Medicus GlucoDr.S User Manual
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Medicus GlucoDr.S User Manual

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  • Page 2: Test Summary

    This summary is intended only as a Remove the battery quick reference and is not a substitute cover and put the for GlucoDr.S Blood Glucose Monitoring battery with “+” sign System User Manual. Please read the facing up. entire User Manual before you begin the test.

  • Page 4: Intended Use

    (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 blood glucose level. The GlucoDr.S Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes mellitus, or for neonatal use.
  • Page 5 (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 about 30 minutes to adjust to the room temperature.
  • Page 6 - Do not insert the same test strip into the test port multiple times. It may cause an improper operation. Safekeeping - Store the GlucoDr.S Meter in a room temperature between 0~40℃ (32~104℉). - Store the GlucoDr.S Meter where relative humidity is between 15~85%.
  • 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: Blood Glucose Monitoring System

    Lancing Device User Manual 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.

  • Page 9: Lcd Display

    - 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.

  • Page 10: Micro Usb Port

    GlucoDr.S Meter Micro USB Port - Transfer your test results from the meter to a computer. Battery Cover Test Strip Eject Button...
  • Page 11 GlucoDr.S Meter LCD Display BATTERY LIFE. SET MODE. AVERAGE MODE. MEMORY MODE. MEMORY NUMBER. The meter displays the current memory order number in the MEMORY MODE. STRIP ICON. When the STRIP ICON blinks, insert a test strip to the meter.

  • Page 12: Test Strip

    GlucoDr.S Test Strip Grip - Hold this part to insert a test strip. Yellow Side-edge - Apply blood sample here; blood is absorbed automatically. Confirmation window (Reaction chamber) - Confirm if enough blood entered the confirmation window. Gold electrodes - Insert this part into the meter’s test port.

  • Page 13: Control Solution

    Checking Your System with GlucoDr.S Control Solution Control solution test is to check the performance of your meter and test strips. GlucoDr.S Control Solution contains a measured amount of glucose that reacts with the GlucoDr.S Test Strips. The control solution test confirms that your meter and test strips are working correctly.
  • Page 14 Checking Your System with GlucoDr.S Control Solution - Do not drink the control solution. - Tightly close the cap of control solution vial and store at a room temperature after the test. Check the expiration date printed on the test strip vial.
  • Page 15 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 countdown.
  • Page 16 ’ still does not appear, contact your local distributor. 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.
  • Page 17 - or Meter malfunction If your control solution test results continue to fall outside the range printed on the test strip vial, the 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.

  • Page 18: Preparing The Lancing Device

    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 19: Lance Your Finger

    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. Lance your Finger Place the lancing device carefully on the tip of your finger and press the release button.
  • Page 20 Preparing the Lancing Device Remove the Used Lancet 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 to dispose the used lancet in a proper bio-hazardous container.
  • Page 21 Performing the Blood Glucose Test with GlucoDr.S GlucoDr.S Meter GlucoDr.S Test Strip Lancing Device Lancets...
  • Page 22 Performing the Blood Glucose Test with GlucoDr.S Check the expiration date printed on the test strip vial. Do not use the test strip beyond the expiration date. E15D23213 2016.11 Insert a Test Strip Insert a test strip, with the printed side facing up, into the test port of the meter.
  • Page 23 - 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 smear the blood sample. 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.
  • Page 24 Peforming the Blood Glucose Test with GlucoDr.S - If insufficient blood is inserted, error message (Er8) 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 despite the fact that the confirmation window is not completely filled, do not apply more blood to the test strip.
  • Page 25 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 26 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 </>...
  • Page 27 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 Select this icon when you have a test after meal (food intake). PRE MEAL ICON Select this icon when you have a test before meal.

