Lifescan ONE TOUCH BASIC BLOOD GLUCOSE MONITORING SYSTEM Owner's Booklet

One touch owner's manual blood glucose monitoring system
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BLOOD GLUCOSE MONITORING SYSTEM
SYSTÈME DE CONTRÔLE DE LA GLYCÉMIE
OWNER'S BOOKLET
MANUEL DU PROPRIÉTAIRE
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Summary of Contents for Lifescan ONE TOUCH BASIC BLOOD GLUCOSE MONITORING SYSTEM

  • Page 1 BLOOD GLUCOSE MONITORING SYSTEM SYSTÈME DE CONTRÔLE DE LA GLYCÉMIE OWNER’S BOOKLET MANUEL DU PROPRIÉTAIRE ® ®...
  • Page 2 ® ® BLOOD GLUCOSE MONITORING SYSTEM OWNER’S BOOKLET...
  • Page 3 Thank you for choosing the ONE TOUCH BASIC Meter. Sincerely, Jackie Graham Manager, Customer Service LifeScan Canada Ltd. P.S. Don’t forget to complete and mail the Warranty Registration Card. When we receive your Warranty Card, we’ll send you a complimentary gift to show our apprecia-...
  • Page 4 CAUTION: Before using any product to test your blood glucose (sugar), read all instructions and practice the test. Consult your diabetes health professional for advice regarding selection of equipment, testing times and procedures. These recommenda- tions apply to all blood glucose monitoring systems and are supported by the Diabetes Educator Section of the Canadian Diabetes Association.
  • Page 5: Table Of Contents

    4. GETTING A DROP OF BLOOD 5. TESTING YOUR BLOOD LifeScan Technical Services: Description and Use ....1 Getting to Know the Meter ... 2 Precautions and Limitations .
  • Page 6 9. QUESTIONS AND ANSWERS 10. SPECIFICATIONS 11. INDEX LifeScan Technical Services: Checking the Amount of Blood ..36 Recording Your Test Results ..37 Displaying Last Test Result ..38 Test Procedure Messages .
  • Page 7 BLANK...
  • Page 8: Description And Use

    1. GETTING STARTED Description and Use The ONE TOUCH BASIC ® Glucose Monitoring System is intended for in vitro diagnostic use. This statement means that the system should be used only for testing purposes and only outside of the human body. The ONE TOUCH BASIC Meter and Test Strips are ®...
  • Page 9: Getting To Know The Meter

    Getting to Know the Meter Study this diagram and become familiar with all the parts of your ONE TOUCH ® BASIC Meter. ® Battery Compartment (on back) Display On/Off Button Test Area with Protective Coating C Button Test Strip Holder...
  • Page 10 ON/OFF BUTTON. This button turns the Meter on and off. DISPLAY. This is where you read your test results and the simple messages that help guide you through the test. BATTERY COMPARTMENT. Holds one J-size battery. The battery is already installed in your Meter. “C”...
  • Page 11 TEST AREA. When the Test Strip Holder is removed, the Test Area is exposed. The Test Area has a clear, protective coating over the Meter optics window that must be kept clean and lint-free for accurate results. Be careful not to scratch or damage this coating.
  • Page 12: Precautions And Limitations

    Precautions and Limitations The following information may be useful to you and your Health Care Professional when using the ONE TOUCH BASIC ® ® monitor your blood glucose level. If you experience symptoms that are not consistent with your blood glucose results, and you have carefully followed the procedure described in the Owner’s Booklet,...
  • Page 13 DO NOT use ONE TOUCH Strips beyond the expiration date printed on the package label. If using Test Strips from a vial, discard the vial and unused Test Strips 4 months after the date first opened. DO NOT use ONE TOUCH Test Strips that are discolored, wrinkled, torn, cut or altered in any way (the Test Spot of a normal Test Strip is...
  • Page 14: Selecting The Display Language And The Unit Of Measurement

    2. SETTING THE METER Selecting the Display Language and the Unit of Measurement The ONE TOUCH BASIC ® displays easy-to-follow messages in English, French, Spanish, German, Dutch, Italian, Portuguese, Swedish, Danish, Norwegian, Finnish, Greek, Turkish, Hungarian, Czech, Polish, Russian, or Japanese to help guide you through the test procedure.
  • Page 15: Coding The Meter

