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Important Information About Your FreeStyle 

Freedom™ Blood Glucose Monitoring System

 

How the FreeStyle System Should Be Used

•  The FreeStyle Freedom System is intended for use outside the body  

  (in other words, 

in vitro

 diagnostic use only).

•  The FreeStyle Freedom System is used for measuring blood glucose  

  (also known as 

blood sugar

) from samples taken from the forearm,  

  upper arm, hand, thigh, calf, or fingers.
•  The FreeStyle Freedom 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 Meter can  

  produce inaccurate results. 
Do use the FreeStyle Freedom Meter for:
  • Testing blood glucose.

  • Testing only with fresh capillary whole blood samples.

Do not 

use the FreeStyle Freedom Meter for:

  • The diagnosis of diabetes.

  • Testing on newborns. 

  • Testing of arterial blood.

WARNING:

  

• 

Patients receiving peritoneal dialysis solutions containing  

   icodextrin should not use the FreeStyle Blood Glucose

  Monitoring System.

•  

The FreeStyle Freedom 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 System. Blood glucose monitoring should be 

done with the guidance of a healthcare professional.

 

ART06690-Rev-B-EN.indd   3

11/17/05   6:11:39 PM

Summary of Contents for Freestyle Fredom

Page 1: ...Owner s Booklet Virtually Pain Free Testing Manual del propietario Pruebas prácticamente Sin Dolor ...

Page 2: ...cing Device Using the Lancing Device 15 16 Testing Your Blood Glucose Testing Your Blood Glucose 17 Performing a Blood Glucose Test 18 23 LO and HI Readings 24 Meter Set Up Setting Up Your Meter 25 Setting the Alarms 25 26 Setting the Sound Time Time Format 27 Setting the Date Date Format 28 Unit of Measurement Software Version Display 29 Meter Results Meter Memory 14 Day Average 30 Test Results B...

Page 3: ...ows the areas where you can test with all the FreeStyle Blood Glucose Monitoring Systems 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 Upper arm Forearm Hand Fingertips Thigh Calf Suggested Test Areas for the Hand Most Test S...

Page 4: ...solutions with the FreeStyle Meter can produce inaccurate results Do use the FreeStyle Freedom Meter for Testing blood glucose Testing only with fresh capillary whole blood samples Do not use the FreeStyle Freedom Meter for The diagnosis of diabetes Testing on newborns Testing of arterial blood WARNING Patients receiving peritoneal dialysis solutions containing icodextrin should not use the FreeSt...

Page 5: ...d glucose results Test results below 60 mg dL mean low blood glucose hypoglycemia Test results greater than 240 mg dL 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 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 advi...

Page 6: ... the difference between finger or palm at the base of the thumb and alternative site test results The palm at the base of the thumb is an alternative site that does not require vigorous rubbing before testing Physiologic differences in the circulation between the finger or palm at the base of the thumb and other test sites like the forearm upper arm top of hand thigh and calf may result in differe...

Page 7: ... Data section for more information Display Screen Displays your test results and other important information m Mode Button Move to different mode settings Changes the test strip code scrolls backward Silences an alarm Sample Areas dark colored half circles on Test Strip Edge Apply blood or control solution to one Test Strip Edge only Insert printed side up with the dark colored rectangle going int...

Page 8: ... Top end of a new FreeStyle Test Strip here The meter powers on when you insert the test strip Bottom FreeStyle Test Strip Sample Area Test Strip Edge Top System Check Screen This screen always appears when meter is first powered on so that you can make sure the display is working properly Do not use the meter if the system check screen does not match the example here Please call Customer Care ...

Page 9: ...ppear Sound Level Symbols Indicates high low or off sound volume Thermometer Symbol Appears if your meter is out of temperature range Memory Symbol Shows you test results stored in the meter memory The meter stores your last 250 blood glucose test results Battery Symbol Appears when you should replace the battery Control Solution Test Symbol Shows that you have marked a test result as a control so...

Page 10: ... to tell you when the meter is ready for you to apply blood or control solution Test Strip Code Symbol Appears when you should check and set the test strip code mg dL U S Standard Indicates unit of measurement 14 Day Average Symbol Shows the average value of glucose readings from the last 14 days Message Area Displays date time number of tests and software version ...

Page 11: ...eedom System has an operating range of 40º to 104º F 4º to 40º C Store the test strip package in a cool dry place between 37º to 86º F 3º to 30º C Use test strips only within the system operating temperature range 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 Never store individual test strips o...

Page 12: ...operly For information on how to obtain Control Solution call Customer Care at 1 888 522 5226 Important Control Solution Information FreeStyle Control Solution is good for three months after opening the bottle or until the expiration date printed on the label whichever comes first Important Count forward three months from the date you open a new bottle of control solution This is your discard date...

