Bayer HealthCare Ascensia Contour Blood Glucose Monitoring System User's Manual
Contents
1. ol Ascensia CONTOUR Blood Glucose Monitoring System i Bayer HealthCare M 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 e Ascensia MICROFILL Test Strips Use for blood glucose or control solution testing Come in handy bottle with an easy to open flip top lid e Ascensia MICROLET Adjustable Lancing Device Use for finger puncture with an Ascensia MICROLET Lancet e BATTERIES Uses two 3 volt CR2032 lithium batteries Replace when necessary For short simple instructions a quick reference guide is also provided for your convenience It can be useful when traveling 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 and change Set up features Scroll W Button Use to RO La Rea scroll through your blood glucose results in the memory mater 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 MICROFILL Test Strips Use for blood glucose or control solution testing Come in a2. 40 Manufactured for Bayer HealthCare Bayer HealthCare LLC Distributed by Mishawaka IN 46544 USA Bayer Inc Diagnostics Division Toronto Ontario M9W 1G6 Bayer and Bayer Cross are registered trademarks of Bayer AG used under license trademarks of Bayer HealthCare LLC used under license 2003 Bayer HealthCare LLC 99971529 Made and Printed in U S A Rev 6 03
3. what item you are currently changing The Meter always scrolls in one direction when the W Button is pressed To scroll quickly press and hold the W Button Set the Time To change the hour press W To enter the hour and move on to change the minutes press M To change the minutes press W 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 V To enter your choice and move on to select the year press M 14 Set the Date To change the year press W To enter the year and move on to choose the month press M To change the month press V To enter the month and move on to choose the day press M To choose the day press V 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 4 or Off amp press V To enter your beeper selection and move on to choose between the Units of Measure mmol L or mg dL press M Select Units of Measure Note Changing the Units of Measure changes the way you see your results A mmol L res
4. 101 1 03x 0 09 0 98 to 1 08 0 33 to 0 11 23B HCP 99 1 13x 0 46 1 05 to 1 21 0 80 to 0 11 Combined HCP 306 1 07x 0 21 1 03 to 1 10 0 36 to 0 07 Opr Operator HCP Healthcare Professional 31 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 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 The glucose range of the samples was 2 5 to 26 9 mmol L with an average concentration of 8 4 mmol L The hematocrit range was 38 to 60 with a mean of 48 30 7 yax 25 20 Ascensia CONTOUR Result mmol L a Cl 0 i i i i i i 0 5 10 15 20 25 30 Plasma Comparative Method Glucose Result mmol L o Lot 22B x Lot 22C Lot 23B 32 Passing and Bablok Regression Statistics Pearson correlation Reagent 95 Confidence Interval Lot y Slope Intercept 56 22B HCP 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 33 Multiple Site Testing Evaluation Forty persons with
5. can obtain these parts in Canada from Bayer Inc Diagnostics Division 77 Belfield Road Toronto Ontario M9W 1G6 Replacement Products Number Product Name 7081 Ascensia MICROFILL Test Strips box of 50 7091 Ascensia MICROFILL Test Strips box of 100 7100 Ascensia MICROFILL Normal Control Solution 7101 Ascensia MICROFILL Low and High Control Solutions 6540B Ascensia MICROLET Adjustable Lancing Device 6546A Ascensia MICROLET Lancets box of 100 6550A Ascensia MICROLET Lancets box of 200 Accessory items may be obtained from Diabetes Care Centers retail drug stores or other home healthcare distributors 38 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 Limitations of Warranty This warranty is subject to the following exceptions and limitations 1 A 90 day warranty only will be extended for consumable parts and or accessories 2 This warranty is limited to replacement due to defects in parts or workmanship Bayer shall not be required to replace any units which malfunction or are damaged due to abuse accidents alterat
6. 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 A Lay User Results ao oO N ol f I Ascensia CONTOUR Result mmol L a Plasma Comparative Method Glucose Result mmol L o Lot 22B x Lot 22C Lot 23B 26 B Health Care Professional Results Ascensia CONTOUR Result mmol L 30 25 20 15 20 25 30 Plasma Comparative Method Glucose Result mmol L o Lot 22B x Lot 22C Lot 23B Passing and Bablok Regression Statistics Pearson correlation Reagent 95 Confidence Interval Lot y Slope Intercept 1 03x 0 00 1 01x 0 28 1 07x 0 14 1 04x 0 08 1 00x 0 14 0 98x 0 20 0 93 to 1 15 0 91 to 1 11 1 00 to 1 16 0 99 to 1 10 0 95 to 1 04 0 94 to 1 05 1 17 to 0 85 1 22 to 0 61 0 79 to 0 45 0 47 to 0 39 0 23 to 0 54 0 27 to 0 62 Opr Operator Lay Lay User HCP Healthcare Professional 27 Arterial Blood Evaluation Effect of pO 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 3 1 to 24 0 mmol L with an average of 8
