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TECHNICAL

INFORMA

TION

Limitations

References

Wickham NWR, Achar KN, Cove DH. Unreliability of
capillary blood glucose in peripheral vascular disease.

Practical Diabetes.

1986; 3(2): 100.

Atkin S, et al. Fingerstick Glucose Determination in Shock.

Ann Intern Med.

1991; 114: 1020-1024.

Desachy A, Vuagnat AC, et al. Accuracy of Bedside
Glucometry in Critically Ill Patients: Influence of Clinical
Characteristics and Perfusion Index.

Mayo Clin Proc.

2008; 83(4): 400-405.

Longo DL, et al.

Harrison

’

s Principles of Internal Medicine

18th Edition, 2011. http://www.accessmedicine.com

Tietz Fundamentals of Clinical Chemistry

, 5th Edition,

Edited by Burtis CA and Ashwood ER, W. B. Saunders Co.,
Philadelphia, PA, 2001, p. 444.

Limitations

Preservatives:

Blood may be collected by health care

professionals into test tubes containing heparin. Do not use
other anticoagulants or preservatives.

Peritoneal Dialysis Solutions:

Icodextrin does not interfere

with C

ONTOUR

EXT

test strips.

Interference:

Reducing substances occurring in the blood

naturally or from therapeutic treatments will not significantly
affect results. See reagent test strip insert for more
information.

Xylose:

Do not use during or soon after xylose

absorption testing. Xylose in the blood will cause
an interference.

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4/15/15 12:50 PM

Содержание CONTOUR NEXT

Страница 1: ...10 13 12 mmol L 5 2 Before Meal 12 24 PM See Options Blood Glucose Monitoring System USER GUIDE Uses only CONTOUR NEXT blood glucose test strips from Bayer...

Страница 2: ...ring system may also be used by health care professionals to monitor hypoglycemia in neonates The system should not be used for diagnosis or screening Diagnosis of neonatal hypoglycemia should be perf...

Страница 3: ...tient use Do not share them with anyone including other family members Do not use on multiple patients All parts of this kit are considered biohazardous and can potentially transmit infectious disease...

Страница 4: ...open or not storing the strips in their original bottle can damage your test strips This could lead to inaccurate results Do not use a test strip that appears damaged or has been used Check the expir...

Страница 5: ...point Example or O Check your display screen to be sure the results are shown the right way If not contact Bayer Diabetes Care Helpline at 1 800 268 7200 The CONTOUR NEXT blood glucose monitoring syst...

Страница 6: ...rol solution test Enough Blood The CONTOUR NEXT meter alerts you when a test strip is under filled and allows you to add more blood Your test strip is designed to easily sip the blood into the sample...

Страница 7: ...27 Intended Use Important Safety Information i Your CONTOUR NEXT Meter 2 Initial Setup 5 Test Reminders 30 Logbook 33 Notes 34 Trends Averages and Summaries 35 Setup 39 AutoLog 45 Caring for Your Mete...

Страница 8: ...tton to scroll continuously through a list Press the OK button to select the highlighted option To exit from the Logbook or Trends and return to the Main Menu press the OK button To exit from Setup an...

Страница 9: ...ange On error screens and when blood sugar test result is either below 0 6 mmol L or above 33 3 mmol L When blood sugar test result is above Target When blood sugar test result is below Target Listed...

Страница 10: ...GETTING STARTED 4 Your CONTOUR NEXT Test Strip Your C ONTOUR N EXT Test Strip Grey Square End Insert this end into the test strip port Sample Tip Blood sample pulled in here...

Страница 11: ...select your desired language Press the button to scroll down to see more language choices 4 A screen confirms your language 5 Press the OK button to complete setup Your meter is now ready to test you...

Страница 12: ...se those strips Contact Bayer Diabetes Care Helpline at 1 800 268 7200 for replacement parts CAUTION Your CONTOUR NEXT meter only works with CONTOUR NEXT test strips and CONTOUR NEXT control solutions...

Страница 13: ...hould never be shared with anyone else even a family member due to risk of infection Use a new lancet each time you test because it is no longer sterile after use Preparing the Lancing Device 2 Loosen...

