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USER GUIDE - Bayer Diabetes Canada

1. To mark a result with the pre meal marker press M when the flashes The will then flash This feature allows you to set a reminder to remind you to run a post meal test The reminder is available only after setting a pre meal marker If you want to set the reminder press M The W will appear and stop flashing If you do not want to set the reminder press A or V and the W will disappear Press M to set To mark a result with the post meal marker press A or V until the flashes Press M to set To mark a result with the logbook press A or V until the QQ flashes Press M to set Need Help 1 800 268 7200 www bayerdiabetes ca 27 sounjee4 puiw y pue eye Hulse V m j Cc D gt lt g C V m Using Marker and Reminder Features Lu V _ QO lt lt A a Lu N Using the Reminder Feature When the reminder sounds the meter will automatically turn on The reminder will beep 20 times and the display will show the pre meal test result you marked when you set the reminder Pressing any button will silence the reminder You can now run another test by placing a test strip in the test strip port and following the testing instructions page 8 When you have completed this test and the result is shown on the display will flash To mark this test as a post meal result press M If you do not want to mark this test remove the test strip to turn t
2. Within Within Within method and 10 15 CONTOUR NEXT EZ meter Number and percent of samples within specified range Acceptance criteria in ISO 15197 2003 are that 95 of all differences in glucose values i e between reference method and meter should be within 0 8 mmol L for glucose values less than 4 2 mmol L and within 20 for glucose values greater than or equal to 4 2 mmol L Contour ry next EZ Technical Information A repeatability study was conducted with the CONTOUR NEXT EZ blood glucose monitoring system using five venous whole blood specimens with glucose levels from 2 2 mmol L to 17 0 mmol L Multiple replicates n 100 were tested using multiple CONTOUR NEXT EZ blood glucose meters and one lot of CONTOUR NEXT blood glucose test strips The following precision results were obtained System accuracy results for CONTOUR NEXT EZ meter using CONTOUR NEXT test strips Pooled Standard Coefficient of Mean mmol L Variation Deviation 2 28 Need Help 1 800 268 7200 www bayerdiabetes ca UOI EULIOJU JEOIUYDOL TVOINHOSL m J O m Ro O gt JJ m Service Information Service Information If you have a problem and none of the problem solving steps in this user guide help contact Bayer Diabetes Care Helpline at 1 800 268 7200 We have trained specialists to help you Important e Speak to a Bayer Diabetes Care Representative before returnin
3. Contour ry next EZ Information For Safety Have all the materials you will need ready before you begin testing This includes your CONTOUR NEXT EZ meter the CONTOUR NEXT test strips the MICROLET 2 lancing device and MICROLET lancets You will also need CONTOUR NEXT control solution to run a quality control check CONTOUR NEXT control solutions are sold separately Examine product for missing damaged or broken parts If the test strip bottle is open inside a new box of strips do not use those strips Contact Bayer Diabetes Care Helpline at 1 800 268 7200 for replacement parts The MICROLET 2 lancing device is intended 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 Do not perform a blood glucose test when the CONTOUR NEXT EZ meter is connected to an external device e g computer Use only approved equipment from the manufacturer or certified body such as UL or TUV Need Help 1 800 268 7200 www bayerdiabetes ca m m Z O AjajeS 104 uonewojzu j g H Y Lu H Getting Ready to Test The following steps are shown in the proper order for performing a blood glucose test pages 8 14 Preparing the Test Strip 1 Wash and dry your hands well before testing 2 Remove a CONTOUR NEXT test strip from the bottle 3 Hold the test strip wi
4. Press A or V Reminder Press A or V Post Meal Press A or V Logbook Press A or V Contour ry next EZ 30 Result is marked as a Press M pre meal test You can Flashing now set a reminder Ba Reminder is set to go off in the Press M amount of time you have set Flashing 1 0 2 5 hours to remind you to run a post meal test I Press M Result is marked as a Flashing post meal test m Result is marked in memory as Press M unique You should note this in Flashing your logbook Need Help 1 800 268 7200 www bayerdiabetes ca 31 s n e y JOpuIWOY pue eye BuIsN V m j Cc y gt lt g C V m Viewing Results Basic Mode Lu N m Z lt Q m Lu N Viewing Basic Mode Results Press M to turn your meter on Press M again to view the memory The 14 day average will appear in the center of the display with the number of results shown at the top of the display Any control results are not included in this 14 day average Press A to view the 7 day high and low summary At the top of the display you will see the number of HI results above 10 0 mmol L and LO results below 4 0 mmol L during the preceding 7 day period and the total number of results during that period Press V twice to review previous results Results will be shown starting with the most recent Each result will show the date and time the test was taken You can p
