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Arkray Glucocard Vital, User Instruction Manual

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Arkray Glucocard Vital User Instruction Manual Download Page 47

47

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). The results you get from your meter may differ from 

the tightly controlled clinical laboratory result. This is due to normal variation. 

To make an accurate comparison between the meter and laboratory results, 

follow the guidelines below.

UNDERSTANDING TEST RESULTS

Summary of Contents for Glucocard Vital

Page 1: ...User Instruction Manual Read this User Instruction Manual carefully before you start testing ...

Page 2: ...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 Food and Drug Administration and the Health Industry Manufacturers Association ...

Page 3: ...Display Screen 11 GLUCOCARD Vital Test Strips 12 Testing with GLUCOCARD Vital test strips 13 Important Test Strip Information 14 Changing the Battery 15 Meter Set Up 18 Setting the Time and Date 18 Using Assure Dose Control Solution 22 Recommended Use of Control Solution 23 Performing a Control Solution Test 24 Comparing Control Solution Results 28 TABLE OF CONTENTS ...

Page 4: ... Important Information About Alternate Site Testing AST 39 Preparing to Test Your Blood Glucose From an Alternate Site 41 Performing a Blood Glucose Test From an Alternate Site 42 Downloading Test Results to a Computer 46 Understanding Test results 47 Comparing Meter and Laboratory Results 47 Expected Blood Glucose Readings 50 High Blood Glucose Readings 50 Low Blood Glucose Readings 51 ...

Page 5: ...sts 54 Marking Other Results 55 Recalling Results 55 Display Screen Images 59 Caring For Your GLUCOCARD Vital Blood Glucose Meter 64 Cleaning the Meter 64 Storage 64 Specifications 66 Warnings Precautions and Limitations 67 Warranty 69 The GLUCOCARD Vital Blood Glucose Meter 69 The Lancing Device 70 ...

Page 6: ... diabetes is changing in ways that affect your treatment plan 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 7 days a week USA and Canada onl...

Page 7: ...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 It is not intended for the diagnosis of or screening for Diabetes Mellitus and is not intended for use on neonates ...

Page 8: ... 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 ...

Page 9: ...COCARD 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 THE GLUCOCARD Vital SYSTEM ...

Page 10: ...10 Front Back Display Screen Back Button On Off Button Forward Button Battery Compartment Cover Test Strip Port UNDERSTANDING THE GLUCOCARD Vital BLOOD GLUCOSE METER Data Connection Port ...

Page 11: ...y Unit of Measurement Temperature Warning Test Strip Apply Blood Insert Remove Test Strip Memory Mode Error Code Result Warning Main Display Test Strip Code Test Countdown Test Results Error Codes If any part of the display screen is missing when the meter is turned on call Customer Service at 800 566 8558 ...

Page 12: ...le application tip the sample is drawn into the test strip reaction site The glucose in the blood reacts with the enzyme on the test strip This reaction produces a current proportional to the amount of glucose in the blood The meter detects the current and converts it into a blood glucose reading TEST STRIP Reaction Site Test Strip Contact Bars Sample Application Tip apply blood to end of test str...

Page 13: ...reeze 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 The GLUCOCARD Vital Blood Glucose Monitoring System works with the GLUCOCARD Vital Test Strips TESTING WITH GLUCOCARD Vital TEST STRIPS ...

Page 14: ...e 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 ...

Page 15: ...nds to change the battery or if the battery is dead before changing it the time and date settings may need to be reset The first time the meter is turned on after changing the battery you may see a display screen message E00 This means you should check that the time and date are correct See pages 18 21 for detailed instructions on changing the time and date Changing the Battery The GLUCOCARD Vital...

Page 16: ...u need to replace the battery If the is flashing there is only enough power for about 20 tests Replace the battery as soon as possible When the battery has run out the meter will not work CR 2032 Li Mn 3V WARNING Keep all batteries out of children s reach If a battery is swallowed consult a doctor immediately ...

