Bayer HealthCare Ascensia Breeze Скачать руководство пользователя страница 40 | Manualshive

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Weighted Deming Agreement Statistics / Pearson correlation

2. Professional / Lay User Evaluation: A patient use

evaluation was conducted at two diabetes clinics. Lay users
with diabetes learned to use the meter system by reviewing
the meter user guide. After reviewing the instructions, the
users performed fingersticks and glucose assays using the
Ascensia

®

B

REEZE

™ System. Two test strip lots were

evaluated, one at each of the two clinics. After the user’s
self test, the attending healthcare professional performed
an Ascensia

®

B

REEZE

™ System assay from the lay user’s

fingerstick. A capillary blood sample was then collected for

34

0

5

10

15

20

25

30

35

0

5

10

15

20

25

30

35

y=x

Ascensia

®

B

REEZE

™ Plasma Glucose (mmol/L)

YSI Plasma Glucose (mmol/L)

95% Confidence Interval

N

Y=

Slope

/

Intercept

R

204

1.07x – 0.21

1.03 to 1.10

–0.48 to 0.06

0.983

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Содержание Ascensia Breeze

Страница 1: ...Ascensia BREEZE and Ascensia AUTODISC Unique 10 Test Disc USER GUIDE Diabetes Care System ...

Страница 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 that you count on from Bayer This user guide shows you how to use your Ascensia BREEZE Diabetes Care System It will answer any questions you might have and guide you through the testing process It is h...

Страница 3: ...r Insert 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 Handle Use this handle to push out a test strip and automatically turn on the meter Button Door Open to expose meter buttons Battery Holder side of meter Holds one CR2025 lithium battery ii ...

Страница 4: ...on 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 features Up Down Buttons Use these buttons with the Memory button to see your results or use with the Set Up button to change the time date etc Accept OK Button Use this but ton to accept changes made ...

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

Страница 6: ...re using any product to test your blood glucose read all instructions carefully and practice the test A full display as shown here indicates that all characters in the display are working properly To view the full display pull the meter handle all the way out Compare your meter to the display shown here If there is a difference please see Troubleshooting page 44 v ...

Страница 7: ...pecifications 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 Limited Warranty 47 The Ascensia BREEZE Diabetes Care System meter test strips and controls is intended for self testing by persons with diabetes and by healthcare professionals to monitor the level o...

Страница 8: ...ter 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 the front cover up 2 Open the new 10 test disc package Check the expiration date on the disc 2 Everyday Use ...

Страница 9: ...de 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 disc may move and become damaged and you may waste test strips 3 ...

Страница 10: ...eter 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 Your meter will also tell you when you need to insert a new 10 test disc It will do this by showing you a picture of a disc being inserted into the meter 4 ...

Страница 11: ...ith soap and warm water Rinse and dry thoroughly 2 Remove the endcap from the MICROLET Adjustable Lancing Device See MICROLET Device package insert for complete instructions 3 Insert lancet firmly until it comes to a full stop This will cock the device 5 ...

Страница 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 Firmly grasp the Meter Handle with the other hand shown here Now just Pull and Push Pull the handle out until it stops and Push it back in until it stops again 6 ...

Страница 13: ...ou 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 to run a blood glucose test 6 Stick your finger with the MICROLET Device and form a small round drop of blood 7 ...

Страница 14: ...test 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 on the screen then move it away By doing this you will make sure the test strip is completely filled 8 ...

Страница 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 ...

Страница 16: ...ree minutes This will save battery power Caution If your glucose result is below 2 8 mmol L 50 mg dL above 13 9 mmol L 250 mg dL or if the meter shows HI or LO test again If your glucose level is still below 2 8 mmol L 50 mg dL above 13 9 mmol L 250 mg dL or if the meter again shows HI or LO it may indicate a potentially serious medical condition If this is the case We recommend you consult your p...

Страница 17: ...For best results Blood is pulled IN the test strip not dropped ON Do not allow blood to run down into the meter Do not add more blood after the meter beeps 11 ...

Страница 18: ... test to check the way you do your test Simply follow these steps Note Look on the bottom flap of the box of test strips to find the control range Push out Test Strip 1 Hold the meter comfortably in one hand Firmly grasp the Meter Handle with the other hand shown here Now just Pull and Push Pull the handle out until it stops and Push it back in until it stops again 12 ...

Страница 19: ...y 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 drop of control solution The control solution is automatically pulled into the test strip Important Hold the test strip in place until the meter beeps and three dashes appear on the screen then move it ...

Страница 20: ... screen 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 your control test now so that it will not be included in your 14 day average See next page 14 ...

Страница 21: ...se 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 down over a waste container Press the release button Make sure the heel of your hand is not against the meter handle Note If you block the meter handle with your hand the test strip may not release prop...

