NIPRO Diagnostics TRUE METRIX Owner's Booklet
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NIPRO Diagnostics TRUE METRIX Owner's Booklet

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SELF MONITORING BLOOD GLUCOSE SYSTEM
Owner's
Booklet
Use only with TRUE METRIX
Self Monitoring Blood Glucose
Test Strips
24/7 Customer Consultation
English or Spanish
1-800-803-6025
www.niprodiagnostics.com
Manufactured by:
Fort Lauderdale, FL 33309 U.S.A.
© 2015 Nipro Diagnostics, Inc.
TRUE METRIX and the Nipro Diagnostics logo
are trademarks of Nipro Diagnostics, Inc.
RE4NPD03 Rev. 6
®

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  • Page 1 Self Monitoring Blood Glucose Test Strips 24/7 Customer Consultation English or Spanish 1-800-803-6025 www.niprodiagnostics.com Manufactured by: Fort Lauderdale, FL 33309 U.S.A. © 2015 Nipro Diagnostics, Inc. TRUE METRIX and the Nipro Diagnostics logo are trademarks of Nipro Diagnostics, Inc. RE4NPD03 Rev. 6...
  • Page 2 SELF MONITORING BLOOD GLUCOSE SYSTEM Fast Test Guide 2 simple steps INSERT APPLY TEST STRIP BLOOD SAMPLE For quick reference only, not intended as a substitute for complete instructions. Please read entire Owner’s Booklet and product Instructions for Use before testing. Expected Results for people without diabetes: Plasma Blood Glucose Result Before eating...

  • Page 3: Introduction And Important Information

    INTRODUCTION: TRUE METRIX® Self Monitoring Blood Glucose System TRUE METRIX is a simple, accurate way to test your whole blood glucose (sugar) level, anytime, anywhere. Our goal is to provide quality healthcare products and dedicated customer service. For questions about TRUE METRIX products, visit our web site at: www.niprodiagnostics.com.
  • Page 4 The TRUE METRIX Self Monitoring Test Strips are for use with the TRUE METRIX Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. The TRUE METRIX Self Monitoring Meter...

  • Page 5: Important Information

    For the most accurate results using TRUE METRIX: • Read all product instructions for use before testing. • Use of TRUE METRIX in a manner not specified in this Owner’s Booklet is not recommended and may affect ability to determine true blood glucose levels.
  • Page 6 Control Solution are available for Control Tests. Call 1-800-803-6025 for assistance in obtaining control solution. • The TRUE METRIX Self Monitoring Blood Glucose System is for one person use ONLY. DO NOT share your meter or lancing device with anyone, including family members.
  • Page 7 IMPORTANT INFORMATION (cont.): • If you have symptoms of low or high blood glucose, check your blood glucose immediately. If your result does not match the way you feel, repeat the test. If your results still do not match the way you feel, call your Doctor or Healthcare Professional.

  • Page 8: Table Of Contents

    How to Test Control Solution ..........17 Testing your Blood Obtaining a Blood Sample............21 How to Test Blood ..............25 TRUE METRIX System and Laboratory Testing ....29 System Out of Range Warning Messages .......30 Meter Set Up Set Time and Date ..............31 Set Event Tags, Ketone Test Alert and Test Reminders ..33...

  • Page 9: Know Your System Meter

    Know Your System Meter Top of Meter ① “ ◀ ” Button Decrease numbers in Meter Set Up; add ALT Symbol; move backward by date/time when viewing results and Averages in Memory; scroll through Event Tags to mark results (if feature on). ②...
  • Page 10 Front of Meter Back of Meter ① Display Screen Shows results, messages, user prompts, information. ② Test Port Insert TRUE METRIX Test Strip here, contact blocks facing up. ③ Strip Release Button Releases test strip after testing for disposal. ④ Battery Door Use one non-rechargeable 3V lithium battery (#CR2032), positive (“+”) side up...
  • Page 11 Full Display Screen 10 11 12 1. Result is from Memory 2. Time, Date 3. Time is AM/PM 4. Event Tag Symbols 5. Result is from 7, 14, or 30 day Average 6. Test Result 7. Control Symbol 8. Battery Symbol 9.

