Abbott Diabetes Care FreeStyle Flash Blood Glucose Monitor User Manual

Owner’s
B l o o d G l u c o s e M o n i t o r i n g S y s t e m
Booklet
Table of Contents
Important Information About Your
FreeStyle Flash™ Blood Glucose Monitoring System ...............................2
Important Health Related Information .............................................. 3-4
The FreeStyle Flash™ Meter and FreeStyle Test Strip
Getting Started With the FreeStyle Flash Meter ................................. 5-6
The FreeStyle Flash Meter and How It Works.................................... 7-8
The FreeStyle Flash Meter Display .................................................. 9-12
The FreeStyle Test Strip.................................................................. 13-14
The FreeStyle Control Solution
All About FreeStyle Control Solution ............................................. 15-18
Performing a Control Solution Test ................................................ 19-20
The FreeStyle Lancing Device
FreeStyle Lancing Device .....................................................................21
Using the Lancing Device .............................................................. 22-23
Lancing on Alternate Sites ....................................................................24
Lancing your Finger .............................................................................25
Removing the Lancet ...........................................................................26
Testing Your Blood Glucose
Blood Glucose Testing and Components........................................ 27-28
Performing a Blood Glucose Test ................................................... 29-32
LO and HI Readings ...................................................................... 33-34
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Appendices
Using your Meter’s Lights ....................................................................35
Using Alarms........................................................................................36
Meter Screen Displays .................................................................... 37-42
Setting Alarms ......................................................................................38
Viewing Your Meter Memory ......................................................... 43-45
Transferring Data .................................................................................45
Error Messages ............................................................................... 46-49
Batteries ...............................................................................................50
Replacing the Batteries .........................................................................51
Troubleshooting ............................................................................ 53-54
Caring for Your Meter ..........................................................................55
Meter Specifications .............................................................................56
Index .............................................................................................. 57-64
Target Range Guideline ........................................................................65
Meter Serial Number ...........................................................................65
Important Phone Numbers ..................................................................65
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The FreeStyle Flash™ System Uses the World’s Smallest Sample So You Can Test on a Variety of Locations
Test On or Off Your Fingers
Suggested Test Areas for the Hand
Upper arm
Forearm
Hand
Fingertips
Thigh
Calf
The FreeStyle Flash System gives you the freedom to obtain a blood sample for testing your glucose level from different areas of your body. You may test your blood glucose from your forearm, upper arm, hand, thigh, calf as well as your fingers. The human figure above shows the areas where you can test with the FreeStyle Flash System. Avoid moles, veins, bones and tendons.
WARNING: We recommend that you test on your fingers or palm (at the base of the thumb) if you are testing for hypoglycemia (low blood glucose) or if you suffer from hypoglycemia unawareness.
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Important Information About Your FreeStyle Flash
How the FreeStyle Flash System Should Be Used
• The FreeStyle Flash System is intended for use outside the body (in other words, in vitro diagnostic use only).
• The FreeStyle Flash System is used for measuring blood glucose (also known as blood sugar) from samples taken from the forearm, upper arm, hand, thigh, calf as well as your fingers (refer to page 1 for more information).
• The FreeStyle Flash Meter should only be used with FreeStyle® Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Flash Meter can produce inaccurate results.
Do use the FreeStyle Flash System for:
• Testing blood glucose.
• Testing only with fresh capillary whole blood samples.
Do not use the FreeStyle Flash System for:
• The diagnosis of diabetes.
• Testing on newborns.
• Testing of arterial blood.
Blood Glucose Monitoring System
WARNING:
children as it contains small parts that may be dangerous if swallowed.
Keep the FreeStyle Flash System away from young
Caution: Please read all the instructions provided in this Owner’s Booklet and practice the testing procedures before using the
FreeStyle Flash System. Blood glucose monitoring should be done with the guidance of a healthcare professional.
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Important Health-Related Information
• Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult your physician immediately.
• Test results below 60 mg/dL (3.3 mmol/L) mean low blood glucose (hypoglycemia).
• Test results greater than 240 mg/dL (13.3 mmol/L) mean high blood glucose (hyperglycemia).
• If you get results below 60 mg/dL or above 240 mg/dL, and do not have symptoms of hypoglycemia or hyperglycemia (refer to pages 33 and 34), repeat the test. If you have symptoms or continue to get results that fall below 60 mg/dL or above 240 mg/dL, follow the treatment advice of your healthcare professional.
• If you are experiencing symptoms that are not consistent with your blood glucose test and you have followed all instructions described in the FreeStyle Flash™ Owner’s Booklet, call your healthcare professional.
