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OneTouch ® UltraSmart ® User Guide

1. 0c ccc eee 73 76 Insulin DOSages csncwtaraaneedeaw seeders de 97 Insulin Intake 116 Insulin Pump eee eee eee 98 100 118 120 Insulin Pump Set up cece cece e ees 72 Insulin Set Up ccc cece ee eee ee eee 70 71 Intended lJse osi ek sada RE e RIEN iv Interface Cable OneTouch 122 124 Laboratory Results e eee ee ee eee 40 41 Lantets ngre REI 1 19 20 24 28 37 Lancet DispoSal c cece cece enes 37 Eot 4 01010 eens iil 4 77 107 109 110 Logbook Electronic lusus iii 77 107 Logbook Entries cece cece 82 107 Logbook Entries Editing or Deleting 103 105 107 Logbook Entries Exercise 83 86 87 Logbook Entries Food 83 101 102 Logbook Entries Health 83 87 94 Logbook Entries Medication 83 95 100 Low GIUCOSE 6 eee eee ee eens v 38 51 Maintenance Meter 0 cece e cece ees 42 Maintenance OneTouch UltraSoft Adjustable Blood Sampler LLL 42 Meal Schedule cc cece eee eee eee 72 75 Medication Logbook Entries 83 95 100 Medication Menu 0 cece eee eee eee 95 Medication SmartButton 4 5 77 82 83 MEMON osito o Raes ages e osten s 77 107 Message Check Ketones 00000 39 50 Message Snack 2 ccc cece eee eee 39 50 Messages Display
2. 31 Discarding Used Test Strips and Lancets 37 Special Messages sssri e E EA 38 COMPARING METER AND LABORATORY RESULTS 40 CARING FOR YOUR SYSTEM ener 42 Maintenance iere rettet terrenae EERE EEES 42 Cleaning the OneTouch UltraSoft Adjustable Blood Sampler 42 vi Batteries ittis 43 DISPLAY MESSAGES t roit iterato tetto 46 WARNINGS AND ERROR MESSAGES 51 PROBLEMS AND POSSIBLE CAUSES 56 METER SET UDP retis cie tees esteeteete cese itents 58 Entering Basic Set Up Mode 58 Selecting Display Language 59 Setting Date and Time recente 60 CUSTOM METER SET UP SEQUENCE 62 Setup Iz rj 62 SOLUS os cast veesbwesves E EEEE E 66 Diabetes Pill Set up eese 68 Insulin Set up eere 70 Insulin Pump Set up eere 72 Advanced Feature Set up esses 72 YOUR ELECTRONIC LOGBOOK eene 77 Comimiellec serie sites testet riste edens ire 77 Rules for Adding Comments 78 How to Add a Comment esses 78 LOgboOk Enltles eicere eene re retener 82 Using the SmartButtons esses 82 Rules for Logbook Entries ssss 84 Entering
3. No power Replace the batteries No batteries or batteries Check that the batteries are incorrectly installed correctly installed Test strip inserted incorrectly Insert the test strip correctly For example upside down with the contact bars end first backward or incompletely and facing up Push it in until it will go no further Defective meter or test strip Call the OneTouch Customer Care Line at 1 800 663 5521 56 If the test does not start after applying the sample POSSIBLE CAUSES WHAT TO DO Insufficient blood sample Repeat the test with a new test strip and a larger sample making sure blood is placed to the narrow channel in the top edge of the test strip Defective test strip Repeat the test with a new test strip Sample applied after automatic Repeat the test with a new test shutoff three minutes after strip apply sample only after inserting a test strip Apply Blood Alternate Site or Control Solution appears on the display Defective meter Call the OneTouch Customer Care Line at 1 800 663 5521 57 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 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 pr
4. e eee eee 46 50 Messages Error cee cece ccc eee eeee 51 55 Messages Special 0 eee eee eeee 38 39 Messages Warning essel 51 55 Millimoles per Litre 9 17 36 49 125 Off BUON i useseter eher E EX dar yer ERN 3 OK BUOM 55 ee ERR E SReERERCERREE EUER 3 OneTouch Diabetes Management Software cece ee ee eee 64 68 70 122 124 OneTouch Interface Cable 122 124 OneTouch Ultra Control Solution 1 12 18 OneTouch UltraClear Cap 1 19 28 30 OneTouch Ultra Test Strips 1 7 8 OneTouch UltraSmart Meter 1 3 OneTouch UltraSmart System 1 8 OneTouch UltraSoft Adjustable Blood Sampler 4 1 19 20 23 30 Owner s Booklet ccc cece cece eee n eens 1 Palmas ves ord RP EE 21 22 27 30 33 Problems and Possible Causes 56 57 132 Product Safety Information 065 126 Quick Reference Guide cc cece eee ees 1 Reduce Chance of Infection 065 20 Repeated Unexpected Results 06 V Schedule Meal 00 ccc ee cece eee 72 75 SCTUNGS c roses oerte nu pete att goes 66 67 Set up Basic Meter cece eee 58 61 Set up Custom Meter cee eee 62 76 Setup MENU xen bie dip een e ates 62 63 Specifications essare eesin eee 125 Syringe Totals ves ro RR ER REEF ERES 117 118 System O
5. 1 You may have high glucose and have tested in an environment near the low end of the system s operating temperature range 6 44 C 43 111 F 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 1 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 WHAT IT MEANS ACTION A WARNING A 2 The sample was 2 If you applied the D MERE improperly applied blood incorrectly review pages 33 35 on blood application and repeat the test with a new test strip Strip problem Please repeat test See Owner s Booklet 3 There may be a 3 If the error problem with the test message appears strip For example again call it may have been the OneTouch damaged or moved Customer Care Line during testing at 1 800 663 5521 A WARNING A 1 Error message that 1 Repeat the test ans indicates the meter has with a new test Invalid test detected a problem Strip Refer to with the test strip pages 33 35 for Possible causes are information on test strip damage or sample an incompletely filled application confir
6. 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 Aft Brkft 30 Bef Lunch 60 Bef Dinner 90 Aft Dinner Night 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 Average by QD Avg by Exercise Exercise 14 Days 30 60 90 14 Before exercise 6 9 3 During exercise 5 7 14 After exercise 6 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 4 0 7 0 mmol L and after meal ranges are factory set at 5 0 11 0 mmol L see pages 75 76 D Glucose Range Info Bef Meal Glucose TTT Range 4 0 7 0 Breakfast Before Meal Lunch Dinner After Meal Night Total Bef Brkft Glucose Bef Brkft Glucose Range 4 0 7 0 o Range 4 0 7 0 7 6 Above 20 14 E Days 60 b In Range 70 90 3 Below 10 115 INSULIN INTA
7. 20 pm Pill A IN a To enter your diabetes pills select the pill you have taken and press the OK button 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 After your medication logbook entry select Exit Meds Entry and press the OK button Q9 or select another item from the menu The logbook entry will be saved this way in your electronic logbook 96 Insulin Dosages 5 Sep8 029 20pm Meds Entry Enter an insulin dosage by highlighting an Pill A insulin type and press the OK button F iut InsulinA InsulinB Exit Meds Entry JB Sep8 02 9 20pm Then record the units of insulin The Meds Entry meter was set at the factory to record units in o 1 increments When entering InsulinA data the value will start at the value you last saved If you wish to record a second insulin D Sep 8 02 9 20 pm choose from the list and then enter the Meds Entry number of units Repeat these steps as Pill A needed After completing your insulin Ms logbook entry select Exit Meds Entry and press the OK button Ql Logbook Sep 8 02 9 20 pm The insulin dosage will be saved this way InsulinA ma in your electronic logbook 97 Insulin Pump You can enter insulin pump information as bolus entries or as a daily total B Sep 8 02 9 20 pm Meds Entry If you are entering bolus
8. Company 1994 959 41 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 power 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 b
9. Microalbumin at the value you last saved Scroll to your EE selection and press the OK button Qf 91 Cholesterol You may enter cholesterol test results in o 1 mmol L steps for Sep 15 02 3 30 pm e Total up to 225 9 mmol L Healih Checks e LDL up to gt 13 0 mmol L Cholesterol Total e HDL up to gt 13 0 mmol L LDL Triglycerides Trig up to gt 33 9 mmol L HDL mes To advance to the next cholesterol entry Trig id press the OK button To return to a previous cholesterol entry on this display press the Back button 9 Note When entering data the value will start at the value you last saved Blood Pressure 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 9 Sep 15 02 3 30 pm Health Checks When entering data the value will start 1201 E at the value you last saved Blood Pressure 92 Eye Exam Sep 15 02 3 30 pm Health Checks To record an eye examination select l Enter Eye Exam and press the OK button Enter Eye Exam Foot Exam 9 Sep 15 02 3 30 pm g P Health Checks To record a foot examination select Enter Foot Exam and press the OK button 93 Weight Height Sep 15 02 3 30 pm _ H