5. Your HI blood glucose setting will now flash default 10 0 mmol L To change press A or V until you reach your desired HI setting Press M to set The range of values for HI is 5 6 13 9 mmol L SETUP AND USE V m j D gt 0 C N m Ga Contour next Need Help 1 800 268 7200 25 E Z www bayerdiabetes ca 24 Using Marker and Reminder Features Lu V m Z lt A LLI N Using the Markers la Contour next EZ If you have set up your meter in Advanced Mode your meter will display three markers after you test your blood E Pre meal Marks a test result that was taken before a meal Post meal Marks a test result that was taken after a meal A Logbook The Logbook marker can be used to mark any result as being unique or different in some way and for which you may want to make notes in your Logbook Seeing a result with this symbol next to it in the memory will help remind you that there is more information recorded about this test result Please see the following pages to use these options If you do not want to mark the test result Remove the used test strip to automatically save the test result in the meter memory with no markers This will also turn the meter off Contour ry next EZ If you want to mark the test result Before you remove your test strip press A or V to select the marker you want to set The marker will flash
6. beeps You will see the meter count down 5 seconds until the test is complete and your control test result is displayed The meter will automatically recognize and mark the control result for you NOTE The VY does not indicate the control test result is within the specified range It only marks it as a control solution test It will not be included in your averages Contour ry next EZ 18 9 Compare your control test result with the Normal Control Range provided on the test strip bottle or carton NOTE Low and High control range values can be found on the bottom of the test strip carton If your control test result is out of range do not use your meter for blood glucose testing until you resolve the issue See What You Should Do on To turn your meter off simply remove the test strip Dispose of the used test strip as medical waste The result will be automatically marked and stored in the meter memory Control results will not be included in your blood glucose averages or in the 7 day HI LO summary IMPORTANT To ensure accuracy of your blood glucose test results and accuracy of your control test results use only CONTOUR NEXT control solutions Need Help 1 800 268 7200 19 www bayerdiabetes ca m m Z O Buljsay uognjos jO1 U0D Setting the Time Date and Sound SETUP AND USE 20 Setting the Time Date and Sound Your CONTOUR NEXT EZ meter allow
7. bottle open or not storing them in the original bottle can damage your test strips This could lead to inaccurate test results Wash and dry your hands well before testing Test strips are for single use only Do not use a test strip that appears damaged or has been used e Your test strip is designed to easily sip the blood into the sample tip Do not drop blood directly on the flat surface of the test strip Need Help 1 800 268 7200 www bayerdiabetes ca A gt JJ n e ma o 0 Ayojes 104 UONEULOJU oa 2 ul m ey m lt I O N Information For Safety e Do not press the test strip against your finger when testing This may block the sample tip e Let the meter and test strips adjust to the temperature where you are testing Whenever the meter is moved from one location to another allow approximately 20 minutes for the meter to adjust to the temperature of a new location before performing a blood glucose test The meter has been designed to give accurate results at temperatures between 5 C and 45 C Check the expiry dates on your test strips and control solution It is important to not use the test strips or control solution if the expiry date printed on the bottle label and carton has passed The control solution should not be used if it has been six months since you first opened the bottle It will help to write the six month discard date on the control solution label
8. www bayerdiabetes ca te heo 8 ADIAGAS sjoquwiAs pue sapo4y 101134 TVOINHOSL Error Codes and Symbols LL Sree LO O 2 a O o W g TT dp If you do not resolve the problem contact Bayer Diabetes Care Helpline at 1 800 268 7200 What What It You See Means What You Should Do Test strip or control soliton past goear dice Donas use the expiry date or is past the expired testing materials discard date Test strip is deteriorated Run another control test with due to heat or a new test strip and control Control exposure to solution test result moisture acetal si Control too high A Gently rock the control bottle or temperature to ensure the control solution too low is mixed well or may not be mixed well Incorrect control solution was used Make sure you are using Bayer s CONTOUR NEXT control solution If result is still out of range contact Bayer Diabetes Care Helpline at 1 800 268 7200 Meter could be damaged Contour ry next EZ If you do not resolve the problem contact Bayer Diabetes Care Helpline at 1 800 268 7200 What What It You See Means What You Should Do Some display segments Compare meter display with do not Possible meter the illustration on page 2 appear electronics If the display is not correct when the failure contact Bayer Diabetes Care meter Helpline at 1 800 268 7200 initially turns on Resu
9. 87 1898 USA 2005 i 3 for assistance and or instructions for the use of this 2 gt O o LL ic LO O w 2 IO o W gt a dp TWOINHOSL 2 m J lt O m Ro O gt JJ m 54 Manufactured For Bayer HealthCare Bayer HealthCare LLC 7 Mishawaka IN 46544 USA Distributed By Bayer Inc Toronto Ontario M9W 1G6 Canada TM Trademarks of Bayer HealthCare LLC used under license by Bayer Inc Bayer and Bayer Cross are registered trademarks of Bayer AG used under license by Bayer Inc All other trademarks are the property of their respective owners 84310760 Rev 02 12 lat 2012 Bayer Inc All rights reserved
