Lifescan Ultra manual

Ul t ra Ul t ra Ul t ra Blood Glucose Monitoring System Owner’ s Booklet DCO_06405104B_OTU_Uni_OBC_US 3/8/06 12:48 PM Page 2[...]

Important Safety Information T o be sure your meter is working properly , EVER Y time you turn it on confirm that: ◗ All segments are visible in the display check ◗ The unit of measure is correct (mg/dL) ◗ The date and time are correct ◗ The code number on the meter display matches the code number on the test strip vial unit of measure date[...]

i OneT ouch ® Ultra ® System Owner’ s Booklet DCO_06405104B_OTU_Uni_OB_US 3/8/06 12:17 PM Page i[...]

ii Each time you turn on your meter , the unit of measure will appear on the display with the R symbol. The unit of measure will also appear under every test result. Y ou may misunderstand your blood glucose results if your meter is set to the incorrect unit of measure. Y our meter’ s unit of measure should be set to mg/dL. If your meter is set t[...]

iii If your meter is set to the other unit of meas- ure, “mmol/L” will appear on the display . The test result will include a decimal point (Fig. 2). Unless your doctor has told you to use this unit of measure, Do Not test your blood glucose. Call LifeScan Customer Service at 1 800 227-8862 immediately for assistance. Always confirm that the un[...]

iv Dear OneT ouch ® Ultra ® System Owner: Y ou have chosen one of the best blood glucose monitoring systems available. This booklet has important information you must know about the OneT ouch ® Ultra ® System. Please read it carefully . Blood glucose monitoring plays an important role in diabetes control. A long-term study showed that keeping b[...]

v Using the Met er Memory 34 Downloading T est Results to a Persona l C omputer 36 C omparing Meter and Laboratory Results 38 Meter Set-up 40 Caring for Y our OneT ouch ® Ultra ® System 46 Meter 46 OneT ouch ® UltraSoft ® Adjustable Blood Sampler 46 Battery 47 Display Messages and Problem- Solving Guide 50 Specification s 60 Guarantee 61 Index [...]

vi About Y our New System The OneT ouch ® Ultra ® System uses the latest blood glucose moni toring technology . It measures the glucose content of a blood sample by means of an electrical current produced in the test strip and measured by the meter . T est results are “plasma-calibrated.” This makes it easier for you and your diabetes-care te[...]

1 The OneT ouch ® Ultra ® Blood Glucose Monitoring System consists of the OneT ouch ® Ultra ® Blood Glucose Meter , OneT ouch ® Ultra ® T est Strips (may be sold separately), and OneT ouch ® Ultra ® Control Solution. These products have been designed, tested, and proven to work together to produce accurate blood glucose results. Use no othe[...]

2 Before using any product to test your blood glucose, read all instructions and practice the test. Do all quality control checks as directed and consult with a diabetes healthcare professional. These recommendations apply to all blood glucose monitoring systems and are supported by the American Association of Diabetes Educators, the American Diabe[...]

3 ◗ Dehydration: Severe dehydration resulting from excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately . ◗ Low glucose results: If your test result is lower than 70 mg/dL or is shown as LO, it may mean hypoglycemia (low blood glucose). This may[...]

4 T he C omplete OneT ouch ® Ultr a ® Blood Glucose Monitoring Sy stem OneT ouch ® Ultr a ® Meter Owner’s Booklet Quick Referenc e Guide OneT ouch ® Ultr aSoft ® Adjustable Blood Sampler Optional OneT ouch ® UltraCle ar ® Cap OneT ouch ® Ultr aSoft ® Sterile Lanc ets OneT ouch ® Ultr a ® Control Solution OneT ouch ® Ultr a ® T est S[...]

5 OneT ouc h ® Ultra ® Blood Glucose Met er DISPLA Y Symbols, simple messages, and test results appear here. M BUTTON Used to enter into: ◗ set-up mode ◗ memory mode DA T A PORT Used to download your test results to a computer . TEST POR T The meter turns on when you insert the OneT ouch ® Ultra ® T est Strip here. C BUTTO N Used to: ◗ ch[...]

6 BL OOD DROP SY MBOL T ells you when to apply the sample. C ODE Appears with the code number of the test strips. Check your code every time you test. CTL Indicates a control solution test result. BA TTERY SYMBOL Warns when the battery is low or must be replaced. DAY A VG – displayed when 14- or 30-day average is shown. OneT ouc h ® Ultra ® Met[...]

