Arkray GLUCOCARD 01-mini User Instruction Manual Download

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User

Instruction

Manual

Summary of Contents for GLUCOCARD 01-mini

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: ...ter 7 Changing the Battery 10 Changing Colored Faceplates 13 Meter Set up 15 Basic Rules 17 Audible Beep 18 Year 20 Month Day 21 Hour Minute 22 Test Average Display 23 Ending Set up 24 Performing a Control Solution Test 25 Troubleshooting Control Solution Test 32 TABLE OF CONTENTS 3 ...

Page 4: ...lagging Test Results 44 Alternate Site Testing AST 46 Understanding Test Results 55 Recalling Results Entering Memory Mode 60 Maintenance 64 Cleaning 64 Storage and Handling 65 Display Screen and Error Messages 66 Product Information 71 Product Specifications 71 Warnings Precautions Limitations 72 Warranty 75 4 ...

Page 5: ...ma values This makes it easy to compare the GLUCOCARD 01 mini Blood Glucose 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: ...e 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 The System Includes Meter Carrying Case Interchangeable Colored Faceplates User Instruction Manual Quick Reference Guide Self testing Logbook Lancing Device and Lancets...

Page 7: ...7 UNDERSTANDING THE GLUCOCARD 01 mini BLOOD GLUCOSE METER Bottom Test Strip Port Top Display Button 1 Battery Cover Strap Hole Button 2 ...

Page 8: ...l Appears when the meter is ready for testing Unit of Measurement Thermometer symbol Sound mute symbol 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 Explanation of the full dis...

Page 9: ... 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 9 0018 F 4 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 ...

Page 10: ... or weak battery Changing the Battery The GLUCOCARD 01 mini blood glucose 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 ...

Page 11: ...to the right a and remove it b 4 Load a new battery into the battery cover Place the side upward CAUTION 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 a b ...

Page 12: ... the clock setting has been deleted SET will appear on the screen If SET appears set the time and date If you do not set the time and date all subsequent results will be stored with a test date and time of January 1 2008 12 00 a m ...

Page 13: ...tes You can attach the color of your choice 1 Pressing on the dotted area shown on the right with your thumb slide the cover in the direction of the arrow 2 Turn your meter over Hold the meter and pull down the display cover until it comes off 3 Remove the color faceplate from the display cover Display cover ...

Page 14: ...e tabs on the display cover into the corresponding slot on your meter 6 Press forcefully on the dotted area shown on the right to snap the display cover back into your meter 7 Slide the display cover back to its original position Make sure the display cover is snapped closed Color faceplate 7 6 6 14 ...

Page 15: ...et time date and test averaging Before using the GLUCOCARD 01 mini 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 Default Settings Audible Beep Volume High 3 Average Off 15 ...

Page 16: ...o to SET 1 Make sure the meter is off 2 Hold down both the buttons for 5 seconds To change the setting press the button NOTE The meter turns itself off if no buttons are pressed for 3 minutes Your changes will have been stored Review the settings for confirmation in the SET mode Your new settings will be saved when you reach the End screen and To change the setting press the button To turn off the...

Page 17: ...you press the button the set up screen changes in the order shown in the diagram to the left Press the 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 minutes of non use Basic rules for meter set up Step 1 Tur...

Page 18: ... the result is displayed The 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 and 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 button The screen will display bEP and the current beep settin...

Page 19: ...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 button to confirm the setting The screen changes to the year set up screen Beep Beep Beep 4 1 2 3 ...

Page 20: ... appears in the middle of the screen The last two digits of the currently set year appear at the bottom of the screen and blink Press the button to change the last two digits of the year to the correct year After you set the year press the button to confirm the setting The screen changes to the month set up screen audible beep ...

Page 21: ...er you set the month press the button to confirm the setting The screen changes to the day set up screen Setting the Day Press the button to change the day After you set the day press the button to confirm the setting The screen changes to the hour set up screen ...

Page 22: ...the hour press the button to confirm the setting The screen changes to the minute set up screen Setting the Minute Press the button to change the minute After you set the minute press the button to confirm the setting The screen changes to the test averaging set up screen ...

Page 23: ...symbol control solution flag or delete flag Setting Test Average Display Press the button to cycle through the test averaging choices oFF not displayed 7 7 day average 14 14 day average or 30 30 day average If you select either 7 day 14 day or 30 day averaging your average test result will appear when you recall results from memory See page 60 After you set test averaging press the button to confi...

Page 24: ...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 button while End is displayed This confirms all settings and turns the meter off The meter will turn off automatically 3 minutes after End is displayed Power OFF Beep ...

Page 25: ...t 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 26: ...r to be abnormally high or low 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 01 mini blood glucose meter has been dropped or stored below 32 F 0 C or above 122 F 50 C Important Use only with GLUCOCARD 01 mini blood gluc...

Page 27: ... the expiration date printed on 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 01 CONTROL is not a cleaning solution Do not clean your GLUCOCARD 01 mini blood gluco...

Page 28: ...he last result will then appear Then the Apply Blood Symbol will alternate with the code number F 2 F 3 or F 4 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 ...

Page 29: ...29 Step 2 Press the button to enter the control mode You will see CONT on the upper left of the screen A CONT flag can also be attached when results are shown on screen ...

Page 30: ...the solution and the meter will beep DO NOT put control solution on top of the test strip The meter will begin to count down Step 4 In 7 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 meter and test strip are worki...