Page 17: ...ur 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 Avoid the use of sharp objects that may damage the meter Step 4 Insert the new battery The on the battery should be facing up Step 5 Replace the battery cover ...

Page 18: ...national 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 any part of the display screen is missing see page 11 call Customer Service The meter then displays the time date unit of measurement and the insert test strip symbol Step 2 Enter se...

Page 19: ...ss the On Off button to select the time format The date format then appears on the display Month Day Format Day Month 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 To change format press either the Back or Forward button Press the On Off button to select the date format The hour setting then fla...

Page 20: ...te appears Hold the Back or Forward button down to scroll through quickly When the correct minute is displayed press the On Off button The month setting then flashes on the display Step 7 Set the month If day month format is selected then Step 7 will set day Press and release the Back or Forward button until the correct month appears Hold the Back or Forward button down to scroll through quickly W...

Page 21: ...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 flashes on the display Step 9 Set the year Press and release the Back or Forward button until the correct year appears Hold the Back or Forward button down to scroll through quickly ...

Page 22: ...ose 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 Call your local supplier or pharmacy if you need to order control solution If they do not stock the product please call Order Services at 800 566 8558 USA and Canada only USING A...

Page 23: ... 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 ...

Page 24: ...ol 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 As soon as you have used the control solution put the cap back on the bottle Always use the control solution within 90 days 3 months of first opening ...

Page 25: ... bottom of test strip port as a guide Align test strip as shown in diagram When the strip is inserted the meter turns on automatically The full screen appears briefly If any part of the display screen is missing see page 11 call Customer Service The screen then displays the test strip symbol and flashing blood drop Contact Bars Test Strip Port Reaction Site Sample Application Tip ...

Page 26: ... remains displayed on the screen If you do not do this the control solution result will NOT be valid will prompt you to add control solution Step 3 Mix control solution by gently inverting control solution bottle several times Remove the cap from the control solution bottle Place cap on flat surface Squeeze the bottle and discard the first drop Apply the second drop to the top of the cap ...

Page 27: ...ion level that you are using If the result falls within the range on the bottle the meter is working correctly Step 6 Remove the test strip The meter shuts off automatically when the test strip is removed Dispose of the test strip immediately 06146A 2010 10 80 120 200 300 Control Solution Range mg dL Rango de la solución de control Normal High Step 4 Bring meter and test strip to the drop Test str...

Page 28: ...trol 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 Cont...

Page 29: ...sult 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 If you are unable to resolve the problem call Customer Service at 800 566 8558 24 hours a day 7 days a week USA and Canada only ...

Page 30: ... Lancet Device body Lancing Button Adjustment dial Band hooks Strap hole Special band Protective cap Groove of special band optional Lancet Disposal and set lever Removable cap Multi Lancet Device body Lancing Button Adjustment dial Band hooks Strap hole Special band Protective cap Groove of special band optional Inserting a Lancet Step 1 Pull the removable cap to remove it Optional Remove special...

Page 31: ... or damaged A lancet should only be used once Dispose of used lancet in a safe manner so as not to cause accidental injury WARNING Lancing devices and lancets are for single patient use only DO NOT share used lancets with another person To prevent possible infection a used lancet should not be touched by another person ...

Page 32: ...in 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 1 2 3 4 5 6 7 Deeper Level indications ...

Page 33: ...rate readings Step 2 Let the arm hang down for 10 to 15 seconds Holding the arm below the heart and massaging the wrist palm and finger makes it easier to obtain a blood drop Step 3 Choose a site on the side of a fingertip to minimize pain Step 4 Press the Disposal and set lever in the direction of the arrow until click is heard Step 5 Press the removable cap to the side of the fingertip Press the...

