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• Page 1
  Blood Glucose Monitoring System GM300 BIONIME CORPORATION 694, Renhua Road, Dali Dist., Taichung City 412, Taiwan Tel: +886 4 24951268 Fax: +886 4 24952568 http: //www.bionime.com E-mail: info@bionime.com BIONIME GmbH USER’S MANUAL Tramstrasse 16, 9442 Berneck Switzerland GM300 0197…
• Page 2
  Blood Glucose Monitoring System. Please read this manual your Bionime authorized representative or call us by phone number, 886 4 24951268 ( GMT+08:00, thoroughly before you start testing. It provides all the information you need to use the product. You 08:30~17:30 ).
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  Precaution Precaution — Before using the System to test your blood gluco se, please read all the instructions and Blood Glucose Meter hasn’t been used for arterial blood testing yet, so it is still not practice the tests including quality control test. ( Refer to page 46.) suitable to be used for arterial blood testing so far.

• Page 4: Table Of Contents

  Table of Contents Table of Contents About System Review Your Test Memory Blood Glucose Monitoring System Recalling Your Test Result Meter Recalling Your Average Test Result Test Strip Quality Control Dummy Code Key About Quality Control Test Smart Code Key Performing a Quality Control Test Being Ready for Test Understanding Control Test Results…

• Page 5: The Blood Glucose Monitoring System

  Blood Glucose Monitoring System Blood Glucose Monitoring System Package of Meter Kit 13. Two AAA Batteries ( not shown )＊ Your Blood Glucose Monitoring System consists of several items. Please identify each 14. Instruction for the lancing device ( not shown )＊ item of your system and learn what they’re called and how they’re used.

• Page 6: The Meter

  Meter Meter Smart Code Key For calibrating your meter. New one comes with every box of test strips. ( Refer to page 17 ) Contain the test strip port for inserting strip. Assemble Smart Code Key into code key base. Up Button ( Down Button ( Test Strip Port…

• Page 7
  Meter Meter Please follow the step ① and step ②. Smart Code Key Release Button Press down to release and switch the Smart Code Key. Smart Code Key Base Assemble Smart Code Key here Battery Cover Slide cover to change batteries. Model Number Meter Serial Number…

• Page 8: The Test Strip

  Test Strip Test Strip Sample Entry Apply a drop of blood or control solution here. The test request is only 1.4 of blood. µl Hand Bar Noble Metal Electrodes Where you can easily Electrochemical sensor hand the strip to do The blood sample will be drawn into the test.

• Page 9: Dummy Code Key

  Dummy Code Key Smart Code Key For package without test strip, not for package with test What is Smart Code Key ? strip Smart Code Key is designed to calibrate your meter to make each lot of A Dummy Code Key will be installed on the new meter in the strips have the same performance.

• Page 10: Smart Code Key Installation

  Smart Code Key Installation Smart Code Key Installation How to switch Smart Code Key ? 3. Push down the Smart Code Key until it snaps into the Smart Code Key base. Every new box of test strips should come with a Smart Code Key inside. Before you install the Smart Code Key, please check that the code number on the strip vial and the code number on the bottom of Smart Code Key should be the same.

• Page 11: Batteries Installation

  Batteries Installation Batteries Installation Your meter kit comes with two AAA, 1.5volt, batteries uninstalled. New set of batteries will provide 4. Meter will do the self test and the whole screen will keep power to perform about 1000 tests under normal use. The low battery symbol » «…

• Page 12: Setting Up Your Meter

  Setting Up Your Meter Setting Up Your Meter Entering Setting Mode Setting the Time, Date and Unit You can enter Setting Mode by below two ways. 1. Year setting 1. Reload batteries: After removing the battery, please press » » button for several times until no With the year format blinking, press the «…

• Page 13
  Setting Up Your Meter Setting Up Your Meter 4. Time Format 12H/24H Selection 7. Setting the Unit of Measurement With the time format blinking, press the » » or » » With milligrams per deciliter ( mg/dL ) or millimol per liter button on the side to adjust it.

• Page 14: Turning On/Off The Meter

  Turning On/Off the Meter Function Screens and Button Operations 1. Auto Power Off Switching the Function Screens The Meter will power off automatically if you don’t operate it for over 3 minutes. 1. Press the » » button to switch function screens including Memory, Average and Time in sequence.