10. Contour v next EZ USER GUIDE Intended Use The CONTOUR NEXT EZ blood glucose monitoring system is intended for self testing by people with diabetes and by health care professionals to monitor glucose concentrations in capillary or venous whole blood Capillary samples may be drawn from the fingertip only It is intended for in vitro diagnostic use only The test provides a quantitative measurement of glucose in blood from 0 6 mmol L to 33 3 mmol L The CONTOUR NEXT EZ blood glucose monitoring system is not intended for diagnosis of or screening for diabetes mellitus and is not for use in neonatal care Information For Safety e Cli Read your CONTOUR NEXT EZ user guide the MICROLET 2 lancing device insert and all instructional materials provided in your meter kit before testing Please follow all instructions for use and care exactly as described to help avoid inaccurate results e Wash and dry your hands well before testing e Used test strips and lancets are possible biohazards and must be disposed of as medical waste Contour ry next EZ WARNING Potential Biohazard Health care professionals or persons using this system on multiple patients 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 preve
11. F LAW INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS eee aon ae Da as oa FOR USE WHICH ARE EXPRESSLY EXCLUDED ee eee a ene UNLESS PROHIBITED BY LAW AND IS THE ONLY 84329992 CONTOUR NEXT control solution Low WARRANTY GIVEN BY BAYER 84330001 CONTOUR NEXT control solution High Limitations of Liability IN NO EVENT SHALL Part numbers are subject to change without notice BAYER BE LIABLE FOR INDIRECT SPECIAL OR References CONSEQUENTIAL DAMAGES EVEN IF BAYER HAS 1 Protection of Laboratory Workers from Occupationally BEEN ADVISED OF THE POSSIBILITY OF SUCH Acquired Infections Approved Guideline Third Edition DAMAGES Clinical and Laboratory Standards Institute CLSI document M29 A3 ISBN 1 56238 567 4 CLSI 940 West i Canadian Diabetes Association Clinical Practice Guidelines Instrument Expert Committee Canadian Diabetes Association 2008 Clinical Practical Guidelines for the Prevention and Management of Diabetes in Canada Can J Diabetes 2008 32 suppl 1 S30 Canadian Diabetes Association www diabetes ca 4 Tietz Fundamentals of Clinical Chemistry 5th Edition Edited by Burtis CA and Ashwood ER W B Saunders Co Philadelphia PA 2001 p 444 Contour 5 Atkin S et al Fingerstick glucose determination in shock R next C7 Ann Int Med 114 1020 24 1991 55 2 For warranty service Purchaser must contact Valiev Road Suite 1400 Wayne Pannen ania 7 z Bayer Diabetes Care Helpline at 1 800 268 7200 190
12. aieric See Eng E4 within the operating range Press M to turn the meter Temperature for the meter 5 C 45 C 2 A f or it will call j out of range Let the meter adjust to this 2 2 off or it will automatically temperature for 20 minutes 3 T turn off after 3 minutes before performing a test 3 V O i kae ah Remove the test strip and E2 eroudidi an retest using a new test 7 a ice test strip Wait until you see the S insifficieht flashing blood drop on the blood drop display before testing IWOINHOSL C8 Contour next C7 Need Help 1 800 268 7200 www bayerdiabetes ca U m JJ lt O m Ro O gt JJ m 36 Error Codes and Symbols LL Sree LO O 2 a O o W g Fi dp 38 If you do not resolve the problem contact Bayer Diabetes Care Helpline at 1 800 268 7200 What What You Should Do You See eRemove the test strip and retest using a new test What It Means eThe meter is E3 sensing aused strip Wait until you see the a test strip flashing blood drop on the C eThe wrong display before testing ms control solution elf control testing make was used sure to use CONTOUR NEXT control solution Fi Test stri sly OENE ae ed Remove and reinsert the test correctly strip properly see page 8 Remove the test strip and retest using a new test strip ae tate o If you continue to have E8 E13 hardware issue problems contact Bayer Diabetes Car
13. ceeceeessseeeeeseeaseeeeeees 15 Control Solution Testing srncccasinercncecscanncernatesemementeceusndsninne 16 Setting the Time Date and SOUNG cccceseeeeeeeees 20 Set up for Basic L 1 and Advanced L 2 Modes 23 Personalizing LO HI and Reminder SettingS 0 24 Using Marker and Reminder Features cccsseeeeees 26 Transferring Results to a Computer cccsseeeseeeeeeeeeees 29 Viewing Results Basic MO e cccccsssseeeeeesseeeenseeees 32 Viewing Results Advanced Mode scsccecesseeeeeeeeeees 34 Error Codes and SYS saseseie cco a cctssineSvcicnacmmosionanansnerdees oF Changing the Batteries c ccssccceecessssseeeeeseeesseeeeeees 42 Caring for Your Meter eecicnicesecsennsorasncucutarcceuee eater 44 Symptoms of High or Low Blood Glucose 0055 45 SPeECIPICATIONS ccccceeeeeeceesseeeceeseeecesuseeeceaeseeeesaaeeeesseas 46 Service Information sscne siesta eadostecsiaterecmdtntesbsennessekniece 52 NE MI EA trea cute A E TA E E 53 MN SS EA EEE E E E PEE N E E A E 55 agLyvLls ONILLAS ONILSAL V m j C yD gt lt 0 C 2 m AYVO 8 ADIAGAS TWOINHOSL oa 2 ul e y m lt Ll ORT Your Meter Overview Your Meter Display The picture below shows all the symbols that appear on your meter display To view with the meter off press and hold A or All display segments will appear for 10 seconds I
14. e Helpline at 1 800 268 7200 E7 Remove the test strip and I itest retest using a new test strip a A Make certain that you are 75 P using a CONTOUR NEXT test strip from Bayer This error occurs only in Communication mode See pages 20 21 to reset the date E10 re ala er or time If you continue time to see this error please contact Bayer Diabetes Care Helpline at 1 800 268 7200 Contour ry next EZ If you do not resolve the problem contact Bayer Diabetes Care Helpline at 1 800 268 7200 What What It What You Should Do Means You See Remove the test strip and retest using a new test strip Be sure you wash and dry your hands well and carefully follow instructions in this user guide Only Bayer s CONTOUR NEXT test strip should be used Abnormal E11 result eWash and dry your hands well and the test site Repeat the test using a new test strip elf your result still flashes HI contact your health care professional immediately Test result is above o 33 3 mmol L CAUTION Glucose levels above 13 9 mmol L may indicate a potentially serious medical condition eRepeat the test using a new test strip elf your result still flashes LO contact your health care professional immediately Test result is below 7 Pa 0 6 mmol L CAUTION Glucose levels below 2 8 mmol L may indicate a potentially serious medical condition Need Help 1 800 268 7200
