® Blood Glucose Monitoring System 10/13/12 12:24 PM mmol/L 5.2 Before Meal See Options Uses only CONTOUR®NEXT blood glucose test strips from Bayer USER GUIDE 84194034_CntrNEXT_UG_ENca_FpBp_v1.indd ofc1 7/8/14 8:59 AM FC: 21 mm BC: 8 mm Footer: 7.5 mm 1/3rd of the Cross clear space has been applied.
INTENDED USE The CONTOUR®NEXT blood glucose monitoring system from Bayer (meter, test strips and control solution) is intended for use by persons with diabetes for self-testing and by health care professionals for use on a single patient. The CONTOUR NEXT system is intended for the quantitative measurement of glucose (from 0.6 mmol/L to 33.3 mmol/L) in fresh capillary whole blood samples drawn from the fingertip or palm. Venous whole blood samples may also be used by health care professionals.
PRECAUTIONS • • • • • • • Read your CONTOUR®NEXT user guide, the lancing device package 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. 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 9 a.m. to 9 p.m.
Table of Contents ® Easy: The CONTOUR NEXT blood glucose monitoring system is about simplicity. You will notice this the first time you use it. Automatic: The CONTOUR NEXT meter from Bayer is designed with No Coding technology, to automatically code itself every time you insert a test strip. It will also automatically mark a control solution test. Test Reminders ....................................................................30 Logbook .................................................................
GETTING STARTED Date Test Result In Target 13.10.12 Time 12:24 mmol/L AutoLog Meal Marker 5.
GETTING STARTED Initial Setup GETTING STARTED Your CONTOUR®NEXT Test Strip 1. Press and hold the OK button until the meter turns on. After a welcome screen, you will see the Select Language screen. LANGUAGE Your CONTOUR®NEXT Test Strip Grey Square End Insert this end into the test strip port 2. Press the button if needed to select your desired language. Press the button to scroll down to see more language choices.
Getting Ready to Test TESTING Getting Ready to Test WARNING WARNING: Potential Biohazard The lancing device provided by Bayer is intended for single patient use only. The lancing device should not be used for assisted blood draws by health care providers or at health care provision sites, and should 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.
Inserting the Test Strip 2. Hold the test strip with the grey square end facing toward the meter. Inserting the Test Strip 4. Twist off the round protective lancet cap. Save it for disposing of the used lancet. Preparing the Lancing Device TESTING TESTING 3. Insert the lancet firmly into the lancing device until it comes to a full stop. 1. Remove a CONTOUR®NEXT test strip from ottle lid the bottle. Tightly close the bottle emoved the immediately after you have removed test strip. 3.
Getting the Blood Drop – Fingertip Testing Apply More Blood Apply More Blood to continue testing. Getting the Blood Drop – Fingertip Testing (E01) Too Little Blood Remove used strip. Repeat test with new strip. If you do not re-apply enough blood within about 30 seconds, you will see a screen telling you to remove the strip and start with a new strip. Apply More Blood 2. Stroke your hand and finger toward the puncture site to form a drop of blood. Do not squeeze around the puncture site.
TESTING Test Results Your meter comes with an AutoLog feature that lets you mark your test result as Fasting, Before Meal, After Meal and No Mark. Fasting – The Fasting marker is used when testing blood sugar levels after going without 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 sugar levels within 2 hours after the first bite of a meal.
Test Results with AutoLog Off 10/13/12 10:20 PM mmol/L 8.2 After Meal Testing... After making your selection, your test result appears. Press the OK button to move to See Options. 5 After applying blood to the test strip when AutoLog is Off, your result will appear. You may see the 5 second countdown screen. HINT: The screen above shows a result that is within the Target Range you set for an After Meal result.
Alternative Site Testing (AST) - Palm WARNING Ask your health care professional if Alternative Site Testing is right for you. ® TESTING Alternative Site Testing (AST) - Palm 84194034_CntrNEXT_UG_ENca_FpBp_v1.indd 16-17 3. Select a puncture site from a fleshy area on the palm. Avoid veins, moles, bones and tendons. Getting a Blood Drop for Alternative Site Testing 16 1. Wash your hands and the puncture site with soap and warm water. Rinse and dry well. 2.
Apply More Blood to continue testing. 6. Lift the device straight up and away from the skin without smearing the blood. If 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. Immediately touch the tip of the test strip to the drop of blood. The blood is pulled into the test strip through the tip.
Ejecting and Disposing of the Used Lancet TESTING • Dispose of the used lancet as medical waste or as advised by your health care professional. • Do not reuse lancets. Use a new lancet each time you test. 20 ® 84194034_CntrNEXT_UG_ENca_FpBp_v1.indd 20-21 • The lancing device, lancets and test strips are for single patient use. Do not share them with anyone including other family members! Do not use on multiple patients. • Always dispose of the used test strip and lancet as medical waste.
