Lifescan SureStep blood glucose monitoring system manuale d’uso

Owner’ s Booklet LSI-98-090 SS booklet.B 7/13/98 11:41 AM Page T1[...]

The SURESTEP ® System is intended for use outside the body (in vitro diagnostic use). It should be used only for testing purposes and only with fr esh whole blood samples. It should not be used for the diagnosis of diabetes. LSI-98-090 SS booklet.B 7/13/98 11:41 AM Page T3[...]

Welcome to LifeScan Congratulations! You’ve chosen a product made by LifeScan, a leading company in providing products to help you manage your diabetes. SURESTEP ® blood glucose monitoring products are widely available without a prescription. Blood glucose monitoring plays an important role in controlling your diabetes. A recent study showed tha[...]

CAUTION: Befor e using any product to test your blood glucose (blood sugar), read all instructions and practice the test. Do all quality contr ol 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 Educat[...]

LEARNING THE SYSTEM 1 SURESTEP ® Blood Glucose Meter 3 SURESTEP ® Test Strips 4 Display Symbols 6 CODING THE METER Three Easy Steps to Coding 10 CHECKING THE SYSTEM SURESTEP ® Glucose Control Solution 12 Control Solution Test 12 Control Solution Range 17 TESTING YOUR BLOOD Getting a Drop of Blood 18 Step-by-Step Test Procedure 24 Optional Color [...]

UNDERSTANDING YOUR RESULTS Overview 34 Comparing Meter and Laboratory Results 35 Expected Test Results (Target Range) 36 Testing Tips to Ensure Accuracy 38 Health Conditions Causing Out-of-Range Results 39 Recommendations for Better Diabetes Control 41 RECALLING RESULTS FROM METER MEMORY Using the Meter for the First Time 42 Recalling All Results i[...]

CHANGING METER SETTINGS 52 (Set-Up Mode) Entering Set-Up Mode 53 Display of Last Result 53 Unit of Measurement (mg/dL or mmol/L) 54 Beep Signals 55 SOL VING PROBLEMS Helpful Messages 57 Error Messages 59 SPECIFICA TIONS Performance Characteristics 64 Guarantee and Warranty 65 QUICK REFERENCE GUIDE 67 LifeScan Customer Services (24 hours a day, 7 da[...]

LSI-98-090 SS booklet.B 7/13/98 11:41 AM Page T10[...]

1 The SURESTEP ® Blood Glucose Monitoring System is the next advance in the self-monitoring of blood glucose. The SURESTEP System is for people with diabetes who need to check the level of sugar (glucose) in their blood. A drop of blood is taken from the finger and placed on a SURESTEP ® T est Strip, which is then inserted into the SURESTEP ® Bl[...]

2 Gluc o se Shake before Not Intended Discard 3 mo Discard date: Lot No. Exp. Date © LIFESCAN IN Color Chart Lancets Inside Tray Extra Space for Diabetes Supplies and Syringes BEFORE TESTING: See inside for instructions on proper blood application and coding the meter. * IMPORTANT: Read detailed instructions in your SureStep ® Owner’s Booklet b[...]

3 SURESTEP ® Blood Glucose Meter POWER BUTTON (Blue) Turns the meter on and off. BATTERY COMPARTMENT Holds two AAA alkaline batteries. C BUTTON (Green) Codes the meter, changes the meter settings, and scrolls through the memory. LENS AREA Contains the meter optics that read the glucose level. Test strip holder covers the lens area. DISPLAY Shows y[...]

4 LEARNING SURESTEP ® T est Strips When blood is applied to the pink test square, it is absorbed and a chemical reaction takes place. A blue color for ms in the confirmation dot on the back of the test strip and is read by the meter to determine the blood glucose level; the darker the color , the higher the blood glucose level. White Tip is insert[...]

5 IMPORT ANT TEST STRIP INFORMA TION ■ Contact with air , moisture, and light can cause false results. Keep test strips sealed in the original moisture-resistant, light-protected package and store in a cool, dry place not above 86° F (30° C). Do not refrigerate, place in direct heat or sunlight, or leave bottle open. ■ DO NOT use SURESTEP ® [...]

