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Trividia TRUEresult Quick Reference Manual

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INTRODUCTION
Welcome to the TRUEresult Blood Glucose
Monitoring System
Our Commitment to You
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.
This booklet contains all the information needed
to get the most from the TRUEresult System. To
start testing quickly, please see the Quick Reference
Guide found inside the cover of this Owner's
Booklet.
Please read complete Owner's Booklet and
all product Instructions for Use before
using the System.
SYMBOLS:
Biological
Risk
For
Assistance
Call
For in vitro
Diagnostic
Lot
Testing Only
Number
Control
Serial
Number
Sterile
Attention! Read
Instructions
for Use.
Authorised
Representative
1
Caution
Control
Level
Use By
Date
Storage
Temperature
Do Not
Range
Resterilise
Date of
Manufacture
Keep
Dry
Single
Use
Only
Manufactured
By

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  • Page 1: Introduction And Important Information

    Welcome to the TRUEresult Blood Glucose Monitoring System Our Commitment to You 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 2 NEVER change a treatment plan without consulting with a Doctor or Healthcare Professional. Use of the TRUEresult Blood Glucose Monitoring System in a manner not specified in this Owner’s Booklet is not recommended and may affect your ability to determine true blood glucose levels.
  • Page 3 TRUEresult System: • Read all product instructions for use before testing. • Use only TRUEresult Test Strips and TRUEresult Control Solution with TRUEresult Meter. • To help prevent false high results, wash hands before using the System to test blood, especially after handling fruit or other foods containing sugar.
  • Page 4 ONLY. DO NOT share your Meter or your Lancing Device with anyone, including family members. DO NOT use on more than one person. ALL parts of the TRUEresult Blood Glucose Monitoring System could carry blood- borne pathogens after use, even after cleaning and disinfection.
  • Page 5 ~ severe hypotension ~ severe dehydration ~ hyperglycaemia with hyperosmolarity, with or without ketosis. • Do not use TRUEresult for the diagnosis of diabetes or for testing blood glucose in neonates (newborns). • Do not use TRUEresult System during a xylose absorption test.

  • Page 6: Table Of Contents

    Testing Blood ............20 Obtaining a Blood Sample .........20 How to Test Blood Glucose .......22 Unusual Blood Glucose Test Results ....25 Ketone Test Alert ..........26 TRUEresult System and Laboratory Testing ...27 Memory..............28 View Averages (7-, 14-, and 30-day) ....28 View Results ............29...
  • Page 7 Meter Set Up ............30 Set Ketone Test Alert ..........32 Set Testing Reminders ........32 Care, Cleaning/Disinfecting .......34 Meter Care ............34 Control Solution Care .........35 Test Strip Care .............35 Changing Battery ..........36 Troubleshooting ..........37 Messages..............38 Technical Information ........40 Performance Characteristics ......40 System Specifications ..........44 Operating Range ..........44 Chemical Composition ........44 EMC Safety Information ........45...

  • Page 8: Know The System

    KNOW THE SYSTEM Meter Top of Meter “ + ” Button Increase numbers in Time/Date Set Up for Meter and Testing Reminders; turn on Testing Reminders and Ketone Test Alert; add ALT Symbol; move forward by date/time when viewing results in Memory.
  • Page 9 Back of Meter Display Screen Shows test results, messages, user prompts, other information. Test Port Insert TRUEresult Test Strip here. Strip Release Button Releases Test Strip after testing. Battery Door Use one non-rechargeable 3V lithium battery (#CR2032), positive (“+”) side up (see Changing Battery).
  • Page 10 Meter Display Full Display Screen 1. Memory Symbol 2. Time, Date 3. Time is AM/PM (Note: Not seen if factory set to 24 hour clock.) 4. Result is from 7-, 14-, and 30-day Average 5. Day of Week 6. Test Result 7.

  • Page 11: Test Strip

    Test Strip Top of Test Strip Contact End - Insert into Test Port with blocks (contacts) facing up. Sample Tip - Touch to top of sample (fresh, capillary or venous blood or Control Solution) after inserting Contact End into Meter. Sample Placement Correct Incorrect...
  • Page 12 Test Strip Vial Label May 30, 2014 May 30, 2014 Lot Number ( ) - Used for identification when calling for assistance. Use By Dates ( ) - 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 on vial label has passed, whichever...

  • Page 13: Control Solution

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

  • Page 14: Getting Started

    GETTING STARTED The TRUEresult Meter comes with pre-set time, date, Ketone Test Alert and all Testing Reminders off. Before using Meter for the first time or after bat tery is changed, check to make sure all of the Meter pre-set functions are correct.

