LINK WIRELESS BLOOD GLUCOSE MONITORING SYSTEM USER GUIDE USES BAYER’S CONTOUR® OR CONTOUR®NEXT BLOOD GLUCOSE TEST STRIPS www.bayerdiabetes.com/us MST_CntrNextLINK_UG_EN_FpBp_v6.indd ofc1 5/18/11 2:54 PM FONTS 18211 NE 68th Street, E120 Redmond, WA 98052 T425-881-5454 DATE: CLIENT: DESCRIPTION: SCHAWK JOB#: BAN#: SKU#: DIMENSIONS: PRINTER SPEC: V-6 May 18, 2011 Bayer HealthCare Contour Next LINK User Guide Master English 905844 XXXXXXXX Rev. 02/11 N/A 6.0" (H) x 4.
Used test strips and lancets are possible biohazards and must be disposed of as medical waste. WARNING: • The meter and lancing device are for single patient use. Do not share them with anyone including other family members! Do not use on multiple patients!1,2 • All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.
Your Meter Features See page 8 for initial setup options. Your compatible Medtronic MiniMed device will only accept the glucose result if the Meter Option in your device’s Utility Menu is set to on and you have programmed the device with the meter’s ID (serial) number. Up to three different meter ID numbers can be accepted. See page 8 in “Initial Setup”. If you have entered your meter’s ID number into your compatible Medtronic MiniMed device, it can receive your blood glucose result.
Bayer’s CONTOUR NEXT LINK Blood Glucose Monitoring System Rechargeable Battery Your Bayer’s CONTOUR NEXT LINK meter has a permanent rechargeable battery. Before you do anything else, charge your meter with the wall charger included with your kit. You may also charge your meter by plugging the USB connector into a computer. Be sure the computer is turned on and not in sleep, hibernate or power saving mode. Your meter will briefly display “Do Not Test-Charging” and the test strip port light will flash.
Meter Overview ▲ Using the Menu Button • To turn on the meter, press and hold the Menu button until the meter turns on. TOP VIEW OK ▼ The Main Menu has 3 choices: Logbook, Trends and Setup. OK Button Getting Started Bayer’s CONTOUR®NEXT LINK meter is simple to use. Every screen gives you choices. The three buttons next to the screen allow you to make your selection by pressing the button next to your choice.
Initial Setup 1. Press and hold the Menu button until the meter turns on. After a welcome screen, you will see the Select Language screen. Getting Started First charge your meter. You can use your computer or the included wall charger to charge your meter. When you first turn on your CONTOUR®NEXT LINK meter, a setup sequence begins. The Setup process walks you through the steps for meter setup and allows your meter to connect to your compatible Medtronic MiniMed device.
AutoLog Feature The high and low limits feature alerts you when you go above or below the settings you choose. Alerts appear as large orange numbers (see page 34). Initial Setup: AutoLog Feature Your meter comes with a AUTOLOG Before Meal simple AutoLog feature that After Meal lets you mark your test result as Before Meal or After No Mark Meal during the 5 second test countdown. You can select No Mark if you are testing at times other than before or after a meal. Your meter comes with AutoLog turned on.
Information for Safety Need Help? Call toll free: 1-800-348-8100 MST_CntrNextLINK_UG_EN_FpBp_v6.indd 12-13 Have all the materials you will need ready before you begin testing. This includes your CONTOUR®NEXT LINK meter, CONTOUR® or CONTOUR®NEXT test strips, and the MICROLET®2 lancing device and MICROLET® lancets. You will also need control solution made for your test strips to perform a quality control check. The MICROLET 2 lancing device is intended for self testing by a single patient.
1. Wash and dry your hands well before testing. ® Testing 2. Remove a test strip from CONTOUR NEXT or CONTOUR® bottle. Tightly close the bottle lid immediately after you have removed the test strip. 3. Hold the test strip with the gray end facing up. Getting Ready to Test 4. Insert the gray end into the test strip port on the meter. 14 APPLY BLOOD Need Help? Call toll free: 1-800-348-8100 MST_CntrNextLINK_UG_EN_FpBp_v6.
Getting the Blood Drop For fingertip testing 3. Insert the lancet firmly into the lancing device until it comes to a full stop. Getting Ready to Test Testing 2. Stroke your hand and finger towards the puncture site to form a drop of blood. Do not squeeze around the puncture site. 5. Replace the gray endcap. 3. Test immediately after you have formed a small, round blood drop (0.6 μl). If the first blood drop is not enough, the meter may beep Suggested Drop twice and display “STRIP UNDERFILLED.
