Bayer HealthCare Ascensia BREEZE and Ascensia AUTODISCTM Unique 10-Test Disc manual

Ascensia ® B REEZE ™ and Ascensia ® A UTODISC ™ Unique 1 0 - T est Disc U SER G UIDE Diabetes Care System[...]

Introduction: Thank you for choosing the Ascensia ® B REEZE ™ Diabetes Care System! W e are proud to be your partner in helping you to manage your diabetes. W e 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 ® B REEZE ™ System, you wi[...]

Fold this page out for easy reference when using your user guide. A look at your Ascensia B REEZE Meter… On/Off Button: Use this button to manually turn the meter On or Off. Data Port: (side of meter) Insert cable here to allow communication between meter and a personal computer . Screen: This is where your test results will be displayed. Release[...]

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. 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 and to view your 14-day average. Set[...]

iv Release Button T est Strip Slot Open Latch (back of meter) Press in and pull up to open meter . Meter Handle[...]

T esting Materials: 10-T est A UTODISC ™ (Contains ten test strips.) Normal Control Solution M ICROLET ® Adjustable Lancing Device and Lancet Important Information: Caution: Before using any pr oduct to test your blood glucose, read all instructions car efully and practice the test. A full display , as shown here, indicates that all characters i[...]

1 T able of Contents: Everyday Use Inserting a 10-T est A UTODISC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Running a Blood Glucose T est . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Running a Control T est . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Beyond Everyday Use Recalli[...]

INSERTING A 10-TEST A UTODISC ™ : W ARNING: 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 up. 2. Open the new 10-test disc package. Check the expiration date on the disc. 2 Everyda[...]

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. J 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. 3[...]

Counting Number of Strips Left Y our Ascensia ® B REEZE ™ Meter will automatically count down the number of test strips you have left. To see this count when the meter is off, press the button. Note: This count is reset to 10 every time you open the meter . T o keep an accurate count, open the meter only when all 10 of the test strips have been [...]

RUNNING A BLOOD GLUCOSE TEST : 1. Wash your hands well with soap and warm water . Rinse and dry thoroughly . 2. Remove the endcap from the M ICROLET ® Adjustable Lancing Device. (See M ICROLET ® Device package insert for complete instructions.) 3. Insert lancet firmly until it comes to a full stop. This will “cock” the device. 5[...]

4. T wist off lancet cap and replace the endcap. Push out T est Strip Caution: Y our 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. Y our Ascensia ® B REEZE ™ Meter was designed with a special, easy-to-use “Pull and Push” design. Here’ s how it works: Hold th[...]

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 r elease 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. Stic[...]

Te s t 7. Y our 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[...]

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[...]

9. T o r elease the used test strip, hold the meter with the test strip pointing down over a waste container . Press the r elease 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 button to turn the meter off. If you fo[...]

For best results: •B lood is pulled IN the test strip not dropped ON. • Do not allow blood to run down into the meter . •D o not add more blood after the meter beeps. 11[...]

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 . Y ou 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 control range. Push out T est Strip 1.[...]

13 Note: The r elease 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 clean piece of wax paper). Do not apply control solution to the test strip directly from the bottle. Note: [...]

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: Y ou will want to “mark” your control test now so that it will [...]

15 Marking a Control T est Marking a test result as a control test excludes it from the 14-day average. Y ou 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 loo[...]

Marking a Deleted Blood T est Marking a test result as a deleted blood test excludes it from the 14-day average. Y ou 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?[...]

17 RECALLING TEST RESUL TS: Y our Ascensia ® B REEZE ™ Meter can store up to 1 00 test results in its memory . This makes it easy to see your earlier blood glucose test results. T o view those results: 1. Open the Button 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 st[...]

V iewing Y our 14-Day A verage Y our Ascensia ® B REEZE ™ Meter also keeps a 14-day average of your bl ood glucose results for you ( ). T o see this aver- age, simply follow these steps. 1. Open the Button Door and press the button. The meter will show you your last result. 2. Press the button again to see your blood glucose average for the last[...]

SETTING TIME, DA TE AND OTHER FEA TURES: J Helpful Hint: Y ou may press the button at 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. Pre[...]

5. Press or to select AM or PM. Press 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[...]

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[...]

22 Setting Buzzer Level Y our Ascensia ® B REEZE ™ Meter has an easy-to-use volume 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. [...]

Setting Units-of-Measure Important: T est 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: 5 5 . . 3 3 or 9 9 5 5 Y our Ascensia ® B REEZE ™ Meter comes with the units-of- measure preset. However , you may change the units-of- measure i[...]

24 Setting Time Format (12- or 24-hour Clock) Y our Ascensia ® B REEZE ™ Meter 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[...]

Setting Date Format Y our Ascensia ® B REEZE ™ Meter will let you set the day and month option on your meter . Y ou 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[...]

TRANSFERRING TEST RESUL TS TO A COMPUTER: Y ou can transfer test results from the Ascensia ® B REEZE ™ Meter to 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 ™ Win Glucofacts ® or Ascensia ™ Win Glucofacts ® Professional software, and Ascensia ™ Data [...]