Cleaning and Disinfection TESTING WARNING Cleaning and Disinfection NOTE: If the meter is being operated by a second person who is providing testing assistance, the meter and lancing device should be disinfected prior to use by the second person. Health care professionals should follow their institution’s policy on the frequency of disinfection. The cleaning and disinfecting directions provided will not cause any damage or degradation to the external case, buttons or display.
Disinfecting Your Meter Supplies Needed for Disinfecting: 2. Remove the endcap and lancet, if present. TESTING TESTING • Germicidal wipes containing 0.55% sodium hypochlorite (bleach) • Paper towels • Timing device 1. Before disinfecting, clean the meter as described in Cleaning Your Meter. 1. Before disinfecting, clean the lancing device as described above in Cleaning Your Lancing Device. For proper disinfection, you must keep all meter surfaces wet for 60 seconds.
Expected Test Result Values Blood sugar values will vary depending on food intake, medication dosages, health, stress, or activity. Non diabetic plasma glucose concentrations are normally maintained within a relatively narrow range, roughly 3.9 mmol/L – 6.1 mmol/L in the fasting state.4 Control Solution Testing CAUTION: Use only CONTOUR®NEXT control solutions from Bayer (Normal, Low and High) with your CONTOUR®NEXT blood glucose monitoring system.
1. Remove the test strip from the bottle and firmly snap the lid closed. 2. Hold the test strip with the grey square end facing up. TESTING Apply Blood 5. Shake the control solution bottle well, about 15 times before every use. 6. Remove the bottle cap and use a tissue to wipe away any solution around the bottle tip before 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.
Test Reminders Turning Off a Reminder After Testing A reminder for your next test can be set after testing or from the Setup menu. See page 40 for Setting a Reminder from the Setup Menu. 1. Press the OK button and if the Countdown is currently on, the screen will show Reminder in. Setting a Reminder After Testing 12/05/12 10:20 PM mmol/L 5.2 Before Meal 1. With the test strip still in the meter, press the OK button when See Options is highlighted. FEATURES REMINDER 2.
Logbook Reviewing the Logbook Reminder in: 2 hrs 30 mins OPTIONS When the Reminder feature is on, the clock symbol is in the header area of many of the menu screens. Remove the test strip from the meter. The meter retains the Reminder time that you set until you change it. Getting a Reminder Continue HINT: If you are testing within 15 minutes of the Reminder, the Reminder will be cancelled. 12:35 AM 1. Press and hold the OK button until the meter turns on. 2.
Notes Trends (Averages and Summaries) Adding a Note The Trends feature displays your average and a summary of your test results as they compare to your targets, over a period of time that you select. The options available are 7, 14, 30 and 90-day averages. Your meter has been preset to 14-day averages. You can review your 14-day Fasting, Before Meal, and After Meal Summaries and Averages. Your 90-day average is not intended to be reflective of your HbA1c result.
Before Meal Average (14 Day) 6.5 mmol/L Overall Average (14 Day) 4. Continue to press the button to see your 14-day Before Meal Average. Readings: 25 3 Above Target 20 In Range 2 Below Target After Meal Average (14 Day) 8.2 mmol/L Readings: 23 3 Above Target 19 In Range 1 Below Target TARGET: 3.9 - 10.0 Before Meal Average (14 Day) 19.1 mmol/L ABOVE TARGET If it happens that your AVERAGE is above or below your target ranges, you will see an added message as shown.
Viewing Trends with AutoLog Off Setup If you have AutoLog turned off, you will only see trends for your overall Target. 1. Turn on the meter by pressing and holding the OK button. 2. Press the button to select Trends and then press the OK button. In Setup you can: Overall Average (14 Day) 6.
Setting a Reminder DATE SETUP Reminder: Off Date Time Sound AutoLog SETUP 1. Press and hold the OK button until the meter turns on. 2. On the Setup Menu, 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 it is set, press the button to go back to Main Menu.
DATE TIME Change Day: 9/23/12 Select Time Format: 7. Change day (highlighted) by using the or button. Press the OK button. 1:03 PM 4. Change the time format if needed. Press the OK button. 12-hour clock 24-hour clock Continue TIME Date set: 9/23/12 TIME Change minutes: SETUP Date and Time 2:05 PM 6. Change minutes (highlighted) by using the or button. Press the OK button. Continue Time 1. Press and hold the OK button until the meter turns on. 2.
AutoLog Your meter comes with AutoLog turned On. Time set: 2:05 PM AutoLog Settings 8. Done will be highlighted. Press the OK button. Time Sound AutoLog: On Targets Language Done Change Sound Your meter comes with the Sound turned on. Certain error messages and the Reminder bell override any Sound setting. One long beep indicates a confirmation when Sound is On. Two beeps indicates an error or something that needs your attention when Sound is On. FEATURES SOUND Sound is On.
Blood Sugar Target Ranges ® Your CONTOUR NEXT meter comes preset with blood sugar Target ranges for Fasting, Before Meal, and After Meal results. The preset range is 3.9 - 7.2 mmol/L for Fasting and Before Meal, and 3.9 - 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 your Target range settings with your health care professional. TARGETS Fasting: 3.