If you are using a STRIP UNDERFILLED CONTOUR®NEXT test strip, you have 20 seconds to APPLY MORE BLOOD NOW apply more blood onto the same strip. If you are not able to provide more blood within that time, discard that strip and start over with a new strip. Follow the instructions on the meter screen. 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.
Removing the Used Lancet CAUTION: CONTOUR® test strips should not be used for Alternative Site Testing (AST) with the CONTOUR®NEXT LINK meter. 1. In one hand, hold the lancing device with your thumb on the grip indent, with your other hand, hold the gray endcap dial as shown, and gently snap off the endcap. Testing Your Blood IMPORTANT: Do not use Alternative Site Testing under the following conditions. Use fingertip testing in any of these cases: 3.
Alternative Site Testing on the palm can only be performed using the CONTOUR®NEXT test strip. Alternative Site Testing is recommended only when it is more than two hours after a meal, diabetes medication, or exercise. NOTE: AST testing (palm only) can only be done using a CONTOUR NEXT test strip. Testing 1. Attach the clear AST endcap to the MICROLET®2 lancing device. Alternative Site Testing 2. Select a puncture site from a fleshy area on the palm. Avoid veins, moles, bones, and tendons. 3.
Testing in the Dark Testing With the meter off, give the Menu button two quick presses to turn on the test strip port light. Insert a test strip and the display screen will appear. Once blood is applied to the test strip the light will go off. Continue with your test. Two quick presses of the Menu button will turn the light off. Testing Your Blood Testing with AutoLog On Before your test result is displayed, the AutoLog screen appears.
Always dispose of test strip and lancet as medical waste. All products that come in contact with human blood should be handled as if capable of transmitting infectious diseases. Testing with AutoLog Off Accepted Testing 5 Stopping a Result While it is Being Sent If you want to stop the transmission of a result, press Cancel immediately and the transmission will be cancelled. (The transmission typically occurs in 5 seconds.) Be aware that the result cannot be resent later.
IMPORTANT: Cleaning and Disinfecting • You may want to test with Send Options set to off if you do not want to create a wireless signal (for example, if you have been asked to turn off all electronic devices on an aircraft). Your CONTOUR®NEXT LINK system should be cleaned and disinfected as recommended. Test Results Testing Your Blood Expected Values: Blood sugar values will vary depending on food intake, medication dosages, health, stress, or activity.
Disinfecting your Meter Disinfecting your Meter (cont’d) Supplies Necessary for Disinfecting: • Household bleach spray with 1.84% sodium hypochlorite • Paper towels • Cotton swabs • Timing device 4. To disinfect the test strip port, moisten a cotton swab with bleach spray and wipe all strip port surfaces until wet. Again, do not allow disinfecting solution to run into the meter. Testing Testing KEEP ALL STRIP PORT SURFACES WET FOR 60 SECONDS, WIPING CONTINUOUSLY.
Disinfecting your Lancing Device (cont’d) High and Low Blood Sugar Alert Screens 1. Before disinfecting, if the lancing device is soiled it must be cleaned as described in CLEANING YOUR LANCING DEVICE (see page 31). • If your blood sugar reading is under 20 mg/dL, the “Follow Medical Advice Immediately” screen will display and the meter will beep twice. Contact your healthcare professional. Testing • If your blood sugar reading is over 600 mg/dL the next screen will tell you to retest.
Control Solution Testing Your meter has been preset with a hypoglycemic (low blood sugar) value of 70 mg/dL and a hyperglycemic (high blood sugar) value of 250 mg/dL. These are the default values, but can be customized by you and/or your healthcare professional. Use only Bayer’s control solutions (Normal, Low and High) with Bayer’s CONTOUR®NEXT LINK blood glucose monitoring system. CONTOUR® control solution should only be used with CONTOUR test strips.
6. Replace the cap on the control solution bottle. APP LY BLO OD Testing 5. Squeeze a small drop of control solution onto a clean non-absorbent surface, such as a piece of wax paper. Do not apply control solution to the test strip directly from the bottle. Control Solution Testing 7. Immediately touch the tip of the test strip to the drop of control solution. If your control test result falls out of the specified range, call Customer Service, 1-800-348-8100.