  • Page 12: Test Strip

    Test Strip Top of Test Strip ① Contact End - Insert into Test Port with contact blocks facing up. ② Sample Tip - Bring Tip of test strip to top of sam- ple drop (blood or control solution) after Drop Symbol appears in the Display.
  • Page 13 Test Strip Vial Label May 30, 2015 ① Lot Number (LOT) - Used for identification when calling for assistance. ② Expiration Dates (EXP) - Write date first opened on vial label. Discard vial and unused test strips if either 4 months after first opening or date printed next to EXP on vial label has passed, whichever comes first.

  • Page 14: Control Solution

    Control Solution (Control) Control Solution Bottle Label ① Lot Number (LOT) - Used for identification when calling for assistance. ② Expiration Dates (EXP) - Write date first opened on bottle label. Discard bottle if either 3 months after first opening or date printed next to EXP on bottle label has passed, whichever comes first.

  • Page 15: Getting Started

    Getting Started Meter comes with pre-set time and date. The Event Tag feature, Ketone Test Alert, and all Test Reminders are off. Before using the meter for the first time or after a battery change, check the time, date, Event Tags, Alert and Reminders, and update as needed (see Meter Set Up).
  • Page 16 Getting Started (cont.) Event Tags allow you to tag your blood glucose results to link to the following events: Before meal –test was taken just before a meal, After meal –test was taken 2 hours after the start of a meal, Exercise –...

  • Page 17: Quality Control Solution

    Quality Control Testing To assure you are getting accurate and reliable results, TRUE METRIX offers two kinds of quality Control Tests. These tests let you know that your System is working properly and your testing technique is good. Automatic Self-Test...

  • Page 18: Control Test

    Note: It is important to perform Control Tests with more than one level of control solution. Three levels of TRUE METRIX Control Solution are available for Control Tests. Call 1-800-803-6025 for assistance in obtaining different levels of control solution.

  • Page 19: How To Test Control Solution

    How to Test Control Solution Use ONLY TRUE METRIX Control Solution with the TRUE METRIX Self Monitoring Meter and Test Strips. 1. Check dates on control solution label and test strip vial label. Do not use control solution or test strips if expiration dates have passed.
  • Page 20 5. Insert test strip into Test Port. Meter turns on. Note: If test strip has been out of the vial too long before testing, an error message appears upon insertion of the test strip into the meter. Contact Blocks Face Up Release and discard old test strip.
  • Page 21 9. With test strip still in meter, touch Sample Tip of test strip to top of drop of control solution. Allow drop to be drawn into test strip. Remove test strip from drop when meter beeps. 10. Dashes appear across the Display to show meter is testing.
  • Page 22 Caution! If Control Test result is outside range, test again. If result is still outside range, system should not be used for testing blood. Call 1-800-803-6025. 12. After result is shown, Strip Release Button flashes. Hold meter with test strip pointing down.

  • Page 23: Obtaining A Blood Sample

    Obtaining a Blood Sample WARNING! • The TRUE METRIX Self Monitoring Blood Glucose System is for one person use ONLY. DO NOT share your meter or lancing device with anyone, including family members. Do not use on multiple patients!! • ALL parts of your blood glucose monitoring system could carry blood-borne pathogens after use, even after cleaning and disinfecting.
  • Page 24 Obtaining a Blood Sample (cont.) Refer to lancing device Instructions for Use for detailed instructions. • Never share lancets or lancing device. Lancets are for single use only. Do not re-use. • Do not use venous blood for testing. • To help prevent false high results, wash hands before using the system to test blood, especially after fruit has been handled.
  • Page 25 From Forearm Important Notes Regarding Forearm Testing • Check with your Doctor or Healthcare Professional to see if forearm testing is right for you. • Results from forearm are not always the same as results from fingertip. • Use fingertip instead of forearm for more accurate results: ~ Within 2 hours of eating, exercise, or taking insulin, ~ If your blood sugar may be rising or falling rapidly or...
  • Page 26 4. Recap and remove lancet from lancing device. The used lancet may be biohazardous. Please discard it carefully according to your healthcare provider's instructions. Caution! The used lancet may be biohazardous. Please discard it carefully according to your healthcare provider's instructions.

