Arkray Glucocard 01 User Instruction Manual
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Arkray Glucocard 01 User Instruction Manual

Blood glucose monitoring system
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  • Page 1 Blood Glucose Monitoring System User Instruction Manual...
  • Page 2 CAUTION: Before using any product to test your blood sugar (blood glucose), read all instructions and practice the test. Do all quality control checks as directed and consult with a diabetes healthcare professional. These recommendations apply to all blood glucose monitoring systems and are supported by the American Association of Diabetes Educators, the American Diabetes Association, the U.S.

  • Page 3: Table Of Contents

    TABLE OF CONTENTS Introduction ......... . . 5 Intended Use .
  • Page 4 Blood Glucose Testing ........33 The Lancing Device .

  • Page 5: Introduction

    INTRODUCTION Thank you for choosing the GLUCOCARD™ 01 Blood Glucose Monitoring System meter. This system measures blood glucose in fresh capillary whole blood. Results are shown as plasma values. This makes it easy to compare the GLUCOCARD™ 01 blood glucose meter and lab results.

  • Page 6: Intended Use

    Intended Use The GLUCOCARD™ 01 Blood Glucose Monitoring System meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

  • Page 7: Understanding The Glucocard™ 01 Blood Glucose Meter

    UNDERSTANDING THE GLUCOCARD™ 01 BLOOD GLUCOSE METER Bottom Battery Compartment Cover Display Test Strip Port Connection Terminal Orange/Up Arrow Gray/Down Arrow...
  • Page 8 Explanation of the full display Memory Mode Symbol Battery Symbol Audible Beep Off Apply Blood Symbol Unit of Measurement Date Time Format Temperature Warning Delete Symbol Control Solution NOTE: Meters in the USA are programmed to show results in mg/dL. Meters used outside the USA are programmed to show results in either mg/dL or mmol/L.
  • Page 9 GLUCOCARD™ 01 SENSOR These test strips need only 0.3 µL (microliter) of blood. Apply blood to the sample application tip. The strip draws in the blood by capillary action. The blood glucose reacts with the enzyme on the test strip. This produces a current proportional to the blood glucose level.

  • Page 10: Changing The Battery

    Changing the Battery blood glucose The GLUCOCARD™ 01 meter comes with one lithium battery CR2032 (or DL2032). CAUTION Replacing the battery will not delete meter settings or test results stored in the meter unless you: • Touch the metal portion on main unit with your fingers or any metal. •...
  • Page 11 To replace battery: 1. Open the battery cover on the back side of the meter by pushing the tab in the direction of the arrow and pulling the cover up. 2. The battery is held in place on the underside of the cover. Slide the battery out of the cover.
  • Page 12 5. Put the battery cover back into correct position and snap to close. If the clock setting has been deleted, either “12:00” or “0:00” will blink when you put a test strip into the meter. The low battery symbol means you need to replace the battery as soon as possible. Discard used batteries as per local guidelines.

  • Page 13: Meter Set-Up

    METER SET-UP Before using the GLUCOCARD™ 01 blood glucose meter for the first time, set the time and date. Do not perform a blood glucose test until you have set-up the meter. Meter set-up allows you to adjust the audible beep volume and to set time, date, and test averaging.
  • Page 14 Step 2: Press the Orange/Up Arrow and Gray/ Down Arrow buttons at the same time for 5 seconds. A beep sounds and the meter turns on. Next, a second beep sounds and “SET” shows on the screen. Step 3: Use the Orange/Up Arrow to change the set-up screen. When you press the Orange/Up Arrow, the set-up screen changes in the order shown in the diagram to the right.

  • Page 15: Year

    Setting Setting the Setting the Setting Audible Month the Year Beep Orange Orange Orange Orange Arrow Arrow Arrow Arrow Orange Arrow Gray Arrow Return Setting Setting the Setting Ending Hour Test Set-up Averaging Minute Orange Orange Orange Arrow Arrow Arrow Orange Arrow <Power OFF>...

