Bayer HealthCare Ascensia Contour User Manual
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Bayer HealthCare Ascensia Contour User Manual

Bayer HealthCare Ascensia Contour User Manual

Blood glucose monitoring system
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Blood Glucose Monitoring System
U
G
SER
UIDE
For Use With
Ascensia
®
C
™
ONTOUR

Blood Glucose Meter

and Ascensia
®
M
™
Test Strips
ICROFILL

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Summary of Contents for Bayer HealthCare Ascensia Contour

  • Page 1: Blood Glucose Meter

    Blood Glucose Monitoring System UIDE For Use With Ascensia ® ™ ONTOUR Blood Glucose Meter and Ascensia ® ™ Test Strips ICROFILL...
  • Page 2 Thank you for choosing the Ascensia ® Blood Glucose Monitoring ™ ONTOUR System! We are proud to be your partner in helping you manage your diabetes. Our goal is to make this the simplest, most straightforward Meter you’ll ever use. Additional Materials: •...
  • Page 3 Your Ascensia ® Meter ™ ONTOUR Screen: This is where your blood glucose result will display. Memory ( M ) Button: Use to view results stored in the memory, your 14-day average and change Set-up features. Scroll ( ) Button: Use to scroll through your blood glucose results in the memory and change Set-up features.
  • Page 4 Ascensia Meter ® ™ ONTOUR Display Segments A full display, as shown here, indicates that all characters in the display are working properly. You will briefly see this display each time the Meter turns on. Compare your Meter to the display shown here. If there is a difference, see Solving Problems, page 21. Apply Sample: When your Meter is ready for you to apply a sample of blood or control solution, it will show you this picture of a blood drop being “sipped”...

  • Page 5: Table Of Contents

    Table of Contents… Everyday Use Testing Your Blood Glucose Level ....4 Viewing Your Stored Test Results ....8 Performing a Control Test .
  • Page 6 Your Ascensia Meter… ® ™ ONTOUR Easy to Use No Coding Required Small Blood Sample 15 Second Test Time Sleek Design Easy: The Ascensia C Blood Glucose Monitoring ONTOUR System is all about simplicity. You’ll notice its noncomplicated approach the first time you see it. Simple things—like the use of two simple buttons and a clear display—are sure to make this your favorite Meter right from the start.

  • Page 7: Everyday Use

    Everyday Use Before You Begin… A few things you should know: A) Gather your testing supplies: your Meter, Test Strips, Ascensia M Adjustable Lancing Device, and ICROLET lancets. B) Wash your hands thoroughly with warm soapy water and dry them well. C) Avoid excessive “milking”...

  • Page 8: Testing Your Blood Glucose Level

    Testing Your Blood Glucose Level… Insert Test Strip 1. Hold the round end of the Test Strip with the gray electrode side up, and insert the Test Strip into the Meter until it stops. The Meter will run a quick self-test and then prompt you to apply blood by showing you a picture of a...
  • Page 9 3. Insert lancet firmly until it comes to a full stop. This will “cock” the device. 4. Twist off lancet cap. 5. Replace the Endcap. 6. Press Ascensia M Device ICROLET firmly against puncture site and press button to release. Form a small drop of blood.
  • Page 10 Test Blood Glucose 7. Bring tip of the Test Strip to lightly touch the drop of blood. Hold until the Meter beeps. Blood is automatically pulled into the Test Strip through the tip. The Meter will now begin counting down the 15 seconds until the test is complete.
  • Page 11 Caution: Dispose of the used Test Strip and lancet carefully to prevent injury or contamination to others. Helpful Hint: You should always turn your Meter off by removing the Test Strip following a test. This will conserve your battery power. However, if you forget to turn the Meter off, the meter will turn itself off after three minutes.

  • Page 12: Viewing Your Stored Test Results

    Viewing Your Stored Test Results… Recall Test Results and Your 14-Day Average Note: Your Ascensia C Meter automatically calculates ONTOUR a 14-day average for you based on your blood glucose readings over the past 14 days. 1. Press the M Button. This will turn your Meter on and display your 14-day average.
  • Page 13 Delete All Test Results If you wish to delete all test results, follow these simple steps: 1) Press the M Button to turn your Meter on and display your 14-day average. 2) Press and hold the Button. (Your results will begin to scroll on the screen.) While holding the Button, press and hold the M Button until “dEL”...

  • Page 14: Performing A Control Test

    Performing 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 perform a test.
  • Page 15 Perform Control Test 3. Bring the tip of the Test Strip to lightly touch the drop of Control Solution. Control Solution is automatically pulled into the strip through the tip. Hold until the Meter beeps. The Meter will now begin counting down the 15 seconds until the test is complete.

  • Page 16: Helpful Hints

    Helpful Hints… When using the Meter… Insert the Test Strip firmly until it comes to a full stop. Your Meter will turn off automatically after 3 minutes. Control Test results are automatically marked with a will not be included in your 14-day average (see page 11). Note: The does not indicate the Control Test result is within the specified range.

