FreeStyle Freedom Lite Manual

FreeStyle Freedom Lite Manual

System Check Screen

System Check Screen

This display always appears when the meter is turned on. You should check that your meter matches the example exactly every time your meter turns on. Do not use the meter if the display check screen does not exactly match the example. If the screen does not match, the meter may show an incorrect result. Please contact Customer Care.

Display Screen
Displays your test results and other important information.

m (Mode) Button

Sample Areas (dark-colored half-circles on test strip)
Apply blood or control solution to one sample area only. Insert strip into the meter printed side up (see image above).

Data Port
Downloads test results. Requires a compatible data management system. For more information, please go to our website or contact Customer Care.

c (Configure) Button

Test Strip Port
Insert the Top end of a new FreeStyle Lite test strip here. The meter powers on when you insert the test strip.

Important Information About Your Blood Glucose Monitoring System

Intended Use

Use outside the body only (in vitro diagnostic use).
The FreeStyle Freedom Lite Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the forearm, upper arm, thigh, calf, fingers and hand and venous whole blood. It is intended for self testing and for use by healthcare professionals for people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control programme. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.


Use only FreeStyle Lite test strips and FreeStyle control solution with this meter. Other products can produce inaccurate results.


Please read all the instructions provided in this owner's booklet and practise the testing procedures before using the FreeStyle Freedom Lite system. Blood glucose monitoring should be done with the guidance of a healthcare professional.

Setting Up the Meter

Purpose

The purpose of this section is to set the meter sound volume, time and date

  1. With the meter off, press and holdfor 3 seconds until appears.
    Purpose
  2. Press to bypass setting the optional reminder alarms. You may choose to set these later (see Setting Reminder Alarms section).

Set Sound Volume

With the sound volume on, your meter will beep when:

You may also choose to silence your meter.

Set sound volume

  1. Set sound volume

Set Time

Note: Your meter can display either the 12-hour (1:24P) or the 24-hour (13:24) time formats. If you prefer the 12-hour format, there is no "A" for AM. If setting a PM time, continue to press until you see the "P" displayed for PM.
Set Time

  1. Set hour
  2. Set minutes
    Set minutes
  3. Set time format
    Set time format

Set Date

Note: The date format can display either:

Set Date Step 1
OR
Set Date Step 2

The month will flash first

  1. Set month
    Set month
  2. Set day
    Set day
  3. Set date format
    Set date format
  4. Set year
    Set year
  5. Press and holdfor 3 seconds until meter turns off. Meter set up is complete.

Testing Your Blood Glucose

Purpose

The purpose of this section is to produce an accurate blood glucose test result.

Prepare to Test

Available Test Sites

Available Test Sites

    Select your test site.
    Note: Avoid moles, veins, bones and tendons. Bruising may occur at the test site. If bruising occurs, consider selecting another site.
    There are differences in testing on fingers versus alternative sites.

Test on your fingers if you are testing for low blood glucose (hypoglycaemia) or if you suffer from hypoglycaemia unawareness. Check for low blood glucose when:

  • Wash your hands and the test site with warm soapy water to ensure accurate results.
    <a href=Prepare to Test Step 1" width="" />
  • Check test strip expiry date.
    <a href=Prepare to Test Step 2" width="" />
    Do not use expired test strips; they may produce inaccurate results.

    Important Test Strip Information

    Please read the FreeStyle Lite test strip package insert for more information.


    Drying agents in the test strip vial or cap may be harmful if inhaled or swallowed and may irritate skin and eyes.

