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OneTouch UltraSmart ® Blood Glucose Monitoring System Owner`s

1. 114 Glucose Range Info If you entered your before and after meal glucose ranges in the Set up mode you may review the percentage of your test results that are above below and within your target ranges The number of tests that make up each percentage is shown on the left in parentheses Otherwise before meal ranges are factory set at 90 130 mg dL After meal target ranges must be set by the user see pages 75 76 QD Glucose Range Info pev Before Meal lune Dinner After Meal Night Total D Bef Brkft Glucose BefBrkft Glucose Range 90 130 Range 90 130 7 6 Above 20 30 Days 60 90 3 Below 10 5 In Range 70 115 INSULIN INTAKE Choose Insulin Intake from the FastFacts Menu Insulin Intake NPH Syringe Totals The individual insulins in this example Regular and NPH are based on insulins selected in the Set up mode see pages 70 71 Use the Arrow button to move to your selection and press the OK Pump button Ql Insulin Intake Regular Choose the number of days you would like to review in your average by using the Arrow button to scroll through choices Press the OK button to proceed Regular Insulin 14 Day Avg 14 Priania 80a Oam 11 00am Lunch 10 5 11 00am 5 00pm In this example the average intake of Regular insulin o
2. MRNA i ce InsulinA and or insulin pump information it will Insulin appear on the display as in this example Pump Bolus Pump Daily Total VW 95 Diabetes Pills R Sep 8 02 9 20 pm Meds Entry To enter your diabetes pills select the Boned pill you have taken and press the OK button InsulinB Pump Bolus Pump Daily Total W Sep 8 02 9 20 pm Meds Entry Enter the number of pills you have taken in 0 5 or one half pill steps and press the OK button When entering data the value will start at the value you last saved Pill A Sep 8 02 9 20 pm Meds Entry Pill B A InsulinA InsulinB Pump Bolus Pump Daily Total Exit Meds Entry After your medication logbook entry select Exit Meds Entry and press the OK button or select another item from the menu O Logbook Sep 8 02 9 20 pm The logbook entry will be saved this way in your electronic logbook 96 Insulin Dosages Sep 8 02 9 20 pm Meds Entry Enter an insulin dosage by highlighting an insulin type and press the OK button Insulin InsulinB Pump Bolus Pump Daily Total Y Then record the units of insulin The ii Sek Eu i meter was set at the factory to record units in o 1 increments When entering data the value will start at the value you last saved 10 0 InsulinA If you wish to record a second insulin choose from the list and then enter the number o
3. Personal Personal Personal Set up Menu Settings Diabetes Pill Set up Insulin Set up Insulin Pump Advanced Features Exit Set up Advanced Features Schedule 14 Glucose Range 30 Before Meal 60 After Meal 90 Hypo Level 70 Advanced Features Before Meal 90 130 After Meal Hypo Level 70 Pre set Schedule 6 00 a 9 00 a 9 00 a 11 00 a 11 00 a 2 00 p 2 00 p 5 00 p 5 00 p 8 00 p Aft Dinner 8 00 p 11 00 p Night 11 00 p 6 00 a E Schedule Bef Brkft 9 00 a Aft Brkft E Bef Lunch Aft Lunch Bef Dinner Aft Dinner Night 11 00 p 6 00a Next the meter will prompt you to select time periods for your usual meal schedule When you set this feature all of your test results will be tagged with the mealtime To view a pre set meal schedule select Pre set and press the OK button The pre set schedule will appear on the display Both Before and After Mealtimes are pre set Whenever you test these mealtimes will be recorded in the electronic logbook whether or not you are eating on schedule To use the pre set schedule press the OK button To personalize your schedule press the Back button choose Personal and press the OK button To change all or some of the personal meal schedule e Scroll through each mealtime Select the correct hours and minutes in 15 minute steps e Press the OK button e f you make a mistake press the Back button
4. 68 A pop up menu of pill choices will appear on the display Use Pills A E to label up to five pills For example if you take glipizide pills you could label them as Pill A You can enter the actual pill names using OneTouch Diabetes Management Software Using the Arrow button Bj scroll down to your choice and press the OK button Q9 Diabetes Pill Set up Select Pills Pill 2 will be highlighted automatically Diabetes Pill Set up To enter a second type of diabetes pill Select hil choose Pill B E to describe the second pill and press the OK button Q9 Repeat these steps to enter other pill types Diabetes Pill Set up If you have completed your diabetes pill choices select Save and press the OK Pill 1 Pill A button If necessary press the Back Pill2 Pill B button to re enter pill types 69 Insulin Set up You can record your daily insulin usage by type of insulin and number of units for up to three different insulin types Insulin types may be chosen from a menu of ten choices Eleven other insulin types up to eight characters in length may be entered using a personal computer loaded with OneTouch Diabetes Management Software If you do not customize your insulin names the factory settings of InsulinA and InsulinB will appear on your medication entry display Set up Menu Settings Diabetes Pill Set up Insulin Pump Advanced Features Exit Set up Choose Insulin Set up on th
5. Settings Diabetes Pill Set up Insulin Set up Insulin Pump Advanced Features Next the meter will prompt you to set a before meal blood glucose range The meter is pre set to 90 130 mg dL To use this range press the OK button twice You may change this range to one recommended by your healthcare professional To change the lower and upper ends of the range in 1 mg dL steps scroll to the correct numbers and press the OK button If you have an after meal glucose range recommended by your healthcare professional and wish to enter it use the Arrow button to scroll to your target numbers and press the OK button The factory set hypoglycemia level is 70 mg dL If your healthcare professional has advised you to use a different level scroll to the correct number and press the OK button Q9 To exit Set up mode choose Exit Set up and press the OK button 76 YOUR ELECTRONIC LOGBOOK The OneTouch UltraSmart electronic logbook is the meter memory It stores over 3 000 records The SmartButtons allow you to enter information about your diabetes management plan including exercise health medication and food Comments Information that you store in your electronic logbook along with a test result is called a comment Following is a list of comments that you may store DEFINITION COMMENTS ON GLUCOSE RESULTS Exercise Before During After Health Stress Feel Hypo Illness Menses Vacation Other Medic
6. You may choose one of up to six other languages in Set up mode Spanish Espa ol Italian Italiano French Francais Portuguese Portugu s German Deutsch Dutch Nederlands Configurar en To change the language use the Arrow English button to scroll to the language pem With your language choice highlighted Deutsch press the OK button pli Nederlands 59 Setting Date and Time After the language has been set the meter will display the factory set time and date If the date and or time are incorrect follow these steps in Set up mode see page 58 Entering Basic Set up Mode You can ONLY change am and pm when you pass 12 00 If you use the 12 hour format make sure am or pm is correct when setting the hour Begin by setting the hour and am or pm if using 12 hour format Use the Arrow button B to scroll to the correct hour Basic Set up Check am pm if applicable If incorrect continue to press the Arrow button B until the hour and am or pm are correct Press the OK button Q9 to continue Sep 15 02 Basic Set up 12 0 am Date Sep 15 02 Use the Arrow button to scroll to the correct minutes and press the OK button If am or pm is not correct press the Back button to go back to the previous display and reset to the desired hour and am or pm setting 60 Basic Set up 12 00 a
7. sample to the test strip Refer to additional information in the OneTouch Ultra Test Strip package BEFORE TESTING Checking the Meter Display Each time you turn the meter on the display background will quickly change from dark to light and form the words OneTouch UltraSmart This tells you that the system is performing several self checks to confirm that the meter is working properly If at any time during the life of the meter these graphics appear to be different call LifeScan Customer Service at 1 800 227 8862 ONETOUCH UltraSmart Setting the Meter The OneTouch UltraSmart Meter is set at the factory to display results in the English language using milligrams per deciliter mg dL as the unit of measure The time and date are also factory set in Pacific Standard Time If you are using the meter for the first time and simply wish to test insert a test strip into the test port and begin by coding the meter If you wish to change the date time or language see Meter Set up pages 58 61 To customize your meter see Custom Meter Set up Sequence pages 62 76 Note It is important that the time of day is correct and that your medication set up and mealtimes are set according to your personal daily schedule Otherwise some FastFacts information will not be correct Coding the Meter Code numbers are used to calibrate the OneTouch UltraSmart Meter with the OneTouch Ultra Test Str
8. t t Exercise Entry Add New Entry for Sep 15 02 3 30 pm Exercise Entry Add New Entry for Sep 15 02 3 30 pm Other Time Select Entry Date Sep 02 1 4567 2 3 BH 1112 13 14 15 16 7 18 19 20 21 22 23 24 25 26 27 28 29 30 t Sep 8 02 What time 10 ET pm EXERCISE LOGBOOK ENTRIES With the meter turned off press the Exercise SmartButton These choices will appear on the display Select the current date and time to add an exercise logbook entry at this time Select Other Time if the logbook entry is for some time in the past and press the OK button Q 3 t Exercise Entry Add New Entry for Sep 15 02 3 30 pm Sep 15 02 3 30 pm Exercise Entry Duration Note Check that the date and time are correct for your entry You may rate the exercise you performed as mild moderate or hard Press the OK button Q Moderate Hard Sep 15 02 3 30 pm Exercise Entry Exercise Hard Duration 00 10 to the nearest five minutes Press the OK Then record the duration of the exercise button to save the logbook entry 86 The exercise logbook entry you recorded will be saved this way in your electronic logbook You may also scroll through the logbook to view previous entries Press the OK button while you are in the logbook to edit or delete the highlighted entry see pages 105 107 HEALTH LOGBOOK ENTRIES After selecting the date and time
9. we offer valuable diabetes related knowledge tools and special offers online www OneTouchDiabetes com www OneTouchEnEspanol com Should you need additional assistance 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 healthcare professional Distributed by LifeScan Inc Milpitas CA 95035 For LifeScan Europe Division of Cilag GmbH International 6300 Zug Switzerland 2006 LifeScan Inc Rev date 02 2011 AW 06078808B Meter Made in China ef LIFESCAN AIRE E igre smelt AW 06078808B
10. 6 44 0 Test not possible See Owner s Booklet PROBLEMS AND POSSIBLE CAUSES If the meter does not turn on after inserting a test strip or the display is not active POSSIBLE CAUSES No power No batteries or batteries incorrectly installed Test strip inserted incorrectly For example upside down backward or incompletely Defective meter or test strip WHAT TO DO Replace the batteries Check that the batteries are correctly installed Insert the test strip correctly with the contact bars end first and facing up Push it in until it will go no further Call LifeScan Customer Service at 1 800 227 8862 If the test does not start after applying the sample POSSIBLE CAUSES Insufficient blood sample Defective test strip Sample applied after automatic shutoff three minutes after inserting a test strip Defective meter WHAT TO DO 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 Repeat the test with a new test strip Repeat the test with a new test strip apply sample only after Apply Blood Alternate Site or Control Solution appears on the display Call LifeScan Customer Service at 1 800 227 8862 METER SET UP Note e t is important that the time of day is correct and that your medication set up and mealtimes are set according