6 LEARNING Display Symbols The SURESTEP ® Blood Glucose Meter uses symbols to guide you through a test and to help you determine if something is wrong with your test strip or meter . T o check that all display symbols are working, press and hold down the power button. All of these symbols should appear . Call LifeScan Customer Services at 1 800 22[...]

7 Meter Memory Result. Y our SURESTEP ® Meter stores up to 10 blood glucose or control solution test results in its memory . Every time you turn the meter on, it will automatically recall and display your last (most recent) result. Code Number . The number on the display must match the code num- ber on your SURESTEP ® T est Strip package. It must[...]

8 LEARNING Apply Blood Sample to Pink T est Square. Push the T est Strip, Pink Side Up, Firmly into the T est Strip Holder Until It Stops. If you fail to completely insert the test strip, the test may start. However , you may receive an inaccurate low result. Meter Is Reading Y our Result. The result appears, on average, in 30 seconds. The clock ma[...]

9 (Example) HI mg/dL. In virtually all cases above 500 mg/dL (27.8 mmol/L), the meter reads “ . ” When proper procedures are fol- lowed, a reading of “ ” means very high blood glucose (severe hyperglycemia). In extremely rar e circumstances, the meter will r ead “ ” instead of “ ” above 500 mg/dL (27.8 mmol/L). Compar e the color of[...]

10 CODING Code numbers are used to calibrate the SURESTEP ® T est Strip with the SURESTEP ® Meter for accurate results. Y ou must code the meter before using it for the first time. Y ou must check the code ever y time you change to another package of test strips. Check that the code number on the display matches the code number on the test strip [...]

11 Step 2: Check the Code Numbers. The code number on the test strip package will range from 1 to 21. If the number on the display matches the code number on the SURESTEP ® T est Strip package, begin testing. If the two code numbers do not match, follow Step 3 to code the meter . Step 3: Code the Meter . After the CODE symbol appears, press the gr[...]

12 CHECKING The SURESTEP ® System does not require a check strip. The meter performs an automatic check ever y time you turn it on. SURESTEP ® Glucose Control Solution Control solution is used instead of blood to tell you that the SURESTEP ® Blood Glucose Meter and SURESTEP ® T est Strips are working together properly . The control solution con[...]

13 IMPORT ANT CONTROL SOLUTION TEST INFORMA TION ■ Use only SURESTEP ® Glucose Control Solution. ■ Check the expiration date. W rite the discard date on the vial. Do not use if expired. Discard the vial 3 months after first opening it. ■ The control range printed on the test strip bottle is for SURESTEP Glucose Control Solution only . It is [...]

14 Follow the test procedure, using SURESTEP ® Glucose Control Solution instead of blood. Before T esting, Check the Code. After turning the meter on, the last result appears, followed by the CODE symbol and number . If the code on the meter does not match the code on the test strip package, pr ess the green C button until the codes match. Step 1:[...]

15 Step 2: Check Confirmation Dot. Check to see that the confirmation dot on the back of the test strip has turned completely blue to ensure you have applied enough control solution. Step 3: Insert the T est Strip and Read Result. W ithin two minutes after applying control solution, insert the test strip firmly into the test strip holder , pink sid[...]

16 The control solution result appears, on average, in 30 seconds. (Example) Note: Do not use the Color Chart to verify control solution tests. Compare the control solution test result with the control range printed on the SURESTEP ® T est Strip package. (Example) SURESTEP Control Range CHECKING LSI-98-090 SS booklet.B 7/13/98 11:41 AM Page 16[...]

17 When the control solution test result is within the control range, you are ready to test your blood. Y our con- trol solution test will be stored in the meter memory . Record control solution tests in your logbook by placing a C next to the result to indicate a control solution test. Control Solution Range If test results fall outside the expect[...]

18 TESTING Getting a Drop of Blood IMPORT ANT : Getting an adequate drop of blood is one of the most important steps in getting an accurate result. Step 1: Insert a Lancet in the PENLET ® II Automatic Blood Sampler . Remove the PENLET ® II Cap by pulling it straight off. CAUTION: ■ Use a new , sterile lancet every time you test. ■ Do not use [...]

