® Wireless Blood Glucose Monitoring System 12:0 0 PM 5.2 Befo re M l 10 mmo /13 l L eal Rem inde r Note s 12:00 PM METER BG 5.2 mmol/L ® Uses only CONTOUR®NEXT blood glucose test strips from Bayer USER GUIDE 84766780_CntrNextLINK_UG_ENca_FpBp_v0.indd ofc1 7mm min. 4/3/13 8:46 AM FC: 17.25mm BC: 8.5mm Footer: 7mm 1/3rd of the Cross clear space has been applied.
INTENDED USE Talk to Your Health Care Professional The CONTOUR®NEXT LINK wireless blood glucose monitoring system from Bayer (meter, test strips and control solution) is intended for self-testing by persons with diabetes to monitor glucose concentrations for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertip or palm. It is intended for in vitro diagnostic use only.
PRECAUTIONS • • • • • • • • Read your CONTOUR®NEXT LINK user guide, the MICROLET®2 lancing device package insert, your Medtronic device user guide 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.
The CONTOUR®NEXT LINK meter from Bayer has a rechargeable battery. You must charge your battery before you can use your meter and you cannot do a blood sugar test while the battery is charging. Charge Your Meter Using a Wall Outlet or a Computer *Charger is available separately from Bayer Customer Service if not included in your meter kit. See contact information for Bayer Customer Service on back cover. vi 84766780_CntrNextLINK_UG_ENca_FpBp_v0.indd vi-1 Logbook ..........................
GETTING STARTED Your MICROLET®2 Lancing Device The CONTOUR®NEXT LINK Wireless Blood Glucose Monitoring System from Bayer Re-setting Handle Grip Indent The CONTOUR NEXT LINK wireless blood glucose monitoring system from Bayer works with CONTOUR®NEXT test strips from Bayer. Display Screen Lancet Holder Lancet Meter USB Plug Round Protective Cap Endcap Dial Adjustable Grey Endcap (fingertip) 12:00 PM l 10/13 5.
GETTING STARTED Turning the Meter On or Off • Press and hold the top Menu button to turn the meter on or off. • Insert a test strip to turn the meter on. • Meter turns off after 3 minutes of inactivity. Using the Main Menu MENU Logbook Trends Setup Initial Setup Meter Overview Using the Top Menu Button • When your choice is highlighted, make a selection by pressing OK. NOTE: Press and hold the or button to scroll through the list faster.
UTILITIES MENU GETTING STARTED LANGUAGE English Deutsch Español OK Set Language OK No 4. Press OK to confirm. If the correct language is not displayed, press No. Connect to a MiniMed Pump? OK Skip 5. If you are connecting to a MiniMed® pump now, press OK and go to Step 6. If not, press SKIP and go to Step 17. NOTE: Pump refers to your compatible Medtronic device. CONNECT TO PUMP Enter this Meter ID into your Pump: 123456 Next Go Back 6. STOP. Do NOT press ANY buttons.
GETTING STARTED REVIEW METER ID 1. 123456 2. -----3. ------ Enter this Meter ID into your pump: 123456 ? Next Go Back 14. Return to your CONTOUR NEXT LINK meter. After you have entered the meter ID into your compatible Medtronic device, press Next. Meter Send Options 15. After the meter and pump are connected, you set your Send Options. This controls how your meter sends blood glucose readings to your Medtronic pump. Your options are: Always Ask Me Never Always Ask me Never Send Options set.
GETTING STARTED The High and Low Alert feature tells you when your test result is above or below the settings you choose. Results above High are marked High Blood Sugar. Results below Low are marked Low Blood Sugar. Alerts appear as large orange numbers. NOTE: Alerts can only be set outside your selected Target Range(s). For additional information, you may contact Customer Service. Contact information for Customer Service is on the back cover. High: 14.
TARGET TESTING Fasting 4.0 - 7.0 mmol/L Before Meal 4.0 - 7.0 mmol/L After Meal 5.0 - 10.0 mmol/L OK 4.2 - 10.0 24. To change the Targets press the or button until the desired Target is reached and then press OK. Press Accept on confirmation screen. You can change these settings later by going to the Main Menu and selecting Setup. See page 49. Setup is complete. Insert strip to start a test. Initial Setup is complete. You may now test your blood sugar. See Testing, below.
