Arkray Glucocard X-Meter, User Instruction Manual

Page 1: ...USER INSTRUCTION MANUAL ...

Page 2: ...ontrol 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: ... Changing the Battery 10 Meter Set up 13 Basic Rules 13 Audible Beep 16 Year 18 Month Day 19 Hour Minute 20 Test Averaging 21 Data Download Baud Rate 22 Ending Set up 22 Performing a Control Solution Test 23 Troubleshooting Control Solution Test 30 TABLE OF CONTENTS 3 ...

Page 4: ...lagging Test Results 42 Alternate Site Testing AST 44 Understanding Test Results 53 Recalling Results Entering Memory Mode 58 Maintenance 62 Cleaning 62 Storage and Handling 63 Display Screen and Error Messages 64 Product Information 69 Product Specifications 69 Warnings Precautions Limitations 70 Warranty 73 4 ...

Page 5: ...ues This makes it easy to compare the GLUCOCARD X METER and lab results Please read this manual before using the system If you have any questions call Customer Service at 800 566 8558 24 hours a day 7 days a week USA and Canada only Contact your healthcare professional with questions if you are unable to reach Customer Service INTRODUCTION 5 ...

Page 6: ...ro 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 The System Includes Meter Carrying Case User Instruction Manual Quick Reference Guide Self testing Logbook May also include Test Strips Control Solution and Lancing Device and or Lancets Carryi...

Page 7: ...7 UNDERSTANDING THE GLUCOCARD X METER Bottom Battery Compartment Cover Display Connection Terminal Test Strip Port Orange Up Arrow Gray Down Arrow Top Tab ...

Page 8: ...bol 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 Results displayed in mmol L will always have a decimal point Results displayed in mg dL will never have a decimal point 8 Date Explanation of the full display screen ...

Page 9: ...zyme on the test strip This produces a current proportional to the blood glucose level The meter detects the current and converts it into a blood glucose reading Code No F 2 3 or 4 Expiration date F 4 7 Test Strip Bottle Front Back Test Strip Sample Application Tip Apply blood to end of test strip Capillary draw will pull blood to reaction site Code No F 2 3 or 4 Contact Bars Insert this way into ...

Page 10: ...Load a used or weak battery Changing the Battery The GLUCOCARD X METER comes with one lithium battery CR2032 or DL2032 WARNING Keep all batteries out of children s reach If a battery is swallowed consult a doctor immediately NOTE To save battery power the meter turns itself off 3 5 minutes after last use Replace batteries when low battery symbol appears Otherwise inaccurate results could be obtain...

Page 11: ...lace on the underside of the cover Slide the battery out of the cover 3 Load a new battery into the battery cover Place the side down when loading the battery into the cover 4 Make sure the battery is loaded in the proper position Otherwise the preprogrammed times will be reset CAUTION Do not touch the metal contacts inside the battery compartment with your finger or any metal ...

Page 12: ...nd 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 12 ...

Page 13: ...ose test until you have set up the meter Meter set up allows you to adjust the audible beep volume and to set time date test averaging and data download baud rate Basic rules for meter set up Step 1 Enter meter set up by first making sure the meter is turned off METER SET UP Orange Up Arrow Gray Down Arrow ...

Page 14: ...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 Press the Gray Down Arrow button to change a setting within a set up screen menu Note If you need to go back to a setting you must scroll through each set up option You cannot go backwards in set up mode In set up mode the meter will turn off automatically after 3...

Page 15: ...ar 2 Setting the Data Download Baud Rate 8 Orange Arrow Orange Arrow Orange Arrow Orange Arrow Orange Arrow Orange Arrow Return Setting the Hour 5 Setting the Day 4 Setting the Minute 6 Setting the Month 3 Setting Test Averaging 7 Orange Arrow Orange Arrow Orange Arrow Orange Arrow ...

Page 16: ...e meter is turned on but you do not use it for several minutes Meter will beep and automatically shut off You go into Memory Mode Make sure the meter is off 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 Press the Orange Up Arrow button The screen will display bUZ and th...

Page 17: ...igh OFF no sound etc A beep sounds at the set volume at each step If OFF is set the audible beep mute Off symbol lights up in the upper right of the screen After you select the beep volume press the Orange Up Arrow button to confirm the setting The screen changes to the year set up screen Beep Beep Beep 1 1 1 1 ...

Page 18: ...iddle of the screen All four digits of the currently set year appear at the bottom of the screen The last two digits will blink Press the Gray Down Arrow to change the last two digits of the year to the correct year After you set the year press the Orange Up Arrow button to confirm the setting The screen changes to the month set up screen 1 2 3 ...