11. AND LABORATORY RESULTS 40 CARING FOR YOUR SYSTEM eere 42 Maintenant Enseres auseire 42 Cleaning the OneTouch UltraSoft Adjustable Blood Sampler 42 iv Batteries ecce eee e OR XR ERE EE UEe x DISPLAY MESSAGES eee recente eter WARNINGS AND ERROR MESSAGES PROBLEMS AND POSSIBLE CAUSES METER SET UP scere ue ene ER ER RR HRS eee Entering Basic Set Up Mode Selecting Display Language Setting Date and Time eese CUSTOM METER SET UP SEQUENCE Set upMenli ries eerie issis iana Rass Sic Diabetes Pill Set up sess Inisulir Set p rcs Insulin Pump Set up eee Advanced Feature Set up esses YOUR ELECTRONIC LOGBOOK eere Comterits cocer erret rr E EEEE ss KESE EEA Rules for Adding Comments How to Add a Comment esses Logbook Entries eese Using the SmartButtons esses Rules for Logbook Entries Entering the Date and Time Exercise Logbook Entries Health Logbook Entries sss Table of Contents continued Ketone Snarare eae etre eee 89 nl n P 91
12. Microalbumin eese 91 Cliole tero zs isete a a aaa ete eie dee tas 92 Blood Pressure sees 92 3 12 c 1 E 93 FOOL EXaII kisendra rar ae srt Rcs 93 Weight Height eese 94 Doctor VISIL oce eorr 94 Medication Logbook Entries 95 Food Logbook Entries sss 101 Adding Changing or Deleting Logbook Information esses 103 OneTouch UltraSmart FastFacts FEATURE 108 FastFacts Meri itt retta 109 Logbook Memory eese 110 Glucose by Meals eese 110 Glucose Analysis eese 111 Interactive Graph of All Results 111 Graph by Time of Day 112 Average of All Results 113 Average by Time of Day 114 Average by Exercise esses 114 Glucose Range Info 115 Insulin Intake eese 116 vi Hypoglycemia Information Food AVELASeS ccesccessccssseesseessseesseessseesnes Health Checks eese Data Downloading eese SPECIFICATIONS ONETOUCH UltraSmart ONETOUC Ult Meter ond Electronic Logbooh in One Owner s Reference Booklet mee THE OneTouch UltraSmart SYSTEM The OneTouch UltraSmart System use
13. fingertip blood sample Alternate Site for forearm and palm blood samples e Control Solution for checking the system 15 Note You must select Control Solution to distinguish control solution tests from blood glucose tests Marked control solution tests will not be included in your averages Do Not use Control Solution mode for testing blood Gr EPS 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 Apply FOP EDGE Drop Her Touch and hold a drop of control solution where the narrow channel meets the TOP EDGE of the strip Note If you do not apply the control solution within three minutes the meter will turn itself off Remove the test strip and insert it back into the test port to restart the test procedure 16 CONFIRMATION WINDOW AG E WARNING If mg dL does not appear with the Control Solution result call LifeScan Customer Service at 1800 227 8862 P The control solution will be drawn into the narrow channel When the Example confirmation window is full the meter will count down from 5 to 1 The control solution test result will appear on the display r EPA Compare Control Solution Result to the Control Range Printed on the TEST STRIP VIAL CAUTION The control solution range printed on Ar mm the
14. or palm for a few seconds then press the release button Keep holding the Sampler and OneTouch UltraClear Cap against your skin until a round drop of blood forms under the cap Maintain pressure until the drop of blood is at least 1pL sample size 6r EP Remove the Sampler Carefully lift the sampler away from your skin Do Not smear the blood sample Note e You may need to wait a little longer to get a large enough drop of blood from the forearm or palm Do Not squeeze the site excessively e f the sample drop of blood runs or spreads due to contact with hair or with a line in your palm Do Not use that sample Try puncturing again in a smoother area Remember You may have to adjust the Sampler to a deeper setting to get a large enough drop of blood sample size Step by Step Test Procedure GTEPD insert Test Strip 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 automatically OneTouch UltraSmart will appear briefly on the display Then the code number will appear Be sure the meter and test strip codes match If they do not code the meter correctly see pages 10 12 for Coding the Meter 31 GPD Select Test Mode Note There are three choices in test mode For blood testing use the Arrow button 8 to select e Apply Blood for fingertip blood sample e Alter
15. test strip vial may contain drying agents that are harmful if swallowed and may cause skin or eye irritation See pages 19 39 Testing Your Blood for complete instructions 7 Important Test Strip Information e Store test strip vials in a cool dry place below 86 F 30 C Keep away from direct sunlight and heat Do Not refrigerate e Store test strips in their original vial only To avoid damage or contamination Do Not transfer test strips to any other place e After removing a test strip from the vial replace the vial cap immediately and close it tightly 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 e Write the discard date 6 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 Do Not use test strips beyond the expiration printed on the package or discard date whichever comes first because they may cause inaccurate results 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 OneTouch Ultra Test Strips in any Way 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 Apply only OneTouch Ultra Control Solution or a blood
16. the Advanced Medical Technology Association WARNING Keep the meter and testing supplies away from young children Small items such as the battery door battery test strips lancets protective disks on the lancets stereo jack cover and the control solution vial cap are choking hazards Important Information Dehydration Severe dehydration and excessive water loss may cause false low results If you believe you are suffering from dehydration consult a healthcare professional immediately Low glucose results If your test result is lower than 7o mg dL or is shown as LOW GLUCOSE it may mean hypoglycemia low blood glucose This may require immediate treatment according to your healthcare professional s recommendations Although this result could be due to a test error it is safer to treat first and then repeat the test High glucose results If your test result is greater than 180 mg dL or is shown as HIGH GLUCOSE 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 Repeated unexpected results If you continue to get unexpected results check your system with control solution See Checking the System with Control Solution on page 12 If you are experiencing symptoms that are not consistent with your bl
17. to return to the top of the schedule and make corrections 74 Personal Schedule Bef Brkft 5 00a 8 00 a Aft Brkft 8 00 a 10 00 a Bef Lunch 10 00 a 12 00 p Aft Lunch 5 00 p Bef Dinner 5 00 p 8 00 p Aft Dinner 8 00 p 11 00 p Night 11 00 p 5 00 a You will only be able to set beginning or start times for each mealtime End times will change to match the start time of the next time period For example if your lunch is usually at 12 00 noon Bef Lunch could be 10 00am to 12 00pm Personal Schedule Bef Brkft 5 00 a 8 00 a Aft Brkft 8 00 a 10 00 a Bef Lunch 10 00 a 12 00 p Aft Lunch 12 00 p 5 00 p Bef Dinner 5 00 p 8 00 p Aft Dinner 8 00 p 11 00 p Night 5 00 a After changing the times press the OK button to save your personal schedule Note e t is important that the time of day is correct and that your medication set up and mealtimes are set according to your personal daily schedule Otherwise some FastFacts information will not be correct You have the option to modify the mealtime for any test if necessary Advanced Features Averages Schedule Glucose Range Before Meal After Meal Hypo Level Advanced Features 14 Day Pre set Averages Schedule Glucose Range Before Meal 90 130 After Meal B Hypo Level 70 Advanced Features 14 Day Pre set Averages Schedule Glucose Range Before Meal After Meal Hypo Level 90 130 Set up Menu
18. Button 4 5 77 82 83 86 gigi 108 122 FastFacts Feature eese 108 122 FastFacts Menu esee ee ee cere erre epe ees 108 109 FastFacts SmartButton ssu 4 5 82 108 Fingertip Testing Procedure suusesse 23 26 Food Averages cece ee eec cee eeseeeeeenaeees 109 121 Food Comments 1 enr et eee re erret pee 79 80 Food Logbook Entries ceeeeeeeeeeeeees 101 102 Food SmartButton 0 ce eee cence eee 4 5 77 82 83 is uo MP 21 22 27 30 33 Forearm or Palm Sampling Important Information esse eeeeeees 21 22 Format Date occ scc2 osc cs died re dr rt er 64 66 Format TIME see ires vaswevhe saad orenevnereeroseaetine 64 66 Glucose Analysis seeeessss 109 111 115 Glucose by Meals ccccceceeseeeeeeeees 109 110 Glucose Graph Interactive L sess 111 113 Glucose Range eene 73 76 115 Graph All Results csceceeeeceeeeceees 109 111 112 Graph Time of Day esesesseses 109 112 113 GuUaralilee co eroe pec a ERE ERES OPERE EREPER EETA 127 Health Checks cece sivas eere 87 94 109 121 Health Comments eese 80 81 Health Logbook Entries eueeseuueuees 87 94 Healtli Notes 5 rire ror EUER pe YE rv Eus 87 88 Health SmartButton usuuuu 4 5 77 82 83 130 HighiGlUCOS
19. EF Eject the Lancet Point the Sampler down and away Push the release button to ensure that the Sampler is not cocked Push forward on the ejection cocking control and eject the lancet directly into a container for sharp objects Used test strips can go into the same container Return the ejection cocking control to the middle position Replace the OneTouch UltraSoft Cap 37 A WARNING A LOW GLUCOSE Below 20 mg dL A WARNING A HIGH GLUCOSE Above 600 mg dL Special Messages The OneTouch UltraSmart Meter displays results between 20 mg dL and 600 mg dL If your test result is lower than 20 mg dL LOW GLUCOSE will appear on the meter display This may mean severe hypoglycemia low blood glucose that requires immediate treatment according to your healthcare professional s recommendations 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 HIGH GLUCOSE will appear on the meter display This may mean severe hyperglycemia high blood glucose You should recheck your blood glucose level If HIGH GLUCOSE again appears on the display call your healthcare professional immediately 38 Sep 14 02 8 30 am mg dL Comment Press OK A v Example When your blood glucose test result is outside the range of 90 130 mg dL or the personal glucose range you set in Custom
20. Exam and press the OK button Q9 Foot Exam To record a foot examination select Enter Foot Exam and press the OK button 93 Sep 15 02 3 30 pm Health Checks Enter Eye Exam Sep 15 02 3 30 pm Health Checks Enter Foot Exam Weight Height Sep 15 02 3 30 pm Health Checks Enter your weight in 0 5 pound steps and your height in o 5 inch steps When entering data the value will start at the value you last saved Weight 150 0 Height YAY Doctor Visit Sep 15 02 3 30 pm Health Checks To record the date of your last visit to the doctor select Enter Dr Visit 94 MEDICATION LOGBOOK ENTRIES Press the Medication SmartButton to access the menu You may track your diabetes pills insulin types and dosages and insulin pump information Select the current date and time or Other Time see page 85 Meds Entry Add New Entry for Sep 8 02 9 20 pm If you entered O pills O insulin and No for pump in the Set up mode this message will appear To select your medications return to Set up mode see Custom Meter Set up Sequence pages 62 76 Please use Set up mode to select pills insulin or pump functions Medication Menu a E Sep 8 02 9 20 pm The medication menu reflects your input i Meds Entry in the Set up mode see pages 68 72 A If you entered diabetes pills insulin Pill B
21. Meter Set up Sequence the meter will prompt you to add a comment When your blood glucose test result is in the range of 240 mg dL to 600 mg dL Check 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 Comment Press OK will also appear Sep 14 02 9 45 am Check Ketones Comment Press OK A Y Example Sep 14 02 9 30 am When your blood glucose result is from 20 mg dL through 59 mg dL Do you need a snack will appear on the display with the test result reminding you that a meal or snack may be necessary mg dL Do you need a snack Comment Press OK Av Example 39 COMPARING METER AND LABORATORY RESULTS OneTouch UltraSmart 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 UltraSmart 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 UltraSmart Meter However results can dif