Страница 14: ...e until it comes to a full stop 4 Twist off the round protective lancet cap Save it for disposing of the used lancet 6 Rotate the endcap dial to adjust the puncture depth The amount of pressure applie...

Страница 15: ...do not apply blood to the test strip within 3 minutes the meter will turn off Remove the test strip and reinsert it to begin a test You will see the Apply Blood screen The meter is now ready to test a...

Страница 16: ...blood Do not squeeze around the puncture site 3 Test immediately after you have formed a small round blood drop as shown 4 Immediately touch the tip of the test strip to the drop of blood The blood i...

Страница 17: ...the first blood drop is not enough the meter will beep twice and display Apply More Blood to continue testing You have about 30 seconds to apply more blood onto the same strip If you do not re apply e...

Страница 18: ...t food or drink for at least 8 hours Before Meal The Before Meal marker is used when testing blood sugar levels within 1 hour before a meal After Meal The After Meal marker is used when testing blood...

Страница 19: ...is outside your Target range setting you will see your result without pushing a button To get the most from your AutoLog feature mark your test result right away If you make your AutoLog selection ve...

Страница 20: ...utton to move to See Options Leave the test strip in the meter to add a note related to this result or set a reminder Press the OK button and you can select Main Menu Add Reminder see page 30 or Add N...

Страница 21: ...ff your result will appear You may see the 5 second countdown screen Your test result appears Press the OK button to move to See Options Leave the test strip in the meter to add a note related to this...

Страница 22: ...feel symptoms of low blood sugar hypoglycemic unawareness If you get alternative site blood sugar results that do not agree with how you feel During illness or times of stress If you will be driving...

Страница 23: ...ructions 3 Select a puncture site from a fleshy area on the palm Avoid veins moles bones and tendons 4 Press the lancing device firmly against puncture site and then press the release button Getting a...

Страница 24: ...he tip of the test strip to the drop of blood The blood is pulled into the test strip through the tip Do not test the blood sample from palm if you get Smeared blood Clotted blood Runny blood Clear fl...

Страница 25: ...our result is above or below your set Target ranges you will always see your result without pushing a button Getting a Blood Drop for Alternative Site Testing If the first blood drop is not enough the...

Страница 26: ...e lancing device Your Bayer device has an automatic lancet ejection feature 2 Refer to the separate lancing device insert provided by Bayer for instructions on automatic ejection of the lancet WARNING...

Страница 27: ...causing other malfunctions Caring for Your Meter Caring for Your Meter CAUTION Avoid exposing meter and test strips to excessive humidity heat cold dust or dirt WARNING Potential Biohazard The lancing...

Страница 28: ...re and after testing and handling the meter lancing device or test strips NOTE If the meter is being operated by a second person who is providing testing assistance the meter and lancing device should...

Страница 29: ...alDevices Safety AlertsandNotices ucm224025 htm Cleaning Your Meter Supplies Needed for Cleaning Germicidal wipes containing 0 55 sodium hypochlorite bleach Paper towels 1 Carefully clean the meter wi...

Страница 30: ...ion to run into the meter through areas such as around the buttons or the meter s test strip or data ports 2 Dry all meter surfaces and test strip port using a clean paper towel if needed Cleaning You...

Страница 31: ...wipe carefully wipe all external and internal surfaces of the endcap until wet 4 Use the germicidal wipes to disinfect all exposed surfaces of your lancing device until wet For proper disinfection you...

Страница 32: ...new strip If you get a similar result call your health care professional as soon as possible Always consult your health care professional before changing your medication based on test results Expecte...

Страница 33: ...te and discard date on the control solution bottle DO NOT use expired materials CAUTION Use only CONTOUR NEXT control solutions from Bayer Normal Low and High with your CONTOUR NEXT blood glucose moni...

Страница 34: ...e dispensing a drop 7 Squeeze a small drop of solution onto a clean nonabsorbent surface Do not apply control solution to your fingertip or to the test strip directly from the bottle 8 Immediately tou...

Страница 35: ...ompare your control test result with the range printed on the test strip bottle or the bottom of the test strip box 12 Remove the test strip and dispose as medical waste If the result you get does not...

