BIONIME RIGHTEST ELSA 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
Blood Glucose Monitoring System
ELSA
User's Manual

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Summary of Contents for BIONIME RIGHTEST ELSA

  • Page 1 Blood Glucose Monitoring System BIONIME CORPORATION No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan ELSA Emergo Europe Tel: +886 4 2369 2388 Prinsessegracht 20 Fax: +886 4 2261 7586 User’s Manual 2514 AP The Hague Email: info@bionime.com The Netherlands http://www.bionime.com...
  • Page 3 The RIGHTEST ELSA Blood Glucose Meter must only be used with RIGHTEST ELSA Blood Glucose The system can test glucose concentration in fresh capillary whole blood (drawn from fingertip, Test Strips and Control Solution GC570.
  • Page 4 2.0 µL 3.0 µL - The RIGHTEST ELSA Blood Glucose Meter can only be used with RIGHTEST ELSA Blood Glucose Test Strips. Test strips from other brands should not be used under any circumstances. Doing so may give inaccurate results.
  • Page 5: Table Of Contents

    Table of Contents Table of Contents About RIGHTEST Blood Glucose Monitoring System Quality Control Contents of the RIGHTEST Blood Glucose Monitoring System " Lo " and " Hi " Readings RIGHTEST Meter Quality Control Test RIGHTEST Test Strip Reviewing Stored Results Preparing for a Test Performing a Quality Control Test Activating the Meter and Changing the Battery...
  • Page 6: Contents Of The Rightest Blood Glucose Monitoring System

    Contents of the RIGHTEST Blood Glucose Monitoring System Contents of the RIGHTEST Blood Glucose Monitoring System Your RIGHTEST ELSA Blood Glucose Monitoring System consists of several items. Please identify 3* each item and make sure you understand how to use them.
  • Page 7: Rightest Meter

    RIGHTEST Meter RIGHTEST Meter Test Strip Port Insert test strips here. Display Window Shows your test result, messages and other information. Meter Label Main Button Used to operate the meter. Please see Battery Cover the following sections for further Slide off to change the battery. details.
  • Page 8 RIGHTEST Meter RIGHTEST Meter Indicates a test result stored in memory Prompt to apply a blood sample Low battery warning. Battery may need Test strip replacing Indicates the average result Appears if an error has occurred Current Date (in Time mode) or Test Date Indicates a control solution test result (in Memory mode) Test result units...
  • Page 9: Rightest Test Strip

    - For detailed information, please refer to the RIGHTEST ELSA Test Strip Insert. - If the RIGHTEST ELSA Meter or Test Strip strips are exposed to a substantial change in temperature, please wait at least 30 minutes before testing again.
  • Page 10: Activating The Meter And Changing The Battery

    Activating the Meter and Changing the Battery Activating the Meter and Changing the Battery Your meter comes with 1 CR2032 3V battery installed. A new battery will provide sufficient power to perform about 1,000 tests under normal use. Press the main button or insert a strip to activate your meter.
  • Page 11: Setting Up Your Meter - Setting The Time, Date, Volume And Test Unit

    Setting Up Your Meter - Setting the Time, Date, Volume and Test Unit Setting Up Your Meter - Setting the Time, Date, Volume and Test Unit You can enter the Settings Mode in two ways: 1. Set the year 1. Reload the battery With the year blinking, tap the button to scroll to the next number.
  • Page 12 Setting Up Your Meter - Setting the Time, Date, Volume and Test Unit Setting Up Your Meter - Setting the Time, Date, Volume and Test Unit 4. Set Time Format (12/24H) 8. Set the units With the time format blinking, tap the Main button to Tap the main button to switch between mg/dL and mmol/L.
  • Page 13: Turning The Meter On/Off

    Turning the Meter On/Off Performing a Blood Glucose Test 1. How to turn on the Meter Depth adjustable cap Release button Press the Main button or insert a test strip. 2. Manually power off Plunger Press the Main button for 3 seconds. Lancet carrier 3.
  • Page 14 Performing a Blood Glucose Test Performing a Blood Glucose Test 6. Rotate the clear top part of the cap to adjust the depth. Check the number of lines visible in the 11. A blood drop symbol appears and is accompanied by a further beep (if volume is turned on).
  • Page 15: Alternative Site Testing (Ast)