7. handy bottle with an easy to open flip top lid E Sample End or Tip of Test Strip _ Lightly touch this end of Test Strip to blood drop 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 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 m Aner am l H J 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 Test Strip Temperature Symbol If you see this on your screen you will know that it is either too cold or too hot for your Meter to test accurately Low Battery Symbol This is the symbol you will see when the battery life is low Replace batteries Control Marker This w is the Meter s way of telling you it has detected Control Solution Note The Y does not indicate the Control Test result is within the specified range Units of Measure Blood glucose results can be displayed either in millimole per liter mmol L or milligram per deciliter mg dL depending on the country where you live Average This A is used when disp
8. on the screen indicate that the number displayed is your 14 day blood glucose average Helpful Hint The display will show three dashes if there are no blood glucose test results in the memory 2 Press the W Button to access memory and scroll through your blood glucose results one by one You will see the most recent test result You may also press and hold this button to continuously scroll through the test results Your Meter can hold up to 240 test results When you reach the end of the test results End will be displayed The Meter will also beep You may press the W Button to view the 14 day average and the blood glucose test results again 3 Press the M Button to turn off your Meter 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 ie average A aces 2 Press and hold the W Button 7 i Your results will begin to scroll on the screen While holding the W 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 The Meter will now show you 3 dashes along with the A and 14d icons Your results have been deleted 4 Press the M Button to turn your Meter off Helpful Hint If you change your mind a
9. 0 12 Opr Operator HCP Healthcare Professional 29 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 The lots were rotated each day of sample collection over the duration of the evaluation Meter results were compared to laboratory glucose assay methods used at each of the sites Corning 860 Beckman LX20 Hitachi 917 analyzers Sample glucose concentrations ranged from 0 8 to 11 5 mmol L with an average of 4 6 mmol L The hematocrit range was 21 to 70 with an average of 48 3 A pO was obtained with 116 samples The range was 33 to 499 mm Hg with an average of 126 9 mm Hg A bilirubin assay was performed with 283 samples The range was 3 4 to 319 8 umol L with an average of 95 8 pmol L 30 Ascensia CONTOUR Result mmol L 0 5 10 15 Plasma Comparative Method Result mmol L o Lot 22B x Lot 22C Lot 23B Passing and Bablok Regression Statistics Pearson correlation Reagent 95 Confidence Interval Lot y Slope Intercept 22B HCP 106 1 05x 0 15 1 00 to 1 11 0 43 to 0 04 22C HCP
10. 5 mmol L The sample hematocrit range was 22 to 58 with an average of 39 The pO values ranged from 43 to 205 mm Hg with an average of 104 mm Hg The reference range for arterial pO is 83 to 108 mm Hg 11 1 to 14 4 kPa Mean biases were 2 9 at pO concentrations lt 83 mm Hg n 33 Mean pO 71 mm Hg 2 5 at pO concentrations between 83 to 108 mm Hg n 40 Mean pO 94 mm Hg and 0 8 at pO concentrations gt 108 mm Hg n 38 Mean pO 143 mm Hg Two samples had glucose concentrations lt 4 2 mmol L and the bias was calculated as an absolute difference rather than a percentage These samples had biases of 0 06 mmol L and 0 44 mmol L pO values were 80 and 112 mm Hg respectively 1 Carl Burtis and Edward Ashwood eds Tietz Textbook of Clinical Chemistry 3rd Ed W B Saunders Co Philadelphia PA 1999 p 1827 28 y x dor 25 20 Ascensia CONTOUR Result mmol L a da tx 0 i i i l i i i i i i 0 5 10 15 20 25 30 Plasma Comparative Method Result mmol L o Lot 22B x Lot 22C Lot 23B Passing and Bablok Regression Statistics Pearson correlation Reagent 95 Confidence Interval Lot y Slope Intercept 22B HCP 1 00x 0 01 0 84 to 1 15 1 08 to 1 04 22C HCP 20 1 06x 0 62 0 92 to 1 19 1 48 to 0 42 23B HCP 39 1 12x 1 22 1 00 to 1 24 1 96 to 0 31 Combined HCP 113 1 08x 0 70 1 00 to 1 15 1 23 to
11. ARNING Keep batteries away from children Lithium batteries are poisonous If swallowed immediately contact your physician or poison control center Discard batteries according to your local environmental regulations 18 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 Wipe dry with lint free tissue after cleaning Caution Do not allow solution to run down or in around the buttons Doing so may cause a malfunction Store Meter in the carrying case provided or a replacement case of your choice whenever possible Warning Potential Biohazard Health care professionals or persons using this system on multiple patients should be aware of the following and should follow the infection control procedure approved by their facility All products or objects which come in contact with human blood even after cleaning should be handled as if capable of transmitting viral diseases The user should follow the recommendations for prevention of blood borne transmissible diseases i