10. 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 iiie Arrow button to view the choices ON Highlight your choice and press the OK button You may choose between the Month am pm Day Year date format e g July 5 2002 MM DD YY Seances or the Day Month Year format e g Cholesterol Units Beep mmal 5 July 2002 Highlight your choice ON and press the OK button 66 For record keeping purposes you may begin your week on Sunday or Monday Use the Arrow button to highlight your choice and press the OK button QJ The cholesterol unit of measure may be either mmol L used in Canada and many other countries or mg dL used in the U S and some European countries Highlight your choice and press the OK 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 For silent meter operation highlight OFF and press the OK button 67 Settings Time Format am pm Date Format MM DD YY Begin of week Sunday Cholesterol Units Beep ON Settings Time Format am pm Date Format MM DD YY Begin of week Sunday Choleste
11. RESULTS Exercise Before During After Health Stress FeelHypo Illness Menses Vacation Other menstruation Medication 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 Ql 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 To remove an entry select from the menu Press and hold the Back button to turn off the meter e 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 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 yo
12. and time settings 45 DISPLAY MESSAGES Following is a summary of screen messages and symbols MESSAGE ONETOUCH Ultra mart Check Code AY WHAT IT MEANS 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 the OneTouch Customer Care Line at 1 800 663 5521 See Coding the Meter pages 10 12 MESSAGE 9 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 Q Check Code Press OK AY Example The meter is prompting you to confirm that the code number on the meter display matches the code number 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 n
13. be saved Food Aft Brkft Health HEALTH COMMENTS You can comment on the result with notes Sep 8 02 8 30 am about your overall health at the time of Sluc 7 5 Comment the test Press the OK button with rags Health highlighted You may add up to six comments from this menu Exer Stress Menses Save Feel Hypo menstruation Illness Vacation Other After adding your first health comment Sep 8 02 8 30 am m aM Gluc 7 5 Comment Health 2 will automatically appear on Food e the display To add additional health Health 1 Feel Hypo comments press the OK button and ness select the comment from the menu Note Exer Menses Vacation w that your previous comment is no longer Save available 80 When you have completed making comments scroll to Save and press the OK button QJ If you do not press the OK button QJ your entries will not be saved EXERCISE COMMENTS You can comment on a test result as occurring before during or after exercise After you add the exercise comment Save will automatically be highlighted If you press the OK button all of the comments you have entered will appear with the test result in the logbook 81 i Sep 8 02 8 30 am Gluc 7 5 Comment Food Aft Brkft Health 1 Stress Health 2 Exer Sep 8 02 8 30 am Gluc 7 5 Comment Food Aft Brkft Health 1 Health 2 Before Exer During Save Sep 8 02 8 30 am Gluc 7 5 Comment
14. cap Maintain pressure until the drop of blood is at least 1pL amp actual size Eid Remove the Sampler Carefully lift the sampler away from your skin Do Not smear the blood sample Note You may need to wait a little longer to get a large enough drop of blood from the forearm or palm Do Not squeeze the site excessively e Ifthe sample drop of blood runs or spreads due to contact with hair or with a line in your palm Do Not use that sample Try puncturing again in a smoother area Remember You may have to adjust the Sampler to a deeper setting to get a large enough drop of blood amp actual size 30 Step by Step Test Procedure S389 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 iid Select Test Mode Note There are three choices in test mode For blood testing use the Arrow button B to select e Apply Blood for fingertip blood sample e Alternate 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 Apply Bloo
15. e 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 call the OneTouch Customer Care Line at 1 800 663 5521 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 T Lancet with Ejection Cocking Control Protective Disk QneTouch UltraClear Cap for Alternate Site Release Button Sampling Puncture Settings Depth l y gt Indicator Lancet Point 4 Protective Disk OneTouch UltraSoft Cap CAUTION To reduce the chance of infection e Never share a lancet or the Sampler with anyone e Always use a new sterile lancet Lancets are for single use only Keep the OneTouch UltraSmart Meter and Sampler clean Make sure to wash the puncture site with soap and wa
16. information Pill A uis select Pump Bolus and press the OK InsulinA InsulinB button o A Pump Daily Total Y 0 Sep 8 02 9 20pm Meds Entry Then enter the units in o 1 steps and press the OK button When entering Pump Bolus data the value will start at the value you last saved 98 JB Sep 8 02 9 20 pm Meds Entry If you have completed your medication DR logbook entry select Exit Meds Entry InsuinA nsulin Pump Daily Total Exit Meds Entry 0 Logbook Sep 8 02 9 20pm A ett The dosage will be saved this way in your Bolus 0 1 electronic logbook JB Sep 8 02 9 20 pm Meds Entry To enter your pump total for the day PIIA scroll to Pump Daily Total and press the PUB OK button Insulin Pump Bolus Pump Daily Total xd 99 ud E Use the Arrow button B to scroll to the number of units you have taken over the Pump Daily Total past 24 hours and press the OK button Ql When entering data the value will start at the value you last saved JB Sep 8 02 9 20 pm Meds Entry PlH When you have completed your e medication logbook entries select ui 1 InsulinB Exit Meds Entry Pump Bolus Exit Meds Entry Logbook 9 20pm A Daily 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 o
17. pc 108 122 FastFacts Feature cc eee ceeeee 108 122 FastFacts Menu ee cece cerees 108 109 FastFacts SmartButton 4 5 82 108 Fingertip Testing Procedure 4 23 26 Food AVerageS cee cc eee cece eee e eee 109 121 Food Comments cece e eee ee eee 79 80 Food Logbook Entries 000 101 102 Food SmartButton 4 5 77 82 83 Forearm tia cutee tse EE bean 21 22 27 30 33 Forearm or Palm Sampling Important Information 06 21 22 Format Date osse ERR PERROS URS 64 66 Format Tie is sy eres m RE RE 64 66 Glucose Analysis leues 109 111 115 Glucose by Meals 2 ee eee eee eee 109 110 Glucose Graph Interactive 111 113 Glucose Range cece cece eee 73 76 115 Graph All ResultS 05 109 111 112 Graph Time of Day 06 109 112 113 Guarantee s ovde scere piu Pe REMO EE IMP IC Ted 127 Health Checks 00 cece 87 94 109 121 Health Comments 0c cece eens 80 81 Health Logbook Entries 87 94 Health Notes ccc cece cece eee eee 87 88 Health SmartButton 4 5 77 82 83 130 High Glucose 6 cece eee e ees v 38 51 Hyperglycemia llus v 38 39 50 51 Hypoglycemia V 21 22 38 39 50 51 Hypoglycemia Information Hypo Info 109 120 Hypoglycemia Level
18. the chosen meal or at night will appear Use the Arrow button B to view more entries QD Glucose by Meals _ Glucose by Meals Bef Brkft Aft Brkft Breakfast Dec12 4 4 6 7 Lunch Dec 11 5 6 6 4 i Dec 10 39 6 9 D D Dec 10 78 Night Dec9 39 69 v 110 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 Q9 D Glucose Analysis 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 result 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 16 7 mmol L or below 2 8 mmol L 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 You may scroll backward or forward in time using the Arrow button to move from one point to another Individual test results
