Bayer HealthCare Ascensia BREEZE and Ascensia AUTODISCTM Unique 10
Contents
1. 000 eee eee ene 46 5 Year Limited Warranty 0 000 ccc ees 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 of glucose in whole blood The Ascensia BREEZE System is specific for glucose and has been referenced to plasma serum glucose Everyday Use INSERTING A 10 TEST AUTODISC WARNING Never open the meter with the 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 the front cover yoo up 2 Open the new 10 test disc package Check the expiration date on the disc Insert Disc 3 Insert a new 10 test disc yellow arrow bumpy side up The arrow may point in any direction Close Meter 4 Close the meter and snap it shut Keep the meter flat Helpful 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 Counting Number of Strips Left Your Ascensia BREEZE Meter will automatically count down the number of test strips you have left To see this count when the meter is off press the C1 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 102. Battery life has ended Meter cannot perform automatic calibration and you must enter the Program Number manually Temperature is either too hot or too cold Test strip removed during the test or release button pressed during the test The meter is open when the meter handle is pulled Replace battery within 20 readings or within one week Replace the battery Check test strip disc or carton for Program Number P Use the or B to select the correct number and press to accept Allow the meter to reach room temperature Take care to not press release button or remove test strip during test Release used test strip and repeat test see pg 8 Close meter and push handle in 41 What You See What It Means What You Do Meter has detected an e You may have applied error accurate test result blood too early to the test not possible 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 Test strip is not error accurate test result completely filled Release not possible used test strip and repeat test see pg 8 or 10 test disc may have been damaged due to intense heat or moisture exposure Replace 10 test disc using a new box if necessary 42 There was a problem filling Review pg 8 and repeat the
3. Finger Stick Result mmol L 37 C Results from Abdomen n 32 20 E y X ae E J o 15 S a e c ve Ea g 10 PA e e m an W e z 5 s y c 3 0 T g T 1 lt 0 5 10 15 20 Ascensia BREEZE Finger Stick Result mmol L D Ascensia BREEZE Thigh Result mmol L Results from Thigh n 32 20 y X P Z So 7 i j ra 15 Pa A e ef 104 e se ee 3 e p 5 oe ee S A va 0 I T T 1 0 5 10 15 20 Ascensia BREEZE Finger Stick Result mmol L Comparison of Multiple Site to Fingertip Results 0 95x 0 51 1 01x 0 57 0 92x 0 98 1 14x 0 21 Palm Forearm 0 77 to 1 13 0 82 to 1 19 0 79 to 1 05 0 92 to 1 37 95 Confidence Intervals Slope Intercept 0 70 to 1 71 0 59 to 1 73 0 05 to 1 91 1 81 to 1 40 t Weighted Deming regression weighted linear correlation coefficeint One outlier excluded from statistics but included in data plot Opr Operator Lay Lay User 38 Solving Problems PROBLEM SOLVING You can solve many of the problems you might have by working through this section 1 Do you have a 10 test disc in the meter Yes No No see pg 2 2 Does it contain new test strips Yes No 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 a
4. Testing Materials 10 Test AUTODISC Contains ten test strips Normal Control Solution MICROLET Adjustable Lancing Device and Lancet Important Information Caution Before 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 Table of Contents Everyday Use Inserting a 10 Test AUTODISC 1 1 ccc es 2 Running a Blood Glucose Test 0 00 c eects 5 Running a Control Test 00 cc ees 12 Beyond Everyday Use Recalling Test Results 0 0 0 0 cc ees 17 Setting Time Date and Other Features 00 cee eens 19 Transferring Test Results to a Computer 005 26 Cleaning Your Meter 0c ccc ees 27 Replacing the Battery 0 ccc ees 28 Technical Information SPECINICALIONS a 4 ouce aide aan sdcteeatwee adhe een nade ee eee ee 31 Performance Evaluations 0c ccc eee eee ees 32 Multiple Site Testing Evaluation 00 cc cee ees 37 Solving Problems Solving Problems sa ireas saaa a eh Oa ee eee dea mes 39 Troubleshooting and Error Codes 00 0c cece neces 40 Customer Service 0 eee eee eens 45 Replacement Items
5. as background material for instruction 27 REPLACING THE BATTERY Your Ascensia BREEZE Meter uses one 3 volt lithium battery CR2025 A battery will already be installed in the meter when you buy it When it is time to put a new battery in the meter the meter will tell you by displaying a flashing battery on the screen You will not erase test results in the meter s memory when you change the battery You will however need to reset the clock see pg 19 Caution If you have a low 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 display and the meter will not respond Things To Remember WARNING Keep battery away from children Lithium batteries are poisonous If swallowed immediately contact your physician or poison control center Dispose of old batteries properly 28 To replace the battery follow these steps Note A replacement battery CR2025 can be found at most pharmacies 1 Hold the 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 op