  • Page 16: Audible Beep

    Setting the Audible Beep If the audible beep is turned “on”, the beep will sound when: • You insert a test strip into the meter. • You apply blood or control solution to a test strip. • The test has ended and the result is displayed. •...
  • Page 17 Press the Gray/Down Arrow button to cycle through the volume levels: “OFF” (no sound) ”on 1” (low) “on 2”(middle) “on 3” (high) “OFF” (no sound) …, etc. A beep sounds at the set volume at each step. If “OFF” is set, the “audible beep mute (Off)”...
  • Page 18 Setting the Year In the year set-up screen, the last two digits of the currently set year appear at the top of the screen. “yER” appears in the middle of the screen. All four digits of the currently set year appear at the bottom of the screen.

  • Page 19: Month/Day

    Setting the Month Press the Gray/Down Arrow button to change the month. After you set the month, press the Orange/ Up Arrow button to confirm the setting. The screen changes to the day set-up screen. Setting the Day Press the Gray/Down Arrow button to change the day.

  • Page 20: Hour/Minute

    Setting the Hour Press the Gray/Down Arrow button to change the hour. After you set the hour, press the Orange/Up Arrow button to confirm the setting. The screen changes to the minute set-up screen. Setting the Minute Press the Gray/Down Arrow button to change the minute.

  • Page 21: Test Averaging

    Setting Test Averaging NOTE: “Lo” results are included as 20 mg/dL in the averages. “Hi” results are included as 600 mg/dL in the averages. Press the Gray/Down Arrow button to cycle through the test averaging choices: “oFF” (not displayed), “14” (14-day average), or“30” (30-day average).“AVE”...

  • Page 22: Ending Set-Up

    Ending Set-up To make further changes to set-up settings, press the Gray/Down Arrow button while “End” is displayed. This will bring up the Audible Beep set-up screen. You can then move through the set-up mode and adjust any settings that you wish. If you are done with set-up, press the Orange/Up Arrow button while “End”...

  • Page 23: Perform A Control Solution Test

    • the meter and test strips are working correctly as a system. • you are testing correctly. Call your local supplier or pharmacy to order control solution. If they do not stock it, call ARKRAY Order Services at 800.818.8877 option 4 (USA and Canada only).
  • Page 24 Perform a Control Solution Test: • Before testing with the GLUCOCARD™ 01 blood glucose meter for the first time. • Whenever you suspect the meter or test strips may not be functioning properly. • If test results appear to be abnormally high or low or are not consistent with clinical symptoms.
  • Page 25 • GLUCOCARD™ 01 CONTROL is not intended for human consumption. Do not drink. • Do not apply to eye. Contact your healthcare professional immediately if solution is swallowed, injected, or applied to the eye. • Dye in control solution may stain skin, clothing, or surfaces. •...
  • Page 26 Step 1: Insert a test strip as shown in diagram. Test strip should seat firmly into meter. The meter will turn on automatically. The full screen will come on for a moment. Make sure all symbols appear on the screen (see page 8). Then the code number (F-2, F-3, or F-4) will appear and will alternate with the Apply Blood symbol.
  • Page 27 Step 2: Press the Orange/Up Arrow button to enter the control mode. will see “CONT” on the bottom right of the screen. If you do not enter the control solution mode, the control solution result will NOT be valid. Orange/Up Arrow Gray/Down Arrow...
  • Page 28 Step 3: Mix control solution by gently inverting bottle. Remove the cap from the control solution bottle. While the Apply Blood symbol and Code No. (F-2, F-3 or F-4) are alternating, place a drop of the control solution on the end of the test strip. DO NOT put control solution on top of the test strip.
  • Page 29 Repeat Steps 1-5 with other Control Solution levels as per recommendations of your healthcare professional. Call your local supplier or pharmacy to order control solution. If they do not stock it, call ARKRAY Order Services at 800.818.8877 option 4 (USA and Canada only). NOTE:...

  • Page 30: Troubleshooting Control Solution Test

    Troubleshooting Control Solution Test If the control solution test result is out-of-range, check the following and repeat the test: Check Action Did you do the test in If not, do the test again. Insert a control solution mode? test strip; press the Orange/Up Arrow Do you see “CONT”...
  • Page 31 Check Action Did you insert test strip Make sure test strip is inserted firmly into meter? all the way into test strip port. See diagram on page 26. Did you follow the Reread “Performing a Control procedure correctly? Solution Test” (pages 24-29) and retest. Were test strips stored correctly If not, retest with a (between 34-86°F (1-30°C))?
  • Page 32 Does your Control Solution result still read outside the range printed on the test strip bottle? If yes, the system may not be working correctly. DO NOT USE the system to test your blood glucose until the control solution result is within range. If you need help, please call Customer Service at 800.566.8558 (24 hours a day, 7 days a week, USA and Canada).

