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Lifescan ONETOUCH II Owner's Booklet

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  • Page 1 ® BLOOD GLUCOSE MONITORING SYSTEM company Owner’s Booklet...
  • Page 2 It contains the same information in a shorter format, and will help you get to know your blood glucose monitoring system. A free videotape is also available by calling the LifeScan Customer Richard P. Thompson Services Department. President, LifeScan Inc.
  • Page 3 RECOMMENDATIONS APPLY TO ALL BLOOD GLUCOSE MONITORING SYSTEMS AND ARE SUPPORTED BY THE AMERICAN ASSOCIATION OF DIABETES EDUCATORS, THE AMERICAN DIABETES ASSOCIATION, THE U.S. FOOD AND DRUG ADMINISTRATION, AND THE HEALTH INDUSTRY MANUFACTURERS ASSOCIATION. LIFESCAN CUSTOMER SERVICES 1 800 227-8862...

  • Page 4: Table Of Contents

    TABLE OF CONTENTS 1. GETTING STARTED Description and Use Getting to Know the Meter Precautions and Limitations 2. BEFORE TESTING Checking the System Coding the Meter 3. GETTING AND TESTING A DROP OF BLOOD Using the PENLET II Automatic Blood Sampler ®...
  • Page 5 5. TAKING CARE OF THE METER Infection Control Information Doing a Daily Check Cleaning the Meter Replacing the Battery 6. SPECIAL FUNCTIONS Setting the Clock Setting Special Functions Recalling Tests from the Meter Memory Setting Event Numbers 7. QUESTIONS AND ANSWERS 8.

  • Page 6: Getting Started

    1. GETTING STARTED Description and Use When blood is applied to the test strip, compounds on the test strip react with the blood blood glucose for people The ONE TOUCH II Blood ® and a blue color is formed. who have been diagnosed Glucose Monitoring System The intensity of the color is is intended for in vitro diag-...

  • Page 7: Getting To Know The Meter

    Getting to Know M Button C Button the Meter Battery Study this diagram and Compartment become familiar with (on back) all the parts of your ONE TOUCH II Meter. ® Display Test Strip Holder On/Off Button Data Port Test Area with Protective Coating...
  • Page 8 ON/OFF BUTTON. This when you want to recall past strip holder. Remove the test button turns the meter on results. For information, see strip holder from the meter for and off. page 63. cleaning. For information, see page 44. DISPLAY. This is where you C (CODE) BUTTON.
  • Page 9 TEST FOR GLUCOSE ™ IN WHOLE BLOOD INC. Milpites,CA Made in U.S.A. 51-453B code10 LifeScan, or other data Carefully read this owner’s management systems. For booklet and all other information, see page 55. instructional material provided with your blood TEST STRIPS.

  • Page 10: Precautions And Limitations

    Precautions and Do not use ONE TOUCH ® Never make significant Test Strips beyond the expira- Limitations changes to your medica- tion date printed on the vial. tion program or ignore Discard the vial and unused The following technical physical symptoms with- test strips four months after information may be useful out consulting your...
  • Page 11 ONE TOUCH Test Strips Clinical Information Hematocrit: Extremes in ® must be stored in a cool, dry whole blood hematocrits place, below 86°F (30°C). Do For use in hospitals, institu- (above 60%) or very low not refrigerate test strips or tions, and clinics, refer to hematocrits (below 25%) can place test strips in heat or...
  • Page 12 The results will be inaccu- without ketosis, which may be rately low. life-threatening if left untreated. The following factors can lead Blood glucose results obtained to severe dehydration: with the ONE TOUCH • vomiting and diarrhea ® Meter may be significantly •...

  • Page 13: Before Testing

    2. BEFORE TESTING Checking the System 1. Checking Your ONE TOUCH Normal Control ® ONE TOUCH Solution should be used to ® System with practice the test procedure There are two ways to make Control Solution and to make sure your meter sure your ONE TOUCH ®...
  • Page 14 Solution is printed on the test drugstore or authorized strip vial. This range is for the LifeScan distributor. control solution only; it is not Check the expiration date intended as a recommended contrl on the control solution vial.
  • Page 15 2. Checking the Meter with within the acceptable range. the Check Strip For assistance, call LifeScan A purple and white check Front Back Customer Services. strip is included with your ONE TOUCH II Meter.
  • Page 16 Do the check strip test at room How to use the check strip: insert temperature (between 64°F strip Step 1: and 79°F [18°–26°C] ). appears. Press on/off Slide the button. check strip into code 7 the test code 7 (example) strip will appear holder...
  • Page 17 Step 2: Step 3: The meter counts down from 4 to 0, then When When A 70 apply insert A ok sample side 2 (example) appears if the number falls appears, appears, within the acceptable check remove turn the strip range. The meter auto- the check check matically tells you if your...
  • Page 18 42. For further acceptable range. meter off or for two minutes, assistance, call LifeScan after which the meter auto- Customer Services. CAUTION: If your check matically turns off. You may...

