Medicus GlucoDr. auto AGM-4000, User Manual

Page 1: ...cose Monitoring System 7102 7107 7402 7403 7406 140 Beolmal ro Dongan gu Anyang si Gyeonggi do 431 804 REPUBLIC OF KOREA www allmedicus com Manufactured by All Medicus Co Ltd EU Representative MT Promedt Consulting GmbH Altenhofstr 80 D 66386 St Ingbert Germany Tel 49 6894 58 10 20 ...

Page 2: ... Insert a test strip The meter will automatically turn on Check the code number The code number displayed on the meter must match the one on the test strip vial Apply the blood drop to the side edge of the yellow window of the test strip Wait for the blood drop to completely fill the yellow window of the test strip then the meter will begin the countdown The blood glucose result will be displayed ...

Page 3: ...This User Manual will tell you all you need to know about the system and how it works Please read this carefully before using the meter Thank you for using Blood Glucose Monitoring System ...

Page 4: ...d glucose testing in fresh capillary whole blood drawn from the fingertips palm arm thigh and calf The GlucoDr auto Blood Glucose Monitoring System is for testing outside the body in vitro diagnostic use The GlucoDr auto Blood Glucose Monitoring System is intended for use by diabetic lay users for self testing to improve management of their blood glucose level The GlucoDr auto Blood Glucose Monito...

Page 5: ...ture between 0 40 32 104 Store the GlucoDr auto Meter at a place where relative humidity is less than 85 Keep the GlucoDr auto Meter in sanitary environment Keep the meter away from direct sunlight Keep the test port away from dirt blood or water Do not store your meter and test strips in the car the bathroom or the refrigerator sensitive to temperature and humidity Keep the meter test strip vials...

Page 6: ... the Meter Caring for GlucoDr autoTM Meter Additional Information Entering the EVENT RECORD MODE l 22 Understanding Your Test Results l 24 Recalling the Previous Test Results l 25 Setting the User ID l 06 Checking the Code Number l 08 Checking Your System with GlucoDr autoTM Control Solution l 09 Preparing the Lancing Device l 14 GlucoDr autoTM Blood Glucose Monitoring System l 01 GlucoDr autoTM M...

Page 7: ...cose Monitoring System 1 Carrying case User Manual GlucoDr autoTM Meter GlucoDr autoTM Test Strips Battery Lancing Device Lancets 7 Upon request of distributor actual package may consist of all or part of items described above ...

Page 8: ...nds SET MODE Delete all the stored test results in the MEMORY MODE Test Port Insert the GlucoDr auto Test Strip for testing Then the meter turns on and displays the code number automatically GlucoDr autoTM Meter Button Change the User ID number in the USER ID MODE Recall the stored test result in the MEMORY MODE Select an event in the EVENT RECORD MODE Change the date and time in the SET MODE ...

Page 9: ...Battery Cover Data Port Transfer your test results from the meter to a computer Test Strip Ejector Button ...

Page 10: ...ter BLOOD DROP ICON When the BLOOD DROP ICON blinks apply blood sample TEMPERATURE ICON When the meter is not used at a recommended temperature range Er1 andTEMPERATURE ICON appear CURRENTTIME andTESTTIME in the MEMORY MODE CURRENT DATE andTEST DATE in the MEMORY MODE UNIT OF MESUREMENT EVENT ICON If you choose an event icon which correlates to test results it helps to manage glucose level more ef...

Page 11: ...art to insert or remove test strip Grip Make sure the confirmation window fills completely Confirmation window Reaction chamber Insert into test port Gold electrodes Apply blood sample here blood is absorbed automatically Yellow Side edge ...

Page 12: ...o insure that the test results are stored to the User ID If a single user wishes to use GlucoDr auto Meter only for him herself there is no need to set up the User ID Setting the User ID Press the power button to turn on the meter The STRIP ICON will blink Turn on the Meter Check the User ID number on your meter If the User ID number is correct start the test Check the User ID number 1 ...