TESTING Preparing the Test Strip 5. Replace the grey endcap before getting blood drop. 6. The puncture depth depends on the endcap setting and the amount of pressure applied to the puncture site. Rotate the endcap dial to adjust the puncture depth. 2. Hold the test strip with the grey square end facing up. 3. Insert the grey square end into the test strip port until the meter beeps (if the Sound is set to ON). APPLY BLOOD You will see the Apply Blood screen. The meter is now ready for you to test.
3. Test immediately after a good drop of blood has formed. Test Results Testing With AutoLog Off TESTING... 5 TESTING TESTING 9.3 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. After applying blood to the test strip when AutoLog is turned OFF, your result will appear after the 5 second countdown. If Always was selected in Send Options during Setup, Send your result is automatically sent to your pump.
YOUR RESULTS Testing With AutoLog On AUTOLOG Fasting Before Meal After Meal No Mark OK After you apply blood to the test strip, use the to select Fasting, Before Meal, After Meal, or No Mark, and then press OK. (Scroll down to see No Mark.) TESTING The Before Meal marker can be used when Before Meal testing blood sugar levels within 1 hour before a meal. After Meal The After Meal marker can be used when testing blood sugar levels within 2 hours after a meal.
TESTING Getting a Blood Drop for Alternative Site Testing 1. Wash your hands and the puncture site with soap and warm water. Rinse and dry well. 2. Attach the clear AST endcap to the MICROLET®2 lancing device. 3. Select a puncture site from a fleshy area on the palm. Avoid veins, moles, bones, and tendons. ® 20 84766780_CntrNextLINK_UG_ENca_FpBp_v0.indd 20-21 5. Maintain steady pressure until a small, round blood drop forms. 6.
STRIP UNDERFILLED If the first blood drop is not enough, the meter will beep twice and display “STRIP UNDERFILLED” and “APPLY MORE BLOOD NOW.” You have about 30 seconds to apply more blood to the same strip. Too Little Blood Remove used strip. Repeat test with new E01 strip. Fasting Before Meal After Meal No Mark Removing the Used Lancet 1. In one hand, hold the lancing device with your thumb on the grip indent, with your other hand, hold the endcap as shown, and gently snap off the endcap. 9.
TESTING Test Results — Expected Values Test Results — Expected Values High and Low Blood Sugar Alert Screens Your meter has been preset with a low blood sugar (hypoglycaemia) value of 3.9 mmol/L and a high blood sugar (hyperglycaemia) value of 13.9 mmol/L. These are the preset values, but can be customized by you and/or your health care professional. You can change the High and Low Alert levels under Main Menu, Setup option (see page 52).
10:30 AM | 10/11 14.0 mmol L High Blood Sugar Reminder Notes ADD NOTES TESTING OK WARNING Shake the control solution well before testing. CAUTION: Use only CONTOUR®NEXT control solution from Bayer (Normal, Low and High) with your CONTOUR®NEXT LINK blood glucose monitoring system. Using anything other than CONTOUR NEXT control solution can cause inaccurate results.
2. Hold the test strip with the grey square end facing up. 3. Insert the grey square end of the test strip into the test strip port until the meter beeps. 4. You will see the Apply Blood screen. The meter is now ready for you to test. Control Solution Testing 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. 6.7 11. Compare your control test result to the ranges printed on the test strip bottle. 12. Remove test strip.
Features Your CONTOUR®NEXT LINK meter includes many testing features. AutoLog (Marking Your Results) Your meter comes with an AutoLog feature that lets you Before Meal, After mark your test result as Fasting, Meal and No Mark. Your meter comes with AutoLog OFF. If you would like to see your results when Fasting, Before Meal or After Meal, we recommend that you turn on this feature (see page 47).
REMINDER COUNTDOWN 2 hrs REMINDER COUNTDOWN 2 hrs Start Change Go Back Start Change Go Back 2. Press Start to begin the countdown. The preset time is 2 hours or, if you have changed it, the last reminder time that you set is now the default. You can change the Reminder Countdown time by pressing Change. Turning Off a Test Reminder FEATURES 10:30 AM | 10/11 Test Reminders After Meal REMINDER REMINDER IN 1 hr 30 mins Reminder Notes Stop Change Go Back 2. To stop the countdown, press Stop.
