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Audio, Video and Text Instructions for Homecare Patients

FreeStyle Freedom Lite

Blood Glucose Monitoring System

Intended Use of FreeStyle

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The FreeStyle Freedom Lite Blood Glucose Monitoring System is intended for self-testing outside

the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the

effectiveness of a diabetes control program by quantitatively measuring glucose in fresh whole blood

from the finger, upper arm and palm. The FreeStyle Freedom Lite Blood Glucose Monitoring System

should not be used for the diagnosis of or screening of diabetes or for neonatal use. It is intended

to be used by a single person and should not be shared. Alternate site testing should be done only

during steady state times (when glucose is not changing rapidly). The FreeStyle Lite Blood Glucose

Test Strips are for use with the FreeStyle Freedom Lite Blood Glucose Meter to quantitatively measure

glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, upper arm and

palm.

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.

If the meter is being operated by a second person who is providing testing assistance to the user,

the meter and lancing device should be cleaned and disinfected prior to use by the second person.

Use only FreeStyle Lite® test strips and FreeStyle® control solution with this meter. Other products

can produce inaccurate results.

• The expected glucose level for a non-diabetic, non-pregnant fasting adult is under

100 mg/dL.

• Two hours after meals, levels should be less than 140 mg/dL.

• Consult your healthcare professional to determine the range that is appropriate for you.

Warning:

• Test on your fingers if you are testing for low blood glucose (hypoglycemia) or if you suffer

from hypoglycemia unawareness.

• This system contains small parts that may be dangerous if swallowed.

Limitations:

• For in-vitro diagnostic use only (external use only).

• Not for diagnosis of or screening for diabetes.

• Not for testing of neonates.

• The test strips are for single use only. Do not reuse test strips.

• The system can give false results greater than 10,000 feet (3,048 meters) above sea level.

• The system can give false results outside the hematocrit range: 15% to 65%.

• Individuals experiencing a hypoxia state may yield falsely low results.

• In situations of decreased peripheral blood flow, capillary blood testing may not be

appropriate as it may not represent the true physiological state. Examples would include but

are not limited to: severe dehydration caused by diabetic ketoacidosis or the hyperosmolar

non-ketotic state, hypotension, shock, or peripheral vascular disease.

• This device should not be used to test critically ill patients.

• Alternative site testing (AST) should not be used to calibrate continuous glucose monitors

(CGMs) nor for use in insulin dose calculations.

• AST testing should only be done during steady-state times (when glucose is not changing rapidly).

• For single patient use at home by a lay user.

• Severe dehydration or excessive water loss may cause false low results. If you believe you are

suffering from severe dehydration, consult your physician immediately.

• Cholesterol up to 500 mg/dL or triglycerides up to 3,000 mg/dL do not significantly affect test

results. However, glucose values in specimens beyond these levels, should be interpreted with

caution.

Setting Up the Meter and Testing Your Blood Glucose

Setting Up the Meter

Purpose

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

With the meter off, press and hold m for 3 seconds until appears.
Press m 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:

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.

Set sound volume

If you prefer: Press c until you see: Then

No sound

A low beep • Press m to save

A louder beep

Contact Customer Care Toll Free at 1-888-522-5226 www.MyFreeStyle.com

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

Set hour

Press c to display correct hour
Press m to save

Minutes

Set minutes

Press c to display correct minutes
Press m to save

Time Format

Set time format

Press m to accept time format or
Press c to change
Press m to save

Set Date

Note: The date format can display either:

Year

Year Month Day Day Month

Month

The month will flash first

Set month

Press c to display correct month
Press m to save

Day

Set day

Press c to display correct day
Press m to save

Date Format

Set date format

Press m to accept date format or
Press c to change
Press m to save

Year

Set year

Press m to accept year or
Press c to change
Press m to save

Press and hold m for 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

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.

Warning: Test on your fingers if you are testing for low blood glucose (hypoglycemia) or if you suffer 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

IMPORTANT:

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.

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.

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 flat 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.

Performing a Blood Glucose Test

Remove test strip from vial.
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.

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.

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.

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.

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.