Lifescan Ultra User's Manual
Contents
1. 5 OneTouch Ultra Blood Glucose Monitoring 4 OneTouch Ultra Control Solution la a san kl sa kew ke da 13 OneTouch Ultra Test o otio eee 8 OneTouch Ultra Test Strips Code 10 OneTouch Ultra Test Strips Expiration 9 OneTouch UltraSoft Adjustable Blood Sampler Cleaning 46 OneTouch UltraSoft Adjustable Blood Sampler Preparing 21 OneTouch UltraSoft Adjustable Blood Sampler Using 22 Plasma O aia NI AN E iud ua Roe E eC RT LE TUE ER i Problems SOWING an OC M E ACRI RU eet op UR e PR Rd Reduce Chance of Infection Repeated Unexpected Results Set the Unit of Measure to mg dL oo cece ete teens 44 Step by Step Test Procedur 545 c wi cete eee oe Che ere eh 28 Temperature Range Blood Testing 14 60 Temperature Range Control Solution Testing 14 Test Pott lt sa sira k eta nag heed n l nn te 5 Test Procedure Step by Step S ac sna de crs ean tre re ehe seas 28 Test Strip Information Important aaneen erennere rere 9 Test Strips OneTouch Ultra 3454 43 ete e OR Ca t e ot iei 8 Time sie ne ley kn yk en mend OR ERR EE RR En ES Rec 41 Unexpected RESUS2. plies contact your healthcare professional or LifeScan Customer Service at 1 800 227 8862 Failure to test could delay treatment decisions and lead to a serious medical condition iy 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 diag nosis of diabetes or for testing newborns IN Before using any product to Cu your blood glucose read all instructions and practice the test Do all quality control checks as directed and consult with a diabetes healthcare 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 P Dehydration Severe dehydration resulting from excessive water loss may cause false low results If you believe you are suffering from severe dehydration consult a healthcare professional immediately P 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 treat ment according to your healthcare professional s recommendations Although this result could be due to a test error it is safer to treat fi
3. about 50 tests The test results will be accurate but it is time to change the battery 47 48 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 S To replace the battery make sure that the meter is turned off Turn the meter over and locate the battery compartment STEP 1 N Open the Battery Compartment Push up on the tab and pull the battery 8 compartment cover toward you P STEP 2 Remove the Old Battery Pull upward on the clear plastic tab Insert one 3 0 V 2032 or equivalent lithium bat tery 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 and buttons to reset the meter before testing See Meter Set up pages 40 45 Also be sure to confirm the unit of measure is mg dL 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 ba
4. applied the blood incorrectly review pages 29 30 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 Y MESSAGE WHAT IT MEANS Error 4 continued 4 There may be a problem with the meter ACTION 4 If the error message appears again call LifeScan Customer Service at 1 800 227 8862 Error message that indicates that the meter has detected a problem with the test strip Possible causes are test strip damage or an incompletely Repeat the test with a new test strip Refer to pages 29 30 for infor mation on sample appli cation filled confirmation window The E symbol appears on the display with the unit of measure The power is getting low It is time to change your battery hil mg dL The 2 symbol appears on the display by itself The power is too low to perform a test Test results will still be accurate but replace the battery as soon as possible Replace the battery at once The meter will not operate 57 58 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 6 440 The meter has detected that the temperature is abo
5. 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 9 button mem and the 14 day average will appear with the number of blood glucose tests performed in fy DAY pua 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 mem glucose results obtained during the last 14 and 1 1 30 calendar days A H result will be included in ced your averages as 600 mg dL and a L result as 20 mg dL Results marked as control solution tests um will not be included in your averages If your mg dL 14 day and 30 day test result averages are not DAY what you expect you should not rely on them 30 ava 38 34 STEP 2 Recall Test Results The most recent test result with date and time will appear Press and release the 9 button and the next most recent test result will appear The meter will recall up to your l
6. of the Li r E display will appear briefly This tells you that h d nl sel hele WEZ mmol L mg dL the system is performing several self checks to 1 90 BAY JOO am confirm that the meter is working properly To check that all display segments are working with the meter off press the Q9 button and immediately hold the 9 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 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 1 Enter the Code Mode Insert a test strip to turn on the meter Push it all f 9z ura 0 30 ther Avoid Example bending the test strip The display check will Note Date and time appear Then the code number is displayed for flash briefl three seconds y The first time you use the meter three pens dashes will flash meaning that there is no code stored in the memory Follow Step 3 to Code code the meter If three dashes appear any other time see page 50 of Display Messages
7. strips manufactured by anyone other than LifeScan has not been evaluated by LifeScan LifeScan Inc 2005 Milpitas CA 95035 02 2006 MINIME lt LirESCAN AW 06405104B