    Performing a Blood Glucose Test

    1. Remove test strip from vial.
    2. Insert test strip to turn meter on.
      Performing a Blood Glucose Test Step 1
      Performing a Blood Glucose Test Step 2
      Note: The meter turns off after 2 minutes of inactivity. Remove and reinsert the unused test strip to restart the meter.
      If the meter does not turn on, go to Troubleshooting section.
    3. Confirm System Check Screen.
      Performing a Blood Glucose Test Step 3
      • This display appears when you turn on the meter. Do not use the meter if the display check screen does not exactly match the example. Contact Customer Care.
      • See The FreeStyle Freedom Lite Meter and How It Works section for more information.
      • If the system check screen does not appear, go to Troubleshooting section.
    4. Obtain a blood drop.
      Performing a Blood Glucose Test Step 4
      When the and appears, use the lancing device to obtain a blood drop. (See FreeStyle lancing device insert for instructions.)
      The test strip requires only a 0.3 microliter of blood for accurate results.
    5. Apply and hold blood to 1 sample area of the test strip until:
      • You see short lines moving clockwise on the display or
      • You hear a beep
        This indicates the test strip obtained enough blood and the meter is checking your glucose level. If a short line does not appear after 5 seconds, the sample may be too small. You can add blood to the same side only for up to 60 seconds. If the test does not start after applying blood drop, go to Troubleshooting section.
        Performing a Blood Glucose Test Step 5
    6. View result
      Performing a Blood Glucose Test Step 6
      The result appears on the display when the test is complete. The time that the meter takes to display a result depends on your blood glucose level. Higher glucose levels require more time.
      Note: If you see an "Er1, Er2, Er3 or Er4" on the display, it is an error code. Go to Error Codes section.
    7. Remove test strip to turn meter off.
      Dispose of used lancet and test strip correctly.

    Understanding Blood Glucose Test Results

    The meter displays results in mmol/L. The unit of measurement is preset. You cannot change this setting.


    The meter displays results from 1.1 – 27.8 mmol/L. Low or high blood glucose results can indicate a potentially serious medical condition.

    Reference:
    1 Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia: report of a WHO/IDF consultation. World Health Organization, Geneva, Switzerland 2006.

    Low and High Blood Glucose Results

    Result What It Means What To Do
    lower than 3.3 mmol/L Low (hypoglycaemic) Repeat the test with a new test strip, even if you do not feel that you have low blood glucose.
    If your blood glucose result is still not consistent with your symptoms, contact your healthcare professional and follow his or her treatment advice.
    higher than 13.3 mmol/L High (hyperglycaemic) Repeat the test with a new test strip, even if you do not feel that you have high blood glucose.
    If your blood glucose result is still not consistent with your symptoms, contact your healthcare professional and follow his or her treatment advice.
    Display What It Means Symptoms What To Do

    Appears when result is: lower than 1.1 mmol/L
    Severe low blood glucose Weakness
    Sweating
    Shakiness
    Headache
    Confusion
    Follow your healthcare professional's advice to treat low blood glucose.
    If your blood glucose result does not match how you feel, perform a control solution test to confirm that your meter and strips are working properly.
    Display What It Means Symptoms What To Do

    Appears when result is: higher than 27.8 mmol/L
    Severe high blood glucose Fatigue
    Thirst
    Excess Urination
    Blurry Vision
    Follow your healthcare professional's advice to treat high blood glucose.
    If your blood glucose result does not match how you feel, perform a control solution test to confirm that your meter and strips are working properly.

    Error Codes

    Troubleshooting

    FreeStyle Control Solution

    Purpose

    FreeStyle control solution is a red liquid that contains a fixed amount of glucose.
    The purpose of doing a control solution test is:

    Contact Customer Care for information on how to obtain control solution.

    Control Solution Information

    Control Solution Information

    For information on how to obtain control solution, contact Customer Care.


    Control solution results should fall within the control solution range printed on the test strip vial. Do not use this range when testing blood glucose.

    Out of Range Control Solution Results

    Performing a Control Solution Test

    Performing a Control Solution Test Step 1

    1. Check control solution expiry date.

    Do not use control solution past expiry date. Discard control solution 3 months after opening or on the expiry date printed on the bottle whichever comes first. (Example: open April 15, discard July 15; write the discard date on the side of the bottle.)

