Lifescan Diabetes Monitoring System manuel d'utilisation

Owner’ s Booklet Complete Diabetes Monitoring System For diabetes and life.[...]

DEAR ONE TOUCH TM BASIC TM PLUS OWNER: Congratulations! Y ou’ve chosen a very easy-to-use blood glucose (sugar) monitoring system for home testing. When used properly , your ONE TOUCH ™ BASIC ™ Plus System will give you the accurate test results you need, in just a few simple steps. Everything you need to know about using the ON E TOUCH BASIC[...]

The ONE TOUCH ™ BASIC ™ Plus Diabetes Monitoring System is intended for in vitro diagnostic use for quantitative determination of glucose in whole blood as an aid in monitoring effectiveness of diabetes management in the home and in clinical settings. It is not intended for use in the diagnosis of diabetes or for neonatal testing (newborns 0 ?[...]

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

T ABLE OF CONTENTS PRECAUTIONS AND LIMIT A TIONS 1 Infection Control 2 GETTING ST ARTED 3 The Complete ONE TOUCH ™ BASIC ™ Plus Diabetes Monitoring System 3 ONE TOUCH ™ BASIC ™ Plus Blood Glucose Meter 5 ONE TOUCH ™ T est Strips 7 BEFORE TESTING 9 Setting Meter Code 9 Checking the System 11 — Checking with the Check Strip 12 — Checkin[...]

— How to T est Y our Blood 27 Special Messages 31 Checking the Amount of Blood on the T est Strip 32 USING THE METER MEMOR Y 34 Entering the Memory Mode 35 Recalling T est Results 36 SETTING METER OPTIONS 37 Entering and Using the Set-Up Mode 37 Clock (T ime and Date) 39 — Setting the T ime 40 — Setting the Date 40 Beep Prompts 41 Language 42[...]

SOL VING PROBLEMS 46 T est Procedure Messages 46 Error Messages 50 T AKING CARE OF YOUR METER 59 Doing a Daily Check 60 Cleaning the Meter 60 Replacing the Batteries 64 SPECIFICA TIONS 67 W ARRANTY 68 Three-Y ear W arranty 68[...]

1 PRECAUTIONS AND LIMIT A TIONS The following information will be useful to you and your healthcare professional when using the ONE TOUCH ™ BASIC ™ Plus System to monitor your blood glucose level. If you experience symptoms that are not consistent with your blood glucose test results AND y ou believe you have followed all instructions described[...]

2 Extremes in hematocrit (the amount of red blood cells in the blood) can affect test results. V ery high hemat- ocrits (above 60%) and very low hematocrits ( below 25%) can cause false results. 1 Abnormally high levels of V itamin C or other reducing substances will cause false low blood glucose results. 2 Normal levels of reducing substances have[...]

3 GETTING ST ARTED The ONE TOUCH ™ BASIC ™ Plus Diabetes Monitoring System consists of three main products: the ONE TOUCH ™ BASIC ™ Plus Blood Glucose Meter , ONE TOUCH ™ T est Strips, and ONE TOUCH ™ Normal Control Solution. These products have been designed, tested, and proven to work together as a system to produce accurate blood glu[...]

4 ONE TOUCH ™ BASIC ™ Plus Meter has a number of settings you can change, including the language, time and date, display formats, and the unit of measure. For a des cri ptio n of these options and how to set them, see pages 37-45.[...]

ONE TOUCH ™ BASIC ™ Plus Blood Glucose Meter Study this diagram and become familiar with all the parts of your ONE TOUCH ™ BASIC ™ Plus Meter . 5 C M C M ON/OFF BUTTON This button turns the meter on and off. DISPLA Y The large, easy-to-read display is where you read the simple messages that guide you through testing. Y our test results are [...]

6 1 ✔[...]

7 TEST SPO T OR THIS NO TE: Y our test strip may look like THIS ONE TOUCH ™ T est Strips The ONE TOUCH ™ BASIC ™ Plus Diabetes Monitoring System measures the amount of blood glucose in whole blood. When blood is applied to a ONE TOUCH T est Strip, certain compounds on the test strip react with the blood to form a blue color . The ONE TOUCH ?[...]

