® Blood Glucose Monitoring System USER GUIDE 84194050_CntrNextEZ_UG_ENca_FpBp_v1.indd ofc1 7/8/14 11:36 AM FC: 18.5mm BC: 7mm Footer: 7mm 1/3rd of the Cross clear space has been applied. 18211 NE 68th Street, E120 Redmond, WA 98052 T: 425-881-5454 BAN#:84194050 Rev.
Intended Use Information For Safety CONTOUR®NEXT The EZ 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 EZ 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 only.
Table of Contents Your CONTOUR®NEXT EZ Meter Up/Down Scroll Buttons Test Strip Port Getting Ready to Test........................................................ 8 Getting the Blood Drop ................................................... 10 Testing Your Blood .......................................................... 11 Cleaning and Disinfection ............................................... 16 Control Solution Testing ..................................................
Your Meter Display GETTING STARTED Icon What it Means GETTING STARTED The picture below shows all the symbols that appear on your meter display. To view, with the meter off, press and hold ▲ or ▼. All display segments will appear for 10 seconds. If you need more than 10 seconds to check the display, press and hold ▲ or ▼ again. Top area on the display presenting date and time. Pre-meal result marker. Post-meal result marker. Your Meter Overview Your Meter Overview Identifies a Logbook entry.
GETTING STARTED • Results in mmol/L will always have a decimal point; • Results in mg/dL will never have a decimal point. Your Meter Features 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 27 - 35.
Information For Safety GETTING STARTED 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 lancing device and 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.
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. TESTING 2. Loosen the round protective cap on a lancet by rotating it ¼ turn, but do not remove it. TESTING 3. Hold the test strip with the gray end facing up. 4. Insert the gray end into the test strip port on the meter. The meter will turn on.
Getting the Blood Drop and Testing 1. Press the lancing device firmly against the puncture site and press the release button. TESTING Testing Your Blood Suggested drop size Testing Your Blood 3. Test immediately after a good blood drop has formed. Do not press the tip against the skin or place the blood on top Fingertip of the test strip or you Testing 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 .
Test Results 6. Remove the test strip to turn your meter off. Dispose of the used test strip as medical waste. 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 the Canadian Diabetes Association, standard medical practice goals for a non-pregnant individual with diabetes1: • Before a meal: 4.0 to 7.0 mmol/L • 2 hours after a meal: 5.0 to 10.
Ejecting and Disposing of the Used Lancet TESTING CAUTION: Avoid exposing meter and test strips to excessive humidity, heat, cold, dust, or dirt. • Store your meter in the carrying case provided whenever possible. • Wash hands and dry well before handling to keep the meter and test strips free of water, oils and other contaminants. • Keep blood, control solution, and cleaning fluid from entering the test strip port.
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: • Germicidal wipes containing 0.55% sodium hypochlorite (bleach) • Paper towels • Timing device 1. Before disinfecting, clean the meter as described in Cleaning Your Meter. TESTING Supplies Needed for Cleaning: • Germicidal wipes containing 0.55% sodium hypochlorite (bleach) • Paper towels 1. Clean the lancing device with germicidal wipes until all soil is removed. 2. Dry as necessary with a clean paper towel.
Control Solution Testing Use only CONTOUR®NEXT control solution with your CONTOUR®NEXT test strips. Using any other control solution may cause inaccurate 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. Quality Control Control Solution Testing 5. Shake the control solution bottle well, about 15 times before every use. Control Solution Testing • Unmixed control solution may cause inaccurate results.
8. Immediately touch the tip of the test strip to the drop of control solution. 9. Hold the tip in the drop until the meter beeps. TESTING Control Solution Testing NOTE: The 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. ® 22 84194050_CntrNextEZ_UG_ENca_FpBp_v1.
Setting the Time, Date and Sound Setting the Time, Date and Sound Setting the Month and Day Format m/d will now flash on the display. Press ▲ or ▼ to select the format you wish (m/d for month/day format or d.m for day.month format). Press M to set. Setting the Time SETUP AND USE The number in the hour position will now flash. Press ▲ or ▼ until you reach the current hour. Press M to set. The minute will now flash. Press ▲ or ▼ to select the current minute. Press M to set.
Setting the Sound Setting the Time, Date and Sound To turn the beep sound off during testing, press ▲ or ▼ . to display Press M to set. SETUP AND USE If you are using Basic Mode (L-1 will appear on your display), you have completed your meter set-up.
Personalizing LO, HI and Reminder Settings Personalizing LO, HI and Reminder Settings SETUP AND USE You have now completed your CONTOUR®NEXT EZ meter set-up for Advanced Mode. SETUP AND USE The LO setting will flash (default 4.0 mmol/ L). To change this setting, press ▲ or ▼ until you reach your desired LO setting, and then press M to set. (The range of values for LO is 3.3 5.0 mmol/L). To change the reminder time for post-meal testing, press ▲ or ▼ to display the options available. Select 2.5, 2.0, 1.
