USER GUIDE - Healthy Outcomes
Contents
1. endcap dial in the other hand Snap the endcap off from top to bottom ots CS i O Need Help Call toll free 1 800 348 8100 Loosen the round Insert the lancet firmly Twist off the round Replace the solid protective cap ona lancet by rotating tt 1 4 turn but do not remove it into the lancing device until it comes to a full stop protective lancet cap Save it for disposing of the used lancet color endcap www bayerdiabetes com us Getting Ready to Test 15 Q D mp Q AJ D amp Q lt mp O D N mp 16 NOTE Your CONTOUR USB meter Vi codes itself every time you insert a test Eh strip so you do not have to worry about e getting inaccurate results due to miscoding or forgetting to code your meter 6 Remove a test strip from the bottle Tightly close the bottle lid immediately after you have removed the test strip NOTE Check the expiration date Make sure the test strip does not appear torn or damaged 7 Hold the test strip with the gray end facing up 8 Insert the gray end into the test strip port on the meter After the meter turns on a solid gray screen with a white border will appear for one second to show that the screen is working properly The CONTOUR USB logo screen will briefly appear before the Apply Blood screen The meter is now ready to test a blood drop Need Help Call toll free 1 800 348 81002. Getting the Blood Drop For fingertip testing Use the 1 Rotate the endcap dial amp ray to adjust the puncture endcap depth The amount of pressure applied to the puncture site also af fects puncture depth Puncture Puncture 2 Press the endcap firmly against the puncture site and press the blue release button with the Bayer logo 3 Stroke your hand and finger towards the puncture site to form a drop of blood Do not squeeze around the puncture site 4 Test immediately after you have formed a small round blood drop 0 6 ul Minimum Drop Size www bayerdiabetes com us Getting the Blood Drop 17 If you selected fingertip testing turn to page Alternative Site Testing Use the 22 to continue reading testing instructions AST is recommended Clear For Alternative Site Testing AST only when it is more than endcap two hours after a meal IMPORTANT Do not use Alternative Site diabetes medication Testing under the following conditions Use or exercise fingertip testing in any of these cases 1 Attach the clear f you think your blood glucose is low AST endcap to the hypoglycemia MICROLET 2 lancing When blood glucose is changing rapidly device after a meal insulin dose or exercise lf you have hypoglycemic unawareness lack of symptoms 2 Select a puncture site from a fleshy area on f you get alternative site blood glucose forearm or palm Avoid veins hair moles bones results t
3. millimoles of glucose per liter Results in mg dL will never have a decimal point Results in mmol L will always have a decimal point 937 o 5 2 Check your screen to ensure that results are being displayed in mg dL If they are not contact Bayer Diabetes Care Customer Service 1 800 348 8100 Example Before You Begin Testing 1 Have your testing materials ready including your CONTOUR USB meter CONTOUR test strips and the MICROLET 2 lancing device with MICROLET lancets You may also need CONTOUR control solution to run a quality control check 2 Wash your hands and puncture site thoroughly with warm soapy water and dry them well before testing www bayerdiabetes com us O O O aa O gt Q i O et Q aa 13 Q D mp Q AJ D 23 Q lt mp O D N mp 14 Getting Ready to Test Read the MICROLET 2 insert for complete instructions If you are using a different lancing device refer to those instructions For Alternative Site Testing instructions see page 18 Potential Biohazard The MICROLET 2 lancing device is designed for self testing by a single patient It must not be used on more than one person due to the risk of infection Use a new MICROLET lancet each time you test because it is no longer sterile after use 1 To remove the endcap hold the device with 4 your thumb on the grip Q indent and hold the a
4. D S D 40 Menu Button To turn on the meter press and hold the Menu button until the meter turns on The Main Menu has 3 choices Logbook Trends and Setup Select one by pressing ajija the button next to your choice To go back a screen press the Menu button once To turn the meter off press and hold the Menu button for 2 seconds To turn the test strip port light on with the meter off press the Menu button twice with one second between each press Press the Menu button twice to turn the light off Logbook To access the Logbook press the Logbook button from the Main Menu In Logbook you can scroll EMEI through all the stored rues test results in memory 18 38 AM by pressing the A or V button Before Meal Need Help Call toll free 1 800 348 8100 END OF LOGBOOK The most recent result is shown first and the 10713709 oldest result last When i you reach the oldest entry WALL you will see the End of Logbook screen Your meter will store 2000 test results Trends 1 Press the Trends button to view averages MENU Logbook Trends Setup 14 days is the default To change the averages to 7 or 30 days plug the meter into your computer and set using GLUCOFACTS Deluxe software If AutoLog is on the TRENDS default Before Meal 7 130 and 7 After Meal target Baba F700 180 ranges will appear To set personalized target ranges see page 48
5. PT the OK button T After Testing amp 1 Press the Reminder button 2 Press the A or Y m button to select the ee 16 36 AM 3 11 5 minutes Minutes 3 hrs m S 902 Reminder change in 15 minute D Mates increments Press the a Before Meal OE button 2 Press the Start button to begin the countdown A screen confirms Bomindor in a The default time is 2 hours or the last reminder the Reminder 3 hours 15 minutes 5 time that was set countdown time 7 Y a3 REMINDER PEEP 35 25 COUNTDOWN Z oa Change The meter will return to 10 30 AM 3711 ED O 2 hrs ar the test result screen emai When the Reminder sole aed Nat s You can change the Reminder countdown time to feature is on the clock the time you wish by pressing the Change button symbol is in the blue REMINDER Start header PAREMO m 3 Remove the test strip from the meter 2 hrs Go Back The meter retains the Reminder time that you set y as the default 32 Need Help Call toll free 1 800 348 8100 www bayerdiabetes com us 33 Jopuiwmay e Huiy s SO ON pue AJ i E 2 i 7 34 From the Setup Menu 1 Go to the Main Menu Press the Setup button MENU Logbook Trends Setup 2 If Reminder is set to off press the OK button to change the Reminder settings 3 To start the countdown press the Start button or press the Change button to scroll to a different countdown time Follow
