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Nipro TRUEresult mini Owner's Booklet

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BLOOD GLUCOSE MONITORING SYSTEM
NO
NO
CODING
CODING
CODING
FAST RESULTS
EASY TO USE
TINY SAMPLE SIZE
Owner's Booklet

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Summary of Contents for Nipro TRUEresult mini

  • Page 1 BLOOD GLUCOSE MONITORING SYSTEM Owner’s Booklet CODING CODING CODING FAST RESULTS EASY TO USE TINY SAMPLE SIZE...

  • Page 2: Fast Test

    BLOOD GLUCOSE MONITORING SYSTEM 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: TRUEresult mini Blood Glucose Monitoring System TRUEresult mini 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 mini products, please see cover for phone number.
  • Page 4 Reuse of Test Strips will cause inaccurate results. NEVER add a second drop of sample to Strip. Adding more sample gives an error message. The TRUEresult mini 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: 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 6 4.2 mmol/L or higher. If patient has recently eaten, fingerstick results from TRUEresult mini can be up to 3.9 mmol/L higher than venous laboratory results. DO NOT perform capillary blood glucose testing on critically ill patients.

  • Page 7: Important Information

    IMPORTANT INFORMATION: For the most accurate results using TRUEresult mini: Read all instructions before testing. TRUEresult mini 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. Plasma values.

  • Page 8: Table Of Contents

    System Out of Range Warning Messages ......23 Time and Date Set-up............24-25 Meter Memory Viewing Averages ..............26 Viewing Results ................27 Caring for TRUEresult mini ..........28-29 Changing Battery ..............30-31 Troubleshooting ...............32 Display Messages ............33-34 Performance Characteristics..........35-40 System Specifications/Chemical Composition ......41 System Safety Information ............42...

  • Page 9: Know Your System Meter

    Know Your System Meter Left Right Bottom “ ” Button Increase numbers in Time/Date Set Up; add ALT Symbol; move forward by date/time when viewing results in Memory. “ ” Button Turn Meter on to view Average values; to view results in Memory and to access Time/Date Set Up.
  • Page 10 Back of Meter Open Closed Battery Tray Gently pull to slide open Battery Tray. Use one non-rechargeable 3V lithium battery (#CR2032), positive (“+”) side up (see Changing Battery). Meter Label Contains Serial Number of Meter.
  • Page 11 Full Display Screen Left Right Bottom 1. Result is from Memory 2. Low Battery Symbol 3. Test Result 4. Time, Date 5. Time is AM/PM 6. Units of Measure (Note: Factory set, cannot be changed by user.) 7. Result is from 7, 14 or 30 day Average 8.

  • Page 12: Test Strip

    Test Strip Top of Test Strip Contact End - Insert into Test Port with blocks (contacts) facing up. Sample Tip - Bring sample (fresh capillary or venous blood or Control Solution) to edge of Tip. Note: Insert Strip into Meter before touching Sample Tip to blood or Control Solution drop.

  • Page 13: Test Strip Vial Label

    Test Strip Vial Label May 30, 2013 Lot Number ( ) - Used for identification when calling for assistance. Use By Date ( ) - 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 14: Control Solution Bottle Label

    Control Solution Bottle Label Lot Number ( ) - Used for identification when calling for assistance. Use By Date ( ) - 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 15: Getting Started

    Getting Started The Meter turns on when a Test Strip is inserted into the Test Port or when “ ” Button is pressed (see Memory and Time and Date Set Up). Meter turns off when the Strip is released from the Meter or after two minutes of non-use.

  • Page 16: Quality Control Testing

    Quality Control Testing To assure you are getting accurate and reliable results, TRUEresult mini offers two kinds of quality control tests. These tests let you know that your TRUEresult mini System is working properly and your testing technique is good.
  • Page 17 Control Test We recommend performing Control Tests for practice before using your Meter for the first time to test your blood. Control Tests should also be performed: heat or cold, or humidity, gotten wet, crushed, etc.). Control Tests check that the System is working properly and your testing technique is good.

  • Page 18: How To Test Control Solution

    How to Test Control Solution 1. Allow Control Solution, vial of Strips and Meter to adjust to 20°C-25°C (room temperature). Write date first opened on Control Solution bottle label and Strip vial label. May 30, 2013 Note: Running a Control Test at temperatures outside the range listed above may cause Control Solution to read as a blood test.

  • Page 19: Troubleshooting

    6. Wait until Drop Symbol appears in Display. Keep Strip in Meter until testing is finished. Apply Sample Note: If Strip is removed before testing is finished, an error message appears. Release and discard old Strip. Use new Strip for testing. 7.
  • Page 20 11. Compare result to Control Solution Range printed on Strip vial label for Control Control Solution Solution Level you are using. Bottle Label If result is in range, System can be used Test Strip for testing blood. If Vial Label result does not fall within range, repeat test using a new Strip.

  • Page 21: 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. From Fingertip 1. Prepare fingertip by washing hands in warm, soapy water. Rinse well. Dry thoroughly. Place end of Lancing Device against tip of finger.
  • Page 22 From Forearm 1. Select area to be lanced. Wash with soap and warm water, rinse and dry thoroughly. 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 23: How To Test Blood Glucose

    How to Test Blood Glucose 1. Check dates on Test Strip vial being used. Do not use if 4 months after opening or after date printed next to on label. Wash hands (and forearm for alternate site testing). Rinse well and dry thoroughly. 3.
  • Page 24 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 dashes appear across Meter Display. Holding the Test Strip Sample Tip to the blood sample too long after the Meter begins testing may cause inaccurate results.