12. Control Test result with the range printed on the Test Strip bottle label This range also appears on the bottom of the test strip box along with the ranges for the Low and High Controls If the control test result falls outside of the control range see Solving Problems page 21 Helpful Hint The Ascensia CONTOUR Meter automatically recognizes and marks a Control Test result for you You will notice that this has been done by the check mark W displayed on the screen This way your Control Test results will not be included in your 14 day blood glucose average Note The Y does not indicate the Control Test result is within the specified range Turn Meter Off Dispose of Used Test Strip n f f 4 To turn your Meter off simply remove the Test Strip The ou marked Control Result will automatically be stored in memory Dispose of the used Test Strip 11 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 Y and will not be included in your 14 day average see page 11 Note The y does not indicate the Control Test result is within the specified range You may mark any result you obtain by pressing the W Button before you remove the Test Strip Remember that marking a result means that it will not be included in your 14 day average When your Me
13. 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 Ascensia MICROLET Adjustable Lancing Device Samples from the palm forearm thigh and abdomen were then obtained and those results were compared to the Ascensia CONTOUR results obtained from the finger One subject was unable to obtain a sample from the abdomen The blood glucose range from the fingerstick measurements was 2 7 to 22 6 mmol L with an average of 9 2 mmol L The hematocrit range was 36 to 52 with an average of 42 A Results from the Palm Ascensia CONTOUR Palm Result mmol L 34 30 7 25 4 20 Ascensia CONTOUR Fingerstick Result mmol L B Results from the Forearm Ascensia CONTOUR Forearm Result mmol L 30 25 204 Ascensia CONTOUR Fingerstick Result mmol L C Results from the Abdomen D Results from the Thigh 30 y X 2 254 E a 20 T CA S 5 x Di a lt f a S a g ee 3 10 e Pa Pa ao o a g 54 n lt BS 0 t t t t t 1 0 10 15 20 25 30 Ascensia CONTOUR Fingerstick Result mmol L 30 y x 2 254 E E Li n 204 A cc 7 e 15 A oe S 9 10 He s a of o A o a ao 4 5 as 0 r i 0 10 15 20 25 30 Ascensia CONTOUR Fingerstick Result mmol L Passing and Bablok Regression Statistics P
14. e 1 800 268 7200 open use date e Deteriorated Test Strip due to heat cold or exposure to moisture e Control Solution not at room temperature Some display Possible meter elec Replace batteries If display is segments do tronics or battery fail still incorrect call the Bayer not appear ure Compare display Diabetes Helpline 1 800 268 7200 during self test with picture on inside This may affect the way you of Front Cover see your results 21 Specifications Test Sample Test Result Reaction Chamber Sample Volume Measuring Range Measuring Time Memory Feature Battery Type Battery Life Operating Temperature Range Humidity Dimensions Weight Alarm CE Certification 22 Whole blood Referenced to plasma serum glucose 0 6 uL 0 6 33 3 mmol L 10 600 mg dL 15 seconds Stores most recent 240 test results Two 3 volt lithium batteries DL or CR2032 Approximately 1000 Tests 1 year of average use 50 104 F 10 40 C 10 93 RH 74mm H x 53mm W x 17 3mm T 2 oz 52 3 grams Beeps whenever a Test Strip is inserted into the Meter when the Test Strip is filled with blood or Control Solution and when a test result appears in the display Two beeps will sound for an error This device conforms to Directive 98 79 EC on in vitro diagnostic medical devices Performance Evaluations for Healthcare Professionals Laboratory Precision To a
15. earson correlation Alternate Site y 40 Palm Forearm Abdomen Thigh 1 00x 0 06 0 96x 0 04 0 85x 0 63 0 97x 0 23 Opr Operator Lay Lay User 95 Confidence Interval a Slope 0 95 to 1 07 0 89 to 1 04 0 76 to 0 95 0 88 to 1 07 Intercept 0 63 to 0 24 0 73 to 0 72 0 09 to 1 14 0 95 to 0 34 35 Transfer Test Results to a Computer You can transfer test results from 222 m the Ascensia CONTOUR Meter to a computer where they can be summarized in a report with graphs and tables i To make use of this feature you need Ascensia WinGlucofacts 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 Use of any other software package can result in erroneous results For more information contact the Bayer Diabetes Helpline 1 800 268 7200 or visit our website at www ascensia ca 36 If attempts to correct a problem fail please call our Bayer Diabetes Helpline We 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 Cl Speak to a Customer Service Representative before returning your Meter for any reason He she will give you the information needed t