6. advice values are 75 to 110mg dL fasting You should fine diately ae consult with your healthcare provider for If your blood sugar reading is over expected values specific to your needs 250 mg dL repeat the test If you get a similar result call your healthcare High and Low Blood Sugar Alert Screens professional immediately Do not change your medication based on CONTOUR USB blood sugar results without the advice of your healthcare professional If your blood sugar reading is under 20 mg dL the normal Immediately screen sequence will E23 appear for 5 seconds The Follow Medical Advice Immediately screen will then display and the meter will beep twice Follow Medical Advice If your blood sugar reading Is over Wash hands or test 600 mg dL the normal site Repeat test with screen sequence will cer NEW Strip display for 5 seconds and the next screen will tell you to retest The meter will beep twice f results are still over 6 600 mg dL Follow Follow Medical Advice Medical Advice Immediately Immediately is displayed G amp 1 Harrison s Principles of Internal Medicine 17th Ed 2008 Need Help Call toll free 1 800 348 8100 www bayerdiabetes com us N om N 9 aa e O 27 D N P AJ D N a 28 High and Low Blood Sugar Readings Your meter has been preset with a hypoglycemic low blood sugar value of 70 mg dL and a hyper glycemic high
7. device straight up and away from the skin without smearing the blood Do not test the blood sample from palm or forearm if you get Smeared blood Clotted blood Runny blood Clear fluid mixed with the blood www bayerdiabetes com us Q O im Q pe O 2 aa Q amp Ee Q o 21 D N ct a d w O O A 22 Collecting Your Blood Drop 1 Immediately touch the tip of the test strip to the drop of blood The blood is drawn into the test strip tip 2 Hold the tip of the test strip in the blood drop until the meter beeps Do not press the tip against the skin or place the blood on top of the test strip Forearm NOTE If you do not APPLY BLOOD apply blood to the test strip in 1 minute the meter screen will dim and the meter beeps Press any button and the Apply Blood screen will become active again After a total of 3 minutes of inactivity the meter turns off Need Help Call toll free 1 800 348 8100 Testing with AutoLog On Before your test result is displayed the AutoLog screen appears Select Before Meal 7 After Meal or No Mark by pressing the button next to it Your test result will not display until you make a selection However if your result is a low blood sugar result or high blood sugar result you will always see your result in 5 seconds UTOLOG AUTOLO Before Meal Y After Meal Your meter features a 5 TESTING second test ti
8. 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 Diabetes Care 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 Diabetes Care shall not be required to replace any units which malfunction or are damaged due to abuse accidents alteration misuse neglect maintenance by someone other than Bayer Diabetes Care or failure to operate the instrument in accordance with instructions Further Bayer Diabetes Care assumes no liability for malfunction or damage to Bayer Diabetes Care instruments caused by the use of reagents other than reagents i e CONTOUR test strips manufactured or recommended by Bayer Diabetes Care 3 Bayer Diabetes Care reserves the right to make changes in design of this instrument without obligation to incorporate such changes into previously manufactured instruments 62 Need Help Call toll free 1 800 348 8100 4 Bayer Diabetes Care has no knowledge of the performance of the CONTOUR USB blood glucose meter when used with any test strips other than CON
9. sO T 5 9 ab es 7p jeaowisay Hbulbieyg snjyeis Aloyeg pue UOI 99 0g 10119 ieviuyoaL N D S O oO Ro O o Battery Charging When you plug your meter into your wall changer or computer it will start to charge immediately While the battery charges the strip port light flashes slowly Press the Menu button at any time to display the charging status Rapid Charge lf the battery is low when you plug in your meter it will Rapid Charge for about 1 minute You can run a blood sugar test as soon as Rapid Charge is complete Normal Charging When Rapid Charge ends normal charging is expected to last up to 2 hours When the battery is full the strip port light turns off NOTE A high power USB port will allow you to access GLUCOFACTS Deluxe and your meter s extra memory It also allows the shortest charging time If the charging status displays Low Power Charging your CONTOUR USB meter may not be plugged into a high power USB port Please try a different USB port on your computer If you are unsure whether your computer has a high power USB port please check with your computer user manual or the computer manufacturer Do Not Test 52 Need Help Call toll free 1 800 348 8100 Extra Memory Your meter contains 500 MB extra memory for your personal use It appears on your computer as a Removable Disk when you insert your meter into the USB port You can use this memory w
10. screen shows AUTOLOG Accept that AutoLog Is on Status On Turn Off AutoLog lets you mark a test as Before Meal or After Meal during the 5 second test time To turn AutoLog off see page 47 Need Help Call toll free 1 800 348 8100 The next screen displays UHIE Accept the default blood sugar 70 130 target range for _ y 70 180 Before Meal and 7 After Meal blood sugar These values can be changed to the range you and or your healthcare professional decide are your personal target ranges You can accept the default ranges or change them by pressing the Change button see page 48 Change A screen confirms your target Is set Setup is complete You may now check your blood sugar Testing in the Dark Your meter has a lighted test strip port to help you test in the dark With the meter off press the Menu button twice with one second between each press to turn on the test strip port light Insert a test strip and the display screen will appear Once blood is applied to the test strip the light will go off Continue with your test Two quick presses of the Menu button will turn the light off www bayerdiabetes com us Q N z O e N O N Q fee 14 SS N 11 3 TS O amp p Q N mp O on O 12 Important Things to Know gt Always keep the test strips in the original bottle Tightly close the bottle im