  • Page 19: Coding The Meter

    You must use the Cleaning and maintaining If you lose or damage the check strip: the check strip: check strip, call LifeScan Customer Services for a At least once a day. Make sure both sides of the free replacement. After cleaning the meter.
  • Page 20 Set the code: Step 1: Turn On the Meter. The code numbers on test Before using the meter for strip vials range from 1 to Press the the first time. 16. If the on/off Every time you open a number on button to new vial of test strips or the display...
  • Page 21 Step 2: Match the code10 Code Numbers. (example) The meter is now properly Press the coded and you may proceed C button. with the test. From now on, With the meter will remember code 7 the selected code until you change the code for a new (example) vial of test strips.

  • Page 22: Getting And Testing A Drop Of Blood

    3. GETTING AND TESTING A DROP OF BLOOD Using the PENLET Step 1: Insert a Lancet. Insert a new, sterile lancet into ® the lancet holder. The lancet Automatic Blood Remove the PENLET II Cap ® will slide into the lancet Sampler by pulling it straight off.
  • Page 23 Hold the lancet firmly and Replace the PENLET II Cap. The PENLET II Sampler ® ® gently twist off the lancet includes two caps. The cap that protective disk. comes attached to the PENLET II Sampler has a single line on the flat side, and works well for children and most adults.
  • Page 24 Step 2: Cock the Step 3: Get a Drop of Blood. Choose a spot on the side of a PENLET II Sampler. different finger each time you ® Wash your hands with soap test. Repeated punctures in and warm water and dry them Holding the lower portion of the same spot can make your thoroughly.
  • Page 25 Hold the PENLET II Sampler Press the dark gray release Step 4: Remove the Lancet. ® firmly against the side of button. Always use caution when the finger, with the cap rest- removing the lancet and ing on the finger. (The hard- Squeeze the finger gently to PENLET II Cap.
  • Page 26 ONE TOUCH ® or properly disinfected HOSPITAL Manual. cap. For more infor- mation, see page 42, or call LifeScan Customer Services. Dispose of the used lancet in a container for sharp objects.

  • Page 27: Testing Your Blood

    Testing Your Blood You can test your blood glucose by following these three simple steps: Step 1: Press power, Step 2: Apply sample. Step 3: Accurate results in insert strip. No wiping. No timing. 45 seconds.
  • Page 28 If you have questions for detailed step-by-step about the testing proce- instructions and infor- dure, call LifeScan mation. Customer Services. The test strip holder and test area of the meter must be clean and lint-free.
  • Page 29 Step-by-Step Instructions Choose a clean, dry work surface. Make sure you have all the materials needed for a test: ONE TOUCH II Meter ® ONE TOUCH Test Strips ® PENLET II Automatic Blood ® Sampler (with choice of caps) Sterile Lancet Tissues Deep Cap Regular Cap...
  • Page 30 Step 1: Press On/Off Button. Make sure the code number Remove Insert Test Strip. on the meter display matches a test strip Test the code number on the test from the Spot Turn your meter on. strip vial. For information, vial.
  • Page 31 The test spot should be white sure you Step 2: Apply Blood Sample. or ivory-colored, with no tears push the or wrinkles. test strip With the test strip in the all the way meter and into the apply holder sample until it stops.
  • Page 32 Make sure that you: The meter will beep when the Be sure to wait for the beeps blood has been applied to the before you note your result. Touch only the tip of test spot. The meter displays results the drop of blood to the which are between 0 and test spot.

  • Page 33: Checking The Amount Of Blood On The Test Strip

    Checking the Amount of Remove the test strip from the meter and look at the Blood on the Test Strip contrl test spot. It should still (example) have a wet, shiny drop that Although the ONE TOUCH ® completely covers the circle. System requires only a small appears on the display, your If the blood sample has a...
  • Page 34 Look at the an inaccurately low result. Back back of the Repeat the test with a new test strip. test strip. You should see a full, dark circle. If there are any white patches or streaks, the blood may have been smeared, or the drop was too small.