19 Inser t a new , sterile lancet into the lancet holder . Hold the lancet firmly , and gently twist and pull off the protective disk. Note: Save the protective disk for safe removal of the lancet after testing. TESTING LSI-98-090 SS booklet.B 7/13/98 11:41 AM Page 19[...]

20 TESTING Choose either the regular or deep penetration PENLET ® II Cap and slide it back onto the PENLET II Sampler . Step 2: Cock the PENLET ® II Sampler . Holding the lower portion of the PENLET II Sampler , pull out the dark gray sliding barrel until it clicks. If it does not click, the PENLET II Sampler may have been cocked when the lancet [...]

21 Step 3: Get a Drop of Blood. W ash your hands with soap and warm water and dry them thor- oughly . W arm water stimulates blood flow to the fingers. Hang your arm down for 10 –15 seconds before you stick your finger . If you use alcohol to clean your finger , make sure you let it dry . T o avoid soreness, choose a site on the side of your fing[...]

22 TESTING Hold the PENLET ® II Sampler firm- ly against the side of the finger , with the cap resting on the finger . (The harder you press, the deeper the puncture.) Press the dark gray release button. By holding your hand down and kneading your palm, blood will flow more quickly and easily to your finger . If necessary , squeeze the finger gent[...]

23 Step 4: Remove the Lancet. When removing the PENLET ® II Cap, be careful not to prick your- self or anyone else. After removing the cap, grasp the two dark gray prongs located near the release button, pointing the lancet down and away from you. Pull back on the dark gray sliding barrel until the lancet drops out. Another way to remove the lance[...]

24 TESTING Step-by-Step T est Procedure When learning to use the meter for your own diabetes care, first do a control solution test. When the control solution test result is within the control range, you are ready to practice by testing your blood. Next you should perform three blood glu- cose tests in a row . Y ou will know you have applied blood [...]

25 Befor e T esting. Press the blue power button. Y our last test result will appear . Next, the code number appears. It must match the code number on the SURESTEP ® T est Strip package. If it does not match, change the meter code number following the instruc- tions on pages 10 –11. (Example) (Example) TESTING LSI-98-090 SS booklet.B 7/13/98 11:[...]

26 TESTING Then these symbols will alternate on the display: Apply blood to Insert test strip test strip. into meter. The meter is ready for a test. Y ou have two minutes to insert the test strip before the meter automatically turns off. Step 1: Apply Blood to the T est Strip. Apply a drop of blood to the center of the pink test square. Note: Do no[...]

27 1) Hold the test strip under your finger and touch the drop of blood to the pink test square. OR 2) T urn the test strip over and dab the pink test square to the finger . Y ou can touch the test strip. The pink test square will quickly absorb the blood and the confirmation dot will begin changing color . Y ou can apply blood to the pink test squ[...]

28 TESTING Y ou have applied too much blood to the test strip if the entire white pad is soaked. Y ou must begin the test with a new test strip to avoid false results from too much blood. Step 2: Check the Confirmation Dot. After a few seconds, look at the confirmation dot on the back of the test strip. If it is com pletely blue, go on with the tes[...]

29 If any white patches or white streaks appear on the confirmation dot, you have not applied enough blood for an accurate test. Y ou must start the test over with a new test strip. Caution: If you do not insert the test strip properly , you may get an inaccurate result. Step 3: Insert the T est Strip and Read Result. T urn the SURESTEP ® T est St[...]

30 The flashing clock symbol appears while the meter is reading your result. Y ou will hear a three-tone beep when the meter displays your result. Results appear , on average, in 30 seconds. The meter displays results between 0 and 500 mg/ dL. In virtually all cases above 500 mg/dL, the meter reads “ . ” Note: Y our meter is designed to give ac[...]

31 Recor d your test result in your LifeScan logbook. The logbook allows you to keep a record of your test results, along with information on your meals and medication. DATE TEST TEST RESULT TIME INSULIN/ MEDICATION DATE NOTES NOTES TEST TEST RESULT TIME INSULIN/ MEDICATION IMPORT ANT : When proper procedur es ar e followed, the meter will display [...]

