Lifescan UltraSmart manuel d'utilisation

Blood Glucose Monitoring System Meter and Electronic Logbook In One Owner’ s Booklet DCO_06158108A_OUS_OBC_GB 5/6/03 1:13 PM Page i[...]

Owner’s Booklet Ul t r aSmart ® ™ Blood Glucose Monitoring System DCO_06158108A_OUS_OB_GB 5/6/03 1:24 PM Page i[...]

ii Serial Number Lot Number In V itro Diagnostic Medical Device Expiration Date Symbol Sterilized b y irradiation S ymbol SN LO T IVD Symbols DCO_06158108A_OUS_OB_GB 5/6/03 1:24 PM Page ii[...]

iii Dear OneT ouch ® UltraSmart ™ System Owner: Y ou have chosen one of the best blood glucose monitoring systems available. This booklet has impor tant information you must know about the OneT ouch ® UltraSmar t ™ Blood Glucose Monitoring System. R ead it carefully . Blood glucose monitoring plays an important role in diabetes control. A lon[...]

iv INTENDED USE: The OneT ouch ® UltraSmar t ™ Blood Glucose Monitoring System is intended to be used for the quantitativ e measurement of glucose in fresh capillary whole blood. The OneT ouch ® UltraSmart ™ System is intended for self-test use outside the body (for in vitro diagnostic use) by people with diabetes at home and health care prof[...]

v Impor tant Information • Severe dehy dration and excessiv e water loss may cause false low results. If y ou believe you ar e suffering from dehydr ation, consult a healthcare professional immediately . • T est results below 3.9 mmol/L mean low blood glucose (hypoglycaemia). T est results greater than 13.3 mmol/L mean high blood glucose (hyper[...]

TH E OneT ouch ® UltraSmar t ™ S YS TE M . . . . . . . . . . . . . 1 OneT ouch ® UltraSmart ™ Meter . . . . . . . . . . . . . . . . 2 Navigation Buttons . . . . . . . . . . . . . . . . . . . . . . . . . 3 SmartButtons ™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Display Symbols . . . . . . . . . . . . . . . . . . . . . . . . [...]

vii DISPL A Y M ESSAG ES . . . . . . . . . . . . . . . . . . . . . . . . . . 42 WAR NI NGS AN D E RROR ME SSAGE S . . . . . . . . . . . . . 47 ME TE R SET -UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Entering Basic Set-up Mode . . . . . . . . . . . . . . . . . 54 Selecting Display Language . . . . . . . . . . . . . . . . . 5[...]

viii DCO_06158108A_OUS_OB_GB 5/6/03 1:24 PM Page viii[...]

1 TH E OneT ouch ® Ultr aSmar t ™ SYST E M The OneT ouch ® UltraSmart ™ System uses the latest blood glucose monitoring technology . It measures the glucose content of a blood sample by means of an electrical current pr oduced in the test strip and sent to the meter for measurement. T est results are “plasma- calibrated.” This makes it ea[...]

OneT ouch ® UltraSmar t ™ Meter 2 TEST POR T The meter turns on when you insert test strip here. DA T A PORT Used to download logbook memory to a computer . DISPLA Y WITH BACKLIGHT T est results, messages, symbols, and other data appear here. SmartButtons ™ (See pages 4–5 for description and use. ) OneT ouch ® Ultra ™ TEST STRIP DCO_06158[...]

3 Navigation Buttons BACK BUTT ON (OFF BUTT ON) Goes back to previous display on certain screens. Pr ess and hold for two seconds to turn off the meter . ARROW BUTT ON Scroll through menus, code numbers, and logbook. OK BUTTON (BACKLIGHT BUTT ON) Accept entries and mov e to next display . Press and hold for two seconds to turn on backlight. Note: P[...]

4 The SmartButtons ™ are your keys to getting the most out of your OneT ouch ® 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 F astFacts ™ Smar tButtons ™ is used to view the records in th[...]

5 HEAL TH Smar tButton ™ Enter information on health. EXERCISE Smar tButton ™ Enter exercise amount and level. MEDIC A TION SmartButton ™ Enter insulin and diabetes pill information. FOOD SmartButton ™ Enter meal and snack information. F astF acts ™ Smar tButton ™ Review test results and logbook memory . Note: For complete information o[...]

6 Display Contrast Y ou can change the contrast of the meter display . T o make it darker , press and hold the Back button and the “up ” Arrow button . T o make it lighter , press and hold the Back button and “ down” Arrow button . Scroll (mo ve) up only . Scroll down only . Scroll up or down. Scroll up or down. No entry . Shows where y ou [...]

OneT ouch ® Ultra ™ T est Strips The OneT ouch ® UltraSmart ™ System measures the amount of glucose in whole blood. Blood is applied to the T OP EDGE of the OneT ouch ® Ultra ™ T est Strip and is automatically drawn into the reaction cell wher e the reaction takes place. See pages 19–35 , T esting Y our Blood , for complete instructions.[...]

