Medicus AGM-3000, User Manual

Page 1: ...cose Monitoring System EU Representative MT Promedt Consulting GmbH Altenhofstr 80 D 66386 St Ingbert Germany Tel 49 6894 58 10 20 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 ...

Page 2: ...ton to turn on the meter Check the code number The code number displayed on the meter must match the one on the test strip vial Insert a test strip The meter will automatically turn on 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 r...

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 Plus Blood Glucose Monitoring System is for testing outside the body in vitro diagnostic use The GlucoDr Plus 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 Plus Blood Glucose Monito...

Page 5: ...ture between 0 40 32 104 Store the GlucoDr Plus Meter at a place where relative humidity is less than 85 Keep the GlucoDr Plus 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: ...tion Setting the Meter Caring for GlucoDr PlusTM Meter Additional Information Table of Contents Entering the EVENT RECORD MODE l 21 Understanding Your Test Results l 23 Recalling the Previous Test Results l 24 Checking the Code Number l 06 Checking Your System with GlucoDr PlusTM Control Solution l 09 Preparing the Lancing Device l 14 GlucoDr PlusTM Blood Glucose Monitoring System l 01 GlucoDr Plu...

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

Page 8: ...r in the CODE 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 Test results icons symbols and simple messages appear here Power Button Turn the meter on off Enter into different MODEs while pressing the power button 1 second CODE MODE 3 seconds SET MODE Delete all the stored test results in the MEMORY MODE ...

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

Page 10: ...ip to the meter 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 l...

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: ...e on the test strip vial Checking the Code Number Press the power button to turn on the meter Then the code number STRIP ICON and BLOOD DROP ICON will appear Turn on the Meter 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 If they do not match follow the next step Check the Code Number 1 ...

Page 13: ...button to adjust the same code number printed on your test strip vial Change the Code Number Check the code number on the test strip vial before inserting the test strip You can not change the code number after the test strip is inserted into the test port If you do not release the power button when the code number blinks your meter will go to SET MODE ...

Page 14: ...e number is correctly adjusted press and release the power button A new code number will be saved and appear on the meter display Save the Code Number To change the code number faster press and hold UP DOWN button ...

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 Plus Control Solution for the test Check the expiration date pri...

Page 16: ...port 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 adjus...

Page 17: ...lay 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 ATTENTION ICON in the EVENT RECORD MODE If you re...

Page 18: ...on range printed on the test strip vial is for the GlucoDr Plus 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: ... button of the meter to select ATTENTION 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 Plus Blood Glucose Monitoring System may not be working properly If this is...

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: ...l sterilized lancets are BD Ultra Fine E Z Ject G P Lite Microlet Monolet Soft Touch Ultra TLC Unilet GP and Greenlan Note Not recommended lancets in the above list may not work properly with the lancing device due to their dimensions Please contact your supplier to make sure you are using proper lancets RECOMMENDED AVALIABLE LANCETS Lancing Device Manufactured by CE GMMC 1112 130 Digital ro Geumc...

Page 23: ...17 Performing the Blood Glucose Test with GlucoDr PlusTM GlucoDr PlusTM Meter GlucoDr PlusTM 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 1 5 micro liters in volume actual size Obtain a Blood Drop Before puncturing gently massage the fingertip to obtain...

Page 25: ...to the arrow 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 there is an insufficient amount of blood in confirmation window you may get inaccurate test result See the picture in the left for proper application of the required blood volume to perform the test properly Even if the meter begin...

Page 26: ...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 27: ...ntion Press UP DOWN button to select an icon which correlates with the test result Select the EVENT ICON After the selection of an EVENT ICON remove the used test strip 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 help you...

Page 28: ...rol solution tests or improper blood glucose test Record all control solution tests with ATTENTION 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 ATTENTION 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 me...

Page 29: ...nd test strip are working correctly 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...

Page 30: ...ith the meter turned on Press UP DOWN Button 1 You can select the number of days for the average 1 28d 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 Value If there is no test result the meter will not display anything and UP DOWN button will not operate When the whole test results average is calculated individ...

