 51
38. t blood control solution or liquids inside the meter through the test port or data port LifeScan recommends that you store the meter in its carrying case after each use A cloth dampened with water and mild detergent can be used to wipe down the outside of the meter Your OneTouch Ultra Meter is a precision instrument Please handle it with care Do Not use alcohol or any other solvent to clean your meter Lancing Device Clean the lancing device and Caps Lancing Device and Clear Cap with soap and water To disinfect the lancing device prepare a disinfectant solution of one part household bleach to 10 parts water Dampen a cloth with this solution and wipe the lancing device thoroughly Soak only the cap or caps for at least 30 minutes in the disinfectant solution Do Not soak the lancing device in liquid Rinse the lancing device and caps with water and dry thoroughly Test Strips and Control Solutions Expiration dates for test strips and control solutions are printed on their vial labels When you first open a new vial of test strips or control solution record the discard date on the label Refer to the test strip vial or control solution vial for instructions on determining the discard date Battery Your OneTouch Ultra Meter comes with a pre installed 3 0 V 2032 or equivalent lithium battery The battery will provide you with enough power to perform about 1 000 tests When replacing the battery use only a 3 0 V
39. tional information in the OneTouch Ultra Control Solution Package 13 Before you begin Use only OneTouch Ultra Control Solution Check the expiration date on the control solution vial Record the discard date date opened plus three months on the vial label Do Not use after expiration or discard date whichever comes first Control solution meter and test strips should be at room temperature 68 77 F 20 25 C before testing with control solution see Specifications section on page 62 for blood testing temperature ranges Shake the vial discard the first drop of control solution and wipe off the tip to ensure a good sample and an accurate result gt Store control solution tightly closed at temperatures below 86 F 30 C Do Not refrigerate A WARNING 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 14 STEP 1 Insert a test strip into the meter Insert a test strip contact bars end first and facing up into the test port Push it all the way in until it will go no further The meter will turn on and the display check will appear briefly A WARNING If mg dL does not appear with the amp symbol call LifeScan Customer Service at 1 800 227 8862 mg dL Then the code number will appear followed by the amp symbol and mg dL Be sure the meter and test strip codes match
40. u may now apply the blood sample ZA WARNING If mg dL does not appear with the symbol call LifeScan Customer Service at 1 800 227 8862 for assistance You may now apply the control solution None required 53 MESSAGE WHAT IT MEANS _ A blood glucose test 1 result in mg dL mala ll 30 1454 Example ketones A blood glucose test result with a suggestion to check your ketone levels Jt JIL I mg dL Wag 454 Example 54 ACTION None required A WARNING If mg dL does not appear with the test result call LifeScan Customer Service at 1 800 227 8862 for assistance Follow the instructions of your health care professional regarding ketone testing MESSAGE WHAT IT MEANS ketones You may have a very high blood glucose level exceeding 600 mg dL You may have a very low blood glucose level lower than 20 mg dL ACTION You should retest your glucose level and if H appears again call your health care professional immediately Treat this condition immediately 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 repeat the test A blood glucose test result stored in the memory None required 55 MESSAGE WHAT IT MEANS ACTION A control solution test None required result stored in the memory No result in memory such You can still perform
41. u to use this unit of measure Do Not test your blood glucose Call LifeScan Customer Service at 1 800 227 8862 immediately for assistance Always confirm that the unit of measure is in mg dL every time you test your blood glucose level Use of the wrong unit of measure may cause you to misinterpret your blood glucose level and may lead to incorrect treatment Dear OneTouch Ultra System Owner D iv You have chosen one of the best blood glucose monitoring systems available This booklet has important information you must know about the OneTouch Ultra System Please read it carefully Blood glucose monitoring plays an important role in diabetes control A long term study showed that keeping blood glucose levels close to normal can reduce the risk of diabetes complications by up to 60 The results you get with the OneTouch Ultra System can help you and your health care professional monitor and adjust your treatment plan to gain better control of your diabetes A warranty registration card is included with your system Please complete and return promptly to receive a gift You may also complete product registration online at www OneTouchDiabetes com American Diabetes Association position statement on the Diabetes Control and Complications Trial 1993 Table of Contents SS ea SS About Your New System vi The Complete OneTouch Ultra Blood Glucose Monitoring System 4 OneTouch Ultra Blood Glucose Mete
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