Page 13: ...n the User ID number flashes release the power button Enter the USER ID NUMBER MODE Press button to select User ID number If button is pressed the User ID number will go up and if button is pressed the User ID number will go down Select the User ID number Once User ID is selected press the power button once Save the User ID ...

Page 14: ...r auto Meter will turn on automatically Then the code number STRIP ICON and BLOOD DROP ICON will appear Insert a GlucoDr auto Test Strip Make sure that the code number displayed on the meter matches the one on the test strip vial If the code numbers match you can begin the test Check the Code Number 1 If the code number on the meter doesn t match the one on the test strip vial insert a new test st...

Page 15: ... test strip When you leave your test strip vial cap open for a long time When you open a new vial of test strips When you think that the test results are not accurate When you drop the meter When you suspect your meter or test strips are not working properly When your blood glucose test results are not consistent Use only the GlucoDr auto Control Solution for the test Check the expiration date pri...

Page 16: ...t of the meter Gently push it all the way in until it goes no further The meter will turn on automatically and beep Then the code number and the BLOOD DROP ICON will appear Make sure that the code number displayed on the meter matches the one on the test strip vial If the code numbers match you can start the test If the code number on the meter doesn t match the one on the test strip vial insert a...

Page 17: ... countdown from 5 to 1 then the test result will appear Test Result Appears in 5 seconds To ensure accurate test results Gently shake the control solution vial to ensure the control solution is mixed well before each test Squeeze the vial to discard the first drop before the test Do not remove the test strip from your meter before you select the CONTROL SOLUTION ICON in the EVENT RECORD MODE If yo...

Page 18: ...on range printed on the test strip vial is for the GlucoDr auto Control Solution only It is used to check the performance of your meter and test strips It is NOT a recommended range for your blood glucose level Out of range test results may be caused by one or more of the followings Expired or contaminated control solution Expired or damaged test strip Use of control solution or test strip past it...

Page 19: ...ton of the meter to select CONTROL SOLUTION ICON Press and release the power button if selection is completed The control solution test results will be saved Record the Control Solution Test Results in the Meter If your control solution test results continue to fall outside the range printed on the test strip vial the GlucoDr auto Blood Glucose Monitoring System may not be working properly If this...

Page 20: ... lancet it will be used to dispose the lancet safely after its use Insert a Lancet into the Lancet Holder Turn the cap of lancing device clockwise until it fits Replace the cap Before using the lancing device wash your hands in warm water with soap Make sure to rinse and dry them thoroughly Perspiration dirt or water remaining on your hands may cause incorrect test results Avoid using hand lotion ...

Page 21: ...t Charge the Lancing Device Place the lancing device carefully on the tip of your finger and press the release button Lance your Finger Place the protective disk on a flat surface With the used lancet still in the lancing device push the lancet needle completely into the protective disk Push the lancet ejector forward with your thumb and simultaneously pull out the sliding barrel to dispose the us...

Page 22: ...w sterile lancet Used strips lancets and meter may be considered bio hazardous waste in your area Make sure to follow your healthcare professional s recommendations or local regulations for proper disposal Lancing Device Manufactured by CE GMMC 1112 130 Digital ro Geumcheon gu Seoul Korea Lancet Manufactured by CE1370 SAEHANMED CORP Na dong Ga dong 331Seongseok ro Ilsandong gu Goyang si Gyeonggi d...

Page 23: ...17 Performing the Blood Glucose Test with GlucoDr autoTM GlucoDr autoTM Meter GlucoDr autoTM Test Strip Lancing Device Lancets ...

Page 24: ...number displayed on your meter and the test strip code number match Insert a Test Strip Do not force the test strip into the meter This may cause malfunction of the meter Obtain a blood drop from your fingertip using the lancing device see page 14 16 The blood sample must be at least 0 5 micro liters in volume actual size Obtain a Blood Drop Before puncturing gently massage the fingertip to obtain...

Page 25: ...only when it has been more than two hours after any one of the followings a meal diabetes medication or exercise You think your blood glucose level is low You have hypoglycemic unawareness lack of symptoms The site test results do not agree with the way you feel After a meal After insulin dose After diabetes medication After exercise During illness During times of stress What s the advantage Finge...

