Abbott Freestyle Freedom Lite User Manual [en, es]

Owner’s Booklet Manual del Usuario

Blood Glucose Monitoring System

Sistema de Control de Glucosa en la Sangre

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.

Display Screen

Displays your test results and other important information.

m (Mode) Button

•Moves to different mode settings

•Scrolls backward

•Silences a reminder alarm

Top

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

•Marks a control solution test

•Scrolls forward

•Silences a reminder alarm

•Changes the date, time, alarm settings, sound options, and reviews stored readings

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.

English

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

Table of Contents

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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

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

Specifications.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 33

Definition of Symbols.. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 35

English

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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 finger, 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 effectiveness 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 Notification: 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

•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 fingers if you are testing for low blood glucose (hypoglycemia) or if you suffer	English
		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 off, press and hold  m   for 3 seconds until   appears..

2. Press  m   to bypass setting the optional reminder alarms.. You may choose to set these later (see Setting Reminder Alarms section)..

3American Diabetes Association Clinical Practice Recommendations: Diagnosis and classification of diabetes mellitus..	2
Diabetes Care 2005;28 (Suppl..1):S37-S42

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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
A low beep	• Press	m   to save
A louder beep

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

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  c   until you see the “P” displayed for PM..
Time Format
4. Set hour
•	Press	c	to display correct hour
•	Press	m   to save
Hour
5. Set minutes
•	Press	c   to display correct minutes
•	Press	m   to save
Minutes
6. Set time format
•	Press	m   to accept time format or
•	Press	c   to change
•	Press	m   to save
Time Format

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Set Date

Note: The date format can display either:

				OR
			Year Month Day	Year Day Month
	The month will flash first
	7. Set month
	•	Press	c   to display correct month
Month	•	Press	m   to save
	8. Set day		c   to display correct day
	•	Press
	•	Press	m   to save
Day

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

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

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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 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

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

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..

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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)..
English	•	Store test strips away from direct sunlight and heat..
	•	Clean and dry your hands before removing a strip from the vial..
	•	Store test strips in their original vial only..
	• 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..

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

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

Performing a Blood Glucose Test

1.	Remove test strip from vial..				Top
2.	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..

Printed side up

Sample areas

3.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..

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..

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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..

		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
	(Example only)	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.. 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..

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

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..

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Low and High Blood Glucose Results

Result	What It Means	What To Do
lower than	Low (hypoglycemic)	Repeat the test with a new test strip, even if you do
60 mg/dL		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	High (hyperglycemic)	Repeat the test with a new test strip, even if you do
240 mg/dL		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..

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Display	What It Means	Symptoms
	Severe low blood	Weakness
	glucose	Sweating
Appears when		Shakiness
		Headache
result is:
		Confusion
lower than
20 mg/dL

What To Do

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..

IMPORTANT:

•Severe dehydration may cause false low results.. If you believe you are suffering 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..

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Display	What It Means	Symptoms
	Severe high blood	Fatigue
	glucose	Thirst
Appears when		Excess Urination
		Blurry Vision
result is:
higher than
500 mg/dL

What To Do

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..

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

Error Codes

Message

What It Means

• 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

What To Do

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..

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Message	What It Means
• There may be a problem
•	with the test strip
	Meter error
•	Very high blood glucose
•	higher than 500 mg/dL
	HIGH control solution
	was applied when the
	temperature was too
	cold.. (Applies only to
	control solution labeled
	as HIGH)..

What To Do

1.Follow your healthcare professional’s advice to treat high blood glucose if you have symptoms

such as:	• Thirst
•  Fatigue
•  Excess urination	•  Blurry vision

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..

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

	Message		What It Means				What To Do
	•	Incorrect test procedure..			1.	Wait for	and   to appear before applying
		For example, putting
		blood on the test strip				blood or control solution..
		before inserting it into			2.	Perform a control solution test using a new
		the meter or applying				test strip.. If the test results are within the range
		blood before		and		printed on the test strip vial, retest using blood
			appear			and a new test strip..
					3.	If the control solution result is out of range or the
	• There may be a problem
						error reappears, contact Customer Care..
	•	with the test strip
		Meter error
	• There may be a problem				1.	Perform a control solution test using a new
	•	with the test strip				test strip.. If the test results are within the range
		Meter error				printed on the test strip vial, retest using blood
						and a new test strip..
					2.	If the control solution result is out of range or the
						error reappears, contact Customer Care..

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Troubleshooting

		What It Means		What To Do
1.The meter	•	Test strip is inserted	1.	Insert test strip print side up, top end in..
does not		upside down, or bottom
enter test		end in, or not fully
mode after		inserted into the meter
inserting a
test strip.	•	No battery is installed	1.	Install battery with (+) facing up..
	•	Battery is installed
		incorrectly
	•	Dead battery	1.	Replace battery.. Reset date and time, if
				necessary..
			2.	If meter still does not enter test mode,
				contact Customer Care..
	•	Defective test strip or	1.	Contact Customer Care..
		meter
	• Blood or foreign objects
		put in the test strip port

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

			What It Means		What To Do
	2.The test	• Blood drop is too small		1.	Add blood to the same sample area within
					60 seconds, or repeat the test using a new
	does not
					test strip and a larger blood drop..
	start after
	applying
	the blood	•	Defective test strip	1.	Repeat the test using a new test strip.. Wait for
	drop.
		•	Sample applied after		and   to appear before applying blood
			meter turns off		or control solution..
				2.	If problem persists, contact Customer Care..
		•	Defective meter	1.	Contact Customer Care..

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