8 IMPORT ANT TEST STRIP INFORMA TION ■ ONE TOUCH ™ T est Strips can be damaged by heat and light. Keep them sealed in the original vial. Store the vial in a cool, dry place below 30°C (86°F). Do not refrigerate. Do not place in direct heat or sunlight. ■ ONE TOUCH T est Strips are intended for use with fresh whole blood or ONE TOUCH ™ Nor[...]

9 CAUTION: If the code number on the meter display does not match the code number on the vial of ONE TOUCH T est Strips, test results may be false. BEFORE TESTING Setting Meter Code Code numbers are used to enable your meter to provide consistent measurements. For this reason, it is important that the code is set correctly . Y ou must code the mete[...]

10 Step 1: Press the On/Off Button. When turning meter on, all display symbols will appear . The last test result will then appear on the display for a moment. (If using the meter for the first time, the message code-- will appear on the display .) If you have already coded the meter , your current test strip code followed by the message check code[...]

11 Step 3: Code the Meter . While the meter displays code-- , or after the word insert is displayed, press and release the C button; the code number will appear . Continue pressing the C button until the number on the display matches the code number on the test strip vial. The code number is now set for the test strips you are using. The meter will[...]

12 (Example) Checking with the Check Strip A purple and white check strip is included in the carrying case of your ONE TOUCH ™ BASIC ™ Plus System. Before doing a check strip test, make sure the test strip holder , test area, and check strip are clean, dry , and lint-free. Do the check strip test at room temperature ( between 18° and 26°C [64[...]

How to do a check strip test: Step 1: Press the On/Off Button. Insert Side 1 of the Check Strip. When insert code 10 (Example) strip appears, slide the notched end of the check strip into the test strip holder with Side 1 (purple side) facing up. wait appears for a moment. Step 2: When apply sample Appears, Remove the Check Strip from the T est Str[...]

14 If these messages appear , repeat the check strip test. If these messages appear again, clean your meter and repeat the test. If you do not obtain an acceptable ( A ok ) check strip reading, redo A will appear each time you turn on your meter , indi- cating that your last check strip test was outside of the check strip range printed on the back [...]

15 ■ Do not scratch the check strip. ■ Do not leave the check strip in sunlight. ■ If you lose or damage the check strip, call your authorized LifeScan representative. Checking with Control Solution ONE TOUCH ™ Normal Control Solution contains a known amount of glucose that reacts with ONE TOUCH ™ T est Strips. Control solution should be [...]

16 Do a control solution test: ■ For practice, before testing your blood with the ONE TOUCH ™ BASIC ™ Plus Meter for the first time ■ When you begin using a new vial of test strips ■ At least once a week ■ Whenever you suspect that the meter or test strips are not working properly ■ When your blood glucose test results are not consist[...]

17 *For detailed information on ONE TOUCH ™ Control Solution, refer to the ONE TOUCH ™ Control Solution insert. IMPORT ANT CONTROL SOLUTION TEST INFORMA TION ■ Use only ONE TOUCH ™ Normal Control Solution. ■ Check the expiration date of the control solution. Do not use if expired. ■ Record the discard date on the control solution vial. [...]

18 How to do a control solution test: Step 1: Press On/Off Button. Insert T est Strip. The code number that appears on the meter display should match the code number on the test strip vial. When insert code10 (Example) strip appears, slide a ONE TOUCH ™ T est Strip into the test strip holder , notched end first, with the test spot facing up. Make[...]

Step 2: Apply Control Solution. Shake the control solution vial well before using. If there are any bubbles on the top of the vial, wipe them off with a clean tissue. Remove the cap and apply a drop of control solution to the middle of the test spot, covering it completely . Do not dab, wipe, or smear control solution on the test spot. A void conta[...]

