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References:

"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

"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

American Diabetes Association . Standards of Medical Care in Diabetes—2011 . Diabetes Care 2011; 34 (Suppl .1)

S11-S61 .

Diabetes Care . January 2010, vol . 33, no . Supplement 1, S11-S61 .

Hirsch, I . (2005) . Glycemic Variability: It’s Not Just About A1C Anymore! Diabetes Technology and Therapeutics,

7 (5), 780-783 .

Mayo Clinic Proceedings February 2007, vol . 82, no . 2, 229-236 .

Pearson J, Bergenstal R . Fine-Tuning Control: Pattern Management Versus Supplementation: View 1: Pattern

Management: an Essential Component of Effective Insulin Management . Diabetes Spectr . April 1, 2001;14(2)

75-78 .

Содержание FreeStyle InsuLinx

Страница 1: ...Blood Glucose Monitoring System Owner s Booklet ...

Страница 2: ...screen Test strip Insert strip into the meter with printed side up Test strip port and light Insert a test strip here The meter powers on when you insert a test strip Touch screen Displays your test results and other important information Use touch screen buttons to work with your meter USB port Plug in your micro USB cable here to download test results FreeStyle InsuLinx at a Glance ...

Страница 3: ...elp Button 7 Turn the Backlight On and Off 7 Turn the Strip Light On and Off 8 Test Your Blood Glucose 9 Your Test Results 14 Low and High Blood Glucose Results 15 Use Meal Markers 17 Error Messages 18 Temperature Warning 18 Control Solution Test 19 View Logbook 22 Change Your Meter Settings 24 Personalize Your Meter 25 Set up and Use Weekly Messages 26 Set up Weekly Messages 26 Use Weekly Message...

Страница 4: ...tem Requirements 38 Change Your Meter Settings 38 Set up Advanced Features for Your Meter Logbook 39 Set up the Insulin Log Feature 39 Set up Notes for Your Meter Logbook 40 Set up Meter Reminders 41 Set up Your Meter Personalization 42 Change Rapid acting Insulin Dose Increments 43 Set up Weekly Messages on Your Meter 44 FreeStyle Auto Assist Reports 45 Set up or Change Report Preferences 47 Crea...

Страница 5: ...rop down menu for sorting results in logbook chart view Strip light on off switch Meal marker Before meal result Reminders Meal marker After meal result Logbook Meal marker Other time no mark Insulin marker Indicates a control solution test result Weekly messages not read and read Low battery Insulin log feature Caution Meter out of temperature range ...

Страница 6: ...due to the risk of spreading infection Do not use on multiple patients All parts of the meter and its accessories are considered biohazardous and can potentially transmit infectious diseases even after performing the cleaning and disinfection procedure 1 2 If the meter is being operated by a second person who is providing testing assistance to the user the meter and lancing device should be disinf...

Страница 7: ...rmacy Intended Use The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip The FreeStyle InsuLinx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for self testing ...

Страница 8: ... 1 Press the meter Home button 2 English Español OK Tap the language you want the meter to use Use the pad of your finger Do not use your fingernail or any other object to tap the screen Note The OK button will appear when you select the language Tap the OK button to move to the next screen ...

Страница 9: ...ll see the Home screen when you complete this step 12 43pm Logbook Set up is complete You can now insert a test strip If you don t complete these steps the meter will continue to prompt you to set the language when you turn it on IMPORTANT If the date and time are not set correctly some meter functions may not work properly If the meter loses time the home screen will display until it is reset ...

Страница 10: ... meter on Press the meter Home button or Insert a test strip To turn the meter off If you re on the home screen press the meter Home button or Remove a test strip or Do nothing for 2 minutes Find the Home Screen 12 43 Logbook Most of your meter activities will begin at the Home screen Press the meter Home button anytime to return to the Home screen except when a test strip is inserted ...

Страница 11: ... you see it and want more information Turn the Backlight On and Off The backlight can help you view the screen in low light To turn the backlight on Press and hold the meter Home button for 3 seconds To turn the backlight off Wait for 15 seconds or Press and hold the meter Home button for 3 seconds ...

