Nipro TRUE result Owner's Booklet
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Nipro TRUE result Owner's Booklet

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BLOOD GLUCOSE MONITORING SYSTEM
NO
NO
CODING
CODING
For assistance, please call 1 800 451 737.
Nipro Australia Pty Ltd.
Suite 3, 500 Pacific Highway
St Leonards, NSW 2065
support@niproaustralia.com.au
© 03/2011 Nipro Diagnostics, Inc.
E4IAU03FD Rev. 20
BLOOD GLUCOSE MONITORING SYSTEM
Owner's Booklet
Owner's Booklet
NO
NO
CODING
CODING
• PRECISE,
FAST RESULTS
• EASY TO USE
• TINY SAMPLE SIZE
ZE
True P
True Performance
P
e r
e
r
f
f
o
o
r
r
m ance
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  • Page 1 Nipro Australia Pty Ltd. CODING CODING Suite 3, 500 Pacific Highway St Leonards, NSW 2065 support@niproaustralia.com.au • PRECISE, True Performance True P m ance FAST RESULTS • EASY TO USE • TINY SAMPLE SIZE © 03/2011 Nipro Diagnostics, Inc. E4IAU03FD Rev. 20...
  • Page 2 The TRUEresult Blood Glucose Monitoring System is intended for the quantitative BLOOD GLUCOSE MONITORING SYSTEM determination of glucose in human whole blood taken from the finger or forearm (capillary or venous). The System may not be Fast Test Guide used for neonates. The System is intended for at-home use (self-testing) and for use by simple steps healthcare professionals in both physicians’...

  • Page 3: Introduction And Important Information

    INTRODUCTION: TRUEresult Blood Glucose Monitoring System TRUEresult 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 TRUEresult products, please see cover for phone number.
  • Page 4 FOR PATIENTS IMPORTANT HEALTH and SAFETY INFORMATION: 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 5: Important Information

    Important Information: The most accurate results come from using fresh, capillary whole blood from the fingertip or forearm. Venous whole blood collected into sodium or lithium heparin vacutainer tubes may be used for testing by healthcare professionals. Use of EDTA vacutainer tubes (purple top) is not recommended and may cause low results.
  • Page 6 IMPORTANT INFORMATION: For the most accurate results using TRUEresult: • Read all instructions before testing. • TRUEresult is an in vitro (outside body) quantitative system that is used for self-testing and point-of-care (bedside) testing of human whole blood only. • Meter displays results as Plasma values. •...

  • Page 7: Table Of Contents

    Phone Number, Fast Test Guide ...........................see covers Introduction and Important Information ....... 1-4 Table of Contents ..............5 Know Your System Meter ................6-7 Meter Display ...............8 Test Strip ................9 Test Strip Vial Label ............10 Glucose Control Bottle Label ..........11 Getting Started Quality Control .............

  • Page 8: Know Your System Meter

    Know Your System Meter Top of Meter ➀ “ + ” Button Increase numbers in Meter Set Up; add ALT Symbol; move forward by date/time when viewing results in Memory. ➁ “ S ” Button Turn Meter on to view Average values, to view results in Memory, and to access Meter Set Up.
  • Page 9 Front of Meter Back of Meter ➀ Display Screen Shows results, messages, user prompts, information. ➁ Test Port Insert TRUEresult Test Strip here. ➂ Strip Release Button Releases Strip after testing. ➃ Battery Door Use one non-rechargeable 3V lithium battery (#CR2032), positive (“+”) side up (see Changing Battery).

  • Page 10: Meter Display

    Full Display Screen 1. Result is from Memory 2. Time, Date 3. Time is AM/PM 4. Result is from 7, 14, or 30 day Average 5. Day of Week 6. Test Result 7. Units of Measure (Note: Factory set, cannot be changed by user.) 8.

  • Page 11: Test Strip

    Test Strip Top of Test Strip ➀ Contact End - Insert into Test Port with blocks (contacts) facing up. ➁ 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 12: Test Strip Vial Label

    Test Strip Vial Label May 30, 2012 May 30, 2012 ➀ Lot Number ( ) - Used for identification when calling for assistance. ➁ Expiry Dates ( ) - Write date first opened on vial label. Discard vial and unused Strips if either 4 months after opening or date printed next to on vial label has passed.

  • Page 13: Glucose Control Bottle Label

    Glucose Control Bottle Label ➀ Lot Number ( ) - Used for identification when calling for assistance. ➁ Expiry Dates ( ) - Write date first opened on bottle label. Discard bottle if either 3 months after opening or date printed next to on bottle label has passed.