8. Follow the instructions of your healthcare professional regarding ketone testing MESSAGE ketones LLI 10 30 mg dL 45 DI IL 15m 0 30 WHAT IT MEANS 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 A blood glucose test result stored in the memory ACTION You should retest your glucose level and if H appears again call your healthcare professional immediately Treat this condition immediately accord ing 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 None required 53 MESSAGE WHAT IT MEANS ACTION A control solution test None required result stored in the memory There is no test result None required stored in this place in the memory Average of results from the If your 14 day and 30 day last 14 days r means test result averages are that 64 tests were per not what you expect you formed within the period should not rely on them Eug The 30 day average appears with a 20 before the amp amp on the screen 54 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 o
9. Lancets Display Messages Problem Solving Guide 50 Fingertip Blood Sampling sese 24 Forearm Blood Sampling eher eem eee le k l 25 GUATA E cor eer eurer ES OVE FO eae PP UC OPENS High Glucose Hyperglycemia Hypoglycemia Important Information about Forearm Testing 27 Use stesse do oro E HI UPC CU ES MD Ue reto PT HERUM 2 CoU i H 33 52 Laboratory Results Comparing Meter Results with 38 C ha RS GREE rr rv 21 22 Yancet Disposal b ania a n states 31 M seio disoe n yo hena mae Sg Rs b ARR RT Ob rie n G y d TRI aa ess 5 Memory USING capa EA Messages Special Ro DLE ER 32 Meter Display ios eese Cete E Y Gad CERRO eo AU 6 7 Meter Display Checking kello ere en 10 Meter Maint fianCe ean sm oleo tier n KR ORG Wen n aka 46 Meter si cs ke ditta kana ken WW de a Wana Q w D Meter SPUD VR ee 40 Meter Specifications or repre ka did di 60 AEE T EEE DD gc ii 7 28 44 51 52 OneTouch Diabetes Management Software 36 OneTouch Interface Cable 26 OneTouch Ultra Blood Glucose
10. 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 etl 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 17 18 STEP 4 Compare control solution result to the range printed on the TEST STRIP VIAL CAUTION The control solution range printed on the test strip vial is for OneTouch Ultra Control CONTROL Solution only It is not a RANGE recommended range for your blood glucose level If the results are not within the control range printed on the test strip vial the meter and 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 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 Expired or contaminated control gt Improper meter coding solution Test strip deterioration The meter test strips or control Meter malfunction solution are too warm or too cold CAUTION If you continue to get control solution test results that fall outside of the
11. ONE TOUCH EN Ik j a Blood Glucose u i UN Monitoring System Owner s Booklet ONE TOUCH anges everything 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 LI TLI LI mmol L mg dL display check 18 00 Ave dE 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 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 meas ure mmol L will appear on the display The test result will include a decimal poi
12. Push forward on the ejection cocking control and eject the lancet directly into a con tainer for sharp objects Return the ejection cocking control to the middle position Replace the OneTouch UltraSoft Cap 32 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 TT TT your healthcare professional s recommen ID 30 gam dations Although this message could be due to a test error it is safer to treat first and then repeat the test If your blood glucose test result is above 600 mg dL will appear ketones 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 healthcare professional immediately When your blood glucose test result is above 240 mg dL or reads H ketones 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 healthcare professional about when and how to test for ketones u 33 Using the Meter Memory Your OneTouch Ultra Meter stores the 150 most recent blood glucose and
13. R ed Tietz Textbook of Clinical Chemistry Philadelphia W B Saunders Company 1994 p 959 39 40 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 page e Press and continue to hold the button until ONLY the time appears on the bottom M right of the display e Release the button Meter on Note You must move through all the settings to save changes ONETOUCH Ultra MA N14 Ig p M Flashing indicates setting can be changed 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 button to change the hour If you go past the desired hour press and release the amp button until you scroll through to the desired hour To scroll faster hold the amp button down Press and release the button to move to the next step STEP 3 Set the minutes Press and release the J button to change to the desired minutes Press and release the button to move to the next step 41 STEP 4 Set the AM PM or 24 hour time format ONETOUCH Ultra ONETOUCH
14. Ultra or Press and release the button to choose between AM PM and 24 hour formats Press and release the button to move to the next step STEP 5 ONFTOLCH Set the year Press and release the button to change to the desired year Press and release the g button to move to the next step 42 STEP 6 OMe Set the month Press and release the button to change to the desired month Press and release the 9 button to move to the next step STEP 7 Set the day Press and release the button to change to the desired day ONETOUCH Ultra Press and release the button Continue to tbe next page 43 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 amp button until mg dL appears on the display Nia mg dL s Press and release the button to save C your entry save your changes and shut the meter off 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 44 45 46 Caring for Your OneTouch Ultra System Meter Your OneTouch Ultra Meter does not require special maintenance or cleaning Take care to avoid getting dirt dust blood control solut