7 TEST RE SUL T AREA T est results are displayed here. MONTH DAY HOUR MINUTE S AM/PM SYMBOL AM/PM Displayed when set to 12-hour time format. Note : mmol/L and . (decimal point) appear in display but are not used in this meter when displaying glucose results. If your meter is set to the correct unit of measure, “mg/dL” will appear on the display[...]

8 OneT ouc h ® Ultra ® T est Strips The OneT ouch ® Ultra ® System measures the amount of glucose in whole blood. Blood is applied in the TOP EDGE of the OneT ouch ® Ultra ® T est Strip and is automatically drawn into the reaction cell where the reaction takes place. C ONTACT BARS Insert this end of the test strip, contact bars facing up, int[...]

9 ◗ Store test strip vials in a cool, dry place below 86˚F (30˚C). Keep away from direct sunlight and heat. Do Not refrigerate. ◗ Store test strips in their original vial only . T o avoid damage or contamina- tion, Do Not transfer test strips to any other place. ◗ After removing a test strip from the vial, replace the vial cap immediately a[...]

10 Each time you turn on the OneT ouch ® Ultra ® Meter either by inserting a test strip or pressing the button, all segments of the display will appear briefly . This tells you that the system is performing several self-checks to confirm that the meter is working properly . T o check that all display segments are working, with the meter off, pres[...]

11 STEP 1 Enter the Code Mode. Insert a test strip to turn on the meter . Push it all the way in until it will go no fur- ther . A void bending the test strip. The display check will appear . Then the code number is displayed for three seconds. The first time you use the meter , three dashes Q will flash, meaning that there is no code stored in the[...]

12 STEP 3 Code the Meter . Immediately press the button, while the code number is displayed on meter to select the correct code. Each time you press and release the button, the number will increase by one. T o move more quickly , press and hold the button. Note : If the apply blood symbol is displayed before the meter is coded correctly , remove th[...]

13 Note : Refer to additional information in the OneT ouch ® Ultra ® Control Solution Package. When y ou should do a contr ol solution test: ◗ T o 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 . ◗ I[...]

14 Befor e you begin: ◗ Use only OneT ouch ® Ultra ® Control Solution. ◗ Check the expiration date on the control solution vial. Record the discard date (date opened plus three months) on the vial label. Do Not use after expiration or discard date, whichever comes first. ◗ Control solution, meter , and test strips should be at room temperat[...]

15 Then the code number will appear , followed by the R symbol and mg/dL . Be sure the meter and test strip codes match. If they do not, code the meter correctly . (See pages 10 – 12.) STEP 1 Insert a test strip into the meter . Insert a test strip, contact bars end first and facing up, into the test port. Push it all the way in until it will go [...]

16 16 STEP 2 Mark this test as a control solution test. ➧ Press and release the button so Ë appears on the display . Note : Mark all control solution tests with Ë to distinguish them from blood glucose tests in the meter memory . Marked control solution tests will not be included in your averages. This mark s the test as a contr ol solution te [...]

17 T o ensure an accurate control solution test, shake the vial, discard the first drop and wipe the dispenser tip before you begin. The control solution test result will appear on the display . Ë will appear above your result. T ouch and hold a drop of control solution where the narrow channel meets the TOP EDGE of the test strip. The control sol[...]

18 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. CAUTION: The control solution range printed on the test strip vial is for OneT ouch ® Ultra ® Control Solution only . It is not a recommended range for your blood glucose level. C [...]

19 C ontrol solution out -of-range resu lts m ay be due to: ◗ Incorrect unit of measure. ◗ Error in performing the test. ◗ Failure to shake the control solution vial well. ◗ Improper meter coding. ◗ T est strip deterioration. ◗ Meter malfunction. ◗ Failure to discard the first drop of control solution and wipe the dispenser tip clean.[...]

20 T esting Y our Blood Read this section and the test strip package insert carefully before testing. Make sure you have all items needed to test. ◗ OneT ouch ® Ultra ® Meter ◗ OneT ouch ® Ultra ® T est Strips ◗ Lancing Device ◗ Sterile Lancets with protective disks DCO_06405104B_OTU_Uni_OB_US 3/8/06 12:17 PM Page 20[...]

