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User Instruction Manual Read this User Instruction Manual carefully before you start testing.
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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.
Always consult your diabetes healthcare professional before making any changes. All of the information needed to use the GLUCOCARD Vital System is included in this manual. Please read it thoroughly before using the system. If you have any questions, call ARKRAY Customer Service at 800.566.8558 (24 hours a day,...
Intended Use The GLUCOCARD Vital Blood Glucose Monitoring System 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.
Important Information • Test results below 70 mg/dL indicate low blood glucose (hypoglycemia) • Test results above 240 mg/dL indicate high blood glucose (hyperglycemia) • If results are below 70 mg/dL or above 240 mg/dL, repeat the test • If results continue to measure below 70 mg/dL or above 240 mg/dL consult your diabetes healthcare professional immediately • If symptoms are not consistent with test results AND all the instructions have been followed carefully, contact your diabetes healthcare professional • Before testing, always make sure both the meter and test strips are at operating temperature...
THE GLUCOCARD Vital SYSTEM The GLUCOCARD Vital System Includes: • GLUCOCARD Vital Meter • Carrying Case • User Instruction Manual • Self-testing Logbook • May include Test Strips, Control Solution, and Lancing Device and/or Lancets...
UNDERSTANDING THE GLUCOCARD Vital BLOOD GLUCOSE METER Front Back Display Screen Data Connection Port Back Button On/Off Button Forward Button Test Strip Port Battery Compartment Cover...
Explanation of the Full Display Screen Control Solution Test Battery Time Memory Mode Date Unit of Measurement Average Test Reading Error Code Temperature Result Warning Warning Main Display: Test Strip Code Test Countdown Insert/Remove Test Strip Test Results Test Strip Error Codes Apply Blood If any part of the display screen is missing when the meter is turned on call...
Test Strip 0.5 µl of blood and provide an end-fill sample Contact Bars application tip for easy blood application. The GLUCOCARD Vital Blood Glucose Monitoring System measures the amount of glucose (sugar) in fresh capillary whole blood. When a drop of blood is added to the sample application tip, the sample is drawn into the test strip reaction site.
TESTING WITH GLUCOCARD Vital TEST STRIPS The GLUCOCARD Vital Blood Glucose Monitoring System works with the GLUCOCARD Vital Test Strips. Important Test Strip Information • Store the test strip bottle in a cool, dry place between 39°F– 86°F (4°C–30°C) • Keep away from direct sunlight and heat • Do not refrigerate or freeze • Do not store or transfer the test strips outside the original bottle • As soon as you have removed a test strip, replace the cap securely on the bottle • Use test strips within 90 days (3 months) of opening and not beyond the expiration date (...
Important Test Strip Information • Write the date of opening on the bottle label to remind you to discard the strips after 90 days (3 months) • Do not bend, cut, or alter a test strip • Do not reuse a test strip • Use only GLUCOCARD Vital Test Strips with the GLUCOCARD Vital Meter • Ensure your hands are clean and dry before handling test strips...
Changing the Battery The GLUCOCARD Vital Blood Glucose Meter has a CR2032 battery installed. Note: Changing the battery should only take a few seconds. If the battery is changed within 30 seconds, the meter memory is not affected. You will not lose any past test results and the settings are not affected.
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WARNING: Keep all batteries out of children’s reach. If a battery is swallowed, consult a doctor immediately. When the battery power is getting low, your meter shows . You have enough power for about 100 tests before you need to replace the battery. If the is flashing, there is only enough power for about 20 tests.
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How to Change the Battery Step 1 Turn the meter off. The battery cover is on the back of the meter. Step 2 Pull the battery cover up with your finger or fingernail. Remove battery cover. Step 3 Remove the old battery. If necessary, turn the meter over and tap it gently against the palm of your hand until the battery falls out.