    Norwegian (mmol/L), “P 15” for Finnish (mmol/L), “P 16” for Greek (mg/dL), “P 17” for Turkish (mg/dL), “P 18” for Hungarian (mmol/L), “P 19” for Czech (mmol/L), “P 20” for Polish (mmol/L), “P 21” for Russian (mmol/L), “P 22” for Japanese (mg/dL), “P 23”...
  • Page 16 Step 1: Turn on the Meter Press the On/Off Button to turn the Meter on. The result from your last blood glucose or Control Solution test will appear for 3 seconds. memory mm 5 . 9 (example) (Your ONE TOUCH BASIC ®...
  • Page 17 Step 2: Match the Code Number Press the “C” Button. With code 7 (example) on the display, press and release the “C” Button, and the number will increase by one. Continue pressing until the number on the display matches the code number on your Test Strip package.
  • Page 18: Checking With The Check Strip

    3. CHECKING THE SYSTEM There are two ways to make sure your ONE TOUCH BASIC ® is working properly. The Check Strip is used to check that the Meter is operating properly. The ONE TOUCH Normal Glucose Control Solution— Blue Formula is used to check that both the Meter and the Test Strips are working together as a system, and that you are doing the test...
  • Page 19 Before doing a Check Strip test, make sure the Test Strip Holder, the Test Area and Check Strip are clean, dry, and lint-free. Do the Check Strip test at room temperature between 18°C and 26°C (64°F–79°F). How to use the Check Strip Step 1: Press On/Off Button.
  • Page 20 When insert strip appears, slide the notched end of the Check Strip into the Test Strip Holder with Side 1 (purple) facing up. wait appears for a few seconds. Step 2: When strip apply sample appears, slide the Check Strip from the Test Strip Holder.
  • Page 21 Step 3: When insert side 2 appears, turn the Check Strip over and slide it back into the Test Strip Holder, notched end first, Side 2 (white) facing up. The Meter counts down from 4 to 0, then A 4 . 4 (example) A ok appears if the number falls within...
  • Page 22 Go back to Step 1 and repeat the Check Strip test. If this message appears again, clean your Meter and repeat the test. For further assistance, call LifeScan Technical Services. If you do not obtain an acceptable Check Strip reading, your last blood...
  • Page 23 DO NOT use the Meter to test your blood until you get a Check Strip reading that is within the printed range. For assistance, call LifeScan Technical Services. You must use the Check Strip: At least once a day. After cleaning the Meter.
  • Page 24: Checking With Control Solution

    If you lose or damage the Check Strip, call LifeScan Technical Services for a free replacement. Checking with Control Solution ONE TOUCH Normal Glucose Control Solution —Blue Formula ONE TOUCH Normal Glucose ® Control Solution—Blue Formula should be used to make sure your Meter and Test Strips are working properly.
  • Page 25 Use only ONE TOUCH Glucose Control Solution—Blue Formula, available from your drug store or Authorized LifeScan Distributor. Check the expiration date on the Control Solution vial. If it has expired, replace it with new Control Solution. Shake the Control Solution vial vigorously before using.
  • Page 26 DO NOT use the system to test your blood until you get a reading that falls within the printed range. For assistance, call LifeScan Technical Services. You should use the Glucose Control ® Solution: At least once a week.
  • Page 27: Using The Penlet Ii

    4. GETTING A DROP OF BLOOD The PENLET II Automatic Blood ® Sampler is an easy, safe tool for obtaining a good drop of blood for testing. Sliding Barrel Release Button Using the PENLET II Automatic Blood Sampler Step 1: Insert a Lancet Remove the PENLET II Cap by pulling it straight off.
  • Page 28 Insert a new, sterile Lancet into the Lancet Holder. The Lancet will slide into the Lancet Holder easier if you DO NOT line up the ridges on the Lancet with the slots in the Lancet Holder. (NOTE: Inserting the Lancet may automatically cock the PENLET II.)
  • Page 29 Regular Deep Penetration Replace the PENLET II Cap. The PENLET II Sampler includes ® two Caps. The Cap that comes attached to the PENLET II Sampler has a single line on the flat side and works well for children and most adults.
  • Page 30 Step 2: Cock the PENLET 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 was inserted.
  • Page 31 Choose a spot on the side of a different finger each time you test. Repeated punctures in the same spot can make your finger sore and calloused. Hold the PENLET ® 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.
  • Page 32 Squeeze the finger gently to obtain a large, hanging drop of blood. Proceed with the blood glucose test. (See Testing Your Blood, page 27.) Step 4: Remove the Lancet Always use caution when removing the Lancet and PENLET II Cap. ®...
  • Page 33 Sampler, each person should always use a new Lancet and a new or properly disinfected Cap. For assistance, call LifeScan Technical Services. Cleaning the PENLET II Sampler Clean the PENLET II Sampler and Cap with soap and water as needed.
  • Page 34 5. TESTING YOUR BLOOD You can test your blood glucose by following these three simple steps: insert insert Step 1: Press On/Off Button (last test result appears), insert Test Strip. NOTE: Be sure to read the following section carefully before testing. Step 2: Apply blood sample.
  • Page 35: Automatic