Страница 12: ... the strip light on If a test strip is inserted press and hold the meter Home button for 3 seconds If a test strip is not inserted turn the backlight on then tap the strip light symbol on the home screen To turn the strip light off Tap the strip light symbol ...

Страница 13: ... are for use by a single person They must not be used on more than one person including other family members due to the risk of spreading infection All parts of the meter and its accessories are considered biohazardous and can potentially transmit infectious diseases even after performing the cleaning and disinfection procedure 1 2 Do not re use lancets due to risk of infection Not suitable for re...

Страница 14: ... 1 Wash your hands with soap and warm water Rinse and dry thoroughly Do not use lotion or cream on the test site 2 Check the test strip expiration date Do not use expired test strips they may cause inaccurate results ...

Страница 15: ...the test a Insert a test strip and close the test strip vial b Use your lancing device loaded with a lancet to obtain a blood drop from your fingertip 1 1 1 1 1 1 1 1 1 2 3 4 5 6 7 3 x 1 2 3 4 Continued on next page ...

Страница 16: ...conds to fill the test strip on the same side of the test strip only The time you have left is shown as a countdown on the screen The time that the meter takes to display a result depends on your blood glucose level The higher your blood glucose level the longer it takes to get a result The meter turns off after 2 minutes of inactivity Remove and reinsert the unused test strip to restart the meter...

Страница 17: ... lancet properly in a puncture resistant container Refer to the Your Test Results section to learn how to understand and mark your test results Notes Your result is now stored in your logbook You should clean and disinfect your meter at least once per week Refer to the Cleaning and Disinfecting Your Meter section for instructions IMPORTANT After performing a blood glucose test wash your hands with...

Страница 18: ...ition Contact your health care professional before taking any action based on an unclear message or result The expected blood 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 health care professional to determine the blood glucose levels that are appropriate for you Consult your health care pr...

Страница 19: ...Low glucose Appears when result is lower than 70 mg dL Follow your health care professional s advice to treat low blood glucose High glucose Appears when result is higher than 240 mg dL Follow your health care professional s advice to treat high blood glucose ...

Страница 20: ...r blood glucose is very high Wash your hands and then repeat the test If the result is HI again follow your health care professional s advice immediately 2 If your blood glucose results do 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 se...

Страница 21: ...wing your blood glucose test result tap the dashes 2 Other time After meal Before meal OK Tap your selection Tap OK to return to the result screen Notes If you mark as Before meal you can choose to set a test reminder for 1 or 2 hours after your meal You can select Other time if you are testing at times other than before or after a meal If you need to you can change a meal marker for the current r...

Страница 22: ...uses and what to do about it Notes Remember to tap the arrow button to see all of the important information Tap OK to return to the Home screen Temperature Warning This symbol may appear after inserting a test strip It will include a message saying the meter is either too hot or too cold to use right now Blood glucose tests taken outside of the operating temperature range may not be accurate Tap O...

Страница 23: ...iscard control solution 3 months after opening or on the expiration date printed on the bottle whichever comes first Example open April 15 discard July 15 write the discard date on the side of the bottle The control solution range is a target range for control solution only not for your blood glucose level Use only FreeStyle control solution with this meter Replace the cap securely on the bottle i...

Страница 24: ...trol solution to strip Perform the control solution test a Insert a test strip and close the test strip vial b Apply control solution to the test strip as shown in the picture c The meter will beep once to let you know that you have applied enough control solution d A butterfly will appear on the screen while you wait for the result The meter will beep twice when the result is ready ...

Страница 25: ...ution test after it is performed by following these steps a At the Home screen tap Logbook b Tap your most recent test You can only modify this result c Tap the down arrow Then tap add or edit notes d Tap the option for control solution test Then tap OK e You can now see your most recent result marked as a control solution test Out of Range Control Solution Results Repeat the test if control solut...