6. 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 liability for malfunction or damage to Bayer instruments caused by the use of reagents other than reagents i e Ascensia AUTODISC Test Strip Discs manufactured or recommended by Bayer Bayer reserves the right to make changes in design of this instrument without obligation to incorporate such changes into previously manufactured instruments 47 4 Bayer has no knowledge of the performance of the Ascensia BREEZE Meter when used with any Test Strip Discs other than Ascensia AUTODISC Test Strip Discs and therefore makes no warranty of the performance of the Ascensia BREEZE Meter when used with any Test Strips or Test Strip Discs other than Ascensia AUTODISC Test Strips or when the Ascensia AUTODISC Test Strip is altered 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 Bayer Inc by calling toll free
7. 0 0 35 0 Laboratory Plasma Glucose Result mmol L o Lot A Lot B Comparison of Meter to Laboratory Results 95 Confidence Intervals Lot Slope l Intercept 0 85x 0 72 0 81 to 0 89 0 38 to 1 06 0 84x 0 65 0 80 to 0 88 0 33 to 0 96 1 02x 0 58 0 96 to 1 08 1 04 to 0 13 1 03x 0 61 0 99 to 1 08 0 94 to 0 29 0 91x 0 21 0 89 to 0 94 0 01 to 0 40 t Weighted Deming regression weighted linear correlation coefficient Opr Operator Lay Lay User HCP Healthcare Professional 36 MULTIPLE SITE TESTING EVALUATION Forty one persons with diabetes in steady state for glucose performed self capillary blood glucose assays using the Ascensia BREEZE System and one test strip lot Lot A A fingerstick was performed with the MICROLET Adjustable Lancing Device Samples from the palm 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 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 A Results from Palm n 36 B Results from Forearm n 30 Ascensia BREEZE Palm Result mmol L Ascensia BREEZE Forearm Result mmol L 0 5 t0 15 20 0 5 10 15 20 Ascensia BREEZE Ascensia BREEZE Finger Stick Result mmol L
8. 1 800 268 7200 for assistance and or instructions for obtaining service of this instrument Bayer HealthCare LLC used under license by Bayer Inc 48 Bayer HealthCare Manufactured by Distributed by Bayer HealthCare LLC Bayer Inc Subsidiary of Bayer Corporation Toronto Ontario M9W 1G6 Canada Mishawaka IN 46544 U S A Bayer and Bayer Cross are registered trademarks of Bayer AG used under license by Bayer Inc 2003 Bayer HealthCare LLC 99A61189 Made and Printed in U S A Rev 4 04
9. Ascensia Introduction Thank you for choosing the Ascensia BREEZE Diabetes Care System We are proud to be your partner in helping you to manage your diabetes We understand that people who regularly check their blood glucose levels want a meter that is simple straightforward and easy to use As you use your Ascensia BREEZE System you will appreciate the e Ease of running a test and discarding a used test strip e Use of a 10 Test Disc which means no individual test strips to fumble with e User friendly design buttons make recalling your results or setting the time as easy as making a telephone call e 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 t is here to help you This User Guide is divided into two sections Part 1 Everyday Use will guide you through the basic use of the meter Part 2 Beyond Everyday Use will guide you through special features such as how to change the time and the date or where to find more help with this product A look at your Ascensia BREEZE Meter Release Button Press to release and discard used test strip Screen This is where your test results will be Battery Holder displayed side of met
10. Discard used test strip Retest using a round drop of blood Clean inside of meter see pg 27 Retest 43 What You See What It Means What You Do Control Test e Control solution is past result is out expiration date or is past of range too the 6 month open use high or too life date low e 10 test disc is past expiration date e Deteriorated test strip due to heat or exposure to moisture e Control solution not at room temperature e Not enough control solution drawn into test strip Meter shows Your meter may be dirty dashes before blood is applied Some display This may affect the way segments do not you see your results appear to be working when the meter handle is all the way out Invalid test result 44 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 Clean meter see pg 27 If you continue to experience difficulty contact the Bayer Diabetes Helpline see pg 45 If there is a difference in your meter s display and the one shown on page v contact the Bayer Diabetes Helpline see pg 45 Discard strip and retest CUSTOMER SERVICE If a problem arises work through the Solving Problems section see pg 39 You may easily find your solution there If you are still having tr
11. G YOUR METER Your Ascensia BREEZE Meter can be cleaned using a moist not wet lint free tissue with a mild detergent or disinfect ing solution 1 part bleach mixed with 9 parts water Wipe both the outside and inside of the meter taking care to keep detergent or disinfecting solution from running down into the test strip slot Wipe dry with a lint free tissue after cleaning If you do get moisture in the test strip slot wick it away with a corner of a tissue as shown WARNING Potential Biohazard Healthcare professionals or persons using this system on multiple patients should be aware of the following and should follow the 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 Committee for Clinical Laboratory Standards Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissues Approved Guideline NCCLS Document M29 A ISBN 1 56238 339 6 NCCLS 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 1997 This document has complete information on the topic of user protection and can be used