11. seconds To turn on the test strip port light with the meter off press the Menu button twice with one second between each press Press the Menu button twice to turn the light off To go back to the www bayerdiabetes com us o 5 en gt O he c D mp D O lt lt D Introducing AutoLog Your meter comes with a GMOT simple AutoLog feature that lets you mark your test result as Before Meal or After Meal during the 5 second test countdown You can select No Mark if you are testing at times other than before or after a meal Your meter comes with AutoLog turned on We recommend that you keep this feature turned on to get the most benefit from your meter features AutoLog can be turned off in Setup Before Meal Y After Meal No Mark To Run a Blood Sugar Test Read user guide and all instructional materials provided in your meter kit before testing To test insert the CONTOUR test strip and the meter will turn on Follow the on screen prompts Remove the test strip to turn the meter off Extra Memory Your meter contains 500 MB extra memory GLUCOFACTS Deluxe software and extra memory require a high power USB port For more details see page 53 Need Help Call toll free 1 800 348 8100 We encourage you to plug your meter into com outers with current anti virus software installed and running NOTE Computer virus
12. the instructions on the previous page COUNTDOWN Change iis ee Go Back Need Help Call toll free 1 800 348 8100 A screen confirms the Reminder in Reminder time set 2 hours When the Reminder SETUP feature is on the clock symbol is in the blue Date header lime www bayerdiabetes com us Setting a Reminder N dm O Oo O a and Notes 35 J puiW y e JO Buluiny SO ON pue AJ i E 2 i 7 36 Turning Off a Reminder A Reminder can be turned off or changed after testing or from the Setup menu After Testing 1 Press the Reminder button 16 36 AM 3 11 677 Before Meal Notes lf the countdown is currently on the screen will read Reminder In with the remaining amount of time displayed 2 To stop the Countdown press the Stop button G REMINDER Stop REMINDER In 1 hr 40 mins docs Go Back A screen confirms Reminder is stopped your choice The Countdown is now stopped and the clock symbol will disappear Need Help Call toll free 1 800 348 8100 From the Setup Menu 1 Press the OK button SETUP Date Time h 2 Press the Stop button The countdown is now stopped The Reminder screen displays the remaining time Turning Off a Reminder G REMINDER Stop REMINDER IN 1 hr 40 mins a Go Back A screen confirms Reminder is stopped your choice Reminders and Notes www bayerdiabetes com
13. you can immediately begin testing You can also change these settings later Need Help Call toll free 1 800 348 8100 Quickstart Customize allows you to adjust settings By default AutoLog Is on Target is set to Before Meal 70 130 mg dL After Meal 70 180 mg dL These settings can be changed in Setup Help provides additional information Initial Startup Using Quickstart Press the Quickstart button Customize Quickstart A screen confirms Quickstart is selected your choice The next screen has the current date and time If it is correct press the Accept button If incorrect press the Change button see pages 43 45 CURRENT DATE amp TIME 3 17 09 Accept 10 30 AM Change Setup is complete You may now check your blood sugar www bayerdiabetes com us E S gt V we N Q E gt wlan N a 5 A N T D C N 5 Q O m E O 3 N D 10 Initial Startup Using Customize Press the Customize button to change the default settings Customize Quickstart A screen confirms Customize is selected your choice The next screen has the current date and time If it is correct press the Accept button If incorrect press the Change button see pages 43 45 CURRENT DATE amp TIME 3 11 09 Accept 10 30 AM Change A screen confirms the date and time are set The next
14. B A BAYER E R Contour USO BLOOD GLUCOSE MONITORING SYSTEM Reminder Before Meal Notes USER GUIDE USES BAYER S CONTOUR BLOOD GLUCOSE TEST STRIPS www bayerdiabetes com us TABLE OF CONTENTS Your CONTOUR USB Blood Glucose Monitoring System 2 Meter Overview 4 GLUCOFACTS Deluxe Data Management Software 7 Initial Startup 8 Important Things to Know 12 Before You Begin Testing 13 Getting Ready to Test Getting the Blood Drop 17 Fingertip Testing 17 Alternative Site Testing Forearm or Palm 18 Testing Your Blood 22 Test Results 26 Symptoms of High and Low Blood Sugar 29 Performing a Control Test 30 Setting a Reminder After Testing 32 Setting a Reminder From the Setup Menu 34 N N Turning Off a Reminder 36 ES 2 Getting a Reminder 38 ESF Adding Notes 39 J oo wo Menu Button Logbook 40 Trends 41 Zv Setup Date Time and Sound 43 EF AutoLog On Off 47 G a Target Range 48 Language 49 HT Error Detection and Battery Status Charging Removal v System Performance Information 55 PO Service Information 58 E a Specifications 59 ET Caring for Your Meter 60 2 Supplies References Warranty 61 3 a O O wa Q C A C N sa O O Q Q O O N D O e z Q N lt N mp D 3 NO Your CONTOUR USB Blood Glucose The CONTOUR USB blood glucose monitoring system meter test strips and controls is intended for self testing by people wit
15. Bayer HealthCare LLC Mishawaka IN 46544 USA www bayerdiabetes com us Bayer the Bayer Cross CONTOUR GLUCOFACTS MICROLET and the No Coding logo are trademarks of Bayer Windows and Vista are registered trademarks of Microsoft Mac OS is a registered trademark of Apple Inc YSI is a trademark of YSI Incorporated Bayer ote 822986110 a Rev 7 09