  • Page 33: Blood Glucose Testing

    BLOOD GLUCOSE TESTING The Lancing Device Removable cap Lancing Button Adjustment dial Multilet (lancet) Multi-Lancet Device body ™ Band hooks Protective cap Disposal-and-set lever Step 1: Pull the removable Strap hole Special band cap to Groove of special band remove it. NOTE: Do not use the lancet if the cap is missing or damaged.
  • Page 34 Step 2: Insert a new, unused lancet into the Holder Holder until it stops. Step 3: Twist off the protective cap. Step 4: Attach the removable cap.
  • Page 35 Step 5: The Multi-Lancet Device offers 7 different levels of skin penetration. For soft or thin skin or first time use, select “1 or 2.” For alternate sites, select “7.” If the obtained amount of blood is excessive, turn the dial to a lower setting. If the obtained amount of blood is insufficient, turn the dial to a larger setting.

  • Page 36: Getting A Drop Of Blood

    Getting a Drop of Blood Step 1: Wash hands with soap and warm water. Dry hands thoroughly. If you use alcohol wipes to cleanse fingers, make sure the area is dry before lancing finger. Residual alcohol may lead to inaccurate readings. Step 2: Let the arm hang down for 10 to 15 seconds.
  • Page 37 Step 5: Set aside the lancing device and wait a few seconds for a blood drop to form. Keeping the hand warm, lowering the hand to waist level and gently massaging your wrist, palm or the base of the finger helps the flow of blood. Use a different site each time you test to help prevent soreness and calluses.

  • Page 38: Performing A Blood Glucose Test

    Performing a Blood Glucose Test NOTE: Four and a half minutes after test strip insertion, a beep sounds every 5 seconds. After 5 minutes, a beep sounds and the meter turns off. Take out unused test strip and insert it again to turn meter back on.
  • Page 39 Step 2: The beep will sound again. The Apply Blood symbol and the Verify that code number (F-2, F-3, or F-4) will alternate on the screen. the code number on the screen matches the code number printed on the bottle. If the code number does not match, the meter may give a false reading.
  • Page 40 Step 3: Obtain a blood drop (see pages 35-37). Apply blood to the end of the test strip. Capillary action will pull the blood into the strip. The meter will beep when it detects that blood has been applied. The meter will begin to count down. Do not add blood on top of the test strip, as you may receive an inaccurate result.
  • Page 41 If it takes longer than 20 seconds to obtain a blood sample and to touch the test strip to the blood drop, repeat Step 3. Step 4: The meter will count down, starting from “7”. mg/dL After 7 seconds, a beep sounds and the test result and date/time are shown.

  • Page 42: Flagging Test Results

    Flagging Test Results You can mark a test result with either “DEL” or “CONT” or leave it unmarked. You must mark the test result after it has been mg/dL displayed, but before you remove the test strip from the meter. You cannot change the marker after removing the test strip from the meter.
  • Page 43 Step 2: When you have selected the desired marker, remove the test strip. When you recall the result from memory, the selected marker will be displayed (“DEL”, “CONT” or no marker). mg/dL NOTE: The following are NOT included in the 14-day or 30-day test averages: •...

  • Page 44: Alternate Site Testing (Ast)