Страница 36: ...ons is highlighted Setting a Reminder After Testing 2 Press the button to select Add Reminder 3 Press the OK button to start the countdown The default time is either 2 hours or the last reminder time...

Страница 37: ...K button to continue 2 Press the or button to select the minutes in 15 minute increments 3 Press the OK button to continue Changing the Reminder Time Turning Off a Reminder After Testing 1 Press the O...

Страница 38: ...the test strip from the meter The meter retains the Reminder time that you set until you change it A screen confirms the Reminder Countdown time Getting a Reminder When the Reminder time is reached 20...

Страница 39: ...leted and saved to the Logbook To review these entries in the Logbook 1 Press and hold the OK button until the meter turns on 2 Press the OK button again to select Logbook from the Main Menu When you...

Страница 40: ...e visible until you scroll up or down Press the OK button when your choice is highlighted A screen confirms your choice All options may not be available based on the meal marker you choose HINT You ca...

Страница 41: ...1 test result Above Target 10 test results In Range and 2 test results Below Target In this example the Target Range is 3 9 7 2 mmol L for the 14 days Trends Averages and Summaries The Trends feature...

Страница 42: ...ress the button to see your 14 day Before Meal Summary This example shows 3 test results Above Target 20 test results In Range and 2 test results Below Target In this example the Target Range is 3 9 7...

Страница 43: ...your results for 14 days and shows an overall average for 58 readings of 6 6 mmol L 1 Select See More Trends and press the OK button 2 You can select the time period by highlighting your choice and p...

Страница 44: ...by pressing and holding the OK button 2 Press the button to select Trends and then press the OK button You will see your 14 day Overall Average first 4 Use the or button to highlight See More Trends o...

Страница 45: ...the OK button Setup 1 Press and hold the OK button until the meter turns on To get to the Setup Menu In Setup you can Turn a Reminder on or off or Set a Reminder Change the Date Change the Time Set So...

Страница 46: ...nu you will see a list of options with the Reminder option highlighted 3 To change a Reminder press the OK button and follow steps on page 31 Changing the Reminder Time To leave the Reminder option as...

Страница 47: ...nd hold the OK button until the meter turns on 2 From the Setup Menu use the button to highlight the Date Press the OK button 3 Change will be highlighted Press the OK button 4 Select Month Day Year o...

Страница 48: ...Change Date and Time 7 Change day highlighted by using the or button Press the OK button Time 1 Press and hold the OK button until the meter turns on 2 From the Setup Menu use the button to highlight...

Страница 49: ...Continue 2 03 PM TIME Change AM PM Continue 2 05 PM Time 4 Change the time format if needed Press the OK button 6 Change minutes highlighted by using the or button Press the OK button 5 Change the hou...

Страница 50: ...g A screen will confirm your choice To turn off the Sound select Turn Off To keep the Sound on select Go Back The Setup menu appears upon completion Some sounds stay on even with the Sound turned off...

Страница 51: ...n 5 A screen then shows the current Target settings Press the OK button to Accept these Target ranges To change the Target range highlight Change and press the OK button To set Targets see the Target...

Страница 52: ...9 10 0 mmol L for After Meal These Target ranges are only available when AutoLog is ON If AutoLog is OFF you will have an Overall Target range only which is preset to 3 9 10 0 mmol L WARNING Discuss...

Страница 53: ...button to highlight Change and press the OK button 9 The Before Meal Target range will appear 3 9 7 2 mmol L You can Accept the Targets by pressing the OK button 6 Use the or button to change the high...

Страница 54: ...og is ON 10 To change the Target press the button to highlight Change and press the OK button 11 Use the or button to change the highlighted Before Meal Target value When you see the Target value you...

Страница 55: ...utton 15 To change the After Meal Target press the button to select Change and press the OK button 18 A screen confirms that Targets are set Done will be highlighted Press the OK button 16 Use the or...

Страница 56: ...ll 3 9 10 0 mmol L 4 The Overall Target screen will appear You can Accept the preset Target range by pressing the OK button Setting Targets When AutoLog is OFF 1 Press and hold the OK button until the...

Страница 57: ...elect Change press the or button until you see the Target value you want Press the OK button to move to the next Target value and use the or button to change the Target Press the OK button to Continue...