TARGETS TARGETS Before Meal: 3.9 - 7.2 mmol/L Accept Change TARGETS Before Meal: 3.9 – 7.2 11. Use the or button to change the highlighted Before Meal Target value. When you see the Target value you want, press the OK button, and you will move to the next Target value. TARGETS Before Meal: 3.9 – 7.2 TARGETS After Meal: 3.9 – 10.0 Continue 16. Use the or button to change the Target value.
Setting Targets When AutoLog is OFF TARGETS SETUP Sound AutoLog Targets Language Display 1. Press and hold the OK button until the meter turns on. 2. From the Setup Menu, select Targets. Press the OK button. 3. Set Targets will be highlighted. Press the OK button. Set Targets More Information Overall 3.9 – 10.0 Continue 5. To change the preset Target, use the button to highlight Change and press the OK button. 6.
Language Display Background You can change the Display to show black background with white text, or white background with black text. 12:35 AM Logbook Trends Setup 1. Press and hold the OK button until the meter turns on. SETUP 2. From the Setup Menu, scroll down to Language and press the OK button. DISPLAY SETUP AutoLog Targets Language Display Customer Service FEATURES Language: English OK Continue No 52 Change Go Back 3. To change the display, select Change and press the OK button.
Transferring Results to a Computer This option is needed only if you are speaking to a Bayer Diabetes Care Helpline representative. It is not for use at any other time. The Helpline representative will give you a code to use to verify certain settings. You can transfer test results from the CONTOUR®NEXT meter to a computer, where they can be summarized in a report with graphs and tables.
Error Detection Displays Changing the Batteries Turn off your meter before changing your batteries. Press firmly on the battery cover and slide in the direction of the arrow. Changing the Batteries For Result Above 33.3 mmol/L or Below 0.6 mmol/L (E22) Result Under 0.6 mmol/L Follow Medical Advice Immediately. Continue (E21) Result Over 33.3 mmol/L Wash hands or test site. Repeat test with new strip. Continue • If your blood sugar reading is over 33.3 mmol/L, the next screen will tell you to retest.
System Support Information Strip Errors (E02) (E03) Used Test Strip Remove used strip. Repeat test with a new strip. Strip Upside Down Remove strip and insert correctly. (E04) Wrong Strip Inserted Remove strip. Repeat test with CONTOUR NEXT strip. A strip error displays if a used strip is inserted, the strip is inserted upside down, or the wrong strip is inserted. (E27) (E28) Too Cold To Test Move meter and strip to warmer area. Test in 20 minutes.
Technical Information User Accuracy Accuracy A study evaluating glucose values from fingertip capillary blood samples obtained by 221 lay persons showed the following results: 100% within ± 0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.55 mmol/L and 98.9% within ± 15% of the medical laboratory glucose concentrations at or above 5.55 mmol/L. The CONTOUR®NEXT blood glucose monitoring system was tested in 100 capillary blood samples using 600 CONTOUR®NEXT test strips.
Test Sample: Venous or capillary whole blood Test Result: Referenced to plasma/serum glucose Sample Volume: 0.6 μL Measuring Range: 0.6 - 33.3 mmol/L Countdown Time: 5 seconds Memory: Stores most recent 800 test results Battery Type: Two 3-volt lithium batteries (DL2032 or CR2032) Battery Life: Approximately 1000 tests (1 yr. average use) Operating Temperature Range: 5°C - 45°C Humidity: 10–93% RH Dimensions: 80 mm (H) x 53 mm (W) x 12.7 mm (T) Weight: 1.6 oz.
TECHNICAL INFORMATION ® 84194034_CntrNEXT_UG_ENca_FpBp_v1.indd 64-65 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 CONTOUR®NEXT 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.
Warranty Warranty TECHNICAL INFORMATION ® 84194034_CntrNEXT_UG_ENca_FpBp_v1.indd 66-67 67 TECHNICAL INFORMATION 66 5. Bayer HealthCare makes no warranty of the performance of the CONTOUR®NEXT meter or test results when used with any control solution other than CONTOUR®NEXT control solution. 6. Bayer HealthCare makes no warranty of the performance of the CONTOUR NEXT meter or test results when used with any software other than GLUCOFACTS®DELUXE diabetes management software from Bayer.
Index After Meal Marker (AutoLog) ............................................................ 12 Alternative Site Testing (AST) ........................................................... 16 AutoLog (Meal Markers) ................................................................... 12 Averages (Trends) ............................................................................. 35 Batteries ........................................................................................... 55 Low Batteries ........
Manufactured for: Bayer HealthCare LLC Subsidiary of Bayer Corporation Mishawaka, IN 46544 USA Distributed by: Bayer Inc. Toronto, Ontario M9W 1G6 Canada www.diabetes.bayer.ca Bayer Customer Service is available from 9 a.m. to 9 p.m. EST, 7 days a week at: 1-800-268-7200 www.diabetes.bayer.ca 4194034_CntrNEXT_UG_ENca_FpBp_v1.indd 70 ®/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.