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A812DA303
08/2015
Manufactured by
All Medicus Co., Ltd.
#7102~7107, #7402, #7403, #7406, 140,
Beolmal-ro, Dongan-gu, Anyang-si,
Gyeonggi-do 431-804 REPUBLIC OF KOREA
www.allmedicus.com
EU Representative
MT Promedt Consulting GmbH
Altenhofstr. 80, D-66386 St. Ingbert, Germany
Tel.: +49 6894 - 58 10 20
BLOOD
GLUCOSE
MONITORING
SYSTEM
User Manual
AGM-4000

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  • Page 1 A812DA303 MONITORING SYSTEM 08/2015 Blood Glucose Monitoring System User Manual Manufactured by All Medicus Co., Ltd. EU Representative #7102~7107, #7402, #7403, #7406, 140, Beolmal-ro, Dongan-gu, Anyang-si, MT Promedt Consulting GmbH AGM-4000 Gyeonggi-do 431-804 REPUBLIC OF KOREA Altenhofstr. 80, D-66386 St. Ingbert, Germany www.allmedicus.com...
  • Page 2 TEST SUMMARY Apply the blood drop This summary is intended only as a to the side edge of quick reference and is not a substitute the yellow window of for GlucoDr auto Blood Glucose the test strip. Monitoring System User Manual. Please read the entire this User Manual before you begin testing.
  • Page 3 “Thank you for using Blood Glucose Monitoring System” 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.
  • Page 4 Precautions for Use - The GlucoDr auto Meter is designed for use with GlucoDr auto Test Strips (manufactured by All Medicus Co., Ltd.) only. - The GlucoDr auto Blood Glucose Monitoring System is calibrated to produce values equivalent to results on plasma specimens obtained from a laboratory analyzer (YSI 2300 STAT Plus).
  • Page 5 - 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 about 30 minutes to adjust to the room temperature. - Do not drop the meter.
  • Page 6 Table of Contents · Getting Started GlucoDr auto Blood Glucose Monitoring System l 01 GlucoDr auto Meter l 02 GlucoDr auto Meter LCD Display l 04 GlucoDr auto Test Strip l 05 · Before Testing Setting the User ID l 06 Checking the Code Number l 08 Checking Your System with GlucoDr auto Control Solution l 09...
  • Page 7 GlucoDr auto Blood Glucose Monitoring System Carrying case User Manual GlucoDr auto Meter GlucoDr auto Test Strips Battery Lancing Device Upon request of distributor, actual package may consist of all Lancets or part of items described above.
  • Page 8 GlucoDr auto Meter LCD Display - Test results, icons, symbols and simple messages appear here. +/- 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 Data Port - Transfer your test results from the meter to a computer. Battery Cover Test Strip Ejector Button...
  • Page 10 GlucoDr auto Meter LCD Display Battery life. SET MODE. AVERAGE MODE. MEMORY MODE. CODE MODE MEMORY and CODE NUMBER. The meter displays the current memory order number in the MEMORY MODE. The meter displays the current code number in the CODE MODE. STRIP ICON.
  • Page 11 GlucoDr auto Test Strip Grip - Hold this part to insert or remove test strip. Yellow Side-edge - Apply blood sample here; blood is absorbed automatically. Confirmation window (Reaction chamber) - Make sure the confirmation window fills completely. Gold electrodes - Insert into test port.
  • Page 12 Setting the User ID The GlucoDr auto Meter can manage 5 users’ test results separately. Select the correct User ID before testing if the meter is used for more than one user. Make sure to confirm the User ID to 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.
  • Page 13 Enter the USER ID NUMBER MODE. When the STRIP ICON flashes, press and hold the power button for one second. The meter will enter the USER ID NUMBER MODE. When the User ID number flashes, release the power button. Select the User ID number. Press +/- button to select User ID number.