Impor tant T est Strip Information • Store test strip vials in a cool, dry place belo w 30 °C. Keep away from direct sunlight and heat. Do not r efrigerate. • Store test strips in their original vial only . T o avoid damage or contamination, do not transfer test strips to any other place. • Do not use test strips beyond the expiration date p[...]

9 BEFORE TES TING Checking the Display Each time you turn the meter on, the display background will quickly change from dark to light and form the words “OneT ouch UltraSmart.” This tells you that the system is performing several self-checks to confirm that the meter is working properly . If, at any time during the life of the meter , these gra[...]

10 Coding the Meter Code numbers are used to calibrate the OneT ouch ® UltraSmart ™ Meter with the OneT ouch ® Ultra ™ T est Strips for accurate r esults. Y ou must code the meter before using it for the first time and then every time you change to another vial of test strips. Each time you test, check to be sure that the code number on the m[...]

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 S tep 4 . (The first time you turn the meter on, three dashes [---] will appear , showing that there is no code stored in the memory .) Match the Code Numbers. STEP 3 See the Co[...]

Mov e up or down using the Arr ow button 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” . Code the Meter . STEP 4 12 Note: Refer to additional information in the OneT ouch ® Ultra ™ Control S[...]

13 Impor tant Contr ol Solution T est Information • Use only OneT ouch ® Ultra ™ Control Solution. • Check the expiration date on the control solution bottle. R ecord the discard date (date opened plus three months) on the bottle label. Do not use after expiration or discard date, whichev er comes first. • Control solution, meter , and tes[...]

14 When to do a control solution test: • Once a week. • When y ou open a new vial of test strips. • Whenev er you suspect that the meter or test strips are not working properly . • If your blood glucose test results ar e not consistent with how you feel. • After dropping the meter . Before you use the OneT ouch ® UltraSmar t ™ Meter to[...]

15 T o turn on the meter , inser t 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 . “OneT ouch UltraSmar t” will appear briefly on the display . Then “ Code 9 (example), Check Code” i s displayed. Be sure the meter and test strip codes match. If they do not, code th[...]

16 Note: Y ou must select “ Control Solution ” to distinguish control solution tests from blood glucose tests. Marked control solution tests will not be included in your aver ages. Do not use the Control Solution mode for testing blood. “ Apply Blood” will appear on the display first. Use the Arrow button to select “Control Solution.” T[...]

17 Compare the control solution r esult with the range printed on the test strip vial. The result should fall within this range. R esult Appears in 5 Seconds. STEP 4 Note: If you do not apply the control solution within three minutes, the meter will turn itself off . Remo ve the test strip and insert it back into the test port to restar t the test [...]

18 If test results fall outside the range printed on the test strip vial, repeat the test. When using control solution mode, very high or v ery low readings will be displayed as a number rather than a “HIG H” or “L OW” warning screen and stored in the logbook as “Control Solution High” or “Contr ol Solution Lo w”. Out-of-range r esu[...]

TE S TI NG Y OUR BL OOD Read this section and the test strip package insert carefully before testing. Make sur e you have all items needed to test. • OneT ouch ® UltraSmar t ™ Meter • OneT ouch ® Ultra ™ T est Strips • OneT ouch ® UltraSoft ™ Adjustable Blood Sampler • OneT ouch ® UltraClear ™ Cap (for arm sampling) • OneT ouc[...]

Preparing the OneT ouch ® UltraSoft ™ Sampler 20 Release Button Ejection/Cocking Control Depth Adjustment Knob Cap OneT ouch ® UltraClear TM Cap for Arm Sampling Protective Disk Lancet Point Lancet with Protective Disk Depth Indicator Puncture Settings C AUTION: T o reduce the chance of infection: • Never share a lancet or the OneT ouch ® Ul[...]

Insert the lancet into the lancet holder and push down firmly until it is fully seated. Do not twist the lancet. T wist the protective disk until it separates from the lancet. Replace the OneT ouch ® UltraSoft ™ Cap. T urn it clockwise until it is snug. Adjust the puncture depth setting if necessary . T wist the depth adjustment knob toward the [...]

22 Slide the ejection/cocking control back until it clicks. If it does not click, the sampler may have been cocked when the lancet was inserted. The sampler is now ready for use. Use warm, soapy water . Rinse and dry thoroughly . Cock the Sampler . STEP 2 W ash Y our Hands and the Puncture Site. STEP 3 DCO_06158108A_OUS_OB_GB 5/6/03 1:24 PM Page 22[...]

Massaging the fingertip gently will help you obtain a round dr op of blood. Do not squeeze excessiv ely on the puncture site. The blood sample must be at least one microlitre ( 1 µL) in v olume ( actual size) or you may get an error message (see page 50 ) or an inaccurate test result. Do not smear the blood sample. Proceed with your blood glucose [...]

Arm Blood Sampling (“ Alternate Site”) The arm has fewer nerve endings than the finger tip so you may find that obtaining a blood sample from the arm may be much less painful than using the fingertip. The technique for arm sampling is different from fingertip sampling. Also there are differences between arm samples and fingertip samples that yo[...]

