Diabetic Supplies

reeStyle Freedom® Blood Glucose Monitoring System


 Product Description
The FreeStyle Freedom blood glucose monitor combines a large numeric display with an ergonomic design for testing that’s easy on your hand and your eyes.  With a 5-second average test time and up to a minute to re-apply the blood sample, the monitor provides a fast result with the flexibility necessary to get the test right.  Plus, programmable alarms and several potential testing sites facilitate timely, comfortable monitoring for better blood glucose control.


Introduction
Self-monitoring of blood glucose is an important part of the treatment plan for people with diabetes. It helps you develop your individual blood glucose profile, so you and your health care team can plan your particular diabetes management regimen. It provides you with the ability to make day-to-day treatment choices with meals and physical activity as well as with oral agents and insulin, and it helps you recognize and understand the effect of lifestyle and diabetes medication on your diabetes control.1
More frequent self-monitoring has been associated with better glucose control, regardless of the diabetes type or therapy.2 However, barriers to frequent testing include the pain associated with the required finger stick along with the accumulated trauma to the fingers. With FreeStyle® meters you can enjoy the benefits of Virtually Pain-Free Testing and the flexibility of the most test sites available through alternate site testing.3 The termalternate site testing (AST) means using parts of the body other than the fingertips to obtain blood for blood glucose testing.




Why Is Alternate Site Testing Less Painful?

Your fingertips are full of nerve endings (receptors), which make the fingertips feel pain more readily. Other body sites such as the forearm have fewer nerve endings per square inch than the fingertips, thus resulting in less pain. This can make alternate site testing with FreeStyle meters Virtually Pain-Free. A 2004 US diabetes patient market study showed that of patients who tested using alternative sites, seven in ten believe alternate site testing to be less painful.4
This graphic shows the concentration of nerve endings (receptors) in the fingertips vs the forearm.

Alternate site testing with FreeStyle meters offers the most test sites available and gives those who have occupations or hobbies that require extensive use of their fingers another option to fingertip testing.3
 

Where Can I Test Using A FreeStyle Meter?

When using a FreeStyle meter, a blood sample test can be performed on the fingertips, forearms, upper arms, thighs, calves, and hands.3 However, it is always best to consult your health care professional for acceptable sites for your testing needs.

When Is Testing On The Finger Preferred?
It is important to note that when your glucose is changing rapidly, there may be a difference in the glucose readings between your finger and other test sites, like the forearm, upper arm, thigh, calf, and other areas of the hand. Because blood flow to the finger is three to five times faster than other alternate sites, blood samples from the finger may show changes in your glucose sooner than the forearm, upper arm, thigh, calf, and other parts of the hand. The possible difference in glucose readings between the finger and other alternate sites could delay your detection of hypoglycemia. Vigorous rubbing of the alternate test sites before lancing will help to minimize the difference between finger and other alternate site test results.3
Testing On The Finger Is Recommended:

• If you think your blood glucose is low (hypoglycemia). Blood glucose that is too low must be treated right away. If you have symptoms such as weakness, sweating, nervousness, headache, or confusion, follow your doctor's recommendation for treating hypoglycemia.

• If you have a history of hypoglycemia unawareness (no symptoms when your blood glucose is low).

How Would I Know If I Have Hypoglycemia Unawareness?

• Have you often obtained blood glucose readings below 55 mg/dL without any of the usual symptoms of hypoglycemia (sweating, tremors, rapid heartbeat, nervousness, extreme hunger)?

• Have you had episodes of impaired thinking?

• Have others observed you in situations where you appeared pale, tired, confused or acting as if you were in "slow motion"?

• Have you acted irritable or forgetful, even though you physically felt fine?

• Have you had difficulty managing a hypoglycemic episode, which required the assistance of others?

• Have you ever had a seizure or loss of consciousness without any warning signs?

• Do you try to maintain very tightly controlled blood sugars (often running below 90 mg/dl)?

• Have you had frequent episodes of hypoglycemia?

• Have you had diabetes over 20 years?

• Have you had a recent episode of severe hypoglycemia?

If you answer yes to any of these questions, please discuss this situation with your physician.


How Do I Perform An Alternate Site Test?
The following graphic shows the general steps involved in forearm testing.

• First, you vigorously rub the area until it's warm to increase blood flow to the surface.

• Second, you lance the arm.

• Third, you touch the test strip to the blood drop. It's that easy.

For more information on how to perform a blood glucose test, please refer to your user's guide


Forearm Testing Example



 
References:

• Self-Monitoring of Blood Glucose: The Basics. Clinical Diabetes, 20, #1, 45-47, 2002

  Benjamin, EM.