19. will go no further EEA WARNING Do Not swallow test strips The 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 30 C 86 F 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 Write the discard date 3 months after first opening the vial on the vial label when you first open it Discard remaining OneTouch Ultra Test Strips after the discard date 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
20. 0 30am 4 Your edited comment will appear this way in your electronic logbook EDITING OR DELETING ELECTRONIC LOGBOOK ENTRY Example All electronic logbook entries are edited Logbook or deleted in the same way Use the Sep 15 02 5 26 pm Arrow button to highlight the electronic 4 logbook entry you wish to change and caros p press the OK button Ql Sep 15 02 5 26 pm Food Entry Press the OK button to edit H Edit 105 Make sure the icon date and time and W Sep 15 02 5 26 pm description are correct If you make an ERR error press the Back button to return Breakfast to the menu Press the OK button on the selected mealtime If you wish to Snack change the entry to another mealtime Alcohol scroll to the mealtime and press the OK button Ql y Dinner Information Carbs EN To keep the entry as it is press the Fats 15 OK button Calories Proteins y Dinner Information Carbs To change the entry use the Arrow button Fats 15 B and press the OK button Calories Proteins 106 Logbook s s Sep 15 02 5 26 pm The edited entry will appear this way in your electronic logbook E a Logbook Sep 15 02 3 30 pm To delete an entry highlight the entry and ECS ON press the OK button Hard 00 10 Sep 15 02 3 30 pm Exercise Entry Use the Arrow button 8 to select Edit Delete and press the OK button Delete Sep 15 02 3 30 pm Exer
21. Food Aft Brkft Health1 Stress Health 2 Exer After 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 Medication O Food O LOGBOOK ENTRIES Mild Duration enter Moderate length of time Hard Health Notes Stress Menses Feel Hypo menstruation Illness Vacation Other Health Checks Ketones Eye Exam HbA1c Foot Exam Microalbumin Weight Height Cholesterol Dr Visit Blood Pressure Pills 1 5 and how many of each Insulin 1 3 and units Insulin Pump Carbs Fats Calories Proteins 83 Rules for Logbook Entries e f you wish to add a logbook entry press a SmartButton to turn on the meter The icon for the category you are choosing will appear in the upper l
22. KE Choose Insulin Intake from the FastFacts Menu QD Insulin Intake The individual insulins in this example Regular and NPH are based on insulins NPH selected in the Set up mode see pages 70 71 Use the Arrow button to move to Syringe Totals X your selection and press the OK button Pump 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 Days Rey Aid In this example the average intake of 14 Breakfast 80 A Regular insulin over the past 14 days is 0am Tisgdam displayed The number in parentheses iub cT before the time segment is the number of logbook entries for that time period Note Each time period includes the before and after period for that meal see pages 74 75 to change your schedule 116 Syringe Totals QD Insulin Intake To view the total of all individual insulins taken by syringe or insulin pen that you Regular have previously stored in the logbook dui select Syringe Totals and press the OK button Pump QD Insulin Intake Syringe Totals Daily Average Daily Totals insulin intake over the last 7 14 30 60 You may view the daily average of your L and 9o days example 14 days In this example the average number of insulin units taken over the last QD nsulin Intake Syringe Totals 14 d
23. ONE IOUCH UltraSrrnart M Meter and Electronic Logbook In One Owner s Booklet ONETOUCH ONE TOUCH UltraSmart Blood Glucose Monitoring System 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 1pL microlitre 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 pla
24. Touch UltraSmart Meter with the OneTouch Ultra Test Strips for accurate results You must code the meter before using it for the first time and then every time you change to another vial of test strips 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 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 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 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 11 Code the Meter Move up or down using the Arrow butto
25. able to set beginning Personal Schedule or start times for each mealtime End Bef Brkt 5 00a 800a Aft Brkft 8 00a 10 00a times will change to match the start time Bef Lunch EEY 12 00 p of the next time period For example if AftLunch 1200p 300p l hi ll t Bef Bef Dinner 3 00p 7 00p your lunch is usually at 12 00 noon Be AfDimer 700p 1200 Lunch could be 10 00am to 12 00pm Night 12 00a 500a Personal Schedule Bef Brkft 5 00a 8 00a Aft Brkft 8 00 a 10 00a After changing the times press the Bef Lunch 1000a 12 00 p OK button to save your personal AftLunch 12 00 300p schedu le Bef Dinner 3 00 p 7 00p Aft Dinner 7 00 p 12 00a Night IPAMEM 500a 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 75 AdvancedFeatures Averages 14 day Schedule Pre set Glucose Range Before Meal After Meal Hypo Level Advanced Features Averages 14 day Schedule Pre set Glucose Range Before Meal 4 0 7 0 After Meal 11 0 Hypo Level 3 9 Advanced Features Averages 14 Day Schedule Pre set Glucose Range Before Meal 4 0 7 0 After Meal 5 0 11 0 Hypo Level Set up Menu Settings Diabetes Pill Set up Insulin Set up Insulin Pump Advanced Featu
26. ample WHAT IT MEANS A blood glucose test result in the range of 13 3 mmol L to 33 3 mmol L with a suggestion to check your ketone levels When your blood glucose result is from 1 1 mmol L through 3 3 mmol L 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 the OneTouch Customer Care Line at 1 800 663 5521 MESSAGE A WARNING A LOW GLUCOSE Below 1 1 mmol L A WARNING A HIGH GLUCOSE Above 33 3 mmol L WHAT IT MEANS You may have a very low blood glucose level lower than 1 1 mmol L You may have a very high blood glucose level exceeding 33 3 mmol L ACTION Treat 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 l
27. ange printed on the test strip vial is for OneTouch Ultra Control Solution only It is not a recommended range for RANGE your blood glucose level CONTROL OE 17 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 e Error in performing solution and wipe the the test dispenser tip clean e Failure to shake the e Expired or contaminated control solution vial control solution well The meter test strips e Improper meter coding control solution are ee too warm or too cold Test strip deterioration Testing blood in Control e Meter malfunction Salusionmode 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 the OneTouch Customer Care Line at 1 800 663 5521 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 OneTouch Ultra Test Strips
28. are experiencing symptoms that are not consistent with your blood 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 BURON S seeded oerte trece runs 3 SmartButtons ee eeseeseeeeseesseeeseeeeseeesseeeeeesees 4 Display SVMDO S3siiceccceceesesetestcctectesseerestestevtecsesesaes 6 Display Contrast esee 6 OneTouch Ultra Test Strips 7 BEFORE TESTING cscisecsccsocecceoccossoceoseoseoseoseoseoseoseoseoseaces 9 Checking the Display eese 9 Setting the Meter reete 9 Coding the Meter eese 10 Checking the System with Control Solution 12 TESTING YOUR BEOOBD iecore eot 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
29. ation about your day Sep 15 02 3 30 pm Health Entry Select Health Notes and press the OK button Q Health Checks Choose from this menu Stress Menses Sep 15 02 3 30 pm Feel Hypo menstruation Health Notes Illness Vacation E Other Feel Hypo Illness Menses Press the OK button to save and view Vacation the logbook entry 87 Logbook will be saved this way in the electronic nM A The logbook entry with your Health Note 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 Sept5 02 3 30 pm Health Entry To record check up information select Health N DS Health Checks and press the OK button Health Checks 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 Arrow 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 Che