• Physiologic differences in the circulation between the finger or palm (at the base of the thumb) and other test sites like the fore­ arm, upper arm, hand, thigh, and calf may result in differences in blood glucose measurements from these test sites and your finger or palm (at the base of the thumb). Differences in blood glucose measurements between the other test sites and your finger or palm (at the base of the thumb) may be observed after eating, insulin medication, or exercise.
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Important Health-Related Information (continued)
• Changes in blood glucose may be observed in finger or palm (at the base of the thumb) blood samples sooner than blood samples from the forearm and other alternate sites. Vigorous rubbing of the alternate test sites before lancing helps to minimize the difference between finger or palm (at the base of the thumb) and alternate site
test results.
WARNING: We recommend that you test on your fingers or palm (at the base of the thumb) if you are testing for hypoglycemia (low blood glucose), or if you suffer from hypoglycemia unawareness.
Key Features of the FreeStyle Flash
Blood
Glucose Monitoring System
• World’s smallest meter
Fast, accurate results in an average of 7 seconds
• Virtually painless testing*
• World’s smallest sample (3/10 microliter)
• Most test sites (test on your forearm, upper arm, hand, thigh, calf, or fingers)
• Display backlight
• Test light to illuminate sampling area
• 4 daily, programmable alarms
• Clock
• 250-test memory with date/time
• 14-day average
• Easy-to-read display
• Data interface port
* Data on file: testing was done on forearm.
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The FreeStyle Flash™ Meter and FreeStyle
®
Test Strip
Getting Started with the FreeStyle Flash Meter
Abbott Diabetes Care has developed and tested your FreeStyle Flash Meter, FreeStyle Test Strips, and FreeStyle Control Solution to provide precise and accurate results.
These items are included in your FreeStyle Flash Blood Glucose Monitoring System:
1. Getting Started Guide
2. Owner’s Booklet
3. Quick Reference Guide
4. FreeStyle® Control Solution
5. FreeStyle Test Strips (10 Count)
6. FreeStyle Lancing Device with Clear Cap (for testing sites other than the finger)
7. Grey Cap for Lancing Device (for finger testing)
8. FreeStyle Flash Meter
9. Sterile FreeStyle Lancets (10 Count)
10. Carrying Case
11. Daily Log
12. Warranty Registration Card (not shown)
13. Two pre-installed #2032, 3 volt, lithium batteries (not shown)
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FreeStyle Flash
System
1. 2. 3.
8.
6.
7.
4.
5.
9.
10.
11.
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The FreeStyle Flash™ Meter and How It Works
Data Port
Allows you to transfer data from the meter’s memory to a computer or upload to a secure, protected website designed for diabetes data management. Refer to “Transferring Data” on page 45 for more information.
Display Screen
Displays your test results and other important information. Built-in display backlight for use in low-light conditions.
m (Mode) Button
The “m” button is used to:
• Moves to different screens such as memory and setup.
• Changes the code (scrolls backward).
• Silences an alarm.
Light Button
Controls the display backlight and test light.
Sample Target Areas (dark-colored half-circles on test strip)
Apply blood or control solution to one edge of the strip only. Insert printed side up (with the dark colored square going into the meter).
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c (Configure) Button
The “c” button is used to:
• Marks a test result as control solution.
• Changes the test strip code (scrolls forward), time, alarm settings, sound options, date, unit of measurement, and reviews stored readings.
• Silences an alarm.
Test Strip Port
Insert the Top end of a new FreeStyle Test Strip here. The meter powers on when you insert the test strip. The test strip port has a test light that can be used to light a testing area in low-light conditions.
Top (for insertion into meter)
FreeStyle® Test Strip
Bottom (for blood sample)
Edge of test strip
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The FreeStyle Flash™ Meter Display
Check Owner’s Booklet Symbol
Appears when the meter detects LO or HI blood glucose, out of temperature range results, low batteries, data cable inserted and error messages.
Note: Always refer to FreeStyle Flash Owner’s Booklet when this appears.
Control Solution Test Result Symbol
Shows that you have marked a test result as a control solution test.
Message Area
Date, time, number of tests in average, and software version number appear here.
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System Check Screen
This screen always appears when the meter leaves clock mode so that you can ensure the display is working properly.
Test Result Area
Test results appear here. A decimal point appears only when the unit of measurement is in millimoles per liter (mmol/L).
Battery Symbol
Appears when you should replace your meter batteries.
Memory Mode Symbol
Shows you a test result stored in the meter memory. The meter stores your last 250 blood glucose
test results.
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The FreeStyle Flash™ Meter Display
Blood Drop and Test Strip Symbols
These symbols work together in an animation to tell you when the meter is ready for you to apply blood
or control solution.
Date Setup Symbol
d-m or m-d appears in Set mode
when setting the date format (for either the day-month or month-day format).
Check and Set Test Strip Code Symbol
Appears when you should check and set the test strip code.