  • Page 17: Beyond Everyday Use Setting Time, Date And Other Features

    Beyond Everyday Use Setting Time, Date and Other Features… To start, press and hold the M Button until you see the time displayed. While you are holding the M Button, the Meter will run a quick self-test (full display shown) and then enter the Set-up mode (time display shown).
  • Page 18 To change the minutes, press To enter the minutes and move on to choose between AM and PM, press M. Note: the PM option is not available when using the 24-hour clock format. To choose between AM and PM, press To enter your choice and move on to select the year, press M.
  • Page 19 Set the Date To change the year, press To enter the year and move on to choose the month, press M. To change the month, press To enter the month and move on to choose the day, press M. To choose the day, press To enter the day and move on to turn the beeper “On”...
  • Page 20 Turn the Beeper “On” or “Off” Your Ascensia C Meter will also let you turn the ONTOUR beeper “On” or “Off.” Be aware that if you turn the beeper off, you may miss important cues from your Meter—such as the two beeps that occur when you get an error. To turn the beeper “On”...
  • Page 21 Select 12-hour or 24-hour Clock To choose the 12- or 24-hour clock, press To enter your choice, press the M Button. Select Date Format To choose the way you see the date, (m/d or d.m) press To enter your choice, press the M Button.

  • Page 22: Installing Batteries

    Installing Batteries… Two 3-volt lithium batteries (size 2032) come already installed in your Meter. Batteries should be replaced when the Meter continually displays the battery symbol. Note: After replacing batteries, you will need to reset the time (see page 13). 1.

  • Page 23: Meter And Test Strip Care

    Meter and Test Strip Care… Wash hands and dry thoroughly before handling to keep the Meter and Test Strips free of oils and other contaminants. Handle the Meter carefully to avoid damaging the electronics or causing other malfunctions. Avoid exposing Meter and Test Strip to excessive humidity, heat, cold, dust, or dirt.

  • Page 24: Solving Problems

    Solving Problems… If you see the letter “E” followed by a number, or if your Meter beeps twice, an error has occurred. The following chart gives you a list of possible errors and describes what they mean. What You See What it Means What You Should Do Low battery...
  • Page 25 What You See What it Means What You Should Do Test result is above Wash your hands and test site. Repeat 600 mg/dL the test. If the test result is still (33.3 mmol/L) “HI,” contact your physician or healthcare professional (HCP) immediately.

  • Page 26: Specifications

    Specifications Test Sample: Whole blood Test Result: Referenced to plasma/serum glucose Reaction Chamber Sample Volume: 0.6 µL Measuring Range: 10 – 600 mg/dL (0.6 –33.3 mmol/L) Measuring Time: 15 seconds Memory Feature: Stores most recent 240 test results Battery Type: Two 3-volt lithium batteries (DL or CR2032) Battery Life:...

  • Page 27: Performance Evaluations

    Performance Evaluations (for Healthcare Professionals) Precision 1. Laboratory Precision: To assess the repeatability (within- run precision) of the Ascensia Blood Glucose ® ™ ONTOUR Monitoring System, 100 blood glucose readings (10 readings on each of 10 instruments) were obtained with venous blood specimens at five glucose concentrations.

