Blood Glucose Monitoring System UIDE For Use With Ascensia ™ ™ ONTOUR Blood Glucose Meter and Ascensia ™ ™ Test Strips ICROFILL...
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: •...
Your Ascensia ™ ONTOUR Note: Fold this page out for easy reference. Caution: Before using any product to test your blood glucose (sugar), read all instructions carefully and practice the test. ™ Meter Screen: This is where your blood glucose result will display.
Ascensia ™ 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”...
Table of Contents… Everyday Use Testing Your Blood Glucose Level Viewing Your Stored Test Results ....8 Performing a Control Test Helpful Hints ........12 Beyond Everyday Use Setting Time, Date and Other Features .
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.
Everyday Use Before You Begin… A few things you should know: A) Gather your testing supplies: your Meter, Test Strips, Ascensia™ M 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.
Testing Your Blood Glucose Level… Insert Test Strip Obtain Blood Drop 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...
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 ﬁrmly against puncture site and press button to release. Form a small drop of blood.
Test Blood Glucose 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 33.3 mmol/L (600 mg/dL) or below 0.6 mmol/L (10 mg/dL). Repeat test. If you receive the same result, call your physician or health care professional immediately.
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.
Viewing Your Stored Test Results… Recall Test Results and Your 14-Day Average Note: Your Ascensia™ C calculates a 14-day average for you based on your blood glucose readings over the past 14 days. Helpful Hint: The display will show three dashes if there are no blood glucose test results in the memory.
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 (Your results will begin to scroll on the screen.) While holding the the M Button until “dEL”...
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.
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.
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.
Beyond Everyday Use Setting Time, Date and Other Features… Helpful Hints: during Set-up by pressing and holding the M Button until the Meter turns off. the icons on the screen will ﬂash. This is an easy way to tell what item you are currently changing. scrolls in one direction when the scroll quickly, press and hold the Set the Time...
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 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 change the year, press To choose the day, press To enter the day and move on to turn the beeper “On”...
Turn the Beeper “On” or “Off” Your Ascensia™ C 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. Select “Units-of-Measure”...
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.
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). up with open slots, and close ﬁrmly.
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.
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 Low battery Temperature out...
What You See What it Means Test result is above 33.3 mmol/L (600 mg/dL) Control Test • Control Solution is result is out-of- past expiration date range (too high or is past the 3-month another Control Test. If still out-of- or too low).
Performance Evaluations (for Healthcare Professionals) Precision 1. Laboratory Precision: To assess the repeatability (within- run precision) of the Ascensia 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 within- Meter %CV at each level.
Normal Control Solution Reagent Operator Lay User Lay User Lay User High Control Solution Reagent Operator Lay User Lay User Lay User Accuracy 1. Bayer Accuracy Evaluation: To assess the accuracy of the Ascensia™ C 60 fresh ﬁngerstick specimens from people with diabetes were tested with the Ascensia C readings per ﬁngerstick) and the YSI 2300 STAT Plus Glucose Analyzer.
YSI Plasma Glucose Result (mmol/L) Passing and Bablok Regression Statistics / Pearson correlation 1.01x – 0.49 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. After reviewing the instructions, the users performed ﬁngersticks and glucose assays using the Ascensia™...
ﬁngerstick. Following the Ascensia™ C 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 1.7 to 23.3 mmol/L with an average of 10.1 mmol/L. The range of hematocrits was 28 to 55% with an average of 44%.
B. Health Care Professional Results Plasma Comparative Method Glucose Result (mmol/L) Lot 22B Passing and Bablok Regression Statistics / Pearson correlation Reagent Opr. Opr. = Operator; Lay = Lay User; HCP = Healthcare Professional Lot 22C Lot 23B 95% Conﬁdence Interval Slope 1.03x –...
Arterial Blood Evaluation (Effect of pO Performance with Arterial Specimens) An arterial specimen study was performed at a hospital site. Ascensia™ C ONTOUR compared to the site blood glucose method. The glucose concentration of the samples ranged from 3.1 to 24.0 mmol/L, with an average of 8.5 mmol/L.
Plasma Comparative Method Result (mmol/L) Lot 22B Passing and Bablok Regression Statistics / Pearson correlation Reagent Opr. Combined Opr. = Operator; HCP = Healthcare Professional Lot 22C Lot 23B 95% Conﬁdence Interval Slope 1.00x – 0.01 0.84 to 1.15 1.06x – 0.62 0.92 to 1.19 1.12x –...
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.
Plasma Comparative Method Result (mmol/L) Lot 22B Passing and Bablok Regression Statistics / Pearson correlation Reagent Opr. Combined Opr. = Operator; HCP = Healthcare Professional Lot 22C Lot 23B 95% Conﬁdence Interval Slope 1.05x – 0.15 1.00 to 1.11 1.03x – 0.09 0.98 to 1.08 1.13x –...
Altitude Evaluation Performance was evaluated at an altitude of 3,048 meters. Fifty-six samples were obtained from 54 different subjects with diabetes. Three reagent lots were used with the Ascensia™ C ONTOUR 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 Reagent Opr. Opr. = Operator; HCP = Healthcare Professional 95% Conﬁdence Interval Slope 0.90x + 0.15 0.85 to 0.97 0.90x + 0.13 0.86 to 0.96 0.89x + 0.21 0.85 to 0.94 Intercept –0.25 to 0.33 0.984 –0.19 to 0.41...
Multiple Site Testing Evaluation Forty persons with diabetes, in steady state for glucose, performed self-capillary blood glucose assays using the Ascensia™ C ONTOUR ﬁngerstick was performed with the Ascensia™ M Adjustable Lancing Device. Samples from the palm, forearm, thigh, and abdomen were then obtained, and those results were compared to the Ascensia C from the ﬁnger.
C. Results from the Abdomen Ascensia C Fingerstick Result (mmol/L) ONTOUR Passing and Bablok Regression Statistics / Pearson correlation Alternate Site Opr. Palm Forearm Abdomen Thigh Opr. = Operator; Lay = Lay User D. Results from the Thigh y = x 95% Conﬁdence Interval Slope 1.00x –...
Transfer Test Results to a Computer You can transfer test results from the Ascensia™ C ™ Meter ONTOUR to a computer, where they can be summarized in a report with graphs and tables. To make use of this feature, you need Ascensia™...
For the Controls, this information is printed on the bottle. __________________________________________ 1-800-268-7200 Blood Glucose Meter and ONTOUR Test Strips available when you phone. It ICROFILL...
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) 99971529 Ascensia™...
Warranty Manufacturer’s Warranty: Bayer Inc. Diagnostics 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.
For warranty service: Purchaser must contact the Bayer Diabetes Helpline of Bayer Inc., by calling toll free 1-800-268-7200, for assistance and/or instructions for obtaining service of this instrument. ™ Blood Glucose Meter when used ONTOUR ™ Test ICROFILL ™ Meter when ™...