  • Page 35: Help! (Troubleshooting)

    4. HELP! (Troubleshooting) MESSAGE APPEARS WHEN The display messages that appear on the You press and hold meter will guide you through the glucose the on/off button. testing and quality control test procedures, It means all display alert you to problems as they occur, and give segments are work- you information about test results stored in ing properly.
  • Page 36 MESSAGE APPEARS WHEN MESSAGE APPEARS WHEN The meter is ready to The meter is counting insert 45..0 perform a blood, check down from 45 seconds strip strip, or control solu- to 0. tion test. A blood test is com- The meter is performing pleted.
  • Page 37 MESSAGE APPEARS WHEN MESSAGE APPEARS WHEN A control solution The check strip test test is completed. result falls into the contrl If you have per- acceptable range. (example) (example) formed a blood test, high it means that the Your blood glucose blood sample was too test result is above small and the meter...

  • Page 38: Error Messages

    In most cases, continually, replace the problems are easy to fix. If you need it, help (example) it means the battery as is available from LifeScan Customer Services battery is soon as 24 hours a day. getting low. possible. MESSAGE...
  • Page 39 MESSAGE PROBLEM WHAT TO DO MESSAGE PROBLEM WHAT TO DO 3. The test 3. Repeat clean 1. There is 1. Clean the strip was the test. test dirt, blood, test area inserted Wait for area or lint on according before the mes- insert the test...
  • Page 40 MESSAGE PROBLEM WHAT TO DO MESSAGE PROBLEM WHAT TO DO error1 The sample Repeat the 2. The test 2. Repeat the retest was applied test with a strip was test with a before apply new test not inserted new test sample strip.
  • Page 41 2. The test 2. Repeat the 7. The meter 7. Call strip was test, push- may not be LifeScan not inserted ing the test operating Customer fully into strip all the correctly. Services. the test strip way into holder.
  • Page 42 PROBLEM WHAT TO DO MESSAGE PROBLEM WHAT TO DO code 7 The last check Stop and not ok Your meter Call LifeScan redo A strip test do a check may have an Customer result was strip test. (example) electronic Services.

  • Page 43: Special Function/Memory Messages

    (If this continues to happen, You have entered the memory there may meter’s memory by be a problem pushing the M button. with your meter. Call There are no test results nodata LifeScan stored in the memory. Customer Services.)
  • Page 44 MESSAGE WHAT IT MEANS MESSAGE WHAT IT MEANS The total number of A blood glucose test n 225 tests (blood, check result marked with event6 (example) strip, and control an event number. (example) solution) stored in the memory. A blood glucose 3 .

  • Page 45: What To Do If You Think Your Test Results Are Wrong

    What to Do If You Think Your Test The test strips have expired. Check the expiration date on the test strip vial, and Results Are Wrong discard the test strips if out of date. Repeat the test with a test strip from a new vial. If you think you are getting inaccurate results, Make sure you reset the meter code number.
  • Page 46 The test strip holder and test area are dirty. For information, see page 43. The test result number is below 33.4 and the letters MM appear before the result. This means you may have accidentally switched from mg/dL to mmol/L, the unit of measure used in Canada and other countries.

  • Page 47: Taking Care Of The Meter

    Do not drop or toss the with another person, or a PENLET II Cap, meter. The meter’s elec- always use a new or please call LifeScan tronics could be damaged properly disinfected Customer Services. by such treatment. If you test strip holder for drop the meter, make sure each person.

  • Page 48: Doing A Daily Check

    Avoid exposing the meter the meter apart will If there is anything blocking or test strips to extremes invalidate the meter the hole, or if the test area in temperature or humidity warranty. has dirt, lint, or blood on it, for long periods of time.
  • Page 49 • At least once each week, Hold the meter and place your Step 2: Clean Test • Whenever the test area thumbs on the two raised dots Strip Holder. looks dirty, and on the test strip holder. Wash the test strip holder •...
  • Page 50 Clean the underside of the test Step 3: Clean Test Area. strip holder and check the CAUTION: DO NOT small hole for any dirt, blood, GET WATER INSIDE or lint. Rinse well. THE METER. The following cleaning agents will damage the meter. Check the clear, protective DO NOT USE: coating over the test area to...
  • Page 51 Dry the test area with a soft, Press down on the raised dots dry tissue or cloth. Remove of the test strip holder until it any lint. snaps firmly into place. Step 4: Replace Test Strip Holder. Hook the bottom of the test strip holder onto the square Rub the test area with a cotton notch on the meter.