Page 34: ...atient use only Protective Cap Step 1 Place the lancet protective cap on a hard surface and remove the removable cap Step 2 Push the lancet into the protective cap Step 3 Press the disposal and set lever forward to eject the used lancet into an appropriate container Disposing the Lancet DO NOT share used lancets with another person To prevent possible infection a used lancet should not be touched ...

Page 35: ... 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 Sample Application Tip Reaction Site Contact Bars Test Strip Port When the test strip is inserted the meter turns on automatically If any part of the display screen is missing see page 11 call Customer Service PERFORMING A BLOOD GLUCOSE TEST ...

Page 36: ...hing Step 2 Lance your finger using the Lancing Device Touch the sample application tip at the end of the strip to the blood drop on your finger The capillary action will pull the blood to the reaction site Add enough blood to the end of the test strip to completely fill reaction site DO NOT add blood to the top of the test strip You may receive an abnormal high result CORRECT INCORRECT ...

Page 37: ...sage Ensure blood completely fills reaction site 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 Displaying the Result The meter will count down The result is displayed in 7 seconds Enough Blood Not Enough Blood Too Much Blood ...

Page 38: ... 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 Remove the used test strip and dispose of it carefully The meter shuts off automatically when the test strip is removed ...

Page 39: ...ly after a meal insulin or exercise Consult with your diabetes healthcare professional prior to testing from a site other than your fingertips Results obtained from sites other than the fingertip may differ significantly as is the case with all blood glucose monitoring systems Rapidly changing results are likely to occur after eating Insulin dosing and physical activity are shown in the fingertip ...

Page 40: ...ffer 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 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 ...

Page 41: ... instead Preparing to Test Your Blood Glucose From an Alternate Site Choose a Site Select a soft fleshy area on the palm that is free of visible veins and moles and away from bone Wash the area with warm soapy water Rinse and dry completely If you use alcohol wipes to cleanse the site make sure the area is dry before lancing the site Prepare Your Lancing Device To order an AST Lancing Kit containi...

Page 42: ...When the strip is inserted the meter turns on automatically Make sure all symbols appear on the screen see page 11 Performing a Blood Glucose Test From an Alternate Site Step 1 Insert lancet and cock lancing device Sample Application Tip Reaction Site Contact Bars Test Strip Port IMPORTANT Insert into me ter this way ...

Page 43: ...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 c Press the release button on the lancing device to lance the skin Continue to hold the lancing device firmly against the skin until a 0 5 µL blood drop forms d Once a large enough drop of blood has formed remove the lancing device ...

Page 44: ...mple until the reaction site is full Immediately remove the meter and test strip from the blood drop 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 ...

Page 45: ...ot 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 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...

Page 46: ... it carefully 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 injury The meter shuts off automatically when the test strip is removed 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 in...

Page 47: ...o 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 The results you get from your meter may differ from the tightly controlled clinical laboratory result This is due to normal variation To make an accurate comparison between the meter and laboratory results follow...

Page 48: ...eference analyzer When at the Laboratory The capillary samples for both tests must be taken and tested within 15 minutes of each other The sample must be collected with anticoagulant appropriate to the laboratory analyzer The recommended technique should be followed Analysis should be performed following the manufacturer s guidelines ALWAYS wash hands in warm soapy water Rinse and dry them thoroug...

Page 49: ...linically acceptable method Circulating blood glucose fluctuates naturally over time Test results can vary over time and can be affected by several factors Some of these include but are not limited to the following 1 time of day the test was performed 2 food eaten 3 activities performed 4 insulin and other medications taken If your result does not seem correct after testing your blood repeat the t...

Page 50: ...ws again contact your healthcare professional immediately Contact your physician for advice if test results are very high3 above 240 mg dL and or you have symptoms of high blood glucose These symptoms include dry mouth thirst frequent urination nausea vomiting blurred vision sleepiness or abdominal pain Symptoms will vary from person to person You may have one or all of these symptoms mg dL Fastin...