Страница 58: ...he OK button until the meter turns on 2 From the Setup Menu scroll down to Language and press the OK button 4 Press the OK button to confirm your choice The Setup Menu will appear in the language you...

Страница 59: ...isplay to show black background with white text or white background with black text 1 Press and hold the OK button until the meter turns on 2 From the Setup menu scroll down to Display and press the O...

Страница 60: ...gs Caring for Your Meter Store meter in the carrying case provided whenever possible Wash and dry hands well before handling to keep the meter and test strips free of water oils and other contaminants...

Страница 61: ...n a report with graphs and tables To make use of this feature you need GLUCOFACTS DELUXE diabetes management software from Bayer and a 1 meter or 3 foot long USB A to MicroUSB B cable This type of cab...

Страница 62: ...ld batteries Replace with two 3 volt lithium batteries DL2032 or CR2032 Turn off your meter before changing your batteries Press firmly on the battery cover and slide in the direction of the arrow Pla...

Страница 63: ...E21 Result Over 33 3 mmol L Wash hands or test site Repeat test with new strip Continue Error Detection Displays For Result Above 33 3 mmol L or Below 0 6 mmol L If your blood sugar reading is under 0...

Страница 64: ...ue E02 E03 E04 Used Test Strip Remove used strip Repeat test with a new strip Strip Upside Down Remove strip and insert correctly Wrong Strip Inserted Remove strip Repeat test with CONTOUR NEXT strip...

Страница 65: ...hen you phone Locate the model number A and serial number B on the back of the meter Locate the test strips expiration date on the bottle Check the battery status Parts Information To replace missing...

Страница 66: ...412 of 420 98 1 419 of 420 99 8 Acceptance criteria in ISO 15197 2013 are that 95 of all differences in glucose values i e between reference method and meter should be within 0 83 mmol L for glucose v...

Страница 67: ...282 1 4 Intermediate precision which includes variability across multiple days was evaluated using 3 control solutions With each of 3 lots of CONTOUR NEXT Test Strips each control was tested once on e...

Страница 68: ...ding to the Canadian Diabetes Association www diabetes ca some of the most common symptoms are Low blood glucose Hypoglycemia shakiness sweating fast heartbeat blurred vision confusion passing out sei...

Страница 69: ...ied in ISO 15197 2013 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...

Страница 70: ...AD glucose dehydrogenase FAD GDH and a phenothiazine derivative as a mediator Electrons are generated producing a current that is proportional to the glucose in the sample After the reaction time the...

Страница 71: ...ition 2011 http www accessmedicine com 5 Tietz Fundamentals of Clinical Chemistry 5th Edition Edited by Burtis CA and Ashwood ER W B Saunders Co Philadelphia PA 2001 p 444 Limitations Preservatives Bl...

Страница 72: ...aged due to abuse accidents alteration misuse neglect maintenance by someone other than Bayer HealthCare or failure to operate the instrument in accordance with instructions Further Bayer HealthCare a...

Страница 73: ...DELUXE diabetes management software from Bayer BAYER HEALTHCARE MAKES NO OTHER EXPRESS WARRANTY FOR THIS PRODUCT THE OPTION OF REPLACEMENT DESCRIBED ABOVE IS BAYER HEALTHCARE S ONLY OBLIGATION UNDER...

Страница 74: ...Replacement 56 Before Meal Marker AutoLog 12 Care and Maintenance 54 Control Solution Testing 27 Display Background 53 Errors 57 Fasting Marker 12 GLUCOFACTS DELUXE diabetes management system 55 Lanc...

Страница 75: ...al After Meal 46 Target Settings 46 Technical Information 60 Test Reminders 30 Getting a Reminder 32 Setting a Reminder 40 Setting a Reminder After Testing 30 Turning Off a Reminder 40 Testing Your Bl...

Страница 76: ...84671533 Rev 04 15 Manufactured for Bayer HealthCare LLC Subsidiary of Bayer Corporation 430 South Beiger Street Mishawaka IN 46544 USA Distributed in Canada by Bayer Inc 2920 Matheson Blvd East Missi...

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