Страница 26: ...n tests Step Action 1 12 43pm Logbook At the Home screen tap Logbook 2 Review your results Notes Use the down arrow to scroll through logbook entries Tap any entry to see details of results and notes if any 23 Feb 22 Feb 22 Feb mg dL 105 143 95 7 30a 10 33p 11 42a OK 23 Feb 7 30a add or edit notes mg dL 105 Continued on next page ...

Страница 27: ... the screen to use the Insulin Log feature and enter your insulin dose Refer to the FreeStyle Auto Assist Set up Advanced Features for Your Meter Logbook section for how to turn off this feature If you turned on Weekly Messages you will see the chart symbol at the top right of the screen Tap it to review your results for up to 14 days To learn more about weekly messages refer to the Set up and Use...

Страница 28: ...ting you want to change Note Tap Sounds to change Notification and Button sounds Notification sound On Meter will beep when the test strip is filled the result appears on the screen an error occurs and when you get a reminder Button sound On Meter will beep each time you tap a button 2 Press the meter Home button to return to the Home screen Note You can change your meter settings anytime by simpl...

Страница 29: ...ap Extras Then tap Personalization 2 cancel my picture none Pictures more Select your picture and tap yes to confirm the change Notes You can also use my picture to select a personal picture such as a family member or pet Refer to the FreeStyle Auto Assist Set up Your Meter Personalization section for how to upload your picture You can change your picture anytime by simply repeating Steps 1 and 2 ...

Страница 30: ...on 1 12 43pm Logbook Personalization Weekly Messages Extras I want to set up At the Home screen tap Extras Then tap Weekly Messages 2 next back Enter target range in mg dL 70 130 to Enter your target range This is the desired target range for blood glucose values This target range will only be used to determine Weekly Messages Tap next to save Notes Target values cannot be set below 70 mg dL or ab...

Страница 31: ...After meal Before meal Mark your meal during the blood glucose test If you have set up weekly messages you will see this screen while you wait for your blood glucose test result Tap your selection 3 Message mg dL 105 Tap Message to read weekly messages from the results screen Then tap OK to get back to your blood glucose test result Notes Weekly messages will also be stored in your logbook is disp...

Страница 32: ... the Clock You will see the Remind me screen with your menu of options 2 cancel save Type Repeat Time Remind me Test Daily 12 00 am a Tap Type of reminder button to select which reminder you want to set Test Take Insulin or Alarm b Tap Repeat button to set how often you want the reminders Daily Once Countdown Timer c Tap Time and tap the arrow buttons to set the reminder time Tap save ...

Страница 33: ... refer to the FreeStyle Auto Assist Set up Meter Reminders section Use Reminders 12 30pm Test dismiss snooze 15 min Reminder Your reminder will appear even if the meter is turned off Tap your selection to snooze or dismiss your reminder Notes Missed reminders will remain on the screen until dismissed If you have set an insulin reminder you will be able to log a dose after tapping dismiss when the ...

Страница 34: ...you change the batteries IMPORTANT After you first see this warning you can perform approximately 28 tests before you need to change the batteries Step Action 1 Change your batteries a Slide open the battery door on the back of the meter b Remove the old batteries c Install new batteries with facing up d Slide the door back into place until it clicks Note The next time you turn your meter on it wi...

Страница 35: ...destroys pathogens such as viruses and other microorganisms on the meter and lancing device surfaces By disinfecting your meter and lancing device you help ensure that no infection is passed when you or others come in contact with your meter and lancing device Step Action 1 Assemble cleaning and disinfecting supplies Dispatch Hospital Cleaner Disinfectant Towels with Bleach EPA 56392 8 available o...

Страница 36: ... performing a blood glucose test Note If you notice any signs of deterioration on the meter or lancing device such as clouding or crazing on the display of the meter corroding or eroding of the plastic housing or button or cracking of plastic housing display or button or if the meter does not turn on or if the lancing device does not work after cleaning and disinfection discontinue use of the mete...