Страница 22: ...average 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 mark as deleted 3 The Delete marker looks like this 4 Press to accept 5 Press the to turn your meter off 16 ...

Страница 23: ...tton 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 there are no stored test results in memory the meter will tell you this by showing three dashes When the memory is full the meter will remember the newest result and discard the oldest Beyond Everyday ...

Страница 24: ...on 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 steps 1 Open the Button Door 2 Press the button 3 Press again and hold the button 4 While holding the button press and hold the button 5 Hold both buttons together until all three dashes are continu...

Страница 25: ...t any time during set up 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 accept and move on 4 Press or to change the minutes Press to accept and move on 19 ...

Страница 26: ...ess 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 day Press to accept and move on 20 ...

Страница 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 ...

Страница 28: ...lume 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 buzzer icon 4 Press or to change the buzzer level Press to accept and move on ...

Страница 29: ... a decimal point Example 5 5 3 3 or 9 95 5 Your Ascensia BREEZE Meter comes with the units of measure preset However you may change the units of measure if you wish Note If you have just set the buzzer level skip ahead to step 4 1 Open the Button Door 2 Press 3 Press until you see a unit of measure icon 4 Press or to choose units of measure Press to accept and move on 23 ...

Страница 30: ...r 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 icon 4 Press or to set 12 or 24 hour clock Press to accept and move on ...

Страница 31: ...y 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 date format icon 4 Press or to set the date format Press to accept 25 ...

Страница 32: ...an be summarized in a report with graphs and tables To make use of this feature you will need the Ascensia WinGlucofacts or Ascensia WinGlucofacts Professional software and Ascensia Data Cable For more information relating to these softwares contact our Diabetes Helpline 1 800 268 7200 or visit our website at www ascensia ca 26 ...

Страница 33: ...he 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 diseases The user should follow the recommendations for prevention of blood borne transmissible diseases in healthcare settings as recommended for potentially infectious human blood specimens in National...

Страница 34: ... battery in your meter you should replace the battery within approximately 20 readings or within one week Note When battery life is very low the display will show only a battery icon When this occurs the meter will not allow you to run a test until the battery is changed This is so you always receive the most accurate results possible When battery life has completely ended nothing will show on the...

Страница 35: ...ter 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 holder DO NOT PRY the battery holder out 3 Remove the old battery The battery should be removed from the holder with your finger 29 ...

Страница 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 You are now ready to resume testing 30 ...

Страница 37: ...ed each time a new test strip disc is used Sample Size Approximately 2 5 3 5 µL Test Range 0 6 33 3 mmol L 10 600 mg dL Test Time 30 seconds Memory Feature Meter stores 100 test results Normal Operating Temperature 10 to 40 C 50 to 104 F Humidity 10 to 80 RH Power Source One 3 volt lithium battery CR2025 31 Technical Information ...

Страница 38: ...onducted 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 strips was used in each of the two locations The table below shows the total standard deviations SD and coefficients of variation CV which include the within run and between run day variations Low Control Solutio...

Страница 39: ... STAT Plus Glucose Analyzer The glucose concentration of the samples ranged from 2 3 to 30 1 mmol L with an average of 9 9 mmol L The range of hematocrits was 29 to 55 with an average of 40 33 Total Total Strip No of Mean SD CV Lot Operator Assays mmol L mmol L A Lay User n 50 100 8 394 0 400 4 8 B Lay User n 50 100 8 317 0 356 4 3 Total Total Strip No of Mean SD CV Lot Operator Assays mmol L mmol...

Страница 40: ...and glucose 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 healthcare professional performed an Ascensia BREEZE System assay from the lay user s fingerstick A capillary blood sample was then collected for 34 0 5 10 15 20 25 30 35 0 5 10 15 20 25 30 35 y x Ascensia B REEZE Plasma Glucose mmol L YSI P...

Страница 41: ... ranged from 2 9 to 28 2 mmol L with an average of 8 9 mmol L The range of hematocrits was 32 to 55 with an average of 45 35 0 0 5 0 10 0 15 0 20 0 25 0 30 0 35 0 0 0 5 0 10 0 15 0 20 0 25 0 30 0 35 0 Laboratory Plasma Glucose Result mmol L Ascensia B REEZE Result mmol L o Lot A Lot B y x A Lay User Results ...