Page 26: ... apply blood to the finger symbol on the test strip as directed Do not put blood on the top of the test strip Apply the blood drop to the side edge of the yellow window of the test strip If insufficient blood is inserted Error message will be displayed See the picture in the left for proper application of the required blood volume to perform the test properly Even if the meter begins the countdown...

Page 27: ...ou to more effective diabetes management Once the meter completes the countdown from 5 to 1 your test result will appear on the meter display If you remove the test strip immediately only the test result without recording the event will be automatically saved in the meter memory Recording the event with each test result may help with effective diabetes management To enter the EVENT RECORD MODE you...

Page 28: ...ICON After the selection of an EVENT ICON remove the used test strip The used test strip will be discharged automatically by pushing the Ejector Button on the side of the meter After discharging the used test strip the test result with the EVENT ICON will be saved in the meter memory automatically Remove the Test Strip For effective diabetes management stored test results with your condition will ...

Page 29: ...e test Record all control solution tests with CONTROL SOLUTION ICON to distinguish them from blood glucose tests in the meter memory Recorded control solution test results will not be calculated in your result averages CONTROL SOLUTION ICON Once you remove the test strip from the meter you cannot go back to the EVENT RECORD MODE Do not remove the test strip from the meter until selecting an EVENT ...

Page 30: ...ly you must contact your healthcare professional immediately Expected Values1 Criteria for the diagnosis of non diabetes Fasting plasma glucose FPG 70 100 mg dL 3 9 5 6 mmol L Two hours after meals plasma glucose 140 mg dL 7 8 mmol L Criteria for the diagnosis of diabetes Fasting plasma glucose FPG 126 mg dL 7 0 mmol L Two hours after meals plasma glucose 200 mg dL 11 1 mmol L Categories of increa...

Page 31: ...e test results over a period of time Options 0d 7d 14d 21d 28d 60d or 90d average You can review the test results stored in the memory by the following steps To enter the MEMORY MODE press button with the meter turned on Press Button 1 If there is no test result the meter will not display anything and button will not operate 25 Recalling the Previous Test Results ...

Page 32: ...mmol L for Lo results You can delete all the stored test results in the meter memory after the average value is displayed Press and hold the power button for 5 seconds until CLr flashes You can select the number of days for the average 0d 7d 14d 21d 28d 60d or 90d in the SET MODE 7d shown in the left side indicates that the value 96 is a calculated average for the past 7 days Indicate the Average ...

Page 33: ... button once to make the most recent test result appear on the meter display Every time you press and release button the meter will display the next result up to 500 test results Recall your Test Results Without any button action for 3 seconds in the MEMORY MODE then code number will be displayed 27 ...

Page 34: ...ete individual test result in the MEMORY MODE press and hold the power button for 5 seconds until dEL flashes 3 times Press and release the power button once to exit from the MEMORY MODE Exit the MEMORY MODE ...

Page 35: ... you and your healthcare professional to track changes in your blood glucose level 1 To exit the SET MODE at any time press and hold the power button for 3 seconds The settings you have already made will be saved With the meter turned on press and hold the power button until SET appears on the meter Release the power button to enter the SET MODE The Year flashes Press and Hold the Power Button for...

Page 36: ...onth If you press and release the power button the meter will advance to the Day Setting Set the month The Day flashes Press and release button until you get the correct day If you press and release the power button the meter will advance to the Date Format Setting Set the Day The Date flashes Press and release button until you get the date format that you want If you press and release the power b...

Page 37: ... hour and advance to the Minutes Setting Set the Hour The 12H or 24H flashes Press and release button to adjust until you get the correct time format If you press and release the power button the meter will advance to the Unit of Measurement Setting Set the Time Format The Unit of Measurement mg dL or mmol L flashes Press and release button until you get the unit measurement that you want If you p...

Page 38: ...21 28 60 or 90 If you press and release the power button the meter will advance to the Beep Setting Set the Alarm up to 4 different Alarms a day The Alarm times flash Press and release button until you get the alarm times 0 to 4th setting that you want If you press and release the power button the meter will advance to the Alarm Time Setting Set the Alarm Time The Hour of the Alarm Time flashes Pr...