25 Impor tant Information About Arm T esting (continued) • Y ou should also use fingertip testing whenever you have a concern about hypoglycaemia (insulin reactions) such as when driving a car , particularly if you suffer from hypoglycaemic unawareness (lack of symptoms to indicate an insulin reaction), as arm testing may fail to detect hypoglyca[...]

26 T o increase blood flow to the punctur e site, massage the area gently . For individuals who experience difficulty in getting sufficient blood for a test, rubbing the area more vigorously or applying heat briefly may be helpful. Select a soft, fleshy area on your arm that is away from bone and free of visible v eins and hair . W ash and dry the [...]

27 Continue holding the sampler against the skin for a few seconds until the blood drop forms. Allow enough blood to form under the cap until you have a blood sample that is sufficient to fill the confirmation window of the test strip ( actual size). If you must massage the area to obtain more blood, do not squeeze the site excessiv ely . Allo w Bl[...]

28 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 . “OneT ouch 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 [...]

29 STEP 2 Note: Ther e are thr ee choices in test mode. For blood testing use the Arrow button to select: • “ Apply Blood” for fingertip blood sample or • “ Alternate Site” for arm blood sample Do not use the Control Solution mode when testing blood. • “Control Solution” is for checking the system Select T est Mode. “ Apply Bloo[...]

30 Obtain a round drop of blood using the OneT ouch ® UltraSoft ™ Adjustable Blood Sampler . The blood sample must be at least 1 µL in volume ( actual size) to fill the confirmation window . Apply Sample. STEP 3 T ouch and hold the drop of blood to the narrow channel in the top edge of the test strip. DO NO T : • Apply sample to the front or [...]

31 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 tr ouble filling the test strip, contact your local LifeScan Customer Service office. See back cover for contact information. If the confirmation window is not full, yo[...]

Y our blood glucose test result will appear after the meter counts down from 5 to 1 . The test results are automatically stor ed in the meter logbook (memory). Y ou may now: • Use the Arro w button to compare results (see “ Additional Feature ” which follows); or • Add comments to your r esult; or • Remo ve the test strip to turn off the [...]

33 Point the sampler down and away . Push forward on the ejection/cocking control and eject the lancet directly into a container for sharp objects. Used test strips can go into the same container . Return the ejection/cocking control to the middle position. Replace the cap . Used Lancet Disposal C AUTION: It is impor tant to discard the used lancet[...]

34 If your blood glucose test result is abo ve 33.3 mmol/L, “H IG H GL UCOSE” will appear on the meter display . This indicates severe hyper glycaemia (high blood glucose). Y ou should recheck your blood glucose level. If “HIGH GL UCOSE” again appears on the display , call your doctor immediately . W ARNING Below 1.1 mmol/L W ARNING Abov e [...]

35 When your blood glucose result is between 1.1 mmol/L and 3.9 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 . When your blood glucose test result is outside the range of 5.0–7.2 mmol/L or the personal glucose range you set in custom meter set-up, the meter[...]

36 COM P AR I NG METE R A ND L ABORA T ORY RE SU L TS OneT ouch ® UltraSmart ™ Meter test results and laboratory test results are both expr essed in plasma-equiv alent units. Howev er , your meter result may differ somewhat fr om your laboratory r esult due to normal variation. Meter r esults can be affected by factors and conditions that do not[...]

37 While at the lab: • Make sure that the meter test and the lab test are performed within 15 minutes of each other . • Wash y our hands before obtaining a blood sample. • Use only fresh capillary blood. Y ou may still have a v ariation from the result because blood glucose levels can change significantly o ver short periods, especially if yo[...]

38 C ARI NG FO R Y OUR SYS TE M Maintenance Y our OneT ouch ® UltraSmart ™ Meter does not require special maintenance or cleaning. T ake care to avoid getting dirt, dust, blood, control solution, or liquids inside the meter through the test port or data por t. LifeScan recommends that you stor e the meter in its carrying case after each use. A c[...]

2 . When this message appears on the display , you cannot test, enter data in your meter logbook, or use the FastF acts ™ feature until you change the batteries. 39 Batteries Y our OneT ouch ® UltraSmart ™ Meter comes with two AA A alkaline batteries already installed. The batteries will pro vide you with enough pow er to perform up to 540 tes[...]

40 1 . Open the battery compar tment by pressing the tab to the left and lifting the battery compartment cover to remo ve it. T o replace the batteries, first turn off the meter . T urn the meter ov er and locate the battery compartment. 2 . Remov e the old batteries. Insert two AA A alkaline batteries. Plus (+) and minus (–) signs will guide you[...]

41 Note: • Replacing the batteries does not affect the meter logbook. Howev er , 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. At this time, you may update the date and time settings. DCO_06158108A_OUS_OB_GB 5/6/03 1:25 PM Page 41[...]

DISPL A Y ME SSAGE S Follo wing is a summary of display messages and symbols. 42 MESSA GE WHA T IT MEAN S 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 . A CT ION If, at any time during the life of the meter , these graphics [...]

43 MESSA GE WHA T IT MEAN S New meter not coded or meter lost power briefly and entered set-up mode. This is the code number stored in the meter . 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. A CT ION See Coding the Meter , pages 10–12 .[...]

