Nipro True2go Owner's Booklet

Nipro True2go Owner's Booklet

Blood glucose monitoring system

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Use only with TRUEtest
Blood Glucose Test Strips
Manufactured by:
© 2014 Nipro Diagnostics, Inc.
TRUE2go, TRUEtest, TRUEresult and the
Nipro Diagnostics logo are trademarks of
Nipro Diagnostics, Inc.
F4NPD03 Rev. 24
Owner's
Booklet
24/7 Customer Consultation
English or Spanish
1-800-803-6025
1-954-677-4599
www.niprodiagnostics.com
Scan this code with your smart phone
for additional TRUE2go information.
Always refer to the Owner's Booklet
for detailed product information.

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Summary of Contents for Nipro True2go

  • Page 1 Use only with TRUEtest Blood Glucose Test Strips Manufactured by: © 2014 Nipro Diagnostics, Inc. TRUE2go, TRUEtest, TRUEresult and the Scan this code with your smart phone Nipro Diagnostics logo are trademarks of for additional TRUE2go information. Nipro Diagnostics, Inc.
  • Page 2: Fast Test

    Fast Test Guide simple steps INSERT TEST STRIP APPLY 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: TRUE2go™ Blood Glucose Monitoring System TRUE2go is a simple, accurate way to test whole blood glucose (sugar) level, anytime, anywhere. Our goal is to provide quality healthcare products and dedicated customer service. For questions about TRUE2go products, visit our web site at: www.niprodiagnostics.com.
  • Page 4 • NEVER add a second drop of sample to Strip. Adding more sample gives an error message. The TRUE2go Blood Glucose Monitoring System is for one person use ONLY. DO NOT share your Meter or your Lancing Device with anyone, including family members.
  • Page 5 FOR PATIENTS IMPORTANT HEALTH and SAFETY INFORMATION: • DO NOT use the TRUE2go System to test your blood glucose if you are undergoing peritoneal dialysis (dialysis through the abdomen/stomach area). • DO NOT use the TRUE2go System to test your blood glucose if you are receiving medical...
  • Page 6 FOR HEALTHCARE PROFESSIONALS IMPORTANT HEALTH AND SAFETY INFORMATION: DO NOT use the TRUE2go System for patients receiving the following treatments: • Peritoneal dialysis using solutions containing icodextrin (Extraneal , Icodial ) that is ® ® metabolized to maltose, • Injections or infusions of solutions containing...
  • Page 7 Safe Practices Recommendations for Healthcare Professionals: • At patient admission/presentation and periodically throughout the patient’s stay at the facility, assess the presence and use of therapies containing interfering drugs (see previous page). • Use only laboratory methods for monitoring blood glucose levels in patients receiving interfering drugs.
  • Page 8 TRUE2go are considered accurate if within 20% of laboratory results. If patient has recently eaten, fingerstick results from TRUE2go can be up to 70 mg/dL higher than venous laboratory results. DO NOT perform capillary blood glucose testing on critically ill patients. Capillary blood glucose...
  • Page 9: Important Information

    IMPORTANT INFORMATION: For the most accurate results using TRUE2go: • Read all instructions before testing. • TRUE2go is an in vitro (outside body) quantitative system that is used for self-testing and point-of-care testing of human whole blood only. • Meter displays results as plasma values.
  • Page 10: Table Of Contents

    Know Your System Meter .................... 9 Test Strip ..................10 Test Strip Vial Label ..............11 Glucose Control Bottle Label ..........12 Attach/Remove TRUE2go Meter to Test Strip Vial ...13 Getting Started Quality Control ..............14-15 Control Test ................ 16-19 Testing your Blood Obtaining a Blood Sample ..........
  • Page 11: Know Your System Meter

    Know Your System Meter Top of Meter Bottom of Meter ① Set Button - Turn Meter on for Memory, view/ scroll results in Memory, mark result as Alternate Site. ② Display - Shows results, messages, user prompts, information. ③ Drop Symbol - Apply blood or Glucose Control. ④...
  • Page 12: Test Strip

    Test Strip Top of Test Strip ① Contact End - Insert into Test Port with blocks (contacts) facing up. ② Sample Tip - Bring sample (fresh, capillary or venous blood or Glucose Control) to edge of Tip. Note: Insert Strip into Meter before touching Sample Tip to blood or Control drop.
  • Page 13: Test Strip Vial Label

    Test Strip Vial Label May 30, 2014 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 Strips if either 4 months after opening or date printed next to EXP on vial label has passed, whichever comes first.
  • Page 14: Glucose Control Bottle Label

    Glucose Control 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 opening or date printed next to EXP on bottle label has passed, whichever comes first.
  • Page 15: Attach/Remove True2Go Meter To Test Strip Vial

    To Attach / Remove TRUE2go Meter to TRUEtest Test Strip Vial The TRUE2go Meter is made to attach to the top of the Test TRUEtest Test Strip vial cap. Port To attach: Vial Lip 1. Set Test Strip vial on flat surface with vial lip facing front.
  • Page 16: Getting Started

    Getting Started The Meter turns on when a Test Strip is inserted into the Test Port or when Set Button is pressed (see Memory). Meter turns off when the Strip is released or after 2 minutes of non-use.
  • Page 17: Quality Control

    Quality Control Testing To assure you are getting accurate and reliable results, TRUE2go offers two kinds of quality control tests. These tests let you know that your TRUE2go System is working properly and your testing technique is good. Automatic Self-Test...
  • Page 18: Control Test