16. CONTOUR USB data compare well with the results from the YSI method Regression Statistics Plasma Serum Reference plasma reference glucose range 58 to 411 mg dL Correlation Coefficient r 0 97x 4 57 mg dL 0 975 1 04x 4 07 mg dL 0 971 1 01x 2 68 mg dL 0 979 Precision A study was conducted with the CONTOUR USB blood glucose monitoring system with five heparinized whole blood specimens with glucose levels from 42 to 340 mg dL Multiple replicates n 100 were tested using multiple CONTOUR USB blood glucose meters and one lot f CONTOUR blood glucose test strips The following precision results were obtained y Plasma Serum Coefficient of variation www bayerdiabetes com us 57 System Performance Information Q e sO 2 o co oe o gt e o ep uonewojzuj BIIAIBS ieviuyoaL N p S O oO Ro O o Service Information If you have a problem and none of the problem solving messages on the meter help call Bayer Diabetes Care Customer Service In the USA call toll free 1 800 348 8100 7 days a week 24 hours a day We have trained specialists to help you Important Speak to a Bayer Diabetes Care Customer Service 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 CONTOUR USB blood glucose meter and CONTOUR test strips available when you
17. O 15197 Electromagnetic emissions are low and unlikely to interfere with other nearby electronic equipment nor are emissions from nearby electronic equipment likely to interfere with the meter Immunity to electrostatic discharge meets the requirements of IEC 61000 4 2 It is advisable to avoid use of electronic devices in very dry environments especially if synthetic materials are present www bayerdiabetes com us 59 Specifications Q e 9 sO T 5 9 ab es 7p JO 9IN 4NO 10 uneg ieviuyoaL N D S O oO Ro O o Caring for Your Meter Only connect to a computer or charger that is certified to UL 60950 1 If you use a cable use the one provided in your meter kit Store your meter in the carrying case provided whenever possible Wash hands and dry them 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 strips 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 cleaning solution to run in or around the buttons USB cap or strip port Doing so may cause a malfu
18. On Turn Off 2 To turn the AutoLog off press the Turn Off button To keep the AutoLog on press the Accept button A screen confirms that AutoLog is off The Setup menu will appear AutoLag Is Off www bayerdiabetes com us Setup Turning AutoLog On Off Functions 0 47 obuey obiey 1e6NS poojg dnjyas suol oun S D D 48 Changing the Blood Sugar Target Range Your CONTOUR USB meter comes preset with 70 130 mg dL for Before Meal testing and 70 180 mg dL for After Meal testing Ranges can be changed to personal targets decided by you and or your healthcare professional Use GLUCOFACTS Deluxe software to make such changes 1 Press the Menu button to go to the Main Menu 2 Press the Setup button 3 Press the A or V button to select Target Press the OK button SETUP Hutolog Language 4 To make changes to TARGET your target range 20 130 press the Change Scie button otherwise Go s Back Press for Help 5 Press the A or V button to select your T 130 desired Before Meal low target Press the OK button Repeat this process to set your personal Before Meal high target and 7 After Meal low and high targets Press the 0K button after each selection CHANGE TARGET v Y 70 180 Need Help Call toll free 1 800 348 8100 A screen confirms that Target is set all target ranges are set an 120 I
19. Press the A or V DATE CHANGE DAY button to select the correct day Press the SIITAN OK button v 42 Need Help Call toll free 1 800 348 8100 www bayerdiabetes com us 43 SWI 94 Buly ag dnjes suoioun D D 44 A screen confirms Date is set the date you entered If correct press the Done button and the Setup menu will appear 3 11 09 If you need to make changes press the Change button and repeat the process Setting the Time 1 Press the Menu button to go to the Main Menu 2 Press the Setup button 3 Press the A or VW button to select Time Press the OK button 4 To change the time TIME press the Change SELECT FORMAT button 5 Select either the 12 hour clock or 24 hour clock button Need Help Call toll free 1 800 348 8100 12 hour clock 24 hour clock 6 Press the A or V TIME CHANGE HOURS button to select the correct hour Press the i 30 AM OK button y 7 Press the A or V TIME l button to select the RRDA MINUNEA correct minute Press 10 INV the OK button v 8 Press the A or V TIME button to select the CHANGE AM PM correct AM PM Press Kikki the OK button A screen confirms the time you entered If correct press the Done button and the Setup menu will appear Time is set Change 10 30 Done If you need to make changes press the Change button and repeat the process www bayerdiabetes com us Setup Se
20. TOUR test strips and therefore makes no warranty of the performance of the CONTOUR USB meter when used with any test strips other than CONTOUR test strips or when the CONTOUR test strip is altered or modified in any manner BAYER DIABETES CARE MAKES NO OTHER EXPRESS WARRANTY FOR THIS PRODUCT THE OPTION OF REPLACEMENT DESCRIBED ABOVE IS BAYER DIABETES CARE S ONLY OBLIGATION UNDER THIS WARRANTY IN NO EVENT SHALL BAYER DIABETES CARE BE LIABLE FOR INDIRECT SPECIAL OR CONSEQUENTIAL DAMAGES EVEN IF BAYER DIABETES CARE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you This warranty gives you specific legal rights and you may also have other rights which vary from state to state For warranty service Purchaser must contact the Customer Service Department of Bayer Diabetes Care by calling toll free 1 800 348 8100 for assistance and or instructions for obtaining service of this instrument Patents The system described herein is covered by one or more of the following US patents 5 120 420 5 266 179 5 582 697 5 620 579 5 723 284 5 954 738 6 059 946 6 451 040 6 599 406 6 827 829 6 911 131 7 232 510 as well as pending applications and international equivalents www bayerdiabetes com us 63 Warranty Q e 9 sO T 5 9 ab es 7p Bayer HealthCare
