Bayer HealthCare Ascensia Autodisc User Manual Download Page 1

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Ascensia

™

REEZE

™

and

Ascensia

™

UTODISC

™

Unique 10-Test Disc

SER

UIDE

Blood Glucose Monitoring System

Summary of Contents for Ascensia Autodisc

Page 1: ...Ascensia BREEZE and Ascensia AUTODISC Unique 10 Test Disc USER GUIDE Blood Glucose Monitoring System...

Page 2: ...ly design buttons make recalling your results or setting the time as easy as making a telephone call Ease of recalling a 14 Day Average This ease of use comes with the added bonus of the reliability t...

Page 3: ...rt cable here to allow communication between meter and a personal computer Screen This is where your test results will be displayed Release Button Press to release and discard used test strip Meter Ha...

Page 4: ...n Use this button to view your blood glucose results stored in memory and to view your 14 day average Set Up Button Use this button to enter the Set Up mode and easily change the time date or other fe...

Page 5: ...iv Release Button Test Strip Slot Open Latch back of meter Press in and pull up to open meter Meter Handle...

Page 6: ...Before using any product to test your blood glucose sugar read all instructions carefully and practice the test A full display as shown here indicates that all characters in the display are working pr...

Page 7: ...cations 31 Performance Evaluations 32 Multiple Site Testing Evaluation 37 Solving Problems Solving Problems 39 Troubleshooting and Error Codes 40 Customer Service 45 Replacement Items 46 5 Year Limite...

Page 8: ...he meter handle pulled out Open Meter 1 Hold the meter with the display screen down Open the meter by pressing down on the back edge of the open latch and then pulling up 2 Open the new 10 test disc p...

Page 9: ...e up The arrow may point in any direction Close Meter 4 Close the meter and snap it shut Keep the meter flat JHelpful Hint The meter must be kept flat when closing If the meter is not kept flat the di...

Page 10: ...ter is off press the button Note This count is reset to 10 every time you open the meter To keep an accurate count open the meter only when all 10 of the test strips have been used in the 10 test disc...

Page 11: ...thoroughly Note For testing sites other than fingertips see page 11 2 Remove the endcap from the Ascensia Microlet Adjustable Lancing Device See Ascensia Microlet Device package insert for complete in...

Page 12: ...out a new test strip with one already showing 5 Your Ascensia BREEZE Meter was designed with a special easy to use Pull and Push design Here s how it works Hold the meter comfortably in one hand Firml...

Page 13: ...ryday use you don t have to worry about turning it on just Pull and Push Note The release button is UP a test strip is pushed out and a flashing blood drop appears on the screen The meter is now ready...

Page 14: ...est strip to touch the edge of the blood drop The blood is automatically pulled into the test strip and fills the test strip Hold the test strip in place until the meter beeps and three dashes appear...

Page 15: ...8 While the meter calculates your blood glucose level you will see a sequence of dashes on the screen After 30 seconds your test result will appear on the screen 9...

Page 16: ...es This will save battery power Caution If your glucose result is below 50 mg dL 2 8 mmol L above 250 mg dL 13 9 mmol L or if the meter shows HI or LO test again If your glucose level is still below 5...

Page 17: ...sample for testing blood glucose whenever you will be participating in risky activities such as before driving a car or operating machinery 2 If you have hypoglycemic unawareness you do not recognize...

Page 18: ...verage You must mark the result immediately after the test is performed while the result is still displayed on the screen To do this follow these steps 1 Open the Button Door 2 Press the button to mar...

Page 19: ...heck the way you do your test Simply follow these steps Note Look on the bottom flap of the box of Ascensia AUTODISC Test Strips to find the control range Push out Test Strip 1 Hold the meter comforta...

Page 20: ...control solution to the test strip directly from the bottle Note The control solution contains a red dye and may stain Test 3 Move the entire front edge of the test strip to touch the edge of the dro...

Page 21: ...een After 30 seconds your Control test result will appear on the screen Compare this Control test result with the range printed on the bottom flap of the test strip carton Note You will want to mark y...

Page 22: ...e steps 5 Open the Button Door Press the button to mark as a control The Control marker looks like this Press to accept 6 To release the used test strip hold the meter with the test strip pointing dow...

Page 23: ...ton Door 2 Press the button The meter will now show you the most recent test result 3 Press the button to see all of your stored results JHelpful Hint Your meter can store up to 100 test results If th...

Page 24: ...n again to review your stored test results Note If there are no results in memory the meter will show you three dashes Clearing Stored Test Results To clear the results from the meter follow these few...

Page 25: ...at any time during setup to turn the meter off Just remember to press the button first to store your changes Setting the Time 1 Open the Button Door 2 Press 3 Press or to change the hour Press to acc...

Page 26: ...ss to accept and move on Setting the Date Note If you have just set the time skip ahead to step 4 1 Open the Button Door 2 Press 3 Press until you see the day icon flashing 4 Press or to change the da...

Page 27: ...5 Press or to change the month Press to accept and move on 6 Press or to change the year Press to accept and move on 21...

Page 28: ...ume control for the buzzer Here are the three different buzzer levels high low off Note If you have just set the date skip ahead to step 4 1 Open the Button Door 2 Press 3 Press until you see the buzz...

Page 29: ...imal point Example 9 95 5 or 5 5 3 3 Your Ascensia BREEZE Meter comes with the units of measure preset to mg dL However you may change the units of measure if you wish Note If you have just set the bu...