15. e the old batteries by pressing the top of the battery which will raise the bottom of the battery up TWOINHOSL LU p ce y lt LO lt O oy O an m 52 o i g C3 Contour gt LLI R JJ V m next Need Help 1 800 268 7200 E Z www bayerdiabetes ca 42 Caring for Your Meter LL ic LO O 2 O O W gt a dp 44 Caring for Your Meter e Store meter in the carrying case provided whenever possible e Wash and dry hands well before handling to keep the meter and test strips free of water oils and other contaminants e Handle the meter carefully to avoid damaging the electronics or causing other malfunctions e Avoid exposing meter and test strips to excessive humidity heat cold dust or dirt e Clean your meter as recommended on page 15 Contour ry next EZ Symptoms of High or Low Blood Glucose You can better understand your test results by being aware of the symptoms of high or low blood glucose According to the Canadian Diabetes Association some of the most common symptoms are Low blood glucose High blood glucose Hypoglycemia Hyperglycemia e shakiness e frequent urination e sweating e excessive thirst e blurred vision e increased fatigue e fast heartbeat e blurred vision e confusion e hunger e passing out e seizure Ketones Ketoacidosis e irritability e shortness of breath e extreme hunger e nausea or vomiting e dizziness e very dry mouth Inf
16. ers 2 5 2 0 1 5 1 0 hours Personal HI and LO test settings To set your meter to Advanced Mode and take advantage of meal markers and other functions available to you 1 Press M to turn your meter on Wait to see the flashing test strip 2 Press and hold A or for 3 seconds 3 L 1 will flash 4 Press A or W to change to L 2 5 Press M to set S poN 2 1 pesueaApy pue 1 7 olseg 104 dn aSs V m Cc D gt lt g C V m Contour ry next EZ Need Help 1 800 268 7200 23 22 www bayerdiabetes ca Personalizing LO HI and Reminder Settings If you selected Advanced Mode L 2 on your display you can change your meter s Post Meal Test Reminder Set up To change the reminder time for post meal testing press A or F to display the options available Select 2 5 2 0 1 5 or 1 0 hour s to set ersonal low and high z 3 anes a SB your post meal reminder p see ee ms default is 2 0 hours Press o Ia personalizing m settings M to set 38 o your CONTOUR NEXT EZ gt 2 JE meter will help you track N EF these HI and LO results a Q N You have now completed D 5 q v The LO setting will flash your CONTOUR NEXT EZ ws 6 5 default 4 0 mmol L To meter set up for Advanced 4 5 D E change this setting press Mode a a x A or V until you reach your no desired LO setting and then press M to set The range of values for LO is 3 3 5 0 mmol L
17. etting the Time Date and Sound Lu U m Z lt A a Lu N The flashing bell symbol will now appear on the display along with the word fa This option controls whether you want to hear the beep sound during testing To turn the beep sound off during testing press A or V to display fIFF Press M to set After setting the sound Hl 7 will flash To keep your meter in Basic Mode press M to set To change your meter to Advanced Mode press A or W to change to g and press M to set If you are using Basic Mode L 1 will appear on your display you have completed your meter set up Set up for Basic L 1 and Advanced L 2 Modes Your new CONTOUR NEXT EZ meter is pre set for the Basic Mode and offers the same easy test procedure in either the Basic or Advanced Mode BASIC MODE L 1 ADVANCED MODE L 2 e 7 day HI and LO summary e 14 day average e 480 test result memory Your meter is pre set to Basic Mode If you have set your meter to the Advanced Mode and want to return to Basic Mode 1 Press M to turn your meter on Wait to see the flashing test strip 2 Press and hold A or V for 3 seconds 3 L 2 will flash 4 Press A or W to change to L 1 5 Press M to set e 7 day HI and LO summary e 7 14 and 30 day averages e 480 test result memory e Pre and post meal markers e 30 day pre and post meal averages e Selectable post meal remind
18. f HI and LO results In the center of the display is the total number of results Press A to view the 7 day average You will see the average in the center of the display and This will display the average in the center and the number of readings along the top Need Help 1 800 268 7200 www bayerdiabetes ca T date and time the test was the number of results along Sb D taken the top d O v You can press A or to scroll forward or backward gt A through the results 5 Press A to view the 30 day c 7 When End appears on the display you have viewed all average D V m 35 S D 5 JJ D oO eF O gt Q lt D O D o3 S O a D Error Codes and Symbols If you do not resolve the problem contact Bayer Diabetes Care Helpline at 1 800 268 7200 AS Press A again to view the O 30 day average of results gt What What It marked with a pre meal You See Means What You Should Do 2 marker will e z remain on Low batteries a AE Sa aia 2 the display p P C will flash for D Press A again to view the 10 seconds Dead Renace hebate 30 day average of results and then the batteries j D marked with a post meal en p turn off E marker K 4 The meter is Proceed with the testing of m gt 17 ready to test your blood a i2 Notenough Add more blood within O 7 EA blood sample 20 seconds 2 D Press A again and you will vedo anaie