    Performing a Blood Glucose Test Alternative Site Testing (AST) 15. Remove the cap from the lancing device. Do not touched the Alternative Site Testing: Palm or Forearm Blood Sampling used lancet. Press the lancet tip into the protective cover. 1. Install the clear cap and follow steps 1 to 5 on page 23. Palm 16.
  • Page 16: Viewing Window Appearance

    Alternative Site Testing (AST) Viewing Window Appearance Make sure your blood sample covers the whole PRECAUTION area of the Viewing Window. An insufficient - Consult your healthcare professional before sampling from your palm or forearm. blood sample will result in an error message - Test results using samples from the palm or forearm may vary at times when glucose is (Er4).
  • Page 17: Lo " And " Hi " Readings

    " Lo " and " Hi " Readings Quality Control Test The RIGHTEST Meter displays results between 10 and 600 mg/dL (0.6 and Use RIGHTEST Control Solution to test the RIGHTEST System in Control Solution Mode. If the test 33.3 mmol/L). If your test result is below 10 mg/dL (0.6 mmol/L), " "...
  • Page 18: Performing A Quality Control Test

    Repeat the Quality Control Test.If your Control Solution test results are still out of range, do not use 5. Shake the bottle of control solution before opening. Remove the cap the system to test your blood glucose. Contact Bionime customer service. and place it on a flat surface.
  • Page 19: Recalling Results And Viewing The Average Result

    Performing a Quality Control Test Recalling Results and Viewing the Average Result 9. Tightly replace the cap on the Control Solution bottle. The RIGHTEST Meter is able to store 500 test results with time and date automatically. If your meter CLOSE already has 500 results stored, the newest test result will replace the oldest one.
  • Page 20 Recalling Results and Viewing the Average Result Recalling Results and Viewing the Average Result 2. To finish reviewing results in the memory, press and briefly hold the main button to enter the PRECAUTION Average screen. "AVG" will be displayed in the upper left corner of the display. The average blood - You must set the time and date to activate the average function.
  • Page 21 Product Maintenance Product Maintenance Indirect transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis Maintaining C Virus (HCV) during the delivery of healthcare services has been increasingly reported. Persons Keep your meter and test strip free of dust, water or any other liquid. Store the meter in the carrying using blood glucose monitoring systems have been identified as one risk group due to sharing of case when not in use.
  • Page 22: Product Maintenance

    - Clean and disinfect the outside of the device only. Do not remove the battery cover when If you have any questions or concerns, please contact your RIGHTEST Blood Glucose Monitoring System authorized distributor or Bionime customer service. cleaning and disinfecting.
  • Page 23: Error Messages And Troubleshooting

    Er4 - Applied blood volume is insufficient. Repeat the test with a new test strip. If error messages still appear, contact Bionime customer service. Temperature Error To ensure accurate results, perform testing at temperatures of 10 - 40°C (50 - 104°F).
  • Page 24: Specification

    Power Saving Battery" on page 16 -17. the " " button for 3 seconds. The meter should now be working normally. If not, please contact Bionime customer service. Operating Temperature 10 - 40°C (50 - 104°F) Operating Relative Humidity 10 - 90%...
  • Page 25: Limitations

    Specification Limitations - RIGHTEST ELSA Blood Glucose Monitoring System is not intended for serum or plasma test. Meter Battery Life Approx. 1,000 tests - Inaccurate test results may be obtained at high altitude more than about 3,048 meters (10,000 feet) above sea level.
  • Page 26: Customer Service

    Warranty Customer Service Bionime wishes to provide complete, considerate service to our customers. Please review all the The manufacturer warrants that your RIGHTEST Meter will be free from defects in materials and instructions to ensure you know how to operate the device correctly. If you have any questions or workmanship for five years from the date of purchase.

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