    ALTERNATE SITE TESTING (AST) Important Information About AST Sites other than your fingertip may have fewer nerve endings so obtaining a blood sample from these sites may be less painful. The technique for alternate site testing is different from fingertip testing. Blood glucose testing results from sites other than your fingertip could be significantly different.
  • Page 45 Consider Alternate Site Testing When: • Testing before a meal. • You are in a fasting state. • Two hours have passed since a meal. • Two hours have passed since insulin dosing. • Two hours have passed since physical activity. Use Fingertip Testing: •...
  • Page 46 Ask your diabetes healthcare professional about recommended testing procedures when operating machinery or driving a car, as fingertip testing is usually the preferred method of testing under these circumstances. If bruising occurs, you may choose to lance a fingertip instead. Preparing to Test Your Blood Glucose From an Alternate Site Choose a Site:...
  • Page 47 Prepare Your Lancing Device: To order an AST Lancing Kit containing the lancing device, lancets and instructions, please call 800.566.8558. Performing a Blood Glucose Test From an Alternate Site Step 1: Insert lancet and cock lancing device.
  • Page 48 Step 2: Remove test strip from the bottle. Immediately replace the bottle cap Insert test strip as shown in tightly. diagram. A beep will sound and the meter will turn on automatically. Verify that all symbols appear on the screen (see page 8). Verify that the code number Code No.
  • Page 49 Step 3: a) PRESS AND VIGOROUSLY RUB THE SELECTED AREA for 10 seconds until it starts to feel warm to the touch. b) Firmly hold the cocked lancing device against the clean skin for 5-10 seconds.

  • Page 50: Lancing Device

    c) Press the release button d) Once a on the lancing device to large enough Continue to lance the skin. drop of blood hold the lancing device has formed, firmly against the skin until remove the a blood drop forms. lancing device.
  • Page 51 IMPORTANT IF NOT, • Was the sample free of clear or watery fluid? REPEAT TEST. • Was the drop large enough (at least 0.3 µL)? • Did the reaction site fill with enough blood all at once? Step 5: The meter will count down and display result in 7 seconds. CONSIDER YOUR RESULT.
  • Page 52 If the repeated alternate site result is still not consistent with how you feel, confirm your blood glucose level with fingertip testing. Step 6: record your results in your self-testing logbook Always along with other information such as insulin dosage, diet, and exercise. The result is automatically stored in memory with the time and date.

  • Page 53: Understanding Test Results

    Understanding Test Results The GLUCOCARD™ 01 blood glucose meter is referenced to a fresh plasma sample. Your meter results may differ from clinical lab results. This is due to normal variation. To compare your meter with lab results, follow the guidelines below. Before you compare Perform a control solution test.
  • Page 54 ALWAYS wash hands with warm soapy water. Rinse and dry them ALWAYS before testing. use fresh capillary whole blood on meter tests. You may still see a difference from the lab result. This can be due to several causes. Blood glucose levels can change over short periods of time, for example due to food or stress.
  • Page 55 Normal Blood Glucose Readings Expected blood glucose levels for adults without diabetes¹ , ²: Fasting 70 to 110 mg/dL 1 to 2 hours after meals <120 mg/dL High Blood Glucose Readings If your blood glucose is above 600 mg/dL, you will receive a “Hi.” Repeat the test with a new test strip.
  • Page 56 Low Blood Glucose Readings If your blood glucose is below 20 mg/dL, you will receive a “Lo.” Repeat the test with a new test strip. If this message shows again, contact your healthcare professional immediately! Contact your physician for advice if test results are very low 4 (below 70 mg/dL) and/or you have symptoms of low blood glucose.

  • Page 57: What This Means For You

    What This Means For You Frequent blood glucose testing is the best means to track how well you are doing with your diabetes management. It helps you track the effects of medications, diet, exercise, and stress management. Blood glucose test results can also tell you if your diabetes is changing. This may alert you to adjust your treatment plan.

  • Page 58: Recalling Results - Entering Memory Mode

    RECALLING RESULTS - ENTERING MEMORY MODE The GLUCOCARD™ 01 blood glucose meter stores up to 360 test results. When more than 360 test results have been performed, the meter drops the oldest result each time you add a new result. Before using the memory, remove test strip from meter and make sure meter is turned off.
  • Page 59 • If Test Averaging has been turned on, the average result will appear first. Either “14d” or “30d” will show at the bottom of the screen for either a 14-day or 30-day average. “AVE” will appear above “14d” or “30d”. •...
  • Page 60 Step 3: After all test results have been reviewed, “End” appears. • Press the Orange/Up Arrow button once to go back to the first result in memory. You can then scroll through results in memory again. • Press the Gray/Down Arrow button for 2 seconds to exit Memory and turn off the meter.
  • Page 61 Deleting all test results Step 1: Press both the Orange/Up Arrow and Gray/Down Arrow buttons for 5 seconds while “End” is shown. You will see “dEL” and “ALL” alternating on the screen. Step 2: Next press the Gray/Down Arrow button for 5 seconds. “End” appears again. All test results have now been deleted.

