Rightest Max Plus User Manual
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Rightest Max Plus 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
Max Plus
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 Max Plus Tel: +886 4 2369 2388 Emergo Europe Fax: +886 4 2261 7586 Prinsessegracht 20 User’s Manual Email: info@bionime.com 2514 AP The Hague http://www.bionime.com...
  • Page 3 Intended Use Preface The RIGHTEST Max Plus Blood Glucose Monitoring System is designed for in vitro diagnostic Thank you for choosing our product. This manual contains all the information you need to use use (for self-testing outside the body) only, and can be used by home user and healthcare your product to get accurate blood glucose test results.
  • Page 4 The RIGHTEST Max Plus system should be used with RIGHTEST Control Solution GC700. - The Max Plus Blood Glucose Meter can only be used with extra spacing Max Blood Blood sample sizes greater than 3.0 µL may contaminate the test strip port and the meter.
  • Page 5 Limitations Limitations - The RIGHTEST Max Plus Blood Glucose Monitoring System is not intended for serum or - Alternative site testing (AST) should only be performed during steady-state times (when plasma testing. glucose is not changing rapidly). Please refer to the Alternative Site Testing (AST) chapter - Do not use at altitudes greater than 10,000 feet (3,048 meters).

  • Page 6: Table Of Contents

    Table of Contents Table of Contents About RIGHTEST Max Plus Blood Glucose Monitoring System Quality Control RIGHTEST Max Plus Blood Glucose Monitoring System About Quality Control Testing RIGHTEST Max Plus Blood Glucose Meter Performing a Quality Control Test RIGHTEST Max Blood Glucose Test Strip...

  • Page 7: Rightest Max Plus Blood Glucose Monitoring System

    2. User Documents (Getting Started Guide, User's Manual, Log Book, Warranty Card, Emergency Card) 3. RIGHTEST Max Blood Glucose Test Strips: 10 or 25 pcs (with Package Insert) * 4. RIGHTEST Control Solution GC700 (with Package Insert) * 5. RIGHTEST Lancing Device (with Package Insert) * 6.

  • Page 8: Rightest Max Plus Blood Glucose Meter

    RIGHTEST Max Plus Blood Glucose Meter RIGHTEST Max Plus Blood Glucose Meter Test Strip Port Battery Cover Display Window Main Button ( Meter Label Meter Battery Up Button ( Down Button ( Cover Release Point.
  • Page 9 RIGHTEST Max Plus Blood Glucose Meter RIGHTEST Max Plus Blood Glucose Meter Indicates a control solution test result. Indicates when to apply the blood sample. Unit of test result. Appears after you insert test strip into meter. Appears when a test result is above Warns when the operating temperature has 240 mg/dL (13.3 mmol/L) to suggest...

  • Page 10: Rightest Max Blood Glucose Test Strip

    Electrochemical sensor. whichever comes first. the test strip into - Store RIGHTEST Test Strips at 4 - 30°C (39 - 86°F) and 10 - 90% relative humidity. Do the test strip port not expose to direct sunlight or heat. with auto code - If the RIGHTEST Meter or Test Strips are exposed to extreme temperature changes, key.

  • Page 11: Meter Activation And Battery Change

    Meter Activation and Battery Change Meter Activation and Battery Change Your RIGHTEST Max Plus Blood Glucose Meter comes with 2 CR2032, 3V, batteries installed. 2 new batteries 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

    2. With Batteries Inserted main button to confirm. Press the main button to turn on RIGHTEST Blood Glucose Meter. Hold down the main button 4. 12 or 24-hour Format Setting for 7 seconds. During this time the screen will go blank until you hear a beep. After the beep, When the time format blinks, press the Up or Down button to select the preferable time format the meter will enter the Settings Mode.
  • Page 13 Setting Up Your Meter - Setting the Date, Time, Volume and Test Unit Setting Up Your Meter - Setting the Date, Time, Volume and Test Unit 5. Hour Setting 9. Before Meal Blood Glucose Range Setting The before meal marker and the lower limit bar will be displayed, and the blood glucose value will When the hour blinks, press the Up or Down button to select the current hour and press the blink.

  • Page 14: Turning On / Off The Meter

    If your blood glucose test result is higher than 240 mg/dL (13.3 mmol/L), the Ketone To power off the RIGHTEST Max Plus Blood Glucose Meter, press and hold the main button Reminder will appear if it is set to on. When "...

  • Page 15: Handling Rightest Max Blood Glucose Test Strips

    Handling RIGHTEST Max Blood Glucose Test Strips Handling RIGHTEST Max Blood Glucose Test Strips Inserting a RIGHTEST Max Blood Glucose Test Strip: Removing a RIGHTEST Max Blood Glucose Test Strip: 1. Hold the test strip between your thumb and middle finger with the View 1.