15. 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 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 number continue to press the 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 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 WARNING If mg dL does not appear with the amp symbol call LifeScan Customer Serv
16. ast 150 test results in order 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 button Marked control solution tests will appear as ctl STEP 3 E Exit the Memory Mode Press the button to turn off the meter 35 36 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 turned off to the meter data port ES Note While in the communication mode you will be unable to perform a blood glucose test If the meter is in either memory or set
17. d is placed to the narrow channel in the top edge of the test strip Defective test strip Sample applied after auto matic 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 59 60 Specifications Result Range 20 to 600 mg dL Calibration Plasma equivalent Sample Fresh capillary whole blood Sample Size Minimum 1 microliter Test Time 5 seconds Assay Method Glucose oxidase biosensor Power Source One replaceable 3 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 The OneTouch Ultra system complies with the following standard UL Und
18. d 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 Apply Sample Obtain a round drop of blood using the Sampler The blood sample must be at least 1 pL in volume amp actual size to fill the confirmation window When the symbol appears on the display touch and hold the drop of blood to the narrow channel in the top edge of the test strip Do Not apply sample to the front or back of the test strip Do Not push your finger against the test strip Do Not apply a smeared sample 29 Hold the blood drop to the top edge of the test strip until the confirmation window is full before the meter begins to count down If the confirmation window does not fill completely before the meter begins to count down Do Not add more blood to the test strip discard the test strip and retest If you have trouble filling the test strip call LifeScan Customer Service at 1 800 227 8862 for assistance If the confirmation window is not full you may get an E 5 message see page 57 or an inaccurate test result Good Sample Sample Too Small Note If you do not apply a blood sample within two minutes after the amp 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 3 Accurate Results i
19. eTouch Gold program to provide members with a monthly e Newsletter as well as tools information and special offers to help make living with diabetes easier Membership is free For more information visit www LifeScan com We have included a warranty registration card with your system Please complete and return it promptly to receive a gift You may also complete product registration online at www OneTouchWarranty com We care about what you think and want to keep you informed about the latest on better living for people with diabetes If you have any questions about your new OneTouch Ultra System please call LifeScan Customer Service at 1 800 227 8862 or visit our website at www LifeScan com American Diabetes Association position statement on the Diabetes Control and Complications Trial 1993 Table of Contents a ee About Your New System vi The Complete OneTouch Ultra Blood Glucose Monitoring System 4 OneTouch Ultra Blood Glucose Meter 5 OneTouch Ultra Meter Display 6 OneTouch Ultra Test Strips 8 ZHN Before Testing 10 Checking the Meter Display 10 Coding the Meter 10 Checking the System with Control Solution 13 Testing Your Blood 20 Preparing the OneTouch UltraSoft Adjustable Blood Sampler 21 Fingertip Blood Sampling 24 Forearm Blood Sampling 25 Step by Step Test Procedure 28 Discarding Used Test Strips and Lancets 31 Special Messages 32 N Using the Meter Memory Downloading T
20. en a test MEM Indicates a test result is above 240 result stored in mg dL to suggest ketone memory testing code ctl ketones mem AWE TEST RESULT AREA Test results are displayed here eS Taxa m Ve mg dL This is the unit of L mg dL measure Be sure this appears with the amp IB BH ave DEH PM DISQUE sample to the test strip WARNING If mg dL does not appear with MONTH DAY the amp symbol call LifeScan Customer AM PM SYMBOL 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 strip 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 contamina tion Do Not transfer test strips to any other place D Af
21. erwriters Laboratories Standard UL 60601 1 gt Internally powered equipment Battery operated with one replaceable 3 0 V lithium battery gt This unit is not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Continuous mode of operation gt Type BF applied part degree of protection against elec trical shock This is a level of electrical safety protection for the user suitable for this medical device 61 62 Averages 14 and 320 34 45 54 ener snaked Dur 47 57 60 61 Blood Sampling Fingertip 5 2 cece eee Blood Sampling FOreatmn xiya erit erts inion dekan Vete l kal GL BUIOD B N canst DD O DD rg dg Checking the Meter Display Checking the System with Control Solution Coding tlie Meler sirs i kusa Control Solution Before you begin Control Solution Checking the System With 13 Control Solution OneTouch Ultra ccc cece eee eee Control Solution Out of range results Data Downloading i yak sy xele sa e xalk qal Xx ope Data Port ELT Dale Changing a lt siyana Dehydration A i y k neya va Kaewan bee yan Pre a a Discarding Used Test Strips and