  • Remove test strip from vial.
    Performing a Control Solution Test Step 2
    Performing a Control Solution Test Step 3
  • Insert test strip to turn meter on.
    Note: The meter turns off after 2 minutes of inactivity. Remove and reinsert the unused test strip to restart the meter.
    If the meter does not turn on go to Troubleshooting section.
  • Confirm System Check Screen.
    Performing a Control Solution Test Step 4
  • Apply and hold control solution to 1 sample area of the test strip until:
    Performing a Control Solution Test Step 5
  • View result.
    Performing a Control Solution Test Step 6
    The result appears on the display when the test is complete.
  • Compare the control solution result to the range printed on the test strip vial. The result should fall within the range.
    Performing a Control Solution Test Step 7
    Note: If you see an "Er1, Er2, Er3 or Er4" on the display, it is an error code. Go to Error Codes section.
  • Press and holdfor 2 seconds until appears on the display to mark the result as a control solution result. To unmark a control solution test result, press and holdfor 2 seconds. A value with the indicates you have marked this reading as a control solution test.
    Performing a Control Solution Test Step 8
  • Remove the test strip to turn meter off.
  • Using Your Meter Memory

    Purpose

    The purpose of this section is to review your stored test results and 7-, 14- and 30-day averages.

    Viewing Blood Glucose Averages in Memory

    Start with the meter off (no test strip inserted). Press . Your 7-day average appears (control solution, LO and HI readings not included).

    Note: To exit meter memory at any time, press and hold .

    Viewing Blood Glucose Averages in Memory

    Viewing Test Results in Memory

    Meter memory stores the last 400 test results with time and date. Press to scroll through the results. The most recent result appears first.

    on the display indicates that you are viewing stored test results.
    shows the average value of glucose readings from the last 7-, 14- or 30-days.
    on the display indicates that the test result occurred when it was too hot or too cold to use the meter and may not be accurate. This result is included in 7-, 14- and 30-day averages.
    a test result of under 1.1 mmol/L is included in memory as LO.
    a test result of over 27.8 mmol/L is included in memory as HI.
    indicates a control solution test result.

    Setting Reminder Alarms (optional)

    Purpose

    The purpose of this section is to set up to four reminder alarms to prompt you to test throughout the day.

    1. With the meter off, press and holdfor 3 seconds until appears and 0 is flashing.
      Setting Reminder Alarms (optional) Purpose Step 1
    2. Press . Reminder alarm 1 flashes.
      Note: You are setting time for Reminder Alarm not clock time.
    3. Set hour
      Setting Reminder Alarms (optional) Purpose Step 2
    4. Set minutes
      Setting Reminder Alarms (optional) Purpose Step 3
    5. Set alarm sound volume

  • Press and repeat 2, 3, 4 and 5 to set remaining reminder alarms or
  • Press and holdfor 3 seconds until meter turns off.
  • Transferring Test Results To a Computer

    appears on the display when you insert a data cable in the data port. The computer must have a compatible data management system to complete the transfer. Remove this cable before performing a test.

    Contact Customer Care to learn more about the data management system.

    Maintaining the Meter

    Replacing the Battery

    The meter comes with a #2032, 3-volt, lithium battery installed. It provides power for about 1000 tests.

    When appears, replace the battery immediately.

  • When you are ready to install a new battery, remove the old battery and install the new battery within 60 seconds to avoid losing time and date settings.
  • If time and date settings are lost, both time and date will flash until reset. Reset time and date to get the correct 7-, 14- and 30-day averages. If the time and date settings are lost, you may still perform an accurate blood glucose test.
  • Memory log and previously stored user settings, such as date and time format, are not affected by removing the battery.
    1. Slide the battery door to the right to open.
    2. To remove the battery, pull the plastic tab up to release the battery.
      Replacing the Battery Step 1
    3. Insert a new battery: (+) facing up.
      Replacing the Battery Step 2
    4. To close, slide the battery door in until it snaps into place.
      Replacing the Battery Step 3

    Note: The European Battery Directive requires separate collection of spent batteries, aiming to facilitate recycling and to protect the environment. The batteries in this product should be removed and disposed of in accordance with local regulations for separate collection of spent batteries.