  • Page 14: Getting Started

    Getting Started The Meter turns on when a Test Strip is inserted into the Test Port or when “ S ” Button is pressed (see Memory and Meter Set Up). Meter turns off when the Strip is released from the Meter or after 2 minutes of non-use.
  • Page 15 Automatic Self-Test An Automatic Self-Test is performed by the Meter each time a TRUEresult Test Strip is inserted correctly into the Test Port. Insert a Strip into the Test Port. The Meter is working properly if: - the full Display appears, then - the time appears in the upper part of the Display, and then, Full Display...

  • Page 16: Control Test

    Control Test Control Tests check that the System is working properly and your testing technique is good. Use ONLY TRUEresult Glucose Control to perform Control Tests. There are two levels of TRUEresult Glucose Control Solution available that contain known amounts of glucose.
  • Page 17 How to Test Glucose Control 1. Allow Control, vial of Strips and Meter to adjust to 15-30ºC (room temperature). Write date first opened on Control bottle label and Strip vial label. Note: Running a Control Test at temperatures outside the range listed above may cause Control to read as a blood test.
  • Page 18 6. Wait until Drop Symbol appears in Display. Keep Strip in Meter until testing is finished. Note: If Strip is removed before testing is finished, an error message Drop Symbol appears. Release and discard old Strip. Use new Strip for testing.
  • Page 19 11. Compare result to Control Range printed on Strip vial label for Glucose Control Bottle Label Control Level you are using. If result is in range, Test Strip System can be used Vial Label for testing blood. If result does not fall within range, repeat test using a new Strip.

  • Page 20: Obtaining A Blood Sample

    Obtaining a Blood Sample Refer to Lancing Device “Instructions for Use” for detailed instructions. • Never share a lancet or lancing device. • Lancets are for single use only. Do not reuse lancets. From Fingertip 1. Prepare fingertip by washing hands in warm, soapy water.
  • Page 21 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 dry compress to increase blood flow. 3. Place end of Lancing Device firmly against forearm. Press trigger button.

  • Page 22: 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 on label. 2. Wash hands (and forearm for alternate site testing). Rinse well and dry thoroughly. 3.
  • Page 23 7. 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 the Meter beeps and dashes appear across Meter Display. Holding the Test Strip Sample Tip to the blood sample too long after the Meter begins testing may cause...

  • Page 24: System Out Of Range Warning Messages

    System Out of Range Warning Messages Meter reads blood glucose levels from 1.1- 33.3 mmol/L (20-600 mg/dL). If blood test result is less than 1.1 mmol/L (20 mg/dL), “Lo” appears in Meter Display. If blood test result is greater than 33.3 mmol/L (600 mg/dL), “HI”...

  • Page 25: 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. Press and hold “ S ” until the full Display is shown and a tone sounds (around 30 seconds).
  • Page 26 4. The month (number) flashes. To change, press “ + ” or “ - ” to select the month. Press “ S ” to set. 5. The day (number) flashes. To change, press “ + ” or “ - ” to select the day.

  • Page 27: Alert And Reminders

    Setting Alert Ketone Testing Alert Note: If the Meter turns off at any time during Set Up, go back to Step #1 under Meter Set Up and begin again. When a blood glucose result is over 13.3 mmol/L (240 mg/dL), the Ketone Testing Alert is a reminder to check your ketones per your treatment plan.
  • Page 28 Testing Reminder Up to four Testing Reminders per day may be set. Reminder sounds at set time for 10 seconds. To set the Testing Reminders: 1. After pressing “ S ” to set Ketone Testing Alert, Display shows first Reminder setting (A-1). Press “ + ” (on) or “...
  • Page 29 5. Turn Reminders on and repeat setting the time for next 3 Reminders (if needed). 6. Press and hold “ S ” when finished to turn off Meter. Meter turns off after 2 minutes of non-use. Note: If Alert or Testing Reminders are set, the Alert Symbol appears in all Displays.

  • Page 30: Viewing Averages (7, 14 And 30-Day)

    Viewing 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 normally included in the Averages. Note: If a Control Test is performed outside the recommended testing temperature (see How to...

  • Page 31: Viewing Results In Memory

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

  • Page 32: Caring For Trueresult

    Caring for TRUEresult • Store System (Meter, Glucose Control, Test Strips) in Carrying Case to protect from liquids, dust and dirt. • Store in a dry place at 30°C 2-30°C (room temperature). DO NOT REFRIGERATE 2°C OR FREEZE. Meter Care •...
  • Page 33 TRUEresult Test Strip Care • Store Strips in original vial only. Do not transfer old Strips to new vial or store Strips outside of vial. • Write date opened on Strip vial. Discard unused Strips in vial if either 4 months after opening or after date printed next to on label has passed.