Page 13: ...y when performed between 59º to 104º F 15º to 40º C 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 test results only It is not a target range for your blood glucose level or blood glucose test results If control solution results are out of this range repeat the test If y...

Page 14: ...Code Wait for the meter to display the Blood Drop and Test Strip Symbols Note Be ready to adjust the code on the meter to match the code number on the test strip vial Gently touch only the Sample Area of the Test Strip Edge to the control solution Important Do not apply control solution to both Test Strip Edges When the test strip is full A short line moves clockwise around the display screen whil...

Page 15: ...ke you can unmark it by pressing and holding the c button again for two seconds Compare your control solution test result to the range printed on your test strip vial Your control solution test results should fall within this range The range shown in picture is only an example 4 Out of range test results may be caused by Expired or bad control solution Expired or bad test strip Error in performing...

Page 16: ...han the fingers Using the Lancing Device 1 2 Remove Cap Snap off the cap on the lancing device at an angle Insert Lancet Insert a new FreeStyle Lancet firmly into the white lancet holder cup Pushing the lancet into the cup may cock the device this is okay Twist Off the Rounded Top Hold the lancet firmly in place with one hand use your other hand to twist off the rounded top 3 ...

Page 17: ...e dark cap for finger tests Set the Lancing Level The FreeStyle Lancing Device offers four different settings Move the dial to the desired setting as shown in the depth indicator window For most test sites we recommend that you start at Level 2 Level 1 is the shallowest depth Level 4 is the deepest To lance your finger we recommend that you start at Level 1 Cock the Handle Pull the dark Cocking Ha...

Page 18: ...sooner than blood from other sites Testing Your Blood Glucose 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 Times when you may be checking for low blood glucose include When you are feeling symptoms such as weakness sweating nervousness headache or confusion Wh...

Page 19: ...er until it stops The meter will power on Performing a Blood Glucose Test System Check Setting the Test Strip Code When the meter powers on four display screens appear Note If you do not start the test within two minutes the meter will power off To restart your meter take out the unused test strip and reinsert it into the meter Date and Time ...

Page 20: ...ial Setting the Test Strip Code cont When you see the word COdE and a code number on the display screen use the c configure button to scroll forward or the m mode button to scroll backward until the number 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 scr...

Page 21: ...ancing Your Palm When lancing on the palm at the base of the thumb use the clear cap as you would for any alternative site but there is no need for vigorous rubbing Physiologic differences in the circulation between the finger or palm at the base of the thumb and other test sites like the forearm upper arm top of hand thigh and calf may result in differences in blood glucose measurements from thes...

Page 22: ... in the meter and the meter is powered on and the Blood Drop and Test Strip Symbols are showing If the meter is powered off take out the test strip and reinsert into the meter You are now ready to apply the blood sample b Bring the test strip to the blood sample at a slight angle Important Use only one Test Strip Edge per test Do not apply blood to both edges or you may get an inaccurate result Te...

Page 23: ...ay add blood to the same Test Strip Edge from which you started for up to 60 seconds from the time of the first application Your blood glucose test result is shown on the display screen If the sound volume is on you will hear two beeps The time that the meter takes depends on your blood glucose level The higher your glucose level the longer it takes to get a result 4 Do not press the test strip ag...

Page 24: ...tial Bruising It is possible you may experience bruising at the test site If bruising does occur you may choose to lance another test site Maintenance Use isopropyl alcohol or soap and water to wipe the outside of the lancing device If you wish remove the cap wash it in warm water and rinse well Important Do not immerse the body of the lancing device in water or any other liquid ...

Page 25: ...t Symptoms IF you have a LO reading but have no symptoms of low blood glucose THEN retest with a new test strip on your fingers or palm at the base of the thumb If you still have a LO reading follow your doctor s recommendation to treat hypoglycemia If your test result is higher than 500 mg dL HI will appear on the meter display screen This reading indicates severe hyperglycemia high blood glucose...

Page 26: ...ess the c configure button Select alarm Setting the Alarms There are four alarms that you can set When an alarm goes off you hear the sound for up to 15 seconds You can silence the alarm by pressing either the m or c buttons or by inserting a test strip You may set up any or all of the alarms 1 4 Note An alarm will never sound during a test To set an alarm or multiple alarms follow these steps 1 W...

Page 27: ...inute appears 6 Press the m button to move to the alarm volume setting Default setting is off 7 Press the c button to select the desired volume setting low high or off 8 Press the m button to finalize your alarm setting This will bring you back to the alarm setting mode If you wish to set multiple alarms press c to move to alarm 2 Repeat steps 2 8 to set each of the 4 alarms Select hour Select min...

