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Summary of Contents for GE GE006

  • Page 2 Thank you for selecting the GE006 Blood Glucose Monitoring System. This manual provides all the The GE006 Blood Glucose Monitoring System is a personal blood glucose monitoring system to be used information you need to operate this product for accurate test results. Please read this entire manual for self-testing only.
  • Page 3 Caution Precaution - Before using the GE006 Blood Glucose Monitoring System to test your blood glucose, please read all of Sample Size Example 0.75µL µL 1.5µL 2.0µL 3.0µL the instructions and conduct all of the tests including the quality control test (Refer to page 37).
  • Page 4: Table Of Contents

    Cleaning and Disinfecting Procedures ............................. Turning On/Off the Bluetooth ..............................Error Messages and Troubleshooting ............................Handling the GE006 Blood Glucose Test Strip ........................Limitations ......................................Real Time Synchronize ..................................Testing Procedure FEDERAL COMMUNICATIONS COMMISION (FCC) STATEMENT ..................
  • Page 5: The Ge006 Blood Glucose Monitoring System

    The GE006 Blood Glucose Monitoring System 3 * Contents Your GE006 Blood Glucose Monitoring System consists of several items. Please identify each item, learn its name and how it is used. 4 * Below are the items included in your GE006 Blood Glucose Monitoring System: *...
  • Page 6: The Ge006 Blood Glucose Meter

    GE006 Blood Glucose Meter GE006 Blood Glucose Meter Test Strip Port Display Window Battery Cover Meter Battery Product name Main Button ( Meter Serial Number Left Button ( Right Button (...
  • Page 7 The GE006 Blood Glucose Meter The GE006 Blood Glucose Meter Indicates a test result stored in memory Indicates when to apply the blood sample Indicates a test result not included into the Average Appears after you insert test strip into meter...
  • Page 8: The Ge006 Blood Glucose Test Strip

    - Do not use expired GE006 Blood Glucose Test Strips. meter. - When you open a new vial of GE006 Blood Glucose Test Strips, record the date on the vial. Discard the vial of test strips after 3 months from opening.
  • Page 9: Meter Activation And Battery Change

    2. With Battery Inserted Press the main button to turn on the GE006 Blood Glucose Meter. Hold down the main button for 7 seconds. During this time the screen will go blank until you hear a beep. After the beep, the meter will 1.
  • Page 10: Setting Up Your Meter - Setting The Date, Time And Volume

    Setting Up Your Meter - Setting the Date, Time and Volume Setting Up Your Meter - Setting the Date, Time and Volume 1. Year setting 4. Time format 12/24H selection With the time format blinking, press the Left or Right With the year format blinking , press the Left or Right button until you see the button to switch between 12H and 24H.
  • Page 11: Turning On/Off The Meter

    (if volume is turned on). All the settings are saved and completed and will return to time screen. NOTE - If you do not change any settings during Meter Set-up for over 2 minutes, the GE006 Blood Glucose Meter will leave setting mode and power off automatically.
  • Page 12: Turning On/Off The Bluetooth

    “ symbol with a beep (If Volume is 2. Put your forefinger on the side of the strip as shown. turned on). 3. Insert the GE006 Blood Glucose Test Strip into test strip port until it clicks 3. Manual turn on the Bluetooth and firmly stops.
  • Page 13: Getting Ready For Testing

    - Rightest™ GD500 Lancing device Depth adjustable cap Release button - Sterile lancet 3. Take the GE006 Blood Glucose Test Strip out of the test strip port. - Alcohol swab (optional) Please follow your health care professional's direction and discard used Lancet carrier...
  • Page 14: Performing A Blood Glucose Test

    9. Take one GE006 Blood Glucose Test Strip from the vial. Close the vial cap immediately. 4. Twist off and set aside the protective cover of the disposable 10. Insert the strip into the test strip port of the GE006 Blood lancet. Glucose Meter with the view window facing up.
  • Page 15 19. Replace the depth adjustable cap after finishing the test. not start. If the blood sample was insufficient, discard the test strip and repeat with a new GE006 Blood Glucose Test Strip. 15. Countdown Mode will begin on the display window. After...
  • Page 16: Setting Markers

    - Do not apply your blood drop to the sample port on the strip until you see the " " appear. result. The GE006 Blood Glucose Meter is performing an internal test and will display " " and 1. After test, the test result is displayed on the screen with time, date and flashing “...
  • Page 17: Alternative Site Testing

    Alternative Site Testing Alternative Site Testing Alternative site testing: palm or forearm blood sampling Palm CAUTION - Test results may vary if blood samples are taken from different sites or under certain - To perform alternative site testing, install the clear cap for your Rightest™...
  • Page 18: View Window Appearance

    Control Solution GC550 to check your GE006 sample will result in an error message ("Er4"). Blood Glucose Meter and GE006 Test Strip (Refer to “Performing a Quality Control Test” on page 40) . If this occurs, repeat the test with a new test strip.
  • Page 19: About Quality Control Testing

    System in the Control Solution Mode. If the test result is within the Control Solution Range printed on the strip vial label, the GE006 Blood Glucose Monitoring System passes the Quality Control Test and your If you still get a “...
  • Page 20 - To prepare for your initial blood glucose test. - To check the GE006 Blood Glucose Test Strip when you open a new vial of strips. Example To check your GE006 Blood Glucose Meter after it has been dropped, damaged or exposed to liquids.
  • Page 21: Performing A Quality Control Test