Страница 37: ...eries are installed Batteries are installed incorrectly Install batteries with facing up Dead batteries 1 Change batteries Reset date and time if needed 2 If problem continues contact Customer Service Meter may be plugged into a computer Unplug the meter from the computer Problem with test strip Try a new test strip Problem with meter Blood or foreign objects put in the test strip port Contact Cus...

Страница 38: ... a new test strip and a larger blood drop Problem with test strip Sample applied after meter turns off 1 Repeat the test using a new test strip Wait for apply blood to strip message to appear before applying blood or apply control solution to strip message if you are applying control solution 2 If problem continues contact Customer Service Problem with meter Contact Customer Service ...

Страница 39: ...dify settings or view reports Reports will be created based on the current data saved on your meter No data from the meter logbook is saved to your computer 1 Meter and Report tabs Provide access to meter setup features or report options 2 Submenu Provides access to additional features within each tab 3 Message box Keeps you posted on software status and any next steps if needed 4 Meter informatio...

Страница 40: ...ter you may use other micro USB cables 2 The software will start automatically for installation or use Follow the InstallShield Wizard prompts Click Next after each entry Note that you may be asked to supply an administrator password 3 Click Finish or Close once installation is complete The program will automatically launch whenever you connect the meter to your computer WARNING To avoid the possi...

Страница 41: ...e Windows folder Double click on this folder to open 4 Locate the Disk1 folder Double click on this folder to open 5 Locate the Setup application icon Double click on this icon to begin the installation Macintosh Computer Systems OS X includes Leopard Snow Leopard and Lion Step Action 1 In the Finder window select the Device called FreeStyle Auto Assist in the Devices section 2 Within the FreeStyl...

Страница 42: ...tems Windows 7 32 and 64 bit Windows Vista 32 and 64 bit Windows XP Service Pack 3 Macintosh Leopard Snow Leopard and Lion Intel processor Change Your Meter Settings Change clock style language or sound preferences Step Action 1 Go to the Meter tab On the left side of the screen click Settings 2 Make your selections a Clock style click your choice b Language select your choice c Sound click On or ...

Страница 43: ...ction 1 Go to the Meter tab On the left side of the screen click Logbook 2 Make your selections a The feature is on when you receive the meter If you want to turn it off click the button to Off If you want to turn it back on click the button to On to record your insulin doses b Check the appropriate boxes for the types of insulin you take 3 Click Save to meter For more information about adding ins...

Страница 44: ...se to accept these or c Edit change order delete or add up to 11 custom notes Click Edit note to change the name of a note Then click Done Change the order of the notes by using the up and down arrows this will change the order they appear on the meter Click the button next to the note you want to delete Click Add note to add a custom note Felt Low Edit note Add note 4 Click Save to meter For more...

Страница 45: ... reminder On or Off b Use the up and down arrows to select the time c Use the drop down menus to select when you want the reminder repeated and the type of reminder You can also add a custom type of reminder d Click Add to add the reminder e Change the order of the reminders by using the up and down arrows this will change the order they appear on the meter f Click the button next to the reminder ...

Страница 46: ...e you perform a blood glucose test If you would like to use a personal picture from your computer go to Step 3 3 Click My Picture 4 Upload a personal picture from your computer a Click Choose b Select your picture Click Open c Adjust your picture so that it fits inside the borders of the box To change the size use the slider bar d Click Set Picture e Click Save to meter For more information about ...

Страница 47: ...nsulin Log feature IMPORTANT It is strongly recommended that you work with your health care professional to determine which insulin dose increment is best for you Step Action 1 Go to the Meter tab On the left side of the screen click Extras 2 Click Dose Increments 3 Click your choice 1 0 unit or 0 5 unit 4 Click Save to meter ...

Страница 48: ...essional for your blood glucose target ranges Step Action 1 Go to the Meter tab On the left side of the screen click Extras 2 Turn on Weekly Messages a Click Weekly Messages b Click the button to On to use this feature c Enter your target range 3 Click Save to meter For more information about weekly messages on your meter refer to the Set up and Use Weekly Messages section ...