  • Page 25: System Out Of Range Warning Messages

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

  • Page 26: Time And Date Set-Up

    Time and Date Set Up Note: If the Meter turns off at any time during Set Up, go back to Step #1 and begin again. 1. Press and hold “ ” until the Full Display appears and the screen goes blank. Release “...
  • Page 27 4. The month (number) flashes. To change, press “ ” or “ ” to select the month. Press “ ” to set. 5. The day (number) flashes. To change, press “ ” or “ ” to select the day. Press “ ”...

  • Page 28: Viewing Averages

    Memory Viewing Averages 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 range (see How to Test Control...

  • Page 29: Viewing Results

    Viewing Results Memory stores 500 results. When the Memory Memory is full, the oldest result is Symbol replaced with the newest result. Only one Control Test is shown in Memory. 1. Press and release “ ” Button. No Memory Meter displays 7, 14 and 30-day Averages.

  • Page 30: Caring For Trueresult Mini

    Caring for TRUEresult mini Strips) in Carrying Case to protect from liquids, dust and dirt. 30°C (room temperature). 2°C DO NOT REFRIGERATE OR FREEZE. Cleaning removes blood and soil, disinfecting removes infectious agents. dirty. Never put Meter in liquids or allow any liquids to enter the Test Port.
  • Page 31 TRUEresult Control Solution Care Discard if either 3 months after opening or after date printed next to on label has passed. 30°C DO NOT REFRIGERATE OR FREEZE. 2°C TRUEresult Test Strip Care old Strips to new vial or store Strips outside of vial.

  • Page 32: Changing Battery

    Changing Battery A low battery displays Battery Symbol while continuing to function. A dead battery displays Battery Symbol and then turns off. To replace battery: 1. Gently slide Battery Tray open by pulling out using the slot at the top of the Meter. 2.
  • Page 33 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 34: 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 35: Display Messages

    Messages Display Reason Action Temperature Move Meter and Strips Error to area between 10°C - 40°C; wait 10 minutes for System to Too Hot reach room temperature before testing. Sample Not Detected or Retest with new Using Wrong TRUEresult Test Strip Test Strip and larger sample.
  • Page 36 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. Retest Memory with new Strip. If Error error persists, call for assistance. Communications Call for assistance. Error Low: About 50 tests can be done before battery dies.
  • Page 37 TRUEresult mini was tested by users at diabetes clinics, large urban hospitals, and diabetes care centers. The table below shows how often user TRUEresult mini fingertip values can achieve these goals. The fingertip data were compared to parallel results obtained on a Yellow Springs Instrument (YSI) Model 2300.
  • Page 38 The table below shows how often user TRUEresult mini forearm values achieve these goals when users’ glucose values are not fluctuating. TRUEresult mini Forearm Sample (user forearm vs. finger) ±0.3 mmol/L 9/13 = 69% ±0.6 mmol/L 10/13 = 77% ±0.8 mmol/L...

  • Page 39: Performance Characteristics

    FOR HEALTH-CARE PROFESSIONALS Performance Characteristics Accuracy: TRUEresult mini accuracy was assessed against the Yellow Springs Instrument (YSI) Model 2300. Studies were conducted at 3 clinical sites by Health-care Professionals. Fingertip Capillary Blood Slope 0.98 y-intercept -0.03 mmol/L r 2 0.98 Range 1.3 - 27.7 mmol/L...
  • Page 40 100% of Health-care Professional (HCP) TRUEresult mini fingertip values fell within 0.83 mmol/L of the YSI results at glucose levels < 4.2 mmol/L and within 20% at glucose levels > 4.2 mmol/L . Fingertip Capillary Blood (HCP finger vs. YSI) ±0.3 mmol/L 25/35 = 71% ±0.6 mmol/L...
  • Page 41 98.5% of Health-care Professional (HCP) TRUEresult mini forearm values fell within 0.83 mmol/L of the fingertip results at glucose levels < 4.2 mmol/L and within 20% at glucose levels > 4.2 mmol/L when users’ glucose values are not fluctuating. Forearm Capillary Blood (HCP forearm vs.
  • Page 42 Precision (Repeatability): Precision describes the variation between results. Precision results were performed in a laboratory. Mean (mmol/L) 16.5 SD (mmol/L) 0.10 0.13 0.15 0.41 0.66 Mean (mmol/L) 16.5 SD (mmol/L) 0.08 0.11 0.14 0.31 0.56 Mean (mmol/L) 17.2 SD (mmol/L) 0.06 0.21 0.74...

  • Page 43: System Specifications/Chemical Composition

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

  • Page 44: System Safety Information

    System Safety Information Electromagnetic Compatibility This meter meets the electromagnetic immunity requirements as per ISO 15197 Annex A. It meets the electromagnetic emissions requirements as per EN 61326 series. Interference from the meter to other electronically driven equipment is not anticipated. The electromagnetic environment should be evaluated prior to operation of the device.

  • Page 45: References

    References 1. Joslin Diabetes Center. Goals for Blood Glucose Control [Electronic Version]. Retrieved February 16, 2012 from http://www.joslin.org/info/ Goals-for-Blood-Glucose-Control.html. 2. FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood Borne Pathogens: Initial Communication Update 11/29/2010 [Electronic Version].

  • Page 46: Notes

    Notes: N4IAU03FD Rev. 20...
  • Page 47 The TRUEresult mini Blood Glucose Monitoring System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm (capillary or venous). The System may not be used for neonates. The System is intended for at-home use (self-testing) and for use by healthcare professionals in both physicians’...
  • Page 48 BLOOD GLUCOSE MONITORING SYSTEM CODING 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 © 06/2012 Nipro Diagnostics, Inc. N4IAU03FD Rev. 20...

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