20 Control solution test results are automatically stored with the word contrl . (If you use a logbook, indicate control solution tests by writing “ C ” after the result.) Control solution results If test results fall outside the range printed on the test strip vial, repeat the test. Results that fall outside the expected range may indicate: ?[...]

C M 21 Detailed T est Procedure Choose a clean, dry work surface. Make sure you have all the items needed to test: ■ ONE TOUCH ™ BASIC ™ Plus Meter ■ ONE TOUCH ™ T est Strips ■ Penlet ™ Plus Adjustable Blood Sampler ■ Sterile lancet Release Button Ejection /Cocking Control Depth Adjustment Knob Penlet Plus Adjustable Blood Sampler C[...]

22 Getting a Drop of Blood CAUTION: T o reduce the chance of infection: ■ Never share a lancet with another person. ■ Always use a new , sterile LifeScan Lancet. Lancets are for single use only . ■ The Penlet ™ Plus Sampler should be used by only one person. ■ A void getting hand lotion, oils, dirt, or debris in or on the lancets and the [...]

While the lancet is in the Penlet ™ Plus Sampler , twist off the protec tive disk. Make two full turns to ensure that the lancet separates from the protective disk. Replace the Penlet ™ Plus Cap. T urn the cap clockwise until it is snug but not overly tight. Adjust the puncture depth setting if necessary . T wist the knob counter- clockwise tow[...]

24 Step 2: Cock the Penlet ™ Plus Sampler . Slide the ejection/cocking control backward until it clicks. If it does not click, the Penlet Plus Sampler may have been cocked when the lancet was inserted. Step 3: W ash Y our Hands. Use warm, soapy water . Rinse and dry hands thoroughly . T o increase blood flow to your fingertips, massage the hand f[...]

25 Step 4: Lance Y our Finger . Choose a spot on the side of a different finger each time you test. Repeated punctures in the same spot may cause soreness and calluses. H old the Penlet ™ Plus Sampler firmly against the side of your finger . Press the release button. (Greater pressure of the device against the finger will also cause a deeper punc[...]

26 Optional: T o replace the protective disk on the lancet, place the disk on a hard surface and push the exposed tip into the protective disk. Always use caution when removing the lancet. Point the lancet down and away from you. Push forward on the ejection/cocking control and eject the lancet directly into a container for sharp objects. Return th[...]

How to T est Y our Blood Step 1: Press On/Off Button. Make Sure Code Number Displayed on Meter Matches Code Number on T est Strip V ial. Insert T est Strip. Make sure the test strip holder is properly in place. (See page 63.) T urn your meter on. All display symbols will appear . The last test result (or , when you first use the meter , the message[...]

28 Remove a test strip from the vial. Replace the vial cap immedi- ately . Do not touch the test spot on the test strip. The test spot should be white or ivory-colored, with no tears or wrinkles. W ith the meter display showing slide the test strip into the test strip holder , notched end first, test spot facing up. Make sure you push the test stri[...]

29 Step 2: Apply Blood Sample. W ith the test strip in the meter and on the display , apply a drop of blood to the test spot. Be sure that you: ■ T ouch only the tip of the drop of blood to the test spot. ■ Apply enough blood to form a round, shiny drop that covers the test spot com pletely and stays wet during the entire test. ■ Do not smear[...]

30 Step 3: Accurate Results in 45 Seconds. The meter then counts down from 45 t o 0 seconds, beeps (if the B e ep option is set to ), and displays your result. Remove the test strip only after the result is displayed. Blood glucose test results are auto- matically stored in your meter ’ s memory with the time and date they were performed. If you [...]

31 Special Messages The meter displays results from 0 to 600 mg/dL (33.3 mmol/L). If your blood glucose test result is 60 mg/dL (3.3 mmol/L) or below , your meter will beep in a low tone (if the Beep option is set to ) and display a special message: (Example) The message is warning you of low blood glucose (hypoglycemia). Y ou may need food or some[...]