Page 30: ...will let you choose either a 12 hour or a 24 hour time setup Note If you have just set the units of measure skip ahead to step 4 1 Open the Button Door 2 Press 3 Press until you see the time format i...

Page 31: ...and month option on your meter You can choose to set it as month day or as day month Note If you just set the time format skip ahead to step 4 1 Open the Button Door 2 Press 3 Press until you see the...

Page 32: ...ith graphs and tables To make use of this feature you need Ascensia WinGlucofacts Diabetes Management Software version 1 3 or higher or Ascensia WinGlucofacts Professional Diabetes Management Software...

Page 33: ...infection control procedure approved by their facility All products or objects which come into contact with human blood even after cleaning should be handled as if capable of transmitting viral disea...

Page 34: ...ow battery in your meter you should replace the battery within approximately 20 readings or one week Note When battery life is very low the display will show only a battery icon When this occurs the m...

Page 35: ...e meter with the display screen down Open the meter by pressing on the open latch and pulling up 2 Slide out the bat tery holder Note You must open the meter first in order to remove the battery holde...

Page 36: ...the holder with the side up 5 Gently slide the battery holder back into the battery compartment Make sure battery holder is pushed all the way in 6 Close the meter 7 Reset the meter s time see pg 19 Y...

Page 37: ...ed each time a new test strip disc is used Sample Size Approximately 2 5 3 5 L Test Range 10 600 mg dL 0 6 33 3 mmol L Test Time 30 seconds Memory Feature Meter stores 100 test results Normal Operatin...

Page 38: ...m was conducted at two diabetes clinics In each location 50 lay persons with diabetes tested the low normal and high control solutions in duplicate using the meter system A different lot of test strip...

Page 39: ...SI 2300 STAT Plus Glucose Analyzer The glucose concentration of the samples ranged from 42 to 542 mg dL with an average of 178 mg dL The range of hematocrits was 29 to 55 with an average of 40 33 Tota...

Page 40: ...e assays using the Ascensia BREEZE System Two test strip lots were evaluated one at each of the two clinics After the user s self test the attending health care professional performed an Ascensia BREE...

Page 41: ...samples ranged from 52 to 508 mg dL with an average of 160 mg dL The range of hematocrits was 32 to 55 with an average of 45 35 A Lay User Results 0 100 200 300 400 500 600 0 100 200 300 400 500 600...

Page 42: ...100 200 300 400 500 600 Laboratory Plasma Glucose Result mg dL Ascensia B REEZE Result mg dL o Lot A Lot B y x 95 Confidence Intervals Lot Opr N Y Slope Intercept R A Lay 100 0 85x 12 91 0 81 to 0 89...

Page 43: ...forearm thigh and abdomen were obtained using the Microlet Vaculance Lancing Device Ascensia BREEZE results from the multiple sites were compared to those obtained from the finger The blood glucose r...

Page 44: ...Thigh Result mg dL y x Comparison of Multiple Site to Fingertip Results Weighted Deming regression weighted linear correlation coefficient One outlier excluded from statistics but included in data pl...

Page 45: ...No see pg 2 3 Is the 10 test disc within its expiration date Yes_____ No______ No see pg 2 4 When you Pull and Push the meter handle are you making sure you Pull all the way out and Push all the way...

Page 46: ...ician or healthcare professional HCP Test result is above 600 mg dL 33 3 mmol L Wash your hands and test site Repeat the test If HI appears again contact your physician or HCP The meter will mark a te...

Page 47: ...Release used test strip and repeat test see pg 8 The meter is open when the meter handle is pulled Close meter and push handle in Meter cannot perform automatic calibration and you must enter the Pro...

Page 48: ...etely full Review pg 8 and repeat test Meter has detected an error accurate test result not possible You may have applied blood too early to the test strip Repeat test and wait until you see the flash...

Page 49: ...ss the button 1 Battery life has ended 2 Battery holder is loose or battery is installed side down 1 Replace Battery see pg 28 2 Check the battery and the battery holder to be sure they are tightly in...

Page 50: ...ip due to heat or exposure to moisture Control solution not at room temperature Not enough control solution drawn into test strip Run another control test If still out of range retest with a new 10 te...

Page 51: ...le to provide information that may help solve your problem quickly Have your Ascensia BREEZE Meter ready for testing when you phone It would also be helpful to have a bottle of Ascensia AUTODISC Norma...

Page 52: ...Department Order Entry P O Box 2004 Mishawaka Indiana 46546 Replacement Products Number Product Name 3416A Ascensia Microlet Vaculance Lancing Device 3610A Ascensia AUTODISC Test Strip Discs box of 5...

Page 53: ...s subject to the following exceptions and limitations 1 A 90 day warranty only will be extended for consumable parts and or accessories 2 This warranty is limited to replacement due to defects in part...

Page 54: ...DESCRIBED ABOVE IS BAYER S ONLY OBLIGATION UNDER THIS WARRANTY IN NO EVENT SHALL BAYER BE LIABLE FOR INDIRECT SPECIAL OR CONSEQUENTIAL DAMAGES EVEN IF BAYER HAS BEEN ADVISED OF THE POSSIBILITY OF SUC...

Page 55: ...Distributed by Bayer HealthCare LLC Mishawaka IN 46544 USA 2003 Bayer HealthCare LLC Made and Printed in U S A 99961179 Rev 4 03...

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