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Important Information About Your FreeStyle
Flash

™

Blood Glucose Monitoring System

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.

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.

WARNING:

Keep the FreeStyle Flash System away from young

children as it 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 Flash System. Blood glucose monitoring should be
done with the guidance of a healthcare professional.

Содержание FreeStyle Flash Blood Glucose Monitor

Страница 1: ...Owner s Booklet B lo o d G lu c o s e M o n it o r in g S y s t e m ...

Страница 2: ... 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...

Страница 3: ...etting 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 ...

Страница 4: ...fferent 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...

Страница 5: ...yle 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 WARNING Keep the FreeStyle Flash ...

Страница 6: ...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...

Страница 7: ...t sites before lancing helps to minimize the difference between finger or palm at the base of the thumb and alternate site test results 4 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 thi...

Страница 8: ...g 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 5 The FreeStyle Flash Meter and FreeStyle Test Strip Getting Started with the FreeStyle Flash Meter Abbott Diabetes Care has deve...

Страница 9: ...6 FreeStyle Flash System 1 2 3 4 5 6 7 8 9 11 10 ...

Страница 10: ... Display Screen Displays your test results and other important information Built in display backlight for use in low light conditions 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 m Mode Button The m button is used to Moves to different screens such a...

Страница 11: ...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 Bottom for blood sample FreeStyle Test Strip Edge of test strip 8 Top for insertion into meter ...

Страница 12: ...n test 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 Message Area Date time number of tests in average and software version number appear here The FreeStyle Flash Meter Display 9 ...

Страница 13: ... only when the unit of measurement is in millimoles per liter mmol L System Check Screen This screen always appears when the meter leaves clock mode so that you can ensure the display is working properly Memory Mode Symbol Shows you a test result stored in the meter memory The meter stores your last 250 blood glucose test results 10 ...

Страница 14: ...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 The FreeStyle Flash Meter Display Check and Set Test Strip Code Symbol Appears when you should check and set the test strip code 11 Thermometer Symbol Appears if your meter is out of temperature range for getting an accurate reading ...

Страница 15: ...e units of measurement used for your test result Clock Symbol A clock symbol appears in the Clock mode and in the Set mode when setting the time 12 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 P Symbol Indicates PM in 12 hour format ...

Страница 16: ...ply 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 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 swallow...

Страница 17: ...l 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...

Страница 18: ...er 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 solu...

Страница 19: ...s 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...

Страница 20: ...ash Meter may produce inaccurate results Replace the cap on the control solution bottle immediately after using Do not use control solution past the expiration date or you may get inaccurate results Do not add water or any liquid to control solution Control solution tests are specified to be accurate only when performed between 59º to 104ºF 15º to 40ºC Caution Results from FreeStyle Control Soluti...

Страница 21: ...d 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 Control solution test done outside 59º 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 proper...

Страница 22: ... facing up Insert the top of the test strip into your meter until it stops This will power on the meter The code number on the meter display should match the code number on the side of your test strip vial They must always match or your results will be inaccurate Refer to Setting the Test Strip Code on pages 29 and 30 Wait for the meter to display the Blood Drop and Test Strip symbols Note Be read...

Страница 23: ... and hold the c button on the FreeStyle Flash Meter for two seconds Wait for the control solution symbol to appear on the display screen If you have marked a test as a control solution test by mistake you can unmark it by pressing and holding the c button again for two seconds Pressing the m button for two seconds saves the test result and allows you to enter the meter memory 4 Compare your contro...

Страница 24: ...e at 1 888 522 5226 www AbbottDiabetesCare com The FreeStyle Lancing Device Cocking Handle Depth Settings Dial Clear Cap for testing sites other than the finger Depth Indicator Window Release Button Grey Cap for finger testing 21 ...

Страница 25: ...et 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 Using the Lancing Device ...

Страница 26: ...g Device offers four different depth settings Move the dial to the desired setting as shown in the depth indicator window Level 1 is the shallowest depth Level 4 is the deepest To lance parts of the body other than the finger we recommend that you start at Level 2 and use the clear cap To lance your finger we recommend that you set the depth setting to its shallowest depth 1 and use the grey cap C...

Страница 27: ... top of your test site Depress the release button Do not lift up c Continue to hold the lancing device and gradually increase pressure for several seconds d While holding the lancing device on your test site look through the clear cap the blood sample should be about the size of a pinhead example e Lift the lancing device straight up be careful not to smear the blood sample on your test site Impor...