    Test Strip package. If the date has passed, discard the Test Strips and open a new package. If using vial Test Strips, discard unused Test Strips 4 months after opening. If you have questions about the testing procedure, call LifeScan Technical Services.
  • Page 36 CODE: TEST FOR GLUCOSE IN WHOLE BLOOD INC. Milpites,CA Made in U.S.A. 51-453B C od e Deep Regular...
  • Page 37 Step 1: Press On/ Off Button to turn the Meter on Your last blood glucose or Control Solution test result will appear for 3 seconds. memory mm 5 . 9 (example) Then • appears on the display for 2 seconds. Make sure the code number on the Meter display matches the code number on the Test Strip package...
  • Page 38 Insert Test Strip Remove a Test Strip from the package. DO NOT touch the white Test Spot. When using Test Strips from a vial, replace the cap imme- diately. When using a foil-wrapped Test Strip, be careful not to tear the Test Strip when opening the foil.
  • Page 39 The Test Spot should be white or ivory-colored, with no tears or wrinkles. Test Spot When insert strip appears, slide the notched end of the Test Strip into the Holder with the Test Spot side up. Make sure you push the Test Strip all the way into the Holder until it stops.
  • Page 40 Step 2: Apply blood sample With the Test Strip in the Meter and apply sample on the display, apply a drop of blood to the Test Spot. sample The Meter will beep when the blood has been applied to the Test Spot. Make sure that you: Do not remove the Test Strip from the Meter to apply blood.
  • Page 41 Step 3: Accurate results in 45 seconds The Meter then counts down from 45 to 0 seconds, followed by a series of beeps when your result is displayed. mm 6 . 0 (example) IMPORTANT: Always check that “MM” and a decimal point are displayed with your blood glucose result.
  • Page 42 6. AFTER TESTING Although the ONE TOUCH 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.
  • Page 43: Checking The Amount Of Blood

    Checking the Amount of Blood on the Test Strip The Meter cannot always tell if a sample is too small, so it is impor- tant that you also look at the Test Strip to make sure that you applied enough blood. Remove the Test Strip from the Meter and look at...
  • Page 44: Recording Your Test Results

    If you run out of space in your Log- book, you can get a new one from your Authorized LifeScan Distributor, drug store, or directly from LifeScan. BASIC System ®...
  • Page 45: Displaying Last Test Result

    Displaying Last Test Result The ONE TOUCH BASIC ® automatically recalls and displays your last result—either from a blood glucose or Control Solution test—whenever the Meter is turned on. memory mm 5 . 9 (example) appears for 3 seconds, then the Meter immediately displays test messages starting with code 7...
  • Page 46 7. HELP! (Troubleshooting) The display messages that appear on the Meter will guide you through the glucose test and quality control test procedures and alert you to problems as they occur. This section provides you with a complete listing of the display messages, what they mean, and what to do if there is a problem.
  • Page 47: Test Procedure Messages

    Test Procedure Messages These messages appear during routine testing. Just follow them carefully and they will guide you through the test. MESSAGE APPEARS WHEN You press and hold the On/Off Button. It provides a visual test that all display segments are working. The Meter is turned on.
  • Page 48 MESSAGE APPEARS WHEN The Meter is ready for you to perform a blood, Check insert Strip, or Control Solution test. strip The Meter is performing internal checks. wait The Meter is ready to receive a blood or Control Solution apply sample.
  • Page 49 MESSAGE APPEARS WHEN A Control Solution test is completed. However, if this c 5 . 4 (example) appears after a blood test, it means that your test result contrl was not accurate because the blood sample was too small and the Meter read it as a Control Solution sample. You are performing a Check Strip test.
  • Page 50: Error Messages