12. Reference Guide You can obtain these parts in Canada from Bayer Inc Healthcare Division 77 Belfield Road Toronto Ontario M9W 1G6 Replacement Products Number 3611A 3628A 3642A 3643A 6540B 6546A 6550A Product Name Ascensia AUTODISC Test Strip Discs box of 50 Ascensia AUTODISC Test Strip Discs box of 100 Ascensia AUTODISC Normal Control Solution Ascensia AUTODISC Low and High Control Solutions MICROLET Adjustable Lancing Device MICROLET Lancets box of 100 MICROLET Lancets box of 200 Replacement products may be obtained from Diabetes Care Centers retail drug stores or other home healthcare distributors Part numbers are subject to change without notice 46 5 YEAR LIMITED WARRANTY Manufacturer s Warranty Bayer Inc Healthcare Division Bayer warrants to the original purchaser that this instrument will be free from defects in materials and workmanship for 5 years from the date of original purchase except as noted below During the stated 5 year period Bayer shall at no charge replace a unit found to be defective with an equivalent or current version of the owner s model Limitations of the Warranty This warranty is subject to the following exceptions and limitations 1 2 A 90 day warranty only will be extended for consumable parts and or accessories This warranty is limited to replacement due to defects in parts or workmanship Bayer
13. en 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 4 Snap 1 new battery CR2025 firmly in 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 Technical Information SPECIFICATIONS Test Capillary blood glucose referenced to plasma serum glucose values Calibration Meter is automatically calibrated each time a new test strip disc is used Sample Size Approximately 2 5 3 5 uL 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 PERFORMANCE EVALUATIONS Precision 1 Laboratory Precision To assess the repeatability within run precision of Ascensia BREEZE 100 blood glucose readings 10 readings on each of 10 instruments were obtained with venous blood specimens at five glucose concentrations The following table summarizes the mean and pooled within meter CV at each level Mean 2 9 mmolL 7 4 mmol L 9 1 mmolL 14 7 mmol L 23 7 mmol L 2 Contr
14. er 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 properly 7 Press the Q to turn your meter off Marking a Deleted Blood Test Marking a test result as a deleted blood test excludes it from the 14 day 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 E button to mark as deleted 3 The Delete marker looks like this X 4 Press Dto accept 5 Press the 1 to turn your meter off 16 Beyond Everyday Use RECALLING TEST RESULTS Your Ascensia BREEZE Meter can store up to 100 test results in its memory This makes it easy to see your earlier blood glucose test results To view those results 1 Open the Button Door 2 Press the M button The meter will now show you the most recent test result 3 Press the E button to see all of your stored results Helpful 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 Viewing Your 14 Day Average Your Ascensia BREEZE Meter also keeps a 14 day average of your blood glucose results
15. er l Holds one CR2025 e Ae lithium battery slae of meter Insert cable here to allow communication between meter and a personal computer On Off Button me Use this button to Ascensia manually turn the REEZE meter On or Off p A Sy Button Door Meter Handle Use this handle to push out a test strip and automatically turn on the meter Fold this page out for easy reference when using your user guide Open to expose meter buttons 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 On Off Button Use this button to manually turn the meter On or Off Memory Button Use this button to view your blood glucose results stored in memory s and to view your 6 Use this but Set Up Button ton to accept 14 day average Use this button to changes made enter the Set Up 1 in the Set Up Accept OK Button mode and easily Oi mode change the time sue date or other le features Ko own Button door open Simply place the easy reference sticker on the Button Door as shown See sheet of stickers provided in your meter package and select the language of your choice amp D o mA Release Button Denen Test Strip Slot Open Latch back of meter Press in and pull up to open meter OPEN OUVERT 6118 BREEZE Meter Handle
16. f 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 physician or healthcare professional immediately Caution Any changes in medication based on Ascensia BREEZE blood glucose results without the advice of a physician or healthcare professional is not recommended For best results e Blood is pulled IN the test strip not dropped ON e Do not allow blood to run down into the meter e Do not add more blood after the meter beeps RUNNING A CONTROL TEST There are times when you will want to do a quality control test so you know that your system is working properly You may also want to do a control 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 w control range Low NORMAL HIGH mmol L Bb 5 8 0 3 139 i0 i m IAZ0GDAA Ped u 2004 04 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 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 control test 2 Squeeze a small drop of control solution onto a nonabsorbent surface such as a clea
