NIPRO Diagnostics TRUE BALANCE Owner's Booklet
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NIPRO Diagnostics TRUE BALANCE Owner's Booklet

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NO
NO
CODING
CODING
For assistance, please call
1 800 451 737
Nipro Australia Pty Ltd
Suite 3, 500 Pacific Hwy
St Leonards NSW 2065
info@niproaustralia.com.au
© 2011 Nipro Diagnostics, Inc.
H4IAU03 Rev. 20
Owner's Booklet
NO
NO
CODING
CODING
EASY TO USE:
• SMALL SAMPLE SIZE
• FAST TEST TIME
True Confidence
For Simple, Accurate Results

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Summary of Contents for NIPRO Diagnostics TRUE BALANCE

  • Page 1 1 800 451 737 Nipro Australia Pty Ltd EASY TO USE: Suite 3, 500 Pacific Hwy St Leonards NSW 2065 • SMALL SAMPLE SIZE • FAST TEST TIME info@niproaustralia.com.au True Confidence For Simple, Accurate Results © 2011 Nipro Diagnostics, Inc. H4IAU03 Rev. 20...
  • Page 2 Notes: 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.

  • Page 3: Introductory Information

    Welcome to the TRUEbalance Blood Glucose Monitoring System Congratulations on your purchase of the TRUEbalance Blood Glucose Monitoring System. You now have a very simple and accurate way to test your blood glucose (sugar) level, anytime, anywhere. TRUEbalance is a no-coding system, which means the Meter does not have to be coded to each lot of Test Strips.
  • Page 4 Importance of Blood Glucose Monitoring The more you know about diabetes, the better you will be able to take care of yourself. A Doctor or Diabetes Healthcare Professional will determine your target range for your blood glucose results and how often to test. Having the majority of your results within your target range helps slow or stop complications of diabetes.
  • Page 5 IMPORTANT INFORMATION: Health Related Information • Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycaemic-hyperosmolar state, with or without ketosis. Critically ill patients should not be tested with a blood glucose meter.

  • Page 6: Important Information

    Important Information For the most accurate results using TRUEbalance: • Read all instructions before testing. • Meter displays results as plasma values. • TRUEbalance 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.
  • Page 7 Health Related Information For Healthcare Professionals: If comparing results between TRUEbalance and a lab system, perform a TRUEbalance blood test within 30 minutes of lab test. Results from TRUEbalance are considered accurate if within +/– 20% of lab results. If patient has recently eaten, fingerstick results from TRUEbalance can be up to 3.9 mmol/L (70 mg/dL) higher than venous lab results.

  • Page 8: Table Of Contents

    Table of Contents Fast Test Guide ...........inside front cover Introductory Information ..........1-6 Know Your System Meter .................7-9 Test Strip ................10 Test Strip Vial Label............11 Control Bottle Label............12 Getting Started Quality Control Tests............13 Automatic Self-test ............14 Glucose Control Test ..........15-18 Testing your Blood How to Obtain a Blood Sample........19-20 How to Test Blood Glucose ..........21-22 System Out of Range Warning Messages......23...

  • Page 9: Know Your System Meter

    Know Your System Front of Meter Meter Top of Meter Œ Button - Decrease numbers in Set Up; remove Control Symbol; move backward by time/date when viewing results in Memory.  Button - Select settings; view Morning Average values; view results in Memory. Ž...
  • Page 10 Back of Meter Right Side of Meter ‘ Data Port - Contact Customer Care at the number located on the cover for more information. ’ Battery Compartment - Use one non-rechargeable 3V lithium battery (#CR2032), positive (“+”) side up. See Changing Battery for details. Note: “...
  • Page 11 Display 1. Time, Date, 14/30 Day Average. 2. Result in Memory. 3. 14- or 30-Day Morning Average. 4. Test result. 5. Battery Symbol (see Display Messages). 6. Temperature Symbol (see Display Messages). 7. Drop Symbol - Apply blood or Glucose Control.