  • Page 52: Replacing The Battery

    Press forward on the base of Replacing the Battery The battery should last the test strip holder to be sure about one year with typical it is properly in place. home use. The ONE TOUCH II Meter ® comes with When the battery is getting a battery low, the display will flash.
  • Page 53 appears on the display, the To replace the battery: Remove the battery door. meter will no longer give Make sure the meter is results and you must replace turned off before you remove the battery before you can the battery. perform another test.
  • Page 54 Remove the old battery and Swing the left side of the door discard properly. Insert a new over the battery and insert the J-size battery in the battery tab on the left side of the compartment as indicated. battery door into the slot by applying pressure with your thumb until it snaps shut.

  • Page 55: Special Functions

    • Select the type of data own special needs. For language are available. management system that example, you can: (Call LifeScan Customer the meter will communi- Services for information cate with. • Set the clock in your meter on other languages that may so that your blood glucose be available in the future.)
  • Page 56 have the correct date and You may save your selection time appear with each test and exit at any time by result that you recall from the turning the meter off. meter memory. You will need to reset the date and time Note: When the date and whenever there is a change to time are changed, the average...
  • Page 57 With the meter off, press The month will flash. The day will flash. and hold the C button. 6. 1 1. 9 9 1. 9 9 Press and release the (example) (example) on/off button. Press the C button to change Press the C button to change the month.
  • Page 58 The hour and AM/PM The minutes will flash. Press the on/off button will flash. to exit. 8p. m . (example) 3: 3 8p. m . (example) Press the C button to change Press the C button to change the minutes. the hour, and select AM/PM.

  • Page 59: Setting Special Functions

    Symbolic your ONE TOUCH II Meter. ® To turn the beeps on or off, Language Chart, call LifeScan The following section will follow the chart on page 57. Customer Services. tell you how to set the beep...
  • Page 60 Selecting the Unit of Measure rather than a decimal point Selecting AM/PM or (6.4 mmol/L). Select this 24-Hour Time The meter is set at the factory option by following the chart to give results in mg/dL Your meter is set at the factory on page 59.
  • Page 61 ONE TOUCH II Meter ® various data to the Data Manager ™ management by LifeScan using the systems. To DTAMGR mode. For communicate information, see page 61. with these systems, you will For information on other data need to select the correct...
  • Page 62 With the meter off, press and beep no beep displays and sounds. displays. There will hold the M button. This selection means you will be no sound when each test hear a beep when each test result is displayed. Press and release the on/off result is displayed.
  • Page 63 engl. espan. Continue to press C to cycle displays. All dis- Spanish franc. back to English. play messages will appear French itali. in English. Italian neder. Press M while the chosen Dutch port. language is displayed to save Press M to save and continue Portuguese svens.
  • Page 64 mg/dl mmol/l dec pt displays. Results will displays. Results will displays. Your appear in milligrams per appear in millimoles per liter, mmol/L result will appear deciliter, the unit of measure the unit of measure used in with a decimal point (example for blood glucose used in the Canada and some European...
  • Page 65 comma m . d . y . d . m . y . displays. Your mmol/L displays. The date will displays (example 11-6-99 result will appear with a appear in this order: month- or 11 June, 1999) comma day-year (example 6,3 mmol/L) (example 6-11-99 or Continue pressing C to alter- June 11, 1999)
  • Page 66 am/pm 24: 0 0 rs-232 displays. The clock is displays. The clock is displays. The meter set in 12-hour time set in 24-hour time is set at the factory for the (example (example RS-232 data manage- 8:15 20:15) ment mode. Press M to save and continue Continue pressing C to alter- nate between the choices.
  • Page 67 Use this mode to mode, the meter is set at the communicate with the Data factory for a baud rate of 9600. Manager by LifeScan. Continue pressing C to rotate ™ Press M to save and continue between the choices.

  • Page 68: Recalling Tests From The Meter Memory

    Data Manager ™ for the past 14 days from the (example) device by LifeScan or another current time. Example: A data management system. 10:00 result from April 1 insert When you have done more...
  • Page 69 will not be included in the will appear. This indicates the Press the M button again, and average at 10:05 on April total number of results stored the time of your most recent 15. Because the average is in the memory, including test appears.