Page 51: ...bling blurred vision hunger headache confusion rapid heartbeat or tingling or numbness around the mouth or fingertips Symptoms will vary from person to person You may have one or all of these symptoms Diabetes Findings In 1993 the National Institute of Health concluded an extensive long term study of people with Type 1 diabetes This study called the Diabetes Control and Complications Trial DCCT fo...

Page 52: ...s that might require an adjustment to your treatment plan Always consult your healthcare professional before making any changes in managing your diabetes Frequency of Testing How often you need to test your blood glucose will vary according to your age the type of diabetes you have the medications you are taking and your physical and emotional health Your healthcare professional will guide you Aft...

Page 53: ... 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 A...

Page 54: ... do not mark control solution tests before applying control solution to the test strip the results may not be accurate and control solution test results will be included in your test result averages The meter does not use results marked when it calculates the 14 and 30 day average This ensures that your 14 and 30 day average includes only results from testing your own blood To mark a result press ...

Page 55: ...o ensure that your 14 and 30 day average includes only those results from testing your own blood that you want included in your average To mark a result with press the Back or Forward button AFTER the meter displays the test result Recalling Results Step 1 Press the On Off button to turn on the meter Then press the Back or Forward button Do not insert a test strip to turn on the meter is displayed...

Page 56: ...have produced the average is displayed when the average is shown Step 3 Press the Back or Forward button again to display the 30 day average The greater the frequency of testing the higher this number will be is displayed when the average is shown If no results are stored or you are using the meter for the first time the meter will display 3 bars Displaying the average 14 day Displaying the aver a...

Page 57: ... 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 Pressing the Forward button after the average displays the oldest test in memory Pressing the Back button after the average displays the second most recent test in memory The meter displays the time each test was recorded in the upper left corner The ...

Page 58: ...d 30 day average If the thermometer symbol is flashing when you perform a test the thermometer symbol will be displayed in the memory with the result These results will not be included in the meter averages NOTE Results that appear as LO are included as 20 mg dL in the glucose averages Re sults that appear HI are included as 600 mg dL in the glucose averages Step 5 Press the On Off button to retur...

Page 59: ...e 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 If this message appears again contact your healthcare professional immediately Your blood glucose level is more than 600 mg dL Repeat the test using a new test strip If t...

Page 60: ... are set correctly The battery power is getting low There is enough power for approximately 100 tests before the battery needs to be replaced A used strip has been inserted or the meter is having difficulty reading the strip Repeat the test with a new test strip ...

Page 61: ...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 ...

Page 62: ...rips 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 Readings obtained wit...

Page 63: ...63 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 ...

Page 64: ...od or control solution should come into contact with the meter if the instructions are followed correctly 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 str...

Page 65: ...s 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 ...

Page 66: ...e Aspergillus niger sourced Power Source Single replacement 3V CR2032 battery Battery Life More than 2 000 tests at 4 tests per day Display Type Liquid Crystal Display LCD Memory 250 results with 14 and 30 day averaging Automatic Shut off 2 minutes after last user action Size Approx 3 x 2 x 80 mm x 46 mm x 16 mm Weight Approx 1 oz 39 g Optimum Operating Ranges 50 F 104 F 10 C 40 C Relative Humidit...

Page 67: ... 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 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 Patients undergoing oxygen ther...

Page 68: ...is less than 60 mg dL or higher than 240 mg dL contact your diabetes healthcare professional for advice 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 malt...

Page 69: ...workmanship for a period of five years from the date of the original purchase If during this time the meter does not work properly because of a defect in materials or workmanship ARKRAY agrees to replace or repair free of charge any and all parts proven to be defective and subject to warranty This warranty is in lieu of all other warranties expressed or implied including any implied warranty of me...

Page 70: ...hould not be returned to your supplier or to ARKRAY unless you receive an authorization number to do so 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 ...

Page 71: ...71 NOTES ...

Page 72: ...8 FAX 952 646 3110 www arkrayusa com 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 ...

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