Meter Set Up Before using the GLUCOCARD Vital Meter for the first time, you must set the time and date. You can choose between the 12-hour format (1-12 o’clock with am or pm) and the Military 24-hour format (0-23). The date format can either be displayed as month/day (U.S.A. format) or day/month (International format). Do not perform a blood glucose test until you have set the meter correctly. Setting the Time and Date Step 1: Turn on meter Press the On/Off button to turn the meter on. The full screen appears briefly. If...
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Step 3: Set the time format The time can be displayed in either 24-hour format or 12-hour format with AM and PM. The meter displays the current time format. To change format, press either the Back or Forward button. Press the On/Off button to select the time format. The date format then appears on the display. Month/Day Format Step 4: Set the date format The date format can either be displayed as month/ day (01/31) or day/month (31/01). The meter displays the current format.
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Step 5: Set the hour Press and release the Back or Forward button to change the hour. Hold the Back or Forward button down to scroll through quickly. When the correct hour is displayed, press the On/Off button. The minute setting then flashes on the display. Step 6: Set the minute Hour flashing Press and release the Back or Forward button until the correct minute appears.
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Step 8: Set the day (If day/month format is selected then Step 8 will set month) Press and release the Back or Forward button until the correct day appears. Hold the Back or Forward button down to scroll through quickly. When the correct day is displayed, press the On/Off button. The year setting then Day flashing flashes on the display.
It is important that you carry out this simple check regularly. Assure Dose Control Solution contains a known amount of glucose that reacts with the GLUCOCARD Vital Test Strip. Assure Dose Control Solutions are available in two levels - Normal and High. Compare the control solution test results with the range printed on the test strip bottle label.
It is recommended to use Control Solution: • When you open a new bottle of test strips. • 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. • If the test strip bottle has been left open or has been exposed to light, temperatures below 39°F(4°C) or above 86°F(30°C), or humidity levels above 80%. • To check your technique. • When the GLUCOCARD Vital Meter has been dropped or stored below freezing or above 122°F(50°C). • Each time the batteries are changed.
Performing a Control Solution Test Before performing a control solution test, always check the expiration date ) of the control solution. Do not use control solution if it is past the expiration date or if the solution has not been stored correctly. When you open a new bottle of control solution, always write the date of opening on the control solution label.
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Step 1 Firmly insert a GLUCOCARD Vital Test Strip into the meter. Insert the contact bars into the test strip port, with the reaction site facing up. Firmly insert test strip using bottom of test strip port as a guide. Align test strip as shown in diagram.
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Step 2 You must press the Back or Forward button BEFORE performing control solution test. Hold the Back or Forward button until appears in the upper right corner of the screen. Verify that remains displayed on the screen. If you do not do this, the control solution result will NOT be valid.
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Step 4 Bring meter and test strip to the drop. Test strip will draw up the solution. The meter will show result in 7 seconds. Note: Dye added to control solution may stain surfaces or fabric. Use with care. 06146A 2010-10 Control Solution Range (mg/dL) (Rango de la solución de control)
Comparing Control Solution Results If the result is outside the range printed on the test strip bottle, repeat the test. One or more of the following may have caused an out-of-range result: • The meter was not placed in control solution mode before adding control solution • The control solution has expired or has been contaminated • The control solution was stored below 35°F (2°C) or above 86°F (30°C) • First drop of control solution was not discarded • The test strip was not stored correctly • The test strip was used after the expiration date of the bottle • The test strip bottle was open for more than 90 days (3 months) • The GLUCOCARD Vital meter has been damaged or has malfunctioned • Contamination due to the tip of the control solution bottle touching the test strip...
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Repeat the test, carefully following instructions, using control solution mode with new control solution or a new test strip, as appropriate. Compare the result with the range printed on the test strip bottle you are using. Note: If your control solution result continues to fall outside the required range, the system may not be working correctly. DO NOT USE the system to test your blood.
Removable cap Lancing Button Adjustment dial Lancet BLOOD GLUCOSE TESTING Multi-Lancet Device body ™ Band hooks Removable cap Multi-Lancet Device Adjustment dial Lancing Button ™ Protective cap Disposal-and-set Lancet lever Strap hole Special band Multi-Lancet Device body ™ (optional) Band hooks Groove of special band Protective cap Disposal-and-set...