Page 39: ...ent alarms can be set You can continually set alarm right after the first setting Press and release the power button after you complete the first alarm time setting Then 2 appears you can repeat to set the next alarm time ...

Page 40: ...e times but the battery should be replaced to new one as soon as possible If bAt appears on the meter display the meter will not operate The battery must be immediately replaced Always turn off the meter before replacing the battery Replacing the battery with the meter power on may lead to malfunction of the meter Press the power button to turn off the meter Turn off the Meter 1 Installing Battery...

Page 41: ...il it clicks into the meter Close the Battery Cover Remove the old battery and put the new one with sign facing up Replace the Battery Press down on the battery cover then slide it out The battery cover will be released Remove the Battery Cover ...

Page 42: ...est result You should check that your meter matches the example exactly every time your meter turns on Do not use the meter if the display check screen does not exactly match the example Please contact your local distributor Insert a test strip into the test port of your meter Make sure the code number displayed on the meter matches the one on the test strip vial Apply a blood sample to the test s...

Page 43: ...est strip Repeat the test using a new test strip and or check the system with the GlucoDr auto Control Solution If the test result is HI again even though your system is working correctly contact your healthcare professional immediately Your blood glucose result is lower than 10 mg dL 0 6 mmol L Repeat the test using a new test strip and or check the system with the GlucoDr auto Control Solution I...

Page 44: ... level of the battery is too low to provide accurate test results The average of blood glucose test results for the past 7 days No action is required Turn off the meter and replace the battery as soon as possible Turn off the meter and replace the battery immediately No action is required Action What it means Message ...

Page 45: ...during testing No action is required Leave the meter at a temperature between 10 40 50 104 for at least 30 minutes before repeating the test Retest with a new test strip Retest with a new test strip Do not remove the test strip until test result appears on the meter display The blood sample or control solution was improperly applied or there was an electronical noise during the test Retest with a ...

Page 46: ...olution was drawn into the test strip for a test or was applied after the test was started Contact your local distributor Contact your local distributor See Troubleshooting Guide Contact your local distributor See Troubleshooting Guide Retest with a new test strip Blood is applied to wrong direction into the test strip Apply blood to right direction into a new test strip ...

Page 47: ...place the battery Check if battery is correctly installed with the positive sign facing up See pages 34 35 Contact your local distributor Insert the test strip correctly with the printed side facing up Not enough blood sample The test strip may be damaged The meter may not be working properly Blood sample is applied after the meter was automatically turned off 5 minutes after last action Retest wi...

Page 48: ...ectrochemicalmethod Freshcapillary venous andarterialwholeblood 0 5 10 900mg dL 0 6 50mmol L 5seconds Plasma equivalent One3 voltlithiumbattery coincelltypeCR2032 Approximately1 000tests mg dLormmol L Temperature 10 40 50 104 RelativeHumidity Lessthan85 Altitude Upto2500m 8202feet Hematocrit 20 60 93 5X49 0X17 5 mm 3 7X1 9X0 69 inches Approximately40gor1 4oz withbattery 37 0X42 0 mm LCD 1 5X1 7 in...

Page 49: ...centration 75 mg dL 4 2 mmol L Repeatability using venous whole blood Level 42 7 mg dL 109 5 mg dL 149 mg dL 202 mg dL 345 mg dL 2 3 mg dL 2 5 mg dL 3 3 mg dL 3 7 mg dL 4 4 mg dL SD 5 3 2 3 2 2 1 8 1 3 CV 36 5 mg dL 125 mg dL 325 mg dL Level 1 9 mg dL 3 1 mg dL 8 2 mg dL SD 5 3 2 4 2 5 CV Repeatability using control Accuracy Range Within 5 mg dL 0 28 mmol L Within 10 mg dL 0 56 mmol L Within 15 mg...

Page 50: ... product fulfills the requirements of Directive 98 79 EC on in vitro diagnostic medical device For in vitro diagnostic use Do not dispose the instrument in the urban waste Consult User Manual Explanation of Symbols ...