32 Checking the Amount of Blood on the T est Strip Although the ONE TOUCH ™ BASIC ™ Plus System requires only a small drop of blood, it is very important that the drop be large enough to cover the test spot completely . In many cases, the meter can detect if the drop of blood was too small to give an accurate reading. However , it is important [...]

33 If the following message appears on the display , your drop of blood was too small, or smeared, or the test strip was not pushed all the way into the test strip holder . Repeat the test with a new test strip and enough blood to cover the entire test spot. ■ Remove the test strip from the meter and look at the test spot. It should still have a [...]

■ Look at the back of the test strip. Y ou should see a full, dark circle. If there are any white patches or streaks, you may have smeared the blood or the drop was too small. In either case, you may have a false low result. Repeat the test with a new test strip. USING THE METER MEMOR Y Y our ONE TOUCH ™ BASIC ™ Plus Meter automatically store[...]

35 Entering the Memory Mode T urn the meter on by pressing the on/off button. Y ou can access the meter ’ s memory and recall test results at any time before or after performing a test by pressing the M button. The word memory with the memory symbol will appear briefly . If you are using the meter for the very first time and have not used it for [...]

36 Recalling T est Results Pressing the M button allows you to see each blood glucose, check strip, and control solution test stored in memory . The records will appear in order from the most recent to the oldest, up to the full 75-record capacity of the memory . T est results will appear on the meter display as follows: (Examples) When the memory [...]

37 SETTING METER OPTIONS Y ou do not have to enter the set-up mode to test. However , you can customize the various option s e ttings of your ONE TOUCH ™ BASIC ™ Plus Meter to best meet your needs. This is done in the set-up mode. Option settings (for example) that you can customize include: ■ Clock (T ime and Date): ■ Beep Prompts: ■ Lan[...]

38 ■ Use the M button to scroll through the options or move within an option. ■ If you want to change an option setting, use the C button. * T ime and Date options appear only if the Clock option is on. † The Decimal Separator option appears only if the unit of measure chosen is mmol/L. † Note: Y ou can exit the set-up mode at any time by p[...]

39 Clock (T ime and Date) The ONE TOUCH ™ BASIC ™ Plus Meter has an internal clock that will record the time and date of each test you perform. Y our meter h as been set to automatically record tests both when the Clock option is set to and when it is set to . Y ou may need to change the time setting in your meter to have the correct time and d[...]

40 Use the C button to change the min- utes. Press the M button to see the new time setting (the colon will flash). Press the M button again to move to the date setting. Setting the Date Enter the set-up mode and set the Clock option to (see page 37). Use the M button to set the date. The current date will show . Press the C button to change the da[...]

41 Press the M button and the day will flash. Press the C button to change the day . Pressing the M button again will display the new date setting. Y ou may now turn the meter off or press the M button to move to the next option. Beep Prompts The meter is set to provide you with audio prompts, or “ beeps, ” during the test procedure to tell you[...]

42 Language The ONE TOUCH ™ BASIC ™ Plus Meter can display messages in 17 languages: English [ engl. ], Spanish [ espan. ], French [ franc. ], Italian [ italia ], Hungarian [ magyar ], Dutch [ neder. ], Norwegian [ norsk ], Polish [ polski ], Portuguese [ port. ], Russian [ pycck. ], Finnish [ suomi ], Swedish [ svens. ], T urkish [ turkce ], C[...]

43 T ime Format The meter can be set to display the time in either a 12-hour (AM/PM) format or a 24-hour format. T o change the time format, enter the set-up mode (see page 37). Use the M button to choose the T ime Format option. Press the C button to change the time format. Y ou may now turn the meter off or press the M button to move to the next [...]

44 Unit of Measure The meter is set to display test results in milligrams per deciliter (mg/dL). Y o u have the option to change to millimoles per liter (mmol/L). T o change the unit of measure, enter the set-up mode (see page 37). Use the M button to choose the Unit of Measure option. Press the C button to change the unit of measure. Y ou may now [...]