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Step 3 Twist off the protective cap. Step 4 Attach the removable cap. NOTE: Do not use the lancet if the cap is missing or damaged. A lancet should only be used once. Dispose of used lancet in a safe manner so as not to cause accidental injury.
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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.” 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. Level indications 1 2 3 4 5 6 7 Deeper...
Obtaining 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.
Step 6 Set aside the Multi-Lancet 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.
PERFORMING A BLOOD GLUCOSE TEST Note: For Instructions on Alternate Site Testing, refer to pages 39-46. Step 1 Insert a GLUCOCARD Vital Test Strip into the meter. Insert the contact bars into the test Test Strip Port strip port with the reaction site facing up.
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The test strip and flashing blood drop tells you the meter is ready for you to apply a drop of blood to the sample ap- plication tip at the end of the test strip. Step 2 Lance your finger using the Lancing Device. Touch the ‘Apply Blood’...
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IMPORTANT: The meter will start to count down when it detects that blood has been applied. Discard test strip if meter does not start to count down after blood drop is applied. IMPORTANT: The minimum sample volume is 0.5 µL. Smaller samples may not start the meter or can start the meter count down and provide an “E13” error message. Ensure blood completely fills reaction site. Enough Not Blood...
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Step 3 Always record your results in your self-testing logbook along with other information such as insulin dosage, diet, and exercise. The result is automatically stored in memory with the time and date. Step 4 A lancet should be used once. After use, put protective cap back on and remove lancet from lancing device. Dispose lancet in a safe manner as not to cause accidental injury.
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 results from sites other than your fingertip could be significantly different due to blood glucose levels changing rapidly after a meal, insulin, or exercise.
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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 When Testing: • Within two hours after a meal • Within two hours after insulin dosing • Within two hours after physical activity • If you have a history of hypoglycemia, are experiencing low blood sugar, or suffer from hypoglycemic unawareness (you cannot tell when you have low blood glucose) • To confirm your blood glucose level if your AST result is not consistent with how you feel • During times of stress or illness...
Ask your diabetes healthcare professional about recommended testing procedures before 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: Select a soft, fleshy area on the...
Performing a Blood Glucose Test From an Alternate Site Step 1 Insert lancet and cock lancing device. Step 2 a) Insert a test strip into the meter. Insert contact bars into test strip port with reaction site facing up. When the strip is inserted, the meter turns on automatically.
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b) Wait until strip with flashing blood drop appears. (You now have 2 minutes to apply blood drop before meter shuts off). Step 3 a) Vigorously rub the selected area for 5 to 10 seconds until it starts to feel warm to the touch. b) Firmly hold the cocked lancing device against the clean skin for 5 to 10 seconds.
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IMPORTANT • Repeat blood draw if fluid is not a deep red color. • DO NOT TEST BLOOD if sample is smeared, flattened out, or not forming a round drop. Repeat steps starting with Step 3. Step 4 Pick up the meter. Touch the end of the test strip to the blood sample until the reaction site is full. Immediately remove the meter and test strip from the blood drop.
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IMPORTANT • Was the sample a deep red color and free of watery fluid? • Was the drop large enough (at least 0.5 µL)? • Did the reaction site fill with enough blood all at once? IF NOT, REPEAT TEST. Step 5 The meter will count down and display result in 7 seconds. CONSIDER YOUR RESULT. REPEAT ALTERNATE SITE TEST: • IF the blood sample appeared to be diluted with clear fluid. • IF you did not vigorously rub the test site. • IF the blood drop was not large enough to fill the reaction site • IF the test was accidentally marked as a “Control” result. • IF your result was not consistent with how you feel. Any of the above situations can lead to an inaccurate test result. Not Enough Enough...