21 Preparing the OneT ouch ® Ultr aSof t ® Adjustable Blood Sampler (Sampler) CAUTION: T o reduce the chance of infection: ◗ Never share a lancet or the Sampler with anyone. ◗ Always use a new , sterile lancet. Lancets are for single use only . ◗ Keep the OneT ouch ® Ultra ® Meter and Sampler clean. ◗ Make sure to wash the puncture site[...]

22 STEP 1 Insert a Lancet. T urn the OneT ouch ® UltraSoft ® Cap counter- clockwise to remove it. Insert the lancet into the lancet holder and push down firmly until it is fully seated. Do Not twist the lancet. T wist the protec- tive disk until it separates from the lancet. Replace the OneT ouch ® UltraSoft ® Cap. T urn it clockwise until it i[...]

23 STEP 3 Wash Y our Hands and the Puncture Site. T o reduce the chance of infection, use warm, soapy water . Rinse and dry thoroughly . STEP 2 Cock the Sampler . Slide the ejection/cocking control back until it clicks. If i t does not click, the Sampler may have been cocked when the lancet was inserted. The Sampler is now ready for use. DCO_064051[...]

The OneT ouch ® Ultra ® System requires a very small blood drop to per- form a test. Y ou may obtain it from a fingertip or forearm. (See page 25 for information on obtaining a blood sample from the forearm.) Choose a different puncture site each time you test. Repeated punctures in the same spot may cause soreness and calluses. STEP 1 Position t[...]

25 For earm Blood Sampling The forearm has fewer nerve endings than the fingertip so you may find that obtaining a blood sample from the forearm may be much less painful than using the fingertip. The technique for forearm sampling is different from fingertip sampling. Also there are differences between forearm samples and fingertip samples that you[...]

STEP 3 Massage the Area. T o increase blood flow to the puncture site, massage the area gently . For individuals who experience difficulty in getting sufficient blood for a test, rubbing the area more vigorously or applying heat briefly may be helpful. STEP 4 Position the Sampler . Press and hold the Sampler against the fore- arm for a few seconds.[...]

27 If bruising occurs, you may choose to lance a fingertip instead. If you are having difficulty obtaining blood from the forearm, call LifeScan Customer Service at 1 800 227-8862 . Important information about forearm testing ◗ Under certain conditions, blood glucose test results obtained using samples taken from your forearm may differ significa[...]

28 Insert This End Step-b y- Step T est Proc edure STEP 1 Insert T est Strip. Insert a test strip, contact bars end first and facing up, into the test port. Push it in until it will go no further . The meter will turn on and the display check will appear briefly . Then the code number will appear , followed by the symbol with mg/dL. Check to make s[...]

29 STEP 2 Apply Sample. Obtain a round drop of blood using the Sampler . The blood sample must be at least 1 µL in volume ( actual size) to fill the confirmation window . When the symbol appears on the dis play , 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 o[...]

Hold the blood drop to the top edge of the test strip until the confirmation window is full before the meter begins to count down. If the confirmation window does not fill completely before the meter begins to count down, Do Not add more blood to the test strip; discard the test strip and retest. If you have trouble filling the test strip, call Lif[...]

31 STEP 3 Accurate Results in Just 5 Seconds. Y our blood glucose test result will appear after the meter counts down from 5 to 1 . Blood glucose test results are automatically stored in the meter memory . Y ou may also record them in the logbook provided with your system. T urn the meter off by removing the test strip. Dispose of used test strip i[...]

STEP 1 Remove the OneT ouch ® UltraSoft ® Cap from the Sampler . T wist the OneT ouch ® UltraSoft ® Cap counter- clockwise. (Optional: Replace the protective disk on the used lancet by placing it on a hard sur- face and pushing the lancet tip into the disk.) STEP 2 Eject the Lancet. Point the Sampler down and away . Push the release button to e[...]

33 If your blood glucose test result is above 600 mg/dL, h1 will appear on the meter display . This may mean severe hyperglycemia (high blood glucose). Y ou should recheck your blood glucose level. If h1 again appears on the display , call your healthcare professional immediately . When your blood glucose test result is above 240 mg/dL or reads h1 [...]

34 Using the Meter Memor y Y our OneT ouch ® Ultra ® Meter stores the 150 most recent blood glucose and control solution test results with date and time in its memory . It also provides you with 14- and 30-day averages of your blood glucose test results. If your 14-day and 30-day test result averages are not what you expect, you should not rely o[...]