30. ays appears The number shown in parentheses is the number of syringe insulin entries over the time period An 24 6 asterisk after the number means there has been at least one day in the time 18 period without an entry 14 Day Avg Total Daily Insulin 117 QD 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 Ql QD Insulin Intake Daily Totals en i If you did not record a syringe insulin mE intake for a particular day will Sep 12 appear in both columns Sep 11 02 Sep 10 Insulin Pump Insulin Intake Regular Select Pump to view bolus intake daily NER averages and daily totals You can review Syringe Totals the last 7 14 30 60 or 90 days 118 Insulin Intake Pump Bolus will display your average bolus Bolus intake for each mealtime Breakfast Bolus Lunch Dinner Night based on your Daily Average schedule see pages 73 76 Daily Totals Pump Bolus 14 Day Avg This example shows the average bolus 14 Breakfast G0 4 6 00am 11 00am intake in units by time The number of 14 Lunch logbook entries appears in parentheses 0 oc vu 11 00am 5 00pm Daily Average displays the average of Insulin Intake the total daily pump insulin This example T SS is for the last 14 days The number of Total Daily entries is l
31. be ance highlighted Insulin Pump Advanced Features Exit Set up 63 Following is a summary of meter settings Meter Settings OPTION Settings Time Format Date Format Begin of Week Cholesterol Units Beep FACTORY SETTINGS CUSTOM SETTINGS am pm MM DD YY Sunday mmol L ON 24 hour DD MM YY Monday mg dL OFF Diabetes Pill Set Up Pill A Pill B Pill Ato E or Customize with OneTouch Diabetes Management Software Insulin Set Up InsulinA InsulinB 64 Rapid Regular 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 7 30 60 90 days Schedule Pre set see pages Personal 74 75 Glucose Range Before Meal 4 0 7 0 mmol L Personal After Meal 5 0 11 0 mmol L Personal Hypo Level 3 9 mmol L Personal 65 Settings Date Format Begin of week Cholesterol Units Beep Settings Time Format Settings Settings include Time format e Date format Beginning of the week Cholesterol unit of measure Beep on or off To change any of these settings press the OK button Q9 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
32. ch UltraSmart Meter OneTouch Ultra Test Strip i Test Port The meter turns on when you insert the OneTouch Ultra Test Strip here ONETOUCH UltraSmart ETE ne 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
33. cise Entry Your entry will be deleted from the Entry electronic logbook removed 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 o FastFacts Glucose by Meals J The FastFacts menu lists several choices See the next page for a description of what Glucose Analysis Insulin Intake x i k is available under each choice Hypo Info Food Averages Health Checks v 108 FastFacts Menu Logbook m Glucose test results with comments 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 Graph by Time of Day Graph of glucose results by time of day Average of All Results Average of all results taken for the last 7 14 30 60 and 90 days Average by Time of Day Averages by time of day for the last 7 14 30 60 and 90 days Averages by Exercise Glucose averages before during and after exercise for the last 7 14 30 60 and 90 days Glucose Range Info Pe
34. cks and press the OK button Ql Your Health Check entry will be saved in the electronic logbook Ketones Sep 15 02 3 30 pm Health Checks When you check ketones you can enter the results in your electronic logbook Results may be Negative Moderate Relofido Trace Large Small 9 Sep 15 02 3 30 pm Health Checks Scroll to your selection and press the OK button Ketones 89 You will return to the Health Checks menu Sep 15 02 3 30 pm with Exit Health Checks highlighted If Mealih Checks you are finished with your entries press Blood Pressure A GA arai Eye Exam the OK button with Exit Health Foot Exam Checks highlighted If you wish to enter ede other Health Checks use the Arrow button Exit Health Checks fg B to scroll to the additional menu choice and press the OK button Logbook Sep 15 02 3 30 pm Kors Moeata A Your entry will be saved this way in the electronic logbook 90 HbA1c Tests for hemoglobin Atc also known Sep 15 02 3 30 pm Health Checks as HbA1c or Alc can be recorded from 4 to 15 in 0 1 steps When entering data the value will start at the value you HbA1c last saved Scroll to your selection and press the OK button 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
35. d cece eee eee 79 80 Comments Health 00000 80 81 Comment Press OK cee cee cece eee 36 Confirmation Window 000ee 7 34 35 Contact Bars seb RIPE REPE ES 7 31 Control Solution Before you begin 13 Control Solution Checking the System with 12 Control Solution OneTouch Ultra 1 12 18 Control Solution Out of range results 17 18 Custom Meter Set up Sequence 62 76 Data Downloading 0 eee 122 124 Data Port ossi e eean e aoa eee ee 2 123 Date and Time Entering 00055 85 Date and Time Setting 005 60 61 Date Format sii siii a aiia nae eee PEE S 64 66 Dehydration s csscessca e ree RR ern V 41 Diabetes Pill Set up 2 eee eee 68 69 Diabetes Pills 96 Display Contrast cece eee eee ee eee ees 6 Display Language cece eee eee 59 Display Meter 0 cece cece ees 2 9 Display Symbols eee e cece ee eee 6 Editing Comments eee eee 103 105 Editing Logbook Entries 105 107 Electronic Logbook eee ee iii 77 107 Entries Logbook 00 cece eeees 82 107 Error Messages eee ee cee ce eee eee 51 55 Exercise Comments ccc cee cece eeeees 81 Exercise Logbook Entries 005 86 87 Exercise SmartButton 4 5 77 82 83 86 FASTRACIS erice
36. d will appear on the display first If you are testing with a fingertip blood sample proceed to Step 3 PF dia If you are testing with a blood sample 4 from the forearm or palm use the Arrow button to scroll to Alternate Site AY 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 32 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 Palm 33 Apply Sample Obtain a round drop of blood using the Sampler The blood sample must be at least 1 pL in volume amp actual size to fill the confirmation window Touch and hold the drop of blood to the narrow channel in the top edge of the test strip Do Not apply sample to the front or back of the test strip Do Not push your finger against the test strip Do Not apply a smeared sample Hold the blood drop to the top edge of the test strip until the confirmation window is full before the mete
37. d the smaller dots on the Sampler for a shallow puncture or toward the larger dots for a deeper puncture 24 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 Edd 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 25 Get a Round Drop of Blood Gently squeeze and or massage your fingertip until a round drop of blood at least 1pL amp actual 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 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 t
38. ealth Checks Enter your weight in 0 5 pound steps Weight 160 5 and your height in 0 5 inch steps When entering data the value will start at the Height 70 0 value you last saved Doctor Visit 9 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 JD Meds Entry access the menu You may track your tee ae diabetes pills insulin types and dosages and insulin pump information Select the Sep 8 02 9 20 pm current date and time or Other Time see page 85 Add New Entry for If you entered 0 pills 0 insulin and No for pump in the Set up mode this B ease use Set up mode message will appear To select your to select pills insulin or medications return to Set up mode pump functions see Custom Meter Set up Sequence pages 62 76 Medication Menu 5 Sep 8 02 9 20 pm The medication menu reflects your input Meds Entry in the Set up mode see pages 68 72 If you entered diabetes pills insulin Pill B and or insulin pump information it will n appear on the display as in this example Exit Meds Entry 95 Diabetes Pills B Sep 8 02 9 20 pm Meds Entry Pill B InsulinA InsulinB Exit Meds Entry D Sep 8 02 9 20 pm Meds Entry Pill A Sep 8 02 9 20 pm Meds Entry PillB InsulinA InsulinB Exit Meds Entry Logbook Sep 8 02 9
