Abbott FreeStyle User manual

Owner’s Booklet
Manual del Usuario
Blood Glucose Monitoring System
Sistema de Control de Glucosa en la Sangre

i
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 to the right). Bottom
FreeStyle Lite test strip
Sample area
Top
Data Port
Downloads test results. Requires
a compatible data management
system. For more information,
please go to our website or
contact Customer Care.
Display Screen
Displays your test results and other
important information.
m (Mode) Button
• Moves to different mode settings
• Scrolls backward
• Silences a reminder alarm
The FreeStyle Freedom Lite® Meter and How It Works
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.
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. c (Configure) Button
• Marks a control solution test
• Scrolls forward
• Silences a reminder alarm
• Changes the date, time, alarm
settings, sound options, and
reviews stored readings
English

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 .......................................................................2
Set Sound Volume .............................................................3
Set Time.......................................................................4
Set Date.......................................................................5
Testing Your Blood Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Purpose .......................................................................7
Prepare to Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Important Test Strip Information ...............................................9
Performing a Blood Glucose Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Understanding Blood Glucose Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Low and High Blood Glucose Results ......................................... 13
Error Codes .................................................................16
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
English

FreeStyle® Control Solution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Purpose ..................................................................... 21
Control Solution Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Out of Range Control Solution Results........................................ 22
Performing a Control Solution Test ........................................... 23
Using Your Meter Memory ..................................................26
Purpose ..................................................................... 26
Viewing Blood Glucose Averages in Memory ................................. 26
Viewing Test Results in Memory .............................................. 27
Setting Reminder Alarms (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Purpose ..................................................................... 28
Transferring Test Results To a Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Maintaining the Meter......................................................30
Replacing the Battery........................................................ 30
Cleaning the Meter .......................................................... 32
Specications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Denition of Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
English

1
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 nger, upper arm and palm and venous
whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus
at home as an aid in monitoring the eectiveness of a diabetes control program. 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.
IMPORTANT:
The device must not be used on more than one person including other family members due to the
risk of spreading infection. All parts of the device and its accessories are considered biohazardous
and can potentially transmit infectious diseases, even after performing the cleaning procedure.1,2
Healthcare professionals handling this system must always wear gloves and should follow the
infection control policies and procedures approved by their facility.
Use only FreeStyle Lite® test strips and FreeStyle® control solution with this meter. Other products
can produce inaccurate results.
1
“FDA Public Health Notication: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne
Pathogens: Initial Communication” (2010) http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
2
“CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens”
(2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
Contact Customer Care Toll Free at 1-888-522-5226 www.MyFreeStyle.com
English

2
• The expected glucose level for a non-diabetic, non-pregnant fasting adult is under 100 mg/dL.3
• Two hours after meals, levels should be less than 140 mg/dL.3
• Consult your healthcare professional to determine the range that is appropriate for you.
Warning:
• Test on your ngers if you are testing for low blood glucose (hypoglycemia) or if you suer
from hypoglycemia unawareness.
• This system contains small parts that may be dangerous if swallowed.
Caution: Please read all the instructions provided in this owner’s booklet and practice
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 o, press and hold
m
for 3seconds until appears.
2. Press
m
to bypass setting the optional reminder alarms. You may choose to
set these later (see Setting Reminder Alarms section).
3
American Diabetes Association Clinical Practice Recommendations: Diagnosis and classication of diabetes mellitus.
Diabetes Care 2005;28 (Suppl.1):S37-S42
English

3
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.
3. Set sound volume
If you prefer: Press
c
until you see: Then
No sound
•Press
m
to save
A low beep
A louder beep
Contact Customer Care Toll Free at 1-888-522-5226 www.MyFreeStyle.com
English

4
Set Time
Time Format
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.
Hour
4. Set hour
• Press
c
to display correct hour
• Press
m
to save
Minutes
5. Set minutes
• Press
c
to display correct minutes
• Press
m
to save
Time Format
6. Set time format
• Press
m
to accept time format or
• Press
c
to change
• Press
m
to save
English

5
Set Date
Note: The date format can display either:
Year Month Day
OR
Year Day Month
Month
The month will ash rst
7. Set month
• Press
c
to display correct month
• Press
m
to save
Day
8. Set day
• Press
c
to display correct day
• Press
m
to save
Contact Customer Care Toll Free at 1-888-522-5226 www.MyFreeStyle.com
English

