DO NOT PRINT FROM THIS FILE FOR REFERENCE ONLY Owner’s Booklet Blood Glucose Monitoring System ART22311-101_rev-B.
The FreeStyle Freedom Lite Meter and How It Works 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. Data Port Downloads test results. Requires a compatible data management system.
Table of Contents The FreeStyle Freedom Lite Meter and How It Works . . . . . . . . . . . . . . . . . . . . . . . . . i Important Information About Your Blood Glucose Monitoring System. . . . . . 1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 Setting Up the Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Purpose . . . . . . . . . . . .
Important Information About Your Blood Glucose Monitoring System Intended Use Caution: 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. Use outside the body only (in vitro diagnostic use).
Set Time Set Sound Volume With the sound volume on, your meter will beep when: • The test strip is full of blood • The test result appears on the display • An error occurs You may also choose to silence your meter. 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 c until you see the “P” displayed for PM. Time Format 3. Set sound volume 4.
Set Date 9. Set date format • Press m • Press c • Press m Note: The date format can display either: to accept date format or to change to save OR Year Month Day Year Day Month Date Format 10. Set year The month will flash first 7. Set month Month • Press c • Press m 8. Set day • Press c • Press m to display correct month to save to display correct day to save Year • Press m • Press c • Press m to accept year or to change to save 11.
Testing Your Blood Glucose Purpose The purpose of this section is to produce an accurate blood glucose test result. Prepare to Test 1. Select your test site. Available Test Sites Upper arm Forearm Hand Fingertips Thigh Calf 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.
Important Test Strip Information Please read the FreeStyle Lite test strip package insert for more information. • Use the test strips within the meter’s operating range: 40° – 104° F (4° – 40° C). • Store test strips in a cool, dry place between 40° – 86° F (4° – 30° C). • Store test strips away from direct sunlight and heat. • Store test strips in their original vial only. • Clean and dry your hands before removing a strip from the vial.
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. The meter displays results in mmol/L.
Low and High Blood Glucose Results Result lower than 3.3 mmol/L What It Means Low (hypoglycaemic) Display 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.
Display What It Means Severe high blood glucose Appears when result is: higher than 27.8 mmol/L Symptoms What To Do 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.
Message What It Means What To Do with the test strip • Meter error • Very high blood glucose higher than 27.8 mmol/L • HIGH control solution was applied when the temperature was too cold. (Applies only to control solution labeled as HIGH). 1. Follow your healthcare professional’s advice to treat high blood glucose if you have symptoms such as: • Fatigue • Thirst • Excess urination • Blurry vision 2. Perform a control solution test using a new test strip.
Troubleshooting What It Means What It Means 1. The meter does not enter test mode after inserting a test strip. • Test strip is inserted upside down, or bottom end in, or not fully inserted into the meter • No battery is installed • Battery is installed What To Do 1. Insert test strip print side up, top end in. 1. Install battery with (+) facing up. incorrectly • Dead battery 1. Replace battery. Reset date and time, if necessary. 2.
FreeStyle Control Solution Out of Range Control Solution Results Purpose • Repeat the test if control solution results are outside the range printed on FreeStyle control solution is a red liquid that contains a fixed amount of glucose.
Performing a Control Solution Test 4. Confirm System Check Screen. • This display appears when you turn on the meter. Do not use the meter if 1. Check control solution expiry date. IMPORTANT: 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.) 2. Remove test strip from vial. 3.
6. View result. Using Your Meter Memory The result appears on the display when the test is complete. Purpose The purpose of this section is to review your stored test results and 7-, 14- and 30-day averages. (Example only) 7. Compare the control solution result to the range printed on the test strip vial. The result should fall within the range. Note: If you see an “Er1, Er2, Er3 or Er4” on the display, it is an error code. Go to Error Codes section. 8.
Viewing Test Results in Memory Meter memory stores the last 400 test results with time and date. Press results. The most recent result appears first. c to scroll through the on the display indicates that you are viewing stored test results. 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.
5. Set alarm sound volume Press If you prefer: No sound A low beep Maintaining the Meter c until you see: Then • Press m to save A louder beep 6. Press c and repeat 2, 3, 4 and 5 to set remaining reminder alarms or Replacing the Battery The meter comes with a #2032, 3-volt, lithium battery installed. It provides power for about 1000 tests. • When • When appears on the display, the battery is low. appears, the meter may fail to turn on.
1. Slide the battery door to the right to open. 2. To remove the battery, pull the plastic tab up to release the battery. 3. Insert a new battery: (+) facing up. Cleaning the Meter Avoid getting dirt, dust, blood, control solution or liquid in the meter test strip and data ports.
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 33 ART22311-101_rev-B.indd 33-34 www.AbbottDiabetesCare.
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.
Distributed by: Abbott Laboratories Ireland, Ltd. Abbott Laboratories Ltd. Abbott Diabetes Care Abbott Diabetes Care 4051 Kingswood Drive Abbott House Citywest Business Campus Vanwall Business Park Dublin 24 Vanwall Road Ireland Maidenhead 1800 77 66 33 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 (N. Z.) Ltd. Ground Floor Bldg. D, 4 Pacific Rise Mount Wellington P.O.