    When any of these messages appear, there is a problem with the Meter or the way in which you are performing a procedure. In most cases, problems are easy to fix. If you need it, help is available from LifeScan Technical Services. MESSAGE...
  • Page 51 MESSAGE PROBLEM The language and unit of (example) measurement have been [No “mm” before the result and no changed to “P 1” English decimal point] (mg/dL) either accidentally or through an electronic malfunction. The battery is too low. The battry Meter will not operate.
  • Page 52 MESSAGE PROBLEM 3) The Test Strip was inserted before insert strip appeared on the display. 4) The center of the Test Strip Holder where the small hole is located is raised. If this message appears after c 3 . 8 (example) a blood test, your blood contrl...
  • Page 53 MESSAGE PROBLEM The sample was applied error1 before apply sample retest appeared. Error in the test procedure error2 such as: retest 1) The Test Strip moved during the test. 2) The Test Strip was not inserted correctly. 3) The Test Strip was removed before the test was completed.
  • Page 54 WHAT TO DO Repeat the test with a new Test Strip and a larger drop of blood. Move the Meter out of direct light and repeat the test with a new Test Strip. Repeat the Check Strip test. Call LifeScan Technical Services.
  • Page 55 MESSAGE PROBLEM When any message flashes insert continually, it means the insert battery is getting low. insert (example) Your last test result was memory not stored in the Meter’s retest memory for one of the following reasons: 1) A not enough blood retest message was dis- played during your last blood or Control Solution...
  • Page 56 4) A power loss, including turning the meter off, occurred during your last test. WHAT TO DO Review the error2 retest problems listed on pages 46–47 before repeating the test. Call LifeScan Technical Services. Repeat the test with a new Test Strip.
  • Page 57 Test Strip and a large, shiny drop of blood. Repeat the test. This time push the Test Strip all the way into the Test Strip Holder. Call LifeScan Technical Services. Clean the Meter and Check Strip. Repeat the Check Strip test.
  • Page 58 MESSAGE PROBLEM The last Check Strip test was redo A outside the acceptable range code 7 (example) and a repeat test that passed has not been performed. The Test Strip was inserted remove before the Meter was ready. strip WHAT TO DO Stop and do a Check Strip test.
  • Page 59 Reset the language and unit of measurement to “P 3” for English (mmol/L) as described in the section Setting the Meter, page 7. If this continues to happen, there may be a problem with your Meter. Call LifeScan Technical Services.
  • Page 60 8. TAKING CARE OF THE METER Your ONE TOUCH BASIC ® is simple to use and easy to main- tain. However, it must be handled carefully and cleaned regularly to remain in good operating condition. You should follow these rules at all times: Keep the Test Strip Holder and Test Area clean.
  • Page 61 Lancet and a new or properly disinfected PENLET II Cap for each person. For disinfecting information, an additional Test Strip Holder, or a PENLET II Cap, please call LifeScan Technical Services. BASIC Meter with another ®...
  • Page 62: Daily Meter Check

    Daily Meter Check Look through the small hole in the Test Strip Holder to make sure there is no lint, dirt, or blood blocking any part of the hole. If there is anything blocking the hole, or if the Test Area has dirt, lint, or blood on it, remove the Test Strip Holder.
  • Page 63 Step 1: Remove Test Strip Holder Hold the Meter and place your thumbs on the two raised dots on the Test Strip Holder. Slide the Test Strip Holder toward you. Remove the Test Strip Holder to expose the Test Area.
  • Page 64 Step 2: Clean Test Strip Holder Wash the Test Strip Holder with soap and water. Clean the underside of the Test Strip Holder and check the small hole for any dirt, blood, or lint. Rinse well. Dry completely with a soft cloth or tissue.
  • Page 65 Check the clear, protective coating over the Meter optics to make sure it is not scratched or damaged. Rub Test Area with a cotton swab or soft cloth dampened with water to remove all blood, dirt, or lint from the Test Area. If necessary, a mild liquid dishwashing detergent mixed with water may also be used.
  • Page 66 Dry the Test Area with a soft, dry cloth or tissue that doesn’t contain lotion or perfume. Remove any lint. Step 4: Replace Test 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.
  • Page 67: Battery Replacement