45 T o change the decimal separator , enter the set-up mode (see page 37) and select mmol/L as the unit of measure. Use the M button to choose the Decimal Separator option. Make your selection using the C button. Y ou may now press the M button to review or change any of the options you have chosen or press the on/off button to turn the meter off. [...]

46 SOL VING PROBLEMS The messages that appear on your ONE TOUCH ™ BASIC ™ Plus Meter di s p l a y guide you through the testing procedure, alert you to problems as they occur , and give you information about test results stored in the meter ’ s memory . This section provides you with a complete listing of the display messages, what they mean,[...]

47 The meter is turned on. This is a reminder that prior to testing you should verify that the code displayed on the meter matches the code on the test strip vial. If it does not, reset by pressing the C button. The meter is ready to perform a blood, check strip, or control solution test. The meter is performing internal checks. The meter is ready [...]

48 A blood test has been completed. This indicates a blood glucose result when the meter is set for mg/dL. A blood test has been completed. This indicates a blood glucose result when the meter is set for mmol/L. A control solution test has been completed. (If you have just performed a blood glucose test, this means that the blood sample was too sma[...]

The check strip test result falls into the acceptable range. The check strip range is printed on the back of your meter . Y our blood glucose test result is low , 60 mg/dL (3.3 mmol/L) or below , possibly indicating hypo- glycemia. Y ou may need food or some source of glucose. Retest. If the test result is still 60 m g/dL (3.3 mmol/L) or below , ca[...]

50 MESSAGE PROBLEM WHA T TO DO Some parts of the dis- play are not working. The messages will be incomplete. Call your authorized LifeScan representative. Error Messages When any of these messages appear , there is a problem with the ONE TOUCH ™ BASIC ™ Plus Meter or the way in which you are performing a test. These messages help to identify ce[...]

51 MESSAGE PROBLEM WHA T TO DO When this symbol appears and stays on the screen, it means the batteries are getting low . This symbol will remain on the display while the meter is o n until the batteries are replaced. When this symbol is flashing, the batteries are too low . Y ou will still be able to test, but replace the batteries as soon as poss[...]

MESSAGE PROBLEM WHA T TO DO clean test area 1. There is dirt, blood, or lint on the test area. 2. Y our hand or an object covered the test area while the meter was turned on. 3. The meter was used in very bright light. The test strip was inserted before the word insert appeared on the display . 1. Clean the test area and test strip holder according[...]

53 MESSAGE PROBLEM WHA T TO DO If the word contrl appears after a blood test, your blood sample was too small, smeared, or another drop was added after the test began. The sample was applied before the words apply sample appeared. 1. The test strip moved during the test. 2. The test strip was not inserted correctly . 3. The test strip was removed b[...]

54 MESSAGE PROBLEM WHA T TO DO 4. There was not enough blood on the test strip. 5. The meter was used in very bright light. 6. The check strip procedure was incorrect. 7. The meter may not be operating correctly . 4. Repeat the test with a new test strip. 5. Move the meter away from the light source. Repeat the test with a new test strip. 6. Repeat[...]

MESSAGE PROBLEM WHA T TO DO error3 retest not enough blood retest The test strip was removed during a test or the test strip was inserted with blood or control solution already applied. 1. The blood or control solution sample was too small or smeared. 2. The test strip was not inserted far enough into the test strip holder . Repeat the test with a [...]

56 MESSAGE PROBLEM WHA T TO DO 3. Y our hand or an object covered the test area while the meter was turned on. 1. If appearing when you turn your meter on, your meter may have an electronic problem. 2. If appearing at the end of a test, your meter may have been moved while applying blood or during the test process. 3. If appearing during the test, [...]

57 MESSAGE PROBLEM WHA T TO DO (Example) The check strip test result is outside the acceptable range (printed on the back of the meter .) The last check strip test was outside the acceptable range and an acceptable repeat test was not performed. The last test failed after the countdown started. Clean the meter and check strip if necessary . Repeat [...]

58 MESSAGE PROBLEM WHA T TO DO code-- The meter requires a test strip code (found on the test strip vial) to operate. ( Note: This is not an error message when the meter has not yet been coded.) Use the C button to reset the meter code to match the test strip vial code. Y ou should also check all of your meter option settings to be sure they are co[...]

