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Bayer HealthCare Ascensia Breeze Ascensia BREEZE and Ascensia AUTODISCTM Unique 10-Test Disc User Manual

Diabetes care system for use with ascensia autodisc unique 10-test disc.
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Ascensia
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Ascensia
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Unique 10-Test Disc
Diabetes Care System
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UTODISC

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   Summary of Contents for Bayer HealthCare Ascensia Breeze Ascensia BREEZE and Ascensia AUTODISCTM Unique 10-Test Disc

  • Page 1 UIDE Ascensia ® REEZE Ascensia ® UTODISC Unique 10-Test Disc Diabetes Care System ™ ™...
  • Page 2 Introduction: Thank you for choosing the Ascensia 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.
  • Page 3 A look at your Ascensia B Release Button: Press to release and discard used test strip. Battery Holder: (side of meter) Holds one CR2025 lithium battery. On/Off Button: Use this button to manually turn the meter On or Off. Meter Handle: Use this handle to push out a test strip and...
  • Page 4 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-Up Button: Use this button to enter the Set-Up mode and easily change the time, date or other...
  • 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: Important Information: Caution: Before using any product to test your blood glucose, read all instructions carefully and practice the test. 10-Test A UTODISC (Contains ten test strips.) Normal Control Solution Adjustable ® ICROLET Lancing Device and Lancet 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 A Running a Blood Glucose Test Running a Control Test ........12 Beyond Everyday Use Recalling Test Results .
  • Page 8: Everyday Use

    INSERTING A 10-TEST A 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 2.
  • 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 ™ ® 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.
  • 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. 2. Remove the endcap from the ® Adjustable Lancing ICROLET Device. (See M ICROLET package insert for complete instructions.) 3. Insert lancet firmly until it comes to a full stop.
  • 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.
  • Page 18: 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 19 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 20 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.
  • Page 21 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 22 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 23: Beyond Everyday Use

    Beyond Everyday Use RECALLING TEST RESULTS: Your Ascensia ® REEZE 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.
  • Page 24 Viewing Your 14-Day Average Your Ascensia ® REEZE also keeps a 14-day average of your blood glucose results for you ( ). To 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.
  • Page 25: Setting Time, Date And Other Features

    SETTING TIME, DATE AND OTHER FEATURES: Helpful Hint: You may press the button at any time during set-up to turn the meter off. Just remember to press the to store your changes! Setting the Time 1. Open the Button Door. 2.
  • Page 26 5. Press 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.
  • Page 27 5. Press the month. Press to accept and move on. 6. Press the year. Press to accept and move on. to change to change...
  • Page 28 Setting Buzzer Level Your Ascensia ® REEZE control for the buzzer. Here are the three different buzzer levels: 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”...
  • Page 29 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: Your Ascensia ® REEZE measure preset. However, you may change the units-of- measure if you wish.
  • Page 30 Setting Time Format (12- or 24-hour Clock) Your Ascensia ® 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. Open the Button Door. 2. Press 3.
  • Page 31 Setting Date Format Your Ascensia ® REEZE month option on your meter. You can choose to set it as “month/day” ( Note: If you just set the time format, skip ahead to step 4. 1. Open the Button Door. 2. Press 3.
  • Page 32: Transferring Test Results To A Computer

    TRANSFERRING TEST RESULTS TO A COMPUTER: You can transfer test results from the Ascensia ™ Meter to ® REEZE 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™...
  • Page 33: Cleaning Your Meter

    CLEANING YOUR METER: ® Your Ascensia REEZE 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.
  • Page 34: Replacing The Battery

    REPLACING THE BATTERY: ™ ® Your Ascensia 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. 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.
  • 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: Calibration: Sample Size: Test Range: Test Time: Memory Feature: Normal Operating Temperature: Humidity: Power Source: Capillary blood glucose referenced to plasma/serum glucose values Meter is automatically calibrated each time a new test strip disc is used. Approximately 2.5–3.5 µL 0.6–33.3 mmol/L (10–600 mg/dL) 30 seconds...
  • Page 38: Performance Evaluations

