BIONIME Rightest ALPHA User Manual
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BIONIME Rightest ALPHA 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
ALPHA
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 ALPHA Emergo Europe Tel: +886 4 2369 2388 Fax: +886 4 2261 7586 Prinsessegracht 20 User’s Manual Email: info@bionime.com 2514 AP The Hague http://www.bionime.com...
  • Page 3 Preface Intended Use Thank you for choosing the RIGHTEST ALPHA Blood Glucose Monitoring System. Please read this The RIGHTEST ALPHA Blood Glucose Monitoring System is designed for in vitro diagnostic (for manual thoroughly before testing. It provides all information you need to use the product.
  • Page 4 - We recommended you to perform the quality control test regularly to ensure the test results are accurate. - The RIGHTEST ALPHA Meter can only be used with RIGHTEST ALPHA Test Strip. Other brands' test Blood sample size above 3.0 µL might contaminate the test strip port and the meter.

  • Page 5: Table Of Contents

    Table of Contents Table of Contents About RIGHTEST ALPHA System Quality Control RIGHTEST ALPHA Blood Glucose Monitoring System "Lo" and "Hi" readings RIGHTEST ALPHA Meter Quality Control Test RIGHTEST ALPHA Test Strip Review Your Test Memory Performing a Quality Control Test...

  • Page 6: Rightest Alpha Blood Glucose Monitoring System

    RIGHTEST ALPHA Blood Glucose Monitoring System RIGHTEST ALPHA Blood Glucose Monitoring System Your RIGHTEST ALPHA Blood Glucose Monitoring System consists of several items. Please identify each item and make sure you understand how to use them. The following items are included in your RIGHTEST ALPHA Blood Glucose Monitoring System: 1.

  • Page 7: Rightest Alpha Meter

    RIGHTEST ALPHA Meter RIGHTEST ALPHA Meter Test Strip Port Insert test strip here until you hear a click. Battery Cover Display Window Slide cover to change Show your test result, messages batteries. and relative information. Meter Battery Main Button (...
  • Page 8 RIGHTEST ALPHA Meter RIGHTEST ALPHA Meter Tell when to apply the blood sample Indicates a test result stored in memory Indicates a test result, not joining into the Average Test strip function of this meter Indicates with the average result...

  • Page 9: Rightest Alpha Test Strip

    - For detailed information, please refer to the RIGHTEST ALPHA Test Strip Insert. up and toward meter. blood sample. It gradually turns red - If the RIGHTEST ALPHA Meter or strips are exposed to a substantial change in temperature. when filled with blood. please wait at least 30 minutes before testing again.

  • Page 10: Meter Activation And Battery Change

    Meter activation and Battery change Meter activation and Battery Change Your meter comes with 1 CR2032, 3 volt, batteries installed. A new batteries will provide power to perform about 1,000 tests under normal use. You can 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 Setting Mode by below two ways. 1. Year setting 1. Reload battery With the year format blinking, press the Left or Right button to adjust it. Then After removing the battery, please press the main button for several times until no signal on press the Main button to confirm it.
  • 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. Time format 12/24H selection 8. Setting of Test Unit With the time format blinking, press the Left or Right button With milligrams per deciliter (mg/dL) or millimole per liter to adjust it.

  • Page 13: Turning On / Off The Meter

    Turning On / Off the Meter Performing a Blood Test 1. How to turn on the Meter Depth adjustable cap Release button Press the Main button or Insert a test strip. 2. Manual Power off Plunger If you want to turn off the meter, please keep pressing the Main button for 4 seconds. Lancet carrier 3.
  • Page 14 Performing a Blood Test Performing a Blood Test 7. Choose a depth of penetration by rotating the top portion of 11. A blood drop symbol appears and is accompanied by a further beep (if volume is turned on). Now you can apply the depth adjustable cap until the setting depth matches the blood sample within 2 minutes.