  • Page 28: Understanding Your Test Results

    Understanding Your Test Results The GlucoDr.S 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.
  • 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.
  • Page 30 Recalling the Previous Test Results The GlucoDr.S 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: 7d, 14d, 30d, 60d, or 90d average). You can review the test results stored in the memory by the following steps.
  • Page 31 Indicate the Average Value 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.
  • Page 32 Recalling the Previous Test Results 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 </>...
  • Page 33 Setting GlucoDr.S Meter 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 of the meter, or if you replace the battery, you need to enter the SET MODE and reset them.
  • Page 34 Setting GlucoDr.S Meter 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.

  • Page 35: Set The Time Format

    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 advances next to the Minutes Setting. Set the Minutes The Minutes flash. Press and release </> button until you get correct minute.
  • Page 36 Setting GlucoDr.S Meter Set the Average Period The Average Period flashes. Press and release </> button until you get the period of average setting that you want (7,14,30,60,or 90). If you press and release the power button, the meter advances next to the Hypoglycemic Warning Limits Setting.

  • Page 37: Set The Alarm Time

    Set the Beep When “On” or “OFF” flashes, press </> button, then you can set the beeper “On” or “Off”. If you set it “On”, press and release the power button. And then 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.

  • Page 38: Installing Battery

    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 39: Remove The Battery Cover

    Remove the Battery Cover 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. Replace the Battery Remove the old battery and put the new one with "+" sign facing up. Close the Battery Cover Put the battery door back in place and snap it closed.

  • Page 40: Data Transfer

    Data Transfer How to Use LinkDr. 2.0 GlucoDr.S is designed to connect with PC using Micro USB cable and to transfer test results to PC. Through diabetes management software LinkDr. 2.0, you can review your test results and print the report.
  • Page 41 Display Message Guide Message System check. The system is The meter is ready The meter displays This display always ready for you to for a blood drop or countdown from appears when you insert a test strip. control solution. 5 to 1, while What it means.
  • Page 42 ICONs using </> strip and/or check button before the system with discarding the the GlucoDr.S used test strip. Action Control Solution. If the test result is “HI” again even though your system is working...
  • Page 43 GlucoDr.S Control Solution. If the test result is “Lo” again even though your system is working correctly, contact your healthcare professional...
  • Page 44 Display Message Guide Message The energy level of The average of The meter is No test result in the battery is too blood glucose test connected with PC memory low to provide results for the past using Micro USB What it means. accurate test 7 days.
  • Page 45 The meter is used The used test strip The test strip was The blood sample The meter has an outside the proper was inserted in the or control solution removed during internal electric range of test port. was improperly testing. circuit problem.
  • Page 46 Display Message Guide Message The meter has a The meter has a Not enough blood Blood is applied to problem with strip or control solution wrong direction problem with strip connection. was drawn into the into the test strip. connection. What it means.

  • Page 47: Troubleshooting Guide

    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

    Specifications Product Name GlucoDr.S Blood Glucose Monitoring System Model Name AGM-513S Assay Method Electrochemical method Sample Type Fresh capillary and venous whole blood Sample Volume 0.5 ㎕ Measurement Range 20~600 mg/dL (1.1~33.3 mmol/L) Measurement Time 5 seconds Calibration Plasma-equivalent Battery Type...

  • Page 49: Performance Characteristics

    Performance Characteristics The performance of the GlucoDr.S Test Strips 3 lots has been evaluated in clinical tests. Accuracy: The accuracy of the GlucoDr.S Blood Glucose Monitoring System was assessed by comparing blood glucose test results obtained from 100 diabetic patients with those obtained using a YSI Model 2300 STAT Plus Glucose Analyzer.
  • Page 50 User Performance Evaluation: A study evaluating glucose values from fingertip capillary blood 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 The interferences except xylose were tested at more than their therapeutic concentrations and their effects on GlucoDr.S test results were less than ± 10 mg/dL at glucose concentrations below 100 mg/dL and less than ± 10% at glucose concentrations above 100 mg/dL.

This manual is also suitable for:

Agm-513s

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