22. est Results to a v o a 5 E E g 3 3 E El Comparing Meter and Laboratory Results Y o Meter Set up Caring for Your OneTouch Ultra System 46 Meter 46 OneTouch UltraSoft Adjustable Blood Sampler 46 Battery 47 ur ZA Display Messages and Problem Solving Guide 50 2 Specifications 2 Guarantee h Index About Your New System 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 consists of the OneTouch Ultra Blood Glucose Meter OneTouch Ultra Test Strips may be sold separately and OneTouch Ultra Control Solution These products have been designed tested and proven to work together to produce accurate blood glucose results Use no other test strips or control solution other than OneTouch Ultra brand with your meter CAUTION If you cannot test due to a problem with your testing sup
23. ia insulin reactions such as when driving a car particularly if you suffer from hypoglycemic unawareness lack of symptoms to indicate an insulin reac tion as forearm testing may fail to detect hypoglycemia What you should do D Use forearm or fingertip samples for testing prior to or more than two hours after meals insulin doses or physical exercise P Routine testing before meals can be done either at the fingertip or the forearm P Consult your healthcare professional before you begin using the forearm for testing 27 28 Step by Step Test Procedure 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 symbol 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 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 Insert This End 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 CAUTION Matching the code on the meter an
24. ice at 1 800 227 8862 ONETOUCH Ultra code 12 Checking the System with Control Solution Why you should do a control solution test gt 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 gt To practice the test process instead of using blood 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 gt If you have had repeated unexpected blood glucose test results as described on page 3 gt After dropping the meter Note Refer to additional 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 20 25 before testing with control solution see Specifications section on page 60 for blood testing temperature ranges Shake the vial discard the first drop of control solution a
25. ion 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 OneTouch UltraSoft Adjustable Blood Sampler Clean the Sampler and Caps OneTouch UltraSoft and OneTouch UltraClear with soap and water To disinfect the Sampler prepare a dis infectant solution of one part household bleach to 10 parts water Dampen a cloth with this solution and wipe the Sampler thoroughly Soak only the cap or caps for at least 30 minutes in the disinfectant solution Do Not soak the Sampler in liquid Rinse the Sampler and caps with water and dry thoroughly 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 2032 or equivalent lithium battery The meter will alert you when the power is getting low by displaying two different messages The symbol appears on the display with mg dL when the meter is turned on and all other display messages are func tional From the time the symbol first appears there is enough power left for
26. ion Quick Reference Guide OneTouch Ultra Test Strips may be sold separately OneTouch UltraSoft Adjustable Blood Sampler Carrying Case Optional OneTouch Warranty Registration Card UltraClear Cap Logbook 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 111 M BUTTON Used to enter into set up mode memory mode C BUTTON Used to change time date and code number mark control solution tests review test results in DATA PORT Emo Used to download your test results to a computer OneTouch Ultra Meter Display A CTL Indicates a control solution test result CODE Appears with the code number of the test strips Check your code every time you test BLOOD DROP SYMBOL Tells you when to apply the sample BATTERY SYMBOL Warns when the battery is low or must be replaced DAY 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 Do Not change this setting this is the correct unit of measure for the United States KETONES Appears wh
27. lt i 45 4543145323 eet esee ees Dy 22 Unit of Measure mg L ii 7 28 44 51 52 63 Glucose Ranges Times of Day for People Without Diabetes mg dL Your Target Ranges mg dL Before breakfast or dinner 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 24 hours a day 7 days a week English 1 800 227 8862 Espafiol 1 800 381 7226 Healthcare Professional Pharmacist Diabetes Educator Other ONE TOUCH changes everything LifeScan Customer Service toll free numbers 24 hours a day 7 days a week U S A English 1 800 227 8862 Espanol 1 800 381 7226 Visit us online at English www LifeScan com Espa ol www onetouchenespanol com The system described herein is covered by one or more of the following 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
28. n Just 5 Seconds Your blood glucose test result will appear after the meter counts down from 5 to 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 Example sealed container Plasma Calibrated Result WARNING If mg dL does not appear with the test result call LifeScan Customer Service at 1 800 227 8862 CAUTION If you tested at the low end of the operating range 43 6 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 local regulations for proper disposal 31 STEP 1 Remove the OneTouch UltraSoft Cap from the Sampler Twist the OneTouch UltraSoft Cap counter clockwise Optional Replace the protective disk on the used lancet by placing it on a hard sur face and pushing the lancet tip into the disk STEP 2 Eject the Lancet Point the Sampler down and away Push the release button to ensure that the Sampler is not cocked