21. blood sugar value of 250 mg dL These are the default values but can be customized by you and or your healthcare professional using the GLUCOFACTS Deluxe software on your computer See the GLUCOFACTS Deluxe User Guide for assistance Low Blood Sugar If your blood sugar reading is under 70 mg dL A screen with large orange numbers will alert you that your blood Sugar Is low High Blood Sugar lf your blood sugar reading is over 250 mg dL A screen with large orange numbers will alert you that your blood sugar Is high f AutoLog is on and you were not able to mark it before the high or low alert appeared press the Notes button You may now select Before Meal After Meal or No Mark by pressing the button next to it Need Help Call toll free 1 800 348 8100 Symptoms of High and Low Blood Sugar You can better understand your test results by being aware of the symptoms of high or low blood sugar this will also help you decide what to do if your results seem unusual Some of the most common symptoms are Low blood sugar Hypoglycemia shakiness sweating fast heartbeat High blood sugar Hyperglycemia frequent urination excessive thirst blurred vision Increased fatigue blurred vision extreme hunger confusion irritability passing out seizure Ketones Ketoacidosis shortness of breath nausea and vomiting very dry mouth CAUTION Blood sugar lev
22. ell 4 Squeeze a small drop of control solution on a clean non absorbent surface such as a piece of wax paper Do not apply control solution to the test strip directly from the bottle Need Help Call toll free 1 800 348 8100 5 Replace the cap on the control solution bottle 6 Immediately touch the tip of the test strip to the drop of control solution 7 Hold it in the drop until the meter beeps Even when AutoLog is on there is no need to mark the control test In 5 seconds the meter displays the control test result 8 Compare your control test result with the Normal Control range printed on the test strip bottle label or on the bottom of the test strip box The Low and High control range values can be found on the bottom of the test strip box If your control test result falls out of the specified range call Customer Service 1 800 348 8100 Do not perform any blood glucose tests until you resolve this issue The result will automatically be marked as a control test and stored in the meter memory Control results will not be included in your blood sugar average Control Test To turn your meter off simply remove the test strip www bayerdiabetes com us Performing a Control Test 31 Setting a Reminder 1 Press the A or V REMINDER COUNTDOWN A A Reminder for your next test can be set after button to select the w testing or from the Setup menu correct hours Press QO min
23. els below 50 mg dL or above 250 mg dL may indicate a potentially serious medical condition If your test result is below 50 mg dL or above 250 mg dL consult a healthcare professional immediately For additional information and a complete list of symptoms contact your healthcare professional or refer to the website for the American Diabetes Association www diabetes org www bayerdiabetes com us N pe 0 2 aa O l ce 4 a D L u O N z O ahead Q z a N 29 V o J O Q fas O O i o D N F 30 Performing a Control Test You should perform a control test When using your meter for the first time To check if you are testing correctly When you open a new vial of test strips If you leave the test strip vial open for an extended period of time f you think your meter may not be working properly f your test results do not match how you feel Low Normal and High control solutions are available Always use CONTOUR control solutions as other brands could present incorrect results 1 Remove a test strip from the bottle and firmly snap the lid closed NOTE Check the expiration date and discard date on the control bottle Make sure the test strip does not appear torn or damaged 2 Prepare to run a control test by inserting a test strip into the meter 3 Gently rock the control bottle before opening to ensure it is mixed w
24. es cannot affect the blood sugar data on your CONTOUR USB meter GLUCOFACTS Deluxe Data Management Software When you plug your CONTOUR USB meter into your computer s USB port follow your computer specific prompts to initiate GLUCOFACTS Deluxe software PLUG IN KNOW MORE bd TAKE ACTION w 8 teacs rorta aa Eedi a tec Darne For more information see the GLUCOFACTS Deluxe User Guide or Quick Start Guide www bayerdiabetes com us 2 F Sea e N E z Q O 14 ele Q Q ag gt Q Q N j lt LL O Q mall n 5 o N Q eF c Initial Startup First charge your meter Your computer can be used to perform initial startup while your meter is charging You can also initiate setup directly on your meter once it is fully charged When you first turn on your CONTOUR USB meter a setup sequence begins Press and hold the Menu button until the meter turns on After a welcome screen you will see the Select Language screen Press the A or V button to select your desired language When highlighted press the 0K button LANGUAGE wv Deutsch Francais y Espa ol A screen confirms Language selected your language English On the next screen choose Customize Quickstart see page 9 Customize see page 10 or Help Quickstart is set to the default settings You will need to confirm the date and time then
25. f correct press the Done button You will be returned to the Setup menu To make changes press the Change button and repeat the process Change y 120 150 Done Setting the Language 1 Press the Menu button to go to the Main Menu 2 Press the Setup button 3 Press the A or V button to select Language Press the OK button SETUP Target Customer Service 4 Press the A or V LANGUAGE button to select the v language you prefer Deutsch Press the OK button Fran ais Espa ol A screen confirms Language selected your choice The Setup English menu will appear in the language you selected www bayerdiabetes com us Setup Setting the Language Functions 0 49 jeaowsay Hbulbieyg snyeis AloyWeg pue UO 99 0g 10119 ieviuyoaL N p S O oO Ro O o Error Detection Displays An error screen will always have an E with a number in the lower left hand corner of the display Remove used strip Repeat test with new eoe Strip If there is an error hardware software testing errors detected by your meter your meter will beep twice You will see specific instructions to guide you The first line of the error screen will tell you what the error is The next lines describe what you should do When an error screen has an OK shown press the button next to it to continue Battery Status Displays The battery status will be MENU Logb
