Bayer HealthCare Blood Glucose Monitoring System manuale d’uso

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. Our goal is to make this the simplest, most straightforward Meter you’ll ever use. Additional Materials: • Ascensia ™ M ICROFILL ™ T est Strips— Use for blood glucose or control soluti[...]

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. Memory ( M ) Button: Use to view results stored in the memory and change Set-up features. Scroll ([...]

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 . B. T emperature Symbol: If you see this on your screen, you will know that it is either too cold or too hot for you[...]

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 . . . . . . . . . . . . . . . . . . . . . . . . 10 Helpful Hints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 B[...]

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. Simple things—like the use of two simple b[...]

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. C) A void excessive “milking” of your finger when forming a drop of blood. D) T est [...]

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. Obtain [...]

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. 5[...]

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. 8. Leave the T est Strip in the Meter until the test result appears on the display .[...]

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. M[...]

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. This will turn your Meter on and display your 14-day average. Note: The “A” and “[...]

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.) While holding the ▼ Button, press and hold the M Button until “dEL” appears 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. Before you begin, gather your testing supplies: your Meter , T est Strips and a bottle of Ascensia ™ M ICROFILL ™ Contr[...]

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. Leave the T est Strip in the Meter until the Control T est res[...]

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). Note: The ✔ does not indicate the Control T est result [...]

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). J Helpful Hints: ❖ Y ou may turn the Meter off at any time during[...]

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 . To turn the beeper “On” or “Off” , press ▼ . To enter your [...]

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.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 [...]

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). 1. Press firmly on battery cover and slide in the direction of the arrow to [...]

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. ❖ A void exposing Meter and T est Strip to excessive humidity , heat, cold, dust, or dirt. ❖ T[...]

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. E 1 T emperature out T est only [...]

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 . CAUTION: Glucose levels above 13.9 mmol/L (250 mg/dL) may indicate a potentially serious me[...]

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: 0.6 – 33.3 mmol/L (10 – 600 mg/dL) Measuring Time: 15 seconds Memory Feature: Stores most recent 240 test results Battery T ype: Tw o 3-volt lithium batteries (DL or CR2032) Battery Life: Approx[...]

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. The following table summarizes the mean and pooled wit[...]

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 . The glucose concentration of the samples ranged from 2.[...]

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. T wo reagent lots were evaluated at each cli[...]

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 10.1 mmol/L. The range of hematocrits was 28 to 55% with an average of 44%. 2[...]

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 1.03x – 0.00 0.93 to 1.15 –1.17 to 0.85 0.947 HCP 50 1.01x – 0.28 0.91 to 1.11[...]

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. Ascensia™ C ONTOUR ™ results from arterial samples were comp[...]

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 –1.08 to 1.04 0.909 22C HCP 40 1.06x – 0.62 0.92 to 1.19 –1.48 to 0.42 0.952 23B HCP 39 1.1[...]

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. premature birth). The median age was two days. Nine venous, 176 capillary an[...]

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 – 0.04 0.958 22C HCP 101 1.03x – 0.09 0.98 to 1.08 –0.33 to – 0.11 0.975 23B HCP 99 1.13x – 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. After performing the Meter assays, additional capillary blood was collecte[...]

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 . = Operator; HCP = Healthcare Professional Passing and Bablok Regression Statistics / Pearson co[...]

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. Samples from the palm, forearm, thigh, and abdomen were the[...]

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 1.14 0.958 Thigh Lay 40 0.97x – 0.23 0.88 to 1.07 –0.95 to 0.34 0.962 Opr . = Operator; Lay [...]

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 1.3 or higher) or Ascensia™ WinGlucofacts ® Professional software (version 3.01 [...]

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.m.– 9 p.m. EST). In Canada, call toll free: 1-800-268-7200 Important: ■ ■ Speak to a Customer Service Representative before returning your Meter for any reas[...]

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 Battery (DL or CR2032) — 2 (Available at most camera stores) 99971529 Ascensia ™ C ONTOUR ™ User Guide 50184257 Ascensia ™ C ONTOUR ™ Quick Refere[...]

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). During the stated 5-year period, Bayer shall, at no charge, replace a unit found[...]

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 no warranty of the performance of the Ascensia™ C ONTOUR ™ Meter when used with any T est Strips other than Ascensia™ M ICROFILL ™ T est Stri[...]

© 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. ® /™ trademarks of Bayer HealthCare LLC, used under l[...]