Blood Glucose Monitoring System USER GUIDE For Use With Ascensia® CONTOUR ™ Blood Glucose Meter and Ascensia® MICROFILL ™ Test Strips
Thank you for choosing the Ascensia® CONTOUR™ Blood Glucose Monitoring 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: • Ascensia® MICROFILL™ Test Strips—Use for blood glucose or control solution testing. Supplied in a handy bottle with an easy-to-open flip-top lid. • Ascensia™ MICROLET ® Adjustable Lancing Device—Use for finger puncture with Ascensia™ MICROLET ® Lancet.
Your Ascensia® CONTOUR ™ Meter 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. Data Port: Allows Meter to communicate with a personal computer via a cable. Test Strip Slot: This is where you insert the Test Strip. Gray Electrode End: Insert this end of Test Strip into Meter.
Ascensia® CONTOUR™ Meter 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. B A D F C } } { { H E G { { K { I J A.
Table of Contents… Everyday Use Testing Your Blood Glucose Level . . . . . . . . . . . . . . . . . . 4 Viewing Your Stored Test Results . . . . . . . . . . . . . . . . . . . 8 Performing a Control Test . . . . . . . . . . . . . . . . . . . . . . . . 10 Helpful Hints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Beyond Everyday Use Setting Time, Date and Other Features . . . . . . . . . . . . . . 13 Installing Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Your Ascensia® CONTOUR™ Meter… ❖ Easy to Use ❖ No Coding Required ❖ Small Blood Sample ❖ 15 Second Test Time ❖ Sleek Design Easy: The Ascensia CONTOUR Blood Glucose Monitoring 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.
Everyday Use Before You Begin… A few things you should know: A) Gather your testing supplies: your Meter, Test Strips, Ascensia MICROLET Adjustable Lancing Device, and lancets. B) Wash your hands thoroughly with warm soapy water and dry them well. C) Avoid excessive “milking” of your finger when forming a drop of blood. D) Test immediately after forming a drop of blood on your finger. E) DO NOT press Test Strip firmly against the finger. F) DO NOT drop blood directly on flat surface of the Test Strip.
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 blood drop being “sipped” into the Test Strip. Obtain Blood Drop 2. Remove the Endcap from the Ascensia™ MICROLET ® Device.
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 MICROLET Device firmly against puncture site and press button to release. Form a small drop of blood.
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. 8. Leave the Test Strip in the Meter until the test result appears on the display. Caution: If you see “HI” or “LO” displayed, your blood glucose level may be above 600 mg/dL (33.3 mmol/L) or below 10 mg/dL (0.6 mmol/L). Repeat test.
Caution: Dispose of the used Test Strip and lancet carefully to prevent injury or contamination to others. JHelpful 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. Multiple Site Testing Blood samples for glucose testing may be taken from sites other than your fingertips.
Viewing Your Stored Test Results… Recall Test Results and Your 14-Day Average Note: Your Ascensia CONTOUR Meter automatically calculates 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. Note: The “A” and “14d” icons on the screen indicate that the number displayed is your 14-day blood glucose average.
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” appears on the screen (this will take about 3 seconds). 3) Release both buttons. “dEL” and “ALL” will now alternate on the screen 5 times and all test results will be deleted.
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. Before you begin, gather your testing supplies: your Meter, Test Strips and a bottle of Ascensia® MICROFILL™ Control Solution. Insert Test Strip 1. Hold the round end of the Test Strip with the gray electrode side up, and insert it in the Meter until it stops.
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. Leave the Test Strip in the Meter until the Control Test result appears on the display. Compare your Normal Control Test result with the range printed on the Test Strip bottle label.
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 ✔ and 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. ❖ You may mark any result you obtain by pressing the ▼ Button before you remove the Test Strip.
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). J Helpful Hints: ❖ You may turn the Meter off at any time during Set-up by pressing and holding the M Button until the Meter turns off. ❖ You will notice that during Set-up, one of the icons on the screen will flash.
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.
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” or “Off,” press M.
Turn the Beeper “On” or “Off” Your Ascensia CONTOUR Meter will also let you turn the 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” “Off” , press ▼. or To enter your beeper selection and move on to choose between the Units-of-Measure (mg/dL or mmol/L), press M. Select “Units-of-Measure” Note: Changing the Units-of-Measure changes the way you see your results.
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. When you have reached the end of Set-up, your Meter will show you all of the current settings and turn off automatically.
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. Press firmly on battery cover and slide in the direction of the arrow to open the cover. 2. Place new batteries under the blue prongs and into the battery compartment with the “+” side up.
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. ❖ The exterior of the Meter can be cleaned using a moist (not wet) lint-free tissue with a mild detergent or disinfectant solution, such as 1 part bleach mixed with 9 parts water.
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 Replace the batteries as soon as possible. E1 Temperature out of range Test only when the Meter temperature is between 50°F and 104°F (10°C and 40°C). E2 Test Strip underfill Remove the Test Strip and repeat the test with a new Test Strip.