19. f you need more than 10 seconds to check the display press and hold A or V again While all characters are displayed it is very important to verify that 4 f is fully displayed If there are missing segments see Error Codes and Symbols page 37 This may affect the way you see your results Contour ry next EZ W mmol J 7dL d m d i em Top area on the display presenting date and time Pre meal result marker Post meal result marker Identifies a Logbook entry Indicates a reminder has been set Center area on the display that shows either your test result or any error codes The meter is ready to test Control solution result marker Indicates it is too cold or too hot for your meter to test accurately Indicates Average Results are displayed as mmol L The 7 appears when viewing 7 day HI LO summary Day month format The batteries are low and need to be changed and will remain on display until batteries are changed Appear if the meter is in 12 hour setup Indicates sound is turned on A gt JJ n e ma o 0 M IAM AQ 1 7 N INOA oa 2 ul e y m lt Ll O N Your Meter Features 4 Thank you for choosing the CONTOUR NEXT EZ blood glucose monitoring system We are proud to be your partner in helping you manage your diabetes Your Meter Features Easy The CONTOUR NEXT EZ blood glucose monitoring system is about si
20. g your meter for any reason He she will give you the information needed to get your problem handled correctly and efficiently e Have your CONTOUR NEXT EZ blood glucose meter and CONTOUR NEXT test strips available when you phone It would also be helpful to have a bottle of CONTOUR NEXT control solution nearby Check List This check list may be helpful when speaking with Bayer Diabetes Care Helpline Lady paa 1 Locate the serial number A and model number B on the back of the meter 2 Locate the CONTOUR NEXT test strips expiry date on the bottle 3 Check the battery icon on the display See page 42 Changing the Batteries Warranty Important Bayer Inc Bayer has no knowledge of the performance of the CONTOUR NEXT EZ meter if used with any test strip other than CONTOUR NEXT and therefore this warranty is invalid if the CONTOUR NEXT EZ meter is used with any test strip than the CONTOUR NEXT test strip or when the CONTOUR NEXT test strip is altered or modified in any manner Manufacturer s Warranty Bayer Inc warrants to the original purchaser that this meter will be free from defects in materials and workmanship for as long as you own your system Bayer Inc shall replace with a reconditioned meter or at its option repair at no charge a meter that is found to be defective This warranty is subject to the following exceptions and limitations 1 The enclosed warranty card mu
21. ge of a test strip with a flashing blood drop will appear letting you know the meter is ready to test e If you think your meter may not be working properly e z T dp om j dp Lu Z Q e f you have repeated unexpected blood glucose results Normal Low or High control solutions are available and sold separately Always use Bayer s CONTOUR NEXT control solutions Other brands could present incorrect results If you need help locating CONTOUR NEXT control solutions call Bayer Diabetes Care Helpline at 1 800 268 7200 1 Wash and dry your hands well before testing 5 Gently rock the control bottle before opening to ensure it is mixed well 6 Squeeze a small drop of control solution on a clean nonabsorbent surface Do not apply control solution to your fingertip or to the test strip directly from the bottle 2 Remove a test strip from the bottle and firmly snap the lid closed NOTE Check the expiry date on the test strip bottle and the expiry and discard dates on control solution Do not use expired materials Bus uognjos jO1 U0D Control Solution Testing re Contour next C7 Need Help 1 800 268 7200 17 16 www bayerdiabetes ca lt p LL H Control Solution Testing 7 Immediately touch the tip of the test strip to the drop of control solution The solution is pulled into the test strip through the tip 8 Hold the test strip in the drop until the meter
22. he Canadian Diabetes Association standard medical practice goals for a non pregnant individual with diabetes e Before a meal 4 0 to 7 0 mmol L e 2 hours after a meal 5 0 to 10 0 mmol L NOTE You can set your meter to use meal marker options See Advanced Mode settings L 2 on pages 23 25 If you want to mark your result you will need to do it before removing the test strip a m dp k dp LI Z Q e f your blood glucose reading is under 2 8 mmol L or you see Lt less than 0 6 mmol L on the meter display follow medical advice immediately e f your test result is above 13 9 mmol L or you see H i greater than 33 3 mmol L on the meter display call your health care professional as soon as possible 6 Remove the test strip to turn your meter off Dispose of the used test strip as e Always consult your health care professional medical waste before changing your medication based on CONTOUR NEXT EZ test results Testing Your Blood poojg Jno Buns L C8 Contour next EZ Need Help 1 800 268 7200 13 www bayerdiabetes ca 12 Removing the Used Lancet Cleaning Your Meter 1 In one hand hold the The exterior of the CONTOUR NEXT EZ meter can be lancing device with your cleaned using a moist not wet lint free tissue with a thumb on the grip indent mild detergent or disinfectant solution such as 1 part With your other hand hold bleach mixed with 9 parts water Wipe dry w