59 T AKING CARE OF YOUR METER Y our ONE TOUCH ™ BASIC ™ Plus Meter is easy to maintain. These tips will help you keep it in good operating condition: ■ Keep the test strip holder and test area clean (see page 60). ■ Keep your meter dry and avoid exposing it to extremes in tem pera- ture or humidity . For example, do not leave it in your car[...]

Doing a Daily Check Look through the small hole in the test strip holder to make sure there is no lint, dirt, or blood blocking it. If there is anything blocking the hole, or if the test area has dirt, lint, or blood on it, remove the test strip holder and clean the test area by following the instructions in the next section. Then do a check strip [...]

Step 1: Remove the T est Strip Holder from the Meter . Hold the meter and place your thumbs on the two raised dots on the test strip holder . Press down on the raised dots and slide the test strip holder toward you. Remove the test strip holder to expose the test area. Step 2: Clean the T est Strip Holder . W ash only the test strip holder with soa[...]

CAUTION: Do not get water inside the meter . Do not immerse meter in water . 62 Step 3: Clean the T est Area. The following cleaning agents will damage the meter . DO NOT USE: ■ Alcohol ■ Cleansers with ammonia or phenol ■ Glass cleaners ■ Abrasive cleansers Check the clear , protective coating over the test area to make sure it is not scra[...]

63 Step 4: Replace the T est Strip Holder . Hook the bottom of the test strip holder onto the square notch on the meter . Press down on the raised dots of the test strip holder until it snaps firmly into place. Press forward on the base of the test strip holder to be sure it is properly in place. Y ou are now ready to do a check strip test. If the [...]

64 When appears flashing on the display , the meter will no longer give results and you must replace the batteries before you can perform another test. The meter ’ s current time and date settings are saved for a minimum of 30 minutes after the batteries have been removed. After that you may need to reset the time and date. Dead batteries and/or [...]

65 T o replace the batteries: 1. Make sure the meter is turned off before you remove the batteries. 2. T urn the meter over so that the front of the meter is resting in the palm of your hand. 4. Remove the battery compartment door . (Back of Meter) 3. W ith your thumb, press upward on the opening tab of the battery compartment door and lift up- war[...]

66 6. Insert the new AAA batteries into the battery compartment, being sure to align the plus (+) and minus (-) signs correctly . T o replace the battery compartment door , insert the tab on the top of the door into the slot in the top of the battery compartment. Press the opening tab upward toward the top of the meter . Lower the battery com- part[...]

67 SPECIFICA TIONS Power Supply: T wo AAA alkaline batteries. Battery Life: About 18 months when testing up to two (2) times a day . Result Range: 0 – 600 mg/dL (0 – 33.3 mmol/L). Higher values are displayed as hi . Display T ype: Liquid crystal. Blood Source: Whole blood (capillary or venous). Do not use samples that contain fluoride (gray-top[...]

68 W ARRANTY Three-Y ear W arranty . If, at any time during the first three years after purchase, the meter does not work for any reason (except for obvious abuse), your authorized LifeScan representative will replace it with a new meter or equivalent product free of charge. The W arranty Policy applies only to the original purchaser of this meter [...]

69 Before you return your meter , or any product, first call your authorized LifeScan representative. This warranty is in lieu of all other warranties, express or implied, including any implied warranty of merchantability or fitness for a particular purpose.[...]

The enclosed LifeScan Blood Glucose Meter , as an electromedical device, has been thoroughly tested and found to comply with the essential requirements of the ElectroMagnetic Compatibility Directive (EMC, 89/336/EEC), 2000. 2000[...]

For further information on LifeScan products, please call your authorized LifeScan representative. © LifeScan, Inc. 2000 Milpitas, California 95035, U.S.A. U.S. and foreign patents; other patents pending. 060-196-01 IFD/OB/OTBP Rev .: 01/2000[...]