    Cleaning the Meter

    Avoid getting dirt, dust, blood, control solution or liquid in the meter test strip and data ports. Clean the outside of the meter using a damp cloth and:


    Do not immerse the meter in water or other liquid.

    Specifications

    Assay method Coulometric electrochemical sensor
    Automatic shutoff 2 minutes of inactivity
    Battery life 1000 tests
    Calibration Plasma equivalent
    Haematocrit 15% to 65%
    Measurement units mmol/L
    Meter storage temperature – 4° to 140°F (–20° to 60°C)
    Memory 400 blood glucose and control solution tests with date and time
    Operating relative humidity 5% to 90% (non-condensing)
    Operating temperature 40° to 104°F (4° to 40°C)
    Power source One CR 2032, 3V lithium battery, replaceable
    Result range 1.1 to 27.8 mmol/L
    Sample Fresh capillary and venous whole blood samples
    Sample size 0.3 microliter (300 nanoliters)
    Size 2.0 in (w) x 3.3 in (l) x 0.63 in (d) 5.1 cm (w) x 8.4 cm (l) x 1.6 cm (d)
    Weight 1.4 to 1.6 oz. (39.7 to 45.4 g) including battery

    Definition of Symbols

    Consult instructions for use Use by
    Temperature limitation For in vitro diagnostic medical device
    Manufacturer Catalogue number
    CE Mark Recycle
    Authorised representative in the European Community Serial number
    Batch code Do not reuse
    The European Battery Directive requires separate collection of spent batteries, aiming to facilitate recycling and to protect the environment. The batteries in this product should be removed and disposed of in accordance with local regulations for separate collection of spent batteries.

    Distributed by:
    Abbott Laboratories Ltd.
    Abbott Diabetes Care
    Abbott House
    Vanwall Business Park
    Vanwall Road
    Maidenhead
    Berkshire
    SL6 4UD
    UK
    0500 467 466
    Abbott Diabetes Care
    666 Doncaster Road
    Doncaster 3108
    Victoria, Australia
    ABN 95000 180 389
    1800-801-478
    Abbott Laboratories Ireland, Ltd.
    Abbott Diabetes Care
    4051 Kingswood Drive
    Citywest Business Campus
    Dublin 24
    Ireland
    1800 77 66 33
    Abbott Laboratories (N. Z.) Ltd.
    Ground Floor Bldg. D, 4 Pacific Rise
    Mount Wellington
    P.O. Box 22-801 Otahuhu
    Auckland, New Zealand
    0800 106 100

    FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions.
    This product(s) and/or its use are protected by one or more of the following patents: US6,071,391; US6,120,676; US6,143,164; US6,156,173; US6,299,757; US6,338,790; US6,503,381; US6,591,125; US6,616,819; US6,618,934; US6,676,816; US6,749,740; US6,893,545; US6,942,518; US7,058,437; US7,615,637; US7,713,406; US7,740,581; US7,802,467; US7,866,026; US7,895,740; US7,901,554; USD611,854S; USD613,190S; USD615,884S; EP1119637; EP1145000; EP0958495, CA2346415; CA2358993; CA2351796; CA2423837; CA121137. Additional patents may be issued and/or pending.


    Abbott Diabetes Care Ltd.
    Range Road
    Witney, Oxon
    OX29 0YL, UK

    Manufacturer:

    Abbott Diabetes Care Inc.
    1360 South Loop Road
    Alameda, CA 94502 USA

    Brand

    Videos

    FreeStyle Freedom Lite Set Up and Perform Video

    Documents / Resources

    Download manual

    Here you can download full pdf version of manual, it may contain additional safety instructions, warranty information, FCC rules, etc.