• Page 15: Easily Handling The Test Strip

  Easily Handling the Test Strip Easily Handling the Test Strip How to easily handle the test strip ? Removing the test strip: 1. Hold the test strip same as insert it. Inserting the test strip: 1. Hold the test strip between thumb and middle finger with indication symbol «…

• Page 16: Getting Ready For Testing

  Getting Ready for Testing Performing a Test in Order Before performing a blood glucose test, Each time of using a new box of test strip, you have to assemble the Smart Code you have to prepare the items below : Key from the new strip package.

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  Performing a Test in Order Performing a Test in Order 4) Twist off and set aside the protective cover of the disposable lancet. Preparing your meter and strip 5) Replace the depth adjustable cap. 6) Choose a depth of penetration by rotating the top portion of the depth adjustable cap until the setting depth matches the window.
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  Performing a Test in Order Performing a Test in Order 5. While the » » symbol flashing, you are ready to apply the blood sample. The Obtaining blood sample code number will appear on the right down corner of the screen. 1.
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  Performing a Test in Order Performing a Test in Order 4. The minimum blood sample size of Glucose Monitoring System is 1.4µl Applying blood sample to test strip µl µl µl µl 4 µl Sample Size Example We suggest you to take 1.4~2.5µl to do the test on glucose monitoring system. Blood sample size above 4.0µl might contaminate the Smart Code Key.
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  Performing a Test in Order Performing a Test in Order View Window Appearance — To ensure accurate test results, make sure the code number on your meter matches the Make sure your blood sample covers code number highlighted on the vial of test strips you are using. the whole area of the View Window — Only place the blood drop to the sample entry of the strip.

• Page 21: Comprehending Test Results And Messages

  Performing a Test in Order Comprehending Test Results and Messages 3. The testing result with time and date is automatically stored in your Blood glucose test results are shown on the meter as mmol/L or mg/dL, depending on which unit of meter’s memory.

• Page 22: Recalling Your Test Result

  Comprehending Test Results and Messages Recalling Your Test Result Meter displays results between 0.6 and 33.3 mmol/L or 10 meter is able to store 300 test results with time and date automatically. If your test and 600 mg/dL. If your test result is below 0.6 mmol/L ( 10 mg/dL ), » «…

• Page 23: Recalling Your Average Test Result

  Recalling Your Test Result Recalling Your Average Test Result 3. If a test result is not yours or you think it is not suitable to be calculated by meter provides you several average test results. You can view the 1-day, 7-day, 14- average, you can mark it as non-average data by pressing and firmly holding day and 30-day average of test results for better blood monitoring of your blood glucose .

• Page 24: About Quality Control Test

  About Quality Control Test About Quality Control Test What is quality control test ? When should perform a quality control test ? — Before doing a blood glucose test with your meter for the first time. To make sure the monitoring system will work properly. It is necessary to do two kinds of quality — When you open and start using a new vial of test strips.

• Page 25: Performing A Quality Control Test

  » symbol blinking appear, remove check key and insert it again. If error screen appears again, your meter is not working correctly. Please contact Bionime authorized distributor or Customer Service Center. — Replace the vial cap of control solution and close tightly right away after using of control 4.

• Page 26
  Performing a Quality Control Test Performing a Quality Control Test Performing test with control solution PRECAUTION — Before you do control solution test, you have to do check key test first. 1. Please run check key test first. After see » «…
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  Performing a Quality Control Test Performing a Quality Control Test 8. When you hear a sound of » beep » , leave the meter on the table while waiting PRECAUTION the test result. The screen will show the countdown mode. — Your quality control test result by control solution test will not be calculated for average reading but still can be recalled.

• Page 28: Understanding Control Test Results

  Cleaning Smart Code Key exist, do not use the System to test your blood glucose. And contact Bionime authorized If your Smart Code Key is stained with blood, control solution or any liquid, please use a dry tissue or distributor or Bionime Customer Service.

• Page 29: Error Messages And Trouble Shooting

  The Smart Code Key is faulty or not assembled well to the meter. Reinsert the Smart Please move the meter to environment with temperature between 10~40℃ Code Key. If the error screen appears again, contact Bionime Customer Service. ( 50~104℉ ) and redo the test after 30 minutes.