DOWNLOADING TEST RESULTS TO A COMPUTER We offer a variety of diabetes management software systems to help you download your test results to a computer. For more information on ARKRAY Diabetes Management Software and which software system meets your needs, call ARKRAY Customer Service at 800.566.8558 (24 hours a day, 7...
UNDERSTANDING TEST RESULTS NOTE: The GLUCOCARD Vital Meter is designed to give results at temperatures between 41°F - 113°F (5°C - 45°C) and relative humidity (non- condensing) of 20–80%. Comparing Meter and Laboratory Results Your GLUCOCARD Vital Blood Glucose Meter is referenced to fresh plasma blood measurement. This was performed in a clinical laboratory with glucose standard calibration to the NIST (National Institute of Science and Technology, Gaithersburg, MD, USA).
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Before You Compare Perform a control solution test to make sure your meter and test strips are working correctly. Wait at least 2 hours after a meal or drink (other than water) before doing comparison blood tests. Fasting is essential if venous blood is required for the reference analyzer.
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You may still experience a difference from the laboratory result because blood glucose levels can change over short periods. This can be for a variety of reasons, such as food, exercise, medication, hematocrit, stress, or loss of body fluids. Data analysis should be performed using a clinically acceptable method. Circulating blood glucose fluctuates naturally over time.
Expected Blood Glucose Readings Expected blood glucose levels for people without diabetes: 1, 2 mg/dL Fasting 70-110 mg/dL 2 hours after meals 70-140 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. If this message shows again, contact your healthcare professional immediately! Contact your physician for advice if test results are very high (above 240 mg/dL) and/or you have symptoms of high blood glucose. These symptoms...
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 (below 70 mg/ dL) and/or you have symptoms of low blood glucose. Symptoms of low blood glucose include sweating, shakiness, trembling, blurred vision, hunger, headache, confusion, rapid heartbeat, or tingling or numbness around the mouth or fingertips.
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What This Means for You Frequent blood glucose testing is the best means you have for keeping track of how well you are doing with the factors that affect your diabetes-medication, diet, exercise, and stress management. Blood glucose test results can also tell you whether your diabetes is changing in ways that might require an adjustment to your treatment plan.
Recommendations for better diabetes control • Follow the advice of your healthcare professional. • Follow the exercise and meal plans recommended by your healthcare professional. • Take insulin or diabetes medication at your scheduled times. • Keep in touch with your emotional and physical condition. • Stress or illness can affect diabetes. • Watch for symptoms of hypoglycemia (low blood glucose) and hyperglycemia (high blood glucose). • Always record your test results in your logbook. The logbook assists you in keeping a record of your blood glucose results, along with information on your food intake, exercise, and medication. • Review your logbook of test results with your healthcare professional regularly.
METER MEMORY Marking Results in the Memory You can mark results in the meter memory in two ways. Marking Control Solution Tests You must mark results with the control bottle symbol . Insert test strip into the meter. Hold the Back or Forward button until appears in the upper right corner of the screen.
Marking Other Results You can also mark results with an when you do NOT want to include the result in your 14- and 30-day average. For example, if someone else used your meter, or if you believe the test result is incorrect because you applied blood to the test strip incorrectly, use the exclamation mark to ensure that your 14- and 30-day average includes only those results from testing your own blood that you want included in your average.
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Step 2 Press the Back or Forward button to display the average of tests over the last 14 days. This can include 1 to 250 results, depending on how frequently you test. The number at the top (20n) shows the number of tests that have produced the average.
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If a test has not been performed in the last 14 days the meter will display the 14-day average screen with 3 bars. This means there are no results stored to produce the average. If a test has not been performed in the last 30 days the meter will display the 30-day average screen with 3 bars. Step 4 Press the Back and Forward buttons to recall other results stored in the memory.
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Results marked with when the test was performed are not included in the average. The marked results can be seen when you scroll through the results saved in the memory. The memory mode also displays if the result was marked before using control solution.
(24 hours a day, 7 days a week, USA and Canada only). If the display screen shows , you should be able to clear the error message yourself. Do not send your meter to ARKRAY or your local dealer without authorization from a company representative. Your blood glucose level is less than 20 mg/dL. Repeat the test using a new test strip.
