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A112DA302
04/2016
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-2100
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Table of Contents
Related Manuals for All Medicus GlucoDr AGM-2100
Summary of Contents for All Medicus GlucoDr AGM-2100
- Page 1 A112DA302 MONITORING SYSTEM 04/2016 Blood Glucose Monitoring System User Manual Manufactured by All Medicus Co., Ltd. #7102~7107, #7402, #7403, #7406, 140, EU Representative Beolmal-ro, Dongan-gu, Anyang-si, MT Promedt Consulting GmbH AGM-2100 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 the quick reference and is not a substitute yellow window of the for GlucoDr Blood Glucose Monitoring test strip. System User Manual. Please read the entire this User Manual before you begin testing Turn on the Meter.
- 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 Meter is designed for use with GlucoDr Test Strips (manufactured by All Medicus Co., Ltd.) only. - The GlucoDr 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 Precautions for Test Strip - Store test strip vials in dry place with temperature ranging between 1~30℃ (34~86℉). - Avoid direct sunlight, heat and excessive humidity. - Always close the vial cap immediately after removing a test strip from the vial. If the test strip vial is left open for a long time, the test strips will become unusable.
- Page 6 Table of Contents · Getting Started GlucoDr Blood Glucose Monitoring System l 01 GlucoDr Meter l 02 GlucoDr Meter LCD Display l 04 GlucoDr Test Strip l 05 · Before Testing Checking the Code Number l 06 Checking Your System with GlucoDr Control Solution l 09 Preparing the Lancing Device l 13 ·...
- Page 7 GlucoDr Blood Glucose Monitoring System Carrying case User Manual GlucoDr Meter GlucoDr Test Strips Batteries Lancing Device Lancets “Upon request of distributor, actual package may consist of all or part of items described above. ”...
- Page 8 GlucoDr Meter LCD Display - Test results, icons, symbols and simple messages appear here. Code Button - Enters into the CODE MODE while pressing the code button. Memory Button - Recall the stored test results in the MEMORY MODE or change the code number in the CODE MODE.
- Page 9 Test Port - Insert the GlucoDr Test Strip for testing. Then the meter turns on and displays the code number automatically. Battery Cover...
- Page 10 GlucoDr Meter LCD Display MEMORY MODE. CODE MODE . Battery life. STRIP ICON. When the STRIP ICON blinks, insert a test strip 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"...
- Page 11 GlucoDr 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 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. Turn on the Meter Press the power button to turn on the meter.
- Page 13 Enter the CODE MODE You can enter the CODE MODE by pressing and holding the code button (ⓒ button). Then the code number blinks on the meter display. Do not release the code button(ⓒ button), because it will cause the meter to exit the CODE MODE.
- Page 14 - To change the code number faster, press and hold ▶button. Save the Code Number When the code number is correctly adjusted, release the code button(ⓒ button). A new code number will be saved and appear on the meter display.
- Page 15 Checking Your System with GlucoDr Control Solution Control solution test is to check the performance of your meter and test strips. GlucoDr Control Solution contains a measured amount of glucose that reacts with the GlucoDr Test Strips. The control solution test confirms that your meter and test strips are working correctly.
- Page 16 Insert a Test Strip 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 code number and the BLOOD DROP ICON will appear.
- Page 17 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. Test Result Appears in 11 seconds Your meter will display countdown from “11”...
- Page 18 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 performing the test, - Failure to shake the control solution vial well, - Code number printed on the test strip vial does not match the one displayed on the meter,...
- Page 19 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 20 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 21 - 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 22 Performing the Blood Glucose Test with GlucoDr GlucoDr Meter GlucoDr Test Strip Lancing Device Lancets...
- Page 23 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 24 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 25 Results in just 11 seconds Once the meter completes the countdown from “11” to “1”, your test result will appear on the meter display. If you remove the test strip, the test result will be automatically saved in the meter memory. If you do not apply a blood drop within 3 minutes, your meter will turn off automatically.
- Page 26 Understanding Your Test Results The GlucoDr Meter will display test result between 20 and 600 mg/dL (1.1~33.3 mmol/L). If your test result is lower than 20 mg/dL (1.1 mmol/L), “Lo” will appear on the meter display. If your test result is higher than 600 mg/dL (33.3 mmol/L), “HI” will appear on the meter display. - If “HI”...
- Page 27 Recalling the Previous Test Results The GlucoDr Meter has a memory capacity to store up to 100 most recent test results with date and time. Press ▶ Button. To enter the MEMORY MODE, press ▶ button with the meter turned on. If there is no test result, the meter will not display anything and ▶...
- Page 28 Press and hold ▶ button in the MEMORY MODE in order to view the test results faster. Exit the MEMORY MODE Press and release the code button(ⓒ button) once to exit from the MEMORY MODE.
- Page 29 Setting the Meter Set the Unit of Measurement. The GlucoDr Meter can display the test results with the unit of milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L). Press and Hold the Power Button for 3 seconds To enter the UNIT SELECT MODE, With the meter turned on, press and hold the power button until "mg/dL"...
- Page 30 Installing Battery Two batteries(CR2032) will provide you enough power to perform about 4,000 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 31 Remove the Battery Cover Press down the top of the battery cover then pull it out. The battery cover will be released. Replace the Batteries Remove the old batteries and put the new one with "+" sign facing up. Close the Battery Cover Insert the battery cover tab into the matching hole on the meter, and push down until you hear the cover click into place.
- Page 32 Display Message Guide Message A blood glucose The meter is ready The meter is ready The meter displays for you to insert a for a blood drop countdown from test result in mg/dL test strip. or control solution. 11 to 1, while What it means.
- Page 33 Message A blood glucose Your blood Your blood A blood glucose test result in glucose result is glucose result is test result stored in mmol/L higher than lower than the memory. What it means. 600 mg/dL 20 mg/dL (33.3 mmol/L). (1.1 mmol/L).
- Page 34 The energy level of The meter is used The meter has The used test strip The meter has outside of the was inserted in the the battery is too some problems. some problems proper range of test port. low to provide while testing temperature.
- Page 35 Troubleshooting Guide Troubleshooting Cause Action 1. The meter does not turn on Batteries are dead. Replace the batteries. after inserting a test strip. The batteries are installed Check if batteries are correctly incorrectly or there is no battery installed.(See pages 24~25) in the meter.
- Page 36 Specifications Product Name GlucoDr™ Blood Glucose Monitoring System Model Name AGM-2100 Assay Method Electrochemical method Sample Type Fresh capillary whole blood Sample Volume 4 ㎕ (minimum 2.5 ㎕) Measurement Range 20~600 mg/dL (1.1~33.3 mmol/L) 11 seconds Measurement Time Calibration Plasma-equivalent Battery Type Two 3-volt lithium batteries (coin cell type CR2032) Battery Life...
- Page 37 Performance Characteristics - The performance of the GlucoDr Test Strips has been evaluated in clinical tests. Accuracy: - The accuracy of the GlucoDr Blood Glucose Monitoring System was assessed by comparing blood glucose test results obtained from 181 diabetic patients with those obtained using YSI Model 2300 STAT Plus Glucose Analyzer.
- Page 38 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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