• Page 30: Limitations

  — The glucose test may be interfered under abnormal concentration of If error screen still appears, contact Bionime Customer Service. Uric acid > 0.54 mmol/L ( > 9.0 mg/dL ) L — Dopa > 0.076 mmol/L ( > 1.5 mg/dL ) About Signal Error — Er3 Methyldopa >…

• Page 31: Specification

  Specification Specification Measurement Technology Hematocrit 30 — 55% Oxidase Electrochemical Sensor Sample Capillary whole blood Power Supply Two 1.5V ( AAA ) batteries 1.4 microliters Minimum Sample Volume Battery Life About 1000 tests Measuring Range 10-600 mg/dL ( 0.6-33.3 mmol/L ) Meter Dimension 85.0 mm x 58.0 mm x 22.0 mm 8 seconds…

• Page 32: Warranty

  You are always welcome to contact us by call: 886 4 24951268 ( GMT+08:00, 08:30~17:30 ), or by e-mail at info@bionime.com This warranty does not apply to the performance of a Meter that has been altered, If you have any question or advice.

• Page 33: Parts Of Critical Component

  Manufacturer: Bionime Corporation 694,Renhua Road, Dali Dist., Taichung City 412, Taiwan Product complied with In Vitro Diagnostic Medical Device Directive 98/79/EC. ( CE0197 ) EC-Rep: Bionime GmbH, Tramstrasse 16, 9442 Berneck / Switzerland Lancing device Manufacturer: Bionime Corporation 694, Renhua Road, Dali Dist., Taichung City 412, Taiwan…

• Page 34: Log Book

  Log Book Log Book DATE DATE Blood Blood Glucose Glucose Breakfast Breakfast Insulin/ Insulin/ Medication Medication Blood Blood Glucose Glucose Lunch Lunch Insulin/ Insulin/ Medication Medication Blood Blood Glucose Glucose Dinner Dinner Insulin/ Insulin/ Medication Medication Blood Blood Glucose Glucose Bedtime Bedtime Insulin/…

• Page 35
  Log Book Log Book DATE DATE Blood Blood Glucose Glucose Breakfast Breakfast Insulin/ Insulin/ Medication Medication Blood Blood Glucose Glucose Lunch Lunch Insulin/ Insulin/ Medication Medication Blood Blood Glucose Glucose Dinner Dinner Insulin/ Insulin/ Medication Medication Blood Blood Glucose Glucose Bedtime Bedtime Insulin/…
• Page 36
  Log Book Log Book DATE DATE Blood Blood Glucose Glucose Breakfast Breakfast Insulin/ Insulin/ Medication Medication Blood Blood Glucose Glucose Lunch Lunch Insulin/ Insulin/ Medication Medication Blood Blood Glucose Glucose Dinner Dinner Insulin/ Insulin/ Medication Medication Blood Blood Glucose Glucose Bedtime Bedtime Insulin/…
• Page 37
  Log Book Log Book DATE DATE Blood Blood Glucose Glucose Breakfast Breakfast Insulin/ Insulin/ Medication Medication Blood Blood Glucose Glucose Lunch Lunch Insulin/ Insulin/ Medication Medication Blood Blood Glucose Glucose Dinner Dinner Insulin/ Insulin/ Medication Medication Blood Blood Glucose Glucose Bedtime Bedtime Insulin/…
• Page 38
  Log Book Log Book DATE DATE Blood Blood Glucose Glucose Breakfast Breakfast Insulin/ Insulin/ Medication Medication Blood Blood Glucose Glucose Lunch Lunch Insulin/ Insulin/ Medication Medication Blood Blood Glucose Glucose Dinner Dinner Insulin/ Insulin/ Medication Medication Blood Blood Glucose Glucose Bedtime Bedtime Insulin/…

• Page 39: Warranty Card

  Monitor. No other warranties, express or implied, are made. Bionime shall not be responsible for any incidental or consequential damages. 4. Activation of this warranty shall be conditioned upon completion and return of the warranty registration card to your local authorized Bionime distributor.

• Page 40: Emergency Card

  Warranty Card Emergency Card Thank you for purchasing our product. Please complete and mail this warranty card within 30 days of purchase of your Blood Glucose Monitoring System. Name Male/Female Date of Birth Address City Country Postal Code Phone Number Healthcare Professional Who Recommended City Country…

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