26. from 20 to 600 mg dL CAUTION For in vitro diagnostic use only Potential Biohazard The CONTOUR USB meter is intended for use with only one person All products or objects that come in contact with human blood even after cleaning should be handled as if capable of transmitting viral diseases Principles of the Procedure The CONTOUR blood glucose test is based on measurement of electrical current caused by the reaction of glucose with the reagents on the electrode of the strip The blood sample is drawn into the tip of the test strip through capillary action Glucose in the sample reacts with FAD glucose dehydrogenase FAD GDH and potassium ferricyanide Electrons are generated producing a current that is proportional to the glucose in the sample After the reaction time the glucose concentration in the sample is displayed No calculation is required www bayerdiabetes com us 55 System Performance Information Q a sO T 5 9 ab es 7p UOIJEWIOJU DOURPULIOLI9g Wia shS eduUYydo N D S O oO Ro O o Limitations Preservatives Blood may be collected by healthcare professionals into test tubes containing heparin Do not use other anticoagulants or preservatives Altitude Up to 10 000 feet 3048 meters does not significantly affect results Lipemic Specimen Cholesterol concentrations gt 500 mg dL or triglyceride concentrations gt 3000 mg dL may produce eleva
27. ght will turn off Unplug your CONTOUR USB meter to test A USB extension cable is included for your convenience For more information on Battery Status Displays and narging see pages 50 53 www bayerdiabetes com us o aD N a N 0 O O 0 N Q Q O x Q aa aa vy _ x O O QO 3 gt G9 D mp D O lt lt D Meter Overview Using the Buttons Bayer s CONTOUR USB meter is simple to use Every screen gives you choices The three buttons next to the screen allow you to make your selection by pressing the button next to your choice A Button Selection Scrolling 0K Button V Button Selection Scrolling Using the Selection Scrolling Buttons When the A or arrows appear on the screen the buttons are used for scrolling When your choice ts highlighted make a selection by pressing the 0K button Pressing and holding the A or V buttons will scroll through the list faster Need Help Call toll free 1 800 348 8100 Using the Menu Button To turn on the meter press and hold the Menu button until the meter turns on e The Main Menu has 3 choices Logbook Trends and Setup Select one by pressing the button next to your Logbook choice Trends Setup previous screen yy press the Menu 7 _ 3 button once hak DI Setup P To turn the meter off press and hold the Menu button for 2
28. h diabetes to monitor glucose concentrations in whole blood The CONTOUR USB system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates Rechargeable Battery Your meter has a permanent rechargeable battery Before you do anything else charge your battery by using the provided wall charger or by plugging your CONTOUR USB meter into your computer Be sure your computer is turned on and not in sleep hibernate or power saving mode Your meter will briefly display Do Not Test Charging and the test strip port light will flash For more details see page 52 Test Strip Insert this end into test strip port with gray end face up Sample Tip e Blood is drawn in here NOTE Your CONTOUR USB Need Help Call toll free 1 800 348 8100 Gray Electrode End meter only works with CONTOUR test strips Monitoring System Meter Front Selection Scrolling Buttons See page 4 USB Connector Display Menu Button Screen Provides access to features See page 4 16 36 AM 3711 127 Reminder L_ l Before Meal MIGS m Test Strip Port Insert the test strip here To turn on the port light see page 11 Protective USB Cap CAUTION Keep out of reach of children Accidental swallowing could cause suffocation You cannot do a blood sugar test while the battery is charging When charging is finished the test strip port li
29. hat do not agree with how you feel and tendons During illness or times of stress If you will be driving a car or operating machinery Consult your healthcare professional to determine if alternative site testing is right for you Getting the Blood Drop G D e 5 re A gt D w O O Q Ss 5 3 Wash your hands and the puncture site with soap and warm water Rinse and dry thoroughly 18 Need Help Call toll free 1 800 348 8100 www bayerdiabetes com us 19 Q D 5 re AP gt D wW O O Q 0 5 20 For forearm testing 1 Rub the testing area Press the clear Maintain steady Lift the device straight vigorously until it feels warm to increase blood flow endcap firmly against the puncture site and then press the blue release button Keep the device in constant contact with the skin and pump apply and release pressure up and down 2 3 times without lifting the device away from the skin pressure until a small round blood drop forms Minimum Drop Size up and away from the skin without smearing the blood Need Help Call toll free 1 800 348 8100 For palm testing it is not necessary to rub the skin or pump the device up and down 1 Press the clear endcap firmly against the puncture site and then press the blue release button 2 Maintain steady pressure until a small round blood drop forms Minimum Drop Size 3 Lift the
30. hile your battery is charging When you read or write to the memory the strip port light flashes quickly Wall Charger For information about your wall charger please refer to the insert contained in your meter kit www bayerdiabetes com us 53 Error Detection and Battery Status Charging Removal Q e 9 sO T 5 9 ab 2s tp jeaowisay Hbulbieyg snyeis AioyWeg pue U01 99 0g 10119 edUYdO N D S O oO Ro O o End of Meter Life Battery Removal NOTE Carry out this process only when you no longer intend to use the meter Meter will not be functional once opened to remove the battery To remove the battery for proper disposal you will need to pry the upper and lower cases apart With a screwdriver beginning near the strip port insert the tip of the screwdriver and twist to pry the case loose Continue to do this down the side until the upper case comes apart Pry off the black plastic cover over the battery A Disconnect the battery from the connector B Dispose of the meter and lithium polymer battery in accordance with your local country laws and regulations 54 Need Help Call toll free 1 800 348 8100 System Performance Information Intended Use The CONTOUR USB system meter test strips and control is intended for self testing by people with diabetes to monitor glucose concentrations in whole blood The test provides a quantitative measurement of glucose in blood