22. ONE IOUCH UltraSrrart Meter and Electronic Logbook In One Owner s Booklet Dear OneTouch UltraSmart System Owner You have chosen one of the best blood glucose monitoring systems available This booklet has important information you must know about the OneTouch UltraSmart Blood Glucose Monitoring System 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 6096 The results you get with the OneTouch UltraSmart System can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes Your OneTouch UltraSmart System requires a small drop of blood at least 1uL microliter and five seconds to provide you with an accurate plasma calibrated test result The OneTouch UltraSmart Meter also has a memory that allows it to function as an electronic logbook Now you can store vital everyday information such as insulin and oral medication doses food intake amount of exercise illnesses and other pertinent data You can use your OneTouch UltraSmart System simply to test or to serve as a complete storehouse of information regarding your diabetes treatment plan A warranty registration card is included with your system If you complete it and mail it to us we will send you a gift If you
23. OneTouch UltraSoft Adjustable Blood Sampler e OneTouch UltraClear Cap for forearm and palm sampling e OneTouch UltraSoft Sterile Lancets CAUTION It is important to learn the correct blood application technique see pages 33 35 If you do not apply blood to the test strip correctly you may get an inaccurately low or high test result or an error message LifeScan recommends that you develop good technique by practicing with control solution prior to using the OneTouch UltraSmart Meter for the first time CAUTION If you cannot test due to a problem with your testing supplies 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 Preparing the OneTouch UltraSoft Adjustable Blood Sampler Sampler OneTouch UltraSoft Adjustable Blood Sampler Depth Adjustment Knob m Lancet with Ejection Cocking Control Protective Disk OneTouche UltraClear Cap for Alternate Site Sampling Release Button Puncture Settings Depth c fS Indicator Lancet Point gt Protective Disk OneTouch UltraSoft Cap CAUTION To reduce the chance of infection Never share a lancet or the Sampler with anyone e Always use a new sterile lancet Lancets are for single use only e Keep the OneTouch UltraSmart Meter and Sampler clean e Make
24. RI ness Menses Vacation w Exer Save Once you select your mealtime Health is automatically highlighted If you are through commenting scroll to Save and press the OK button If you do not press the OK button your entries will not be saved HEALTH COMMENTS You can comment on the result with notes about your overall health at the time of the test Press the OK button with Health highlighted You may add up to six comments from this menu Stress Menses Feel Hypo Vacation Illness Other After adding your first health comment Health 2 will automatically appear on the display To add additional health comments press the OK button Q and select the comment from the menu Note that your previous comment is no longer available 80 Sep 8 02 10 30 am Gluc 135 Comment Food Bef Lunch Health 1 Stress When you have completed making comments scroll to Save and press the OK button If you do not press a coin the OK button your entries will not Exer e be saved EXERCISE COMMENTS Sep 8 02 10 30 am Gluc 135 Comment Food Bef Lunch Health 1 Health 2 Before Save occurring before during or after You can comment on a test result as exercise Sep 8 02 10 30 am Gluc 135 Comment Food Bef Lunch Health 1 Stress Health 2 Exer After you add the exercise comment Save will automatically be highlighted I
25. Schedule ore rore er conanti 72 75 Medication Logbook Entries 83 95 100 Medication Menu seeccecnecceeenceceeseeeees 95 Medication SmartButton 4 5 77 82 83 MEMON sirop key Re AR EY ERE TSRRROSR EDANA NS 77 107 Message Check Ketones cceeeeeeeeeeeeees 39 50 Message Snack esee 39 50 Messages Display esee 46 50 Messages ENO c ceev ere ere eth e ha e e Een 51 55 Messages Special seeccceeeseecceeeeeees 38 39 Messages Warning esee 51 55 Milligrams per Deciliter 9 17 36 49 125 dsl e Em 3 OIKCBUEOI 2224 ccs ebbo toner a Ed lentis 3 OneTouch Diabetes Management Software eee 64 68 70 122 124 OneTouch Interface Cable cceeeeee eens 122 124 OneTouch Ultra Control Solution 1 12 48 OneTouch UltraClear Cap 1 19 28 30 OneTouch Ultra Test Strips cece sees ee ee ees 1 7 8 OneTouch UltraSmart Meter LLsuuussss 13 OneTouch UltraSmart System suus 18 OneTouch UltraSoft Adjustable Blood Sampler usssss 1 19 20 23 30 Owner s Booklet eese 1 Palitizzzo See oe rieprose ei Rbe NIS ireE 21 22 27 30 33 Problems and Possible Causes 56 57 132 Product Safety Information sccceeeee
26. and logbook Meter Memory entries by date and time Glucose by Meals m Glucose test results by date before and after meals Glucose Analysis m Graph of All Results Interactive graph of all glucose test results by date m Graph by Time of Day Graph of glucose results by time of day m Average of All Results Average of all results taken for the last 7 14 30 60 and 90 days m Average by Time of Day Averages by time of day for the last 7 14 30 60 and 90 days m Averages by Exercise Glucose averages before during and after exercise for the last 7 14 30 60 and 90 days m Glucose Range Info Percent of glucose test results within above and below target range before and after meals for the last 7 14 30 60 and 90 days Insulin Intake m Average insulin doses by insulin type before and after meals for the last 7 14 30 60 and 90 days Hypo Info m Incidents of hypoglycemia blood glucose of 70 mg dL or less before and after meals for the last 7 14 30 60 and 90 days Food Averages m Average daily intake of carbohydrates fats calories and proteins for the last 7 14 30 60 and 90 days Health Checks m Dates and results of medical tests Help m LifeScan Web site address 109 LOGBOOK MEMORY To review the details of each glucose test comments and logbook entries select Logbook The logbook is the meter memory You may review all entries in your
27. at this condition immediately according to your healthcare professional s recommendations Although this message could be due to a test error it is safer to treat first and then repeat the test You should retest your blood glucose level and if HIGH GLUCOSE appears again call your healthcare professional immediately MESSAGE A WARNING A Error 1 Call customer service See Owner s Booklet A WARNING A Error 2 Meter or strip problem Please repeat test See Owner s Booklet WHAT IT MEANS There may be a problem with the meter or the meter may need to be reset Error message that could be caused by either a used test strip or a problem with the meter ACTION To reset the meter you must turn the meter off and enter Set up mode see pages 58 61 Reset the language time and date You must also reset the meter code to match the code on the test strip vial If you continue to get an Error 1 message 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 7 8 for test strip information If the error message persists call LifeScan Customer Service at 1 800 227 8862 MESSAGE A WARNING A Error 3 Meter not ready Please repeat test See Owner s Booklet A WARNING A Error 4 Strip problem Please repea
28. ation None Food Before Breakfast After Breakfast Before Lunch After Lunch Before Dinner After Dinner Night 77 Rules for Adding Comments Following are rules for adding comments in your logbook e f you wish to add a comment to a test result press the OK button while viewing the test result e Use the Arrow button to scroll up and down through the various menus and choices e Use the OK button to make a selection You must save your selections by using the Arrow button B to highlight Save and pressing the OK button Qf Prior to seeing the logbook display you may press the Back button 9 and return to the previous display to review or edit the information you have stored e To remove an entry select from the menu e Press and hold the Back button to turn off the meter After one minute of no activity the meter will turn off automatically To go back into the logbook press the FastFacts SmartButton With Logbook highlighted press the OK button Qf You can comment on a test as occurring before or after a meal how you are feeling at the time of the test and if there was any exercise involved In all you may add one food comment one exercise comment and up to six health comments to a test result How to Add a Comment Following are the steps you take to comment on a test result 78 The meter will automatically prompt you to add a c
29. ber on the vial of test strips you are currently using Check to be sure the code number on the display matches the code number on the test strip vial If they match press the OK button to confirm the code number If they do not match scroll to the correct number using the Arrow button B MESSAGE WHAT IT MEANS Apply Blood 4 t r1 AY Alternate Site 4 LI av Control Solution ey E av The system is ready to accept a blood sample from the fingertip The system is ready to accept a blood sample from the forearm or palm The system is ready to accept a control solution sample ACTION You may now apply the fingertip blood sample You may now apply the forearm or palm blood sample You may now apply the control solution MESSAGE 5 Sep 8 02 10 30 am 104 mg dL AV Example WHAT IT MEANS Five second countdown After the countdown the meter will display the test result A test result in mg dL ACTION None required None required WARNING If mg dL does not appear with the test result call LifeScan Customer Service at 1 800 227 8862 Sep 8 02 10 30 am 135 mg dL Comment Press OK av Example A test result outside of your target range with a message prompting you to add a comment If you wish to add a comment press the OK but
30. e 1 e erre tr rr rere rre Y e ees iii 38 51 Hyperglycemia eeeeeeeeeeeee iii 38 39 50 51 Hypoglycemia eceeeeeees ili 21 22 38 39 50 51 Hypoglycemia Information Hypo Info 109 120 Hypoglycemia Level ceeeeeeeeeeeeeeeeeeees 73 76 INSUIINIDOSAGES vs ie oco rore Er rrr rop E Tre rr 97 Insulinilntake 155 er e RR inr Rent Reni 116 Insulin Pump oec enr arn 98 100 118 120 Insulin PUMP SeEUp essere pne rt RR Pr Rer RES 72 Insulin Setup se orem eer e reme nere e 70 71 Intended USE oe decret peer me eie eR ERE prex ii Interface Cable OneTouch uusuueuss 122 124 Laboratory Results seeeeeeeeeeeeeeee 40 41 LANCERS 523 eroe a PERI RIEN 1 19 20 24 28 37 Lancet Disposal 2 2520 e rre pr pop propr reg aeree ee 37 l ogbook sciet eie ar ord i 4 77 107 109 110 Logbook Electroriic 45 oce rore rr ren i 77 107 Logbook A E 82 107 Logbook Entries Editing or Deleting 103 105 107 Logbook Entries Exercise LLsusse 83 86 87 Logbook Entries Food eeeeeeee eens 83 101 102 Logbook Entries Health suuuuu 83 87 94 Logbook Entries Medication 83 95 100 HOW GIUCOSE ss iei dee e exer peo eene Rus iii 38 51 Maintenance Meter esee 42 Maintenance OneTouch UltraSoft Adjustable Blood Sampler 42 Meal
31. e Set up Menu and press the OK button Ql Scroll to the number of insulin types you use and press the OK button Qf You can choose up to three types of insulin If you do not wish to use this feature enter O If you select O no insulin names will appear on the display when you press the Medication SmartButton Insulin Set up How many types of insulin do you take 70 To enter your first insulin type review the insulin Set up menu choices Select insulinls Rapid Premixed Regular Other Lente InsulinA Insulin 2 NPH InsulinB Ultralen Ultralente InsulinC Insulin Set up Select insulin s Use the Arrow button B to scroll through the menu Press the OK button on your selection Repeat these steps until all of your insulin types have been selected Insulin 1 Insulin Set up To save your insulin choices use the Insulin 1 Rapid Arrow button 8 to scroll to Save and press the OK button Qf Insulin 2 Regular 71 Insulin Pump Set up If you are using an insulin pump the OneTouch UltraSmart Meter allows you to store current information about your pump The factory setting will be set as if you do not use a pump Set up Menu Settings Diabetes Pill Set up Insulin Set up Advanced Features Exit Set up Select Insulin Pump on the Set up Menu and press the OK button Select Yes to use this feature and press the OK button You can the
32. e communication mode You are now ready to transfer all test results with date and time stored in the meter memory to your computer If the command is not received within one minute the meter will turn itself off You may also press and hold the Back button Q to turn off the meter For order information and to learn more about OneTouch Diabetes Management Software visit www OneTouchDiabetesSoftware com or call LifeScan Data Management Line at 1 800 382 7226 124 SPECIFICATIONS Result Range 20 to 600 mg dL Calibration Plasma equivalent Sample Fresh capillary whole blood Sample Size Minimum 1 microliter uL Test Time 5 Seconds Assay Method Glucose oxidase biosensor Two AAA alkaline batteries About six months at three tests per day one test using Power Source Battery Life backlight Glucose Units mg dL Memory Over 3 000 records Automatic Shutoff Three minutes after inserting a test strip if sample has not been applied one minute after all other user actions Size Approx 3 8 in L x2 3 in W x o 9 in H Weight 2 8 ounces with batteries Temperature 43 111 F 6 44 C Relative humidity 10 9096 Hematocrit 30 55 Operating Ranges 125 PRODUCT SAFETY INFORMATION The OneTouch UltraSmart System complies with the following standard UL Underwriters Laboratories Standard UL 60601 1 e Internally powered equipment Battery ope