32 TESTING Pr ess the blue power button to turn off the SURESTEP ® Blood Glucose Meter . (T o save energy , the meter automatically turns off three minutes after the meter displays your test result.) Optional Color Chart A Color Chart is included with each package of SURESTEP ® T est Strips. It is useful as an additional check that your meter and[...]

33 1 . Befor e testing. Compare the confirmation dot on the back of the new test strip to the shade marked unused on the chart. Do not use the test strip if the confirmation dot is darker than the color of an unused test strip on the Color Chart. 2 . After testing . Directly after read- ing a meter result, you can com- pare the color of the test st[...]

34 RESULTS Overview Recent Diabetes Findings. In 1993 the National Institutes of Health concluded an extensive long- term study of people with T ype 1 diabetes. This study , called the Diabetes Control and Complications T rial (DCCT), found that by keeping your blood glucose close to the levels of people without diabetes you can reduce the risk of [...]

35 Frequency of T esting. How often you need to test your blood glucose will vary according to your age, the type of diabetes you have, the medications you are taking, and your physical and emotional health. Y our healthcare professional will guide you. After you decide when and how often you should test, it is important that you make testing part [...]

36 RESULTS exercised, taken medication, or experienced stress. 3 In addition, if you have eaten recently , the blood glucose level from a fingerstick can be up to 70 mg/ dL higher than that of a venous sample (blood drawn from a vein) used for a laboratory test. 4 Therefore it is best to fast for eight hours before doing the com- parison tests. Fac[...]

37 GLUCOSE RANGES FOR PEOPLE WITHOUT YOUR TARGET DIABETES, 5 mg/dL RANGES, mg/dL Before breakfast 70 –105 ______________________ Before lunch or dinner 70 –110 ______________________ 1 hour after meals Less than 160 ______________________ 2 hours after meals Less than 120 ______________________ Between 2 and 4 a.m. Greater than 70 _____________[...]

38 RESULTS T esting T ips to Ensure Accuracy If you have a test r esult that falls outside of your tar get range and you cannot link it to diet, exer cise, medication, or stress, r epeat the test. If the result is similar and still outside of your range, tr y these tr oubleshooting steps: Before T esting : ■ W ash your hands. ■ Use a new , ster[...]

39 the test strip confirmation dot to be certain it turned completely blue. ■ Make sure you did not apply too much blood to the test strip. Y ou have applied too much blood if there is no white visible on the white pad. ■ Directly after the meter displays a result, compare the color of the test strip confirmation dot with the Color Chart on the[...]

40 RESULTS “ Do I have symptoms of high blood glucose (hyperglycemia): fatigue, dry mouth and skin, increased thirst or hunger, blurry vision, increased uri- nation, rapid deep breathing, or a fruity smell to the breath?” “What have I eaten?” “How much have I exercised?” “Am I ill (common cold, flu, etc.)?” “Have I been under stre[...]

41 Recommendations for Better Diabetes Contr ol ■ Follow the advice of your healthcare professional. ■ Follow the exercise and meal plans recommended by your healthcare professional. ■ T ake insulin or diabetes medication at your scheduled times. ■ Keep in touch with your emotional and physical condition. Stress or illness can affect diabet[...]

42 MEMORY The SURESTEP ® Blood Glucose Meter is pre-set to automatically display your last test result when the meter is turned on. Y ou can also r eview your last result immediately after a new test is completed. The meter stores your 10 most recent blood glucose or control solution test results in its memory . When the memory is full, the oldest[...]

43 Recalling All Results in Meter Memory T o access the meter memory , press the blue power button and hold down for five seconds. When the display flashes, r elease the blue power button. Y ou ar e now in memory mode. Y our most recent r esult will appear on the display . Order of test result Result (most recent test first) (Example) Pr ess the gr[...]

44 If a previous test resulted in an error condition, the error will be stored in the memory . Order of test result Result (third most recent) (Example) Recalling Y our Last Result Immediately after completing a test, you can also review your previous test result. W ith the current test r esult displayed, press and hold the green C button. Y our pr[...]