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The battery has been replaced. Check that the time and date are set correctly. A used strip has been inserted or the meter is having difficulty reading the strip. Repeat the test with a new test strip. The battery power is getting low. There is enough power for approximately 100 tests before the battery needs to be replaced.
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The battery power is low. There is only enough power for about 20 more tests. Replace with a new CR2032 battery as soon as possible. The battery power is too low for testing. Replace with a new CR2032 battery.
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Thermometer flashing. The meter and test strips are outside the optimum temperature range of 50°F - 104°F (10°C - 40°C). Make sure your meter and strips are in an environment with a temperature between 50°F - 104°F (10°C - 40°C). Treat test result obtained where the thermometer is flashing with caution. The flashing thermometer will be displayed on all screens during glucose testing until the meter has reached acceptable temperature.
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Corrupted memory. Call Customer Service at 800.566.8558. Not enough blood was added to test strip. Retest with new test strip. Apply at least 0.5µL of blood to sample application tip.
Storage The GLUCOCARD Vital Blood Glucose Meter is designed to be stored within a 32°F - 122°F (0°C - 50°C) temperature range. • Do not leave your meter in extremely hot or cold places such as near a heat source (radiator) or in a car in very hot or cold weather • Do not store or use your meter or test strips where they may be exposed...
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• Never hold the meter or test strips under running water • Do not use or store your meter on or near a strong electro-magnetic field such as a microwave oven, stereo amplifiers, or a mobile phone • Do not store your meter or test strips near bleach or cleaners that contain bleach...
WARNINGS, PRECAUTIONS, AND LIMITATIONS • The GLUCOCARD Vital Blood Glucose Monitoring System is not designed to substitute for pathology laboratory equipment and should not be used for the diagnosis of diabetes. • Severe dehydration (excessive water loss) may cause false low results. If you believe you are suffering from dehydration, consult your healthcare professional immediately. • A red blood cell count (hematocrit) that is very high (above 52%) can give abnormally low results. A very low hematocrit level (below 33%) can give abnormally high results.
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• Do not use the GLUCOCARD Vital system at altitudes in excess of 10,000 ft (3,048 m). • Triglycerides up to 3,300 mg/dL do not significantly affect test results. However, glucose values in specimens beyond this triglycerides level should be interpreted with caution. • Metabolites of icodextrin (maltose, maltotriose, and maltotetraose) do not affect test results. • Use only fresh capillary blood. Do not use serum or plasma or venous whole blood. IMPORTANT: Low or high blood glucose readings can indicate a potentially serious medical condition. If your blood glucose reading is unusually low or high, or you do not feel the way your readings indicate, repeat the test using a new strip. If your result is still not consistent with your symptoms or if your blood glucose result is less than 60 mg/dL or higher than 240 mg/dL, contact your diabetes healthcare professional for advice.
WARRANTY THE GLUCOCARD Vital BLOOD GLUCOSE METER You are a valued customer of ARKRAY. It is important to us that you are completely satisfied with your GLUCOCARD Vital Blood Glucose Meter. ARKRAY warrants that your GLUCOCARD Vital Meter will be free from defects in materials and workmanship for a period of five years from the date of the original purchase.
This warranty does not apply to the performance of the GLUCOCARD Vital meter that has been damaged by accident or has been altered, misused, tampered with, or abused in any way. This warranty only applies to the original purchaser of the meter and/or its agents. THE LANCING DEVICE ARKRAY warrants that the Lancing Device functions effectively for a period of 3 years from the date of purchase.
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RETURNS You must contact ARKRAY Customer Service at 800.566.8558 before returning your meter. If you are located outside of the USA and/or Canada, please contact your ARKRAY distributor. You will be instructed how to return the meter to ARKRAY. Returned meters without this authorization will not be accepted. ARKRAY USA, Inc. Minneapolis, MN 55439 USA TEL 800.566.8558...
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