What You See What it Means What You Should Do HI Test result is above 600 mg/dL (33.3 mmol/L) Wash your hands and test site. Repeat the test. If the test result is still “HI,” contact your physician or healthcare professional (HCP) immediately. CAUTION: Glucose levels above 250 mg/dL (13.9 mmol/L) may indicate a potentially serious medical condition. Control Test result is out-ofrange (too high or too low). • Control Solution is past expiration date or is past the 3-month open use date.
Specifications Test Sample: Test Result: Reaction Chamber Sample Volume: Measuring Range: Measuring Time: Memory Feature: Battery Type: Battery Life: Whole blood Referenced to plasma/serum glucose 0.6 µL 10 – 600 mg/dL (0.6 –33.3 mmol/L) 15 seconds Stores most recent 240 test results Two 3-volt lithium batteries (DL or CR2032) Approximately 1000 Tests (1 year of average use) Operating Temperature Range: 50º– 104ºF (10º– 40ºC) Humidity: 10 – 93% RH Dimensions: 74mm (H) x 53mm (W) x 17.3mm (T) Weight: 2 oz.
Performance Evaluations (for Healthcare Professionals) Precision 1. Laboratory Precision: To assess the repeatability (withinrun precision) of the Ascensia® CONTOUR ™ Blood Glucose Monitoring System, 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 withinMeter %CV at each level. Mean %CV 46 mg/dL 2.4% 92 mg/dL 2.5% 144 mg/dL 2.8% 235 mg/dL 3.1% 376 mg/dL 2.
Normal Control Solution Reagent Lot 22B 22C 23B Operator HCP Lay User HCP Lay User HCP Lay User (n = 1) (n = 51) (n = 4) (n = 53) (n = 5) (n = 104) Duplicate Assays (n = ) Mean (mg/dL) Overall SD (mg/dL) Overall CV (%) 35 76 39 78 74 154 119.6 120.6 122.0 122.3 120.9 120.1 4.58 3.90 3.23 4.88 3.04 3.67 3.8 3.2 2.6 4.0 2.5 3.1 Duplicate Assays (n = ) Mean (mg/dL) Overall SD (mg/dL) Overall CV (%) 35 76 39 78 74 154 337.2 341.5 351.9 351.2 345.6 324.8 13.28 14.94 8.98 11.16 10.41 9.44 3.9 4.
Ascensia CONTOUR Result (mg/dL) 600 y=x 500 400 300 200 100 0 0 100 200 300 400 500 YSI Plasma Glucose Result (mg/dL) 600 Passing and Bablok Regression Statistics / Pearson correlation 95% Confidence Interval n y= Slope 746 1.01x – 8.42 1.00 to 1.02 / Intercept r –10.05 to –7.00 0.992 2. Professional / Lay User Evaluation A Patient Use evaluation was conducted at two diabetes clinics. Lay users with diabetes were given product instructions with no training.
Following the Ascensia CONTOUR System assays, a blood 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%. A.
B. Health Care Professional Results Ascensia CONTOUR Result (mg/dL) 600 y=x 500 400 300 200 100 0 0 100 200 300 400 500 600 Plasma Comparative Method Glucose Result (mg/dL) Lot 22B Lot 22C Lot 23B Passing and Bablok Regression Statistics / Pearson correlation Reagent Lot 22B 22C 23B 95% Confidence Interval Opr. n y= Lay HCP Lay HCP Lay HCP 50 50 51 51 101 101 1.03x – 0.05 1.01x – 5.07 1.07x – 2.58 1.04x – 1.37 1.00x + 2.60 0.98x + 3.62 Slope 0.93 0.91 1.00 0.99 0.95 0.
Arterial Blood Evaluation (Effect of pO2: Performance with Arterial Specimens) An arterial specimen study was performed at a hospital site. Ascensia CONTOUR results from arterial samples were 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. The sample hematocrit range was 22 to 58%, with an average of 39%. The pO2 values ranged from 43 to 205 mm Hg, with an average of 104 mm Hg.
Ascensia CONTOUR Result (mg/dL) 600 y=x 500 400 300 200 100 0 0 100 200 300 400 500 600 Plasma Comparative Method Glucose Result (mg/dL) Lot 22B Lot 22C Lot 23B Passing and Bablok Regression Statistics / Pearson correlation 95% Confidence Interval Reagent Lot Opr. n 22B 22C 23B Combined HCP HCP HCP HCP 34 40 39 113 y= 1.00x 1.06x 1.12x 1.08x – – – – 0.25 11.08 21.93 12.54 Slope 0.84 0.92 1.00 1.00 to to to to 1.15 1.19 1.24 1.15 / Intercept r –19.39 to 18.82 –26.67 to 7.
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. premature birth). The median age was two days. Nine venous, 176 capillary and 121 arterial samples were evaluated with the Ascensia CONTOUR Blood Glucose Monitoring System using three reagent lots.