  • Page 28: Accuracy

    Normal Control Solution Duplicate Overall Overall Reagent Assays Mean Operator (n = ) (mg/dL) (mg/dL) (n = 1) 119.6 4.58 Lay User (n = 51) 120.6 3.90 (n = 4) 122.0 3.23 Lay User (n = 53) 122.3 4.88 (n = 5) 120.9 3.04 Lay User...
  • Page 29 YSI Plasma Glucose Result (mg/dL) Passing and Bablok Regression Statistics / Pearson correlation 95% Confidence Interval Slope Intercept 1.01x – 8.42 1.00 to 1.02 –10.05 to –7.00 0.992 2. Professional / Lay User Evaluation A Patient Use evaluation was conducted at two diabetes clinics.
  • Page 30 Following the Ascensia C System assays, a blood ONTOUR sample was collected for comparative laboratory glucose and hematocrit determinations. The glucose concentration of the samples from the two sites ranged from 31 to 420 mg/dL with an average of 182 mg/dL. The range of hematocrits was 28 to 55% with an average of 44%.
  • Page 31 B. Health Care Professional Results Plasma Comparative Method Glucose Result (mg/dL) Lot 22B Lot 22C Lot 23B Passing and Bablok Regression Statistics / Pearson correlation 95% Confidence Interval Reagent Opr. Slope Intercept 1.03x – 0.05 0.93 to 1.15 –21.16 to 15.28 0.947 1.01x –...
  • Page 32 Arterial Blood Evaluation (Effect of pO Performance with Arterial Specimens) An arterial specimen study was performed at a hospital site. Ascensia C results from arterial samples were ONTOUR compared to the site blood glucose method. The glucose concentration of the samples ranged from 55 to 432 mg/dL, with an average of 153 mg/dL.
  • Page 33 Plasma Comparative Method Glucose Result (mg/dL) Lot 22B Lot 22C Lot 23B Passing and Bablok Regression Statistics / Pearson correlation 95% Confidence Interval Reagent Opr. Slope Intercept 1.00x – 0.25 0.84 to 1.15 –19.39 to 18.82 0.909 1.06x – 11.08 0.92 to 1.19 –26.67 to 7.60 0.952...
  • Page 34 Neonatal Blood Evaluation (Performance with Neonatal / Hospitalized Infant Samples) Neonatal samples (n = 306) were collected from routine, intermediate care, and intensive care nurseries at three sites. The infants ranged in age from less than one day to 5 months (11 wks.
  • Page 35 Plasma Comparative Method Result (mg/dL) Lot 22B Lot 22C Lot 23B Passing and Bablok Regression Statistics / Pearson correlation 95% Confidence Interval Reagent Opr. Slope Intercept 1.05x – 2.74 1.00 to 1.11 –7.67 to –0.75 0.958 1.03x – 1.59 0.98 to 1.08 –5.92 to –1.98 0.975 1.13x –...
  • Page 36 Altitude Evaluation Performance was evaluated at an altitude of 10,000 ft. Fifty-six samples were obtained from 54 different subjects with diabetes. Three reagent lots were used with the Ascensia C System to measure each subject’s capillary ONTOUR blood glucose. After performing the Meter assays, additional capillary blood was collected for a comparative blood glucose (Yellow Springs Instruments Analyzer) and hematocrit determination.
  • Page 37 Passing and Bablok Regression Statistics / Pearson correlation 95% Confidence Interval Reagent Opr. Slope Intercept 0.90x + 2.78 0.85 to 0.97 –4.59 to 5.91 0.984 0.90x + 2.39 0.86 to 0.96 –3.41 to 7.43 0.988 0.89x + 3.84 0.85 to 0.94 –1.70 to 8.73 0.983 Opr.

  • Page 38: Multiple Site Testing Evaluation

    Multiple Site Testing Evaluation Forty persons with diabetes, in steady state for glucose, performed self-capillary blood glucose assays using the Ascensia C System and one reagent lot. A fingerstick ONTOUR was performed with the Microlet Adjustable Lancing Device. Samples from the palm, forearm, thigh, and abdomen were obtained using the Ascensia™...
  • Page 39 C. Results from the Abdomen D. Results from the Thigh Ascensia C Fingerstick Result (mg/dL) Ascensia C Fingerstick Result (mg/dL) ONTOUR ONTOUR Passing and Bablok Regression Statistics / Pearson correlation 95% Confidence Interval Alternate Site Opr. Slope Intercept Palm 1.00x – 1.00 0.95 to 1.07 –11.43 to 4.26 0.986...

  • Page 40: Transfer Test Results To A Computer

    Transfer Test Results to a Computer You can transfer test results from the Ascensia C Meter to a ONTOUR computer, where they can be summarized in a report with graphs and tables. To make use of this feature, you need Ascensia™ WinGlucofacts ®...

  • Page 41: Service

    1-800-348-8100 (24 hours a day). We have trained specialists to help you. Important: Speak to a Bayer HealthCare Representative before returning your Meter for any reason. He/she will give you the information needed to get your problem handled correctly and efficiently.

  • Page 42: Supplies

    ® ONTOUR 3479 Ascensia™ Data Cable These parts are available in the United States from: Bayer HealthCare LLC Customer Service Department Order Entry P. O. Box 2004 Mishawaka, Indiana 46546 or call 1-800-348-8100 to order *Part numbers are subject to change without notice...
  • Page 43 ACCESSORY ITEMS Product Code Number Item 7080 Ascensia ™ Test Strips (50) ® ICROFILL 7090 Ascensia ™ Test Strips (100) ® ICROFILL 7100 Ascensia ™ Normal Control ® ICROFILL 7101 Ascensia ™ Low and High Controls ® ICROFILL 3416 Ascensia™ M ®...

  • Page 44: Warranty

    (i.e., Ascensia ™ Test Strips) ® ICROFILL manufactured or recommended by Bayer HealthCare. 3. Bayer HealthCare reserves the right to make changes in design of this instrument without obligation to incorporate such changes into previously manufactured instruments.
  • Page 45 4. Bayer HealthCare has no knowledge of the performance of the Ascensia ® ™ Blood Glucose Meter when ONTOUR used with any Test Strips other than Ascensia M ICROFILL Test Strips, and therefore makes no warranty of the performance of the Ascensia C...
  • Page 46 Bayer HealthCare LLC Mishawaka, IN 46544 www.bayercarediabetes.com www.ascensia.com © 2003 Bayer HealthCare LLC 99971519 Made and Printed in U.S.A. Rev. 6/03...

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