Rightest GM280 User Manual
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Rightest GM280 User Manual

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BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: +886 4 2369 2388
Fax: +886 4 2261 7586
Email: info@bionime.com
http://www.bionime.com
Made in Taiwan
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Email: EmergoVigilance@ul.com
0197
Blood Glucose Monitoring System
GM280
User's Manual

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  • Page 1 Blood Glucose Monitoring System BIONIME CORPORATION No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan Emergo Europe Tel: +886 4 2369 2388 GM280 Fax: +886 4 2261 7586 Prinsessegracht 20 Email: info@bionime.com 2514 AP The Hague User’s Manual http://www.bionime.com...
  • Page 3 Intended Use Preface The RIGHTEST Blood Glucose Monitoring System GM280 is designed for in vitro diagnostic use Thank you for choosing the RIGHTEST Blood Glucose Monitoring System GM280. This manual contains all the information you need to use your product to start getting accurate blood glucose (for self-testing outside the body) only, and can be used by home user and healthcare test results.
  • Page 4 - Follow all environmental protection regulations when disposing of batteries, strips and lancets. - Avoid contact with spilled liquids. - The RIGHTEST System has not been validated for use on neonates. Do not use the RIGHTEST System to test neonates.
  • Page 5 Limitations Limitations - The RIGHTEST Blood Glucose Monitoring System GM280 is not intended for serum or plasma - Alternative site testing (AST) should only be performed during steady-state times (when glucose testing. is not changing rapidly). Please refer to the Alternative Site Testing (AST) chapter before you - Do not use at altitudes greater than 10,000 feet (3,048 meters).

  • Page 6: Table Of Contents

    Setting Up Your Meter- Setting the Date, Time, Volume and Test Unit Recalling Test Results Turning On / Off the Meter Recalling Average Test Results Testing Procedure Error Messages and Troubleshooting Handling the RIGHTEST Blood Glucose Test Strip GS280 Specification Performing a Blood Glucose Test Customer Service Setting Markers Warranty...

  • Page 7: Rightest Blood Glucose Monitoring System Gm280

    RIGHTEST Blood Glucose Monitoring System GM280 Your RIGHTEST Blood Glucose Monitoring System GM280 consists of several items. Please identify each item and make sure you understand how to use them. The items in RIGHTEST Blood Glucose Monitoring System GM280: 1. RIGHTEST Blood Glucose Meter GM280 (with 1 CR2032 battery installed) 2.
  • Page 8 RIGHTEST Blood Glucose Meter GM280 RIGHTEST Blood Glucose Meter GM280 Test Strip Port Insert a test strip here until you hear a click. Display Window Meter Label Shows your test result, messages and related information. Main Button ( Battery Cover...

  • Page 9: Rightest Blood Glucose Meter Gm280

    RIGHTEST Blood Glucose Meter GM280 RIGHTEST Blood Glucose Meter GM280 Indicates when to apply the blood Indicates a test result stored in memory sample Indicates a test result not included into Appears after you insert test strip into the average results of the meter...

  • Page 10: Rightest Blood Glucose Test Strip Gs280

    Grip here to insert whichever comes first. the test strip into - Store RIGHTEST Test Strips at 4 - 30°C (39 - 86°F) and with 10 - 90% relative humidity. meter. Do not expose to direct sunlight or heat. Indication Symbol...

  • Page 11: Meter Activation And Battery Change

    Meter Activation and Battery Change Meter Activation and Battery Change Your meter comes with 1 CR2032 3V battery installed. 1 new battery provide sufficient power for approximately 1000 tests under normal usage. Press the main button or insert a strip to activate your meter.

  • Page 12: Setting Up Your Meter- Setting The Date, Time, Volume And Test Unit

    After removing the battery, press the main button several times until there is no signal on year and press the main button to confirm. screen. Then follow the battery installation steps to replace the battery. The RIGHTEST Meter will perform a self-test. Press the main button to exit the Self-Testing Mode and enter the Settings Mode.
  • Page 13 When the "OFF" blinks, press the Left or Right NOTE button to turn the volume on or off and press the - When idle for more than 2 minutes, the RIGHTEST Meter will exit Settings Mode and main button to confirm. power off automatically.

  • Page 14: Turning On / Off The Meter

    Turning On / Off the Meter Handling the RIGHTEST Blood Glucose Test Strip GS280 1. How to turn on the RIGHTEST Blood Glucose Meter GM280 Inserting the RIGHTEST Blood Glucose Test Strip GS280: Press the main button or insert a test strip.

