BIONIME RIGHTEST Max User Manual
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BIONIME RIGHTEST Max 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
http: //www.bionime.com
E-mail: info@bionime.com
Made in Taiwan
BIONIME GmbH
Tramstrasse 16
9442 Berneck
Switzerland
E-mail: info@bionime.ch
0197
Blood Glucose Monitoring System
Max
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 User’s Manual BIONIME GmbH Tel: +886 4 2369 2388 Tramstrasse 16 Fax: +886 4 2261 7586 9442 Berneck http: //www.bionime.com Switzerland E-mail: info@bionime.com E-mail: info@bionime.ch...
  • Page 3 RIGHTEST Max Control Solution is for use with RIGHTEST Max Blood Glucose Meter and email to rightest@bionime.com RIGHTEST Max Blood Glucose Test Strip to check that the meter and test strips are working together properly and that the test is performing correctly.
  • Page 4 - Please perform the quality control test regularly to make sure the test results are fine. µL 0.75 - RIGHTEST Max Blood Glucose Meter can only be used with RIGHTEST Max Blood Glucose Test 0.75 µL 1.0 µL 1.5 µL 2.0 µL...
  • Page 5 Caution Limitations - RIGHTEST Max Blood Glucose Monitoring System is not intended for serum or plasma testing. Important Safety Notes: - Do not use at altitudes greater than 10,000 feet (3,048 meters). - All parts of the kit are considered biohazardous and can potentially transmit infectious - Hematocrit levels below 10% may cause falsely high reading.

  • Page 6: Table Of Contents

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

  • Page 7: Rightest Max Blood Glucose Monitoring System

    1. User Documents (Getting Started Guide, User's Manual, Log Book, Warranty Card, Emergency Card). 2. RIGHTEST Max Blood Glucose Meter (with battery installed) 3. RIGHTEST Max Blood Glucose Test strips 10 or 25 pcs (with Package Insert) 4＊ 5＊ 7＊...
  • Page 8 RIGHTEST Max Blood Glucose Meter RIGHTEST Max Blood Glucose Meter Test Strip Port Display Window Battery Cover Meter label Do not put Main Button ( battery here. Meter Battery Pen press to open the Down Button ( Up Button (...
  • Page 9 RIGHTEST Max Blood Glucose Meter RIGHTEST Max 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 240 mg/dL Warns when the operational temperature limit is to suggest ketone testing.
  • Page 10 RIGHTEST Max Blood Glucose Test Strip RIGHTEST Max Blood Glucose Meter can only be used with RIGHTEST Max Blood Glucose Test Strip and RIGHTEST Max Control Solution. The use of other test strips or control solutions can lead to incorrect results.
  • Page 11 Meter Activation and Battery Change Meter Activation and Battery Change Your RIGHTEST Max Blood Glucose Meter comes with one CR2032, 3 volt, battery installed. One new battery will provide power to perform approximately 1000 tests under normal use. Press the main button or insert a strip to activate your meter.
  • Page 12 Set Up Your Meter - Set Up the Date, Time and Volume Set Up Your Meter - Set Up the Date, Time and Volume You can enter the Setting Mode two ways. 1. Year setting When the year blinks, press the Up or Down button to select the current year and press the main 1.
  • Page 13 Set Up Your Meter - Set Up the Date, Time and Volume Set Up Your Meter - Set Up the Meal Glucose Range 5. Hour setting 9. Before Meal Blood Glucose Range Setting The before meal mark 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 main blink.
  • Page 14 Set Up Your Meter - Ketone Reminder Set Up Your Meter - Set Up the Time Alarm 11. Ketone Reminder Setting This feature reminds the user when to perform a test. There are 8 sets of alarm available per day. The meter will beep when the alarm is triggered and it will be Ketone test reminder is default set to off.
  • Page 15 Inserting RIGHTEST Blood Glucose Test Strip: 2. Manual Power off 1. Hold RIGHTEST Max Blood Glucose Test Strip between your thumb and To power off RIGHTEST Blood Glucose Meter, press and hold the Main button for 3 seconds. middle finger with the view window "...
  • Page 16 1. Hold RIGHTEST Blood Glucose Test Strip as shown. prepare the items below : - RIGHTEST Max Blood Glucose Meter - RIGHTEST Max Blood Glucose Test Strip (Please check the expiration date on the test strip vial. Do not use expired test strips) 2.
  • Page 17 Close the vial cap immediately. 4. Insert a new disposable lancet firmly into lancet carrier. 10. Insert the strip into the test strip port of RIGHTEST Max Blood Glucose Meter with the view window facing up. 5. Twist off and set aside the protective cover of the 11.
  • Page 18 Performing a Blood Glucose Test Performing a Blood Glucose Test 12. After inserting a test strip, the " " icon will flash 15. Countdown Mode will begin on the display window. on the screen. Pressing the Up or Down button to After 5 seconds, your test result will appear.
  • Page 19 Performing a Blood Glucose Test Setting Markers According to actual life status, you can set meal markers with test result. CAUTION You have to perform meal marker setting before testing. - Do not apply your blood drop to the sample port on the strip until you see the " "...
  • Page 20 Recalling Test Results Recalling Test Results The RIGHTEST Max Blood Glucose Meter is able to automatically store a 3. The Quality Control Test result can be recalled from the saved data. maximum of 500 test results with time and date. If your meter has stored 500 When "...
  • Page 21 Recalling Average Test Results Recalling Average Test Results The RIGHTEST Max Blood Glucose Meter provides several average test results. View the 1-day, NOTE 7-days, 14-days, 30-days, 60-days and 90-days average test results for better blood glucose - The Average function requires that the correct time and date is set. Whenever the battery is monitoring.
  • Page 22 Alternative Site Testing Alternative Site Testing Alternative site testing: palm or forearm blood sampling Palm CAUTION - Consult your healthcare professional before sampling from your palm or forearm. - To perform alternative site testing, install the clear cap for Forearm - Alternate site testing should only be done during steady-state time (when glucose is not your RIGHTEST Lancing Device.
  • Page 23 An insufficient blood You can also run a Quality Control Test with RIGHTEST Max Control Solution to check your sample will result in an error message RIGHTEST Max Blood Glucose Meter and RIGHTEST Max Blood Glucose Test Strip (Refer to ("...