Page 19: ... 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 After you set the day press the Orange Up Arrow button to confirm the setting The screen changes to the hour set up screen 1 2 3 4 ...

Page 20: ...range 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 After you set the minute press the Orange Up Arrow button to confirm the setting The screen changes to the test averaging set up screen 1 2 3 4 ...

Page 21: ...veraging choices oFF not displayed 14 14 day average or 30 30 day average AVE appears near the middle of the screen If you select either 14 day or 30 day averaging your average test result will appear when you recall results from memory See page 58 After you set test averaging press the Orange Up Arrow button to confirm the setting The display changes to the data download baud rate set up screen ...

Page 22: ...p 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 is displayed This confirms all settings and turns the meter off The meter will turn ...

Page 23: ...est 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 PERFORM A CONTROL SOLUTION TEST ...

Page 24: ...ow or are not consistent with clinical symptoms The test strip bottle has been left open or has been exposed to temperatures below 34 F 1 C or above 86 F 30 C or humidity levels above 80 To check your technique When the GLUCOCARD X METER has been dropped or stored below 32 F 0 C or above 122 F 50 C Important Use only with GLUCOCARD X METER and GLUCOCARD X SENSOR Blood Glucose Test Strips GLUCOCARD...

Page 25: ... bottle Use the control solution within 3 months of first opening It is recommended that you write the date of opening on the control solution bottle label OPEN DATE as a reminder to dispose of the opened solution after 3 months Always replace the cap immediately after use GLUCOCARD X METER CONTROL is not a cleaning solution Do not clean your GLUCOCARD X METER with GLUCOCARD X METER CONTROL Do not...

Page 26: ... page 8 Then the code number F 2 F 3 or F 4 will appear and will alternate with the Apply Blood symbol Make sure that the code number on the screen matches the code number on the test strip bottle If screen code does not match the test strip code use a new test strip If code still does not match use a new bottle of test strips or call Customer Service at 800 566 8558 24 hours a day 7 days a week U...

Page 27: ...range Up Arrow button to enter the control mode You 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: ...ip DO NOT put control solution on top of the test strip The test strip will draw up the solution and the meter will beep The meter will begin to count down Step 4 In 5 seconds the meter will beep again and display the control solution result Compare the result to the range printed on the test strip bottle Make sure the result is within the acceptable range If the result falls within this range the...

Page 29: ...page 42 for additional information Step 5 Remove test strip Dispose of the used test strip Control solutions are available in three 3 levels Low L Normal N and High H 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 8...

Page 30: ...lution mode the screen with the result CONT should appear on screen Have the test strips and or Make sure that test strips and control control solution expired solutions are not past expiration date This date is shown on bottle Were control solutions at room If not retest with new bottle temperature 72 82 F 22 28 C of control solution or warm up cool when used down to room temperature Does the cod...

Page 31: ...llow 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 new bottle of test strips Was the bottle cap replaced immediately after removing a test strip Is the meter damaged If yes contact Customer Service at Does it show an error code 800 566 8558 ...

Page 32: ... 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 Contact your diabetes healthcare professional if you cannot reach Customer Service ...

Page 33: ...missing or damaged BLOOD GLUCOSE TESTING Multilet 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 Step 1 Pull the removable cap to remove it ...

Page 34: ...34 Step 3 Twist off the protective cap Step 4 Attach the removable cap Step 2 Insert a new unused lancet into the Holder until it stops Holder ...

Page 35: ...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 1 2 3 4 5 6 7 Deeper Level indications ...

Page 36: ...oroughly 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 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 ...

Page 37: ...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 NOTE A lancet should only be used once Dispose of used lancet in a safe manner so as not to cause accidental injury WARNING DO NOT share used lancets with another person To prevent possible infection a used lancet should not be touched by another person ...

Page 38: ...ip as shown in diagram A beep will sound and the meter will turn on automatically Verify that all symbols appear on the screen 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: ... number does not match the meter may give a false reading If code does not match use a new strip If code still does not match use a new bottle of test strips or call Customer Service at 800 566 8558 24 hours a day 7 days a week USA and Canada only Verify that the date and time appear on the screen and are correct If date and time are not correct reset them see Meter Set up page 13 Code No F 2 3 or...

Page 40: ...curate result If meter does not start after adding the first blood drop you may apply a second drop within 10 seconds of the first drop Discard strip if meter does not start to count down after second blood drop is applied Important Ensure that enough blood is applied to fill the check window and it turns red When the check window is filled with blood and a beep sounds remove the tip of the test s...