• Self-Monitoring of Blood Glucose Levels and Glycemic Control: The Northern California Kaiser Permanente Diabetes Registry. The American Journal of Medicine, 111, #1, 1-9, 2002

  Karter, AJ et.al.,

• If you are using an Abbott Diabetes Care meter, when testing for hypoglycemia or if you have hypoglycemia unawareness, we recommend testing on the finger only.

• 2004 NOP World Roper Consumer Study.

FreeStyle Freedom® System Product Specifications

Virtually Pain-Free Testing in an easy-to-read, easy-to hold meter.
The FreeStyle Freedom Blood Glucose Monitoring System has the largest reading of any leading meter, so it's really easy to see and hold. The FreeStyle Freedom system delivers Virtually Pain-Free Testing by taking the smallest sample of blood. And it's fast—you'll get results in an average of 5 seconds. With 4 programmable alarms, you'll know when it's time for another reading.
 
Assay Method:
Coulometric Electrochemical Sensor
Automatic Shutoff:
Two minutes after last user action
Battery Life:
1,000 tests
Calibration:
Plasma equivalent
Hematocrit:
15% to 65%
Measurement Units:
mg/dL (milligrams per deciliter)
Meter Storage Temp:
-4° to 140°F (-20° to 60°C)
Memory:
250 blood glucose and control solution tests with date and time
Operating Relative Humidity:
5% to 90% (non-condensing)
Operating Temperature:
40° to 104°F (5° to 40°C)
Power Source:
One #2032 battery, 3 volt lithium replaceable
Result Range:
20 to 500 mg/dL
Sample:
Whole blood, capillary
Sample Size:
0.3 microliters (300 nanoliters)
Size:
Width 2.00"x Length 3.30"x Thickness 0.63" (at thickest point)
Test Time:
Average of 5 seconds
Weight:
1.43 oz. (including battery)

Items included in the FreeStyle Freedom Blood Glucose Monitoring System:

• Owner's Booklet

• Getting Started Guide

• FreeStyle Lancing Device with Clear Cap (for testing sites other than the finger)

• Blue Cap for Lancing Device (for finger testing)

• FreeStyle Freedom Meter

• Sterile FreeStyle Lancets (10 Count)

• Carrying Case

• Daily Log

• Warranty Registration Card

• One #2032 battery, 3 volt Lithium replaceable

The IV Pillars of Technology

FreeStyle® systems offers the combination of four key technical elements:

• Coulometry

• Reliable Sample Detection

• Glucose Dehydrogenase

• Low Potential (Voltage) Measurement

In fact, FreeStyle systems are the only systems to have all four technical elements and provide outstanding clinical accuracy and precision. The state of the art technology minimizes influences from many of the common factors affecting clinical results.
1. Coulometry
While most blood glucose monitoring systems use other technologies, which measures only a fraction of the glucose reaction signal in a blood sample, FreeStyle systems uses a technology based on coulometric measurement. Coulometry is a unique, patented, electrochemical measurement technique employed exclusively in FreeStyle technology. The benefit of the coulometric analysis is that it is unaffected by reaction rates.
It is an ideal technique for measuring a small sample size since the total accumulated charge is used to calculate glucose concentration. In fact, FreeStyle systems require the world’s smallest blood sample, just 0.3 microliter. Most leading meters use other technologies for glucose measurement, which are more challenging to adapt to smaller blood sample requirements.

2. Reliable Sample Detection
Reliable sample detection is an important element for system accuracy. Blood testing procedures for modern glucose meters are simple, but application of an adequate blood sample to the test strip is necessary for accurate measurements. FreeStyle systems have the ability to detect an adequate sample. The difference between FreeStyle systems and systems without reliable sample detection is that the FreeStyle meters do not report a result when an insufficient sample is applied to the test strip. When a sufficient sample is applied, a correct result is obtained.

 
Reliable Sample Detection Technology

• Meter is designed not to start the test until it has enough blood.

• You can add more blood to the same sample area for up to 60 seconds.

• When there is enough blood, the meter "beeps" and begins the test.

The test strip uses capillary action and acts like a sponge to "pull" the exact amount of blood (0.3 microliter) into the test strip.
Ifnot enough blood fills the test strip area andnothing happens, the user has up to 60 seconds to add more blood to the same sample area of the test strip.
Ifenough blood fills the test strip sample chamber, the meter then “beeps” indicating there is sufficient blood andbegins the test.

3. Glucose Dehydrogenase (GDH)
A key contributor to the accuracy of FreeStyle systems is the unique enzyme and mediator combination used in the test strip. The enzyme used in the FreeStyle test strip is called Glucose Dehydrogenase (GDH). This enzyme can be used to perform electrochemical glucose measurements without interference by oxygen in the blood sample. The commonly used enzyme in most other electrochemical strips, Glucose Oxidase (GOX), is capable of reacting with oxygen to produce interference in the measurement.