44 MESSA GE WHA T IT MEAN S The system is ready to accept a blood sample from the fingertip. The system is ready to accept a blood sample from the arm. The system is ready to accept a control solution sample. A CT ION Y ou may now apply the fingertip blood sample. Y ou may now apply the arm blood sample. Y ou may now apply the control solution. Con[...]

45 MESSA GE WHA T IT MEAN S Five-second countdown. After the countdown, the meter will display the test result. A blood glucose test result in mmol/L. A test result outside of your target r ange with a message prompting you to add a comment. A CT ION None required. None required. If you wish to add a comment, press OK . (See page 74 ). OK 5 (Exampl[...]

46 MESSA GE WHA T IT MEAN S 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 between 1.1 mmol/L and 3.9 mmol/L, “Do you need a snack?” will appear on the display with the test result, reminding y ou that a meal or snack may be necessary . A CT[...]

WAR N I NGS AN D E RROR M E SSAGE S These messages help to identify certain problems but do not appear in all cases when a problem has occurred. Impr oper use may cause an inaccurate result without pr oducing a warning or an error message. In the event of a problem, r efer to the information under ACTION. Assistance is available fr om your local Li[...]

48 MESSA GE WHA T IT MEAN S 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 of 6–44 °C. There may be a problem with the meter or the meter may need to be reset. A CT ION Perform the test after the meter and test[...]

49 MESSA GE WHA T IT MEAN S Error message that could be caused by either a used test strip or a problem with the meter . 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 . A CT ION Repeat the test with a new test str[...]

50 MESSA GE WHA T IT MEAN S 1 ) Y ou may have high glucose and have tested in an environment near the low end of the system’ s operating temperature r ange 6–44 °C. 2 ) There may be a problem with the test strip. F or example, it may have been damaged or mov ed during testing. 3 ) The sample was improperly applied. A CT ION If you tested in a [...]

51 MESSA GE WHA T IT MEAN S Error message that indicates the meter has detected a problem with the test strip. Possible causes are test strip damage or an incompletely filled confirmation window . The battery sign appears on the display . The po wer of the batteries is getting low . The backlight will be disabled when the battery sign is displayed.[...]

52 POSSIBL E C A USES Need batteries. No batteries or batteries incorrectly installed. T est strip inser ted incorrectly . (For example, upside do wn, backward, or incompletely .) Defective meter or test strip . WHA T T O DO Replace the batteries. Check that the batteries are correctly installed. Insert the test strip correctly with the contact bar[...]

53 If the test does not start after applying the sample: POSSIBL E C A USES Insufficient blood sample. Defective test strip . Sample applied after automatic shutoff (three minutes after inserting a test strip). Defective meter . WHA T T O DO Repeat the test with a new test strip and a larger sample. Repeat the test with a new test strip. Repeat the[...]

ME TER S ET -UP The OneT ouch ® UltraSmart ™ Meter was preset at the factory with the date, time and display language. The glucose units ar e preset at the factory and cannot be changed. Y ou must enter Set-up mode to: • Change the date, time, or display language. (Glucose units cannot be changed.) • Customize the meter features that allo w [...]

55 T o change the language, use the Arrow button to scroll to the language. With your language choice highlighted, press OK . OK Spanish (Español) French (F rançais) German (Deutsch) Italian (Italiano) Portuguese (Por tuguês) Dutch (Nederlands) T o use English, press OK . OK Selecting Display Language The meter is set at the factory to use Engli[...]

56 Begin by setting the hour . Use the Arrow button to scroll to the correct hour . Press OK . OK 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, follo w these steps in Set-up mode. (See page 54 , Entering Basic Set-up Mode .) Use the Arrow button to[...]

57 The meter will ask you if you wish to customize it. Select “Y es” (press OK ) if you wish to customize other meter settings. (See Custom Meter Set-Up , page 58 .) If you select “No ” (use Arrow button and press OK ), the meter will turn off and continue to use the factory settings. OK OK Note: It is important to select the correct date a[...]

CUST OM M ETE R SET -UP The OneT ouch ® UltraSmart ™ Meter has a number of optional features that you may use to tr ack all your diabetes information. The Set-up menu allo ws you to customize the meter with your personal diabetes management plan including the type and amount of medication you take; your tar get glucose range; your usual meal tim[...]

59 “Set-up Menu” will appear on the display with a list of options. “Settings” will be highlighted. Y ou should have y our OneT ouch ® UltraSmart ™ Owner’ s Booklet available to refer to while customizing the meter . DCO_06158108A_OUS_OB_GB 5/6/03 1:25 PM Page 59[...]

60 F ollowing is a summar y of meter settings: OPTION Settings: Time Format Date Format Begin Week Cholesterol Units Beep Diabetes Pill Set-Up: Insulin Set-Up: Insulin Pump: F A CT OR Y 24 -hour DD/MM/YY Monday mmol/L ON Pill A Pill B InsulinA InsulinB OFF CUS T OM AM/PM MM/DD/YY Monday mg/dL OFF Pill A to E or Customize with OneT ouch ™ Software[...]