Page 41: ...fter 5 seconds a beep sounds and the test result and date time are shown Results will be shown in units of mg dL Record result in your logbook Step 5 When the test is done pull out test strip Dispose of used test strip The meter shuts off automatically when you remove the test strip Remove lancet from lancing device Dispose used lancet according to local guidelines mg dL ...

Page 42: ...strip from the meter DEL Mark a test result with DEL if you feel the result is incorrect or the test procedure was not followed correctly The result will be store in memory but will not be used for Test Averaging See page 21 CONT Mark control solution test results with CONT See page 23 Step 1 Wait for test result to be displayed Be sure test strip is still in meter Press the Orange Up Arrow button...

Page 43: ...Results collected in Control Mode automatically show CONT when the result is first displayed and when it is reviewed in Memory NOTE The following are NOT included in the 14 day or 30 day test averages Results collected in Control Solution mode and therefore marked CONT Results marked CONT or DEL by you Results obtained when date and time have not been set 1 2 mg dL mg dL mg dL ...

Page 44: ...ly different due to blood glucose levels changing rapidly 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 d...

Page 45: ...se Fingertip 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 glucose 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 st...

Page 46: ...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 palm forearm or upper arm that is free of visible veins moles and hair 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 l...

Page 47: ...ncing Device To order an AST Lancing Kit containing the lancing device lancets and instructions please call 800 566 8558 Step 1 Insert lancet and cock lancing device Performing a Blood Glucose Test From an Alternate Site ...

Page 48: ...test strip as shown in 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 displayed on the screen matches the code number on the bottle of test strips used Code No F 2 3 or 4 Expiration date F 4 7 ...

Page 49: ...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: ...device Step 4 Pick up the meter and 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 IMPORTANT Repeat blood draw if fluid is clear IMPORTANT Insert strip VERTICALLY into blood sample NOT at an angle IMPORTANT If it takes longer than 20 SECONDS to obtain a blood sample and to touch the strip to the bl...

Page 51: ...d 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 IF more than 20 seconds elapsed from sample collection to measurement evaporation of the blood sample may cause a test result that is higher than the actual value I...

Page 52: ...esults 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 7 Remove the test strip and dispose of it in accordance with local guidelines or as directed by your healthcare professional The meter shuts off automatically when the test strip is removed ...

Page 53: ...er and test strips are working correctly Wait at least 2 hours after a meal or drink other than water before doing a comparison If the lab test needs venous blood you must fast before giving a blood sample When at the lab Blood samples for both tests must be taken and tested within 15 minutes of each other Collect blood for the lab test with an approved preservative EDTA heparin and mono iodoaceti...

Page 54: ...est strip results also may vary due to medications or to low or high hematocrit Analyze data with a clinically acceptable method Your test results will vary over time For example results may vary due to 1 The time of day the test was done 2 The food you eat 3 Activities you do 4 The insulin and other medications you take If your readings do not seem correct repeat the test Contact your healthcare ...

Page 55: ...i 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 include dry mouth thirst frequent urination nausea vomiting blurred vision sleepiness or abdominal pain Symptoms will vary person to person Y...

Page 56: ...ting shakiness trembling blurred vision hunger headache confusion rapid heartbeat or tingling or numbness around the mouth or fingertips Symptoms will vary person to person You may have one or all of these symptoms Recent Diabetes Findings In 1993 the National Institutes of Health reported a study of people with Type 1 diabetes This study was called the Diabetes Control and Complications Trial DCC...

Page 57: ...essional to decide when and how often to test This will depend on such things as age type of diabetes and medications It is important to make testing part of your daily routine References 1 Burtis C A Ashwood E R eds Tietz Textbook of Clinical Chemistry 2nd Edition Philadelphia W B Saunders 1994 2190 2 Krall L P and Beaser R S Joslin Diabetes Manual Philadelphia Lea and Fibiger 1989 138 3 Krall L ...

Page 58: ...emory remove test strip from meter and make sure meter is turned off Step 1 Press the Orange Up Arrow button for 2 seconds A beep sounds and the test meter turns on and shows all screen symbols The meter next shows the year date and time After 2 seconds either the Test Average or the most recent test result will appear RECALLING RESULTS ENTERING MEMORY MODE Orange Up Arrow Gray Down Arrow ...

Page 59: ... will briefly flash the number 1 at the bottom of the screen Then the most recent test result appears with the date and time of the test MEM will display at the top of the screen This shows it is a stored result Step 2 Press the Orange Up Arrow button to scroll through memory Press and hold the Orange Up Arrow button to move through the results quickly Press the Gray Down Arrow button to move back...