4. Low Potential (Voltage) Measurement
Low Potential Measurements offer a method for minimizing the interference by substances present in blood. In order for an electrochemical reaction to occur, a potential (voltage) must be applied between a working and counter electrode. The larger the applied potential, the greater the number of interfering substances that can react and produce a signal. The proprietary osmium based mediator used in the FreeStyle test strip allows the glucose reaction to occur at a low potential. For this reason, very few substances can interfere with the FreeStyle system readings. Unlike strips that use iron-based mediators, the FreeStyle strip minimizes the effects of interfering agents such as uric acid, aspirin and acetaminophen (at elevated levels).1

SeeStyle Freedom® System Quick Facts

The FreeStyle Freedom system—Virtually Pain-Free Testing in an easy-to-read, easy-to-hold meter

• 
Largest numeric display of any leading meter makes it easy to read

  Freedom to See Clearly

• 
Ergonomic design makes it easy to hold

  Freedom of Comfort

• 
Fast, 5-second average test time—no meter is faster

  Freedom from Waiting

• 
4 programmable alarms remind patients when to test

  Freedom from Forgetting

Innovative technology for Virtually Pain-Free Testing

• The FreeStyle Freedom system uses coulometric technology to accurately measure glucose in the blood sample for increased clinical performance.

• World’s smallest sample size – 0.3 microliter – delivers Virtually Pain-Free Testing

• 60-second sample reapplication time and fill-trigger designed to prevent test from starting without an adequate blood sample

• 1

  Most test sites

 
References
1. When testing for hypoglycemia or if you have hypoglycemia unawareness, we recommend testing on the finger only.

Warranty Information

At Abbott, our first priority is you. That's why we've created theFriends for Life Program1 — a commitment to help you better manage your diabetes.

Here are some of the benefits Friends for Life members receive:

• 2 — If you ever have a problem with your meter, just call ourCustomer Care team toll free at(888) 522-5226. If we can't resolve the issue, we'll send you a free replacement meter. You're covered for life!

  Lifetime Warranty

• 2 — When we introduce a new meter in the future, you cantrade in your old meter for a new one — on us.

  Free Lifetime Meter Upgrades

• — If for any reason you are not completely satisfied with your FreeStyle® or Precision® meter, just callCustomer Care at(888) 522-5226 andwe'll happily refund your money.

  90-Day Money Back Guarantee

• — Includes training materials to help you get the most from your new FreeStyle® or Precision® meter.

  Welcome Kit

• — If you ever have a question about your meter, just call our expert team ofCustomer Care professionals toll-free — we are available 24 hours a day, 365 days a year at(888) 522-5226.

  Comprehensive Customer Care

• — Health insurance coverage can be confusing. Specialists can assist you with understanding yourinsurance coverage for FreeStyle® and Precision® products. Give us a call at (866) 246-2683 (Monday-Friday, 9:00a.m.-5:00 p.m. coast to coast.)

  Insurance Helpline

• — Right here on our Web site you will find helpful tools and information and so much more.

  Educational Support Materials

 
Becoming a Member is Easy — by simply registering your FreeStyle® or Precision® meter today.
 

• Abbott may modify or discontinue this program at any time without notice.

• Lifetime warranty and free meter upgrades require enrollment in the Friends for Life Program and use of your meter for a minimum of three years. Choice of replacement meter will be at the discretion of Abbott.

FreeStyle Freedom® System FAQs


When calibrating my meter, how do I change the code number to my FreeStyle Freedom Blood Glucose Monitoring System?
When the meter is turned on by inserting a test strip, three display screens will appear: 1) System Check, 2) Code Number and 3) Blood Drop and Test Strip. When you see the word "COdE" and a code number on the meter display screen, use the "c" button to scroll up or the "m" button to scroll down to the number that matches the number on your test strip vial. The FreeStyle Freedom Meter has a total of 50 codes. After you set your code number, the "Blood Drop and Test Strip" symbols will appear on the display screen. If you want to return to the code number display screen after the "Blood Drop and Test Strip" symbols have appeared, press the "c" button. (Precaution: Take care to not press the "c" or "m" buttons when you are holding the meter to perform the blood test. If you do, you might change the code and get an incorrect reading or an Error 6.)


How do I set the time?
To enter "Set-Up Mode," start with the meter off and no test strip inserted. Press and firmly hold the "m" button until the SET display screen appears. To move though the set-up screens, press the "m" button to bring up the blinking "HOUR" display screen.

With the hour blinking, press the "c" button until the correct hour appears. If using the 12-hour time format, be sure to press the "c" button until the correct choice between "AM" and "PM" is seen.

Then press the "m" button to bring up the blinking "MINUTE" display screen. With the minute blinking, press the "c" button until the correct minute appears.

To exit set-up mode, press and hold the "m" button until the meter turns off.