Notes Using the Main Menu You may add notes to your test result that may help explain results. Your notes will be saved in the Logbook. The option to add a note is available only after a test result. 1. From the test result screen, press Notes. The Main Menu has three choices: Logbook, Trends, and Setup. Select one by pressing the button next to your choice.
Viewing Trends With AutoLog On The Trends feature displays your averages and your 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, but you can change this under Trends Range in the Setup Menu (see page 51). Your 90 day average is not intended to be reflective of your HbA1c result. 1. Press and hold the top Menu button to turn the meter on. 2.
Setup PUMP OPTIONS You can view and change options on your meter and personalize it from the Setup Menu. 1. Press and hold the top Menu button to turn the meter on. 2. Press the button next to Setup. SETUP The current settings in the meter for the Reminder, Date, Time, Sound and AutoLog can be viewed by scrolling through the Setup Menu items. To view the settings of the other items, or to make any changes to any of the items, you can select the item using the and keys and pressing OK.
UTILITIES MENU Alarm Clock Connect Devices Block DEVICE OPTIONS Meters Remotes Other Devices 8. Scroll to Connect Devices and press ACT. Then scroll to Meters and press ACT. METER ID MENU Add ID Delete ID Review ID Off On METER OPTION METER ID MENU Add ID Delete ID Review ID 12. To add a new meter, select Add ID and press ACT. Refer to Step 6 (or see meter back) to find meter ID (SN). Use the up and down arrow buttons to enter the six character meter ID shown on the meter screen.
Send Options set. Meter will ask you OK before sending results. 16. The next screen confirms your Send Option choice. Press OK. NOTE: If you want to disconnect the pump from the meter, you do not need to take action on your meter. Please refer to your Medtronic device user guide.
REMINDER CHANGE COUNTDOWN OK 3 hrs 15 mins Reminder in: 3 hrs 15 mins Change Done 5. After you have selected hours, press OK. After you have selected minutes, press OK. 6. A confirmation screen appears and you can select Change or Done. Turning Off a Reminder To turn off a reminder, you can use the Setup Menu, or do a blood sugar test within 15 minutes of the reminder time. To use the Setup Menu: 1. Press and hold the top Menu button to turn the meter on. 2. Press the button next to Setup.
Setting or Changing the Time 1. Press and hold the top Menu button to turn the meter on. 2. Press the button next to Setup. SETUP Date Time: 11:30 Sound 11:30 TIME SELECT SETUP Change Go Back 12 Hour Clock 24 Hour Clock OK 10:30 AM Time Sound: On AutoLog OK 5. Select either the 12 Hour Clock or 24 Hour Clock option. 6. Press the or button to select the correct hour and minute. Press OK after each selection. 7.
SETUP Sound AutoLog: Off Target OK 3. Press the button to highlight AutoLog. Press OK to select. AUTOLOG AutoLog is Off. Accept 4. Press Turn On to activate AutoLog. Turn On AutoLog is On. A screen confirms your choice. AutoLog NOTE: Your meter comes with AutoLog OFF. 1. Press and hold the top Menu button to turn the meter on. 2. Press the button next to Setup. OK 3. Press the button to highlight AutoLog. Press OK to select. 48 Targets are your personal ranges for your blood sugar results.
TARGET OK 4.2 - 10.0 5. Use the or button to change each value of the Target. Press OK after each selection. Target is set. Done Change Changing Targets With AutoLog On CONTOUR®NEXT When AutoLog is ON, your LINK meter comes preset with the following Target ranges for testing: Fasting Before Meal After Meal 3.9 - 7.2 mmol/L 3.9 - 7.2 mmol/L 3.9 - 10.0 mmol/L Ranges can be changed to personal Targets decided by you and/or your health care professional.
TRENDS RANGE 7 Day 14 Day 30 Day 90 Day OK 6. Select 7, 14, 30 or 90 Day by using the button and then press OK. A screen confirms your choice. High and Low Alerts High and Low Alerts 1. Press and hold the top Menu button to turn the meter on. 2. Press the button next to Setup. SETUP USING THE MAIN MENU HIGH AND LOW ALERTS High: 13.9 mmol/L Low: 3.9 mmol/L Alerts are set. Accept Change ® 52 84766780_CntrNextLINK_UG_ENca_FpBp_v0.indd 52-53 4.