39. eft 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 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 If the entry is for a previous date and time select Other Time and press the OK button Q 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 Exercise Entry Add New Entry for Sep 15 02 3 30 pm Other Time Exercise Ent
40. evel 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 the OneTouch Customer Care Line at 1 800 663 5521 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 the OneTouch Customer Care Line at 1 800 663 5521 MESSAGE A WARNING A Error 3 Meter not ready Please repeat test See Owner s Booklet A WARNING A Error 4 Strip problem Please repeat 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
41. f important nutritional information for each meal or snack by type of nutrient Food Entry Press the Food SmartButton and Add New Entry for select either the current date and time or Other Time Sep 15 02 5 26 pm Other Time Sep 15 02 5 26 pm Food Entry Breakfast Lunch Snack Alcohol meal menu You may also record alcohol Then enter the type of meal from the usage 101 You may enter carbohydrates carbs fats and proteins in the range of o to 250 in 1 unit steps Carbohydrates may be entered y Dinner as units or grams whichever you prefer Information Calories may be entered in 5 unit steps Carbs Ey in the range of o to 2550 Use the Arrow Fats be button to change the units for each Calories E item If you do not wish to enter units for Proteins m an item select and press the OK button Do Not enter 0 because it will be included in your FastFacts averages see page 108 Dinner Information Carbs 60 Press the OK button to advance to Fats 15 the next nutrient To return to a previous Calories nutrient press the Back button amp Proteins Le Note When entering data the value will start at the value you last saved O Logbook Sep 15 02 5 26 pm E Your food logbook entry will be saved this Fats way in the electronic logbook Calories 102 Adding Changing or Deleting Logbook Information Step 1 Press the FastFacts SmartButt
42. health Enter insulin and diabetes pill information FastFacts SmartButton 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 BCE 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 8 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
43. ic Shutoff Three minutes after inserting a test strip if sample has not been applied one minute after all other user actions Size Approx 9 4 cm L x 5 8 cm W x2 1cm H Weight 79 grams with batteries Operating Ranges Temperature 6 449C 43 111 F Relative humidity 10 90 Hematocrit 30 55 125 PRODUCT SAFETY INFORMATION The OneTouch UltraSmart System complies with the following standards CAN CSA Canadian Standards Association CAN CSA 22 2 No 601 1 94 CAN CSA 22 2 No 601 1 2 94 e Internally powered equipment Battery operated with two 1 5 volt AAA alkaline batteries e 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 See Accompanying Documentation Read and understand your Owner s Booklet and test strip package insert before using this system Q 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 g
44. isted in parentheses An Pump Insulin asterisk means there are days with 52 3 y no entries 12 119 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 o Insulin Intake Pump Daily Totals Sep 14 02 85 0 Sep 14 02 92 0 Sep 13 02 82 5 Sep 12 02 76 5 Sep 10 02 840 v 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 meals and during the night for the last 7 14 30 60 and 90 days is displayed Use the Arrow button to view the other time periods Hypo Info 3 9 mmol L or less Total 14 Days Bef Brkft Aft Brkft Bef Lunch Aft Lunch Hypo Info 3 9 mmol L or less 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 D Food Averages 7l Breakfast 14 a Avg 14 60 14 Fats 90 10 Calories L 12 Proteins HEALTH CHECKS To view results and dates of various check ups se
45. lect 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 Health Checks trace 120 80 150 0 67 0 done 5 2 10 4 Sep 3 024 Sep 3 02 Sep 3 02 Sep 3 02 Sep 3 02 Sep 3 02 Sep 3 02v HbA1c Sep 3 02 Jul 14 02 121 SOURCES FOR HELP Information This choice prompts you to contact Contact LifeScan Customer Service or visit our CUM a Web site when you need help with testing Call the OneTouch Customer or isit the Website at al LTES canco Care Line at 1 800 663 5521 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 OneTouch ca or call the OneTouch Customer Care Line at 1 800 663 5521 122 E134 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 Connect the OneTouch Interface Cable Connect the OneTouch Interface Cable to an available por
46. lin 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 Eid Remove the OneTouch UltraSoft Cap by Twisting it Off 23 Wi 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 Replace the OneTouch UltraSoft Cap by Twisting it Back On Until it is Snug Adjust the Depth Setting If necessary twist the depth adjustment knob towar
47. mation window Please repeat test See Owner s Booklet 2 There may bea 2 If the error message problem with the appears again call meter the OneTouch Customer Care Line at 1 800 663 5521 MESSAGE A WARNING A Low Batteries You should replace the batteries soon See Owner s Booklet You MUST replace the batteries now A WARNING A Batteries See Owner s Booklet A WARNING AV Meter is outside of operating temperature range Test not possible See Owner s Booklet WHAT IT MEANS The battery sign appears on the display The power of the batteries is getting low The backlight will be disabled when the battery sign is displayed You can complete about 100 more tests from the time this symbol first appears Battery power is too low to run a test The meter has detected that the temperature is outside the system operating range Do Not perform a test until the meter and test strips reach a temperature within the operating range 6 44 C 43 111 F ACTION Test results will still be accurate but replace the batteries as soon as possible Replace the batteries at once Perform the test after the meter and test strips have reached a temperature within the operating range PROBLEMS AND POSSIBLE CAUSES If the meter does not turn on after inserting a test strip or the display is not active POSSIBLE CAUSES WHAT TO DO
48. mize customize it Select Yes press the OK your meter now button QI if you wish to customize other Yes meter settings see Custom Meter Set up Sequence pages 62 76 D tt tomi If you select No use Arrow button B Purmer non 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 After completing Basic Set up choose Yes Yes to customize your meter 62 Please use your Owner s You should have your OneTouch Booklet to help you set UltraSmart Owner s Booklet available up your aes OneTouch to refer to while customizing the meter UltraSmart Set up Menu Set up Menu will appear on the display Diabetes Pill Set with a list of options Settings will
49. n A warranty registration card is included with your OneTouch UltraSmart System Please complete it and mail it to us if you prefer to fill it out online please visit www OneTouch ca 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 sys
50. n B to the code number that 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 Example Checking the System with Control Solution Why you should do a control solution test OneTouch Ultra Control Solution is used to check that the meter and the test strips are working together as a system and that you are performing the test correctly pd LI EN E in z 1 E 3 1 E e t is very important that you do this simple check routinely to make sure you get an accurate result gt x E Z 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 three 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 20 and 25 C between 68 and 77 F 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 30 C 86 F Do Not refrigerate WARNING Do Not swallow co