    6-VOLT Battery Replacement The ONE TOUCH BASIC ® comes with a battery already in- stalled. When the battery must be replaced, use only a Duracell alkaline battery (J-size, 6 volts, part #7K67), which is commonly available in drug and hardware stores.
  • Page 68 When battry appears on the display, the Meter will no longer give results and you must replace the battery before you can perform another test. A dead battery or battery removal will not affect the previous test result stored in the Meter’s memory, as long as the battery is replaced within 30 days.
  • Page 69 Remove the old battery and discard properly. Insert a new J-size battery in the battery compartment. To replace the battery door, insert the tabbed side of the door into the slot in the battery compartment.
  • Page 70 With your thumb, press in and down on the ridged side of the battery door until it snaps shut.
  • Page 71 Meter. If you have a question ® that isn’t covered here, consult your Health Care Professional or call LifeScan Technical Services. Q. Why should I test my blood glucose (sugar)? A. No doubt your Health Care Professional has explained the importance of keeping your diabetes under control.
  • Page 72 Q. How often should I test my blood glucose? A. This is best decided by you and your Health Care Professional. It may vary according to your age, the type of diabetes you have, any medication you are using, whether you are ill, and any physical or emotional changes in your life.
  • Page 73 Keep your Meter clean at all times. Use enough blood. The entire Test Spot must be completely covered with blood. Touch the drop of blood lightly to the middle of the Test Spot to fill the entire Spot. The drop of blood should form a round, shiny circle over the entire Spot, and stay wet during the entire test.
  • Page 74 your Health Care Professional. If your blood glucose test results remain consistently high, contact your Health Care Professional. Q. What are the expected blood glucose values associated with well-controlled diabetes? A. Fasting: 3.3–7.2 mmol/L After meals (1 hour): Less than 10.0 mmol/L After meals (2 hours): Less than 8.3 mmol/L...
  • Page 75 In addition to the common factors listed above which cause real variations in blood glucose results, there are certain abnormal condi- tions which can interfere with the accuracy of your blood glucose monitoring results. These limitations are described below and should be discussed with your physician: Extremes in hematocrit (the amount of red blood cells in the blood) can...
  • Page 76 Vomiting and diarrhea Prescription drugs, e.g., diuretics Inability to recognize or respond to “thirst” sensations Sustained uncontrolled diabetes Whenever inadequate fluid intake or excessive water loss occurs, CONSULT A PHYSICIAN IMMEDIATELY. Remember, if you ever experience symptoms which are not consistent with your blood glucose monitoring results and you have eliminated common procedural errors described...
  • Page 77 Q. Why don’t my Meter results match the results that I got from my doctor’s laboratory exactly? A. Many Health Care Professionals believe that the result that you get with your Meter should fall within 15% to 20% of the result obtained when whole blood is tested on laboratory equipment.
  • Page 78 4 Cohen FE, et al: Diabetes Care (1986) 9(3):320–322. 5 Clarke WL, et al: Diabetes Care (1987) 10:622–628. 6 Gadsen RH: Challenges in Diabetes Management, Milpitas CA, LifeScan, Inc. (1988) 63–66. If your lab 7 Caraway WT: Carbohydrates, in Tietz NW (ed). Fundamentals of Clinical Chemistry.
  • Page 79: Performance Characteristics

    10. SPECIFICATIONS Performance Characteristics See the ONE TOUCH ® package insert for ONE TOUCH System accuracy and precision. Power Supply: One Duracell alkaline battery, size J (6V) part # 7K67 is included with Meter. Battery Life: Approximately one year (at two tests per day). Result Range: 0–33.3 mmol/L.
  • Page 80: Guarantee And Warranty

    Three-Year Warranty If, at any time during the first three years after purchase, the Meter does not work for any reason (except for obvious abuse), LifeScan will replace it with a new or rebuilt Meter or equivalent product free of charge.
  • Page 81 Test Strips are changed or modified in any way. Before you return your Meter, or any product for warranty replace- ment, first call your LifeScan Technical Representative at the toll-free number for detailed instructions. This warranty is in lieu of all other...
  • Page 82 Test Strip Holder ......... . 57 LifeScan Technical Services:...
  • Page 83 Performance Characteristics ........72 LifeScan Technical Services:...
  • Page 84 Warranty ........... . 73 LifeScan Technical Services:...
  • Page 85 *05160052A* AW *05160052A* Toll-Free customer service: Appels sans frais: Canada 1 800 663-5521 U.S.A. 1 800 227-8862 Burnaby, B.C. V5C 6C6 Printed in U.S.A. Imprimé aux États-Unis © 1994 LIFESCAN INC. 6/94...

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