Error Detection Displays Transferring Data to Medtronic’s CareLink® Personal Therapy Management Software • An error screen will always have an “E” with a number in the lower left corner of the display. Transferring Data to Medtronic’s CareLink® Personal Therapy Management Software You can easily transfer blood glucose results from your meter to CareLink Personal Therapy Management software.
MENU Logbook Trends Setup Charge Soon Battery low. A series of low battery alerts tell you that the battery is low and to Charge Soon. A40 If you do not charge the battery, a display alerts you: “Shutting down, Battery is dead.” You must charge immediately. Shutting Down Battery is dead. A42 Battery Status Displays Plug the meter into your wall charger or into the USB port of your computer. Be sure your computer is turned on and not in sleep, hibernate or power save mode.
End of Meter Life/Battery Removal NOTE: Carry out this process only when you no longer intend to use the meter. Meter will not be functional once opened to remove the battery. End of Meter Life/Battery Removal Pry up rechargeable battery here (A). Disconnect battery by pulling battery connector (B). B Dispose of the meter and lithium polymer battery in accordance with your local/country laws and regulations.
Technical Information Precision Accuracy A repeatability study was conducted with the CONTOUR®NEXT LINK blood glucose monitoring system using five venous whole blood specimens with glucose levels from 2.4 to 18.2 mmol/L. Multiple replicates (n=100 per lot) were tested using multiple CONTOUR NEXT LINK blood glucose meters and 3 lots of CONTOUR®NEXT test strips. The following precision results were obtained.
Service Information The CONTOUR®NEXT LINK system is designed for use with 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).9 If you have a problem and none of the problem solving messages on the meter help, contact Bayer Customer Service. Please see back cover for contact information. We have trained specialists to help you.
Symbols Used System Specifications The following symbols are used throughout the product labeling for the CONTOUR®NEXT LINK blood glucose monitoring system (meter packaging and labeling, and reagent and control solution packaging and labeling). Control Range Low Test Sample: Capillary whole blood Test Result: Referenced to plasma/serum glucose Sample Volume: 0.6 μL Measuring Range: 1.1 mmol/L to 33.
Caring for Your Meter 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 or USB plug. • Handle the meter carefully to avoid damaging the electronics or causing other malfunctions.
Disinfecting Your Lancing Device Supplies Needed for Disinfecting: Buttons USB Connector (under cap) Strip Port 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. For proper disinfection, you must keep all meter surfaces wet for 60 seconds.
Replacement Parts Items 4. Use the germicidal wipes to disinfect all exposed surfaces of your lancing device until wet. 5. Dry all lancing device surfaces and endcap with a clean paper towel if needed. Signs of Deterioration Your MICROLET®2 lancing device has been tested for 260 cycles of the cleaning and disinfection procedure (one cycle per week for 5 years). The MICROLET 2 lancing device has been demonstrated to withstand 5 years of cleaning and disinfection without damage.
Manufacturer’s Warranty Warranty ® 72 84766780_CntrNextLINK_UG_ENca_FpBp_v0.indd 72-73 73 TECHNICAL AND CARE TECHNICAL AND CARE 5. Bayer HealthCare makes no warranty of the performance of the CONTOUR®NEXT LINK meter or test results when used with any control solution other than CONTOUR®NEXT control solution. 6.
Index Accuracy .........................................60 Alerts ...............................................10 Battery ...............................................55 High/Low Blood Sugar ......................25 Alternative Site Testing (AST) ..........19 Apply More Blood............................16 AutoLog/Meal Marking ..................... 9 Turning Off .........................................48 Turning On .........................................47 Averages/Trends .............................
Manufactured for: Bayer HealthCare LLC Subsidiary of Bayer Corporation Mishawaka, IN 46544 USA Distributed by: Bayer Inc. Toronto, Ontario M9W 1G6 Canada www.bayerdiabetes.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.bayerdiabetes.ca 4766780_CntrNextLINK_UG_ENca_FpBp_v0.indd 78 ®/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.