33. eeeeeees 126 Quick Reference Guide cc cccce cece ceeeeesceeeees 1 QuickStartG lde 5 rtr Ro Rr EIE rus 1 Reduce Chance of Infection eceeeeeeeeeeeeeee 20 Repeated Unexpected Results euesseuuee iii Schedule Meal cccccecceceeeeeeessseeeeees 72 75 Eu cM DT 66 67 Set up Basic Meter cceecceeeeseceeeeneeees 58 61 Set up Custom Meter eeeeeeeeeesl 62 76 Set up Menu ecceeee se e n pr prre e ree rr neus 62 63 SpecifiCatiolis ss ucisa ere vun eue ee ERE etn ENRRER EM 125 Syringe Totals errore rre t rr v ve ters 117 118 System Overview csseseeeeeeeee nne 8 Temperature Range 8 13 36 53 55 125 II diioro e 15 32 Test POM iiss esas exten tora civ ee rrr iR KR Ee y LORI 2 31 TeSt Procedure 22i oe nnova rnos neue 3135 Time Format specin IR RR RR ana 64 66 TIME SEUNG sensere or see tero prece a esee t0s 60 Unexpected Results eee iii Unit of Measure mg dL 9 17 36 49 125 Vial Control Solution seeeeeee 12 13 16 18 Vial lest Strip oec e e iE Re v E ETT 8 10312 17 Warning Messages eese nnn 51 55 Warranty Registration Card cceeeeeeeeeeeeeeees i1 Week Beginning of secccceeeeseeeees 64 66 67 133 Notes 134 Notes 135 Notes 136 ONETOUCH UltraSmart As your partner in diabetes care
34. electronic logbook by date and time by pressing the Arrow button B In addition to reviewing records you may also edit the records see pages 103 107 Following are sample records Comments are attached to a test result logbook entries are not Logbook Logbook Sep 8 02 10 30 am Sep 15 02 3 30 pm Glucose 125 mg dL 4 Exercise A Bef Lunch Hard 00 10 Before Exer Test Result with Comments Logbook Entry GLUCOSE BY MEALS To review test results before and after meals select Glucose by Meals Highlight the desired mealtime and press the OK button A summary of all test results by date before and after the chosen meal or at night will appear Use the Arrow button to view more entries D Glucose by Meals Glucose by Meals Bef Brkft Aft Brkft Sep8 80 120 Sep 7 100 115 Lunch Sep 6 70 125 Dinner Sep 6 140 Night Sep5 70 125 Sep4 90 140 v GLUCOSE ANALYSIS When you select Glucose Analysis on the FastFacts menu an additional menu of choices appears Use the Arrow button to move to the desired menu and press the OK button Ql D Glucose Analysis _ a er eae rae Graph of All Results Graph by Time of Day Average of All Results Average by Time of Day Average by Exercise Glucose Range Info Interactive Graph of All Results The interactive graph displays three days of test results at a time with the most recent test re
35. er countries marae Highlight your choice and press the OK Beep button The meter was set at the factory to give audio signals beeps at key points in the test procedure To keep the beeps highlight ON and press the OK button iceman For silent meter operation highlight OFF and press the OK button Settings 67 Set up Menu Settings Insulin Set up Insulin Pump Advanced Features Exit Set up Diabetes Pill Set up How many types of pills do you take Diabetes Pill Set up You may record up to five types of diabetes pills This feature helps you track when you have taken each of your medications The names of the medications may be chosen from a menu Pills A through E or the brand or generic names entered using a personal computer and OneTouch Diabetes Management Software If you do not customize your pill names the factory settings of Pill A and Pill B will appear on your pill entry display Using the Arrow button B scroll to Diabetes Pill Set up and press the OK button Enter the number of pill types you are taking not the number of tablets you take each time Scroll to the correct number and press the OK button 9 You can enter up to five types of pills If you do not take pills or do not wish to use this feature enter O If you enter 0 the diabetes pill choices will not appear on the display when you press the Medication SmartButton
36. ere may be a problem with the meter ACTION 2 If you applied the blood incorrectly review pages 33 35 on blood application and repeat the test with a new test strip 3 If the error message appears again call LifeScan Customer Service at 1 800 227 8862 1 Repeat the test with a new test strip Refer to pages 33 35 for information on sample application 2 If the error message appears again call LifeScan Customer Service at 1 800 227 8862 MESSAGE WHAT IT MEANS ACTION A WARNING A The battery sign Test results will Tow Batteries appears on the display still be accurate The power of the but replace the You should replace batteries is getting batteries as me ellen low The backlight will soon be disabled when the as possible battery sign is displayed You can complete about 100 more tests from the time this symbol first appears A WARNING A Battery power istoolow Replace the Batteries to run a test batteries at i once You MUST replace the batteries now See Owner s Booklet N WARNING A The meter has detected Perform the test Meter is outside of p that the temperature after the meter operating is outside the system and test strips temperature range i operating range Do Not have reached perform a test untilthe a temperature meter and test strips within the reach a temperature operating range within the operating range 43 111 F
37. f units Repeat these steps as needed After completing your insulin logbook entry select Exit Meds Entry and press the OK button Sep 8 02 9 20 pm Meds Entry Pill A Pill B InsulinB Pump Bolus Pump Daily Total Exit Meds Entry G Logbook Sep 8 02 9 20 pm The insulin dosage will be saved this way InsulinA IA A in your electronic logbook 97 Insulin Pump You can enter insulin pump information as bolus entries or as a daily total A Sep 8 02 9 20 pm Meds Entry Pill A A If you are entering bolus information ED select Pump Bolus and press the OK button Q InsulinB Pump Daily Total v JR Sep 8 02 9 20 pm Meds Entry Then enter the units in o 1 steps and press the OK button When entering data the value will start at the value you last saved Pump Bolus 98 E Sep 8 02 9 20 pm Meds Entry If you have completed your medication Fl logbook entry select Exit Meds Entry Insulin nsulin Pump Daily Total Exit Meds Entry Oy Logbook Sep 8 02 9 20 pm A Bolus 0 1 The dosage will be saved this way in your electronic logbook JE Sep 8 02 9 20 pm Meds Entry To enter your pump total for the day Pill A A scroll to Pump Daily Total and press the RA OK button aga Pump Bolus Pump Daily Total v 99 Ji Sep 8 02 9 20 pm Meds Entry Use the Arrow button B to scroll to the number of uni
38. f you do not wish to enter units for an item select and press the OK button Do Not enter 0 because it will be included in your FastFacts averages see page 108 Press the OK button to advance to the next nutrient To return to a previous nutrient press the Back button Note When entering data the value will start at the value you last saved Your food logbook entry will be saved this way in the electronic logbook 102 Adding Changing or Deleting Logbook Information Step 1 Press the FastFacts SmartButton to enter the FastFacts menu Step 2 Select Logbook from the FastFacts menu and press the OK button The most recent entry in your electronic logbook will appear on the display Step 3 Use the Arrow button B to scroll through your logbook entries Note the location of the highlight in Wi iegbek Sep 8 02 10 30 am the logbook display Note also on the A right hand margin the arrows A V Aft Brkft They indicate the direction you may scroll through your logbook Step 4 Press the OK button to edit add to or change or delete logbook information EDITING OR DELETING TEST COMMENTS Example i Logbook To edit or delete a comment be sure Sep 8 02 10 30 am the highlight is on the glucose test result A to which the comment is attached Aft Brkft Press the OK button see page 105 for electronic logbook entry exam
39. f you press the OK button all of the comments you have entered will appear with the test result in the logbook 81 Logbook Entries Logbook entries are activities concerning exercise health medication and food that are not associated with a test You do not have to perform a blood glucose test in order to add valuable diabetes information to your electronic logbook Using the SmartButtons The SmartButtons allow you to enter information about your diabetes management plan There are SmartButtons for exercise health medication and food To make a logbook entry press the appropriate SmartButton to turn on the meter and enter the menu for the type of entry Note You may press any SmartButton to turn on the meter and move directly to the category Exercise Food Health FastFacts Medication 82 Following is a list of logbook entries you can make SmartButton Exercise Q Health Q Medication O Food LOGBOOK ENTRIES Mild Moderate Hard Health Notes Stress Feel Hypo Illness Health Checks Ketones HbAic Microalbumin Cholesterol Blood Pressure Duration enter length of time Menses Vacation Other Eye Exam Foot Exam Weight Height Dr Visit Pills 1 5 and how many of each Insulin 1 3 and units Insulin Pump Carbs Calories 83 Fats Proteins Rules for Logbook Entries e f you wish to add a logbook entry press a SmartButton to
40. fer by more than 20 in some situations See the OneTouch Ultra Test 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 you go 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 e Make sure that the meter test and the lab test are performed within 15 minutes of each other e Wash your hands before obtaining a blood sample Useonly fresh capillary blood You may still have a variation between the results 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 7o 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 amount 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 Diabete
41. flow to the forearm than to the fingertips To help you get a large enough drop of blood you may gently massage or apply warmth to the site to increase blood flow Palm sampling Choose a fleshy area on the palm below your thumb or pinky finger Select a spot with no visible veins and away from deep lines which may cause your blood sample to smear 27 OneTouch UltraClear Cap is used for forearm and palm m A 1 sampling only Replace the blue OneTouch UltraSoft Cap with the OneTouch UltraClear Blue cap for fingertip sampling only Cap Gerd Remove the OneTouch UltraSoft Cap by Twisting it Off GEF Insert a Sterile Lancet Into the Sampler Insert the lancet into the holder and push in firmly Twist the protective disk until it separates from the lancet and save the disk for later use Do Not twist the lancet 28 GrP 3 Twist On the OneTouch UltraClear Cap Until it is Snug GrEP 4 Adjust the Depth Setting You may have to adjust the Sampler to a deeper setting to get a large enough drop of blood from your forearm or palm Twist the depth adjustment knob toward the larger dots to increase the depth GEF Cock the Sampler Slide the ejection cocking control back until it clicks If it does not click it may have been cocked when you inserted the lancet 29 GEJ Puncture Your Forearm or Palm Press and hold the Sampler against your forearm
42. id Syringe Totals Select Pump to view bolus intake daily averages and daily totals You can review the last 7 14 30 60 or 90 days 118 Insulin Intake ump Daily Average Bolus will display your average bolus intake for each mealtime Breakfast Lunch Dinner Night based on your schedule see pages 73 76 Daily Totals Pump Bolus 14 Day Avg 14 Breakfast 6 0 A 6 00am 11 00am Lunch 8 0 11 00am 5 00pm intake in units by time The number of logbook entries appears in parentheses This example shows the average bolus 14 Insulin Intake Pump 14 Day Avg Total Daily Pump Insulin a 52 3 Daily Average displays the average of the total daily pump insulin This example is for the last 14 days The number of entries is listed in parentheses An asterisk means there are days with no entries 119 Insulin Intake Pump Daily Totals Pump Daily Totals gives the pump totals you have entered for each day If you did not enter a pump total for a day will appear Insulin Intake Pump Daily Totals Sep 14 02 85 0 Sep 14 02 92 0 Sep 13 02 82 5 Sep 12 02 Sep 10 02 HYPOGLYCEMIA INFORMATION If you select Hypo Info from the FastFacts menu the meter will display the actual number of hypoglycemic events defined by the level set in Advanced Features see page 76 The number of events before and after
