Instruction/ maintenance manual of the product Ascensia Contour Blood Glucose Monitoring System Bayer HealthCare
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F or Use W ith Ascensia ™ C ONTOUR ™ Blood Glucose Meter and Ascensia ™ M ICROFILL ™ T est Strips U SER G UIDE Blood Glucose Monitoring System.
Thank you for choosing the Ascensia ™ C ONTOUR ™ Blood Glucose Monitoring System! W e are proud to be your partner in helping you manage your diabetes.
Y our Ascensia ™ C ONTOUR ™ Meter Screen: This is where your blood glucose result will display . Gray Electrode End: Insert this end of T est Strip into Meter . Sample End or Tip of T est Strip: Lightly touch this end of T est Strip to blood drop.
Ascensia ™ C ONTOUR ™ Meter Display Segments A. 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” into the T est Strip .
T able of Contents… Everyday Use T esting Y our Blood Glucose Level . . . . . . . . . . . . . . . . . . 4 Vi ewing Y our Stored T est Results . . . . . . . . . . . . . . . . . . . 8 Performing a Control T est . . . . . . . . . . . . . . . . . . . . .
2 Y our Ascensia ™ C ONTOUR ™ Meter… ❖ Easy to Use ❖ No Coding Required ❖ Small Blood Sample ❖ 15 Second T est Time ❖ Sleek Design Easy: The Ascensia C ONTOUR Blood Glucose Monitoring System is all about simplicity . Y ou’ll notice its noncomplicated approach the first time you see it.
Everyday Use Before Y ou Begin… A few things you should know: A) Gather your testing supplies: your Meter , T est Strips, Ascensia™ M ICROLET ® Adjustable Lancing Device, and lancets. B) W ash your hands thoroughly with warm soapy water and dry them well.
T esting Y our Blood Glucose Level… Insert T est Strip 1. Hold the round end of the T est Strip with the gray electrode side up, and insert the T est 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 T est Strip.
3. Insert lancet firmly until it comes to a full stop. This will “cock” the device. 4. T wist off lancet cap. 5. Replace the Endcap. 6. Press Ascensia™ M ICROLET ® Device firmly against puncture site and press button to release. Form a small drop of blood.
T est Blood Glucose 7. Bring tip of the T est Strip to lightly touch the drop of blood. Hold until the Meter beeps. Blood is automatically pulled into the T est Strip through the tip. The Meter will now begin counting down the 15 seconds until the test is complete.
Caution: Dispose of the used T est Strip and lancet carefully to pr event injury or contamination to others. J Helpful Hint: Y ou should always turn your Meter off by removing the T est 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.
V iewing Y our Stored T est Results… Recall T est Results and Y our 14-Day A verage Note: Y our Ascensia ™ C ONTOUR ™ 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.
Delete All T est 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. (Y our results will begin to scroll on the screen.
10 Performing a Control T est… There are times when you will want to do a quality Control T est so you know that your system is working properly . Y ou may also want to do a Control T est to check the way you perform a test.
Perform Control T est 3. Bring the tip of the T est 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 T est Strip firmly until it comes to a full stop. ❖ Y our Meter will turn off automatically after 3 minutes. ❖ Control T est results are automatically marked with a ✔ and will not be included in your 14-day average (see page 11).
13 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).
14 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 .
15 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 .
16 Tu rn the Beeper “On” or “Off” Y our Ascensia™ C ONTOUR ™ 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 .
17 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.
18 Installing Batteries… T wo 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).
19 Meter and T est Strip Care… ❖ W ash hands and dry thoroughly before handling to keep the Meter and T est Strips free of oils and other contaminants. ❖ Handle the Meter carefully to avoid damaging the electronics or causing other malfunctions.
20 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 Y ou See What it Means What Y ou Should Do Low battery Replace the batteries as soon as possible.
21 What Y ou See What it Means What Y ou Should Do HI T est result is above W ash your hands and test site. Repeat 33.3 mmol/L the test. If the test result is still (600 mg/dL) “HI,” contact your physician or healthcare p r ofessional (HCP) immediately .
22 Specifications T est Sample: Whole blood Te st Result: Referenced to plasma/serum glucose Reaction Chamber Sample V olume: 0.6 µL Measuring Range: 0.
Precision 1. Laboratory Precision: To assess the repeatability (within- run precision) of the Ascensia ™ C ONTOUR ™ Blood Glucose Monitoring System, 1 00 blood glucose readings (10 readings on each of 10 instruments) were obtained with venous blood specimens at five glucose concentrations.