61 Meter Settings (continued) OPT ION Advanced F eatures: Averages Schedule Glucose Range Before Meal After Meal Hypo L evel F A CT OR Y 14 days Pre-set (see pages 70–71. ) 5.0 – 7.2 mmol/L ––– 3.9 mmol/L CUS T OM 7 , 30 , 60 , 90 days Personal Personal Personal Personal DCO_06158108A_OUS_OB_GB 5/6/03 1:25 PM Page 61[...]

62 Settings “Settings” include: • Time format • Date format • Beginning of the week • Cholesterol unit of measure • Beep on or off T o change any of these settings, press OK with “Settings” highlighted on the Set-up Menu. Each setting has a pop-up menu of available choices. Y ou must review all fiv e settings and choose one for ea[...]

63 Settings Begin of week Monday Time Format 24 hour Date Format DD/MM/YY Beep OFF ON Cholesterol Units mmol/L Settings Begin of week Monday Time Format 24 hour Cholesterol Units Date Format DD/MM/YY mg/dL Beep mmol/L The meter was set at the factory to give audio signals (“beeps”) at key points in the test procedure. T o keep the beeps, highli[...]

Diabetes Pill Set-up Y ou may recor d up to five types of diabetes pills. This feature helps you tr ack 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 enter ed using a personal computer and OneT ouch ™ Software*. If you do not customize y our p[...]

65 A pop-up menu of pill choices will appear on the display . Use Pills A-E to label up to five pills. F or example, if you take glipizide pills you could label them as “Pill A.” Y ou can enter the actual pill names using OneT ouch ™ Diabetes Management Software. Using the Arro w button , scroll down to your choice and pr ess OK . “Pill 2 ?[...]

Insulin Set-up Y ou can recor d 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 OneT ouch ™ Software. If you do not cust[...]

67 T o enter your first insulin type, review the menu choices: Use the Arrow button to scroll through the menu. Press OK on your selection. Repeat these steps until all of your insulin types have been selected. OK T o save your insulin choices, use the Arr ow button to scroll to “Save” and pr ess OK . OK Rapid Regular L ente NPH Ultralente (Ult[...]

Advanced F eature Set-up The final item on the Set-up menu is called “ Advanced Featur es.” These featur es allow y ou to: • Choose the number of days included in your glucose test averages • Input your usual meal schedule • Include your target glucose r ange • Customize your hypogly caemic level 68 Insulin Pump Set-up If you are using [...]

The first advanced featur e is aver ages. Each time you test, the meter is set to display a 14 -day average of y our glucose tests along with your test result. Y ou can change the number of days that make up this average to the last 7 , 14 , 30 , 60 , or 90 days. Scroll to the number of days you want to include in your test display average and pr e[...]

T o personalize your schedule, press the Back button , choose “Personal,” and press OK . T o change all or some of the personal meal schedule: • Scroll through each mealtime • Select the correct hours and minutes (in 15 -minute steps) • Press OK . • If you make a mistake, press the Back button to return to the top of the schedule and ma[...]

71 Next, the meter will prompt you to set a befor e- meal blood glucose range. The meter is pre-set to 5.0–7.2 mmol/L. T o use this range, press OK twice. Y ou may change this range to one recommended by your healthcar e professional. T o change the lower and upper ends of the range in 0.1 -mmol/L steps, scroll to the corr ect numbers and press O[...]

72 T o exit Set-up mode, choose “Exit Set-up” and press OK . OK If you have an after -meal glucose range recommended by your healthcar e professional and wish to enter it, use the Arrow button to scroll to your tar get numbers and press OK . OK The factory-set hypoglycaemia lev el is 3.9 mmol/L. If your healthcare professional has advised you t[...]

73 Y OUR M ETE R L OGBOOK The OneT ouch ® UltraSmart ™ Meter logbook is the meter memory . It stores o ver 3 , 000 recor ds. The SmartButtons ™ allow you to enter information about your diabetes management plan, including exer cise, health, medication, and food. DEFINITION C OMMENT S ON GL UCOSE RESUL TS Comments Information that you store in [...]

74 Rules for Adding Comments Follo wing are rules for adding comments in your logbook. • I f you wish to add a comment to a test result, press OK while viewing the test result. • Use the Arrow button to scroll up and down thr ough the various menus and choices. • Use the OK button to make a selection. • Y ou must save your selections by usi[...]

75 FOOD COMMENT S In this example we ’ll use food. If y ou wish to change the food comment to a different mealtime, use the Arro w button to select “Food” and press OK . Use the Arrow button to select your food comment and press OK again. Y our choices are Bef Brkft, Aft Brkft, Bef L unch, Aft Lunch, Bef Dinner , Aft Dinner , and Night. OK OK[...]

76 After adding your first health comment, “Health 2 ” will automatically appear on the display . T o add additional health comments, press OK and select the comment from the menu. Note that your previous comment is no longer av ailable. OK Once you select your mealtime, “Health” is automatically highlighted. If you are through commenting s[...]