  • Page 27: How To Test Blood

    How to Test Blood 1. Check dates on test strip vial being used. Do not use if either 4 months after first opening or after date printed next to EXP on label, whichever comes first. 2. Wash hands (and forearm for alternative site testing).
  • Page 28 5. Lance fingertip or forearm. Allow drop to form (see Obtaining a Blood Sample). 6. With test strip still in meter, touch Sample Tip of test strip to top of blood drop and allow blood to be drawn into test strip. Remove test strip from blood drop immediately after the meter beeps and dashes appear across the Display.
  • Page 29 7. After the test is finished, result is displayed. The Strip Release Button flashes. To mark the result with an Event Tag, make sure that Event Tags are turned on Test Result (see Set Event Tags, Ketone Alert and Test Reminders).
  • Page 30 8. Hold meter with test strip pointing down. Press test strip Release Button to discard test strip in the appropriate container. Meter turns off. Result is stored in Memory with date and time. Note: Removing test strip before result displays cancels the test.

  • Page 31: True Metrix System And Laboratory Testing

    System blood tests should be performed within 30 minutes of a laboratory test. If you have recently eaten, fingerstick results from the TRUE METRIX Self Monitoring Blood Glucose System can be up to 70 mg/ dL higher than venous laboratory results.

  • Page 32: System Out Of Range Warning Messages

    System Out of Range Warning Messages WARNING! Meter reads blood glucose levels from 20-600 mg/dL. If test result is less than 20 mg/dL, “Lo” appears in Display. If test result is greater than 600 mg/dL, “Hi” appears in Display. ALWAYS repeat blood tests to confirm Low (“Lo”) and High (“Hi”) results.

  • Page 33: Meter Set Up

    Meter Set Up Note: If the meter turns off at any time during Set Up, go back to Step #1 under Meter Set Up and begin again. 1. With meter off, press and hold “ • ” Button until the full Display is shown and a series of beeps sound (after about 10 seconds).
  • Page 34 4. The month (number) flashes. To change, press “ ▶ ” or “ ◀ ” Button to select the month. Press “ • ” Button to set. 5. The day (number) flashes. To change, press “ ▶ ” or “ ◀ ” Button to select the day.

  • Page 35: Set Event Tags, Ketone Test Alert And Test Reminders

    Set Event Tags, Ketone Alert and Test Reminders Meter comes with Event Tags, Ketone Test Alert and all Test Reminders off. Note: If the meter turns off at any time during Set Up, go back to Step #1 under Meter Set Up and begin again. Event Tags Event Tags are used to mark a test result that was taken during a specific event.
  • Page 36 Test Reminder Up to four Test Reminders per day may be set. Reminder sounds at set time for 10 seconds. Meter comes with all Test Reminders off. To set the Test Reminders: 1. After pressing “ • ” Button to set Ketone Test Alert, Display shows first Reminder setting (A-1).
  • Page 37 4. Turn Reminders on and repeat setting the time for next 3 Reminders (if needed). Exit Set-Up Press and hold “ • ” Button until meter turns off. Meter also turns off after 2 minutes of non use. Set Up choices are saved.

  • Page 38: Meter Memory View Averages (7-, 14-, And 30-Day)

    Meter Memory View Averages (7-, 14-, and 30-day) The Averages feature allows you to view the average of all your blood glucose results within a 7-, 14-, or 30-day period. Control Test results are not included in the Averages. You can review the average of your glucose 7-Day results from the last 7-, 14-, or 30-days.

  • Page 39: View Results

    View Memory Meter Memory stores 500 results. When Memory is full, the oldest result is replaced with the newest result. 1. Press and release “ • ” Button. Memory Symbol Meter displays 7-, 14- and 30-day Averages. Press and release “ • ” Button again to view most recent Control Test result in Memory.