If you want to mark the test result If you have set up your meter in Advanced Mode, your meter will display three markers after you test your blood. Pre-meal = Marks a test result that was taken before a meal. Post-meal = Marks a test result that was taken after a meal. SETUP AND USE 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.
When the reminder sounds, the meter will automatically turn on. The reminder will beep 20 times, and the display will show the premeal 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). SETUP AND USE If you do not want to mark this test, remove the test strip to turn the meter off. Dispose of the used test strip as medical waste.
To Mark Results You Will See (Flashing) Post-Meal Press ▲ or ▼ (Flashing) Logbook Press ▲ or ▼ (Flashing) What It Means Press M Result is marked as a pre-meal test. You can now set a reminder. Press M Reminder is set to go off in the amount of time you have set (1.0–2.5 hours) to remind you to run a post-meal test. Press M Result is marked as a post-meal test. Press M Result is marked in memory as unique. You should note this in your logbook.
Viewing Basic Mode Results Press M to turn your meter on. Press M again to view the memory. Viewing Results: Basic Mode SETUP AND USE When appears on the display, you have viewed all of the results in the memory. SETUP AND USE Press ▲ 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.
Viewing Results: Advanced Mode Viewing Advanced Mode Averages In Advanced Mode (L-2), you have all of the options described in Basic Mode plus additional items available. Press M to turn your meter on. Press M again to view the 14 day average including the number of results used to obtain the average. 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.
Error Codes and Symbols SETUP AND USE Press ▲ again to view the 30 day average of results marked with a post-meal marker. Press ▲ again and you will see . Press M to turn the meter off, or it will automatically turn off after 3 minutes. What You See What It Means (will remain on the display) Low batteries. (will flash for 10 seconds and then the meter will turn off) Dead batteries. Replace the batteries. E1 E2 What You Should Do Replace the batteries as soon as possible.
If you do not resolve the problem, contact Bayer Diabetes Care Helpline at 1-800-268-7200. What You See E3 •Remove the test strip and retest using a new test strip. •The meter is sensing a used Wait until you see the flashing blood drop on the display test strip. before testing. •The wrong control solution •If control testing, make sure to use CONTOUR®NEXT was used. control solution. Test strip not inserted correctly. Remove and reinsert the test strip properly (see page 8).
If you do not resolve the problem, contact Bayer Diabetes Care Helpline at 1-800-268-7200. What You See What It Means What You Should Do Test strip or control solution Check all expiry dates and is past the discard dates. Do not use expiry date expired testing materials. or is past the discard date. Error Codes and Symbols Control solution is not at room temperature or may not be mixed well.
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.] 1. Turn off your meter before changing your batteries. 2. Press firmly on the battery cover and slide in the direction of the arrow. 5. Slide the battery cover back into place, lining up with the open slots, and close firmly.
Caring for Your Meter Caring for Your Meter Low blood glucose (Hypoglycemia): • shakiness • sweating • fast heartbeat • blurred vision • confusion • passing out • seizure • irritability • extreme hunger • dizziness High blood glucose (Hyperglycemia): • frequent urination • excessive thirst • blurred vision • increased fatigue • hunger Ketones (Ketoacidosis): • shortness of breath • nausea or vomiting • very dry mouth Information For Safety If you are experiencing any of these symptoms, test your blood g
System Specifications Specifications ® 50 84194050_CntrNextEZ_UG_ENca_FpBp_v1.indd 50-51 Need Help? 1-800-268-7200 www.diabetes.bayer.ca 51 TECHNICAL, SERVICE & CARE TECHNICAL, SERVICE & CARE Specifications Test Sample: Venous or capillary whole blood Test Result: Referenced to plasma/serum glucose Sample Volume: 0.6 μL Measuring Range: 0.6 - 33.
Specifications Technical Information 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. Peritoneal Dialysis Solutions: Icodextrin does not interfere with CONTOUR®NEXT test strips.
Technical Information Technical Information Table 3 – System accuracy results for glucose concentrations between 1.0 mmol/L and 25.6 mmol/L Table 4 – System repeatability results for CONTOUR®NEXT EZ meter using CONTOUR®NEXT test strips Within ± 0.83 mmol/L or ±15% 600 of 600 (100%) 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 values less than 5.
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: Bayer Inc.
Supplies Warranty When calling or writing for supplies be sure to include the number with the name of the replacement part or accessory item.
Manufactured for: Bayer HealthCare LLC Subsidiary of Bayer Corporation Mishawaka, IN 46544 USA Distributed by: Bayer Inc. Toronto, Ontario M9W 1G6 Canada 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 4194050_CntrNextEZ_UG_ENca_FpBp_v1.indd 60 ®/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.