45 Y our SURESTEP ® Blood Glucose Meter is easy to maintain. However , to keep it in good operating condi- tion, follow these simple rules: General Care ■ Keep your meter dry and avoid exposing it to extr emes in temper- ature. Do not store your meter or test strips in a car or refrigerator . ■ Dropping the meter could damage its electronics .[...]

46 MAINTENANCE Always clean your meter when this symbol appears: If you are concerned that your test results do not compare with how you feel, clean the meter and do a control solution test to check if it is working properly . Clean the meter using these easy steps: Step 1: Remove the T est Strip Holder . Press down at the top end (near the power b[...]

47 Make sure you thoroughly wipe the gray area on the inside cover . W ash both sides of test strip holder base; carefully clean around the hole. Dry the test strip holder completely with a soft cloth or lint-free tissue. Step 3: Clean the Lens Area and Contact Points. Use a cotton swab or a soft cloth dampened with water to wipe the lens area and [...]

48 MAINTENANCE Step 4: Replace the T est Strip Holder . Slide the test strip holder into the meter , press down, and push forward at the strip insertion point until you hear a click. Make sure the test strip holder is firmly in place. Make sure it does not extend beyond the meter . Note: Y ou can clean the outside of the meter by lightly wiping it [...]

49 If this symbol appears after cleaning the meter , check to see if you insert- ed the test strip holder completely and securely . The test strip holder may be out of position. See pages 59– 63 for error descriptions. Note: I f using a 10% bleach solution, this message may indicate that you have not completely removed the bleach residue on the g[...]

50 MAINTENANCE low batteries. If the symbol is flash- ing, the batteries are dead and you should replace them immedi ately . Y ou will not be able to do a test when the symbol is flashing. Replace both batteries with new AAA alkaline batteries. Do not use rechargeable batteries. Note: Low batteries, dead batteries, and battery removal will not affe[...]

51 Step 2: Remove the Old Batteries. Use your fingers or gently tap the meter on the palm of your hand. Never tap the meter against a hard surface. Step 3: Insert New Batteries. Insert two new AAA alkaline batteries, matching the + end of each battery with the + signs inside the meter . Step 4: Close the Battery Door . Insert the two hinges into th[...]

52 SETTINGS The SURESTEP ® Meter has been pre-set to meet the needs of most users. There are three features you can change. Be sure you want to change these settings before enter- ing the set-up mode to avoid having meter settings that do not meet your needs. CHANGING METER SETTINGS ( Set-Up Mode) FEA TURE PRE-SET AL TERNA TIVE Automatic display O[...]

53 Entering Set-Up Mode 1. Make sure the meter is off. 2. Press and hold down the green C button. 3. Press and release the blue power button while holding the C button. 4. Release the C button. In the set-up mode, the current set- ting for each of the three changeable features is automatically displayed in sequence. Each setting flashes on the disp[...]

54 SETTINGS If you wish to turn off the auto- matic display of your last result, press the C button. This symbol will flash indicating that the automatic display is turned off. Then, wait for the next feature setting (unit of measurement) to appear . Unit of Measurement The meter is pre-set to display test results in milligrams per deciliter (mg/ d[...]

55 If you wish to change the unit of measurement to mmol/L, press the C button. This symbol will flash on the display . Then, wait for the next feature set- ting (beep signals) to appear . Beep Signals The SURESTEP ® Blood Glucose Meter uses beeping tones to signal various steps in the meter procedures. However , these tones do not indicate that t[...]

56 If you want the meter to operate without beeps, enter the set-up mode. After the meter displays the memor y and unit of measur ement features, the meter will sound a three- tone beep and flash this message Press the C button to turn off the beep signals. The following display will appear Y ou will hear a three-tone beep when is first displayed. [...]

57 When any of the following symbols or error messages appear , there may be a problem with the meter , test strip, or the way in which you are doing the procedure. These messages help to identify certain problems but do not appear in all cases when a problem has occurred. In most cases, a problem is easy to solve. Assistance is available from Life[...]