  • Page 15: Quality Control Testing

    Quality Control Testing To assure you are getting accurate and reliable results, TRUEresult offers two kinds of quality control tests. These tests let you know that your TRUEresult System is working properly and your testing technique is good. Automatic Self-Test An Automatic Self-Test ensures that the Meter is working correctly.

  • Page 16: Control Test

    Control Test The Control Test checks that the System is working correctly and testing technique is good. Use ONLY TRUEresult Control Solution to perform Control Tests. Perform Control Tests: • For practice before using the System for the first time, •...

  • Page 17: How To Test Control Solution

    How to Test Control Solution Use ONLY TRUEresult Control Solution with the TRUEresult Meter. 1. Check supplies. See Getting Started. 2. Allow Control Solution, vial of Test Strips and Meter to adjust to room May 30, 2014 temperature (20°C-25°C). Note: Running a Control Test at...
  • Page 18 7. With cap removed, turn Control Solution bottle upside down. Gently squeeze one drop of Control Solution onto a clean tissue. Wipe off bottle tip with the tissue. Drop Symbol Note: If Test Strip is removed before testing is finished, an error message appears. Release and discard old Test Strip.
  • Page 19 11. Compare result to Control Test Range printed on Test Strip Control Solution Bottle Label vial label for Control Solution Level you are using. Test Strip If result is in range, Vial Label System can be used for testing blood. If result does not fall within range, repeat test using a new Test Strip.

  • Page 20: Testing Blood

    TESTING BLOOD Obtaining a Blood Sample Refer to lancing device’s Instructions for Use for detailed instructions. The lancing device is for single patient use ONLY. For cleaning/disinfecting your lancing device see Lancing Device Care in the lancing device’s Instructions for Use. Wash your hands thoroughly with soap and warm water after handling the Meter, lancing device, or Test Strips.
  • Page 21 From Forearm Note: Some lancing devices include a special end cap for alternate site testing. Check lancing device’s Instructions for Use. 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.

  • Page 22: How To Test Blood Glucose

    How to Test Blood Glucose 1. Check supplies. See Getting Started. 2. Wash hands (and forearm for alternate site testing). Rinse well and dry thoroughly. 3. Remove one Test Strip from vial. Close vial immediately. Use Test Strips quickly after removal from vial.
  • Page 23 5. Lance fingertip or forearm. Allow drop to form (see Obtaining a Blood Sample). 6. With Test Strip still in Meter, touch Sample Tip to top of blood drop and allow blood to be drawn into Test Strip. Remove from blood drop immediately after the Meter beeps and dashes appear across Meter Display.
  • Page 24 8. Hold Meter with Test Strip pointing down. Press Strip Release Button to discard Test Strip in the appropriate container. Note: Removing Test Strip before result displays cancels the test. An error message appears and result is not stored in Memory. Retest with a new Test Strip and do not remove before result is displayed.

  • Page 25: Unusual Blood Glucose Test Results

    Unusual Blood Glucose Test Results If you have symptoms of low or high glucose, check your blood glucose immediately. If your result does not match the way you feel, repeat test. If your results still do not match the way you feel, call your Doctor or Healthcare Professional.

  • Page 26: Ketone Test Alert

    Ketone Test Alert If blood glucose test result is greater than 13.3 mmol/L (240 mg/dL), and Ketone Test Alert is turned on, “Ketone” appears in Display with glucose result (see Set Ketone Test Alert). Ketone Test Alert When the Ketone Alert Symbol is shown, it does not mean that ketones have been detected in blood.

  • Page 27: Trueresult System And Laboratory Testing

    (100 mg/dL), and within 15% of a laboratory method when the glucose concentration is 5.55 mmol/L (100 mg/dL) or higher. If the patient has recently eaten, fingerstick results from the TRUEresult System can be up to 3.9 mmol/L (70 mg/dL) higher than venous laboratory results.

  • Page 28: Memory

    MEMORY View Averages (7-, 14-, and 30-Day) The Averages feature allows you to view the average of all blood glucose results within a 7-, 14-, and 30-day period. Results marked as Control Test results are not included in the Averages. Note: If a Control Test is performed outside the recommended testing...

  • Page 29: View Results

    View Results Memory stores 500 total blood and Control Test results, which are displayed from most recent to oldest. 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.