  • Page 12: Test Strip

    Test Strip Front of Test Strip Œ Contact End - Insert into Meter with Contacts (metallic blocks) facing up before adding sample.  Sample Tip - Touch sample (blood or Glucose Control) to edge of Tip. Placement of Sample to Test Strip Correct Incorrect •...

  • Page 13: Test Strip Vial Label

    Test Strip Vial Label May 30, 2012 May 30, 2012 Œ Lot Number - Used for identification when calling for assistance.  Expiration Dates - Write date first opened on vial label. Discard vial and unused Test Strips 120 days after written date or date printed next symbol, whichever comes first.

  • Page 14: Control Bottle Label

    Control Bottle Label Œ Lot Number - Used for identification when calling for assistance.  Expiration Dates - Write date first opened on bottle label. Discard bottle if either 3 months after opening or date printed next to symbol on bottle label has passed. Ž...

  • Page 15: Getting Started

    Getting Started The Meter turns on automatically when a Test Strip Contact End is inserted into the Test Port or when is pressed (see Set Up and Memory). The Meter turns off automatically after the Test Strip is removed from the Test Port or after 2 minutes of non-use.

  • Page 16: Quality Control Tests

    Quality Control Testing To assure you are getting accurate and reliable results, TRUEbalance offers two kinds of quality control tests. These tests let you know that your TRUEbalance System is working properly and your testing technique is good. Automatic Self-Test An Automatic Self-Test is performed by the Meter each time a TRUEbalance Test Strip is inserted...

  • Page 17: Glucose Control Test

    Glucose 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 18 How to Test Glucose Control 1. Wash hands with soap and water, dry thoroughly. Allow Control, vial of Strips and Meter to adjust to room temperature (20-25ºC). Write date first opened on Control Label and/or Strip vial label. 2. Check dates on Control label and Strip vial label. Do not use Control if 3 months past written opened date or past date printed next to symbol.
  • Page 19 6. Press . Control Symbol appears in Meter Display. Note: If you decide not to perform a Control Test, press remove Control Symbol. Control 7. Turn Control bottle upside Symbol down. Squeeze one drop of Control onto a clean tissue. Wipe off bottle tip.
  • Page 20 10. Compare result to Control range printed on Strip vial 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. Note: Control Test result shows the Control Symbol in the Display.

  • Page 21: How To Obtain A Blood Sample

    How to Obtain a Blood Sample Refer to Lancing Device “Instructions for Use” for detailed instructions. • Lancing device is for self-testing and intended for use by one patient only. Not suitable for use by healthcare or care workers. • Never share lancets or lancing device. •...
  • Page 22 For Forearm Testing 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 23: How To Test Blood Glucose

    How to Test Blood Glucose Check supplies. Always check your supplies before using. Check Meter for damage (damaged or cracked Display, missing or damaged buttons). If any damage is seen, do not use Meter. Call for assistance. Check Strip vials for damage. Discard any vials that appear cracked or broken.
  • Page 24 5. Wait until Drop Symbol appears in Display. 6. Lance fingertip or forearm. Allow drop to form. 7. With Strip still in Meter, touch edge of Sample Tip to blood drop and hold. Allow blood to be drawn into Strip until Meter beeps.

  • Page 25: System Out Of Range Warning Messages

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

  • Page 26: Set Up (Time/Date)

    Set Up (Time/Date) 1. Start with Meter off. Do not insert Test Strip. Press and hold . Date/Time appears in display. Release after full Display appears and Meter beeps. Set Time Full Display 2. The hour flashes. To change, press on top of Meter to select the hour.
  • Page 27 Set Date 4. The month (number) flashes. To change, press select the month. Press to set. 5. The day (number) flashes. To change, press select the day. Press to set. 6. The year flashes Year To change, press Month select the year. Press to set.

  • Page 28: Memory

    Memory Morning Averages (14 and 30 Day) For Morning Average values, only the earliest blood test result performed between 4:00 am - 9:59 am (according to Meter clock) is used. Meter clock must be set correctly (see Set Up) for accurate Morning Average values.