How do I set the Date?
To enter "Set-Up Mode," start with the meter off and no test strip inserted. Press and firmly hold the "m" button until the SET display screen appears. To move though the set-up screens, press the "m" button.

With the "MONTH" display screen blinking, press the "c" button until the correct month appears. Then press the "m" button to move to the "DAY" setting. With the day blinking, press the "c" button until the correct day appears. Then press the "m" button to move to the "YEAR" setting. With the year blinking, press the "c" button until the correct year appears.

To exit set-up mode, press and hold the "m" button until the meter turns off.


Can I use my fingers for testing with the FreeStyle Freedom system?
Yes. Even though the FreeStyle Freedom system allows alternate site testing on the body — forearms, upper arms, hands, thighs and calves — the fingertips are always a testing option. When testing for hypoglycemia (low blood sugar) or if you have hypoglycemic unawareness, we recommend testing on the finger only.


What is the proper technique for obtaining a blood glucose sample using the FreeStyle Freedom system?
To obtain an adequate sample, the following procedure is recommended:

• Wash the test site thoroughly with soap and water and then dry.

• To bring fresh blood to the surface of your testing site, rub the site vigorously until you feel it getting warm.

• Use FreeStyle lancets.

• Avoid lancing areas with obvious veins or moles to avoid excess bleeding or bruising.

• Place the cocked lancing device firmly against the skin, but do not press into the skin. Pressing into the skin at this point may cause bruising or red marks and can impede blood flow.

• With the lancing device pressed firmly against the skin, depress the release button and do not lift up. Continue to hold the lancing device and gradually increase pressure for several seconds.

• Lift the lancing device straight up; be careful not to smear the blood sample.

• Bring the test strip to the sample at a slight angle and gently touch only one edge of the test strip to the sample. Do not press the test strip against the sample, scrape the blood or use the flat side of the test strip

• Wait until you hear the confirmation beep from the FreeStyle Freedom system, or see the moving arrows or moving lines on the display screen; this means you have enough blood

• The test strip acts like a sponge and pulls the blood into the edge of the test strip

How can I get...
Owner's Booklet for the FreeStyle Freedom system?

A log book?
You may request a log book at no charge by filling out and sending the mail-in order card located on the last page of the log book that was supplied with the FreeStyle Freedom system. Please allow 6-8 weeks for delivery.
A lancing device?
We will gladly replace your broken or lost lancing device, free of charge. To request a replacement, please call Customer Service, toll-free at (888) 522-5226.
CR2032 Batteries?
The FreeStyle Freedom system uses what is commonly referred to as a CR2032 "coin cell" battery, which is commonly available at grocery stores, drugstores, and electronics retailers.


What is control solution and when should I use it?
Control solution is a red liquid that contains a fixed amount of glucose. It is not blood. Control solution has three important uses:

• To practice testing, without having to use blood.

• To insure that your meter and test strips are working together properly.

• To check that you are following the correct testing procedure.

It is recommended that you perform a control solution test:

• When you first get your meter, before doing a blood glucose test.

• When you open and begin using a new vial of test strips.

• When you suspect that your meter or test strips are not working properly.

• When you think your test results are not accurate, or if your test results are not consistent with how you feel.

• When your meter is dropped, damaged or exposed to liquids.

• When your health care provider advises you to do so.

How do I perform a control solution test?
Gently touch only one edge of the test strip to the control solution. Apply the control solution to the test strip edge next to one of the dark colored half-circles. If the sound prompt is on, your meter will beep when the test strip is full. Once the sample is finished processing, your meter will beep twice and the result will appear on the display screen.
To mark the result as a control solution result, press and hold the "c" button for 2 seconds. Wait for the meter to display the control solution symbol at the top of the display screen and the date and time on the bottom of the display screen. Pressing the "m" button for 2 seconds will save the test result and allow you to enter the meter’s memory.

Compare your control solution test results to the range printed on your test strip vial label. Your control solution results should fall within the range printed on the side of your test strip vial. If your test results continue to fall outside the range printed on the test strip vial, call Customer Service at (888) 522-5226.





Can I erase test results from the memory of my meter?
It is not possible to erase or delete test results from the memory of the meter. Most meters are designed this way, as the test results in the memory of a meter are often used by health care providers, as key information for evaluation and treatment. The test results will eventually “roll out” of the memory, in the order that they were entered, once the meter memory has reached its capacity of 250 results.


Is the FreeStyle Freedom system reimbursable by medical insurers?
The FreeStyle Freedom system is reimbursed like other commercial blood glucose monitoring products.


Does the FreeStyle Freedom system have data management capabilities?
Yes, the FreeStyle Freedom meter has a data port that enables you to download your blood glucose test results to a PC using a data cable and a compatible data management system.




Where can I purchase the FreeStyle Freedom system?
BreakThruMedical Give us a call today for all of your supplies and testing lancets.
586-296-7000
800-474.1484