Bayer HealthCare Ascensia Breeze User Manual
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Bayer HealthCare Ascensia Breeze User Manual

Blood glucose meter 10-test disc
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Blood Glucose Monitoring System
U
G
SER
UIDE
Ascensia
™
Ascensia
™
Unique 10-Test Disc
B
™
and
REEZE
A
™
UTODISC

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Summary of Contents for Bayer HealthCare Ascensia Breeze

  • Page 1 Blood Glucose Monitoring System UIDE Ascensia ™ ™ REEZE Ascensia ™ ™ UTODISC Unique 10-Test Disc...
  • Page 2 • 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 Diabetes Care System. It will answer any...
  • Page 3 A look at your Ascensia B Meter… REEZE Release Button: Press to release Screen: This is and discard where your test used test strip. results will be displayed. Battery Holder: (side of meter) Data Port: Holds one CR2025 (side of meter) lithium battery Insert cable (included).
  • Page 4 Up/Down On/Off Button: Buttons: Use this button to Use these buttons manually turn the with the Memory meter On or Off. button to see your results or use with Memory Button: the Set-Up button Use this button to to change the view your blood time, date, etc.
  • Page 5 Release Button Test Strip Slot Open Latch (back of meter) Press in and pull up to open meter. Meter Handle...
  • Page 6 Testing Materials: 10-Test Disc (Disc contains ten test strips.) Normal Control (Included with some kits.) Microlet Adjustable ® Lancing Device and Lancet Important Information: Caution: 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 properly.

  • Page 7: Table Of Contents

    Table of Contents: Everyday Use Inserting a 10-Test Disc ........2 Running a Blood Glucose Test .

  • Page 8: Everyday Use

    Everyday Use INSERTING A 10-TEST DISC: 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 up.
  • Page 9 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.
  • Page 10 Counting Number of Strips Left Your Ascensia B Meter REEZE 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.

  • Page 11: Running A Blood Glucose Test

    RUNNING A BLOOD GLUCOSE TEST: 1. Wash your hands well with soap and warm water. Rinse and dry 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 instructions.) 3.
  • Page 12 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.
  • Page 13 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.
  • Page 14 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.
  • 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.
  • Page 16 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.
  • Page 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. Multiple Site Testing: Blood samples for glucose testing may be taken from sites other than your fingertips.
  • Page 18 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.

  • Page 19: Running A Control Test

    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.
  • Page 20 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 clean piece of wax paper).
  • Page 21 4. While the meter calculates your Control 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.
  • Page 22 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.

  • Page 23: Beyond Everyday Use

    Beyond Everyday Use RECALLING TEST RESULTS: Your Ascensia B Meter REEZE 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.
  • Page 24 Viewing Your 14-Day Average Your Ascensia B Meter also REEZE keeps a 14-day average of your blood glucose results for you ). To see this average, simply follow these steps. 1. Open the Button Door and press the button. The meter will show you your last result.

  • Page 25: Setting Time, Date And Other Features

    SETTING THE TIME, DATE AND OTHER FEATURES: Helpful Hint: You may press the button 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.
  • Page 26 5. Press 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”...
  • Page 27 5. Press to change the month. Press to accept and move on. 6. Press to change the year. Press to accept and move on.
  • Page 28 Setting Buzzer Level Your Ascensia B Meter has an easy-to-use volume REEZE control for the buzzer. Here are the three different buzzer levels: high Note: If you have just set the date, skip ahead to step 4. 1. Open the Button Door. 2.
  • Page 29 Setting Units-of-Measure Important: Test results are shown in either mg/dL or mmol/L. The mg/dL results do not include a decimal point. The mmol/L results will always include a decimal point. 9 9 5 5 Example: 5 5 . . 3 3 Your Ascensia B Meter comes with the units-of-measure REEZE...
  • Page 30 Setting Time Format (12- or 24-hour Clock) Your Ascensia B Meter will let you choose either a REEZE 12-hour ( ) or a 24-hour time setup ( Note: If you have just set the units-of-measure, skip ahead to step 4. 1.
  • Page 31 Setting Date Format Your Ascensia B Meter will let you set the day and REEZE 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.

  • Page 32: Transferring Results To A Computer

    TRANSFER TEST RESULTS TO A COMPUTER: You can transfer test results from the Ascensia B Meter to REEZE a computer, where they can be summarized in a report with graphs and tables. To make use of this feature, you need Ascensia™ WinGlucofacts ®...

  • Page 33: Cleaning Your Meter

    CLEANING YOUR METER: Your Ascensia B Meter can be cleaned REEZE using a moist (not wet) lint-free tissue with a mild detergent or disinfecting 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.

  • Page 34: Replacing The Battery

    REPLACING THE BATTERY: Your Ascensia B Meter uses one 3-volt lithium battery REEZE (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.
  • Page 35 To replace the battery, follow these steps: Note: A replacement battery (CR2025) can be found at most pharmacies (see pg. 46). 1. Hold the meter with the display screen down. Open the meter by pressing on the open latch and pulling up. 2.
  • Page 36 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.