16. et 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 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 Turn Meter Off Dispose of Used Test Strip 9 To turn your Meter off simply remove the used Test Strip Your test result will automatically be stored in memory Caution Dispose of the used Test Strip and lancet carefully to prevent injury or contamination to others hie ascens if of TORPE i ri 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 Multiple Site Testing Blood samples for glucose testing may be taken from sites other than your fingertips Multiple site
17. ion misuse neglect maintenance by other than Bayer or failure to operate the instrument in accordance with instructions Further Bayer assumes no liability for malfunction or damage to Bayer instruments caused by the use of reagents other than reagents i e Ascensia MICROFILL Test Strips manufactured or recommended by Bayer 3 Bayer reserves the right to make changes in design of this instrument without obligation to incorporate such changes into previously manufactured instruments 39 4 Bayer 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 M Test Strips or when the Ascensia MICROFILL Test Strip is altered or modified in any manner BAYER MAKES NO OTHER EXPRESS WARRANTY FOR THIS PRODUCT THE OPTION OF REPLACEMENT DESCRIBED ABOVE IS BAYER S ONLY OBLIGATION UNDER THIS WARRANTY Limitations of Capability IN NO EVENT SHALL BAYER BE LIABLE FOR INDIRECT SPECIAL OR CONSEQUENTIAL DAMAGES EVEN IF BAYER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES 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
18. laying the 14 day average Date Format The date can be displayed either as month day m d or as day month d m depending on the country where you live Date The month and day are displayed here Beeper This picture will tell you if the beeper is on or off Time The hour minutes and AM PM are displayed here Results Errors This is the area where your test results or any possible error codes will be displayed Table of Contents Everyday Use Testing Your Blood Glucose Level 4 Viewing Your Stored Test Results 8 Performing a Control Test 10 Helpful Hints LL 12 Beyond Everyday Use Setting Time Date and Other Features 13 Installing Batteries 18 Meter and Test Strip Care 2 0 eee ees 19 Solving Problems cipria ttd nan in aDi i 20 SPECIFICALIONS 05 sartoria 22 Performance Evaluations PRECISION cosina ea Ae irta 23 ACUTI Sareri iagugadatudi ip 24 Multiple Site Testing Evaluation 34 Transfer Test Results to a Computer 36 SOVICO atriale eee 37 SUDDIICS ssiipueve troie Ert pre E 38 NUON suuserisegia badare 39 The Ascensia CONTOUR Blood Glucose Monitoring System Meter Test Strips and Controls is intended for self testing by persons with diabetes and by healthcare professionals to monitor the level of glucose in whole blood The Ascensia CONTOUR System is specific for glucose and has been referenced to plas
19. ma serum glucose values 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 Automatic The designers of the Ascensia CONTOUR Meter have worked very hard to make your life a little easier You no longer have to worry about coding the Meter it s automatic or marking a Control Test result it s automatic too The Ascensia CONTOUR Meter will even automatically tell you if a Test Strip is underfilled Makes Sense Your new Ascensia CONTOUR Meter just makes sense You ll find features that customers just like you asked for Practical features like a 15 second test time a very small blood sample size and a simple testing procedure make the Ascensia CONTOUR Meter your Meter Convenient The Meter s small size sleek design and ease of use means you ll take it everywhere with you Your Ascensia CONTOUR Meter takes up about as much room in your pocket or bag as your key ring You ll have it with you and will be more likely to test more often which can mean better control of your diabetes Everyday Use Before You Begin A few things you should know A Gather your
20. n healthcare settings as recommended for potentially infectious human blood specimens in National Committee for Clinical Laboratory Standards Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissues Approved Guideline NCCLS Document M29 A ISBN 1 56238 339 6 NCCLS 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 1997 This document has complete information on the topic of user protection and can be used as background material for instruction 19 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 WhatitMeans What You Should Do Low battery Replace the batteries as soon as possible Temperature out Test only when the Meter tempera of range ture is between 50 F and 104 F 10 C and 40 C J Ega Test Strip underfill Remove the Test Strip and repeat the Ega test with a new Test Strip Used Test Strip Replace Test Strip with a new unused Test Strip Wait until you see the flashing blood drop before you add blood sample E4 n Test Strip not Remove the Test Strip and insert it Ca inserted correctly properly See pg 4 E 5 and above All other errors When you see the letter E followed by a number that is not listed here remove Test Strip and retest with a