43. ime settings may need to be updated The first time you turn on the meter after replacing the batteries the meter will go into the Set up mode see pages 58 61 At this time you may update the date and time settings DISPLAY MESSAGES Following is a summary of screen messages and symbols MESSAGE WHAT IT MEANS ONETOUCH UltraSmart Check Code AY Initial display that appears whenever the meter is turned on It indicates that the system has performed several self checks to confirm that the meter is working properly New meter not coded or meter lost power briefly and entered Set up mode ACTION If at any time during the life of the meter these graphics appear to be different call LifeScan Customer Service at 1 800 227 8862 See Coding the Meter pages 10 12 MESSAGE Check Code AY Example WHAT IT MEANS This is the code number stored in the meter ACTION Make sure that this code number matches the code number on the vial of the test strips you are using 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 9 Check Code Press OK AY Example The meter is prompting you to confirm that the code number on the meter display matches the code num
44. indow lseeeeeeeeeeee 7 34 35 ContacEBals sasore naeron an Eu ERRRRRSIRER UNE RE 7 31 Control Solution Before you begin 13 Control Solution Checking the System with 12 Control Solution OneTouch Ultrae 1 12 18 Control Solution Out of range results 17 18 Custom Meter Set up Sequence 62 76 Data Downloading ceeeeeeeeeeeeeeeeeeee 122 124 Data Poil erise dees cde xr P RU IT EAEE OIRRE RRS 2 123 Date and Time Entering esee esee sees 85 Date and Time Setting cece cece eee eeeeeees 60 61 Date Format eser aen ERE dee eer E SE EE 64 66 Dehydration 252 e Ep IER Pr e ORI iii 41 Diabetes Pill Set up esses eese 68 69 Diabetes Pills reissen annen eaaa 96 Display Contrast s ss deed eto pet rro ge EENE OEO 6 Display Language eeeeee m 59 Display Meter coeise tros ener re EP UR PES E PRI 2 9 Display Symbols id dads oec red mee epe petens 6 Editing Comments eccceeseceeeseceeees 103 105 Editing Logbook Entries ceeeeeeee ees 105 107 Electronic Logbook 00seeeeeeeeeeeeeees i 77 107 Entries Logbook 51 rere eet ron eere 82 107 Error Messages ce cese eee eene nen rne nnn 51 55 Exercise Comments cessere 8 Exercise Logbook Entries 0 ceeeeeeeeee eens 86 87 Exercise Smart
45. ips 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 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 Grd Enter the Code Mode Insert a OneTouch Ultra Test Strip to turn on the meter Push it all the way in until it will go no further OneTouch UltraSmart will appear on the display briefly The first time you turn the meter on three dashes will appear showing that there is no code stored in the memory Follow Step 4 to code the meter 10 GEP See the Code Number The code number will appear on the display After every 25 tests the meter will display the code number and will prompt Check Code Press OK Press the OK button if the code number is still correct Gr EPS 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 4 Example Note The code number appears on the display briefly If you were unable to change the code in time or entered a code number in error press the Back button to return to Step 3 GEP Code the Meter Move up or down using the Arrow button B to the code number tha
46. ith testing Call LifeScan Customer Service at 1 800 227 8862 Contact us 7 days a week 8 a m 10 p m Eastern Time Data Downloading Transferring test results to your personal computer for home viewing requires OneTouch Diabetes Management Software from LifeScan and a OneTouch Interface Cable OneTouch Diabetes Management Software and a OneTouch Interface Cable are not included with your OneTouch UltraSmart System For order information and to learn more about OneTouch Diabetes Management Software visit www OneTouchDiabetesSoftware com 122 Gr EPD Install OneTouch Diabetes Management Software Install OneTouch Diabetes Management Software on your computer following the instructions provided in the OneTouch Diabetes Management Software User Manual r EPD Connect the OneTouch Interface Cable Connect the OneTouch Interface Cable to a serial port on the back of your computer With the meter turned on connect the OneTouch Interface Cable to the data port located on the upper left side of the meter Be sure the cable plug is inserted all the way Note While in the communication mode you will be unable to perform a blood glucose test 123 GrrP3 Transfer Data Follow the instructions in the OneTouch Diabetes Management Software User Manual to initiate the data transfer command PC will appear on the display once the first command is received indicating that the meter is in th
47. m OK button Repeat these steps to select Sep 15 0 Then select the correct year and press the the month and day Note It is important to select the correct date and time or your logbook may not show the most recent result first The meter will ask you if you wish to Do you want to customize customize it Select Yes press the OK your meter now button if you wish to customize other Yes meter settings see Custom Meter Set up Sequence pages 62 76 Do you want to customize If you select No use Arrow button B jour meier nowi and press the OK button the meter will turn off and continue to use No the factory settings 61 CUSTOM METER SET UP SEQUENCE The OneTouch UltraSmart Meter has a number of optional features that you may use to track all your diabetes information The Set up Menu allows you to customize the meter with your personal diabetes management plan including the type and amount of medication you take your target glucose range your usual meal times and much more information Note If you are starting the custom set up sequence with the meter off you must press the Back button and the OK button at the same time to turn on the meter To access the Set up Menu you must go through Basic Set up first see pages 58 61 Set up Menu Do you want to customize your meter now Yes After completing Basic Set up choose Yes to customize you
48. meals and during the night for the last 7 14 30 60 and 90 days is displayed Use the Arrow button Bto view the other time periods P 70 aS ae 70 dl or end Total 14 Days Bef Brkft Aft Brkft Bef Lunch Aft Lunch Days 120 FOOD AVERAGES Select Food Averages to view average daily intake of carbohydrates fats calories and proteins over the last 7 14 30 60 and 90 days The number of tests that make up each average is shown on the left in parentheses Food Averages QD Food Averages 7 Breakfast 14 Day Avg 30 Pays 14 Carbs 45 60 14 Fats 14 90 10 Calories 362 12 Proteins 14 HEALTH CHECKS To view results and dates of various check ups select Health Checks Scroll to the type of Health Check using the Arrow button and press the OK button The entries for each will appear on the display Health Checks Health Checks Ketones trace Sep 3 024 HbA1c B P 120 80 Sep 3 02 Sep 3 02 5 2 Weight 150 0 Sep 3 02 jul 14 02 5 9 Height 670 Sep 3 02 Dr Visit done Sep 3 02 5 2 Sep 3 02 Chol 187 Sep3 02y 121 Information Contact LifeScan Customer Service or visit the Website at www OneTouchDiabetes com SOURCES FOR HELP This choice prompts you to contact LifeScan Customer Service or visit our Web site when you need help w
49. n consumption Do Not apply control solution to the skin or eyes as it may cause irritation When you should do a control solution test To practice the test process instead of using blood When you open a new vial of test strips Once a week Whenever you suspect that the meter or test strips are not working properly f you have had repeated unexpected blood glucose results as described on page v After dropping the meter Note Refer to additional information in the OneTouch Ultra Control Solution package 14 6r EPD Insert a Test Strip into the Meter To turn on 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 OneTouch UltraSmart will appear briefly on the display Then Code 9 Example Check Code is displayed Be sure the meter and test strip codes match If they do not code the meter correctly see pages 10 12 Apply Blood 6 uA Control Solution oy t GEF Select Control Solution Apply Blood will appear on the display first Use the Arrow button to select Control Solution The meter will automatically identify the test as a control solution test in the logbook There are three choices in test mode Use the Arrow button BI to select one Do Not apply a sample until your choice appears on the display Apply Blood for
50. n use this feature to enter your bolus doses and total insulin amounts If you do not use an insulin pump or you do not wish to set up this feature now select No and press the OK button After choosing Yes or No the meter will return you to the Set up Menu Insulin Pump Do you use an insulin pump Yes Advanced Feature Set up The final item on the Set up Menu is called Advanced Features These features allow you to e Choose the number of days included in your glucose test averages Input your usual meal schedule e Include your target glucose range e Customize your hypoglycemic level 72 ADVANCED FEATURES FACTORY SETTINGS CUSTOM SETTINGS Averages Schedule 14 days Pre set Glucose Range Before Meal 90 130 mg dL After Meal Hypo Level 70 mg dL Select Advanced Features as follows Select Advanced Features and press the OK button The first advanced feature is averages Each time you test the meter is set to display a 14 day average of your glucose tests along with your test result You can change the number of days that make up this average to the last 7 30 60 or 90 days Scroll to the number of days you want to include in your test display average and press the OK button You can still look at averages for all five time periods by reviewing your electronic logbook 73 See pages 74 75 7 30 60 90 days Personal
51. n and press the OK button Q9 Microalbumin You can enter your test results for Sep 15 02 3 30 pm microalbumin as Normal Positive a Health Checks numeric value from 1 to 1000 or gt 1000 When entering data the value will start Microalbumin at the value you last saved Scroll to your a selection and press the OK button 91 Cholesterol You may enter cholesterol test results in 1 mg dL 0 1 mmol L steps for e Total up to gt 1000 gt 25 9 mmol L e DL up to 7500 gt 13 0 mmol L e HDL up to gt 500 13 0 mmol L Triglycerides Trig up to gt 3000 733 9 mmol L To advance to the next cholesterol entry press the OK button Q9 To return to a previous cholesterol entry on this display press the Back button Note When entering data the value will start at the value you last saved Blood Pressure Sep15 02 3 30 pm Health Checks Cholesterol Total LDL sze The logbook range for the first number systolic is 80 200 mmHg The range for the second number diastolic is 40 150 mmHg Both are in 1 mmHg steps Blood pressure B P above or below these ranges will appear on the display as and will not be recorded in the logbook Sep 15 02 3 30 pm Health Checks When entering data the value will start at the value you last saved Blood Pressure 120 E 92 Eye Exam To record an eye examination select Enter Eye
52. nate Site for forearm and palm blood samples Do Not use Control Solution mode when testing blood e Control Solution is for checking the system Apply Blood ey 1 AY Alternate Site of 1 AV Before you test with blood make sure Apply Blood or Alternate Site is displayed on the screen Correct test mode selection is important to ensure all blood and control solution tests are properly included or excluded from averages Failure to select the correct test mode may cause blood averages to be incorrect Apply Blood will appear on the display first If you are testing with a fingertip blood sample proceed to Step 3 If you are testing with a blood sample from the forearm or palm use the Arrow button B to scroll to Alternate Site Gr EPB Prepare to Apply Sample The drop of blood should be next to the top edge of the test strip Blood should not be applied to the flat surface of the test strip When applying a drop of blood from your forearm or palm keep your forearm or palm steady and bring the top edge of the test strip to the drop of blood with your other hand Fingertip Forearm r EP Apply Sample Obtain a round drop of blood using the Sampler The blood sample must be at least 1pL in volume 9 sample size to fill the confirmation window Touch and hold the drop of blood to the narrow channel in the top edge of the test strip Do Not appl