Страница 28: ...and to waist level and by gently massaging your finger a We recommend that you set the depth setting on the lancing device to its shallowest depth 1 b Lightly touch the lancing device with the grey cap against the side of your finger tip c Press the release button and then place the lancing device on the table or desk near you d Gently squeeze your finger if needed until a blood drop the size of a...

Страница 29: ...sing It is possible you may experience bruising at the test site If bruising does occur you may choose to lance your finger or another site instead of your forearm Refer to page 1 for information on testing other sites 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 immers...

Страница 30: ...ood glucose on your forearm upper arm hand thigh calf as well as your fingers Testing with the FreeStyle Flash System requires a very small sample size just 3 10th microliter of blood about the size of a pinhead example Most healthcare professionals recommend testing when blood glucose values are stable before meals and before bedtime How ever when blood glucose is changing blood from the fingerti...

Страница 31: ...Meter Blood Glucose Testing Components Clear Cap for testing sites other than the finger 28 Test Strips Control Solution Lancet Lancing Device Grey Cap for testing on the finger ...

Страница 32: ...Performing a Blood Glucose Test 1 System Check Setting the Test Strip Code When the meter powers on three display screens appear in the following order Top for insertion into the meter Insert only the Top end of the test strip into the meter with the dark colored rectangle going into the meter Bottom for blood sample Note If you do not start the test within two minutes the meter returns to clock m...

Страница 33: ...ing or an Error 6 b 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 Flash Meter has a total of 50 codes c After you set your code number the Blood Drop and Test Strip symbols will alternate on the display screen d If you w...

Страница 34: ...the blood sample at a slight angle 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 c The test strip acts like a sponge and pulls the blood into the strip through the edge 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 ...

Страница 35: ...ation The test result is complete when you hear two beeps if sound is turned on Your blood glucose test result is shown on the display screen 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 Results appear in an average of 7 seconds Important Make sure the apply sample symbols show on the display alternating test st...

Страница 36: ...mol L LO appears on the meter display screen This reading indicates severe hypoglycemia low blood glucose LO Reading with Symptoms If you have a LO reading and have symptoms such as weakness sweating nervousness headache or confusion then follow your doctor s recommenda tions to treat hypoglycemia LO Reading without Symptoms If you get a LO reading but have no symptoms of low blood glucose then re...

Страница 37: ...oms If you feel symptoms such as fatigue thirst excess urination or blurry vision then follow your doctor s recommendation to treat hyperglycemia HI Reading without Symptoms If you get a HI reading but have no symptoms of high blood glucose then retest with a new test strip If you still get a HI reading follow your doctor s recommendation to treat hyperglycemia HI Reading 34 ...

Страница 38: ...t when applying a sample for example clock memory and set The display backlight goes out when you press the light button again or when the meter is inactive for 10 seconds Using the Test Light Pressing the light button while the Blood Drop and Test Strip symbols appear on the display screen powers on the test light The test light goes out When you press the light button again When the meter receiv...

Страница 39: ... is complete 2 Using Alarms 36 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 alarms by pressing either the m or c buttons or by inserting a test strip The bell icon will be displayed if any of the four alarms has been set Refer to page 38 for information on setting an alarm ...

Страница 40: ...Any Time Press and hold the m button until the meter returns to clock mode To Move Through the Screens Press the m button to move through all the set up screens such as alarm sound level time date unit of measurement and software version number Press the c configure button to change setting within a set up screen Example Use the m button to bring up the blinking unit of measurement display screen ...

Страница 41: ...he alarm volume setting Default setting is off 7 With one of the bell icons appearing press the c button until the desired alarm volume appears 8 Press the m button to return to the main alarm setup screen Repeat steps 1 through 8 as needed to set the other alarms You can set up to four alarms An alarm is set if the sound level is set to low or high This will show in set up mode with a bell alarm ...

Страница 42: ...Sound There are three sound volume options to let you know when the test strip is full when the reading is done and when an error occurs Off Low and High default setting 1 Press the c button until the desired sound level appears 2 Press the m button to move to Setting the Time Low Off High ...

Страница 43: ... minute setting 3 With the minute blinking press the c button until the correct minute appears 4 Press the m button to move to the time format setting 12 or 24 hour format 5 With the 12 for 12 hour format or 24 for 24 hour format blinking press the c button to toggle to your format choice The time automatically updates to the format selected 6 Press the m button to move to Setting the Date Hour Mi...