77 After you add the exer cise comment, “Save ” will automatically be highlighted. If you press OK , all of the comments you have enter ed will appear with the test result in the logbook. OK When you have completed making comments, scroll to “Save ” and press OK . If you do not press OK , your entries will not be saved. OK OK Y ou can comme[...]

78 Logbook Entries “Logbook entries” ar e activities concerning exer cise, health, medication, and food that are not associated with a test. Y ou do not have to perform a blood glucose test in order to add v aluable diabetes information to your meter logbook. Using the SmartButtons ™ The SmartButtons ™ allo w you to enter information about [...]

79 Follo wing is a list of logbook entries you can make. Smar tButton ™ L O GBOOK ENTRIES Pills ( 1–5 and how many of each) Insulin ( 1–3 and units) Insulin Pump Health Notes: Health Checks: Mild Moderate Hard Duration (enter length of time) Stress Feel Hypo Illness Menses V acation Other Carbs Calories Fats Proteins K etones HbA 1 c Microalb[...]

80 Rules for Logbook Entries • If you wish to add a logbook entry , press a SmartButton ™ to turn o n the meter . The icon for the category you are choosing will appear in the upper -left-hand corner of the display and the title of the category will appear at the top of the display . If you press a SmartButton ™ in er r or , either press anot[...]

81 A calendar will appear on the display . Scroll to the correct month and day and press OK . OK Entering the Date and T ime If the logbook entry is for the current date and time, press OK . OK If the entry is for a previous date and time, select “Other T ime” and pr ess OK . OK Record the time in hours and minutes and press OK . Then make y ou[...]

EXERCISE L OGBOOK ENTRIES 82 With the meter turned off, pr ess the Exercise SmartButton ™ . These choices will appear on the display . Select the current date and time to add an exer cise logbook entry at this time. Select “Other Time ” if the logbook entry is for some time in the past and press OK . OK Note that the date and time is correct [...]

83 HEAL TH LOGBOOK ENTRIES After selecting the date and time, two menu choices will appear . Y ou may make health logbook entries for the current time or another time (see page 81 ). “Health Notes” allow you to enter information about your day . The exercise logbook entry y ou recorded will be saved this way in your meter logbook. Y ou may also[...]

84 The logbook entry with your Health Note will be saved this way in the logbook. T o record check-up information, select “Health Checks” and press OK . OK Choose from this menu: K etones E ye E xam HbA 1 c Foot Exam Microalbumin W eight/Height Cholesterol Dr . Visit Blood Pressur e “Health Checks” are another type of health logbook entry t[...]

85 Many Health Checks allow you to input numeric values. In or der to adjust the number , use the Arrow button to scroll up and down. Press OK to save your selection and r eturn to the Health Checks menu. Follo wing are sample entries under “Health Checks.” When y ou have completed your Health Check entries, scroll to “Exit Health Checks” a[...]

Y ou will return to the Health Checks menu with “Exit Health Checks” highlighted. If you are finished with your entries, press OK with “Exit Health Checks” highlighted. If you wish to enter other Health Checks, use the Arrow button to scroll to the additional menu choice and press OK . OK OK 86 Y our entry will be saved this way in the logb[...]

87 Microalbumin Y ou can enter your test results for microalbumin as normal, positive, or a numeric value fr om 1 to >1000 . When entering data, the value will start at the value y ou last saved. Scr oll to your selection and press OK . OK T ests for haemoglobin A 1 c , also known as HbA 1 c or A 1 c , can be recorded fr om 4 to 15 % in . 1 step[...]

Blood Pressur e The logbook range for the first number (systolic) is 80–200 mmHg. The r ange for the second number (diastolic) is 40–150 mmHg. Both are in 1 -mmHg steps. Blood pressure (B.P .) abo ve or below these ranges will appear on the display as - - - and will not be recorded in the logbook. 88 15 Sep 02 15:30 Health Checks LDL: Cholester[...]

89 T o record a foot examination, select “Enter Foot Exam” and press OK . OK F oot E xam T o record an ey e examination, select “Enter E ye E xam” and press OK . OK E ye E xam DCO_06158108A_OUS_OB_GB 5/6/03 1:25 PM Page 89[...]

90 T o record the date of y our last visit to the doctor , select “Enter Dr . V isit.” Enter your weight in 0.5 kg steps and your height in 0.5 cm steps. When entering data, the value will start at the value y ou last saved. W eight/Height Doctor Visit DCO_06158108A_OUS_OB_GB 5/6/03 1:25 PM Page 90[...]

91 The medication menu reflects your input in the Set-up mode. (See pages 64 – 68 .) If you entered diabetes pills, insulin, and/or insulin pump information, it will appear on the display as in this example. Press the Medication SmartButton ™ to access the menu. Y ou may track your diabetes pills, insulin types and dosages, and insulin pump inf[...]

92 The logbook entry will be saved this way in your meter logbook. Diabetes Pills T o enter your diabetes pills, select the pill you have taken and pr ess OK . OK Enter the number of pills you have taken (in 0.5 - or one-half pill steps) and press OK . When entering data, the v alue will start at the value you last saved. OK After your medication l[...]