51. ntrol solution it is not for human 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 e If you have had repeated unexpected blood glucose results as described on page v e After dropping the meter Note Refer to additional information in the OneTouch Ultra Control Solution package dd 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 A Gy c Ln Example 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 Eid Select Control Solution Apply Blood b O AY 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 to select one Do Not apply a sample until your choice appears on f t4 the displa
52. nvironment 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 before meal range of 4 0 7 0 mmol L or after meal range of 5 0 11 0 mmol L 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 Your Result 5 8 Pes a After you complete a blood glucose test you Sep 7 02 Ag can compare the result with your last test 959PM 14days and your average for this time of day by 6 3 5 3 pressing the down Arrow button Bl AY Example 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 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 iig 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 objec
53. o increase blood flow Forearm 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 L OneTouch UltraClear Cap 8 is used for forearm and palm d sampling only Replace the aay blue OneTouch UltraSoft Cap with the OneTouch Blue cap for fingertip sampling only UltraClear Cap Remove the OneTouch UltraSoft Cap by Twisting it Off Eid 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 Twist On the OneTouch UltraClear Cap Until it is Snug 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 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 Eid Puncture Your Forearm or Palm Press and hold the Sampler against your forearm 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
54. oceed with the test see pages 19 39 The OneTouch UltraSmart Meter was pre set at the factory with the date and Eastern 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 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 ONETOUCH 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 A i Espafio To use English press the OK button Ql F Frangais eutsci Italiano Portugu s Nederlands 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 To change the language use the Arrow button to scroll to
55. on 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 amp to scroll through your logbook entries Logbook Note the location of the highlight in 1 the logbook display Note also on the ea right hand margin the arrows A Y 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 To edit or delete a comment be sure D Logbook the highlight is on the glucose test result pe y to which the comment is attached Aft Brkft Press the OK button see page 105 for electronic logbook entry example 103 Sep 8 02 10 30 am Gluc 6 9 Comment Food Aft Brkft _ To change the mealtime select Food Actum and press the OK button Ql Exer Save Sep 8 02 10 30 am Gluc 6 9 Comment Scroll to the desired mealtime and press Health the OK button again Exer Bef Lunch Save AftLunch wv Sep 8 02 10 30 am You may edit other comments at this time Gluc 6 9 Comment _ To delete a comment scroll to and Food Bef Lunch press the OK button When you have completed editing the comments scroll to Exer Save and press the OK button Ql 104 Logbook Sep 8 02 1
56. ouch Diabetes Management Software Using the Arrow button B scroll down to your choice and press the OK button Ql Pill 2 will be highlighted automatically To enter a second type of diabetes pill choose Pill B E to describe the second pill and press the OK button Repeat these steps to enter other pill types If you have completed your diabetes pill choices select Save and press the OK button QJ If necessary press the Back button amp to re enter pill types 69 Diabetes Pill Set up Select Pills Diabetes Pill Set up Select Pills Pill 1 Pill B Pill C Pill 2 Pill E Diabetes Pill Set up Pill 1 Pill A Pill 2 Pill B 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 il Set up Choose Insulin Set up on the Set up Insulin Set up Menu and press the OK button Insulin Pump aa pressi 9 Advanced Features Exit Set up Scroll to the number of insulin types you Insulin Set up use and press the OK button You can How many type ins
57. r 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 the OneTouch Customer Care Line at 1 800 663 5521 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 SULE Accurate Results in Just 5 Seconds Sep 8 02 8 30am Your blood glucose test result will appear after the meter counts down from 5 to 1 u The test results are automatically stored in mmol L the electronic logbook memory You may iv now g Plasma Calibrated Result Use the Arrow button to compare results Example see Additional Feature which follows Add comments to your result Remove the test strip to turn off the meter 35 WARNING If mmol L does not appear with the test result call the OneTouch Customer Care Line at 1 800 663 5521 CAUTION If you test at the low end of the operating range 6 C 43 F and your glucose is high over 10 0 mmol L the reading on your meter may be lower than your actual glucose In this situation repeat the test in a warmer e
58. rcent 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 3 9 mmol L 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 electronic logbook by date and time by pressing the Arrow button Bl 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 30pm Glucose 6 9 mmol L A iExercise 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
59. rerit tete ice 125 PRODUCT SAFETY INFORMATION eee 126 EXPLANATION OF SYMBOLS ON THE METER 127 GU gl 127 INDEX TUTTI UU 128 Quick Reference Owner s Booklet THE OneTouch UltraSmart SYSTEM The OneTouch UltraSmart System uses the latest blood glucose monitoring technology It measures the glucose content of a blood sample by means of an electrical current produced in the test strip and 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 The OneTouch UltraSmart Blood Glucose Monitoring System consists of three main products the OneTouch UltraSmart Meter OneTouch Ultra Test Strips Sold Separately 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 OneTouch UltraSmart Meter Owner s Booklet e OneTouch Ultra Control e Carrying Case Solution Quick Reference Guide e OneTouch UltraSoft Warranty Registration Card Adjustable Blood Sampler Two AAA Alkaline Batteries e OneTouch UltraClear Cap Installed e OneTouch UltraSoft Sterile Lancets OneTouch Ultra Test Strips Sold Separately OneTou
60. res Exit Set up Next the meter will prompt you to set a before meal blood glucose range The meter is pre set to 4 0 7 0 mmol L 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 0 1 mmol L steps scroll to the correct numbers and press the OK button The meter will prompt you to set an after meal glucose range The meter is pre set to 5 0 11 0 mmol L To use this range press the OK button twice You may change this to one recommended by your healthcare professional To change the lower and upper ends of the range in 0 1 mmol L steps scroll to the correct numbers and press the OK button The factory set hypoglycemia level is 3 9 mmol L If your healthcare professional has advised you to use a different level scroll to the correct number and press the OK button To exit Set up mode choose Exit Set up and press the OK button Ql 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
61. rol Units mg dL Beep mmol L Settings Time Format am pm Date Format MM DD YY Begin of week Sunday Cholesterol Units mmol L ON Set up Menu Using the Arrow button 8 scroll to Insulin Set up Diabetes Pill Set up and press the OK Insulin Pump Advanced Features Exit Set up 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 button Enter the number of pill types you are taking not the number of tablets you take Diabetes Pill Set up each time Scroll to the correct number and press the OK button You can How many types of enter up to five types of pills If you do pills do you take not take pills or do not wish to use this feature enter 0 If you enter 0 the diabetes pill choices will not appear on the display when you press the Medication SmartButton 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 OneT
