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Medicus AGM-513S, User Manual

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Medicus AGM-513S User Manual Download Page 48

Product Name
Model Name
Assay Method
Sample Type
Sample Volume
Measurement Range
Measurement Time
Calibration
Battery Type
Battery Life
Unit of Measurement
Operating Ranges

Dimension
Weight
Display
Memory Capacity 
Data Management
Automatic Shuto

ff

GlucoDr.S

TM

 Blood Glucose Monitoring System

AGM-513S
Electrochemical method
Fresh capillary and venous whole blood
0.5 

㎕

20~600 mg/dL (1.1~33.3 mmol/L)
5 seconds
Plasma-equivalent
One 3-volt lithium battery (coin cell type CR2032) 
Approximately 1,000 tests
mg/dL or mmol/L
Temperature: 10~40

℃

 (50~104

℉

)

Relative Humidity: 15~85%
Altitude: Up to 3,048m (10,000 feet)
Hematocrit: 20~65%
50 X 87.3 X 17.5 (mm), 2.0 X 3.4 X 0.69 (inches)
Approximately 47.2g or 1.7 oz. (with battery)
44.0 X 38.0 (mm) LCD, 1.7 X 1.5 (inches) LCD
500 test results (with date, time & event)
Micro USB
5 minutes after last action

Speci

fi

cations

41

Summary of Contents for AGM-513S

Page 1: ......

Page 2: ...iration date printed on the strip vial label Insert a test strip The meter will automatically turn on The blood glucose result will be displayed on the meter in just 5 seconds 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 and then the meter will begin the countdown Remove the battery cover...

Page 3: ......

Page 4: ...r heparin containing tubes Do not shake the tube vigorously For Self testing GlucoDr S Blood Glucose Monitoring System is intended for self testing outside the body in vitro diagnostic use for quantitative measurement of glucose in fresh capillary whole blood drawn from fingertips The GlucoDr S Blood Glucose Monitoring System is intended for use by diabetic lay users as an aid to monitor their blo...

Page 5: ...toring System is calibrated to produce values equivalent to the results on plasma specimens on a laboratory analyzer YSI 2300 STAT Plus The GlucoDr S Blood Glucose Monitoring System should not be used for the diagnosis of diabetes Rapid change in temperature may cause inaccurate test results in reading When taking the meter from cold to warm area or from warm to cold area let the meter sit for abo...

Page 6: ... water Do not immerse the meter in water or other liquid Use the test strip immediately after removing it from the vial Use all the test strips within 4 months after the first opening Store test strips only in their original vial and do not transfer them to a new bottle or any other container Do not touch the test strip with wet hands Do not use the test strip beyond the expiration date printed on...

Page 7: ...Display Message Guide l 34 Troubleshooting Guide l 40 Specifications l 41 Performance Characteristics l 42 Explanation of Symbols l 45 ...

Page 8: ...ood Glucose Monitoring System may include the following items GlucoDr STM Test Strips Lancing Device Lancets All the including items are listed on the main box Check the items after opening GlucoDr S Blood Glucose Monitoring System package If any of the items are missing from your kit Contact your local distributor 7 GlucoDr STM Blood Glucose Monitoring System 1 ...

Page 9: ...conds Delete all the stored test results in the AVERAGE MODE Delete each test results in the MEMORY MODE Test Port Insert the GlucoDr S Test Strip for testing Then the meter turns on and BLOOD DROP ICON will blink Button Recall the stored test result in the MEMORY MODE Select an event in the EVENT RECORD MODE Change the date time and options in the SET MODE GlucoDr STM Meter 2 ...

Page 10: ...Battery Cover Micro USB Port Transfer your test results from the meter to a computer Test Strip Eject Button GlucoDr STM Meter 3 ...

Page 11: ... 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 effectively ALARM You can set up to four different alarms Each alarm rings for 10 seconds HYPERGLYCEMIC HYP...

Page 12: ...nfirm if enough blood entered the confirmation window Confirmation window Reaction chamber Insert this part into the meter s test port Gold electrodes Apply blood sample here blood is absorbed automatically Yellow Side edge GlucoDr STM Test Strip 5 ...

Page 13: ... 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 S Control Solution for the test Check the expiration date printed on ...

Page 14: ... DROP ICON still does not appear contact your local distributor Do not use the test strip beyond the expiration date Check the expiration date printed on the test strip vial 1 Insert a test strip with the printed side facing up into the test 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 BLOOD DROP ICON will appear In...