35 STEP 2 Recall T est Results. The most recent test result with date and time will appear . Press and release the button and the next most recent test result will appear . The meter will recall up to your last 150 test results in order from the most recent to the oldest. If memory is not full, - - - will appear for memory locations that are empty [...]

36 Downloading T est Results to a Personal Computer T ransferring test results with date and time from the meter memory to your personal computer requires OneT ouch ® Diabetes Management Software with the accompanying OneT ouch ® Interface Cable. (OneT ouch ® Diabetes Management Software is available separately .) Note to users of OneT ouch ® D[...]

37 STEP 3 T ransfer Data. Follow the instructions in the OneT ouch ® Diabetes Management Software User’ s Manual to initiate the data transfer command. O will appear on the meter display when the first com- mand is received, indicating that the meter is in the communi- cation mode. If the command is not received within two minutes, the meter wil[...]

38 Comparing Meter and Laborator y Results OneT ouch ® Ultra ® Meter test results and laboratory test results are both expressed in plasma-equivalent units. However , your meter result may differ somewhat from your laboratory result due to normal variation. Meter results can be affected by factors and conditions that do not affect laboratory resu[...]

39 While at the lab: ◗ Make sure that the meter test and the lab test are performed within 15 minutes of each other . ◗ Wash your hands before obtaining a blood sample. ◗ Use only fresh capillary blood obtained from the fingertip. Y ou may still have a variation from the laboratory result because blood glucose levels can change significantly [...]

40 Meter Set-up • Start with the meter off. • Press and continue to hold the button until ONL Y the time appears on the bottom right of the display . • Release the button. Meter on Y ou may need to update the meter settings when you first receive your meter or when you replace the battery . Follow these instructions. If you need assistance, c[...]

41 Press and release the button to move to the next step. Press and release the button to change to the desired minutes. Press and release the button to move to the next step. If you use the 12-hour format, the AM or PM will change each time you reach 12:00. Be sure the AM/PM setting is correct when you set the hour . T o scroll faster , hold the b[...]

42 Press and release the button to change to the desired year . Press and release the button to move to the next step. Press and release the button to choose between AM/PM and 24-hour formats. Press and release the button to move to the next step. or STEP 4 Set the AM/PM or 24-hour time format. STEP 5 Set the year . DCO_06405104B_OTU_Uni_OB_US 3/8/[...]

43 Press and release the button to change to the desired month. Press and release the button to move to the next step. Press and release the button to change to the desired day . Press and release the button. Continue to the next page. STEP 6 Set the month. STEP 7 Set the day . DCO_06405104B_OTU_Uni_OB_US 3/8/06 12:17 PM Page 43[...]

44 Press and release the button until mg/dL appears on the display . Press and release the button to save your entry , save your changes, and shut the meter off. W W A A R R N N I I N N G G : : T T h h e e m m g g / / d d L L u u n n i i t t o o f f m m e e a a s s u u r r e e i i s s t t h h e e s s t t a a n n d d a a r r d d i i n n t t h h e e [...]

45 Note : The 14- and 30-day averages in the meter memory are calculated from results obtained during the 14 and 30 calendar days preceding the current date and time settings. When the date and time are changed, the averages may change. If your 14-day and 30-day test averages are not what you expect, do not rely on them. DCO_06405104B_OTU_Uni_OB_US[...]

46 Caring for Y our OneT ouch ® Ultra ® System Meter Y our OneT ouch ® Ultra ® 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 port. LifeScan recommends that you store the meter in its carrying case after each use. [...]

47 Batt er y Y our OneT ouch ® Ultra ® Meter comes with a pre-installed 3.0 V (#2032 or equivalent) lithium battery . The battery will provide you with enough power to perform about 1,000 tests. When replacing the battery , use only a 3.0 V (#2032 or equivalent) lithium battery . The meter will alert you when the power is getting low by displayin[...]

48 When the symbol appears on the display by itself, it means that the battery will not provide enough power for a test. Y ou must change the battery . T o replace the battery , make sure that the meter is turned off. T urn the meter over and locate the battery compartment. STEP 1 Open the Battery Compartment. Push up on the tab and pull the batter[...]

49 Note : Replacing the battery does not affect previous test results stored in memory . However , the time and date settings may need to be updated. Always confirm the unit of measure is mg/dL. STEP 2 Remove the Old Battery . Pull upward on the clear plastic tab. Insert one 3.0 V (#2032 or equivalent) lithium bat- tery , making sure the positive ?[...]