23. he meter off Dispose of the used test strip as medical waste If you decide not to test after the reminder sounds press any button to turn your meter off The meter will only set one reminder at a time It will remember the last reminder set Contour ry next EZ To Cancel a Reminder When the meter is off press M to turn on the meter The date and time will appear along with the Press A or V twice and the reminder icon will disappear Press M to cancel the reminder Transferring Results to a Computer You can transfer test results from the CONTOUR NEXT EZ meter to a computer where they can be summarized in a report with graphs and tables To make use of this feature you need Bayer s diabetes management software GLUCOFACTS Deluxe and a data cable from Bayer For a free download of the software go to www bayerglucofacts com or call Bayer Diabetes Care Helpline at 1 800 268 7200 IMPORTANT The CONTOUR NEXT EZ meter has not been tested by Bayer for use with any software other than Bayer s diabetes management software Bayer is not responsible for any erroneous results from the use of other software Need Help 1 800 268 7200 www bayerdiabetes ca 29 J yndwo e 0 syns y Hulejsuesy V m Cc y gt lt g C V m Using Marker and Reminder Features Lu V _ QO lt lt A a Lu N After performing a test To Mark X Results Pre Meal
24. ith lint free the gray endcap dial as tissue after cleaning shown and gently snap off the endcap CAUTION Do not allow cleaning solution to run 2 Place the round protective in or around the button battery cover or test strip lancet cap on a flat port Doing so may cause a malfunction surface with the Bayer logo facing down 3 With the used lancet still in the lancing device push the lancet needle completely into the middle of the exposed side of the cap z m dp F dp TT Z Q 4 While pressing the release button a pull the re setting handle b and the lancet will drop into the container you have selected 5 Dispose of the used lancet as medical waste Testing Your Blood 49 9IN INOA HulueslD Do not reuse lancets Use a new MICROLET lancet each time you test C8 Contour next EZ Need Help 1 800 268 7200 15 14 www bayerdiabetes ca Control Solution Testing Use only Bayer s CONTOUR NEXT control solutions Normal Low or High with your CONTOUR NEXT EZ blood glucose monitoring system Using anything other than CONTOUR NEXT control solution could present incorrect results 3 Hold the test strip with the gray end facing up 4 Insert the gray end into the test strip port on the meter You should perform a control test e When using your meter for the first time e When you open a new bottle or package of test strips The meter will turn on An ima
25. lts are not displayed This will affect in the way you Contact Bayer Diabetes Care expected see your Helpline at 1 800 268 7200 units of results measure mmol L Need Help 1 800 268 7200 www bayerdiabetes ca sjoquwiAs pue sapo4y 10113 TVOINHOSL U m J O m Ro O gt JJ m Changing the Batteries 4 Place new batteries under the prongs and into the battery compartment with the side up Use two 3 volt DL2032 or CR2032 lithium batteries Batteries should be replaced when the meter continually displays or the meter briefly shows and then turns off See Error Codes and Symbols page 37 5 Slide the battery cover back into place lining up with the open slots and close firmly 1 Turn off your meter before changing your batteries 2 Press firmly on the battery cover and slide in the direction of the arrow NOTE If you put the new batteries in the meter Information for Safety within 5 minutes of taking the old ones out all your settings and results will be saved If you take more Keep batteries away from children Lithium than 5 minutes you will need to reset the date and batteries are poisonous If swallowed time although your other settings and results will immediately contact your doctor or poison be saved control center Discard batteries according to your local environmental regulations Changing the Batteries soueyeg ou buibueyD 3 Remov
26. mplicity You will notice its simple approach the first time you see it Automatic You no longer have to worry about coding your meter or marking a control test result Your CONTOUR NEXT EZ meter is designed with No Coding technology to automatically code itself every time you insert a test strip It will even tell you when a test strip is underfilled E Programmed Your CONTOUR NEXT EZ meter has been preset at the factory with the standard date time and units of measure mmol L where you purchased your meter IMPORTANT NOTE e Your meter has been preset and locked to display results in mmol L millimoles of glucose per liter In some countries the meters are preset to display units in mg dL milligrams of glucose per deciliter Contour ry next EZ e Results in mmol L will always have a decimal point e Results in mg dL will never have a decimal point E Jano OF ng Example AA T or AD a Check your display to ensure that results are being displayed in mmol L If they are not contact Bayer Diabetes Care Helpline at 1 800 268 7200 Customizable The CONTOUR NEXT EZ meter allows you to set personal choices for some features For more information please see pages 23 31 Information For Safety e Always keep the test strips in the original bottle Tightly close the bottle immediately after removing a test strip The bottle is designed to keep the test strips dry Exposure to room humidity from leaving the
27. ntion of blood borne transmissible diseases in health care settings as recommended for potentially infectious human specimens prior to repair service or investigation For complete cleaning instructions see page 15 e The MICROLET 2 device is not suitable for use by health care professionals It must not be used on more than one person due to risk of infection Need Help 1 800 268 7200 www bayerdiabetes ca Your CONTOUR NEXT EZ Meter P next EZ Display Up Down Scroll Buttons Memory Button On Off Memory Recall Enter Test Strip Port Your CONTOUR NEXT Test Strip Gray End Insert this end into the test strip port Sample Tip Blood sample pulled in here Your MICROLET 2 Lancing Device Re setting Handle Grip Indent Release Button s 2 z a Lancet Holder lt c Lancet r Round Protective Cap Endcap Dial iii Adjustable Endcap Table of Contents Your Meter Overvie W cccccsssececesseeeceesseeeceasseesssaaeeeees lil Your Meter Features sci iececccrncia ineiseintientenncisteacenunniersianccebanwatce 4 Information For SATCU sccsccnssnaceasetedcenteusseceaccsasneetwesecsnctasacms 5 Getting Ready to TES t snaseeseseeseciecncssusaesccutsenasesentesenectiooeuss 8 Getting the Blood Drop srtececiscscncacetetanenocretasvandinadetciasadive 10 Testing Your Blood sesssnnseennnnoennnnnennesnnneenernnnnnneeennne nee 11 Cleaning Your Meter cccccccsssssee