  • Page 29: Viewing Results In Memory

    Viewing Results in Memory Memory stores 365 results, which are displayed from most recent to oldest. The oldest result is removed from Memory when Memory is full and a new result is added. 1. Start with Meter off. Press and release .

  • Page 30: Caring For Truebalance

    Caring for TRUEbalance • Store System (Meter, Glucose Control, Test Strips) in Carrying Case to protect from liquids, dust and dirt. • DO NOT REFRIGERATE OR FREEZE. Meter Care • Wipe Meter with clean, lint-free cloth dampened with one of the following: –...
  • Page 31 Test Strip Care • Store Strips in original vial only. Do not transfer old Strips to new vial. • Write date opened on vial. Discard unused Strips from vial 120 days after opening or after date printed next to symbol, whichever comes first. Use of Strips past either date may give incorrect results.

  • Page 32: Changing Battery

    Changing Battery Replace battery when Low or Dead Battery Symbol appears in Display or Meter does not turn on. Dead 1. Lift tab on Battery Cover. 2. Turn Meter over, tap gently to loosen and remove battery. 3. Insert new battery, positive (“+”) side up.

  • Page 33: Troubleshooting

    Troubleshooting 1) After inserting Test Strip, Meter does not turn on. Reason Action Strip inserted upside Remove Strip. down or backwards Re-insert correctly. Strip not fully Remove Strip. Re-insert inserted Strip fully into Meter. Strip Error Repeat with new Strip. Dead or no battery Replace battery.

  • Page 34: Display Messages

    Messages Display Reason Action Wait 10 minutes Temperature for Meter and Test Error Strips to reach Temperature room temperature change too quick before testing. Move Meter and Temperature Test Strips to area Too Cold Meter temperature between less than 10ºC 10º-40ºC before testing.
  • Page 35 Messages (continued) Display Reason Action Call for Meter Error assistance. Retest with new Strip. If error Test Strip Error persists, call for assistance. Retest with new Strip. If error Test Strip persists, call for Removed assistance. During Test Call for Meter assistance.
  • Page 36 Messages (continued) Display Reason Action Turn Meter off and on again. If Communication error persists, call Error for assistance. About 50 tests can be done Low Battery before battery must be replaced. Dead Battery Replace battery. Out of range - Retest with new Result >33.3 mmol/L Strip.

  • Page 37: Performance Characteristics

    Performance Characteristics Accuracy (ISO 15197: 2003 data) 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 38 Repeatability: N=300 Mean (mmol/L) 13.0 19.6 Mean (mg/dL) SD (mmol/L) 0.14 0.17 0.23 0.47 0.68 SD (mg/dL) 12.2 Intermediate Precision: N=1000 Mean (mmol/L) 15.7 Mean (mg/dL) 38.7 98.2 283.5 SD (mmol/L) 0.21 0.26 0.59 SD (mg/dL) 10.6 Consumer Study TRUEbalance was tested at diabetes clinics of a large urban area hospital and diabetes care centers.

  • Page 39: Specifications

    Specifications Result Range: 1.1 - 33.3 mmol/L (20 - 600 mg/dL) Sample Size: Minimum 1 microlitre (1 µL) Sample: Human capillary whole blood or Glucose Control Test Time: 10 seconds Result Value: Plasma values Assay Method: Electrochemical Reference Method: Yellow Springs Instrument (YSI) Power Supply: One 3V lithium battery #CR2032 (non-rechargable) Total power when active...

  • Page 40: Chemical Composition

    Chemical Composition TRUEbalance Test Strips: Glucose Oxidase (Aspergillus sp.) 2.5 Units, Mediators, Buffers and Stabilisers. TRUEcontrol Glucose Control: Contents: Volume: 3 mL. Water - 73%, D-glucose - 0.09 - 0.20%, Viscosity Enhancing Agent - 25%, Inorganic Salts - 1.8%, Amaranth - 0.08%, and Preservatives - 0.03%.

  • Page 41: 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 from www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm079138.htm . 2. Larsson-Cohn U: Difference between capillary and venous blood glucose during oral glucose tolerance tests.
  • Page 42 Notes _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ H4IAU03 Rev. 20...

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