24 Accuracy 1. Bayer Accuracy Evaluation: To assess the accuracy of the Ascensia™ C ONTOUR ™ System, 60 fresh fingerstick specimens from people with diabetes were tested with the Ascensia C ONTOUR System (12 – 14 readings per fingerstick) and the YSI 2300 ST A T Plus Glucose Analyzer .
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™ C ONTOUR ™ System.
fingerstick. Following the Ascensia™ C ONTOUR ™ 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 1.7 to 23.3 mmol/L with an average of 10.
27 B. Health Care Professional Results 0 5 10 15 20 25 30 05 1 0 1 5 20 25 30 Plasma Comparative Method Glucose Result (mmol/L) Ascensia C ONTOUR Result (mmol/L) Lot 22B Lot 22C Lot 23B Reagent 95% Confidence Interval Lot Opr . n y = Slope / Intercept r 22B Lay 50 1.
1 Carl Burtis and Edward Ashwood (eds.): T ietz T extbook of Clinical Chemistry . 3rd Ed., W .B. Saunders Co. Philadelphia, P A. 1999, p. 1827. Arterial Blood Evaluation (Effect of pO 2 : Performance with Arterial Specimens) An arterial specimen study was performed at a hospital site.
29 0 5 10 15 20 25 30 05 1 0 15 20 25 30 Plasma Comparative Method Result (mmol/L) Ascensia C ONTOUR Result (mmol/L) Lot 22B Lot 22C Lot 23B y=x Reagent 95% Confidence Interval Lot Opr . n y = Slope / Intercept r 22B HCP 34 1.00x – 0.01 0.84 to 1.15 –1.
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.
31 0 5 10 15 05 1 0 15 Plasma Comparative Method Result (mmol/L) Ascensia C ONTOUR Result (mmol/L) Lot 22B Lot 22C Lot 23B y=x Reagent 95% Confidence Interval Lot Opr . n y = Slope / Intercept r 22B HCP 106 1.05x – 0.15 1.00 to 1.11 –0.43 to – 0.
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 ™ System to measure each subject’ s capillary blood glucose.
33 Reagent 95% Confidence Interval Lot Opr . n y = Slope / Intercept r 22B HCP 56 0.90x + 0.15 0.85 to 0.97 –0.25 to 0.33 0.984 22C HCP 56 0.90x + 0.13 0.86 to 0.96 –0.19 to 0.41 0.988 23B HCP 56 0.89x + 0.21 0.85 to 0.94 –0.09 to 0.48 0.983 Opr .
Multiple Site T esting Evaluation Forty persons with diabetes, in steady state for glucose, performed self-capillary blood glucose assays using the Ascensia™ C ONTOUR ™ System and one reagent lot. A fingerstick was performed with the Ascensia™ M ICROLET ® Adjustable Lancing Device.
35 Alternate 95% Confidence Interval Site Opr . n y = Slope / Intercept r Palm Lay 40 1.00x – 0.06 0.95 to 1.07 –0.63 to 0.24 0.986 Forearm Lay 40 0.96x – 0.04 0.89 to 1.04 –0.73 to 0.72 0.973 Abdomen Lay 39 0.85x + 0.63 0.76 to 0.95 –0.09 to 1.
T ransfer T est Results to a Computer Y ou can transfer test results from the Ascensia ™ C ONTOUR ™ 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 ® (version 1.
Service If attempts to correct a problem fail, please call our Bayer Diabetes Helpline. W e have friendly , knowledgeable people who are there to help 12 hours a day , 7 days a week (9 a.
Supplies When calling or writing for supplies be sure to include the number with the name of the replacement part or accessory item. REPLACEMENT P ARTS Part Number* Item 40030030 3-volt Lithium Batter.
39 Wa rranty 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).
4. Bayer has no knowledge of the performance of the Ascensia™ C ONTOUR ™ Blood Glucose Meter when used with any T est Strips other than Ascensia™ M ICROFILL ™ T est Strips, and therefore makes.
© 2003 Bayer HealthCare LLC 99971529 Made and Printed in U.S.A. Rev . 6/03 Manufactured for: Bayer HealthCare LLC Mishawaka, IN 46544 USA Distributed by: Bayer Inc. Diagnostics Division T oronto, Ontario M9W 1G6 Bayer and Bayer Cross are registered trademarks of Bayer AG, used under license.
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