    PERFORMANCE EVALUATIONS: Precision 1. Laboratory Precision: To assess the repeatability (within-run precision) of Ascensia 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 mmol/L 7.4 mmol/L 9.1 mmol/L 14.7 mmol/L 23.7 mmol/L 8.9%...
  • Page 39 Normal Control Solution Strip Operator Lay User (n=50) Lay User (n=50) High Control Solution Strip Operator Lay User (n=50) Lay User (n=50) Accuracy 1. Bayer Accuracy Evaluation: To assess the accuracy of the Ascensia 102 fresh fingerstick specimens from people with diabetes were tested with the Ascensia fingerstick) and the YSI 2300 STAT Plus Glucose Analyzer.
  • Page 40 YSI Plasma Glucose (mmol/L) Weighted Deming Agreement Statistics / Pearson correlation 1.07x – 0.21 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 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...
  • Page 42 B. Healthcare Professional Results 35.0 30.0 25.0 20.0 15.0 10.0 10.0 15.0 20.0 25.0 30.0 35.0 Laboratory Plasma Glucose Result ( mmol/L ) o = Lot A Comparison of Meter to Laboratory Results Opr. 0.85x + 0.72 0.84x + 0.65 1.02x –...
  • Page 43: Multiple Site Testing Evaluation

    MULTIPLE SITE TESTING EVALUATION: Forty-one persons with diabetes, in steady state for glucose, performed self-capillary blood glucose assays using the Ascensia ® ™ System and one test strip lot (Lot A). A REEZE fingerstick was performed with the M Lancing Device. Samples from the palm, forearm, thigh and abdomen were obtained using the M Lancing Device.
  • Page 44 C. Results from Abdomen (n = 32) Ascensia Finger Stick Result (mmol/L) Comparison of Multiple Site to Fingertip Results Site Opr. Palm Forearm Abdomen Lay ‡ Thigh † Weighted Deming regression, weighted linear correlation coefficeint ‡One outlier excluded from statistics, but included in data plot Opr.
  • Page 45: Solving Problems

    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.
  • 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 Test result is below 0.6 mmol/L (10 mg/dL). Test result is above 33.3 mmol/L (600 mg/dL).
  • Page 47 What You See What It Means Low Battery icon flashes if battery power is low. 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.
  • Page 48 What You See What It Means Meter has detected an error; accurate test result not possible. Meter has detected an error; accurate test result not possible. There was a problem filling the test strip completely full. Your Blood Glucose Level is very high or meter error.
  • Page 49 What You See What It Means E11 or higher Meter Malfunction The display goes 1. You may have blank when the accidentally pressed meter is turned 2. 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.
  • Page 50 What You See What It Means Control Test • Control solution is past result is out of range (too high or too low). • 10-test disc is past • Deteriorated test strip • Control solution not at • Not enough control Meter shows Your meter may be dirty.
  • 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 Bayer Diabetes Helpline. We have friendly, knowledgeable people who are there to help 12 hours a day, 7 days a week (9 –...
  • Page 52: Replacement Items

    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 You can obtain these parts in Canada from: Bayer Inc. Healthcare Division 77 Belfield Road Toronto, Ontario M9W 1G6 Replacement Products...
  • Page 53: 5-year Limited Warranty

    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.
  • Page 54 Diabetes Helpline of Bayer Inc., by calling toll free 1-800-268-7200, for assistance and/or instructions for obtaining service of this instrument. /™ Bayer HealthCare LLC, used under license by Bayer Inc. ® ™ Meter when used with any Test Strip ®...
  • Page 55 Mishawaka, IN 46544 U.S.A. Bayer and Bayer Cross are registered trademarks of Bayer AG, used under license by Bayer Inc. 99A61189 Distributed by: Bayer Inc. Toronto, Ontario M9W 1G6 Canada © 2003 Bayer HealthCare LLC Made and Printed in U.S.A. Rev. 4/04...

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