Ascensia CONTOUR Result (mg/dL) 300 y=x 250 200 150 100 50 0 0 50 100 150 200 250 300 Plasma Comparative Method Result (mg/dL) Lot 22B Lot 22C Lot 23B Passing and Bablok Regression Statistics / Pearson correlation 95% Confidence Interval Reagent Lot Opr. n 22B 22C 23B Combined HCP HCP HCP HCP 106 101 99 306 y= 1.05x 1.03x 1.13x 1.07x – – – – Slope 2.74 1.59 8.22 3.73 1.00 0.98 1.05 1.03 to to to to 1.11 1.08 1.21 1.10 / Intercept –7.67 –5.92 –14.41 –6.51 to to to to –0.
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 CONTOUR System to measure each subject’s capillary blood glucose. After performing the Meter assays, additional capillary blood was collected for a comparative blood glucose (Yellow Springs Instruments Analyzer) and hematocrit determination.
Passing and Bablok Regression Statistics / Pearson correlation 95% Confidence Interval Reagent Lot Opr. n y= Slope 22B 22C 23B HCP HCP HCP 56 56 56 0.90x + 2.78 0.90x + 2.39 0.89x + 3.84 0.85 to 0.97 0.86 to 0.96 0.85 to 0.94 / Intercept r –4.59 to 5.91 –3.41 to 7.43 –1.70 to 8.73 0.984 0.988 0.983 Opr.
Multiple Site Testing Evaluation Forty persons with diabetes, in steady state for glucose, performed self-capillary blood glucose assays using the Ascensia CONTOUR System and one reagent lot. A fingerstick was performed with the Microlet Adjustable Lancing Device. Samples from the palm, forearm, thigh, and abdomen were obtained using the Ascensia™ MICROLET VACULANCE ® Lancing Device. Ascensia CONTOUR results from the multiple sites were compared to those obtained from the finger.
C. Results from the Abdomen D. Results from the Thigh y=x 600 y=x Ascensia CONTOUR Thigh Result (mg/dL) Ascensia CONTOUR Abdomen Result (mg/dL) 600 500 400 300 200 100 500 400 300 200 100 0 0 0 100 200 300 400 500 600 0 Ascensia CONTOUR Fingerstick Result (mg/dL) 100 200 300 400 500 600 Ascensia CONTOUR Fingerstick Result (mg/dL) Passing and Bablok Regression Statistics / Pearson correlation 95% Confidence Interval Alternate Site Opr.
Transfer Test Results to a Computer You can transfer test results from the Ascensia CONTOUR Meter to a computer, where they can be summarized in a report with graphs and tables. To make use of this feature, you need Ascensia™ WinGlucofacts ® software (version 1.3 or higher) or Ascensia™ WinGlucofacts ® Professional software (version 3.01 or higher), and an Ascensia™ Data Cable. Caution: The Ascensia CONTOUR Meter cannot be used with any other software except software supplied by Bayer HealthCare.
Service If attempts to correct a problem fail, please contact our Customer Service Department. In the U.S.A., call toll free: 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. ■ Have your Ascensia CONTOUR Blood Glucose Meter and Ascensia MICROFILL Test Strips available when you phone.
Supplies When calling or writing for supplies be sure to include the number with the name of the replacement part or accessory item. REPLACEMENT PARTS Part Number* Item 40030030 3-volt Lithium Battery (DL or CR2032) — 2 (Available at most Camera Stores) 99971519 Ascensia® CONTOUR ™ User Guide 50184256 Ascensia® CONTOUR ™ Quick Reference Guide 3479 Ascensia™ Data Cable These parts are available in the United States from: Bayer HealthCare LLC Customer Service Department Order Entry P. O.
ACCESSORY ITEMS Product Code Number Item 7080 Ascensia® MICROFILL™ Test Strips (50) 7090 Ascensia® MICROFILL™ Test Strips (100) 7100 Ascensia® MICROFILL™ Normal Control 7101 Ascensia® MICROFILL™ Low and High Controls 3416 Ascensia™ MICROLET VACULANCE ® Lancing Device 6540B Ascensia™ MICROLET ® Adjustable Lancing Device 6546B Ascensia™ MICROLET ® Lancets (100) 6550B Ascensia™ MICROLET ® Lancets (200) 3420C Ascensia™ WinGlucofacts ® Diabetes Management Software* *Cable included Accessory items may be obtaine
Warranty Manufacturer’s Warranty: Bayer HealthCare 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 HealthCare shall, at no charge, replace a unit found to be defective with an equivalent or current version of the owner’s model. Limitations of Warranty: This warranty is subject to the following exceptions and limitations: 1.
4. Bayer HealthCare has no knowledge of the performance of the Ascensia® CONTOUR ™ Blood Glucose Meter when used with any Test Strips other than Ascensia MICROFILL Test Strips, and therefore makes no warranty of the performance of the Ascensia CONTOUR Meter when used with any Test Strips other than Ascensia MICROFILL Test Strips or when the Ascensia MICROFILL Test Strip is altered or modified in any manner. BAYER HEALTHCARE MAKES NO OTHER EXPRESS WARRANTY FOR THIS PRODUCT.
Bayer HealthCare LLC Mishawaka, IN 46544 www.bayercarediabetes.com www.ascensia.com 99971519 © 2003 Bayer HealthCare LLC Made and Printed in U.S.A. Rev.