    10. The control solution result will appear. Compare your Quality Control Test result 2. Insert the GE006 Blood Glucose Test Strip horizontally (not to the Control Solution Range printed on the GE006 Blood Glucose Test Strip vial vertically) with the colored view window facing up into the test label.
  • Page 22: Understanding Control Test Results

    Rightest™ Control If Rightest™ Control Solution GC550 results are out of range, your GE006 Blood Glucose Monitoring System Solution GC550 . The control solution test result will not be used when recalling test average results.
  • Page 23: Recalling Average Test Results

    Recalling Test Results Recalling Average Test Results The GE006 Blood Glucose meter provides several average test results. View the 1-day, 7-days, 14-days, 5. Quick Searching: To view test results in sequential order automatically, enter the Memory Mode. Press the Right or Left 30-days, 60-days and 90-days average test results for better blood glucose monitoring.
  • Page 24: Caring For Your Meter

    NOTE: the cleaning procedure can only remove visible contaminates from surfaces. Only the disinfecting to ensure the GE006 Blood Glucose Meter is working properly. procedure can eliminate non-visible pathogens.
  • Page 25 4. Allow to air dry. NOTE NOTE - Your GE006 Blood Glucose Meter has been tested to ensure that there is no change in the - Your Rightest™ GD500 Lancing Device has been tested to ensure that there is no...
  • Page 26: Error Messages And Troubleshooting

    - Thin, sliver streaks appear on the screen, 3. If the GE006 Blood Glucose Meter and Test Strips are exposed to a substantial - The screen becomes cracked, soft, dissolved, brittle or swollen.
  • Page 27 Please check the Meter Malfunction If the GE006 Blood Glucose Meter will not turn on, please follow the steps below: test strip vial to ensure you are using the GE006 Test strips.
  • Page 28: Limitations

    Error Messages and Troubleshooting Limitations - GE006 Blood Glucose Monitoring System is not intended for serum or plasma testing. CAUTION - Inaccurate test results may be obtained at altitudes greater than 10,000 feet (3048 meters) above sea A blood sample should ONLY be applied to the test strip after the test strip has been inserted level.
  • Page 29: Real Time Synchronize

    GE006 Blood Glucose Meter. Upon detection or activation of the GE006 Blood Glucose Meter, the HeartSquare App will display the current status of the GE006 Blood Glucose Meter, as well as a step by step walk through of performing a new blood glucose test.
  • Page 30: Federal Communications Commision (Fcc) Statement

    FEDERAL COMMUNICATIONS COMMISION (FCC) STATEMENT FEDERAL COMMUNICATIONS COMMISION (FCC) STATEMENT 15.21 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: You are cautioned that changes or modifications not expressly approved by the part responsible for 1) this device may not cause harmful interference and compliance could void the user's authority to operate the equipment.
  • Page 31: Ncc警語

    NCC警語 Specification A) 根據NCC低功 電波 射性電機管 辦法第十條規定: 率 輻 理 Measurement Technology Oxidase Electrochemical Sensor 經型式認證合格之低功率射頻電機,非經許可,公司、商號或使用者均不得擅 第十二條 Sample Capillary whole blood 自變更頻率、加大功率或變更原設計之特性及功能。 第十四條 低功率射頻電機之使用不得影響飛航安全及干擾合法通信;經發現有干擾現象 0.75 microliters Minimum Sample Volume 時,應立即停用,並改善至無干擾時方得繼續使用。 前項合法通信,指依電信 法規定作業之無線電通信。低功率射頻電機須忍受合法通信或工業、科學及醫 Measuring Range 10-600 mg/dL 療用電波輻射性電機設備之干擾。 Test Time 5 seconds Memory Capacity 500 blood glucose test results with date and time Turns off automatically 2 minutes after last user...
  • Page 32: Warranty

    30 - 60% for five years from the date of purchase. Two AAA Batteries This warranty does not apply to the performance of a GE006 Blood Glucose Meter that has been Power Supply altered, misused, tampered with or abused in any way.
  • Page 33: Customer Service

    Customer Service Expected Glucose Values Without Diabetes Please review all of the instructions to make sure you are performing the steps correctly. If you have Expected glucose values without diabetes ⁽¹⁾ any questions or concerns, please contact your Bionime authorized representative. We will make every Status Range (mg/dL) effort to provide assistance and solutions for you.
  • Page 34: Component Manufacturer Information

    Component Manufacturer Information Log Book Blood Glucose Meter, Test Strip, Control Solution Manufacturer: Bionime Corporation Name: No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan Product complies with In Vitro Diagnostic Medical Device Directive 98/79/EC. ( CE0197 ) Address: EC-Rep: Bionime GmbH, Tramstrasse 16, 9442 Berneck / Switzerland E-mail: [email protected]...
  • Page 35: 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 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 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 40 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 41 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 42: Warranty Card

    2. Bionime guarantees the performance of the GE006 Blood Glucose Meter only if used as directed and provided that the failure to perform has not been caused in whole or in part by the use of test strips that are not GE006 Blood Glucose Test Strips manufactured by Bionime.
  • Page 43: 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 GE006 Blood Glucose Monitoring System. Name Male/Female Date of Birth Address EMERGENCY CARD City Country Postal Code...

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