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Liberty System Manual

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INTRODUCTION:
Liberty Blood Glucose Monitoring System
The Liberty System 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.
Caution! Please read complete Owner's Booklet
and all product Instructions for Use.
Importance of Blood Glucose Monitoring
The more you know about diabetes, the better you
will be able to care for yourself. A Doctor or Diabetes
Healthcare Professional will determine your target
range for blood glucose results and how often to test.
Keeping results within your target range helps slow or
stop complications from diabetes.
Having most blood glucose results within your target
range shows how well a treatment plan is working to
control glucose levels. NEVER change your
treatment plan without consulting a Doctor or
Diabetes Healthcare Professional.
Use of the Liberty System in a manner not specified
in this Owner's Booklet is not recommended and may
affect ability to determine true blood glucose levels.
1

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Summary of Contents for Liberty Liberty System

  • Page 1: Introduction And Important Information

    NEVER change your treatment plan without consulting a Doctor or Diabetes Healthcare Professional. Use of the Liberty System in a manner not specified in this Owner’s Booklet is not recommended and may affect ability to determine true blood glucose levels.
  • Page 2 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 hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill patients should not be tested with a blood glucose meter.
  • Page 3 WARNING! Do not use the Liberty System if you are receiving: • Peritoneal dialysis using solutions containing icodextrin (Extraneal ® , Icodial ® ) that is metabolized to maltose, • Injections or infusions of solutions containing galactose or maltose, including some human immunoglobulin preparations (Octagam ®...

  • Page 4: Important Information

    EDTA (purple top tube) or heparin (green top tube) may be used. Mix tube contents gently before using. • If comparing results between the Liberty System and a lab system, perform a Liberty System blood test within 30 minutes of lab test.

  • Page 5: Table Of Contents

    Time and Date...............23-24 Alert and Reminders .............25-27 Memory Viewing Averages (7, 14 and 30-day) ........28 Viewing Results in Memory ..........29 Care and Troubleshooting Caring for the Liberty System ........30-31 Changing Battery ............32-33 Troubleshooting..............34 Display Messages ............35-36 Meter Specifications/Chemical Composition......37 Meter Warranty ..............38...

  • Page 6: Know Your System Meter

    Know Your System Meter Top of Meter Œ “ + ” Button Increase numbers in Meter Set Up; add Alternate Site Symbol; move forward by date/time when viewing results in Memory.  “ S ” Button Select settings; view Average values; view results in Memory.
  • Page 7 Front of Meter Back of Meter Œ Display Screen Shows results, messages, user prompts, information.  Test Port Insert Liberty Test Strip here. Ž Strip Release Button Releases Strip after testing.  Battery Door Use one non-rechargeable 3V lithium battery (#CR2032), positive (“+”) side up (see Changing...

  • Page 8: 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 9: Test Strip

    Test Strip Top of Test Strip Œ Contact End - Insert into Test Port with contact end facing up.  Sample Tip - Bring sample (fresh, capillary or venous blood or Glucose Control) to edge of Tip. Tip draws sample into Strip for testing. Sample Placement Correct Placement Incorrect Placement...

  • Page 10: Test Strip Vial Label

    Test Strip Vial Label May 30, 2010 Œ Lot Number (LOT) - Used for identification when calling for assistance.  Expiration Dates (EXP) - Write date first opened on vial label. Discard vial and unused Strips if either 3 months after opening or date printed next to EXP on vial label has passed.

  • Page 11: Glucose Control Bottle Label

    EXP on bottle label has passed. Ž Control Level (1 and 2) - Two levels of Liberty Control are available. We recommend testing at least 2 levels of Control. Use the number on the front cover for information on how to obtain different levels of Control.

  • Page 12: Getting Started

    • When Meter results seem unusually low or high, or • Meter was dropped. Quality Control Testing To assure you are getting accurate and reliable results, the Liberty system offers two kinds of quality control tests. These tests let you know that your Liberty System is working properly.
  • Page 13 Automatic Self-Test An Automatic Self-Test is performed by the Meter each time a Liberty Test Strip is inserted correctly into the Test Port. (Contact end facing up.) If after inserting a Test Strip properly in the Test Port, the Full Display (no...