Page 31: ...page 44 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 32: ...n with the result CONT should appear on screen A CONT flag can also be attached when results are shown 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 warm up cool temperature 72 82 F 22 28 C down to room temperature when used Does the code...

Page 33: ...llow the Reread Performing a Control procedure correctly Solution Test pages 25 31 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 34: ... 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 35: ...s 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 36: ...36 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 37: ...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 38: ...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 39: ...m 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 40: ...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 41: ...ches the code number printed on the bottle If the code 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 Code No F 2 3 or 4 Expiration date F 4 9 0018 F 4 Apply Blood Symbol Code Number ...

Page 42: ...d The meter will begin to count down Do not add blood on top of the test strip as you may receive an inaccurate result 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 strip from your finger If there is not enough blood E 7 or Lo will be displayed Filled Not Filled Not Fil...

Page 43: ... 7 After 7 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 test strip The meter shuts off automatically when you remove the test strip Remove lancet from Multi Lancet Device Dispose used lancet according to local guidelines ...

Page 44: ...played Be sure test strip is still in meter Press the button to cycle through the options Attach To Pre meal flag Blood glucose result obtained before eating Post meal flag Control test flag Delete flag Blood glucose result obtained after eating Control test result These results are not part of your result averages see page 23 Blood glucose result that is clearly incorrect The delete flag sets inc...

Page 45: ...45 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 ...

Page 46: ...nd palm may result in differences in blood glucose measurements between these sites Differences in glucose concentrations may be observed after eating taking insulin medication or exercise and are typically shown more quickly in the fingertip than in the palm Consult with your diabetes healthcare professional prior to testing from a site other than your fingertips Consider Alternate Site Testing W...

Page 47: ... 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 when operating machinery or driving a car as fingertip testing is usually the preferred method of testing under these circumstances If bruising occ...

Page 48: ...hoose 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 ...

Page 49: ...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 50: ...ill 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 50 Code No F 2 3 or 4 Expiration date F 4 9 0018 F 4 Step 2 Remove test strip from the bottle Immediately replace the bottle cap tightly Insert test strip as shown in diagram A beep will sound and the meter will turn on automatically Verify that all symbols a...

Page 51: ...51 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 52: ... the lancing 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 If it takes longer than 20 SECONDS to obtain a blood sample and any sample has been applied to the strip discard strip and use a new strip before p...

Page 53: ...ed 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 ...

Page 54: ...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 55: ...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 Heparin samples of blood may be used See te...

Page 56: ...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 57: ...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 58: ...weating 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 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 DCCT It...

Page 59: ...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 60: ...sult each time you add a new result Before using the memory remove test strip from meter and make sure meter is turned off Step 1 Press the button for 2 seconds A beep sounds and the test meter turns on and shows all screen symbols After two seconds either the Test Average or the most recent test result will appear RECALLING RESULTS ENTERING MEMORY MODE ...

Page 61: ...flash the number 1 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 button to scroll through memory Press and hold the button to move through the results quickly Press the button to move backwards through results in memory ...

Page 62: ... 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 or button is pressed a beep sounds and the test meter turns off automatically Deleting all test results from the memory You can delete all test results from the memory Remember that test...

Page 63: ... go to the End screen Step 4 Hold down both the and buttons for 5 seconds dEL and ALL will alternately flash on the screen To cancel this function at this point press the button Step 5 Hold down the button for 5 seconds The End screen appears again once all test results are deleted from the memory To turn off the meter hold down the button for 2 seconds The meter turns itself off if buttons are no...

Page 64: ... 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 65: ...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 66: ...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 67: ...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 68: ...e battery page 10 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 Contact Customer Service at 800 566 8558 ...

Page 69: ...sample Code 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...

Page 70: ...n 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 7 day 14 day or 30 day but there are no results stored yet in memory For errors not listed do not attempt to use meter Contact Customer Service at 800 566 8558 ...

Page 71: ...sourced Power Source One 3 volt lithium battery CR2032 or DL2032 Battery Life Approximately 3 000 tests Screen Type Liquid Crystal Display LCD Memory 50 results with time date stamp Average 7 day 14 day or 30 day averaging Automatic Shut Off 3 5 minutes after last user action Size 3 6 x 1 2 x 0 5 92mm x 30mm x 14 mm Weight 1 1 oz with battery Operating Ranges 50 F 104 F 10 C 40 C 20 80 relative hu...

Page 72: ...nsulting with your healthcare professional Patients undergoing oxygen therapy may yield false results Heparin samples of blood may be used Do not use other preservatives Do not grasp the meter near the test strip port A built in thermosensor used to minimize measurement errors is installed just inside the port If you hold this area it will be warmed by your fingers which will adversely affect test...

Page 73: ...y 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 bilirubin triglycerides and hemoglobin do not interfere with your blood glucose resu...

Page 74: ...Do not use serum or plasma or venous whole blood Do not use the GLUCOCARD 01 mini Blood Glucose Monitoring System 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 00...

Page 75: ...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 merchantability or fitness for any purpose other than stated herein This warranty does not apply to the performance of the GLUCOCARD 01 mini blo...

Page 76: ...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 7344 00 Rev 2 08 TEL 800 566 8558 FAX 952 646 3110 www arkrayusa com 2008 ARKRAY Inc ...

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Arkray GLUCOCARD 01-mini, User Instruction Manual

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