Страница 44: ...ting 5 With the year blinking press the c button until the correct year appears 6 Press the m button to move to the date format setting month day m d or day month d m format 7 With the m d or d m icon blinking press the c button to toggle to your format choice The date automatically updates to the format selected 8 Press the m button to move to Setting the Unit of Measurement 41 1 Press the c butt...

Страница 45: ... an example Your meter may have a different number Write the software version shown on your meter display on page 65 Customer Care may ask you to provide this number when you call with questions or concerns regarding your FreeStyle Flash Meter To exit the software version display screen press and hold the m button for a few seconds until the meter returns to clock mode ...

Страница 46: ...de and no test strip inserted Press the m button and release the first memory screen to appear is your 14 day average To Exit at Any Time Press the m button until the meter returns to clock mode then release 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 current date and time shown on the meter Co...

Страница 47: ...s Eventually it scrolls to the most recent reading again Blood Glucose Test A result without a control solution symbol indicates that it is a blood glucose reading The date and time of the test appears on the bottom of the screen Control Solution Test A value with indicates that you have marked this reading as a control solution test refer to page 20 This result is not included in your 14 day aver...

Страница 48: ...ory it is not included in your 14 day average Values over 500 mg dL are recorded in memory as HI 45 Transferring Data The data port allows you to download test results from the meter s memory to a computer or upload to a secure protected website designed for diabetes data management Requires FreeStyle Data Cable and FreeStyle data management software or other software programs that accept FreeStyl...

Страница 49: ...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 solution does not work or the error persists call ...

Страница 50: ...on that is labeled as HIGH What You 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 ...

Страница 51: ...e meter What You Should Do 1 Be sure you see the Blood Drop and Test Strip symbols on the display screen before you apply blood or control solution 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 does no...

Страница 52: ... printed on the side of your test strip vial retest using blood and a new test strip 2 If the retest using control solution does not work or if the error persists call Customer Care Note Error 5 is not used Error 6 Possible Causes Blood sample was applied while code number was being changed What You Should Do 1 Retest using a new test strip Do not touch the m or the c button while applying blood o...

Страница 53: ...ve enough power for approximately 25 more tests To avoid losing the time and date settings replace the batteries within one minute of removing the old batteries If you take more than one minute to replace the batteries you must reset the time and date to get the correct 14 day average Note If the time and date are lost the time and date displays flash 12 00 and 00 00 until they are reset Removing ...

Страница 54: ...ies Turn the meter over Press in the battery door clip to open Swing the battery door up to open and then off the meter Install the batteries with the positive sign facing up towards you To close angle the battery door back onto the meter and swing down until it snaps gently into place 3 2 1 51 ...

Страница 55: ...52 ...

Страница 56: ...ts put into test strip port What to Do Replace the meter batteries refer to page 51 Check that batteries are installed correctly with the positive sign facing upward toward you refer to page 51 Note If the batteries have been installed incorrectly or have been out of the meter for more than one minute reset the date and time refer to page 50 Insert the test strip with the printed side up and the t...

Страница 57: ...est strips What to Do Repeat the test using a new test strip and a larger blood sample Repeat the test with a new test strip Repeat the test using a new test strip Wait until you see the Blood Drop and Test Strip symbols on the display screen before you apply the blood sample refer to page 31 Call Customer Care Test does not start after applying the blood sample ...

Страница 58: ...Store the meter in the carrying case after each use Cleaning the Meter 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 Avoid getting water or any other liquid into the test strip port and data port Never immerse the meter in water or any other liquid...

Страница 59: ...mol L Memory 250 blood glucose and control solution tests with date and time Operating Relative 5 to 90 Humidity Operating Temperature 40º to 104º F 5º to 40º C Power Source Two 2032 3 volt lithium batteries replaceable Result Range 20 to 500 mg dL 1 1 to 27 8 mmol L Sample Whole blood capillary Sample Size 300 nanoliters 3 10 microliter Dimensions Width 1 6 x Length 3 0 x 0 8 at thickest point Te...

Страница 60: ...atteries Replacing 51 Batteries Troubleshooting 53 Battery Life 50 56 Battery Symbol 10 50 Blood Drop Symbol 11 19 30 31 Blood Glucose Test Performing a 29 32 Memory Viewing your Meter 43 45 Lancing Forearm Upper Arm Hand Thigh or Calf 24 Lancing On Your Finger 25 Blood Glucose Testing Components 28 Blood Sample Applying Sample After Shut Off 54 Size 24 27 56 Too Small 32 46 54 Troubleshooting 53 ...