50 Display Messages and Problem-Solving Guide Following is a summary of all display messages. These messages help to identify certain problems but do not appear in all cases when a problem has occurred. Improper use may cause an inaccurate result without pro- ducing an error message or a symbol. In the event of a problem, refer to the information u[...]

51 MES SAGE WHA T IT MEANS ACTION This is the code number stored in the meter . Make sure that this code num- ber 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 n[...]

52 A blood glucose test result in mg / dL. None required. W ARNING: If mg/dL does not appear with the test result, call LifeScan Customer Service at 1 800 227-8862 for assistance. A blood glucose test result with a suggestion to check your ketone levels. Follow the instructions of your healthcare professional regarding ketone testing. MES SAGE WHA [...]

53 T reat this condition immediately accord- ing to your health- care professional’ s recommendations. Although this message could be due to a test error , it is safer to treat first, and then repeat the test. Y ou may have a very low blood glucose level, lower than 20 mg/dL. Y ou may have a very high blood glucose level, exceeding 600 mg /dL. Y [...]

54 MES SAGE WHA T IT MEANS ACTION A control solution test result stored in the memory . None required. There is no test result stored in this place in the memory . None required. A verage of results from the last 14 days ( √ means that 64 tests were per- formed within the period) . The 30-day average appears with a © before the on the screen. If[...]

55 MES SAGE WHA T IT MEANS ACTION Do Not use the meter . Call LifeScan Customer Service at 1 800 227-8862 for a replacement meter . Error message could be caused either by a used test strip or a problem with the meter . Repeat the test with a new test strip. Refer to pages 8–9 for test strip information. If the error message persists, call LifeSc[...]

56 1. Y ou may have high glu- cose and have tested in an environment near the low end of the system’ s oper- ating temperature range (43–111°F / 6–44°C). 2. There may be a problem with the test strip. For example, it may have been damaged or moved during testing. 1. If you tested in a cool environment, repeat the test in a warmer environ- m[...]

57 4. If the error message appears again, call LifeScan Customer Service at 1 800 227- 8862. 4. There may be a problem with the meter . Error 4 continued Error message that indicates that the meter has detected a problem with the test strip. Possible causes are test strip damage or an incompletely filled confirmation window . Repeat the test with a[...]

58 Repeat the test after the meter and test strips have reached a temperature within the oper- ating range. The meter has detected that the temperature is above the system operating range. Do Not perform a test until the meter and test strips reach a temperature within the operating range of 43–111°F (6–44°C). Repeat the test after the meter [...]

59 If the meter does not display a message after inserting a test strip: If the test does not start after applying the sample: POSSIBLE CAUS E WHA T 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 Repe[...]

60 Specifications Result Range: 20 to 600 mg /dL Calibration: Plasma-equivalent Sample: Fresh capillary whole blood Sample Size: Minimum 1 microliter T est Time: 5 seconds Assay Method: Glucose oxidase biosensor Power Source: One replaceable 3.0 V (#2032 or equivalent) lithium battery Battery Life: About 1,000 tests (about one year at three tests p[...]

61 Guarantee The makers guarantee that the OneT ouch ® Ultra ® Meter shall be free of defects in material and workmanship for a period of three years. This guarantee is valid from the date of purchase. The guarantee extends only to the original purchaser and is not transferable. PRODUCT SAFETY INFORMA TION The OneT ouch ® Ultra ® system complie[...]

62 Index A verages, 14- and 30-Day . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34, 45, 54 Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47, 57, 60, 61 Blood Sampling, Fingertip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .[...]

63 Low Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3, 32 M Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Memory , Using . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .[...]

Glucose Ranges for People Without Diabetes, mg /dL Y our Target Ranges, mg /dL Before breakfast Before lunch or dinner 1 hour after meals 2 hours after meals Between 2 and 4 AM 70 –1 05 70 –1 10 Less than 1 60 Less than 1 20 Greater than 70 Source: Krall, L.P ., and Beaser , R.S.: Joslin Diabetes Manual. Philadelphia: Lea and Febiger (1989), p.[...]

© LifeScan, Inc. 2005 Milpitas, CA 95035 02/2006 The system described herein is covered b y one or more of the follo wing U.S . patents: 6,045,567, 6,156,051, 6,197,040, 6,284,125, and D428,150. Use of the monitoring device included herein is protected under one or more of the follo wing U.S . patents: 6,413,410, 6,733,655. Purchase of this device[...]