93 The insulin dosage will be saved this way in your meter logbook. Insulin Dosages Enter an insulin dosage by highlighting an insulin type and press OK . OK Then record the units of insulin. The meter was set at the factory to record units in 0.1 increments. When entering data, the value will start at the value you last saved. If you wish to recor[...]

94 Then enter the units in 0.1 steps and press OK . When entering data, the value will start at the value y ou last saved. OK Insulin Pump Y ou can enter insulin pump information as bolus entries or as a daily total. If you are entering bolus information, select “Pump Bolus” and press OK . OK DCO_06158108A_OUS_OB_GB 5/6/03 1:25 PM Page 94[...]

95 T o enter your pump total for the day , scroll to “Pump Daily T otal” and press OK . OK If you have completed y our medication logbook entry , select “Exit Meds Entry .” The dosage will be saved this way in your meter logbook. DCO_06158108A_OUS_OB_GB 5/6/03 1:25 PM Page 95[...]

96 Y our daily pump total will be saved this way in your meter logbook. Use the Arrow button to scroll to the number of units you have taken o ver the past 24 hours and press OK . When entering data, the value will start at the value y ou last saved. OK When you have completed y our medication logbook entries, select “Exit Meds Entry .” DCO_061[...]

97 Then enter the type of meal from the meal menu. Y ou may also record alcohol usage. FOOD L OGBOOK ENTRIES Food and blood glucose lev els are closely linked. Logbook entries allo w you to keep track of important nutritional information for each meal or snack by type of nutrient. Press the F ood SmartButton ™ and select either the current date a[...]

Y our food logbook entry will be saved this way in the meter logbook. 98 Y ou may enter carbohydrates (carbs), fats, and proteins in the range of 0 to 250 in 1 -unit steps. Carbohydrates may be entered as units or grams, whichev er you prefer . Calories may be entered in 5 -unit steps in the range of 0 to 2550 . Use the Arrow button to change the u[...]

99 T o edit or delete a comment, be sure the highlight is on the glucose test result to which the comment is attached. Press the OK button . (See page 101 for logbook entry example.) OK Adding, Changing, or Deleting Logbook Information Step 1 . Press the F astF acts ™ button to enter the FastF acts ™ menu. Step 2 . Select “Logbook” fr om th[...]

Y ou may edit other comments at this time. T o delete a comment, scroll to - - - and press OK . When y ou have completed editing the comments, scroll to “Save ” and press OK . OK OK 100 T o change the mealtime, scroll to “Food” and press OK . OK Scroll to the desired mealtime and pr ess OK again. OK DCO_06158108A_OUS_OB_GB 5/6/03 1:25 PM Pa[...]

101 Press OK to edit. OK Y our edited comment will appear this way in your meter logbook. EDITING OR DELETING L OGBOOK ENTRY (Example) All logbook entries are edited or deleted in the same way . Use the Arrow button to highlight the logbook entry you wish to change and press OK . OK DCO_06158108A_OUS_OB_GB 5/6/03 1:25 PM Page 101[...]

102 T o change the entry , use the Arrow button and press OK . OK Make sure the icon, date and time, and description are correct. (If y ou make an error , press the Back button to return to the menu.) Press OK on the selected mealtime. If you wish to change the entry to another mealtime, scroll to the mealtime and press OK . OK OK T o keep the entr[...]

103 Y our entry will be deleted from the logbook. The edited entry will appear this way in your meter logbook. T o delete an entry , highlight the entry and press OK . OK Use the Arrow button to select “Delete” and pr ess OK . OK DCO_06158108A_OUS_OB_GB 5/6/03 1:25 PM Page 103[...]

104 F astF acts ™ Smar tButton ™ OneT ouch ® UltraSmart ™ FastF acts ™ FEA TURE F astF acts ™ Menu The FastF acts ™ menu lists several choices. See next page for a description of what is available under each choice. Enter FastF acts ™ by pressing the FastF acts ™ Smar tButton ™ . This will put you in the meter memory . The FastF [...]

105 F astF acts ™ Menu Logbook ■ Glucose test r esults with comments and logbook entries b y date and time. Glucose by Meals ■ Glucose test results by date before and after meals. Glucose Analysis ■ Graph of A ll R esults. Interactive gr aph of all glucose test results by date. ■ Graph by Time of Day . Graph of glucose results by time of [...]

L OGBOOK MEMORY T o review the details of each glucose test, comments, and logbook entries, select “Logbook.” The logbook is the meter memory . Y ou may review all entries in your meter logbook, by date and time, by pr essing the Arrow button . In addition to reviewing records, you may also edit the recor ds. (See pages 99–103 .) Follo wing a[...]

107 GL UCOSE ANAL YSIS When you select “Glucose Analysis” on the FastF acts ™ menu, an additional menu of choices appears. Use the Arrow button to mo ve to the desired menu and press OK . Interactive Gr aph of A ll R esults The interactive gr aph displays three days of test results at a time with the most recent test r esult flashing. A bold [...]