53. omment when you have a test result outside of your glucose target range You can however add a comment to a test result whether or not Comment Press OK appears In this example we will comment on a test result with food exercise and health information Sep 8 02 10 30am 135 mg dL Comment Press OK AV Example Sep 8 02 10 30 am Gluc 135 Comment Food Aft Brkft Exer Save With any test result or test result with average on the display press the OK button You will be able to add comments for food health and exercise Health is always highlighted first since the food comment is automatically added based on your pre set or personal schedule see Advanced Feature Set up pages 72 76 FOOD COMMENTS In this example we ll use food If you wish to change the food comment to a different mealtime use the Arrow button to select Food and press the OK button Use the Arrow button to select your food comment and press the OK button again Your choices are Bef Brkft Aft Brkft Bef Lunch Aft Lunch Bef Dinner Aft Dinner and Night Sep 8 02 10 30 am Gluc 135 Comment Food Health Bef Brkft Aft Brkft Exer Bef Lunch Save Aft Lunch wv 79 Sep 8 02 10 30 am Gluc 135 Comment Food Bef Lunch Health Exer Sep 8 02 10 30 am Gluc 135 Comment Sep 8 02 10 30 am Gluc 135 Comment Food MNA Health 1 Feel Hypo E
54. ood glucose 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 professional Hematocrit A hematocrit percentage of your blood that is red blood cells that is either very high above 5596 or very low below 3096 can cause false results Table of Contents THE OneTouch UltraSmart SYSTEM 1 OneTouch UltraSmart Meter 2 Navigation BUTTONS estier asenu isere ierse a naaa 3 SmartBUttOnS occ rr eere aiana 4 Display Syr bols 1 rtt s 6 Display Contrast eserse 6 OneTouch Ultra Test Strips 7 BEFORE TESTING eei retentis 9 Checking the Display eeseeeeeereeeee 9 Setting The Meter cce crie tette tette titer 9 Coding the Meter eeeeeeeeeeeeee eene 10 Checking the System with Control Solution 12 TESTING YOUR BLOOD eere etes 19 Preparing the OneTouch UltraSoft Adjustable Blood Sampler 20 Lancing and Sampling from Your Fingertip 23 Lancing and Sampling from an Alternate Site 27 Step by Step Test Procedure 31 Discarding Used Test Strips and Lancets 37 Special Messages eere 38 COMPARING METER
55. ple 103 Sep 8 02 10 30 am Gluc 125 Comment Food Aft Brkft _ To change the mealtime select Food and press the OK button Qf Exer Save Sep 8 02 10 30 am Gluc 125 Comment Scroll to the desired mealtime and press the OK button again You may edit other comments at this Cluc 125 Comment time To delete a comment scroll to Food Bef Lunch and press the OK button When you Health have completed editing the comments xet Hess scroll to Save and press the OK button Sep 8 02 10 30 am 104 Logbook Sep 8 02 10 30 am A Your edited comment will appear this way in your electronic logbook Baf Lurich EDITING OR DELETING ELECTRONIC LOGBOOK ENTRY Example Logbook All electronic logbook entries are edited or deleted in the same way Use the a i Arrow button B to highlight the Carbs 60 electronic logbook entry you wish to Fats 15 change and press the OK button IM Sep15 02 5 26 pm Food Entry Press the OK button to edit Edit 105 Make sure the icon date and time and J Sep 15 02 5 26 pm description are correct If you make an Fogd Entry error press the Back button to return Breakfast to the menu Press the OK button Lunch on the selected mealtime If you wish to change the entry to another mealtime Alcohol scroll to the mealtime and press the OK button Dinne
56. prefer to fill out a warranty card online please visit www LifeScan com American Diabetes Association position statement on the Diabetes Control and Complications Trial 1993 INTENDED USE The OneTouch UltraSmart Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood The OneTouch UltraSmart System is intended for use outside the body for in vitro diagnostic use by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control The OneTouch UltraSmart System should not be used for the diagnosis of diabetes or testing of newborns The OneTouch UltraSmart Blood Glucose Monitoring System provides the user with electronic logbook functions which serve to store such data as insulin and oral medication doses food intake amount of exercise health information such as illnesses and other pertinent data The meter includes a data port that enables the user to download logbook data to a personal computer CAUTION Before 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 healthcare professional These recommendations apply to all blood glucose monitoring systems and are supported by the American Association of Diabetes Educators the U S Food and Drug Administration and
57. r Information E 7 keep the entry as it is press the OK button Ql Dinner Information To change the entry use the Arrow button B and press the OK button Ql 106 Logbook Sep 15 02 5 26 pm Carbs 45 The edited entry will appear this way in Fats 15 your electronic logbook Logbook 3 30 pm To delete an entry highlight the entry and press the OK button Sep 15 02 3 30 pm Exercise Entry Delete Use the Arrow button amp to select Delete and press the OK button Ql Sep 15 02 3 30 pm Exercise Entry Entry removed Your entry will be deleted from the electronic logbook 107 OneTouch UltraSmart FastFacts FEATURE FastFacts Menu Enter FastFacts by pressing the FastFacts SmartButton This will put you in the meter memory The FastFacts feature allows you to view charts and graphs of your test results and other logbook information you have entered FastFacts SmartButton Note The meter will turn itself off after one minute of inactivity Press any SmartButton to turn the meter back on FastFacts A Glucose by Meals Glucose Analysis Insulin Intake Hypo Info Food Averages Health Checks See the next page for a description of The FastFacts menu lists several choices what is available under each choice v 108 FastFacts Menu Logbook m Glucose test results with comments
58. r meter 62 Please use your Owner s You should have your Booklet to help you set OneTouch UltraSmart Owner s Booklet Mg youi available to refer to while customizing OneTouch the meter UltraSmart Set up Menu with a list of options Settings will be d highlighted Insulin Pump Advanced Features Exit Set up Set up Menu will appear on the display l 63 Following is a summary of meter settings Meter Settings OPTION FACTORY SETTINGS CUSTOM SETTINGS Settings Time Format am pm 24 hour Date Format MM DD YY DD MM YY Begin of Week Sunday Monday Cholesterol Units mg dL mmol L Beep ON OFF Diabetes Pill Pill A Pill A to E Set Up Pill B or Customize with OneTouch Diabetes Management Software InsulinA Rapid Regular Insulin Set Up InsulinB Lente NPH Ultralen Ultralente Premixed Other InsulinA InsulinB InsulinC or Customize with OneTouch Diabetes Management Software Meter Settings continued OPTION FACTORY SETTINGS CUSTOM SETTINGS Insulin Pump No Yes Advanced Features Averages 14 days Schedule Pre set see pages 74 75 Glucose Range Before Meal 90 130 mg dL After Meal Hypo Level 70 mg dL 7 30 60 90 days Personal Personal Personal Personal Settings Settings include e Time format Date format Beginning of the week Choles
59. r turns on when you insert the OneTouch Ultra Test Strip here ONETOUCH UltraSmart Data Port Used to download logbook memory to a computer Display with Backlight Test results messages symbols and other data appear here SmartButtons See pages 4 5 for description and use Navigation Buttons Note Press and release buttons Do Not hold buttons down for an extended period of time Back Button Off Button Go back to previous display on certain screens Press and hold for two seconds to turn off the meter Arrow Button Scroll through menus code numbers and logbook OK Button Backlight Button Accept entries and move to next display Press and hold for two seconds to turn on backlight SmartButtons The SmartButtons are your keys to getting the most out of your OneTouch UltraSmart Meter They allow you to enter information about your diabetes management plan into the large logbook memory There are SmartButtons for exercise health medication and food The FastFacts SmartButton is used to view the records in the logbook memory You may press any SmartButton to turn on the meter and move directly to the category Exercise SmartButton Food SmartButton Enter exercise amount and Enter meal and snack level information Health SmartButton Medication Enter information on SmartButton health Enter insulin and diabetes pill information FastFacts SmartBu
60. rated with two 1 5 volt AAA alkaline batteries This unit is not suitable for use in the presence of flammable anesthetic mixture with air oxygen or nitrous oxide e Continuous mode of operation e PX4 degree of protection against ingress of water This is a level of water resistance protection against splashing water Type BF applied part degree of protection against electrical shock This is a level of electrical safety protection for the user suitable for this medical device 126 EXPLANATION OF SYMBOLS ON THE METER N See Accompanying Documentation Read and understand your Owner s Booklet and test strip package insert before using this system This indicates type BF applied part degree of protection against electrical shock This is a level of electrical safety protection for the patient or user suitable for this medical device amp This indicates electrical safety certification by the Canadian Standards Association CSA in accordance with UL 60601 1 CAN CSA 22 2 No 601 1 94 and CAN CSA 22 2 No 601 1 2 94 GUARANTEE The makers guarantee that the OneTouch UltraSmart 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 127 INDEX Advanced Features cccceceeeeeeeeeeeeeeeees 72 76 Alternate Site Te
61. rm or palm sample It has been less than two hours after a meal a rapid acting insulin injection or insulin pump bolus physical exercise or you think your glucose level is changing rapidly You are concerned about the possibility of hypoglycemia or an insulin reaction such as when driving a car This is especially important if you suffer from hypoglycemia unawareness lack of symptoms to indicate an insulin reaction Remember Consult with your healthcare professional before using your forearm or palm for testing 22 Choose a different puncture site each time you test Repeated punctures in the same spot may cause soreness and calluses If bruising occurs at an alternate site or you have difficulty getting a sample consider sampling from a fingertip instead You may want to review the choice of sites with your healthcare professional Preparing Your Sample Site Before you test your blood glucose wash your hands and forearm if applicable thoroughly with warm soapy water Rinse and dry thoroughly Lancing and Sampling from Your Fingertip GPD Remove the OneTouch UltraSoft Cap by Twisting it Off 23 Grd Insert a Sterile Lancet Into the Sampler Insert the lancet into the holder and push in firmly Twist the protective disk until it separates from the lancet and save the disk for later use Do Not twist the lancet f tis E 1 GTEP Replace the OneTouch UltraSof
62. row button B to scroll up and down Press the OK button to save your selection and return to the Health Checks menu Following are sample entries possible under Health Checks When you have completed your Health Check entries scroll to Exit Health Checks and press the OK button Your Health Check entry will be saved in the electronic logbook Ketones When you check ketones you can enter the results in your electronic logbook Results may be Ketones Negative Moderate Trace Large Small Sep15 02 3 30 pm Scroll to your selection and press the OK button Ql L Ketones 89 Sep15 02 3 30 pm Health Checks Health Checks You will return to the Health Checks menu with Exit Health Checks highlighted If you are finished with your entries press the OK button with Exit Health c r Checks highlighted If you wish to enter cL other Health Checks use the Arrow button ERENCE to scroll to the additional menu choice and press the OK button Q Sep15 02 3 30 pm Health Checks Blood Pressure A Eye Exam Foot Exam O Sep 15 02 3 30 pm gt Your entry will be saved this way in the electronic logbook Logbook 90 HbA1c Tests for hemoglobin Alc also known Sep15 02 3 30 pm as HbA1c or Alc can be recorded from Health Checks 4 to 1596 in 0 1 steps When entering data the value will start at the value you HbAlc last saved Scroll to your selectio