    Control Test We recommend performing Control Tests for practice before using your Meter for the first time to test your blood. Control Tests should be performed: • For practice to ensure your testing technique is good, • Occasionally as you use the vial of Strips, •...
  • Page 19 How to Test Glucose Control Use ONLY TRUEtest Glucose Control Solution with the TRUE2go. 1. Allow Control, vial of Strips and Meter to adjust to 68-77ºF (room temperature). Write date first opened on Control bottle label and Strip vial label.
  • Page 20 6. Wait until Drop Symbol appears in Display. Keep Strip in Meter until testing is finished. Note: If Strip is removed before testing Drop Symbol is finished, an error message appears. Release and discard old Strip. Use new Strip for testing. 7.
  • Page 21 11. Compare result to Control Range printed on Strip vial label for Control Level you are using. Glucose Control Bottle Label If result is in range, System can be used for testing blood. If result does not fall within range, repeat test using a new Strip.
  • Page 22: Obtaining A Blood Sample

    Obtaining a Blood Sample Refer to Lancing Device “Instructions for Use” for detailed instructions. Caution! The Lancing Device is for single patient use ONLY. For cleaning/disinfecting your Lancing Device see Lancing Device Care in the Lancing Device Instructions for Use. Wash your hands thoroughly with soap and warm water after handling the Meter, Lancing Device, or Test Strips.
  • Page 23 From Forearm 1. Select area to be lanced. Wash with soap and warm water, rinse and dry thoroughly. 2. Rub area vigorously or apply a warm compress to increase blood flow. 3. Place end of Lancing Device firmly against forearm. Press trigger button. Apply firm pressure on lancing device for 10 seconds.
  • Page 24: Testing Blood Glucose

    How to Test Blood Glucose 1. Check dates on Test Strip vial being used. Do not use if either 4 months after opening or after date printed next to EXP on label, whichever comes first. 2. Wash hands (and forearm for alternate site testing).
  • Page 25 With Test Strip still in Meter, touch edge of Sample tip to blood drop and allow blood to be drawn into Strip. Remove Test Strip Sample Tip from sample drop immediately after dashes appear across the Meter Display. Note: If Meter does not begin testing soon after touching blood drop to Sample Tip, discard Strip.
  • Page 26: System Out Of Range Warning Messages

    System Out of Range Warning Messages WARNING! Meter reads blood glucose levels from 20-600 mg/dL. If blood test result is less than 20 mg/dL, “Lo” appears in Meter Display. If blood test result is greater than 600 mg/dL, “HI” appears in Meter Display. ALWAYS repeat test to confirm Low (“Lo”) and High (“HI”) results.
  • Page 27: Meter Memory Viewing Results In Memory

    Memory Memory stores 99 results. When Memory is full, the oldest result is replaced with the newest result. Press and release the Set Button. Meter turns on to view results in Memory. The last result is shown first. Press and release Set Button again to go to the next result in Memory.
  • Page 28: Caring For True2Go

    Caring for TRUE2go • Store System (Meter, Glucose Control, Test Strips) in Carrying Case to protect from liquids, dust and dirt. • Store in a dry place at room temperature (36-86°F). DO NOT REFRIGERATE OR FREEZE. Meter Care, Cleaning/Disinfection Cleaning removes blood and soil, disinfecting removes infectious agents.
  • Page 29 TRUEtest Glucose Control Care • Write date opened on Control label. Discard if either 3 months after opening or after date printed next to EXP on label has passed, whichever comes first. • After use, wipe bottle tip clean and recap tightly. •...
  • Page 30: Changing Battery

    If “Lb” or “db” appears in Display, change battery. To replace battery: 1. Remove Meter from vial (see Attach/ Remove TRUE2go Meter to TRUEtest Test Strip Vial). 2. Turn Meter over to see Meter label and Battery Cover are showing.
  • Page 31 8. Discard old battery in appropriate container. 9. Press Set Button to turn Meter on. If Meter does not turn on, check that battery was installed properly with “ + ” facing up. If not, remove and reinsert battery and try again. Call for assistance if problem persists.
  • Page 32: Troubleshooting

    Troubleshooting 1) After inserting Test Strip, Meter does not turn on. Reason Action Strip inserted upside Remove Strip. Re-insert down or backwards correctly. Strip not fully inserted Remove Strip. Re-insert Strip fully into Meter. Strip Error Repeat with new Strip. Replace battery.
  • Page 33: Display Messages

    Messages Display Reason Action Temperature Move Meter and Strips Error to area between • 50-104ºF; wait 10 minutes Too Cold/ for System to reach room Too Hot temperature before testing. Sample Not Detected or Retest with new or Using Wrong correct Strip and Test Strip larger sample.
  • Page 34 Messages (continued) Display Reason Action Strip Retest with new Strip. Removed Make sure result During Test is displayed before removing Strip. Result was not recorded in Memory Memory. Retest with new Error Strip. If error persists, call for assistance. About 50 tests can be done before Battery battery dies.
  • Page 35: System Specifications/Chemical Composition

    System Specifications Result Range: 20-600 mg/dL Sample Size: Minimum 0.5 microliter (0.5 µL) Sample: Fresh capillary whole blood, venous blood drawn in EDTA or heparin tubes, or Glucose Control Test Time: Results in as little as 4 seconds Result Value: Plasma equivalent values Assay Method: Electrochemical Power Supply: One 3V Lithium Battery #CR2032 (non-rechargeable)
  • Page 36: Meter Warranty

    Nipro Diagnostics, Inc. provides the following Warranty to the original purchaser of the TRUE2go Blood Glucose Meter: 1) Nipro Diagnostics Inc. warrants this Meter to be free of defects in materials and workmanship at the time of purchase. If the...
  • Page 37: References

    References 1. American Diabetes Association. Diagnosis and Classification of Diabetes Mellitus. Diabetes Care, Volume 36, Supplement 1, January 2013. 2. 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.

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