  • Page 14 Checking the Code Number Code numbers are used to calibrate your meter with the test strips for accurate test results. Whenever you test, you must check if the code number displayed on the meter matches the one on the test strip vial. Insert a GlucoDr auto Test Strip Insert a GlucoDr auto Test Strip into the test port and the GlucoDr auto Meter will turn on automatically.
  • Page 15 Checking Your System with GlucoDr auto Control Solution Control solution test is to check the performance of your meter and test strips. GlucoDr auto Control Solution contains a measured amount of glucose that reacts with the GlucoDr auto Test Strips. The control solution test confirms that your meter and test strips are working correctly.
  • Page 16 - Do not drink the control solution. - Tightly close the cap of control solution vial and store at a room temperature after the test. Insert a Test Strip Insert a test strip, with the printed side facing up, into the test port of the meter.
  • Page 17 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 following the finger symbol. Once the confirmation window fills completely, your meter will begin the countdown.
  • Page 18 The Control Solution 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. Compare Control Solution Test Results Compare the control solution test result to the control solution range printed on the test strip vial.
  • Page 19 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 is the case, do not use the system to test your blood glucose levels. - Contact your local distributor.
  • Page 20 Preparing the Lancing Device Remove the cap Turn the cap of the lancing device counter-clockwise to remove the cap. Insert a Lancet into the Lancet Holder. Insert the lancet firmly into the holder until it comes to a full stop. When the lancet is placed in the lancing device, twist off the protective disk of the lancet.
  • Page 21 Adjust the Puncture Depth Setting The dial for setting the puncture depth is at the tip of the lancing device. Higher number indicates deeper puncture. Thus, dial to the lower number for thin skin. Charge the Lancing Device. Draw back the end part of lancing device until it clicks, and then release it.
  • Page 22 - To reduce the risk of infection, never share a lancet with another person. - Lancets are for single use only. Always use a new 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.
  • Page 23 Performing the Blood Glucose Test with GlucoDr auto GlucoDr auto Meter GlucoDr auto Test Strip Lancing Device Lancets...
  • Page 24 Insert a Test Strip Insert 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. Then the code number and the BLOOD DROP ICON will appear.
  • Page 25 About Alternate Site Testing(AST) IMPORTANT: There are limitations for doing AST. ● Please consult your healthcare professional before you do AST. What is AST? ● Alternate site testing(AST) means you can use parts of the body other than your fingertips to check your blood glucose levels. GlucoDr auto Meter allows you to test on your palm, arm, thigh, and calf.
  • Page 26 Apply the Blood Sample Apply the round drop of blood to the side edge of the yellow window of the test strip and then blood drop will be absorbed into the narrow channel. Touch and hold the blood drop to the side edge of the yellow window of test strip until blood completely fills the confirmation window and the meter beeps.
  • Page 27 Test Results Appear in 5 seconds 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.
  • Page 28 Entering the EVENT RECORD MODE For effective diabetes management, stored test results with your condition will help you and your healthcare professional to track changes in your blood glucose level. Press +/- Button after the Test Press +/- button after the test. Once the test result appears on the meter display, press any of +/- button to enter the EVENT RECORD MODE.
  • Page 29 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. POST MEAL ICON PRE MEAL ICON Select this icon when you have a Select this icon when you test after meal (food intake).
  • Page 30 Understanding Your Test Results The GlucoDr auto Meter will display test result between 10 and 900 mg/dL (0.6~50 mmol/L). If your test result is lower than 10 mg/dL (0.6 mmol/L), “Lo” will appear on the meter display. If your test result is higher than 900 mg/dL (50 mmol/L), “HI” will appear on the meter display. - If “HI”...
  • Page 31 Recalling the Previous Test Results The GlucoDr auto Meter has a memory capacity to store up to 500 most recent test results with date, time and event. It also provides you averages of your blood glucose 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.
  • Page 32 Indicate the Average Value 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. When the whole test results' average is calculated, individual event records are not considered.
  • Page 33 Recall your Test Results Press and release +/- 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. Press and hold +/- button in the MEMORY MODE in order to view the test results faster.