Page 60: ...he Gray Down Arrow button for 2 seconds to exit Memory and turn off the meter You can exit Memory in this way at any time when recalling results Note If no tests have been performed or all test results have been deleted the current date and time appear first then End appears If 3 minutes elapse before either the upper or lower button is pressed a beep sounds and the test meter turns off automatica...

Page 61: ...s the Gray Down Arrow button for 5 seconds End appears again All test results have now been deleted Step 3 Press the Gray Down Arrow button for 2 seconds to turn off test meter Note To get to End of memory results quickly turn off meter then enter Memory Mode Next press the Gray Down Arrow button to go backwards in the memory list to reach End 1 2 3 Note Deleted test results cannot be recovered ...

Page 62: ... 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 Do not clean inside battery compartment MAINTENANCE ...

Page 63: ...at has been dropped into water or if any water has entered the meter Even if you dry it correct test results may not be obtained and malfunction may result Do not store meter or test strips near bleach or cleaners that contain bleach Do not drop meter This can damage the meter If you do drop meter check it with a control solution test Do not take the meter apart Do not leave test strips out of the...

Page 64: ...r Service Do not send your meter to ARKRAY or your local dealer without first calling to get approval to do so If any part of the display screen is missing when the meter is turned on call Customer Service at 800 566 8558 If you have technical problems or questions please call Customer Service at 800 566 8558 24 hours a day 7 days a week USA and Canada only Contact your healthcare professional wit...

Page 65: ...s more than 600 mg dL Repeat test with new test strip If this message shows again contact your healthcare professional immediately Battery power is too low for testing Replace batteries immediately Results may not be accurate when testing with low battery symbol on Thermometer symbol The meter temperature is outside acceptable range of 50 F 104 F 10 C 40 C Allow the meter and test strips to warm u...

Page 66: ...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 Contact Customer Service at 800 566 8558 The meter is faulty Contact Customer Service at 800 566 8558 ...

Page 67: ...ode Number This shows the code number currently in the meter The number on the screen must match the number on the test strip bottle If screen code does not match the test strip code use a new test strip If code still does not match use a new bottle of test strips or call Customer Service at 800 566 8558 Apply Blood Sample The Apply Blood symbol flashes alternately with strip code number F 2 F 3 o...

Page 68: ...een This shows the meter is ready for you to apply control solution Test Result The meter shows results between 20 and 600 mg dL Test Average has no results stored Test Averaging has been set to 14 day or 30 day but there are no results stored yet in memory mg dL For errors not listed do not attempt to use meter Contact Customer Service at 800 566 8558 ...

Page 69: ...e Dinucleotide Burkholderia sourced Power Source One 3 volt lithium battery CR2032 or DL2032 Battery Life Approximately 2 000 tests Screen Type Liquid Crystal Display LCD Memory 360 results with time date stamp Average 14 day or 30 day averaging Automatic Shut Off 3 5 minutes after last user action Size 2 x 3 9 x 0 5 Weight 1 6 oz with battery Operating Ranges 50 F 104 F 10 C 40 C 20 80 relative h...

Page 70: ... may thus mask hypoglycemia Icodextrin and its metabolites maltose maltotriose and maltotetraose will cause falsely higher results Do not use during a xylose absorption test for diagnostic evaluation of malabsorption as this will cause falsely higher results Infusion of galactose will cause falsely higher results EDTA heparin and mono iodoacetic acid samples of blood may be used Do not use other p...

Page 71: ...s experiencing a hyperglycemic hyperosmolar state with or without ketosis Critically ill patients should not be tested with blood glucose meters Triglycerides up to 3 000 mg dL do not significantly affect test results However glucose values in specimens beyond this triglycerides level should be interpreted with caution Normal endogenous within body natural levels of uric acid ascorbate vitamin C b...

Page 72: ...Do not use the GLUCOCARD X METER to test neonates It has not been validated for neonatal use Always insert the test strip into the meter first then prick the finger Not doing so may result in an E 6 appearing on the display or a test result that is higher than the actual value Do not use at altitudes higher than 10 000 ft 3 048 m Interference testing demonstrated an 18 bias when 10 mg dL mannose w...

Page 73: ...n 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 merchantability or fitness for any purpose other than stated herein This warranty does not apply to the performance of the GLUCOCARD X METER that has been...

Page 74: ...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 P N 7250 01 Rev 3 08 TEL 800 566 8558 FAX 952 646 3110 www arkrayusa com 2007 ARKRAY Inc ...