Thermometer Symbol
Appears if your meter is out of temperature range for getting an accurate reading.
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mg/dL (U.S. Standard) or mmol/L
The units of measurement used for your test result.
14-Day Average Symbol
Appears with a glucose reading that equals the average value of the readings from the last 14 days (refer to page 43).
Clock Symbol
A clock symbol appears in the Clock mode and in the Set mode when setting the time.
P Symbol
Indicates PM in 12-hour format.
Sound Level Symbols
Indicates whether the meter sound prompt (beep) is set to high, low, or off.
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The FreeStyle
®
Test Strip
Apply blood or control solution to only
one edge of the test strip per test.
Important: Use only one edge of the test
strip per test. Do not apply blood to both edges. Test strips may be used only once. Discard used test strips.
The Test Strip Does the Work
The test strip acts like a sponge and pulls the blood into the strip through the edge.
Edge of test strip
Edge of test strip
WARNING: Keep the test strip vial away from children. The cap
is a choking hazard. The cap or vial contains drying agents that may be harmful if inhaled or swallowed and may cause skin or eye irritation.
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Important Test Strip Information
• The FreeStyle Flash™ System has an operating range of 40º to 104ºF (5º to 40ºC).
• Use the test strips only within the system operating temperature range.
• Store the test strip package in a cool, dry place between 37º to 86ºF
(3º to 30ºC).
• Keep away from direct sunlight and heat.
• Store your test strips in their original vial only; never transfer them
to another vial or any other container or carrying case.
• Never store individual test strips outside the vial.
®
• After removing a FreeStyle
Test Strip from the vial, immediately
replace the vial cap and close tightly.
• With clean, dry hands, you may gently touch the test strip anywhere
when removing it from the vial or inserting it into the meter.
• Do not use test strips beyond the expiration date printed on the
package as this may cause inaccurate results.
• Do not bend, cut, or alter FreeStyle Test Strips in any way.
Note: For detailed storage and usage information, refer to the FreeStyle Test Strip package insert.
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The FreeStyle
®
Control Solution
All About FreeStyle Control Solution
What is FreeStyle Control Solution?
It is a red liquid that contains a fixed amount of glucose and has three important uses:
• To practice testing without having to use your
own blood.
• To ensure that your meter and test strips are
working together properly.
• To check that you are following the correct testing procedure.
What is the best way to check my FreeStyle Flash™ Meter?
Perform a test using the FreeStyle Control Solution. A control solution test follows the same procedure as a blood glucose test, except that you use a sample of control solution instead of a drop of blood (refer to pages 19 to 20 for information on performing a control solution test).
How does the control solution test tell me my meter is working properly?
If the meter reading is within the control solution acceptable range, the meter is working properly.
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When should I perform a control solution test?
• When you question your results and want to confirm that your
monitor and test strips are working properly. For information on how to obtain Control Solution, call Customer Care at 1-800-522-5226.
How do I know if my control solution has expired?
FreeStyle® Control Solution is good for three months after opening the bottle, or until the expiration date printed on the label, whichever comes first. Count forward three months from the date you open a new bottle of control solution. This is your discard date. Write this date on the side of the control solution bottle.
Example: You open the control solution on January 15th. Count forward three months to April 15th. This is the discard date that you record on the bottle.
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Ensuring Accurate Control Solution Results.
• Use only FreeStyle® Control Solution with your FreeStyle Flash™
Meter. The use of other brands of control solution with the FreeStyle Flash Meter may produce inaccurate results.
ce the cap on the control solution bottle immediately after using.
• Repla
• Do not use control solution past the expiration date or you may get
inaccurate results.
not add water or any liquid to control solution.
• Do
• Control solution tests are specified to be accurate only when
performed between 59º to 104ºF (15º to 40ºC).
Caution: Results from FreeStyle Control Solution tests do not reflect your blood glucose level.
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How do I know if the control solution test results are accurate?
• The control solution test results should fall within the range printed
on the test strip vial label.
Important: The control solution range is a target range for control solution only. It is not a target range for your blood glucose level.
• If control solution test results are out of this range, repeat the test.
• Out of range test results may be caused by:
– Expired or bad control solution. – Expired or bad test strip. – Error in performing test. – Watered-down control solution. – Code on test strip vial does not match code set in meter. – Meter malfunction.
º
– Control solution test done outside 59
to 104ºF (15º to 40ºC).
If your control solution test results continue to fall outside the range printed on the test strip vial:
1. The FreeStyle Flash™ System may not be working properly.
2. Do not use the FreeStyle Flash System to test your blood glucose.
3. Call Customer Care.
Where can I obtain FreeStyle Control Solution?
• Contact Customer Care to find out where you can
obtain FreeStyle Control Solution.
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