  • Page 15: Performing A Blood Glucose Test

    Handling the RIGHTEST Blood Glucose Test Strip GS280 Performing a Blood Glucose Test Removing the RIGHTEST Blood Glucose Test Strip GS280: Depth Adjustable Cap Release Button 1. Hold the test strip as shown. Plunger Lancet Carrier Safety Switch Prepare the Lancing Device: 2.
  • Page 16 15. The screen will display a countdown timer. Your test NOTE result will be displayed after 5 seconds. - The RIGHTEST Meter will automatically detect the Code Number of the test strip. You do not need to check the Code Number on the meter display and strip vial.
  • Page 17 Performing a Blood Glucose Test Performing a Blood Glucose Test Lancet and Test Strip Disposal: PRECAUTION 16. Separate the cap from the hub. Press the lancet needle - Do not apply the blood sample to the strip's sample port until you see " "...

  • Page 18: Setting Markers

    Device with the clear cap. (For detailed information, Forearm meal), " " (no marker). Then apply a drop of blood and the meter will reocrd the marker refer to the instruction manual for the RIGHTEST automatically. Lancing Device.) - To increase the blood flow, massage the intended puncture area of your palm or forearm for a few Before meal: You test the blood glucose before meal.

  • Page 19: View Window Appearance

    – below 10°C (50°F) or above 40°C (104°F)– please wait at least - Use the clear cap provided with the RIGHTEST Lancing Device when testing sites other 30 minutes before testing again.

  • Page 20: Lo" And "Hi" Readings

    Use a bottle of RIGHTEST Control Solution GC550 when testing your RIGHTEST Blood Glucose result, contact your healthcare professional. Monitoring System GM280 in the Control Solution Mode. If the test result falls within the Control If your test result is above 600 mg/dL (33.3 mmol/L), "...
  • Page 21 - To check RIGHTEST Test Strip when you open a new vial of strips. - To check your RIGHTEST Meter after it has been dropped, damaged or exposed to liquids. - If you suspect that your test results are inaccurate, or if your test results are not consistent with Example how you are feeling.

  • Page 22: Performing A Quality Control Test

    Control Solution to the strip. - The Control Solution Test should be performed at temperatures ranging from 15 to 40°C 5. Gently swirl the bottle of RIGHTEST Control Solution GC550 (59 to 104°F), with relative humidity ranging from 10 to 90%.

  • Page 23: Understanding Control Test Results

    HIV, HBV and HCV on the device. NOTE: The cleaning procedure can only remove visible contaminates from surfaces. Only - You left the RIGHTEST Test Strip vial or the Control Solution opened for a long period after use. the disinfecting procedure can eliminate non-visible pathogens.
  • Page 24 Maintaining the Products Maintaining the Products Cleaning and Disinfecting frequency: at least once a week. Cleaning and Disinfecting frequency: at least once a week. To clean the meter: To clean the Lancing Device: 1. Wipe the whole surface of the meter using the disinfectant wipes listed above 1.

  • Page 25: Recalling Test Results

    Recalling Test Results Recalling Test Results The RIGHTEST Blood Glucose Meter GM280 can automatically store up to 500 test results along 4. Quick Searching: with the time and date. If your meter has 500 stored results, the most recent test result will take To view test results in sequential order automatically, enter the Memory Mode.

  • Page 26: Recalling Average Test Results

    Recalling Average Test Results Recalling Average Test Results The RIGHTEST Blood Glucose Meter GM280 provides several average test results. View the NOTE 1-day, 7-days, 14-days, 30-days, 60-days and 90-days average test results for better blood - The Average function requires that the correct time and date be entered. Test results glucose monitoring.

  • Page 27: Error Messages And Troubleshooting

    " and flashing " " symbols appear on the screen after 3. If your RIGHTEST Meter or RIGHTEST Test Strips have been exposed to temperatures that completing the proper steps, it signifies the RIGHTEST Test Strip has been below 10°C (50°F) or above 40°C (104°F), take the meter and strips back to an environment inserted incorrectly more than twice.
  • Page 28 Er3 - The transmission of the signal has been disrupted. Repeat the test Change" on p18-19. with a new test strip. The RIGHTEST Meter should be working normally after finishing above steps. If not, please Er4 - The blood sample volume is insufficient. Repeat the test using a contact Bionime Customer Service.

  • Page 29: Specification

    " button for 4 seconds. Operating Temperature 10 - 40°C (50 - 104°F) Sample Operating Relative Humidity 10 - 90% Minimum Sample Volume Refer to RIGHTEST Blood Glucose Test Strip GS280 Insert. Power Supply 1 CR2032 battery Hematocrit Meter Battery Life About 1,000 tests...

  • Page 30: Customer Service

    Bionime Customer Service. This warranty does not apply to the performance of a RIGHTEST Blood Glucose Meter GM280 that has been altered, misused, tampered with or abused in any way.

  • Page 31: Expected Glucose Values

    Expected Glucose Values Expected glucose values without diabetes Fasting Blood Glucose GLUCOSE LEVEL INDICATION From 70 to 99 mg/dL (3.9 to 5.5 mmol/L) Normal fasting glucose From 100 to 125 mg/dL (5.6 to 6.9 mmol/L) Pre-diabetes (Impaired fasting glucose) 126 mg/dL (7.0 mmol/L) and above on more than Diabetes one testing occasion References...

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