  • Page 70: Setting Event Numbers

    (11 June 1999 example) Press the M button again and You can get a LifeScan will appear if you have Logbook from your autho- selected the day-month-year - - - - rized LifeScan distributor, format.
  • Page 71 Some examples of event Event 9. Results during cemia). To choose Event 9, categories you might hyperglycemia or follow these steps: choose are: when urine ketones are present With 345 on the display, Event 1. Blood glucose results press the C button. before a meal You may select an Event 2.
  • Page 72 Continue pressing the C To cancel an event number: button to advance the event With the test result on the number from 1 to 9 until the Meter display: (example) desired number is selected. The event number for this result has now been event1 event6 cancelled.

  • Page 73: Questions And Answers

    LifeScan your diabetes. your diabetes control plan. Customer Services. Test results can also indicate Q. Why should I test my...
  • Page 74 Q. How often should I test my variations provide useful Keep your meter clean at all blood glucose? clues about your condition times. For information, see and how well your treatment page 43. A. This is best decided by you program is working.
  • Page 75 Do not use expired test Q. What should I do if my Q. What are the expected strips. Never use test strips blood glucose test results are blood glucose values associ- after the expiration date on consistently high for my own ated with well-controlled the package label has passed.
  • Page 76 A. Many healthcare profes- whole blood. Whole blood You can still expect a varia- sionals believe that the result results are approximately tion from this number based that you get with your meter 10% –12% lower than serum on other factors, noted below. should fall within 15% to or plasma results from the 20% of the result obtained...
  • Page 77 (1987) 10:622-628. very different results. 6 Gadsen RH: Challenges in Diabetes Management, Milpitas CA, LifeScan, Inc. (1988) 63-66. 7 Caraway WT: Carbohydrates, in Tietz NW (ed). Fundamentals of Clinical Chemistry. Philadelphia, WB Saunders Company (1976) 242-244.

  • Page 78: Specifications

    8. SPECIFICATIONS Performance Result Range: 0–600 mg/dL Operating Humidity Range: (0–33.3 mmol/L). Higher 0%–90% relative humidity Characteristics values displayed as high. (noncondensing). See the ONE TOUCH ® Display Type: Alphanumeric; Memory: Storage capacity— Test Strips package insert 6-character, 14-segment LCD. 250 test results including for ONE TOUCH II System...

  • Page 79: Guarantee And Warranty

    30-Day Money-Back five years after purchase, the warranty replacement, first Guarantee meter does not work for any call your LifeScan Customer reason (except for obvious Services Representative at If you are not fully satisfied abuse), LifeScan will replace the toll-free number for with the ONE TOUCH ®...
  • Page 80 The warranty policy does not apply to the performance of the ONE TOUCH II Meter ® when used with any test strip other than ONE TOUCH ® Test Strips, or when the ONE TOUCH II Meter or ONE TOUCH Test Strips are changed or modified in any way.

  • Page 81: Glossary And Index

    9. GLOSSARY AND INDEX Glossary of Medical Terms expiration date - the date hyperglycemia - an abnor- specified by the manufacturer mally high level of glucose This glossary is provided to after which the product in the blood help you better understand should not be used key medical terms that relate hypoglycemia -...
  • Page 82 mmol/L - millimoles per liter. serum - the clear portion of a The unit of measurement for clotted blood sample remain- the concentration of glucose ing after cells and clotting in blood used in Canada and proteins have been removed other countries.
  • Page 83 Index Laboratory Comparison Information ..70 Battery Replacement ......47 Memory Blood Glucose Values (Expected) ..70 Average Blood Glucose..... 63 Blood Sample Size ....... 28, 35, 36 Recalling Tests........63 Check Strip ........... 10 Number of Stored Results ....64 Cleaning and Maintaining Event Numbers........
  • Page 84 Special Functions Test Procedure Messages Setting the Clock ......50, 52 “Clean Test Area” Message..34, 44 Setting the Beeps......54, 57 “Error 1” Message......35 Setting the Language....54, 58 “Error 2” Message......35 mg/dL or mmol/L......9, 50, 55, “Not OK”...
  • Page 85 LifeScan Customer Services toll-free numbers: El Folleto para el Propietario del ONE TOUCH II se encuentra ® (24 hours a day, 7 days a week) disponible en español. Para recibir su copia gratuita, favor del llamar al número gratis 1 800 381-7226.

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