108 Graph by Time of Day Y ou may view test results on a gr aph by time period when you select “Graph by Time of Day .” Logbook 21 Nov 02 19:20 Glucose 7.5 mmol/L Aft Dinner 45 Carbs: Dinner Note: If you press OK 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 gra[...]

109 Results by time period ar e shown day by day , one week at a time. Each time you reach the end of the graph, it will mo ve by one day . W eekends are noted by a bold bar abov e the dates. Average of A ll Results T est result averages ar e av ailable for the last 7 , 14 , 30 , 60 , and 90 days with the number of tests completed during that time [...]

110 Average by Exercise T est result averages befor e, during, and after exer cise are av ailable for the last 7 , 14 , 30 , 60 , and 90 days. The number of tests used for each average ar e shown to the left in parentheses. Average by Time of Day T est averages by time of day ar e available for the last 7 , 14 , 30 , 60 , and 90 days. The number of[...]

111 Glucose Range Info If you entered your befor e- and after -meal glucose ranges in the Set-up mode, you may r eview the percentage of your test r esults that are abo ve, belo w , and within your target r anges. Otherwise, before-meal ranges are factory-set at 5.0 – 7.2 mmol/L. After -meal target ranges must be set b y the user (see pages 71 ?[...]

112 In this example, the average intake of Regular insulin o ver the past 14 days is displayed. The number in parentheses before the time segment is the number of logbook entries for that time period. Note that each time period includes the before and after period for that meal. (See pages 70–71 to change your schedule.) INSULIN INT AKE Choose in[...]

113 In this example, the average number of insulin units taken ov er the last 14 days appears. The number sho wn in parentheses is the number of syringe insulin entries ov er the time period. An asterisk (*) after the number means there has been at least one day in the time period without an entry . 6 Syringe T otals T o view the total of all indiv[...]

114 Select “Pump ” to view bolus intake, daily averages, and daily totals. Y ou can review the last 7 , 14 , 30 , 60 , or 90 days. T o view your total syringe insulin intake for each day , scroll to “Daily T otals” and press OK . OK If you did not recor d a syringe insulin intake for a particular day , “- - -” will appear in both column[...]

115 “Daily Average ” displays the average of the total daily pump insulin. This example is for the last 14 days. The number of entries is listed in parentheses. An asterisk (*) means there are days with no entries. “Bolus” will display your aver age bolus intake for each mealtime (Breakfast, Lunch, Dinner , Night) based on your schedule (se[...]

HYPOGL YCAEMIA INFORMA TION If you select “Hypo Info ” from the FastF acts ™ menu, the meter will display the actual number of hypoglycaemic ev ents defined by the level set in Advanced F eatures (see page 72 ). 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 A[...]

117 HEAL TH CHECKS T o view results and dates of v arious check-ups, select “Health Checks.” Scroll to the type of health check using the Arrow button and press OK . The entries for each will appear on the display . OK B. P . Weight Height Chol Ketones Dr . Visit 120/80 68.0 170.0 5.2% 4.8 done 3 Sep 02 3 Sep 02 3 Sep 02 3 Sep 02 3 Sep 02 3 Sep[...]

This choice prompts you to call your local LifeScan Customer Service office or visit our W eb site when you need help with testing. See back cov er for contact information. 118 Data Downloading T ransferring test results to your personal computer for home viewing requires OneT ouch ™ Diabetes Management Software from LifeScan and a LifeScan Inter[...]

119 Connect the LifeScan Interface Cable to a serial port on the back of your computer . With the meter turned on, connect the LifeScan 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 . will appear on the display once the first command is received, indicating that the met[...]

T o learn more about OneT ouch ™ Diabetes Management Software or to purchase a LifeScan Interface Cable separately , contact your local LifeScan Customer Service office. See back cover for contact information. 120 Follo w the instructions in the OneT ouch ™ Diabetes Management Software User’ s Manual to initiate the data transfer command. If [...]

121 SPECI FIC A T IONS Result R ange: 1.1 to 33.3 mmol/L Calibration: Plasma-equiv alent Sample: Fresh capillary whole blood Sample Size: Minimum 1 microlitre T est Time: 5 seconds Assay Method: Glucose oxidase biosensor Power Sour ce: T wo AA A alkaline batteries Battery Life: About six months at three tests per day (one test using backlight) Gluc[...]

122 GU ARANT E E The makers guarantee that the OneT ouch ® UltraSmart ™ Meter shall be free of defects in material and workmanship for a period of three years. This guarantee is v alid from the date of pur chase. The guarantee extends only to the original purchaser and is not transferable. 0336 Blood Glucose Meter , T est Strips, and Control Sol[...]

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AW 06158108A Customer Care Fr eephone: UK 0800 121 200 Ireland 1800 535 676 www .LifeScan.co.uk Distributed by: LifeScan UK A Division of Ortho-Clinical Diagnostics Enterprise House, Station Road, Loudwater , High W ycombe, Buckinghamshire HP 10 9 UF United Kingdom © LifeScan, Inc. 2003 Milpitas, CA 95035 Rev. 04 / 2003 U.S. and foreign patents; o[...]