  • Page 40: Care, Cleaning/Disinfecting And Troubleshooting

    Care, Cleaning/Disinfecting and Troubleshooting • Store System (meter, control solution, test strips) in Carrying Case to protect from liquids, dust and dirt. • Store in a dry place at temperatures between 40°F-86°F. DO NOT FREEZE. • Do not share your meter with anyone, including family members.
  • Page 41 To Clean and Disinfect the Meter: 1. Wash hands thoroughly with soap and water. 2. To Clean: Make sure meter is off and a test strip is not inserted. With ONLY PDI Super Sani Cloth Wipes (EPA* reg. no. 9480-4), rub the entire outside of the meter using 3 circular wiping motions with moderate pressure on the front, back,...
  • Page 42 5. Wash hands thoroughly again after handling meter. 6. Verify that the System is working properly by performing an Automatic Self-Test (see Getting Started). Stop using the meter and call Customer Care for assistance at 1-800-803-6025 if: • Meter display appears cloudy or any display segments are missing, •...
  • Page 43 Lancing Device Care, Cleaning and Disinfecting Cleaning removes blood and soil from the lancing device. Disinfecting removes most, but not all possible infectious agents (bacteria or virus) from the lancing device, including blood-borne pathogens. • Clean and disinfect immediately after getting any blood on the lancing device or if lancing device is dirty.
  • Page 44 3. To Disinfect: Using fresh wipes, make sure that all outside surfaces of the lancing device remain wet for 2 minutes. Super Sani-Cloths may be purchased at the following places: • Amazon.com, • Officedepot.com or visit your local store, • Walmart.com 4.
  • Page 45 • After each use, wipe bottle tip clean and recap tightly. • Store at temperatures between 36°F-86°F. DO NOT FREEZE. TRUE METRIX Self Monitoring Test Strip Care • Store test strips in original vial only. Do not transfer test strips to new vial or store test strips outside of vial.

  • Page 46: Changing Battery

    Changing Battery A low battery displays Battery Symbol while continuing to function. A dead battery displays Battery Symbol, beeps, and then turns off. To replace battery: 1. Lift tab on Battery Door. 2. Turn meter over, tap gently on the palm of your other hand to loosen and remove battery.

  • Page 47: Troubleshooting

    Troubleshooting 1. After inserting test strip, meter does not turn on. Reason Action Test strip inserted upside Remove test strip. down or backwards Re-insert correctly. Test strip not fully Remove test strip. Re-insert inserted test strip fully into meter. Test strip error Repeat with new test strip.

  • Page 48: Display Messages

    Messages Display Reason Action Repeat with new test strip, using capillary whole Invalid blood from the finger or Hematocrit forearm. If error persists, call 1-800-803-6025. Move meter and test Temperature strips to area between Error 41°F-104°F; wait • 10 minutes for system to Too Cold/ reach room temperature Too Hot...

  • Page 49: Removing Test Strip

    Display Reason Action Retest with new test strip. If error persists, call Test Strip 1-800-803-6025. If you have Error, or very symptoms such as fatigue, high blood excess urination, thirst, or glucose result blurry vision follow your (higher than healthcare professional’s 600 mg/dL) advice for high blood glucose.
  • Page 50 Display Reason Action Do not use meter Broken for testing. Display Call 1-800-803-6025. WARNING!! WARNING!! Retest with new test Out of Range strip. If result is still - High Results “Hi” (High) > 600 mg/dL “Lo” (Low) - Low Results contact Doctor <...

  • Page 51: System Specifications/Chemical Composition

    Altitude: Up to and including 10,200 feet Note: Use within specified environmental conditions only. Chemical Composition TRUE METRIX Test Strips: Glucose dehydrogenase-FAD (Aspergillus species), mediators, buffers and stabilizers. TRUE METRIX Control Solution: Water, d-glucose, buffers, viscosity enhancing agent, salts, dye and...

  • Page 52: Meter Warranty

    TRUE METRIX Self Monitoring Limited Lifetime Warranty Nipro Diagnostics, Inc. provides the following Warranty to the original purchaser of the TRUE METRIX Self Monitoring Blood Glucose Meter: Nipro Diagnostics Inc. warrants this meter to be free of defects in materials and workmanship at the time of purchase.

  • Page 53: References

    References American Diabetes Association. Diagnosis and Classification of Diabetes Mellitus. Diabetes Care, Volume 37, Supplement 1, January 2014. FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood Borne Pathogens: Initial Communication (2010) http://www.fda.gov/ MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.

  • Page 54: Notes

    Notes: RE4NPD03 Rev. 6 EN...

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