Страница 49: ...es notes that inform you and your health care professional about important trends in blood glucose data by putting the data into words Up to six notes will be displayed at one time in order of clinical significance The Modal Day Report shows the daily pattern of blood glucose levels over the specified date range The Logbook Report is a table of blood glucose and insulin values for each day in the ...

Страница 50: ... a series of easy to read tables The Meal Event Averages Report compares the before meal and after meal blood glucose levels for the morning midday and evening times over the specified date range This report also shows before and after meal averages and insulin intake for meals The Meter Settings Report shows current meter and insulin settings ...

Страница 51: ...ypoglycemia threshold preferences will only be used in the reports and will not change any meter settings Note to health care professionals These preferences will be stored on your computer and will be used when creating reports from any meter Step Action 1 Go to the Reports tab If this is the first time you are creating reports click Create Reports to be guided through the report preferences setu...

Страница 52: ...es These changes are not stored in Report Preferences 2 If you would like to preview the reports click View on Screen Use the arrows to view the next previous report page To save the report as a PDF click Save Note The Adobe Acrobat Reader program must be installed on your computer to save files in Adobe Acrobat PDF format Go to www Adobe com for instructions on downloading this program free over ...

Страница 53: ...to Assist software and meter Your FreeStyle Auto Assist software will alert you when updates are ready Backup Meter Files Saves a backup file containing your current meter settings and preferences Go to the Meter tab On the left side of the screen click Backups Click Save backup file Restore Meter Files Replaces your current meter settings with settings from a backup file Go to the Meter tab On th...

Страница 54: ...ry life Up to 3000 tests Calibration Plasma equivalent glucose values Cleaning and Disinfection testing 522 cleaning and 522 disinfection cycles equivalent to cleaning and disinfecting once a week over the 5 year service life of the meter and lancing device Hematocrit 15 to 65 Mean Service Life 5 years Measurement unit mg dL Meter storage temperature 4 F to 140 F 20 C to 60 C ...

Страница 55: ...elative humidity 5 to 90 non condensing Operating temperature 40 F to 104 F 4 C to 40 C Power source Three CR 2032 3V lithium batteries two of which are replaceable Result range 20 mg dL to 500 mg dL Sample Fresh capillary whole blood samples Sample size 0 3 microliter 300 nanoliters Size 2 4 in w x 3 8 in l x 0 6 in d 6 0 cm w x 9 5 cm l x 1 5 cm d Weight 2 1 to 2 3 oz 59 4 to 65 6 g including ba...

Страница 56: ... The meter will no longer operate once opened to remove the backup battery Step Action 1 Remove battery door 2 Insert small screwdriver blade between case above the USB port 3 Pry case open with screwdriver Continue prying around the case until the case separates 4 Remove backup battery and dispose of battery and meter properly ...

Страница 57: ...tionsafety Fingerstick DevicesBGM html 3 American Diabetes Association Standards of Medical Care in Diabetes 2011 Diabetes Care 2011 34 Suppl 1 S11 S61 4 Diabetes Care January 2010 vol 33 no Supplement 1 S11 S61 5 Hirsch I 2005 Glycemic Variability It s Not Just About A1C Anymore Diabetes Technology and Therapeutics 7 5 780 783 6 Mayo Clinic Proceedings February 2007 vol 82 no 2 229 236 7 Pearson ...

Страница 58: ...40 US6 893 545 US6 942 518 US7 058 437 US7 615 637 US7 713 406 US7 740 581 US7 802 467 US7 866 026 US7 895 740 US7 901 554 US7 918 012 US7 918 988 US7 996 988 US8 033 162 US5 822 715 US6 379 301 US7 167 818 US7 392 167 US7 941 308 US5 918 603 US5 601 435 US6 144 837 USD611 854S USD613 190S USD615 884S USD646 787S USD648 640S EP2069771 EP1119637 EP1145000 EP0958495 CA2346415 CA2358993 CA2351796 CA2...

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