CLEANING YOUR METER: Y our Ascensia ® B REEZE ™ Meter can be cleaned using a m oist (not wet) lint-free tissue with a m ild 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 slo[...]

28 REPLACING THE BA TTER Y : Y our Ascensia ® B REEZE ™ 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. Y ou will not erase test results in the meter’ s m[...]

To r eplace 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: Yo u must open the meter first in order to remove the battery holder . DO NOT PR Y[...]

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). Y ou are now ready to resume testing! 30[...]

SPECIFICA TIONS: T est: 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 µL T est Range: 0.6–33.3 mmol/L (10–600 mg/dL) T est Time: 30 seconds Memory Feature: Meter stores 1 00 test results. Normal Opera[...]

PERFORMANCE EV ALUA TIONS: Precision 1. Laboratory Precision: To assess the repeatability (within-run precision) of Ascensia ® B REEZE ™, 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[...]

Normal Control Solution High Control Solution Accuracy 1. Bayer Accuracy Evaluation: To assess the accuracy of the Ascensia ® B REEZE ™ System, 102 fresh fingerstick specimens from people with diabetes were tested with the Ascensia ® B REEZE ™ (2 readings per fingerstick) and the YSI 2300 ST A T Plus Glucose Analyzer . The glucose concentra[...]

W eighted 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[...]

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%. 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 (mmo[...]

Comparison of Meter to Laboratory Results † † Weighted Deming regression, weighted linear correlation coef ficient Opr . = Operator; Lay = Lay User; HCP = Healthcare Professional 36 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 =[...]

MUL TIPLE SITE TESTING EV ALUA TION: Forty-one persons with diabetes, in steady state for glucose, performed self-capillary blood glucose assays using the Ascensia ® B REEZE ™ System and one test strip lot (Lot A). A fingerstick was performed with the M ICROLET ® Adjustable Lancing Device. Samples from the palm, forearm, thigh and abdomen were[...]

38 Comparison of Multiple Site to Fingertip Results † † Weighted Deming regression, weighted linear correlation coef ficeint ‡One outlier excluded from statistics, but included in data plot Opr . = Operator; Lay = Lay User; 95% Confidence Intervals Site Opr . N Y= Slope / Intercept R P alm Lay 36 0.95x + 0.51 0.77 to 1.13 –0.70 to 1.71 0.[...]

PROBLEM SOL VING: Y ou 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? Y es____ No_____ No? (see pg. 2) 2. Does it contain new test strips? Y es____ No_____ No? (see pg. 2) 3. Is the 10-test disc within its expiration date? Y es_____ No______ No? (see pg. 2) 4. When you “P[...]

The 10-test disc is out of test strips. Insert a new 10-test disc. 40 Y ou have not pushed the meter handle all the way in. Push the meter handle in until it clicks. Y ou must push the handle all the way in and see the flashing blood drop before you touch the strip to the blood drop. T est result is below 0.6 mmol/L (10 mg/dL). Repeat test and mak[...]

41 What Y ou See What It Means What Y ou Do T emperature is either too hot or too cold. Allow the meter to reach room temperature. T est strip removed during the test, or release button pressed during the test. T ake care to not press release button or remove test strip during test. Release used test strip and repeat test (see pg. 8). The meter is [...]

42 What Y ou See What It Means What Y ou Do Y our Blood Glucose Level is very high or meter error . Tu rn meter off, then on using . Retest. If error appears again, call your physician or healthcare professional (HCP). Y our 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 Ba[...]

43 What Y ou See What It Means What Y ou Do Meter Malfunction T urn meter off, then on using . Retest. If error remains, contact the Bayer Diabetes Helpline (see pg. 45). E11 or higher 1. Y ou may have accidentally pressed the button. 2. Meter will turn off after 3 minutes without use or 15 minutes of no use while waiting for you to apply blood or [...]

44 This may affect the way you see your results. 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). Some display segments do not appear to be working when the meter handle is all the way out. What Y ou See What It Means What Y ou Do • Control solution is past expirat[...]

CUSTOMER SERVICE: If a problem arises, work through the Solving Problems section (see pg. 39). Y ou may easily find your solution there. If you are still having trouble, please call our Bayer Diabetes Helpline. W e 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-[...]

46 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* Item 40030035 1 lithium battery (CR2025) (available at most stores) Duracell Inc. DL2025 Panasonic Industrial Company CR2025 Renata CR2025 99A61189 Ascensia ® B REEZE ™ User Guide 501[...]

5-YEAR LIMITED W ARRANTY : Manufacturer’ s W arranty: 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, replac[...]

4. Bayer has no knowledge of the performance of the Ascensia ® B REEZE ™ Meter when used with any T est Strip Discs other than Ascensia ® A UTODISC ™ T est Strip Discs, and therefore makes no warranty of the performance of the Ascensia ® B REEZE ™ Meter when used with any T est Strips or T est Strip Discs other than Ascensia ® A UTODISC ?[...]

Bayer and Bayer Cross are registered trademarks of Bayer 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. T oronto, Ontario M9W 1 G6 Canada[...]