58 SYMBOL MESSAGE WHA T TO DO 1. The test strip was 1. Remove the test strip inserted before the and reinsert the meter was turned on strip after this or before the insert test symbol appears. strip symbol appeared, or 2. The test strip was inserted 2. Reinsert the test strip, tip incorrectly , or first, with the pink side facing up. 3. The test st[...]

59 Err or Messages The meter gives specific error mes- sages when it detects a problem with its internal functions, the test strip, or the testing procedure. However , improper use may cause an inaccurate result without producing an error message or a symbol. When error mes- sages appear , note the error number , turn off the meter , then resolve t[...]

60 MESSAGES ERROR POSSIBLE CAUSE WHA T TO DO 3. The test strip was 3. Repeat the test with a new test inserted more than strip. Insert it within 2 minutes 2 minutes after after applying blood. applying blood, or 4. Y ou may have a 4. Do a visual check of the color of very high blood the confirmation dot versus the glucose level, Color Char t on the[...]

61 ERROR POSSIBLE CAUSE WHA T TO DO 2. The test strip has 2. Check the expiration date on been altered, exposed your test strip package. Do not to air , or has passed store test strips outside of the its expiration date. original bottle. Do not alter test strips. 1. The test strip was 1. Do not remove the test strip removed or partially until the m[...]

62 ERROR POSSIBLE CAUSE WHA T TO DO The meter is not Allow the meter to warm or within the temperature cool slowly before performing range of 50 – 95°F another test. Do not apply heat (10–35°C). or cold to the meter or test strips. 1. The meter test strip 1. Clean; refer to pages 45–49. holder , lens area, and contact points are dirty , or [...]

63 MESSAGES ERROR POSSIBLE CAUSE WHA T TO DO 3. The test strip was 3. Remove test strip and turn partially inserted meter off. T urn meter on, then before turning the reinsert test strip when insert meter on. test strip symbol appears. A possible failure has T urn meter on. Before testing, occurred in the meter . check that the code on your meter m[...]

SPECIFICATIONS 64 Perfor mance Characteristics See the SURESTEP ® T est Strip package insert for accuracy and precision information. Power Supply: T wo AAA alkaline batteries. Battery Life: Approximately 18 months when doing two tests a day . Result Range: 0 – 500 mg/ dL (0 – 27.8 mmol/L). Higher results are displayed as “ . ” Display: Liq[...]

65 Guarantee and W ar ranty 30-Day Money-Back Guarantee If you are not fully satisfied with the SURESTEP ® System, a full refund may be obtained by calling a LifeScan Customer Services Representative at the toll-fr ee number within 30 days of purchase. After calling LifeScan, you will need to return the SURESTEP ® Meter and a copy of your receipt[...]

The W arranty Policy does not apply to the performance of the SURESTEP ® Meter when used with any test strip other than SURESTEP ® T est Strips from LifeScan, or when the SURESTEP Meter or T est Strips are modified in any way . Before you return your meter , or any product, first call your LifeScan Customer Services Representative at the toll-fre[...]

67 QUICK REFERENCE CODING THE METER 1 Press power button. 2 Meter automatically displays last test result. 3 Code number is automatically displayed. 4 Press C button until code number on meter matches cod e number on test strip package. 3-STEP TEST PROCEDURE → C Button Before testing, make sure the meter is coded correctly. 2 C heck confirma- tio[...]

QUICK REFERENCE 68 BLOOD AP PLICA TION How you can be sure that you have applied the right amount of blood: Pink test square is where you apply a drop of blood. White pad absorbs the excess blood that may extend beyond the pink test square. Do not apply blood directly onto the white pad. Confirmation dot on back of test strip is where you check to [...]

El Folleto para el Propietario del SURESTEP ® se encuentra disponible en español. Para recibir su copia gratuita, favor del llamar al número gratis 1 800 381-7226. The SURESTEP instructional materials are available in Spanish. To receive your free copy, please call toll-free 1 800 381-7226. LifeScan Customer Services toll-free numbers: (24 hours[...]