  • Page 15: Alternative Site Testing (Ast)

    Performing a Blood Test Alternative Site Testing (AST) 15. Pull off the depth adjustable cap. Without touching the used Alternative site testing-palm or forearm blood sampling disposable lancet, stick the lancet tip into the protective cover. 1. Choose Clear Cap and follow step 1 - 5 on page 23. Palm 16.

  • Page 16: View Window Appearance

    Alternative Site Testing (AST) View Window appearance Make sure your blood sample covers the PRECAUTION whole area of the View Window to get an - Consult your healthcare professional before sampling from your palm or forearm. accurate test result. An insufficient blood - Test results using samples from the palm or forearm may vary at times when glucose is sample will result in an error message changing rapidly (e.g.

  • Page 17: Lo" And "Hi" Readings

    - To prepare for your initial blood glucose test. meter and test strip. If the test result still remains unusually high or low, contact your - To check the RIGHTEST ALPHA Test Strip when you open a new vial of strips. healthcare professional immediately.

  • Page 18: Performing A Quality Control Test

    3 seconds until the " " symbol appears. OPEN If Control Solution results are out of range, your Bionime BGMS may not be working properly. Repeat 4. You will see blinking " " symbol and " " symbol on the screen, the Quality Control Test.

  • Page 19: Maintain The Products

    Performing a Quality Control Test Maintain the products 9. Close the control solution cap immediately after use, and make sure to close it Indirect transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis CLOSE C Virus (HCV) during the delivery of healthcare services has been increasingly reported. Persons tightly using blood glucose monitoring systems have been identified as one risk group due to sharing of lancets, lancing devices, and blood glucose meters.
  • Page 20 Maintain the products Maintain the products Maintaining Cleaning and Disinfecting frequency: at least once a week. Keep your meter and test strip free of dust, water or any other liquid. Store the meter in the carrying To clean the meter: case when not in use.

  • Page 21: Recalling Test Result And Average

    Recalling Test Result and Average Cleaning and Disinfecting frequency: at least once a week. The RIGHTEST ALPHA Meter is able to store 500 test results with time and date automatically. If your To clean the lancing device: meter has stored 500 results, which is the maximum memory of the meter, the newest test result will 1.
  • Page 22 Recalling Test Result and Average Recalling Test Result and Average NOTE - The average function is related to the time setting. You must set the time right and have enough time intervals on the basis of current inquiry time, to make sure that the average test results will show. Use the 14-day average for example;...

  • Page 23: Error Messages And Trouble Shooting

    Er3 - Signal transmission is disrupted, repeat the test with a new test strip. Er4 - Applied blood volume is insufficient, please repeat the test with a new test strip. Above, if error screen still appears contact your local Bionime Customer Service.
  • Page 24 If the meter can not be started, please follow the steps below: 1. Open the battery cover, remove the batteries. 2. If the RIGHTEST ALPHA Blood Glucose Meter and Test Strips are exposed to a 2. Wait for 5 minutes and insert the batteries as described "Meter activation and Battery change"...

  • Page 25: Specification

    Sample Press the " " button for 3 seconds. Operating Temperature 10 - 40°C (50 - 104°F) Minimum Sample Volume Refer to RIGHTEST ALPHA Strip insert Operating Relative Humidity 10 - 90% Hematocrit Power Supply 1 CR2032 battery Test Strip Storage / Transportation Conditions...

  • Page 26: Limitations

    Limitations Customer Service - RIGHTEST ALPHA Blood Glucose Monitoring System is not intended for serum or plasma test. We sincerely like to provide complete, considerate services to our customers. Please review all the - Inaccurate test results may be obtained at high altitude more than about 3,048 meters (10,000 feet) instructions to make sure you are performing the steps correctly.

  • Page 27: Warranty

    The manufacturer warrants that your RIGHTEST ALPHA Meter will be free from defects in materials and workmanship for five years from the date of purchase. This warranty does not apply to the performance of a RIGHTEST ALPHA Meter that has been altered, misused, tampered with or abused in any way.

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