21. nd decide that you do not wish to delete all of the test results while the dEL and ALL icons are alternating on the display simply press any button and the test results will not 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 Hold the round end of the Test Strip with the gray electrode side Up and insert it in the Meter until it stops The Meter will run a quick self test and then you will see a flashing drop on the screen This is your signal to apply Control Solution Prepare Control Drop 2 Squeeze a small drop of Control Solution on a clean nonabsorbent surface such as a clean piece of wax paper Do not apply Control Solution to the Test Strip directly from the bottle 10 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
22. new Test Strip If you continue to experience difficulty call the Bayer Diabetes Helpline 1 800 268 7200 The display e Meter will turn off e Insert new Test Strip to test press goes blank after 3 minutes of the M Button when the inactivity This fea meter is ture prolongs your turned on battery life OR OR e The battery may e Replace the batteries if needed need to be replaced Test result is below Repeat test If LO appears again 0 6 mmol L 10 mg dL contact your healthcare professional HCP immediately CAUTION Glucose levels below 2 8 mmol L 50 mg dL may indicate a potentially serious medical condition What You See What it Means What You Should Do Test result is above Wash 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 professional HCP immediately CAUTION Glucose levels above 13 9 mmol L 250 mg dL may indicate a potentially serious medical condition Control Test e Control Solution is Check all expiration dates Do not result is out of past expiration date use expired testing materials Run range too high or is past the 3 month another Control Test If still out of or too low open use date range retest with a new Test Strip e Test Strip is past and Control Solution If still out of expiration date or is range call the Bayer Diabetes past the 6 month Helplin
23. o get your problem handled correctly and efficiently Have your Ascensia CONTOUR Blood Glucose Meter and Ascensia MICROFILL Test Strips available when you phone It would also be helpful to have a bottle of Ascensia MICROFILL Normal Control Solution nearby Fill out the following check list before calling Check List 1 The Meter serial number found on the back of the meter is 2 The date and time the problem occurred was 3 have read the user guide and followed the testing steps 4 am using Control Solution and Test Strips that have not expired or passed their open use life dates 5 do not need to replace the batteries 6 Please include the Lot number and expiration date of the Test Strips and Controls being used For the Test Strips this information is printed on the carton as well as on the back of each bottle For the Controls this information is printed on the bottle 37 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 CONTOUR User Guide 50184257 Ascensia CONTOUR Quick Reference Guide 3479 Ascensia Data Cable 3420C Ascensia WinGlucofacts Diabetes Management Software Part numbers are subject to change without notice Cable included You
24. perator n mmol L mmol L 35 3 9 76 4 4 HCP n 1 Lay User n 51 HCP n 4 Lay User n 53 HCP n 5 Lay User n 104 Accuracy 1 Bayer Accuracy Evaluation To assess the accuracy of the Ascensia CONTOUR System 60 fresh fingerstick specimens from people with diabetes were tested with the Ascensia CONTOUR System 12 14 readings per fingerstick and the YSI 2300 STAT Plus Glucose Analyzer The glucose concentration of the samples ranged from 2 5 to 25 2 mmol L with an average of 8 4 mmol L The range of hematocrits was 32 to 49 with an average of 40 24 Ascensia CONTOUR Result mmol L 0 5 10 15 20 25 30 YSI Plasma Glucose Result mmol L Passing and Bablok Regression Statistics Pearson correlation 95 Confidence Interval y Slope Intercept 746 1 01x 0 49 1 00 to 1 03 0 58 to 0 39 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 After reviewing the instructions the users performed fingersticks and glucose assays using the Ascensia CONTOUR System Two reagent lots were evaluated at each clinic one was common to both sites After the user s self test the attending HCP performed Ascensia CONTOUR System assays from the lay user s 25 fingerstick Following the Ascensia CONTOUR System assays a blood sample was