  • Page 30: Meter Set Up

    METER SET UP Meter Set Up is to be used if changes need to be made to the pre-set time and date, to turn on the Ketone Test Alert and Testing Reminders, or if settings need to be reset because of battery change. Note: Meter turns off after 2 minutes of non-use.
  • Page 31 3. The minutes flash. Slowly press the “ + ” Button to scroll minutes up or the “ - ” Button to scroll minutes down. Release “ + ” or “ - ” Button when the correct minutes are displayed. Press “ S “ Button and release to save the minutes and go to the next step.

  • Page 32: Set Ketone Test Alert

    Set Ketone Test Alert 7. After setting year, press “ + ” or “ - ” Button to turn Alert on or off. Press “ S ” Button to set and go to the Testing Reminders. Set Testing Reminders Up to four Testing Reminders per day may be set. Reminder sounds at set time for 10 seconds.
  • Page 33 10. The minutes flash. Press “ + ” Button or “ - ” Button to set the minutes. Press “ S ” Button to set. 11. Turn Reminders on and repeat setting the time for next 3 Reminders (if needed). 12.

  • Page 34: Care, Cleaning/Disinfecting

    CARE, CLEANING/DISINFECTING Caring for TRUEresult • Store System (Meter, Control Solution, Test Strips) in Carrying Case to protect from liquids, dust and dirt. • Store in a dry place at 2°C-30°C (room temperature). 30°C • DO NOT REFRIGERATE 2°C OR FREEZE.

  • Page 35: Control Solution Care

    Control Solution Care • Write date opened on Control Solution label. Discard if either 3 months after first opening or after date printed next to on bottle label has passed, whichever comes first. 30°C • Store at 2°C-30°C (room temperature). DO NOT REFRIGERATE 2°C OR FREEZE.

  • Page 36: 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 the palm of your other hand Door to loosen and remove battery.

  • Page 37: 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 38: Messages

    Messages Display Reason Action Temperature Move Meter and Test Error Strips to area between • 10°C-40°C; wait 10 Too Cold/ minutes for System to Too Hot reach room temperature before testing. Sample Not Retest with new Detected or Test Strip and Using Wrong larger sample.

  • Page 39: Removing Test Strip

    Messages (continued) Display Reason Action Test Strip Retest with new Test Removed Strip. Make sure result During Test is displayed before removing Test Strip. Result was not recorded Memory in Memory. Retest with Error a new Test Strip. If error persists, call for assistance.

  • Page 40: Technical Information

    Performance Characteristics Precision: Precision describes the variation between results. There are two types of precision results measured, repeatability (using blood) and intermediate precision (using control solution). Repeatability: N=100 Mean (mmol/L) 3.4 12.1 19.2 Mean (mg/dL) 62 SD (mmol/L) 0.11 0.14 0.27 0.37 0.66...
  • Page 41 For Healthcare Professionals 99.3% of TRUEresult fingertip values performed by healthcare professionals (HCP) fell within 0.83 mmol/L (15 mg/dL) of the YSI results at glucose levels < 5.55 mmol/L (100 mg/dL) and within 15% at glucose levels > 5.55 mmol/L (100 mg/dL).
  • Page 42 Zone A and 0.4% fell within Zone B of the Parkes Error Grid (PEG). For Consumers 99% of TRUEresult fingertip values performed by users fell within 0.83 mmol/L (15 mg/dL) of the YSI results at glucose levels < 5.55 mmol/L (100 mg/dL) and within 15% at glucose levels >...
  • Page 43 100% of TRUEresult forearm values performed by users fell within 0.83 mmol/L (15 mg/dL) of the YSI results at glucose levels < 5.55 mmol/L (100 mg/dL) and within 15% at glucose levels > 5.55 mmol/L (100 mg/dL). Forearm Samples (User vs. YSI) for glucose concentrations < 5.55 mmol/L (100 mg/dL)

  • Page 44: System Specifications

    Temperature: 10°C-40°C Haematocrit: 20-55% Altitude: 3094 metres Note: Use within specified environmental conditions only. Chemical Composition TRUEresult Test Strips: Glucose dehydrogenase-FAD (Aspergillus sp.), mediators, buffers and stabilisers. TRUEresult Control Solution: Water, d-glucose, buffers, viscosity enhancing agent, salts, dye and preservatives.

  • Page 45: Emc Safety Information

    EMC Safety Information This meter meets the electromagnetic immunity requirements as per ISO 15197:2013 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 46: 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 47: Notes

    NOTES:...
  • Page 48 NOTES: E4INP03FDA Rev. 30...

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