29. nd 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 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 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 If they do not code the meter correctly See pages 10 12 15 STEP 2 Mark this test as a control solution test This marks the test as a control solution test ctl mg dL Press and release the 9 button so ctl 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 16 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
30. ng 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 p STEP 2 Cock the Sampler Slide the ejection cocking control back until it clicks If it does not click the Sampler may have been cocked when the lancet was inserted The Sampler is now ready for use STEP 3 Wash Your Hands and the Puncture Site To reduce the chance of infection use warm soapy water Rinse and dry lw thoroughly 23 24 Fingertip Blood Sampling The OneTouch Ultra System requires a very small blood drop to per form 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 site each time you test Repeated punctures in the same spot may cause soreness and calluses STEP 1 Position the Sampler Hold the Sampler firmly against the side of your finger Press the release button Note Do Not use OneTouch UltraClear Cap on your finger STEP 2 Massage the Fingertip Massaging the fingertip gently will help you obtain a round drop of blood Do Not squeeze excessively on the puncture site The blood sample must be at least one microliter 1 pL in volume 6 actual size or you may get an E 5 message see page 57 or an inac curate test result Do Not smear the blood sam ple Proceed with your blo
31. nt Fig 2 Unless your doctor has told you 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 iii Dear OneTouch Ultra System Owner 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 healthcare professional monitor and adjust your treat ment plan to gain better control of your diabetes As the maker of OneTouch brand blood glucose monitoring systems LifeScan is dedi cated to your health and satisfaction You can count on 24 hour customer service by highly trained professionals who are ready to answer your questions about meter operation self monitoring and diabetes in general LifeScan com offering online access to information about our products and services as well as diabetes care Our On
32. od glucose test 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 4 STEP1 Install the OneTouch UltraClear Cap To aid in obtaining a blood sample from the forearm replace the OneTouch UltraSoft Cap on the Sampler with the OneTouch UltraClear Cap If necessary set the Sampler 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 veins and hair 25 26 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 Sampler Press and hold the Sampler against the fore arm for a few seconds Press the release button STEP 5 Allow Blood Drop to Form Continue holding the Sampler against the skin for a few seconds until the blood drop forms Allow enough blood to form under the OneTouch UltraClea
33. or important information on Limitations of Procedure To make an accurate comparison between meter and laboratory results follow these guidelines Before going to the lab gt 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 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 per centage 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 2 Sacks D B Carbohydrates Burtis C A and Ashwood E
34. r Cap until you have a blood sample amp actual size that is sufficient to fill the confirmation window of the test strip If you must massage the area to obtain more 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 D When blood glucose is changing rapidly fingertip samples show these changes more quickly than forearm samples D 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 P 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 exer cise 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 hypo glycem
35. r 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 30 for information on sample application 55 56 MESSAGE WHAT IT MEANS Error message that indicates one of the following condi tions may be present 1 You may have high glu cose and have tested in an environment near the low end of the system s oper ating temperature range 43 111 F 644 C N There may be a problem with the test strip For example it may have been damaged or moved during testing 3 The sample was improperly applied ACTION 1 If you tested in a cool environment repeat the test in a warmer environ ment with a new test strip If the error mes sage appears again call LifeScan Customer Service at 1 800 227 8862 If you were testing in a normal or warm environ ment 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
36. 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 di Read this section and the test strip package insert carefully N before testing Make sure you have all items needed to test OneTouch Ultra Meter OneTouch Ultra Test Strips Lancing Device gt Sterile Lancets with protective disks Preparing the OneTouch UltraSoft Adjustable Blood Sampler Sampler Depth Adjustment Knob Puncture Settings da OneTouch r Ejection Cocking Control UltraClear Cap Release Button Lancet with For Forearm Protective Disk Sampling Depth Indicator Protective Disk k OneTouch UltraSoft Cap CAUTION To reduce the chance of infection P Never share a lancet or the Sampler with anyone D Always use a new sterile lancet Lancets are for single use only P Keep the OneTouch Ultra Meter and Sampler clean P Make sure to wash the puncture site with soap and water before testing STEP 1 Insert a Lancet Turn the OneTouch UltraSoft Cap counter clockwise to remove it Insert the lancet into the lancet holder and push down firmly until it is fully seated Do Not twist the lancet Twist the protec tive disk until it separates from the lancet Replace the OneTouch UltraSoft Cap Turn it clockwise until it is snug Adjust the puncture depth setti