17. for you 4 d A To see this aver age simply follow these steps 1 Open the Button Door and press the M button The meter will show you your last result 2 Press the M button again to see your blood glucose average for the last 14 days You may press the M button 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 n 4 While holding the button press and hold the button 5 Hold both buttons together until all three dashes are continuously lit for about 3 seconds If you change your mind and do not want to clear results simply let go of the buttons before all three dashes have been lit 18 gm i g y A I h o a E iy oe E 7 1 A E W r a AS E 7 A I QD l a l 1 N F gt f Q ff F Yg Ar l Ne L LD AN D Q i AE BZ AN a Ft Fe lt amp l J I AN E A Oha O Helpful Hint You may press the 1 button at any time during set up to turn the meter off Just remember to press the D button first to store your changes 1 Open the Button Door 2 Pres 3 Press or 5 to change the hour Press D to accept and move on 4 Press O or 5 to change the minutes Press D
18. ll 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 39 TROUBLESHOOTING AND ERROR CODES When you have a problem or a question concerning what you see on your screen the following may be helpful What You See What It Means What You Do Test result is below 0 6 mmol L 10 mg dL Test result is above 33 3 mmol L 600 mg dL You have not pushed the meter handle all the Way in The 10 test disc is out of test strips 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 40 Repeat test and make sure test strip is completely filled If LO appears again contact your physician or healthcare professional HCP Wash your hands and test site Repeat the test If HI appears again contact your physician or HCP Push the meter handle in until it clicks You must push the handle all the way in and see the flashing blood drop before you touch the strip to the blood drop Insert a new 10 test disc Test only when the meter temperature is between 10 C and 40 C 50 F and 104 F What You See What It Means What You Do La Ez A e ae 5 Low Battery icon flashes if battery power is low
19. mol L Weighted Deming Agreement Statistics Pearson correlation 95 Confidence Interval __ Confidence Interval Slope Intercept 204 1 1 07x 0 21 0 21 1 03 t0 1 10 0 48 to 0 06 to 1 10 0 48 to 0 06 0 983 983 2 Professional Lay User Evaluation A mee meo 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 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 comparative laboratory glucose and hematocrit determinations The glucose concentrations of the 196 samples 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 A Lay User Results 35 0 30 0 25 0 20 0 15 0 10 0 5 0 Ascensia BREEZE Result mmol L 0 0 0 0 5 0 10 0 15 0 20 0 25 0 30 0 35 0 Laboratory Plasma Glucose Result mmol L o Lot A Lot B 35 B Healthcare Professional Results 35 0 30 0 25 0 20 0 Ascensia BREEZE Result mmol L 0 0 5 0 10 0 15 0 20 0 25 0 3
20. n a blood glucose test 6 Stick your finger with the MICROLET Device and form a small round drop of blood Test 7 Your test strip is like a straw it sips in a sample of blood Move the entire front edge of the 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 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 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 properly 10 Press the Q button to turn the meter off 10 If you forget to turn your meter off the meter will turn off automatically after three 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 i
21. n piece of wax paper Do not apply 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 away By doing so you will make sure the test strip is completely filled 4 While the meter calculates your control test result you will see a sequence of dashes on the 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 Marking a Control Test Marking a test result as a control test excludes it from the 14 day 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 5 Open the Button Door Press the button to mark as a control The Control marker looks like this y Press Dito accept 6 To release the used test strip hold the meter with the test strip pointing down over a waste contain
22. 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 RUNNING A BLOOD GLUCOSE TEST Wash your hands well with 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 4 Twist off lancet cap and replace the endcap Push out Test Strip Caution Your meter is designed to push out one test strip at a time Do not attempt to push 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 Note This will automatically turn your meter on if it is not al ready on For regular everyday 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 to ru