62. ry Add New Entry for Sep 15 02 3 30 pm Other Time Select Entry Date What time 10 El pm EXERCISE LOGBOOK ENTRIES With the meter turned off press the Exercise SmartButton These choices will Add New Entry for 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 t Exercise Entry Sep 15 02 3 30 pm Other Time Sep 15 02 3 30 pm Exercise Entry Exercise 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 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 D s 4 Logbook will be saved this way in your electronic SUAM XS logbook You may also scroll through eT the logbook to view previous entries Hard 00 10 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 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 inform
63. 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 When your blood glucose result is from 1 1 mmol L through 3 3 mmol L Do you need a snack will appear on the display with the test result reminding you that a meal or snack may be necessary 39 Sep 14 02 8 30 am mmol L Comment Press OK A V Example Sep 14 02 8 30am 23 0 mmol L Check Ketones Comment Press OK A V Example Sep 14 02 8 30am mmol L Do you need a snack Comment Press OK AV Example 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 differ 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 Limita
64. t on 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 iid 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 the 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 to turn off the meter For order information and to learn more about OneTouch Diabetes Management Software visit www OneTouch ca or call the OneTouch Customer Care Line at 1 800 663 5521 124 SPECIFICATIONS Result Range 14 to 33 3 mmol L Calibration Plasma equivalent Sample Fresh capillary whole blood Sample Size Minimum 1 microlitre uL Test Time 5 Seconds Assay Method Glucose oxidase biosensor Power Source Two AAA alkaline batteries Battery Life About six months at three tests per day one test using backlight Glucose Units mmol L Memory Over 3 000 records Automat
65. tems and are supported by the Diabetes Educator Section of the Canadian Diabetes 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 e Low glucose results If your test result is lower than 3 9 mmol L 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 10 0 mmol L 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 10 0 mmol L 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
66. ter 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 e within two hours after a meal e within two hours after a Fingertip rapid acting insulin injection or insulin pump bolus or e during or within two hours after exercise When you are concerned about the possibility of hypoglycemia low blood sugar 21 CAUTION Do Not test on your forearm or palm when e You think your blood glucose is rapidly falling such as within two hours of exercise or a rapid acting insulin injection or insulin pump bolus Testing with a fingertip sample may identify hypoglycemia or an insulin reaction sooner than testing with a forearm or palm sample It has been less than two hours after a meal a rapid acting insu
67. the Date and Time sss 85 Exercise Logbook Entries sess 86 Health Logbook Entries esse 87 vii Table of Contents continued Ketoras ee eects 89 HbATC iii ie tee ri dee Ee S PH essen 91 Mictoalb rih tette ches 91 Cholesterol 92 Blood Pressure esee 92 2 126 eer 93 Foot l 93 Weight Height essere 94 Doctor Visit eee 94 Medication Logbook Entries 95 Food Logbook Entries sse 101 Adding Changing or Deleting Logbook Information esses 103 OneTouch UltraSmart FastFacts FEATURE 108 FastFacts Menu iiiter eret bosses 109 Logbook Memoty cerent 110 Gl cose by Meals ts 110 Glucose Analysis eres 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 eese 114 Glucose Range Info 115 msilim Intake eorr nite 116 viii Hypoglycemia Information 120 Food Averages eese eene nennen 121 Health Checks 4 121 Data Downloading esses 122 SPECIFICATIONS 5
68. the language Espa ol With your language choice highlighted press the OK button Italiano Portugu s 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 Basic Set up if using 12 hour format Use the Arrow button B to scroll to the correct hour Check am pm if applicable If incorrect Sep 15 02 continue to press the Arrow button until the hour and am or pm are correct Press the OK button to continue Basic Set up Use the Arrow button B to scroll to 12am the correct minutes and press the OK Sep 15 02 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 am Sep 15 0 OK button Repeat these steps to Then select the correct year and press the select 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 custo
69. tions 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 40 While at the lab 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 3 9 mmol L 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 Diabetes 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
70. to it Apply only OneTouch Ultra Control Solution or a blood sample to the test strip e 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 ONETOUCH self checks to confirm that the meter is UltraSmart working properly If at any time during the life of the meter these graphics appear to be different call the OneTouch Customer Care Line at 1 800 663 5521 Setting the Meter The OneTouch UltraSmart Meter is set at the factory to display results in the English language using millimoles per litre mmol L as the unit of measure The time and date are also factory set in Eastern 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 One
71. ts Used test strips can go into the same container Return the ejection cocking control to the middle position Replace the OneTouch UltraSoft Cap 37 Special Messages A WARNING N LOW GLUCOSE Below 1 1 mmol L A WARNING A HIGH GLUCOSE Above 33 3 mmol L The OneTouch UltraSmart Meter displays results between 1 1 mmol L and 33 3 mmol L If your test result is lower than 1 1 mmol L 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 33 3 mmol L 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 When your blood glucose test result is outside the before meal range of 4 0 7 0 mmol L or after meal range of 5 0 11 0 mmol L or the personal glucose range you set in Custom Meter Set up Sequence the meter will prompt you to add a comment When your blood glucose test result is in the range of 13 3 mmol L to 33 3 mmol L Check Ketones will appear on the meter display This message does not mean that the
72. u take to comment ona test result 78 The meter will automatically prompt you to add a comment 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 Sep8 02 8 30am With any test result or test result with 5 average on the display press the OK button You will be able to add mmol L comments for food health and exercise Comment Press av Example Health is always highlighted first since mer 830 am the food comment is automatically x added based on your pre set or personal schedule see Advanced Feature Set up Er pages 72 76 Save FOOD COMMENTS In this example we ll use food If you wish to change the food comment to a different Food Bef Brkft mealtime use the Arrow button Bj to Gide 7 5 Comment select Food and press the OK button Use the Arrow button to select your Health food comment and press the OK button Exer Bef Lunch again Your choices are Bef Brkft Aft Brkft Bef Lunch Aft Lunch Bef Dinner Aft Dinner and Night Save AftLunch w 79 Sep 8 02 8 30 am Once you select your mealtime Health is automatically highlighted If you are through commenting scroll to Save MN and press the OK button If you do not press the OK button your entries will not