28. on in the sample is displayed No calculation is required Comparison Options The CONTOUR NEXT EZ system is designed for use with venous and capillary whole blood Comparison to a laboratory method must be done simultaneously with aliquots of the same sample NOTE Glucose concentrations drop rapidly due to glycolysis approximately 5 7 per hour Need Help 1 800 268 7200 www bayerdiabetes ca SUOI eOIINNdS TWOINHOSL U m J lt O m Ro O gt JJ m Specifications LL ic LO O w 2 TO o W gt g dp Limitations Preservatives Blood may be collected by health care professionals into test tubes containing heparin Do not use other anticoagulants or preservatives Altitude Up to 6301 meters does not significantly affect results Alternative Site Testing Not for use with Alternative Site Testing Lipemic Specimen Cholesterol concentrations gt 30 2 mmol L or triglyceride concentrations gt 53 2 mmol L may produce inaccurate results Peritoneal Dialysis Solutions Icodextrin does not interfere with CONTOUR NEXT 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 hyperglycaemia and severe dehydration are examples of clinical conditi
29. ons 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 on your test strip insert Contour ry next EZ Technical Information The CONTOUR NEXT EZ blood glucose monitoring system was tested using 100 capillary blood samples duplicate replicates from three CONTOUR NEXT strip lots The results were compared to the YSI Glucose Analyzer laboratory reference method traceable to the CDC hexokinase method The tables below show how well the two methods compared Table 1 System accuracy results for glucose concentration lt 4 2 mmol L Difference range in values between YSI laboratory reference method and 0 3 0 6 0 8 CONTOUR NEXT EZ meter mmol L mmol L mmol L Number and percent of samples 48 of 54 54 of 54 54 of 54 within specified 88 9 100 0 100 0 range Need Help 1 800 268 7200 www bayerdiabetes ca UONEWUOJU JEOIUUDOL a m O I O gt Lge AYVO 8 ADIAGAS Technical Information LU Sree LO O o a O o W g TT dp 50 Technical Information Table 2 System accuracy results for glucose concentration 4 2 mmol L Difference range in values between YSI laboratory reference Within
30. ormation For Safety If you are experiencing any of these symptoms test your blood glucose If your test result is under 2 8 mmol L or above 13 9 mmol L contact your health care professional immediately For additional information and a complete list of symptoms contact your health care professional or refer to the Canadian Diabetes Association website at www diabetes ca so njH poojg mo 10 YUBIP Jo swozdwAsg AYVO 8 ADIAGAS TWOINHOSL Specifications LL ic LO O w 2 TO o W gt g dp System Specifications Test Sample Venous or capillary whole blood Test Result Referenced to plasma serum glucose Sample Volume 0 6 uL Measuring Range 0 6 33 3 mmol L Results 5 second countdown Memory Feature Stores most recent 480 test results Battery Type Two 3 volt lithium batteries 225 mAh capacity DL2032 or CR2032 Battery Life Approximately 1000 tests 1 yr average use Operating Temperature Range 5 C 45 C Humidity 10 93 RH Dimensions 77 mm H x 57 mm W x 19 mm T Weight 47 5 grams 1 7 oz Sound A beep sounds when the meter is turned on a test strip is inserted when a test strip is filled with blood or when a test result appears on the display Two beeps sound when the meter turns off or to indicate an error You will hear twenty beeps when a programmed reminder sounds Electromagnetic Compatibility EMC The CONTOUR NEXT EZ meter complies with the electromagne
31. rds the puncture site to form a drop of blood Do not squeeze around the puncture site 3 Test immediately after a good blood drop has formed 4 Immediately touch the tip of the test strip to the drop of blood The blood is pulled into the test strip through the tip 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 or you could get inaccurate results or errors If the first blood drop is not enough the meter may beep twice and display a strip underfill screen image x i You have 20 seconds to apply more blood onto the same strip If you are not able to provide enough blood within that time an E2 error code will be displayed Dispose of the used test strip as medical waste and start over with a new strip Fingertip Testing Need Help 1 800 268 7200 www bayerdiabetes ca a m m Z O poojg Jno Buns L Test Results 5 After a beep you will see the Expected Values meter count down 5 seconds Your blood test result will be displayed and automatically stored in the meter memory Please do not touch the test strip during the countdown as this may result in an error Blood glucose values will vary depending on food intake medication dosages health stress or exercise Consult with your health care professional for the target value that is appropriate for you According to t
32. ress A or W to scroll forward or backward through the results When E nd appears on the display you have viewed all of the results in the memory NOTES e Averages include the specified time period plus the current day e The meter will hold 480 results in the memory When the maximum is reached the oldest test result will be removed as a new test is completed and saved to the memory e Press M to turn the meter off or it will automatically turn off after 3 minutes e i represents the number of test results SpoW JIseg Syns y HUIMIA V m j D gt g C N m rs Contour next EZ Need Help 1 800 268 7200 33 32 www bayerdiabetes ca Viewing Advanced Mode Results Viewing Advanced Mode Averages In Advanced Mode L 2 you have all of the options Press M to turn your meter on Press M again to view described in Basic Mode plus additional items available the 14 day average including the number of results used to obtain the average Viewing Results Advanced Mode Press M to turn your meter on Briefly press M again to view the 14 day average including the number of results used to obtain the average Press V to review previous results Results will be shown starting with the most recent Each result will show the of the results in the memory Contour ry next EZ 34 Press A to view the 7 day high and low summary At the top of the display you will see the number o