Page 31: ...50 test results Recall your Test Results 25 Press and release the power button once to exit from the MEMORY MODE Exit the MEMORY MODE To delete all the stored test results in the MEMORY MODE press and hold the power button for 5 seconds until dEL flashes 3times You can not delete any test result separately Press and hold UP DOWN button in the MEMORY MODE in order to view the test results faster ...

Page 32: ...t result will help 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 th...

Page 33: ... you press and release the power button the meter will save hour and advance to the Minutes Setting Set the Hour The Minutes flash Press and release UP DOWN button until you get correct minute If you press and release power button the meter will advance to the Time Format Setting Set the Minutes The time flashes Press and release UP DOWN button to adjust until you get the correct time format If yo...

Page 34: ...meter will advance to the Day Setting Set the Month The Date flashes Press and release UP DOWN button until you get the date format that you want If you press and release the power button the meter will advance to the Unit of Measurement Setting Set the Date Format The Unit of Measurement mg dL or mmol L flashes Press and release UP DOWN button until you get the unit measurement that you want If y...

Page 35: ...ou get the period of average setting that you want 1 28d If you press and release the power button the meter will advance to the Alarm Setting Set the Alarm Time The setting for the Alarm Time Setting will start flashing Press and release UP DOWN button until you get the time that you want The Hour of the Alarm Time flashes Press and release UP DOWN button to set the alarm time the same as the Tim...

Page 36: ...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 37: ...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 your meter before replacing the batteries Replacing the batteries with the meter power on may lead to malfunction of the meter When replacing new batteries make sure to use only AAA batteries and replace two batteries at once Press the p...

Page 38: ...ter and push down until you hear the cover click into place Close the Battery Cover Remove the old battery and put the new one Replace the Battery Press down the top of the battery cover then pull it out The battery cover will be released Remove the Battery Cover ...

Page 39: ...sult 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 strip S...

Page 40: ...0 mg dL 50 mmol L No action is required No action is required Select an EVENT ICONs using UP DOWN button before discarding the used test strip Repeat the test using a new test strip and or check the system with the GlucoDr Plus Control Solution If the test result is HI again even though your system is working correctly contact your healthcare professional immediately Action What it means Message ...

Page 41: ...de accurate test results Repeat the test using a new test strip and or check the system with the GlucoDr Plus Control Solution If the test result is Lo again even though your system is working correctly contact your healthcare professional immediately 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 Action W...

Page 42: ... used outside the proper range of temperature The used test strip was inserted in the test port No action is required 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 Action What it means Message ...

Page 43: ... was an electronical noise during the test The meter has an internal electric circuit problem The meter has a problem with strip connection Retest with a new test strip Do not remove the test strip until test result appears on the meter display Retest with a new test strip Contact your local distributor Contact your local distributor Action What it means Message ...

Page 44: ... inserted upside down or incompletely Replace the batteries Check if batteries are correctly installed See pages 31 32 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 3 minutes after last acti...

Page 45: ...ringSystem AGM 3000 Electrochemicalmethod Freshcapillary venous andarterialwholeblood Minimum1 5 20 900mg dL 1 1 50mmol L 5seconds Plasma equivalent TwoAAAbatteriesDC3V Approximately5 000tests mg dLormmol L Temperature 10 40 50 104 RelativeHumidity Lessthan85 Altitude Upto2500m 8202feet Hematocrit 20 60 64 0X87 0X25 0 mm 2 5X3 4X0 98 inches Approximately80gor2 8oz withbattery 41 0X41 5 mm LCD 1 6X...

Page 46: ...oncentration 75 mg dL 4 2 mmol L Repeatability using venous whole blood Level 41 8 mg dL 101 mg dL 145 mg dL 198 mg dL 326 mg dL 2 6 mg dL 2 5 mg dL 3 2 mg dL 5 4 mg dL 8 0 mg dL SD 7 6 2 5 2 3 2 9 2 4 CV 32 1 mg dL 123 mg dL 280 mg dL Level 2 1 mg dL 3 3 mg dL 5 7 mg dL SD 5 9 2 6 1 7 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 47: ...f Symbols 1 CAUTION This 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 ...

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