Page 15: ...ol solution is mixed well before each test Squeeze the vial to discard the first drop before the test Apply Control Solution Shake the control solution vial well Prepare a drop of the control solution on a clean plate Slowly let the side edge of the yellow window of the test strip touch the drop of the control solution Once the confirmation window fills completely your meter will begin the countdo...

Page 16: ...he use Compare Control Solution Test Results The Control Solution range printed on the test strip vial is for the GlucoDr S 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 CONTROL SOLUTION ICON Check the CONTROL SOLUTION ICON to appear If CONTROL SOLUTION ICON is not displayed repeat the test with a ...

Page 17: ...GlucoDr S Blood Glucose Monitoring System may not be working properly If this is the case do not use the system to test your blood glucose levels Contact your local distributor 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 its discarding date Error in perform...

Page 18: ...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 o...

Page 19: ...per puncture Thus dial to the lower number for thin skin Adjust the Puncture Depth Setting Draw back the end part of lancing device until it clicks and then release it Charge the Lancing Device Place the lancing device carefully on the tip of your finger and press the release button Lance your Finger 12 ...

Page 20: ...ng gu Goyang si Gyeonggi do Korea Some general 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 Place the protectiv...

Page 21: ...GlucoDr STM Meter GlucoDr STM Test Strip Lancing Device Lancets Performing the Blood Glucose Test with GlucoDr STM 14 ...

Page 22: ...a test strip with the printed side facing up into the test port of the meter Push it all the way in until it goes no further The meter will turn on automatically and beep Obtain a Blood Drop Obtain a blood drop from your fingertip using the lancing device see pages 11 13 The blood sample must be at least 0 5 micro liters in volume Do not force the test strip into the meter This may cause malfuncti...

Page 23: ...trip until blood completely fills the confirmation window and the meter beeps Then your meter will start the countdown Apply the Blood Sample You should apply blood to the left side edge of the test strip as directed Do not put blood on the top of the test strip Before puncturing gently massage the fingertip to obtain a round drop of blood Do not squeeze the finger to obtain a drop of blood Do not...

Page 24: ... the required blood volume to perform the test properly Even if the meter begins the countdown despite the fact that the confirmation window is not completely filled do not apply more blood to the test strip Discard the test strip and repeat the test with a new test strip Peforming the Blood Glucose Test with GlucoDr STM 17 ...

Page 25: ... you 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 y...

Page 26: ... 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 left 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 help you ...

Page 27: ...e POST MEAL ICON Select this icon when you have a test before meal PRE MEAL 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 ICON is completed 20 ...

Page 28: ...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 increased...

Page 29: ...f you need to change the pre set limits please go the SET MODE page 29 If your test result is lower than 70 mg dL 3 9 mmol L or hypoglycemic warning limit will appear on the meter display If your result is higher than 140 mg dL 7 8 mmol L or hyperglycemic warning limit will appear on the meter display 22 ...

Page 30: ...ults with date time and event It also provides you averages of your blood glucose test results over a period of time Options 7d 14d 30d 60d or 90d average You can review the test results stored in the memory by the following steps If there is no test result the meter will not display anything and button will not operate Recalling the Previous Test Results 23 ...

Page 31: ...mory after the average value is displayed Press and hold the power button for 5 seconds until CLr flashes and appears You can select the number of days for the average 7d 14d 30d 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 The meter is pre set with the average day of 7d Indicate the Average Value 2 A 24 ...

Page 32: ... time you press and release button the meter will display the next result up to 500 test results Recall your Test Results M To delete individual test result in the MEMORY MODE press and hold the power button for 5 seconds until dEL flashes and appears Press and release the power button once to exit from the MEMORY MODE Exit the MEMORY MODE M Recalling the Previous Test Results 25 ...

Page 33: ...ay If you press and release the power button the meter advances next to the Month Setting Set the Year 2 Setting GlucoDr STM Meter 26 The GlucoDr S Meter comes with date 1 1 date format dd mm time 12 00AM time format 12h alarm 0 average day 7d hypoglycemic 70 mg dL 3 9 mmol L hyperglycemic 140 mg dL 7 8 mmol L and unit of measurement mg dL beep On preset However if you need to change the setting o...

Page 34: ...s and release the power button the meter advances next 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 advances next 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 button the mete...

Page 35: ...nces next 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 advances next 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 press an...

Page 36: ... meter advances next to the Hyperglycemic Warning Limits Setting Set Hypoglycemic Warning Limit 11 140 mg dL 7 8 mmol L flashes press button to select the hyper upper blood glucose level If you press and release power button the meter advances next to the Beep Setting Set Hyperglycemic Warning Limit 12 Hypoglycemic warning limit cannot be higher than hyperglycemic warning limit Hyperglycemic warni...