  • Page 34: 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 Battery Door the palm of your other hand to loosen and remove battery.
  • Page 35 Batteries might explode if mishandled or incorrectly replaced. Do not dispose of battery in fire. Do not take apart or attempt to recharge battery. Dispose according to local/country specific regulations.

  • Page 36: 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. Dead or no battery Replace battery.

  • Page 37: Display Messages

    Messages Display Reason Action Temperature Move Meter and Strips Error to area between 10-40ºC; • wait 10 minutes Too Cold/ for System to Too Hot reach room temperature before testing. Sample Not Retest with new Detected or TRUEresult Test Strip Using Wrong and larger sample.
  • Page 38 Messages (continued) Display Reason Action Strip Retest with new Strip. Removed Make sure result During Test is displayed before removing Strip. Wrong Test Strip used. Test Strip Use only TRUEresult Error Test Strips. Communication Call for assistance. Error Low: About 50 tests can be Low or done before battery dies.
  • Page 39 FOR CONSUMERS • Performance Characteristics Accuracy: Diabetes experts have suggested that glucose meters should agree within 0.83 mmol/L (15 mg/dL) of a laboratory method when the glucose concentration is less than 4.2 mmol/L (75 mg/dL), and within 20% of a laboratory method when the glucose concentration is 4.2 mmol/L (75 mg/dL) or higher.
  • Page 40 The table below shows how often user TRUEresult forearm values achieve these goals when users’ glucose values are not fluctuating. TRUEresult Forearm Sample < 4.2 mmol/L (75 mg/dL) (user forearm vs. finger) ±0.3 mmol/L (5 mg/dL) 3/6 = 50% ±0.6 mmol/L (10 mg/dL) 6/6 = 100% ±0.8 mmol/L (15 mg/dL) 6/6 = 100%...

  • Page 41: Performance Characteristics

    FOR HEALTH-CARE PROFESSIONALS Performance Characteristics Accuracy: TRUEresult accuracy was assessed against the Yellow Springs Instrument (YSI) Model 2300. Studies were conducted at 4 clinical sites by Health-care Professionals. Fingertip Capillary Blood (ISO15197: 2003 data finger vs. YSI): N=376 Slope 0.98 y-intercept -0.14 mmol/L (-2.44 mg/dL) r 2 0.97 Range 3.2 - 26.4 mmol/L (57-475 mg/dL) Venous Blood: N=342...
  • Page 42 Fingertip Capillary Blood < 4.2 mmol/L (75 mg/dL) (HCP finger vs. YSI) ±0.3 mmol/L (5 mg/dL) 12/18 = 67% ±0.6 mmol/L (10 mg/dL) 18/18 = 100% ±0.8 mmol/L (15 mg/dL) 18/18 = 100% Fingertip Capillary Blood > 4.2 mmol/L (75 mg/dL) (HCP finger vs. YSI) ±5% 182/358 = 51% ±10%...
  • Page 43 Forearm Capillary Blood < 4.2 mmol/L (75 mg/dL) (HCP forearm vs. HCP finger) ±0.3 mmol/L (5 mg/dL) 6/9 = 67% ±0.6 mmol/L (10 mg/dL) 8/9 = 89% ±0.8 mmol/L (15 mg/dL) 8/9 = 89% Forearm Capillary Blood > 4.2 mmol/L (75 mg/dL) (HCP forearm vs.
  • Page 44 Precision (Repeatibility): Precision describes the variation between results. Precision results were performed in a laboratory. Within Lot Precision (n=100) Mean (mmol/L) 12.7 19.0 Mean (mg/dL) SD (mmol/L) 0.06 0.11 0.21 0.41 0.74 SD (mg/dL) 13.3 Within-Vial Precision (n=10) Mean (mmol/L) 12.7 19.0 Mean (mg/dL)

  • Page 45: Meter Specifications/Chemical Composition

    Meter Specifications Result Range: 1.1-33.3 mmol/L (20-600 mg/dL) Sample Size: Minimum 0.5 microlitre (0.5 µL) Sample: Fresh capillary whole blood, venous blood drawn in sodium or lithium heparin tubes, or Glucose Control. Test Time: Results in as little as 4 seconds Result Value: Plasma values Assay Method: Electrochemical Power Supply: One 3V lithium battery...

  • Page 46: References

    References 1. U.S. Food and Drug Administration. Draft Guidance for Industry and Staff. Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring System. [Electronic Version]. Retrieved July 6, 2009. www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm079138. htm. 2. Larsson-Cohn U: Difference between capillary and venous blood glucose during oral glucose tolerance tests.

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