Page 28: ...ss the c button until the correct hour appears The default for the meter is the 12 hour time format The P displays for PM times 2 Press the m button to move to minute setting 3 With the minute blinking press the c button until the correct minute appears 4 Press the m button to move to Setting the Time Format Setting the Time Format 1 With the hour mode blinking press the c button to move between 1...

Page 29: ...rmat selected 2 Press the m button to move to the Unit of Measurement Setting the Date 1 With the month blinking press the c button until the correct month appears 2 Press the m button to move to the day setting 3 With the day blinking press the c button until the correct day appears 4 Press the m button to move to the year setting 5 With the year blinking press the c button until the correct year...

Page 30: ...Software Version Display Software Version Display This is the software version programmed in your FreeStyle Freedom Meter It is for display only and cannot be changed The picture here is an example Your meter may have a different number You have completed Meter Set Up To move to Setting the User Alarms press the m button To exit press and hold the m button ...

Page 31: ...l of the test results by pressing and holding the c button The first test result you see is the most recent As you continue to push the c button the meter will scroll back to older test results Eventually it will scroll to the most recent test result 14 Day Average The first memory display screen you see is your 14 day average This includes all the readings from the last 14 days starting from the ...

Page 32: ... cable is inserted in the meter data port You cannot perform a test while the data cable is in the meter data port The meter will display PC until the cable is removed from the data port Requires FreeStyle Data Cable and FreeStyle data management software or other software programs that accept FreeStyle Freedom data For more information please go to our website or call Customer Care Test Results c...

Page 33: ...battery immediately To avoid losing the time and date settings replace the battery within one 1 minute of removing the old battery If you take more than one 1 minute to replace the battery you must reset the time and date to get the correct 14 day average If the time and date settings are not reset test results will be stored in memory with a time of 12 00 a m 00 00 and a date of 00 00 Removing th...

Page 34: ...uid in the meter s test strip and data ports Clean the outside of the meter using a cloth dampened with one of the following Mild detergent mild soap and water 70 isopropyl alcohol A mix of one part household bleach nine parts water Important Never the immerse the meter in water or any other liquid Install the battery with the positive sign facing up towards you 2 ...

Page 35: ...hat You Should Do 1 If you have symptoms such as weakness sweating nervousness headache or confusion follow your doctor s recommendation for treating hypoglycemia 2 Conduct a control solution test using a new test strip If the results of the control solution test are within the range printed on the side of your test strip vial retest using blood and a new test strip 3 If the retest using control s...

Page 36: ...Should Do 1 If you have symptoms such as thirst fatigue excess urination or blurry vision follow your doctor s recommendation for treating hyperglycemia 2 Conduct a control solution test using a new test strip If the results of the control solution test are within the range printed on the side of your test strip vial retest using blood and a new test strip 3 If the retest using control solution do...

Page 37: ...nduct a control solution test using a new test strip If the results of the control solution test are within the range printed on the side of your test strip vial retest using blood and a new test strip 3 If the retest using control solution does not work or if the error persists call Customer Care Error 4 Possible Causes Problem with test strip Problem with the meter What You Should Do 1 Conduct a...

Page 38: ... when applying blood sample or control solution What You Should Do 1 Retest using a new test strip Do not touch the m or the c button while applying blood or control solution to the test strip 2 If the error persists call Customer Care Error 5 Note Error 5 is not used ...

Page 39: ... wrong end in or incompletely top of the strip in the meter inserted into the meter Make sure the test strip is fully inserted Defective meter or test strips Call Customer Care Blood or foreign objects put into test Call Customer Care strip port Probable Cause What to Do Blood sample is too small You may add blood to the Test Strip Edge for up to 60 seconds from the time of the first application I...

Page 40: ...ge Temp 4º to 140º F 20º to 60º C Memory 250 blood glucose and control solution tests with date and time Operating Relative 5 to 90 non condensing Humidity Operating Temperature 40º to 104º F 5º to 40º 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 microliter 300 nanoliters Size Width 2 00 x Length 3 30 x Thickne...

Page 41: ...e atención al cliente está disponible las 24 horas del día 7 días a la semana Covered by one or more of the following U S Patents Amparado por una o varias de las siguientes patentes estadounidenses D424 696 D426 638 6 071 391 6 120 676 6 143 164 6 299 757 6 338 790 6 071 391 6 143 164 6 299 757 6 338 790 6 461 496 6 503 381 6 591 125 6 592 745 6 616 819 6 618 934 6 676 816 6 749 740 6 893 545 6 9...

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