  • Page 37: Technical Information

    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 µL Test Range: 10–600 mg/dL (0.6–33.3 mmol/L) Test Time: 30 seconds Memory Feature: Meter stores 100 test results.

  • Page 38: Performance Evaluations

    PERFORMANCE EVALUATIONS: Precision 1. Laboratory Precision: To assess the repeatability (within-run precision) of Ascensia™ B ™, 100 blood glucose REEZE 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.
  • Page 39 336.7 17.3 Lay User (n=50) 339.6 14.4 Accuracy 1. Bayer Accuracy Evaluation: To assess the accuracy of the Ascensia B system, 102 REEZE fresh fingerstick specimens from people with diabetes were tested with the Ascensia B (2 readings per fingerstick) REEZE and the YSI 2300 STAT Plus Glucose Analyzer.
  • Page 40 YSI Plasma Glucose (mg/dL) Weighted Deming Agreement Statistics / Pearson correlation 95% Confidence Interval Slope Intercept 1.07x – 3.23 1.04 to 1.10 –7.11 to 0.66 0.983 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.
  • Page 41 laboratory glucose and hematocrit determinations. The glucose concentrations of the 196 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%. A. Lay User Results Laboratory Plasma Glucose Result (mg/dL) = Lot A + = Lot B...
  • Page 42 B. Health Care Professional Results Laboratory Plasma Glucose Result (mg/dL) = Lot A + = Lot B Comparison of Meter to Laboratory Results † 95% Confidence Intervals Opr. Slope Intercept 0.81 to 0.89 6.81 to 19.00 100 0.85x + 12.91 0.98 0.80 to 0.88 6.01 to 17.21...

  • Page 43: Multiple Site Testing Evaluation

    MULTIPLE SITE TESTING EVALUATION: Forty-one subjects with diabetes participated in the study. Subjects were in steady state for glucose (no insulin or oral hypoglycemic medication; nothing to eat or drink, other than water; and no vigorous exercise in the past two hours). The subjects performed self-capillary blood glucose assays using the Ascensia B System and one test strip lot (Lot A).
  • Page 44 C. Results from Abdomen (n = 32) D. Results from Thigh (n = 32) Ascensia B Finger Stick Result (mg/dL) Ascensia B Finger Stick Result (mg/dL) REEZE REEZE Comparison of Multiple Site to Fingertip Results † 95% Confidence Intervals Site Opr.

  • Page 45: Solving Problems

    Solving Problems SOLVING PROBLEMS: 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.

  • Page 46: Troubleshooting And Error Codes

    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 Repeat test and make sure 10 mg/dL (0.6 mmol/L).
  • Page 47 What You See What It Means What You Do Low Battery icon flashes if Replace battery within 20 battery power is low. readings or one week. Battery life has ended. Replace the battery. Meter cannot perform Check test strip disc automatic calibration, or carton for Program and you must enter...
  • Page 48 . Retest. If error appears again, call your physician or healthcare professional (HCP). Your blood glucose may be above 1500 mg/dL (83.3 mmol/L). If the problem is with the meter and cannot be corrected, contact your Bayer Customer Service Department (see pg. 45).
  • Page 49 E11 or higher Meter Malfunction Turn meter off, then on using . Then retest. If error remains, contact your Bayer Customer Service Department (see pg. 45). The display goes 1. You may have 1. Press the button. blank when the...
  • Page 50 If • Deteriorated test strip still out of range, contact due to heat or exposure your Bayer Customer to moisture. Service Department • Control solution not at (see pg. 45). room temperature.

  • Page 51: Customer Service

    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 trouble, please call our Customer Service Department. We have friendly, knowledgeable people who are there to help 24 hours a day. 1-800-348-8100 In the U.S.A., call toll free: (24 Hours a day)

  • Page 52: Replacement Items

    ™ User Guide REEZE 50184229 Ascensia™ B ™ Quick Reference Guide REEZE You can obtain these parts in the United States from: Bayer Corporation Customer Service Department Order Entry P.O. Box 2004 Mishawaka, Indiana 46546 Replacement Products Number Product Name 3416A Ascensia™...

  • Page 53: 5-Year Limited Warranty

    Bayer instruments caused by the use of reagents other than reagents (i.e., Ascensia A Test Strip Discs) UTODISC manufactured or recommended by Bayer. 3. Bayer reserves the right to make changes in design of this instrument without obligation to incorporate such changes into previously manufactured instruments.
  • Page 54 4. Bayer has no knowledge of the performance of the Ascensia B Meter when used with any Test Strip REEZE Discs other than Ascensia A Test Strip Discs, and UTODISC therefore makes no warranty of the performance of the Ascensia B...
  • Page 55 Distributed by: © 2003 Bayer HealthCare LLC Made and Printed in U.S.A. Bayer HealthCare LLC 99961179 Rev. 4/03 Mishawaka, IN 46544 USA...

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