33. s you to set the date time and sound as you like them e You can view 12 or 24 hour time e month day or day month and e choose to have your meter beep or not To get into set up mode when the meter is off press and hold M for 3 seconds A complete display will briefly appear then numbers will flash in the top left corner of the display Setting the Time With the 12H flashing on the display press A or V to select the 12H with AM and PM or 24H setting Press M to set The number in the hour position will now flash Press A or V until you reach the current hour Press M to set The minute will now flash Press A or V to select the Current minute Press M to set Contour ry next EZ If you selected a 12 hour time setting the AM or PM will now flash Press A or V to select AM or PM Press M to set Setting the Month and Day Format m d will now flash on the display Press A or V to select the format you wish m d for month day format or d m for day month format Press M to set The year will be flashing Press A or to select the current year Press M to set The month will now flash Press A or V to select the month Press M to set The day will now flash Press A or to select the day Press M to set Need Help 1 800 268 7200 www bayerdiabetes ca 21 punos pue 9 eq eu y Bulyjes V m Cc D gt lt g C V m Setting the Sound S
34. st be completed signed and returned to validate your warranty 2 This warranty is limited to replacement due to defects in parts or workmanship Bayer Inc shall not be required to replace any meters which are necessitated by abuse accidents alteration misuse neglect maintenance by other than Bayer or failure to operate the meter in accordance with instructions Further Bayer assumes no liability for malfunction or damage to Bayer meters caused by the use of reagents other than the appropriate Bayer reagents e g CONTOUR NEXT test strips manufactured or recommended by Bayer AWUeLIeN LL ic LO O w 2 TO O W gt a dp TWOINHOSL m J lt O m Ro O gt JJ m Need Help 1 800 268 7200 www bayerdiabetes ca Supplies 3 Bayer Inc reserves the right to make changes When calling or writing for supplies be sure to include in design of this instrument without obligation the number with the name of the replacement part or to incorporate such changes into previously accessory item manufactured meters Replacement Parts 4 This warranty is available only to registrants with a Part Number Item Canadian address 40030030 Two 3 volt lithium batteries DL2032 THIS WARRANTY IS EXPRESSLY LIMITED TO THE or CR2032 METER AND MADE IN LIEU OF ANY AND ALL OTHER 84310760 CONTOUR NEXT EZ user guide WARRANTIES EXPRESSED OR IMPLIED EITHER IN 84245772 CONTOUR NEXT test strips box of 50 FACT OR BY OPERATION O
35. th the gray end facing up 4 Insert the gray end into the test strip port on the meter The meter will turn on An image of a test strip witha flashing blood drop ts will appear letting you Know the meter is ready to test Preparing the Lancing Device 1 Remove the endcap from the MICROLET 2 lancing device with your thumb on the grip indent as shown 2 Loosen the round protective cap on a lancet by rotating it turn but do not remove it Always use MICROLET lancets for best operation Shallow Puncture Deep Puncture 3 Insert the lancet firmly into the lancing device until it comes to a full stop This will re set the device You can also pull and release the re setting handle Twist off the round protective lancet cap Be sure to save it for disposing of the used lancet Replace the gray endcap prior to getting your blood drop The puncture depth depends on the endcap setting and the amount of pressure applied to the puncture site You will determine which combination works best for you Need Help 1 800 268 7200 www bayerdiabetes ca j m lt Q S L 0 Ape y Buiy 9 TESTING Testing Your Blood ra Suggested drop size Contour RZ next EZ 10 Getting the Blood Drop and Testing 1 Press the endcap firmly against the puncture site and press the blue release button with your thumb Stroke your hand and finger towa
36. tic requirements specified in ISO 15197 2003 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 CONTOUR NEXT EZ system Contour ry next EZ Immunity to electrostatic discharge meets the requirements of IEC 61000 4 2 2008 It is advisable to avoid use of electronic devices in very dry environments especially if synthetic materials are present The CONTOUR NEXT EZ meter has been tested for radio frequency interference at the frequency range and test levels specified by ISO 15197 2003 To avoid radio frequency interference do not use the CONTOUR NEXT EZ meter near cellular or cordless telephones walkie talkies garage door openers radio transmitters or other electrical or electronic equipment that are sources of electromagnetic radiation as these may interfere with the proper operation of the meter Principles of the Procedure The CONTOUR NEXT 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 the mediator Electrons are generated producing a current that is proportional to the glucose in the sample After the reaction time the glucose concentrati

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