Страница 42: ... 35 0 Laboratory Plasma Glucose Result mmol L Ascensia B REEZE Result mmol L o Lot A Lot B y x 95 Confidence Intervals Lot Opr N Y Slope Intercept R A Lay 100 0 85x 0 72 0 81 to 0 89 0 38 to 1 06 0 98 HCP 100 0 84x 0 65 0 80 to 0 88 0 33 to 0 96 0 98 B Lay 96 1 02x 0 58 0 96 to 1 08 1 04 to 0 13 0 97 HCP 96 1 03x 0 61 0 99 to 1 08 0 94 to 0 29 0 98 A B All 392 0 91x 0 21 0 89 to 0 94 0 01 to 0 40 ...

Страница 43: ...Lancing Device Ascensia BREEZE results from the multiple sites were compared to those obtained from the finger The blood glucose range for the fingerstick measurements was 3 3 to 13 6 mmol L with an average of 7 5 mmol L The hematocrit range was 38 to 53 with an average of 45 37 0 5 1 0 1 5 2 0 1 0 1 5 5 0 2 0 Ascensia BREEZE Finger Stick Result mmol L y x 0 5 1 0 1 5 2 0 0 5 1 0 1 5 2 0 y x Ascen...

Страница 44: ...0 77 to 1 13 0 70 to 1 71 0 92 Forearm Lay 30 1 01x 0 57 0 82 to 1 19 0 59 to 1 73 0 93 Abdomen Lay 31 0 92x 0 98 0 79 to 1 05 0 05 to 1 91 0 97 Thigh Lay 32 1 14x 0 21 0 92 to 1 37 1 81 to 1 40 0 91 0 5 1 0 1 5 2 0 0 5 1 0 1 5 2 0 Ascensia B REEZE Abdomen Result mmol L Ascensia BREEZE Finger Stick Result mmol L Ascensia BREEZE Finger Stick Result mmol L Ascensia B REEZE Thigh Result mmol L y x 0 ...

Страница 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 in Yes____ No_____ No see pg 6 5 Do you need to replace the battery Yes____ No_____ Yes see pg 28 6 Is the battery holder pushed all the way into the battery compartment Yes____ No_____ No see pg 30 3...

Страница 46: ...sician or healthcare professional HCP Test result is above 33 3 mmol L 600 mg dL Wash your hands and test site Repeat the test If HI appears again contact your physician or HCP The meter will mark a test result with a thermometer and an X if the meter is too cold or too hot when the test is performed The result will not be included in any averages calculated Test only when the meter temperature is...

Страница 47: ...elease 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 Program Number manually Check test strip disc or carton for Program Number P Use the or to select the correct number and press to accept Battery life has ended Replace the battery Low Battery icon flashes ...

Страница 48: ...y 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 flashing blood drop to apply blood There might also be moisture on the test strip guide Clean meter if needed and dry thoroughly see pg 27 Repeat test Meter has detected an error accurate test result not possi...

Страница 49: ...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 place and correctly installed see pg 28 If display is still blank replace battery CR2025 The display goes blank when the meter is turned on Meter will not turn on 1 Not enough blood 2 The inside of your met...

Страница 50: ...st strip 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 test disc and control solution with an acceptable expiration date and open use life date If still out of range contact the Bayer Diabetes Helpline see pg 45 Control Test result is out of range too...

Страница 51: ...ble to provide information that can 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 Normal Control Solution with you Fill out the following check list before you call Check List 1 The meter serial number 2 Date and time the problem occurred 3 I have tested with Normal Control Yes The Nor...

Страница 52: ...Canada from Bayer Inc Healthcare Division 77 Belfield Road Toronto Ontario M9W 1G6 Replacement Products Number Product Name 3611A Ascensia AUTODISC Test Strip Discs box of 50 3628A Ascensia AUTODISC Test Strip Discs box of 100 3642A Ascensia AUTODISC Normal Control Solution 3643A Ascensia AUTODISC Low and High Control Solutions 6540B MICROLET Adjustable Lancing Device 6546A MICROLET Lancets box of...

Страница 53: ...will be extended for consumable parts and or accessories 2 This warranty is limited to replacement due to defects in parts or workmanship Bayer shall not be required to replace any units which malfunction or are damaged due to abuse accidents alteration misuse neglect maintenance by other than Bayer or failure to operate the instrument in accordance with instructions Further Bayer assumes no liabi...

Страница 54: ...tered or modified in any manner BAYER MAKES NO OTHER EXPRESS WARRANTY FOR THIS PRODUCT THE OPTION OF REPLACEMENT 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 SUCH DAMAGES For Warranty service Purchaser must contact the Bayer Diabetes Helpline of Bay...

Страница 55: ...r AG used under license by Bayer Inc 99A61189 Rev 4 04 2003 Bayer HealthCare LLC Made and Printed in U S A Manufactured by Bayer HealthCare LLC Subsidiary of Bayer Corporation Mishawaka IN 46544 U S A Distributed by Bayer Inc Toronto Ontario M9W 1G6 Canada ...

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