  • Page 24: About Quality Control Testing

    To ensure proper monitoring function, it is necessary to regularly perform a quality control test. screen. Please repeat your test with by a new test strip. Use one of RIGHTEST Max Control Solution when testing your RIGHTEST Max Blood Glucose If you still get a "...

  • Page 25: Rightest Max Blood Glucose Meter

    - Each time you open a new bottle of control solution, write the expiration date on the label. working properly. RIGHTEST Max Control Solution is good for 3 months after opening the bottle, or until the - To confirm that you are following the correct testing procedures.

  • Page 26: Performing A Quality Control Test

    Performing a Quality Control Test Performing a Quality Control Test 1. Take one RIGHTEST Max Blood Glucose Test Strip from the vial and 9. Tightly replace the cap on RIGHTEST Max Control Solution bottle. CLOSE 10. The control solution result will appear. Compare your Quality Control Test result close the vial cap immediately.

  • Page 27: Understanding Control Test Results

    - RIGHTEST Blood Glucose Meter or RIGHTEST Blood Glucose Test Strip have malfunctioned. disinfecting procedure can eliminate non-visible pathogens. If RIGHTEST Max Control Solution results are out of range, your RIGHTEST Blood Glucose If the meter is being operated by a second person who is providing testing assistance to the user, Monitoring System may not be working properly.
  • Page 28 Maintain the Products Maintain the Products - CAVIWIPES DISINFECTING TOWELETTES, manufacturer: Metrex. It is with Isopropanol as the Cleaning and Disinfecting frequency: at least once a week. active ingredient, have been shown to be safe for use with the meter and lancing device. To clean the meter: 1.
  • Page 29 If you have any questions or concerns, please contact your RIGHTEST Max Blood Glucose Monitoring System authorized distributor or contact your local Bionime customer service.

  • Page 30: Error Messages And Troubleshooting

    Error Messages and Troubleshooting Error Messages and Troubleshooting Temperature Error Battery Error 1. In order to get accurate testing results, please test between 6°C (43°F) and 44°C 1. The " " symbol is blinking when the battery power is low. Please change battery as soon as you can.
  • Page 31 Please consult your User Manual and/or contact Customer (2) Turn off the meter (press and hold the Main button for 3 seconds). Service for support on how to correctly insert a RIGHTEST Max Blood Glucose Test Strip. (3) Press the main button to turn ON the meter.

  • Page 32: Specification

    " " for 3 seconds. Sample Minimum Sample Volume Operating Temperature 6 - 44 °C (43 - 111 °F) Refer to RIGHTEST Max test strip insert Hematocrit Operating Relative Humidity 10 - 90% Test Strip Storage/ Transportation Conditions...

  • Page 33: Warranty

    Warranty Customer Service Bionime Corporation warrants that this product will be free from defects in materials and We sincerely like to provide complete, considerate services to our customers. Please review all the workmanship for five years from the date of purchase.

  • Page 34: Expected Glucose Values

    Product complies with in vitro Diagnostic Medical Device Directive 98/79/EC (CE 0197). Normal fasting glucose From 70 to 99 mg/dL (3.9 to 5.5 mmol/L) EC-Rep: Bionime GmbH, Tramstrasse 16, 9442 Berneck, Switzerland 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...

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