31. me If you make your selection in less than 5 seconds you will see the remainder of the testing countdown Your test result is displayed in large numbers for 2 seconds before changing to the normal test result screen For results under 20 mg dL or over 600 mg dL see page 26 www bayerdiabetes com us x O aa Ea O gt Oo p 23 D N ct re d w O O A 24 You can now set an optional Reminder see page 32 or add a Nate see page 39 16 36 AM 3 11 mg 92 dL Reminder Before Meal Notes Remove the test strip to turn the meter off Always dispose of test strip and lancet properly All products that come in contact with human blood should be handled as if capable of transmitting viral diseases Need Help Call toll free 1 800 348 8100 Testing with AutoLog Off After applying blood to the MEE test strip when AutoLog is turned off the testing countdown screen appears for the 5 second countdown Your test result is displayed 16 36 AM 37 Reminder Notes You may add a Note or Reminder www bayerdiabetes com us x O aa Ea O gt ay amp p 25 D N A AJ N a 26 Test Results CAUTION Expected Values Blood sugar values will vary depending on food intake medication dosages health stress or activity Non diabetic expected If your blood sugar reading is under 50 mg dL follow medical
32. mediately after removing a test strip The bottle is designed to keep the test strips dry Exposure to room humidity from leaving the bottle open or not storing them in the original bottle can damage your test strips gt Do not drop blood directly on the flat surface of the test strip Your test strip is designed to easily sip the blood into the sample tip gt Do not press the test strip against your finger This may block the sample tip gt Test strips are for single use only gt Do not use a test strip that appears damaged or has been used gt Let the meter and test strips adjust to the temperature of the location where you are testing Allow 20 minutes for the meter to adjust to the temperature of that new location before performing a blood glucose test The products have been designed to give accurate results at temperatures between 41 F and 11 F Please be aware that USB ports in some computers and self powered USB hubs can become much warmer than the room A USB cable has been provided for your convenience If you wish to test immediately after disconnecting from your computer please use the USB cable gt Check the expiration dates on your test strips and control solution Need Help Call toll free 1 800 348 8100 Important Note Your meter has been preset and locked to display results in mg dL milligrams of glucose per deciliter In some countries the meters are preset to display units in mmol L
33. nction The USB cap of your CONTOUR USB meter is designed to protect the USB port Should you lose the cap call 1 800 348 8100 for a replacement 60 Need Help Call toll free 1 800 348 8100 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 82286110 CONTOUR USB User Guide 81363014 Bayer s USB Extension Cable 81675369 USB Cap 81675377 Wall Charger Part numbers are subject to change without notice These parts are available in the United States from Bayer HealthCare LLC Customer Service Department Order Entry P O Box 2004 Mishawaka Indiana 46546 or call 1 800 348 8100 to order References 1 American Diabetes Association www diabetes org 2 Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition Clinical and Laboratory Standards Institute CLSI document M29 A3 ISBN 1 56238 567 4 CLSI 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 2005 3 Atkin S et al Fingerstick Glucose Determination in Shock Ann Int Med 114 1020 24 1991 www bayerdiabetes com us 61 Supplies References Q e 9 sO T 5 9 ab es 7p MN ueHeM ieviuypaL N D S O to Ro O o Warranty Manufacturer s Warranty Bayer Diabetes Care warrants to the original purchaser that this
34. ook displayed with a battery symbol 4 on the Apply Blood screen and the Main Menu screen It shows how much battery life is left This screen displays full battery Trends Setup As the battery is used MENU Logbook the battery symbol on the screen gradually shows less fill color The color of the battery fill turns yellow when the battery is low and then red when your battery is almost out of charge Trends Setup 50 Need Help Call toll free 1 800 348 8100 A series of low battery alerts will tell you that the battery is low and to charge soon AAG Battery low Battery is almost dead f A411 If you do not charge the battery a display will alert you Shutting down Battery is dead Age Charge immediately Battery is dead Plug the meter into your wall charger or computer Be sure your computer is turned on and not in sleep hibernate or power save mode Please be aware that USB ports in some computers and self powered USB hubs can become much warmer than the room A USB cable has been provided for your convenience If you wish to test immediately after disconnecting from your computer please use the USB cable The test strip port light will flash during charging and stop flashing when charging is complete Please remove the meter and store in the wallet until you are ready to test www bayerdiabetes com us 51 Error Detection and Battery Status Charging Removal Q e