  • Page 16: Performing A Blood Glucose Test

    Bend the cap downwards until a gap immediately close the vial. 10. Insert the strip into the Test Strip Port of the RIGHTEST appears. The device will gently pop open. Meter with the View Window face up.
  • Page 17 Window is not filled, the test will not start. In this case, discard the test strip and repeat the test procedure 18. Discard the lancet into a suitable biohazard container. with a new RIGHTEST Test Strip. 19. Replace the Depth Adjustable Cap after finishing the test.

  • Page 18: Setting Markers

    Performing a Blood Glucose Test Setting Markers Status markers help you recall when you performed a test. CAUTION You must select a marker before you test. - Do not apply the blood sample to the strip's sample port until you see " "...

  • Page 19: Uploading Data

    Bluetooth is set to on by default. When the mobile app is activated, the meter will automatically The RIGHTEST Care App is designed to provide people with diabetes with a digital platform for connect with your mobile device if it has been paired.

  • Page 20: Alternative Site Testing

    - Continue pressing the lancing device against your palm or forearm and gradually increase the - Use the clear cap provided with the RIGHTEST Lancing Device when testing sites other pressure for a few seconds until the blood sample is of sufficient size.

  • Page 21: View Window Appearance

    View Window. An insufficient blood sample will result in an error You can also use the RIGHTEST Control Solution GC700 to perform a Quality Control Test on message (" Er4 "). If this happens, your RIGHTEST Max Plus Blood Glucose Meter and RIGHTEST Max Blood Glucose Test Strip repeat the test with a new test strip.

  • Page 22: About Quality Control Testing

    Please repeat your test with a new test strip. Use a bottle of RIGHTEST Control Solution GC700 when testing your RIGHTEST Max Plus Blood If you still get a " " result, contact your healthcare professional.
  • Page 23 - To prepare for your first blood glucose test. Example - To check RIGHTEST Blood Glucose Test Strip when you open a new vial of strips. - To check your RIGHTEST Blood Glucose Meter if it has been dropped, damaged or exposed to liquids. YYYY-MM-DD - If you suspect that your test results are inaccurate, or if your test results are inconsistent with how you are feeling.
  • Page 24 " and " " will flash on the screen. You are ready to apply Control Solution to the strip. 5. Gently swirl the bottle of RIGHTEST Control Solution GC700 to ensure it is evenly mixed before removing the cap. OPEN 6.

  • Page 25: Performing A Quality Control Test

    - Keep the test strip port clean and dry. Clean immediately if the test strip port solution results are still out of range, do not use RIGHTEST Blood Glucose Meter to test your is stained or is overly exposed to moisture.

  • Page 26: Maintaining The Products

    Maintaining the Products Maintaining the Products Indirect transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Cleaning and disinfection frequency: at least once a week. Hepatitis C Virus (HCV) during the delivery of healthcare services has been increasingly To clean the meter: reported.
  • Page 27 Maintaining the Products Maintaining the Products Cleaning and disinfection frequency: at least once a week. CAUTION To clean the lancing device: - Users should wash their hands thoroughly with soap and water after handling the meter, 1. Wipe down the whole surface of the lancing device using lancing device or test strips.

  • Page 28: Recalling Test Results

    Recalling Test Results Recalling Test Results The RIGHTEST Max Plus Blood Glucose Meter can automatically store up to 500 test results 3. The Quality Control Test result can be recalled from the saved data. along with the time and date. If your meter has 500 stored results, the most recent test result will When the symbol "...

  • Page 29: Recalling Average Test Results

    Recalling Average Test Results Recalling Average Test Results The RIGHTEST Max Plus Blood Glucose Meter provides several average test results. View NOTE the 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 30: Error Messages And Troubleshooting

    " and flashing " " symbols appear on the screen after completing the 3. If your RIGHTEST Meter or Test Strips have been exposed to temperatures that below 6°C proper steps, it signifies the RIGHTEST Test Strip has been inserted incorrectly (43°F) or above 44°C (111°F), take the meter and strips back to an environment within the...
  • Page 31 After completing the instructions above, the meter should function normally. Please contact your local Er4 - The blood sample volume is insufficient. Repeat the test using a new test RIGHTEST Customer Service or email us at info@bionime.com, if the meter is still not working. strip.

  • Page 32: Specification

    " " for 3 seconds Sample Operating Temperature 6 - 44°C (43 - 111°F) Minimum Sample Volume Refer to RIGHTEST Max Test Strip insert Operating Relative Humidity 10 - 90% Hematocrit Power Supply 2 CR2032 batteries...

  • Page 33: Warranty

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

  • Page 34: 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 one Diabetes testing occasion References...

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