  • Page 34 To delete individual test result in the MEMORY MODE, press and hold the power button for 5 seconds until "dEL" flashes 3 times. Exit the MEMORY MODE Press and release the power button once to exit from the MEMORY MODE.
  • Page 35 Setting the Meter The GlucoDr auto Meter comes with the time, date, alarm(0), average day(7d) and unit of measurement (mg/dL) preset. However, if you need to change the setting of the meter, or if you replace the battery, you need to enter the SET MODE and reset them. It is important to set the correct time and date.
  • Page 36 Press and release the power button in order to advance to the next setting steps in the SET MODE. Press and release +/- button to adjust the number in the SET MODE. To move faster, press and hold +/- button. Set the month The Month flashes.
  • Page 37 Set the Hour The Hour flashes. Press and release +/- button until you get the correct hour. If you press and release the power button, the meter will save hour and advance to the Minutes Setting. Set the Minutes The Minutes flash. Press and release +/- button until you get correct minute. If you press and release power button, the meter will advance to the Time Format Setting.
  • Page 38 Set the Average Period The Average Period flashes. Press and release +/- button until you get the period of average setting that you want (0,7,14,21,28,60,or 90). If you press and release the power button, the meter will advance to the Beep Setting. Set the Beep When “ON”...
  • Page 39 Totally four different 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 Installing Battery A battery(CR2032) will provide you enough power to perform about 1,000 tests. The meter will alert you when the energy level is getting low by displaying the message ). In this case you can test a few more times but the battery should be replaced to new one as soon as possible.
  • Page 41 Remove the Battery Cover Press down on the battery cover then slide it out. The battery cover will be released. Replace the Battery Remove the old battery and put the new one with "+" sign facing up. Close the Battery Cover Slide the battery cover back into place until it clicks into the meter.
  • Page 42 Display Message Guide Message System check. The meter is ready The meter is ready The meter displays This display always for you to insert a for a blood drop countdown from appears when you test strip. or control solution. 5 to 1, while What it means.
  • Page 43 A blood glucose A blood glucose System is ready to Your blood Your blood test result in test result in record the EVENT glucose result is glucose result is mg/dL mmol/L ICON which higher than lower than correlate with your 900 mg/dL 10 mg/dL test result.
  • Page 44 Message A blood glucose Battery is low but The energy level of The average of test result stored in you can still the battery is too blood glucose test the memory. perform a few low to provide results for the past What it means.
  • Page 45 No test result in The meter is used The used test strip There may be a The blood sample problem with the or control solution memory. outside the was inserted in the test strip. It may was improperly proper range of test port.
  • Page 46 The meter has an The meter has a The meter has a Not enough blood Blood is applied to or control solution internal electric problem with strip problem with strip wrong direction was drawn into the circuit problem. connection. connection. into the test strip.
  • Page 47 Troubleshooting Guide Troubleshooting Cause Action 1. The meter does not turn on Battery is dead. Replace the battery. after inserting a test strip. Check if battery is correctly installed The battery is installed incorrectly with the positive "+" sign facing up. or there is no battery in the meter.
  • Page 48 Specifications Product Name GlucoDr auto Blood Glucose Monitoring System Model Name AGM-4000 Assay Method Electrochemical method Sample Type Fresh capillary, venous, and arterial whole blood Sample Volume 0.5 ㎕ Measurement Range 10~900 mg/dL (0.6~50 mmol/L) Measurement Time 5 seconds Calibration Plasma-equivalent Battery Type One 3-volt lithium battery (coin cell type CR2032)
  • Page 49 Performance Characteristics - The performance of the GlucoDr auto Test Strips has been evaluated in clinical tests. Accuracy: The accuracy of the GlucoDr auto Blood Glucose Monitoring System was assessed by comparing blood glucose test results obtained from 140 diabetic patients with those obtained using YSI Model 2300 STAT Plus Glucose Analyzer.
  • Page 50 Explanation of Symbols 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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