Страница 61: ...ate 16 Ensuring Accurate Results 17 Control Solution Symbol 9 10 20 44 Control Solution Test Performing a 19 21 Memory In the Meter s 44 When Should I Perform a 16 Control Solution Test Results Target Range 18 20 Target Range Out of 18 20 Accuracy of 17 18 Customer Care 18 46 49 53 54 Daily Log 5 6 Data Data Port 7 8 Transferring Data 45 Date 11 12 Date Setting the 41 Dehydration 3 58 ...

Страница 62: ...ymbol 9 10 Date 11 Memory 9 10 Milligrams mg dL 11 12 Millimoles mmol L 11 12 System Check Screen 10 29 Test Result Area 9 10 Test Strip Symbol 11 12 Thermometer Symbol 11 45 Error Messages Error 1 46 Error 2 47 Error 3 48 Error 4 49 Error 6 49 14 Day Average 43 FreeStyle Blood Glucose Monitoring System 2 FreeStyle Control Solution What is 15 Ensuring Accurate Results 17 Expiration Date 16 ...

Страница 63: ...ings Dial 21 23 24 25 Using the Lancing Device 22 25 Lancing On Your Forearm Upper Arm Hand Thigh or Calf 24 Lancing Your Finger 25 Maintenance 26 Release Button 21 FreeStyle Flash Meter Batteries 5 51 53 56 c Button 8 30 36 41 44 Caring for Your 55 Carrying Case 5 6 Cleaning the 55 Control Solution 5 6 15 20 Data Port 7 8 45 Dimensions 56 Display Screen 7 12 Getting Started 5 6 Hematocrit 56 ...

Страница 64: ...s LO and HI 33 34 45 Serial Number 65 Setting Up Your Meter 37 42 Specifications 56 Memory 9 10 56 Test Strip Code 19 28 Test Strip Port 8 Test Time 32 56 Troubleshooting 53 54 Warranty Registration Card 5 Weight 56 FreeStyle Test Strips 5 6 7 8 13 14 19 27 28 Code Number Setting the Test Strip 19 29 30 Important Information 13 14 Storage and Usage 14 Target Areas Sample 7 8 Troubleshooting 53 54 ...

Страница 65: ...ions 1 LO Reading 33 45 Maintenance FreeStyle Lancing Device 26 FreeStyle Flash Meter 55 m Button 7 8 30 37 43 Measurement Units 56 Memory FreeStyle Flash Meter Blood Glucose Test 44 Control Solution Test 44 14 Day Average 43 Getting In and Out of 43 Size 10 56 Working the 44 Temperature 45 Memory Viewing Your Meter s 43 45 Meter Setting Up your Date 41 Date Format 41 Sound 39 ...

Страница 66: ...ngs To Enter Exit 37 Operating Temperature 56 Operating Relative Humidity 56 Power Source 56 Result Range 56 Sample Size Blood Glucose 24 27 56 Serial Number 65 Sharps Container 26 Size 56 Software Version Display 42 Sound Setting the 39 Specifications FreeStyle Flash Meter 56 Symbols General Battery 10 50 Blood Drop 11 19 30 31 Control Solution 9 10 20 44 Thermometer 11 45 ...

Страница 67: ...ger 1 25 Test Result Area 10 Test Strip Code Setting the 19 29 30 Test Strip Port 7 8 Test Strips FreeStyle 5 6 7 8 13 14 19 27 28 Important Information 13 14 Troubleshooting 53 54 Test Time 56 Thermometer Symbol 11 45 Time Format Setting the 40 Troubleshooting 53 54 Unit of Measurement Milligrams per Deciliter mg dL 11 12 56 Millimoles per Liter mmol L 11 12 56 Setting the 41 Water Loss Excessive...

Страница 68: ... than 140 __________________ mg dL Bedtime Not specified __________________ mg dL Between 2am and 4am Not specified __________________ mg dL Source ADA Clinical Practice Recommendations 2003 Meter Serial No _______ _______________ Found on the back of your meter Software Version No ______________________________ Important phone numbers Customer Care Toll Free 1 888 522 5226 24 hours a day 7 days a...

Страница 69: ... the following U S Patents D424 696 and D426 638 and 6 071 391 and 6 120 676 and 6 143 164 and 6 299 757 and 6 338 790 and 6 071 391 and 6 120 676 and 6 143 164 and 6 299 757 and 6 338 790 and 6 461 496 and 6 503 381 and 6 591 125 and 6 592 745 and 6 616 819 and 6 618 934 and 6 676 816 and 6 749 740 and 6 893 545 2005 Abbott Printed in U S A ART03992 Rev B 10 05 ...

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