35. phone It would also be helpful to have a bottle of CONTOUR control solution nearby Check List This check list may be helpful when speaking with Bayer Diabetes Care Customer Service 1 Locate the model number A and serial number B on the back of the meter 2 Locate the test strips expiration date on the bottle 3 Check the battery symbol I on the screen See page 50 Battery Status Displays and Charging 58 Need Help Call toll free 1 800 348 8100 Specifications Test Sample Whole blood Test Result Referenced to plasma serum glucose Sample Volume 0 6 uL Measuring Range 20 600 mg dL Measuring Time 5 seconds Memory Stores most recent 2000 test results Battery Type Non serviceable 280mAh rechargeable lithium polymer battery 3 4v 4 2v Meter Battery Life 5 years Operating Temperature Range 41 113 F Humidity 10 93 RH Dimensions 3 82 in H x 1 18 in W x 63 in T Weight 1 2 oz 34 grams Sound A beep sounds when the meter is turned on or off a test strip is inserted when a test strip is filled with blood or when a test result appears on the screen Two beeps sound when a strip is removed and the meter is turned off or to alert the user Twenty beeps will sound when a programmed Reminder sounds Extra Memory 1 GB portable flash drive with 500 MB user accessible partition Emissions The CONTOUR USB meter complies with the electromagnetic requirements specified in IS
36. ted readings Peritoneal dialysis solutions lcodextrin does not interfere with CONTOUR test strips Xylose Do not use during or soon after xylose absorption testing Xylose in the blood will cause an interference Contraindications Capillary blood glucose testing may not be clinically appropriate for persons with reduced peripheral blood flow Shock severe hypotension hyperosmolar hyperglycemia and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood Interference Reducing substances occurring in the blood naturally uric acid bilirubin or from therapeutic treatments ascorbic acid acetaminophen will not significantly affect results The limiting concentrations of these compounds are listed in your test strip insert System Requirements Windows XP SP3 Vista SP2 High Power USB port Java 1 6 0_07 or higher For latest compatibility www BayerContourUSB com 56 Need Help Call toll free 1 800 348 8100 Precision and Accuracy Summary Accuracy The accuracy of the CONTOUR USB blood glucose monitoring system has been assessed in a correlation study conducted by healthcare professionals In this study 100 fresh capillary blood specimens were tested with the CONTOUR USB blood glucose monitoring system by 100 untrained people with diabetes using three test strip lots The reference measurement was done on the YSI Glucose analyzer
37. tting the Time Functions 0 45 JJO UO punos dy Burung dnyas suol oun D D 46 Turning the Sound On Off Sound is turned ON when you receive your meter It can be turned off using the Setup menu Certain error messages and the Reminder bell will override the Sound off setting One long beep indicates a confirmation Two beeps indicate an error or situation that requires your attention 1 Press the Menu button to go to the Main Menu 2 Press the Setup button 3 Press the A or V button to select Sound Press the OK button SETUP Time Autolog 4 To turn the sound off SOUND press the Turn Off button To keep the sound on press the fo Back button A screen confirms that sound is off The Setup menu will appear Sound is Off Need Help Call toll free 1 800 348 8100 Turning AutoLog On Off The AutoLog feature lets you mark your test result as Before Meal or After Meal during the 5 second test countdown You can select No Mark if you are testing at times other than before or after a meal Your meter comes with AutoLog turned on We recommend that you keep this feature turned on Note When AutoLog is ON a result will not appear unless marked as Before Meal After Meal or No Mark or if the result is outside the High Low ranges 1 Press the A or VW button to select AutoLog Press the OK button A Yv AUTOLOG Accept Status
38. us 37 J puiw y e Bul 9e5 SO ON pue AJ i E 2 i 7 38 Getting a Reminder When the Reminder time is reached 20 beeps will sound The meter will turn on and a Reminder screen will appear You can stop the beeps by pressing the OK button or inserting a test strip 1 Press the OK button Time for your nest test 2 Proceed with testing QAZEL see page 14 J If you are testing when the Reminder countdown time is within 15 minutes of the reminder neither screen will appear and the countdown will be stopped Need Help Call toll free 1 800 348 8100 Adding Notes You may add Notes to your test result that may help explain results Your notes will be saved in the Logbook 1 From the test result screen press the Notes button 19 36 AM 167 C Before Meal Notes 2 Press the A or V NOTES button to scroll through Don t Feel Right the choices Some may not be visible until Stress you scroll up or down ipe Press the OK button when your choice is highlighted A screen confirms Sick is added to Notes your choice After the confirmation 10 36 AM screen disappears you may add additional Notes by repeating the steps above The notes will scroll across the bottom so that you can read them all Before Meal Notes www bayerdiabetes com us Adding Notes N dm O Oo O a and Notes 39 yooqbo7y uo1nng nue suoi oun4 S
39. www bayerdiabetes com us Trends co Functions 41 The next three screens will show 14 day Before Setup Meal 14 day After Meal and 14 day total average _ Also shown are the total number of test results Setting the Date included in the average the number of tests 1 Press the Menu button to go to the Main Menu T above Y within and below target 2 Press the Setup button 2 Press the V button to 14 ORY BEFORE MEAL 3 Press the A or VW button to select Date Press display the 14 Day the OK button Before Meal Average 128 SETUP Q This example shows as alae A that your Before Meal average is 128 mg dL and 38 test results are lime included in the Before Meal average with 26 in 4 To change the date D the yf target range 8 over your target range press the Change and 4 under the target range ation dita i O Day Month Year N I 3 Press the V button to 14 ORV AFTER MEAL 5 Select either the a go to the 14 Day After iiaiines r Month Day Year or Day Month Year button a MANNIE 1757 6 Press the A or V DATE N m TT button to select the pila iei ty Press the utton 14 DAY RESULTS correct year Press the 5 as to go to the 14 Day jaiii OK aaa shale S5 zz eoulieciern 1517 7 Press the A or V DATE ce a 2 button to select the einiee mien SI NOTE If you turn off AutoLog only the 14 Day correct month Press 144 09 Results total will display the OK button v 8
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