37. rst and then repeat the test 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 healthcare 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 P 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 If you are experiencing symptoms that are not consistent with your blood glu cose results and you have followed all instructions in this booklet call your healthcare professional Never ignore symptoms or make significant changes to your diabetes control program without speaking to your healthcare profes sional D Hematocrit A hematocrit percentage of your blood that is red blood cells that is either very high above 55 or very low below 30 can cause false results WARNING Keep the meter and testing supplies away from small children The battery door test strips lancets protective disks and control solution cap are choking hazards The Complete OneTouch Ultra Blood Glucose Monitoring System _ Cea T ber Lili ra sape gn OneTouch Ultra Meter OneTouch UltraSoft Sterile Lancets Owner s Booklet OneTouch Ultra Control Solut
38. tation of test results 1 See Coding the Meter pages 10 12 2 Do Not rely on the 14 and 30 day averages It is important to call LifeScan Customer Service at 1 800 227 8862 MESSAGE WHAT IT MEANS ACTION This is the code number Make sure that this code num stored in the meter ber matches the code number on the vial of the test strips you are using CAUTION Matching the code 0 30 is 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 The system is ready You may now apply the to accept a blood sample blood sample WARNING If mg dL does not appear with the male symbol call LifeScan Customer Service at 1 800 227 8862 for assistance etl The system is ready to You may now apply the accept a control solution control solution _ test sample mg dL Five second countdown None required The meter is calculating the result After the countdown the meter will display the test result 51 WHAT IT MEANS MESSAGE A blood glucose test result in mg dL ILI mg dL 10 30 15 Example A blood glucose test result with a suggestion to check your ketone levels ketones J71 JIL 1 mg dL H Example 10 30 ACTION None required WARNING If mg dL does not appear with the test result call LifeScan Customer Service at 1 800 227 8862 for assistance
39. ter removing a test strip from the vial replace the vial cap immediately and close it tightly P Use each test strip immediately after removing it from the vial P Do Not use test strips from any vial that is damaged or left open to air P Write the discard date 3 months after first opening the vial on the vial label when you first open it Discard remaining OneTouch Ultra Test Strips after the discard date P 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 P Do Not bend cut or alter a OneTouch Ultra Test Strip in any way P 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 P Apply only OneTouch Ultra Control Solution or blood sample to the test strip D Refer to additional information in the OneTouch Ultra Test Strip package 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 ct Ket n mem Each time you turn on the OneTouch Ultra LI n Meter either by inserting a test strip or pressing the button all segments
40. ting mode it will not respond to computer commands STEP 3 Transfer Data Follow the instructions in the OneTouch Diabetes Management Software User s Manual to initiate the data transfer command FPE will appear on the meter display when the first com mand is received indicating that the meter is in the communi cation mode If the command is not received within two minutes the meter will turn itself off Pressing the button will also turn the meter off 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 LifeScan com 37 38 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 Test Strip package insert for typical accuracy and precision data and f
41. ttery 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 49 50 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 pro ducing 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 24 hours a day seven days a week Call LifeScan Customer Service at 1 800 227 8862 MESSAGE WHAT IT MEANS Display check Appears when ever the meter is turned on To verify that all segments are present on the display with the meter off press the button and immediately hold the amp button down Compare the meter display with page 10 code ctl ketones mem DI lI OOL mmol L mg dl 18 88 ave COBB pm 1 This message appears immediately after the display check if your meter has not been coded 2 If this message appears at any time after the first time the meter was coded the code number has been lost The test results stored in the meter memory may be out of order ACTION If segments are missing call LifeScan Customer Service at 1 800 227 8862 for further action Missing seg ments can lead to misinter pre
42. ve 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 6 440 ACTION You must reset the time time format and date See Meter Set up pages 40 45 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 experi enced 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 oper ating range Repeat the test after the meter and test strips have reached a temperature within the oper ating range If the meter does not display a message after inserting a test strip 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 incor rectly 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 bloo
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