  • Page 62: Maintenance

    MAINTENANCE Cleaning To prevent malfunction of the meter, keep the test strip port free of blood, moisture, dirt, or dust. Use a lint-free cloth dampened with water to clean meter. Thoroughly wring out cloth before use. Do not use an abrasive cloth or antiseptic solution, as these may damage the display screen.

  • Page 63: Storage And Handling

    Storage and Handling • Store meter at 32°F-122°F (0°C-50°C). • Do not leave the meter in very hot or cold places. Do not leave it near a heat source (radiator) or in a car in hot or cold weather. • Do not store or use meter or test strips: •...

  • Page 64: Display Screen And Error Messages

    Service at 800.566.8558 (24 hours a day, 7 days a week, USA and Canada only). Contact your healthcare professional if you cannot reach Customer Service. Do not send your meter to ARKRAY or your local dealer without first calling to get approval to do so.
  • Page 65 Your blood glucose level is less than 20 mg/dL or there was not enough blood on test strip. Repeat test with new test strip. Make sure you use enough blood to fill the strip. If this message shows again, contact your healthcare professional immediately! Your blood glucose level is more than 600 mg/dL.
  • Page 66 The meter is faulty. Contact Customer Service at 800.566.8558. The meter temperature is outside acceptable range of 50˚F-104˚F (10˚C-40˚C). Allow the meter and test strips to warm up or cool down slowly (20 minutes) until the temperature warning symbol goes away. The meter is faulty.
  • Page 67 Test strip problem. Contact bars on test strip may be dirty. Incorrect test strip used. Used test strip has been inserted. Repeat test with new test strip. Not enough blood added to test strip. Or incorrect blood application technique. Retest with new test strip. Code Number.
  • Page 68 Apply Control Solution. The Apply Blood symbol flashes alternately with the strip code number (F-2, F-3, or F-4) and “CONT” appears at the bottom of the screen. This shows the meter is ready for you to apply control solution. Test Result. The meter shows results between 20 and 600 mg/dL.

  • Page 69: Product Information

    PRODUCT INFORMATION Product Specifications Test Strips: GLUCOCARD™ 01 SENSOR. Result Range: 20-600 mg/dL . Calibration: Plasma referenced. Sample Size: Minimum 0.3 µL. Blood Source: Fresh capillary whole blood. Hematocrit Range: 30% - 54%. Test Time: 7 seconds. Assay Method: Biosensor, Glucose Oxidase (Aspergillus niger sourced). Power Source: One 3-volt lithium battery (CR2032 or DL2032) Battery Life:...

  • Page 70: Warnings, Precautions & Limitations

    Warnings, Precautions & Limitations • You may get test results higher than your actual glucose level if taking PAM (1-Methylpyridine-6-carbaldehyde oxime). Taking unnecessary measures to lower your blood glucose level may induce severe low blood glucose symptoms such as coma. •...
  • Page 71 • Extremes in hematocrit may affect test results. Hematocrit levels less than 30% may cause falsely high readings. Hematocrit levels greater than 54% may cause falsely low readings. • Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis.
  • Page 72 • The GLUCOCARD™ 01 Blood Glucose Monitoring System is not designed to be a substitute for pathology laboratory equipment and should not be used for the diagnosis of diabetes. • Use only fresh capillary blood. Do not use serum or plasma or venous whole blood.

  • Page 73: Warranty

    Warranty You are a valued customer of ARKRAY. It is important to us that you are completely satisfied with your GLUCOCARD™ 01 blood glucose meter. ARKRAY warrants your GLUCOCARD™ 01 blood glucose meter will be free from defects in materials and workmanship for a period of five years from the date of the original purchase.
  • Page 74 Returns You must contact ARKRAY Customer Service at 800.566.8558 before returning your meter. You will be instructed how to return the meter to ARKRAY. Returned meters without this authorization will not be accepted. TEL 800.566.8558 FAX 952.646.3110 www.arkrayusa.com P/N 7267-00 ©2008 ARKRAY, Inc.

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