23. ol Testing Precision An imprecision study of the Ascensia BREEZE System 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 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 Solution Strip No of Mean Lot Operator Assays mmol L mmol L Lay User n 50 e tay User in 32 Normal Control Solution Strip No of Mean Lot Operator Assays mmol L mmol L A_ Lay User n 50 100 8 394 0400 48 e tay Usertnesoy 100 8317 0356 a3 High Control Solution Total Strip No of Mean CV ES Operator Assays mmol L mmol L Accuracy 1 Bayer Accuracy Evaluation To assess the accuracy of the Ascensia BREEZE System 102 fresh fingerstick specimens from people with diabetes were tested with the Ascensia BREEZE 2 readings per fingerstick and the YSI 2300 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 oo o ao oO M o 20 Ascensia BREEZE Plasma Glucose mmol L 0 5 10 15 20 25 30 35 YSI Plasma Glucose m
24. on 4 Press or amp to choose units of measure Press D to accept and move on 23 Setting Time Format 12 or 24 hour Clock Your Ascensia BREEZE Meter will let you choose either a 12 hour i H or a 24 hour time setup 24 Note If you have just set the units of measure skip ahead to step 4 1 Open the Button Door 2 Pres 3 Press D until you see the time format icon 4 Press or amp to set 12 or 24 hour clock Press D to accept and move on 24 Setting Date Format Your Ascensia BREEZE Meter will let you set the day and month option on your meter You can choose to set it as month day F d or as day month i 7 Note If you just set the time format skip ahead to step 4 1 Open the Button Door 2 Pres 3 Press D until you see the date format icon 4 Press or E to set the date format Press D to accept 25 TRANSFERRING TEST RESULTS TO A COMPUTER You can transfer test results from mee the Ascensia BREEZE Meter to E iG a computer where they can be summarized in a report with graphs and tables To make use of this feature you will need the Ascensia WinGlucofacts or Ascensia WinG ucofacts 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 CLEANIN
25. ouble please call our Bayer Diabetes Helpline We have friendly knowledgeable people who are there to help 12 hours a day 7 days a week 9 9 EST In Canada call toll free 1 800 268 7200 Important e Always speak with a customer service representative before returning your meter for any reason They will be able to provide information that can help solve your problem quickly e 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 e Fill out the following check list before you call Check List 1 The meter serial number 2 Date and time the problem occurred 3 have tested with Normal Control Yes ___ No The Normal Control result was Lot Number Expiration Date 4 Please also give the Lot Number and Expiration Date of the test strip disc currently being used This information is printed on the test strip disc and the test strip disc box Lot Number__ Expiration Date 45 REPLACEMENT ITEMS If you call or write for supplies please include the number with the name of the replacement part or product Replacement Parts Part Number 40030035 99A61189 50184270 Item 1 lithium battery CR2025 available at most stores Duracell Inc DL2025 Panasonic Industrial Company CR2025 Renata CR2025 Ascensia BREEZE User Guide Ascensia BREEZE Quick
26. test strip completely test full Your Blood Glucose Level is Turn meter off then on very high or meter error using Retest If error appears again call your physician or healthcare professional HCP Your blood glucose may be above 55 5 mmol L 1500 mg dL If the problem is with the meter and cannot be corrected contact the Bayer Diabetes Helpline see pg 45 What You See What It Means What You Do The display goes blank when the meter is turned on Meter will not turn on Meter fails to start countdown after blood is applied Meter Malfunction You may have accidentally pressed the O button Meter will turn off after 3 minutes without use or 15 minutes of no use while waiting for you to apply blood or control solution This is a normal expected action that saves battery life Battery life has ended Battery holder is loose or battery is installed side down Not enough blood The inside of your meter may be dirty or foil from the 10 test disc may be lodged in the front of the meter Turn meter off then on using 1 Retest If error remains contact the Bayer Diabetes Helpline see pg 45 1 Press the 1 button Press the 1 button Replace Battery see pg 28 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
27. to accept and move on 5 Press or E to select AM or PM Press D 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 Pres 3 Press D until you see the day icon flashing 4 Press D or 5 to change the day Press D to accept and move on 20 5 Press B or v to change the month Press D to accept and move on 6 Press or v to change the year Press D to accept and move on 21 Setting Buzzer Level Your Ascensia BREEZE Meter has an easy to use volume control for the buzzer Here are the three different buzzer levels hng Blow Aof Note If you have just set the date skip ahead to step 4 1 Open the Button Door 2 Pres 3 Press D until you see the buzzer icon 4 Press or E to change the buzzer level Press D to accept and move on 22 Setting Units of Measure Important Test results are shown in either mmol L or mg dL The mmol L results will always include a decimal point The mg dL results do not include a decimal point Example 53 si or 95 dL 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 Pres 3 Press D until you see a unit of measure ic
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