63. s Forecast 1988 April 49 51 2 Sacks D B Carbohydrates Burtis C A and Ashwood E R ed Tietz Textbook of Clinical Chemistry Philadelphia W B Saunders Company 1994 959 CARING FOR YOUR SYSTEM Maintenance Your OneTouch UltraSmart Meter does not require special maintenance or cleaning Take care to avoid getting dirt dust 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 UltraSmart Meter is a precision instrument Please handle it with care Do Not use alcohol or any other solvent to clean your meter Cleaning the OneTouch UltraSoft Adjustable Blood Sampler Clean the Sampler and OneTouch UltraSoft and OneTouch UltraClear Caps with soap and water To disinfect the Sampler prepare a disinfectant 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 cap with water and dry thoroughly 42 Batteries Your OneTouch UltraSmart Meter comes with two AAA alkaline batteries already installed The batteries will provide you with enough po
64. s 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 is 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 UltraSmart System are about 12 higher The OneTouch UltraSmart Blood Glucose Monitoring System consists of three main products the OneTouch UltraSmart Meter OneTouch Ultra Test Strips and OneTouch Ultra Control Solution These products have been designed tested and proven to work together as a system to produce accurate blood glucose test results Use no other test strips or control solution other than the OneTouch Ultra brand with your meter Your system kit includes e OneTouch UltraSmart Meter Owner s Booklet e OneTouch Ultra Control Carrying Case Solution Quick Reference Guide e OneTouch UltraSoft Quick Start Guide Adjustable Blood Sampler Warranty Registration Card OneTouch UltraClear Cap Two AAA Alkaline Batteries e OneTouch UltraSoft Installed Sterile Lancets OneTouch Ultra Test Strips sold separately OneTouch UltraSmart Meter b OneTouch Ultra Test Strip Test Port The mete
65. sting 15 21 23 27 30 32 Arrow Button eoe eer er yr yx Ree y epe Verr Eres 3 Averages All Results Leeseeeeeeeeee 109 113 Averages By Exercise 0 cccce cece eeeeeeeeees 109 114 Averages By Time of Day eseesees 109 114 Averages Food ceeeeeeceecceeeeeeeeeeees 109 121 Averages Insulin Daily ce eee eee eeeeees 117 119 Back BUOM eds aries nirera vacedeeseiea paeas 3 Backlight seoir ene ET EE 3 Backlight Button eiior erarnan airera 3 Basic Set up Mode eeeeeeeeeeeees 58 61 Batteries oiiire pentier arians 1 43 45 55 125 126 illi 64 66 67 Blood Glucose Testing ssseseess 19 39 Blood Sampling Fingertip suu 23 26 Blood Sampling Forearm or Palm 27 30 CAMYING CaSO ccs eccndes seve dndetsancens iiinn niione iiias 1 Checking the System with Control Solution 12 348 Cholesterol Units ssseeeeeesseeeeeeee 64 67 Code Numbers eeeeeeeeeeee 10 12 15 31 46 47 Coding the Meter ccceeccceeesecceeeeneeees 10312 COMMONS ss rex i eprsR RTI Prey Mp ne 36 39 77 81 Comments Exercise 0eeeeeeeeeccecccccceeeeeees amp Comment Food eerte aeree tr tre gru 79 80 Comments Health ccceeeeeeeeeeeeeeeeeees 80 81 Comment Press OK seeseeeeeeeeeeeeeeeee 36 Confirmation W
66. sult flashing A bold bar above the dates indicates a weekend The two dotted lines indicate the lowest and highest values of your before and after meal glucose ranges see Advanced Feature Set up pages 72 76 If you have not selected an after meal range only the before meal range will appear Results above 300 mg dL or below 50 mg dL are indicated by an arrow at the top or bottom edge of the graph Interactive Glucose Graph Graph shows all results Use arrows to scroll OK for details E E AY Sep22 Sep23 Sep24 You may scroll backward or forward in time using the Arrow button to move from one point to another Individual test results will flash as you scroll To view the details of a test press the OK button while that test result is flashing Press the Back button to return to the graph You may move back and forth between the graph and the logbook as often as you wish Note If you press the OK button while in the logbook you will begin to edit or delete test comments and will not be able to use the Back button amp to return to the graph Logbook Sep 21 02 7 20 pm OMAETTE A Aft Dinner Dinner 5017 Carbs 45 12727712 miniaintal AY Sep21 Sep22 Sep23 Graph by Time of Day You may view test results on a graph by time period when you select Graph by Time of Day Graph daily results by time period Before Breakfast iN After Breakfas
67. sure to wash the puncture site with soap and water before testing Note If you Do Not have a OneTouch UltraSoft Adjustable Blood Sampler please refer to the instructions that came with your lancing device 20 Choosing the right sampling site at the right time The OneTouch UltraSmart Meter allows you to sample blood from your fingertip forearm or palm At times results obtained at the forearm or palm may be different from a fingertip measurement Talk to your healthcare professional before you begin using your forearm or palm for sampling Use blood sample If you are testing from your Routinely before meals Prior to or more than two hours Fingertip after forearm or a meal palm a rapid acting insulin injection or insulin pump bolus exercise When your blood glucose is changing rapidly such as within two hours after a meal within two hours after a rapid acting insulin injection or insulin pump bolus or e during or within two hours after exercise Fingertip When you are concerned about the possibility of hypoglycemia low blood sugar 21 CAUTION Do Not test on your forearm or palm when You think your blood glucose is rapidly falling such as within two hours of exercise or a rapid acting insulin injection or insulin pump bolus Testing with a fingertip sample may identify hypoglycemia or an insulin reaction sooner than testing with a forea
68. t Cap by Twisting it Back On Until it is Snug GED Adjust the Depth Setting If necessary twist the depth adjustment knob toward the smaller dots on the Sampler for a shallow puncture or toward the larger dots for a deeper puncture 24 61 EPS Cock the Sampler Slide the ejection cocking control back until it clicks If it does not click it may have been cocked when you inserted the lancet Grer Puncture Your Finger Hold the Sampler firmly against the side of your finger Press the release button Remove the Sampler from your finger Note Do Not use the OneTouch UltraClear Cap on your finger GEZ Get a Round Drop of Blood Gently squeeze and or massage your fingertip until a round drop of blood at least 1 uL 6 sample size forms on your fingertip Do Not squeeze excessively on the puncture site If the blood smears or runs Do Not use that sample Dry the area and gently squeeze another drop of blood or puncture a new site 26 Lancing and Sampling From an Alternate Site Sampling from your forearm or palm allows you to use your fingertips less often You may find that obtaining a blood sample from an alternate site is less painful than using a fingertip Getting a blood sample from your forearm or palm is different than getting a sample from your fingertips Forearm sampling Choose a fleshy area of the forearm away from bone visible veins and hair Sometimes there is less blood
69. t Before Lunch After Lunch Before Dinner After Dinner v Results by time period are shown day by day one week at a time Each time you reach the end of the graph it will move by one day Weekends are noted by a bold bar above the dates Graph daily results by time period Before Breakfast Glucose Results AY Sep21 Average of All Results Test result averages are available for the last 7 14 30 60 and 90 days The number of tests that make up each average is shown on the left in parentheses o Average of all Results Number of Days Avg 18 7 120 33 14 147 75 30 187 153 60 200 202 90 201 113 Average by Time of Day Test averages by time of day are available for the last 7 14 30 60 and 90 days The number of tests that make up each average is shown on the left in parentheses Average by Avg by time of time of Day Day 14 Days 7 Bef Brkft 95 Aft Brkft 135 30 Bef Lunch 80 60 Aft Lunch 128 90 Bef Dinner 128 Aft Dinner 125w Average by Exercise Test result averages before during and after exercise are available for the last 7 14 30 60 and 90 days The number of tests that make up each average is shown on the left in parentheses a Average by Avg by Exercise Exercise 14 Days 14 Before exercise 125 30 60 90 14 After exercise 110 3 During exercise 103
70. t 1 800 227 8862 CAUTION If you test 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 Note If Comment Press OK appears at the bottom of the display your test result is outside the range of 90 130 mg dL or a personal glucose range you set see pages 62 76 Custom Meter Set up Sequence To add a comment to the test result see pages 77 81 Your Electronic Logbook Additional Feature After you complete a blood glucose test you can compare the result with your last test and your average for this time of day by pressing the down Arrow button B Your Result 1 04 Previous Bef Brkft Sep 13 02 Avg 9 55 pm 14 days 114 95 36 Discarding Used Test Strips and Lancets CAUTION 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 GEJ Remove the OneTouch UltraSoft Cap from the Sampler Twist the OneTouch UltraSoft Cap counterclockwise Optional Replace the protective disk on the used lancet by placing it on a hard surface and pushing the lancet tip into the disk G
71. t matches the code number on the test strip vial The new code number will flash on the display for about three seconds after which the meter will prompt you to Apply Blood V Example Checking the System with Control Solution ve 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 AE E are performing the test correctly o E Mim Mo nem e t is very important that you do s T this simple check routinely to S E uie VGl66 make sure you get an accurate ae result 12 Before you begin e Use only OneTouch Ultra Control Solution e Check the expiration date on the control solution vial Record the discard date date opened plus six months on the vial label Do Not use after expiration or discard date whichever comes first e Control solution meter and test strips should be at room temperature between 68 and 77 F between 20 and 25 C before testing with control solution see Specifications section on page 125 for blood testing temperature ranges e Shake the vial discard the first drop of control solution and wipe off the dispenser tip to ensure a good sample and an accurate result e Store the control solution tightly closed at temperatures below 86 F 30 C Do Not refrigerate WARNING Do Not swallow control solution it is not for huma
72. t test See Owner s Booklet WHAT IT MEANS Error message that indicates that the blood or control solution sample was applied before Apply Blood Alternate Site or Control Solution appeared on the display 1 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 6 44 C ACTION Repeat the test with a new test strip Apply the blood or control solution sample only after Apply Blood Alternate Site or Control Solution appears on the display Refer to pages 33 35 for information on sample application a If you tested in a cool environment repeat the test in a warmer environment with a new test strip If you were testing in a normal or warm environment repeat the test with a new test strip see pages 7 8 for test strip information MESSAGE A WARNING A Error 4 Strip problem Please repeat test See Owner s Booklet N WARNING A Error 5 Invalid test Please repeat test See Owner s Booklet WHAT IT MEANS 2 The sample was improperly applied 3 There may be a problem with the test strip For example it may have been damaged or moved during testing 1 Error message that indicates the meter has detected a problem with the test strip Possible causes are test strip damage or an incompletely filled confirmation window 2 Th
73. terol unit of measure Beep on or off To change any of these settings press the OK button with Settings highlighted on the Set up Menu Each setting has a pop up menu of available choices You must review all five settings and choose one for each Press the OK button to save them After setting the last setting the Beep press the OK button to save your settings before turning off the meter or allowing it to turn off automatically You may set your meter to use a 12 hour am pm time format or a 24 hour military time format 24 00 Use the Arrow button to view the choices Highlight your choice and press the OK button gl Settings TE Date Format Begin of week Sunday Cholesterol Units mg dL Beep Settings You may choose between the Month Day Year date format e g July 5 2002 or the Day Month Year format e g 5 July 2002 Highlight your choice and press the OK button Time Format am pm Prime PVA AA Begin of week DD MM YY Cholesterol Units mg dL Beep ON 66 Settings For record keeping purposes you may Time Format am pm begin your week on Sunday or Monday Date Format MM DD YY Use the Arrow button 8 to highlight your EEEE choice and press the OK button CholesterolUnits Monday Beep ON The cholesterol unit of measure may be oan either mg dL used in the U S and some ue Pads modu European countries or mmol L used Begin f week Sunday in Canada and many oth