73. uarantee that the OneTouch UltraSmart Meter shall be free of defects in materials 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 0ce cee eeee 72 76 Alternate Site Testing 15 21 23 27 30 32 Arrow B ttOTl epe o Rr eR ERU EE RCM ean ee 3 Averages All Results 0 00 eee 109 113 Averages By ExerciSe seen eee 109 114 Averages By Time of Day 109 114 Averages Food cece cece eee eens 109 121 Averages Insulin Daily 06 117 119 Back Button 2a us s urne mr eed eR edis 3 Backlight 11e ter ceo Rok mre due 3 Backlight Button oet et ee ERR nS 3 Basic Set up Mode suuuuulusus 58 61 Batteries eee e ee 1 43 45 55 125 126 BeeDa contis eter vto bd dad 64 66 67 Blood Glucose Testing 000ee 19 39 Blood Sampling Fingertip 23 26 Blood Sampling Forearm or Palm 27 30 Carrying Case cies ver ry eed v eR ete E 1 Checking the System with Control Solution 12 18 Cholesterol Units 0c eee eee eee 64 67 Code Numbers 6 10 12 15 31 46 47 Coding the Meter ccc cece ee eens 10 12 COMIMENES eode pen os 36 39 77 81 Comments Exercise cece cece cece ee eee 81 Comments Foo
74. ulin do you take choose up to three types of insulin If you sof do not wish to use this feature enter 0 If you select 0 no insulin names will appear on the display when you press the Medication SmartButton 70 To enter your first insulin type review the insult Setup menu choices seine 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 Insulin 1 your insulin types have been selected d Ultralen Premixed Insulin Set up A pa Insulin 1 Rapid Arrow button B to scroll to Save and To save your insulin choices use the i press the OK button Insulin 2 NPH 71 Set up Menu Settings Diabetes Pill Setup Select Insulin Pump on the Set up Menu Insulin Set up and press the OK button Insulin Pump Advanced Features Exit Set up 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 Select Yes to use this feature and press the OK button You can then use this nsuinPump feature to enter your bolus doses and Do you use an insulin pump Yes total insulin amounts If you do not use an ins
75. ulin 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 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 e Input your usual meal schedule e Include your target glucose range e Customize your hypoglycemic level 72 ADVANCED FEATURES FACTORY SETTINGS CUSTOM SETTINGS Averages 14 days 7 30 60 90 days Schedule Pre set Personal see pages 74 75 Glucose Range Before Meal 4 0 7 0 mmol L Personal After Meal 5 0 11 0 mmol L Personal Hypo Level 3 9 mmol L Personal Select Advanced Features as follows Set up Menu Setti Select Advanced Features and press Diabetes Pill Set up the OK button Insulin Set up Insulin Pump Advanced Features Exit Set up 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 Advanced Features can change the number of days that make Schedule up this average to the last 7 30 60 or Glucose R nge 90 days Scroll to the number of days Before Meal you want to include in your test display A average and press the OK button Ql You can still look at averages for all five time periods by reviewing
76. umber If they do not match scroll to the correct number using the Arrow button Bl MESSAGE Apply Blood n n O AY Alternate Site oy O AY Control Solution oy T AY WHAT IT MEANS 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 8 30am mmol L AY Example WHAT IT MEANS Five second countdown After the countdown the meter will display the test result A test result in mmol L ACTION None required None required WARNING If mmol L does not appear with the test result call the OneTouch Customer Care Line at 1 800 663 5521 Sep8 02 8 30am 1 9 mmol L Comment Press OK A v 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 button see page 78 MESSAGE Sep 14 02 8 30 am 23 0 mmol L Check Ketones Comment Press OK PNA Example Sep 14 02 8 30 am 1 9 mmol L Do you need a snack Comment Press OK AV Ex
77. verview lees iii 8 Temperature Range 8 13 36 53 55 125 Test Mode ice e Ree meer Rees 15 32 TESE POFLE suse eater eke ee sees S 2 31 Test Procedure lees 31 35 Time Formatus uoce p RE ER DEP 64 66 Tafrie Settlhig ii eese one Rx re RR ce os 60 Unexpected Results cece eee eee ees V Unit of Measure mmol L 9 17 36 49 125 Vial Control Solution 12 13 16 18 Vial Test Strip cece eee ee eee eee 8 10 12 17 Warning MessageS ce cee eeeeees 51 55 Warranty Registration Card 000 iii 1 Week Beginning of 000005 64 66 67 133 134 ONETOUCH UltraSmart ONETOUCH changes everything OneTouch Customer Care Line Canada 1 800 663 5521 U S A 1 800 227 8862 Monday Friday 9am 8pm Eastern Time 6am 5pm Pacific Time www OneTouch ca Distributed by LifeScan Canada Ltd Burnaby B C V5C 6C6 Manufactured by LifeScan Europe Division of Cilag GmbH International 6300 Zug Switzerland 2006 LifeScan Inc Rev 05 2010 The system described herein is covered by one or more of the following U S patents D428 150 5 708 247 5 951 836 6 045 567 6 156 051 6 197 040 6 241 862 6 284 125 6 413 410 and 6 733 655 ar AW 06139304A e LIrESCAN LUI
78. 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 to return to the graph Logbook Sep 21 02 7 20 pm Glucose 7 4 mmol L A Aft Dinner Carbs 45 Graph by Time of Day You may view test results on a graph by time period when you select Graph by Time of Day p Graph daily results by time period a After Breakfast Before Lunch After Lunch Before Dinner After Dinner v 112 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 i Glucose Results Ss oe Aw sepel Sep co 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 Average of all Results Number of Days Avg 6 7 82 10 4 11 1 11 2 113 Average by Time of Day Test averages by time of day are available for the last 7
79. y e Apply Blood for fingertip blood sample ay e 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 Apply Control Solution to the Test Strip To ensure an accurate control solution test shake the vial discard the first drop and wipe the dispensertip before you begin NARROW CHANNEL Apply TOP 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 CONFIRMATION WINDOW W WARNING Sep t4 sisaan If mmol L does A not appear D with the Control Solution result call the OneTouch Customer Care Line The control solution will at 1 800 663 5521 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 Compare Control Solution Result to the Control Range Printed on the TEST STRIP VIAL CAUTION The control solution r
80. y displaying two different messages A WARNING A 1 When this message appears on the Low Batteries display the batteries are low and should be replaced as soon as possible You should replace The backlight will no longer turn on the batteries soon See Owner s Booklet 2 When this message appears on the A WARNING A display you cannot test enter data in your electronic logbook or use the FastFacts feature until you change You MUST replace the batteries e batteries now See Owner s Booklet 43 To replace the batteries first turn off the meter Turn the meter over and locate the battery compartment N j Open the battery compartment by pressing the tab to the left and lifting the battery compartment cover to remove it 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 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 e Replacing the batteries does not affect the electronic logbook However the date and time 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
81. your electronic logbook 73 Advanced Features Averages 14 Glucose Range Before Meal 4 0 7 0 After Meal 5 0 11 0 Hypo Level 3 9 Pre set Schedule Bef Brkft 6 00a 9 00a Aft Brkft 9 00a 11 00a Bef Lunch 11 00a 2 00p Aft Lunch 2 00p 5 00p Bef Dinner 5 00p 8 00p Aft Dinner 8 00p 11 00p Night 11 00 p 6 00a Personal Schedule Bef Brkft 9 00 a Aft Brkft 9 00a 11 00 a Bef Lunch 11 00a 2 00 p Aft Lunch 2 00 p 5 00 p Bef Dinner 5 00 p 800p Aft Dinner 8 00 p 11 00 p 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 Ql 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 Ql 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 Press the OK button e If you make a mistake press the Back button to return to the top of the schedule and make corrections 74 You will only be

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OneTouch ® UltraSmart ® User Guide