  • Page 14: Control Test

    Use ONLY Liberty Glucose Control to check performance of the System. Important Information: There are two levels of Liberty Glucose Control Solution available that contain known amounts of glucose. It is important to perform Control Tests with more than one level of Control to assure your System is working properly and your testing technique is good.
  • Page 15 How to Test Glucose Control 1. Allow Control, vial of Strips and Meter to adjust to room temperature 59-86°F. Write date first opened on both Control 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 16 6. Wait until Apply Sample Symbols appear in Display. Keep Strip in Meter until testing is finished. Note: If Strip is removed before testing is finished, an error message Apply Sample appears. Release and discard Symbols old Strip. Use new Strip for testing.
  • Page 17 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 Test Strip Vial Label range, repeat test using a new Strip.

  • Page 18: 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. From Fingertip 1. Prepare fingertip by washing hands in warm, soapy water. Rinse well. Dry thoroughly. 2.
  • Page 19 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 dry compress to increase blood flow. 3. Place end of Lancing Device firmly against forearm. Press trigger button.

  • Page 20: Testing Blood Glucose

    How to Test Blood Glucose 1. Check dates on Test Strip vial being used. Do not use if either 3 months after opening or after date printed next to EXP on label has passed. 2. Wash hands (and forearm for alternate site testing).
  • Page 21 7. With Strip still in Meter, touch edge of Test Strip Sample Tip to blood drop and hold. Allow blood to be drawn into Strip until Meter beeps. Note: If Meter does not beep or begin testing after touching blood drop to Strip Sample Tip, discard Strip.

  • Page 22: 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 23: 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 tone sounds (around 30 seconds). Release “...
  • Page 24 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 25: 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 240 mg/dL, the Ketone Testing Alert is a reminder to check your ketones per your treatment plan.
  • Page 26 Testing Reminder Up to four Testing Reminders per day may be set. Reminder sounds at set time for 10 seconds. Reminder turns off when Strip is inserted for testing. To set the Testing Reminders: 1. After pressing “ S ” to set Ketone Testing Alert, Display shows first Reminder setting (A-1).
  • Page 27 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 28: 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 Perform a Control Test), the...

  • Page 29: Viewing Results In Memory

    Viewing Results in Memory Memory stores 500 results. Oldest result drops from Memory when Memory is full and a new result is added. 1. Press and release “ S ” Button. Meter displays 7, 14 and 30-day Averages. Press and release “ S ” again to view most recent Control Test result in Memory.

  • Page 30: Caring For The Liberty System

    Caring for the Liberty System • 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 •...
  • Page 31 Liberty 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 3 months after opening or after date printed next to EXP on label has passed.

  • Page 32: 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 33 Caution! 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. Note: Changing battery may affect date, time, Alert and Reminder settings. Check settings by going to Meter Set Up.

  • 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

    • minutes for System to Too Cold/ reach room temperature Too Hot before testing. Sample Not Detected or Retest with new Liberty Test Strip and Using Wrong Test Strip larger sample. Used Strip Repeat with new Strip. or Test Strip...
  • Page 36 Messages (continued) Display Reason Action Retest with new Strip. Strip Removed Make sure result is displayed before During Test removing Strip. Result was not recorded in Memory. Retest with Memory new Strip. If error Error persists, call for assistance. Communication Call for assistance.

  • Page 37: Meter Specifications/Chemical Composition

    Relative Humidity: 10-90% (Non-condensing) Temperature: 50-104ºF Hematocrit: 20-60% Note: Use within specified environmental conditions only. Chemical Composition Liberty Test Strips: Glucose dehydrogenase-PQQ (Acinetobacter calcoaceticus), mediators, buffers and stabilizers. Liberty Glucose Control: Contents: Water, d-glucose, buffers, viscosity enhancing agent, salts, dye and preservatives.

  • Page 38: Meter Warranty

    Liberty Limited Lifetime Warranty Home Diagnostics, Inc. provides the following Warranty to the original purchaser of the Liberty Blood Glucose Meter: 1) Home Diagnostics Inc. warrants this Meter to be free of defects in materials and workmanship at the time of purchase. If the...

  • Page 39: References

    References 1. Joslin Diabetes Center. Goals for Blood Glucose Control. [Electronic Version]. Retrieved June 2, 2008: www.joslin.org/Beginners_guide_523.asp. 2. Food & Drug Administration 2007. Draft Guidance for Industry and Staff. Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring System. [Electronic Version]. Retrieved February 5, 2007: www.fda.gov/cdrh/oivd/guidance/1603.pdf 3.
  • Page 40 Notes: E4LBT04 Rev. 1...

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Blood glucose monitoring system

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