Page 37: ...the meter advances next to the Alarm Setting If you set it Off you don t need to set the alarm and the meter exits the SET MODE Set the Alarm Time The Hour of the Alarm Time flashes Press and release button to set the alarm time the same as the Time Setting Save the Setting Information Press and release the power button and then the meter will turn off The setting information you entered will be s...

Page 38: ... 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 39: ...ose the Battery Cover Remove the old battery and put the new one with sign facing up Replace the Battery Remove the battery door from the back of the meter by pushing the tab in the direction of the arrow and pulling up the door Remove the Battery Cover 2 32 ...

Page 40: ...isplay Select Date Range and click Yes Meter data will be transferred to your PC After the download is completed you can see the summary report and the meter turns off Until the download is completed do not disconnect the meter with PC and do not turn off the meter GlucoDr S is designed to connect with PC using Micro USB cable and to transfer test results to PC Through diabetes management software...

Page 41: ...ood glucose test 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 Apply a blood sample to the test strip See pages 14 18 for how to test your blood glucose level No action is ...

Page 42: ... is higher than 600 mg dL 33 3 mmol L No action is required No action is required Select an EVENT ICONs using button before discarding the used test strip Repeat the test using a new test strip and or check the system with the GlucoDr S 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 ...

Page 43: ...t stored in the memory Repeat the test using a new test strip and or check the system with the GlucoDr S 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 No action is required No action is required Battery is low but you can still perform a few more tests Turn off the meter and replac...

Page 44: ...The average of blood glucose test results for the past 7 days The meter is connected with PC using Micro USB cable No test result in memory Turn off the meter and replace the battery immediately No action is required Transfer meter data to PC page 33 No action is required Action What it means Message A ...

Page 45: ...plied or there was an electrical noise during the test 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 Retest with a new test strip The meter has an internal electric circuit problem Contact your local distribu...

Page 46: ... drawn into the test strip for a test or was applied after the test was started Blood is applied to wrong direction into the test strip Contact your local distributor Contact your local distributor Retest with a new test strip Apply blood to right direction into a new test strip Action What it means Message Display Message Guide 39 ...

Page 47: ...lace the battery Check if battery is correctly installed with the positive sign facing up 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 5 minutes after last action Retest wit...

Page 48: ...lectrochemicalmethod Freshcapillaryandvenouswholeblood 0 5 20 600mg dL 1 1 33 3mmol L 5seconds Plasma equivalent One3 voltlithiumbattery coincelltypeCR2032 Approximately1 000tests mg dLormmol L Temperature 10 40 50 104 RelativeHumidity 15 85 Altitude Upto3 048m 10 000feet Hematocrit 20 65 50X87 3X17 5 mm 2 0X3 4X0 69 inches Approximately47 2gor1 7oz withbattery 44 0X38 0 mm LCD 1 7X1 5 inches LCD ...

Page 49: ...Lot Within 5 mg dL Within 0 28 mmol L Within 10 mg dL Within 0 56 mmol L Within 15 mg dL Within 0 83 mmol L 1st Lot 49 64 76 6 64 64 100 64 64 100 2nd Lot 48 64 75 64 64 100 64 64 100 3rd Lot 49 64 76 6 63 64 98 4 64 64 100 Total 3Lots 146 192 76 191 192 99 5 192 192 100 For glucose concentration 100mg dL 5 55 mmol L Lot Within 5 Within 10 Within 15 1st Lot 103 136 75 7 133 136 97 8 136 136 100 2n...

Page 50: ...samples obtained by 146 lay persons showed the following results 100 within 15 mg dL 0 83 mmol L of the medical laboratory values at glucose concentrations below 100 mg dL 5 55 mmol L and 100 within 15 of the medical laboratory values at glucose concentrations at or above 100 mg dL 5 55 mmol L ...

Page 51: ...No Interference Therapeutic concentration mg dL Test concentration mg dL No Interference Therapeutic concentration mg dL Test concentration mg dL 1 Acetaminophen 23 3 25 0 13 Ibuprofen 42 7 50 0 Icodextrin 468 468 14 2 Ascorbic acid 3 0 3 5 15 L DOPA 0 2 2 0 3 Bilirubin C UC 12 0 25 0 16 Maltose 100 0 1000 0 4 Cholesterol 250 0 309 0 17 Methyl DOPA 1 2 1 5 5 Creatinine 5 0 10 0 18 PAM 57 0 60 0 6 ...

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