74. test strip vial is for OneTouch Ultra Control EM Solution only It is not a a 5 recommended range for i S i 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 When using Control Solution mode very high or very low readings will be displayed as a number rather than a HIGH or LOW warning screen Control solution out of range results may be due to Incorrect unit of Failure to discard the measure first drop of control Error in performing solution and wipe the the test dispenser tip clean Failure to shake the Expired or control solution vial contaminated control solution well The meter test strips or control solution are too warm or too cold Improper meter coding Test strip deterioration SOCIEERIAMRREHOIN Testing blood in Control Solution mode CAUTION If you continue to get control solution test results that fall outside of the range printed on the test strip vial the system may not be working properly Do Not use the meter Call LifeScan Customer Service at 1 800 227 8862 TESTING YOUR BLOOD Read this section and the test strip package insert carefully before testing Make sure you have all items needed to test e OneTouch UltraSmart Meter e OneTouch Ultra Test Strips e
75. to your personal daily schedule Otherwise some FastFacts information will not be correct You do not need to change any of the meter settings in order to begin testing Simply insert a test strip to turn on the meter and proceed with the test see pages 19 39 The OneTouch UltraSmart Meter was pre set at the factory with the date and Pacific Standard Time and display language The glucose units are pre set at the factory and cannot be changed You must enter Set up mode to Change the date time or display language Glucose units cannot be changed e Customize the meter features that allow you to track diabetes pills insulin doses and insulin pump information e Customize advanced features such as averages meal schedule target glucose range and hypoglycemia level Entering Basic Set up Mode To enter Set up mode press and hold down BOTH the Back button 9 and the OK button at the same time for at least two seconds 58 This message will appear briefly The language menu will follow immediately The meter is now in Set up mode The ONEIOUCH SmartButtons cannot be used while you UltraSmart are in Set up mode You may still test at any time simply by inserting a test strip Selecting Display Language The meter is set at the factory to use English Set up in Espafiol To use English press the OK button Qf Francais Deutsch Italiano Portugu s Nederlands
76. ton see page 78 MESSAGE Sep 14 02 9 45 am Check Ketones Comment Press OK 4A V Example Sep 14 02 9 30 am mg dL Do you need a snack Comment Press OK A V Example WHAT IT MEANS A blood glucose test result in the range of 240 mg dL to 600 mg dL with a suggestion to check your ketone levels When your blood glucose result is from 20 mg dL through 59 mg dL Do you need a snack will appear on the display with the test result reminding you that a meal or snack may be necessary ACTION Follow the instructions of your healthcare professional regarding ketone testing Follow the instructions of your healthcare professional WARNINGS AND ERROR 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 a warning or an error message In the event of a problem refer to the information under ACTION Assistance is available from LifeScan Customer Service at 1 800 227 8862 Contact us 7 days a week 8 a m 10 p m Eastern Time MESSAGE A WARNING A LOW GLUCOSE Below 20 mg dL N WARNING A HIGH GLUCOSE Above 600 mg dL WHAT IT MEANS You may have a very low blood glucose level lower than 20 mg dL You may have a very high blood glucose level exceeding 600 mg dL ACTION Tre
77. ts you have taken over the Pump Daily Total past 24 hours and press the OK button When entering data the value will start at the value you last saved Ji Sep 8 02 9 20 pm Meds Entry Pill A When you have completed your Pill B medication logbook entries select InsulinA Exit Meds Entry InsulinB Pump Bolus ANRA V Logbook Sep 8 02 9 20pm A Y Total 25 2 Your daily pump total will be saved this way in your electronic logbook 100 FOOD LOGBOOK ENTRIES Food and blood glucose levels are closely linked Logbook entries allow you to keep track of important nutritional information for each meal or snack by type of nutrient Food Entry Add New Entry for Sep 8 02 5 26 pm select either the current date and time or Other Time Press the Food SmartButton and Sep 8 02 5 26 pm Food Entry Then enter the type of meal from the meal menu You may also record alcohol did usage Snack Alcohol 101 Dinner Information y Dinner Information Carbs 60 Fats 15 Calories Proteins y Logbook Sep 8 02 5 26 pm Dinner Carbs Fats Calories You may enter carbohydrates carbs fats and proteins in the range of o to 250 in 1 unit steps Carbohydrates may be entered as units or grams whichever you prefer Calories may be entered in 5 unit steps in the range of o to 2550 Use the Arrow button to change the units for each item I
78. tton Review test results and logbook memory Note For complete information on using the Exercise Health Medication and Food SmartButtons please see pages 82 107 See pages 108 122 for more information on the FastFacts Feature and the FastFacts SmartButton Display Symbols These symbols guide you while using your meter Meaning Scroll move up only Scroll down only Scroll up or down Scroll up or down No entry Shows where you are on the HIGHLIGHT display Press the OK button to accept highlighted area Display Contrast You can change the contrast of the meter display To make it darker press and hold both the Back button and the up Arrow button B To make it lighter press and hold both the Back button and the down Arrow button Bl OneTouch Ultra Test Strips The OneTouch UltraSmart System measures the amount of glucose in whole blood Blood is applied to 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 WARNING Do Not swallow test strips The
79. turn on the meter The icon for the category you are choosing will appear in the upper left hand corner of the display and the title of the category will appear at the top of the display If you press a SmartButton in error either press another SmartButton or choose from the selection menu Before making a logbook entry the time must be selected Use the Arrow button B to choose either the date and time displayed or Other Time e Use the OK button to confirm your choices The logbook display will appear If no logbook display appears your entries have not been saved e It is possible to enter the same logbook entry information more than once for a given date and time e To remove an entry select from the menu e Prior to seeing the logbook display you may press the Back button and return to the previous display to review or edit the information you have stored e Press and hold the Back button to turn off the meter 84 Entering the Date and Time If the logbook entry is for the current date and time press the OK button C9 If the entry is for a previous date and time select Other Time and press the OK button A calendar will appear on the display Scroll to the correct month and day and press the OK button Ql Record the time in hours and minutes and press the OK button Note that am and pm change every 12 hours Then make your logbook entry 85
80. two menu choices will appear You may make health logbook entries for the current time or another time see page 85 Health Notes allow you to enter information about your day Select Health Notes and press the OK button Q Choose from this menu Stress Menses Feel Hypo Vacation Illness Other Press the OK button to save and view the logbook entry 87 q Logbook Sep 15 02 3 30 pm Ecm A Hard 00 10 Sep15 02 3 30 pm Health Entry Health Notes Health Checks Sep 15 02 3 30 pm Health Notes Stress Feel Hypo Illness Menses Vacation al The logbook entry with your Health Note Logbook will be saved this way in the electronic logbook Health Checks are another type of health logbook entry that you can record Health Checks include home and laboratory tests as well as doctors examinations All of this information is vital to a good diabetes management plan Health Checks may be stored in your electronic logbook at the time they occur or at some later time Sep 15 02 3 30 pm Health Entry Health Notes Health Checks Health Checks and press the OK To record check up information select button Choose from this menu Ketones Eye Exam HbA1c Foot Exam Microalbumin Weight Height Cholesterol Dr Visit Blood Pressure 88 Many Health Checks allow you to input numeric values In order to adjust the number use the Ar
81. ver the past 14 days is displayed The number in parentheses before the time segment is the number of logbook entries for that time period 14 Note Each time period includes the before and after period for that meal see pages 74 75 to change your schedule 116 Syringe Totals Insulin Intake To view the total of all individual insulins Regular taken by syringe or insulin pen that you NPH have previously stored in the logbook select Syringe Totals and press the OK button Pump Insulin Intake Syringe Totals Daily Average insulin intake over the last 7 14 30 60 You may view the daily average of your and 9o days example 14 days Daily Totals In this example the average number of insulin units taken over the last O edo 14 days appears The number shown in 14 Day Avg parentheses is the number of syringe Total Daily Insulin insulin entries over the time period An 24 6 asterisk after the number means there has been at least one day in the 18 time period without an entry 117 Insulin Intake Syringe Totals To view your total syringe insulin intake Daily Average for each day scroll to Daily Totals and press the OK button Insulin Intake Daily Totals Sep 15 02 If you did not record a syringe insulin intake for a particular day will appear in both columns Insulin Pump Insulin Intake Premixed Rap
82. wer to perform up to 540 tests depending on backlight use When replacing the batteries use only two AAA alkaline batteries The meter will alert you when the power is getting low by displaying two different messages A WARNING A Low Batteries You should replace the batteries soon 1 When this message appears on the display the batteries are low and should be replaced as soon as possible The backlight will no longer turn on See Owner s Booklet 2 When this message appears on the A WARNING A ies display you cannot test enter data Batteries in your electronic logbook or use the FastFacts feature until you change You MUST replace the batteries now the batteries See Owner s Booklet 43 To replace the batteries first turn off the meter Turn the meter over and locate the battery compartment pressing the tab to the left and lifting the battery compartment cover to remove it 1 Open the battery compartment by 2 Remove the old batteries by pulling the black ribbon upward Insert two AAA alkaline batteries on top of the black ribbon Plus and minus C signs will guide you in placing the batteries 3 Insert the tabs of the battery cover into the slots on the left hand side of the battery compartment Push down on the battery cover until you hear the tab click into place 44 Note Replacing the batteries does not affect the electronic logbook However the date and t
83. y 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 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 34 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 Good Sample Sample Too Small If the confirmation window is not full you may get an error message or an inaccurate test result Note If you do not apply a blood sample within three minutes the meter will turn off automatically Remove the test strip and then insert it back into the meter to turn the meter back on Sep 8 02 10 30 am AY Plasma Calibrated Result Example GEP 5 Accurate Results in Just 5 Seconds Your blood glucose test result will appear after the meter counts down from 5 to 1 The test results are automatically stored in the electronic logbook memory You may now e Use the Arrow button to compare results see Additional Feature which follows Add comments to your result Remove the test strip to turn off the meter 35 WARNING If mg dL does not appear with the test result call LifeScan Customer Service a

OneTouch UltraSmart ® Blood Glucose Monitoring System Owner`s

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OneTouch UltraSmart &reg; Blood Glucose Monitoring System Owner`s

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OneTouch UltraSmart ® Blood Glucose Monitoring System Owner`s