25. ssess the repeatability within run 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 within Meter CV at each level Mean 2 6 mmol L 5 1 mmol L 8 0 mmol L 13 1 mmol L 20 9 mmol L 2 Control Testing Precision Precision results were obtained from duplicate assays of Control Solutions at two diabetes clinics with the Ascensia CONTOUR System Testing was performed over 63 days People with diabetes and healthcare professionals HCP at each clinic evaluated two reagent lots One lot was evaluated at both clinics The tables below show the combined results for the lay users and HCPs The overall standard deviations SD and coefficients of variation CV include the within run and between run day variations Low Control Solution Duplicate a ua Reagent Assays Mean Lot Operator n mmol L alb 4 35 HCP n 1 Lay User n 51 HCP n 4 Lay User n 53 HCP n 5 Lay User n 104 23 Normal Control Solution Duplicate Overall Overall Reagent Assays Mean SD CV Lot Operator n mmol L mmol L 35 3 8 76 3 HCP n 1 Lay User n 51 HCP n 4 Lay User n 53 HCP n 5 Lay User n 104 High Control Solution Duplicate Overall Overall Reagent Assays Mean SD CV Lot O
26. ter has 240 results in memory and you perform another test the Meter will keep the most recent result taken This will replace the oldest result taken When using a Test Strip Always check the expiration date on the Test Strip bottle or box If the Test Strips have expired replace with new Test Strips Always use Test Strips within 6 months 180 days after opening bottle Don t forget to write the first opening date in the space provided on the bottle label To be sure the Test Strip fills completely lightly touch the Test Strip end to the blood drop or Control Solution drop until the Meter beeps Capillary action will automatically sip the blood or Control Solution into the Test Strip Test Strips can not be reused The Ascensia CONTOUR Meter has been designed for use with Ascensia MICROFILL Test Strips only Do not use any other Test Strips with the Ascensia CONTOUR Meter 12 Beyond Everyday Use in 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 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 This is an easy way to tell
27. 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 B A BAYER E R Sip in Sampling Automatic Sensor filling Action F DO NOT drop blood directly on flat surface of the Test Strip Your Test Strip is designed to easily sip the blood into the Test Strip WARNING Do not change your medication based on Ascensia CONTOUR results without the advice of your physician or healthcare professional Testing Your Blood Glucose Level Insert Test Strip i d A JA ih r 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 2 Remove the Endcap from the Ascensia MICROLET Device See package insert for Ascensia MICROLET Adjustable Lancing i Device for complete instructions for T obtaining a blood drop 3 Insert lancet firmly until it comes to a full stop This will cock the device 4 Twist off lanc
28. testing using blood from the forearm palm abdomen or thigh may give glucose results that significantly differ from fingertip blood Differences occur when blood glucose levels are changing rapidly such as after a meal after insulin and with exercise We recommend the following 1 Use a fingertip sample for testing blood glucose whenever you will be participating in risky activities such as before driving a car or operating machinery 2 If you have hypoglycemic unaware ness you do not recognize the symp toms of or cannot tell when you have low blood sugar Multiple Site Testing is not recommended Please consult with your Healthcare Professional if you have low blood glucose levels 3 Select a soft fleshy area of skin that is free from hair and visible veins for Multiple Site Sampling 4 Consult your Healthcare Professional to determine if Multiple Site Testing is right for you 5 Use Multiple sampling sites for blood glucose tests only when it is more than 2 hours after a meal more than two hours after taking medication or more than two hours after exercise 7 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
29. ult looks like this 5 3 with a decimal point A mg dL result looks like this 95 no decimal point To choose the Units of Measure press V a mmol L millimoles per liter Or m g dL mg dL milligrams per deciliter To enter the Units of Measure and move on to choose between a 12 hour or 24 hour clock press M 16 Select 12 hour or 24 hour Clock To choose the 12 or 24 hour clock press V 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 W 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 Slide cover back into place lining Up swith open ue and close firmly Test results stored in the memory are not erased when batteries are changed The date units of measure and other formatting choices do not need to be reset W
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