6
Date Format
9. Set date format
• Press
m
to accept date format or
• Press
c
to change
• Press
m
to save
Year
10. Set year
• Press
m
to accept year or
• Press
c
to change
• Press
m
to save
11. Press and hold
m
for 3seconds until meter turns o. Meter set up is
complete.
English

7
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.
Note: Avoid moles, veins, bones, and tendons. Bruising may occur at the test site. If bruising
occurs, consider selecting another site.
There are dierences in testing on ngers versus alternative sites.
Warning:
Test on your ngers if you are testing for low blood glucose (hypoglycemia) or if you suer from
hypoglycemia unawareness.
Check for low blood glucose when:
• You feel symptoms such as weakness, sweating, shakiness, headache, or confusion
• You eat a delayed meal after taking insulin
• You are following your healthcare professional’s advice
Contact Customer Care Toll Free at 1-888-522-5226 www.MyFreeStyle.com
English

8
IMPORTANT:
2. Wash your hands and the test site with warm water and soap to ensure
accurate results.
• Thoroughly dry your hands and the test site.
• Do not use lotion or cream on the test site.
3. Check test strip expiration date.
Do not use expired test strips; they may produce inaccurate results.
IMPORTANT: Use only FreeStyle Lite® test strips. Other test strips
can produce inaccurate results. The test strips are for single use only.
English

9
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.
• Close the vial cap tightly immediately after removing a test strip.
• Do not transfer test strips to another container.
• Do not store test strips outside the vial.
• Do not bend, cut, or alter test strips.
• Do not apply blood to both sides of the test strip.
• Do not press the test strip against the test site.
• Do not scrape the blood onto the test strip.
• Do not apply blood to the at side of the test strip.
• Do not apply blood to the test strip when the test strip is out of the meter.
• Do not put blood or foreign objects into the meter.
Warning: Drying agents in the test strip vial may be harmful if inhaled or
swallowed and may irritate skin and eyes.
Contact Customer Care Toll Free at 1-888-522-5226 www.MyFreeStyle.com
English

10
Performing a Blood Glucose Test
1. Remove test strip from vial.
2. Insert test strip to turn meter on.
Note: The meter turns o 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. Conrm System Check Screen.
• 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.
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.
Top
Printed side up
Sample areas
English

11
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.
(Example only)
6. View result
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 o.
Discard used lancet and test strip properly.
8. Wash your hands and test site thoroughly with warm water and soap after
handling the meter, lancing device or test strips.
Contact Customer Care Toll Free at 1-888-522-5226 www.MyFreeStyle.com
English

12
Understanding Blood Glucose Test Results
The meter displays results in mg/dL. The unit of measurement is preset. You cannot change
this setting.
IMPORTANT: The meter displays results from 20 – 500 mg/dL. Low or
high blood glucose results can indicate a potentially serious medical
condition.
English

13
Low and High Blood Glucose Results
Result What It Means What To Do
lower than
60 mg/dL
Low (hypoglycemic) 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
240 mg/dL
High (hyperglycemic) 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.
Contact Customer Care Toll Free at 1-888-522-5226 www.MyFreeStyle.com
English

14
Display What It Means Symptoms What To Do
Appears when
result is:
lower than
20 mg/dL
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 conrm that
your meter and strips are working
properly.
IMPORTANT:
• Severe dehydration may cause false low results. If you believe you are suering
from severe dehydration, contact your healthcare professional immediately.
• Contact your healthcare professional if you have symptoms that do not match
your test result, and you have followed the instructions in this owner’s booklet.
English

15
Display What It Means Symptoms What To Do
Appears when
result is:
higher than
500 mg/dL
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 conrm that
your meter and strips are working
properly.
Contact Customer Care Toll Free at 1-888-522-5226 www.MyFreeStyle.com
English

16
Error Codes
Message What It Means What To Do
• The sample is too small
• There may be a problem
with the test strip
• Meter error
• Very low blood glucose
lower than 20 mg/dL
1. Follow your healthcare professional’s advice to
treat low blood glucose if you have symptoms
such as:
•Weakness •Shakiness
•Sweating •Headache
•Confusion
2. Perform a control solution test using a new
test strip. If the test results are within the range
printed on the test strip vial, retest using blood
and a new test strip.
3. If the control solution result is out of range or the
error reappears, contact Customer Care.
English