Setting a Reminder 1. Press the Reminder button. 10:30 AM l 3/11 92 mg dL Before Meal Reminder Notes 2. Press the Start button to begin the countdown. The default time is 2 hours or the last reminder time that was set. Reminders and Notes REMINDER COUNTDOWN 2 hrs Start Change Go Back You can change the Reminder countdown time to the time you wish by pressing the Change button. REMINDER COUNTDOWN 2 38 hrs Start 2. Press the L or M button to select the minutes (in 15 minute increments).
From the Setup Menu MENU Reminder in: 2 hours Setup When the Reminder feature is on, the clock symbol is in the blue header. SETUP 2. If Reminder is set to off, press the OK button to change the Reminder settings. SETUP ▲ Reminders and Notes Reminder: Off Date Time OK ▼ 3. To start the countdown press the Start button or press the Change button to scroll to a different countdown time. Follow the instructions on the previous page.
A Reminder can be turned off or changed after testing or from the Setup menu. 1. Press the OK button. SETUP After Testing Reminder: On Date Time 1. Press the Reminder button. ▲ OK ▼ 10:30 AM l 3/11 mg dL 167 Before Meal Reminder Notes 2. Press the Stop button. The countdown is now stopped. The Reminder screen displays the remaining time. Reminders and Notes If the countdown is currently on, the screen will read “Reminder In:” with the remaining amount of time displayed.
Adding Notes When the Reminder time is reached, 20 beeps will sound. The meter will turn on and a Reminder screen will appear. You can stop the beeps by pressing the OK button or inserting a test strip. You may add Notes to your test result that may help explain results. Your notes will be saved in the Logbook. 2. Proceed with testing (see page 14).
Menu Button END OF LOGBOOK The most recent result is mg shown first and the oldest dL result last. When you reach the oldest entry you will see the After Meal End of Logbook screen. Your meter will store 1000 test results. 140 The Main Menu has 3 choices: Logbook, Trends and Setup. Menu Button/Logbook Main Menu Functions 46 • Select one by pressing the button next to your choice.
128 SETUP 1. Make your selection: Send Options or Connection. Send Pump Options Reminder: Off options controls when your Date blood glucose readings are sent to your compatible Medtronic MiniMed device. Choosing Connection will display steps to connect your CONTOUR®NEXT LINK meter to your compatible Medtronic MiniMed device. (Go to Step 6) 2. Press Send Options to change your current setting. PUMP OPTIONS Send Options Trends Connection 3. Press the M button to go to the 14 Day After Meal Average.
Setting the Date Pump Options 7. Press OK to continue the connection process. Press Go Back if you do not wish to continue the connection. 1. Press the Menu button to go to the Main Menu. 2. Press the Setup button. 3. Press the L or M button to select Date. Press the OK button. PUMP OPTIONS SETUP Send Options Connection ▲ Reminder Date: 3/11/09 Time 4. To change the date, press the Change button. CONNECT TO PUMP Connect to a Medtronic Pump? OK Go Back Main Menu Functions CONNECT TO PUMP 8.
Change 10/13/10 Done If you need to make changes, press the Change button and repeat the process. Setting the Time Setup: Setting the Time Main Menu Functions 52 1. Press the Menu button to go to the Main Menu. 2. Press the Setup button. 3. Press the L or M button to select Time. Press the OK button. SETUP 4. To change the time, press the Change button. OK ▼ TIME SELECT FORMAT 5. Select either the 12 hour clock or 24 hour clock button.
Sound is turned ON when you receive your meter. It can be turned off using the Setup menu. Some error messages and the Reminder bell will override the Sound off setting. One long beep indicates a confirmation. Two beeps indicate an error or situation that requires your attention. The AutoLog feature lets you mark your test result as Before Meal or After Meal during the test countdown. You can select No Mark if you are testing at times other than before or after a meal.
Changing the Blood Glucose Target Range Your CONTOUR®NEXT LINK meter comes preset with 70–130 mg/dL for Before Meal testing and 70–180 mg/dL for After Meal testing. Ranges can be changed to personal targets decided by you and/or your healthcare professional. 80 - 120 120 - 150 Change Done To make changes, press the Change button and repeat the process. 2. Press the Setup button. 3. Press the L or M button to select Target. Press the OK button.
High and Low Limits HIGH AND LOW LIMITS High: 250 mg/dL Low: 70 mg/dL ? 2. Press the Setup button. Change 3. Press the L or M button to select Language. Press the OK button. Choose Change if you wish to use different limits. HIGH AND LOW LIMITS 3. Press the L or M button to select your low limit. Press OK. HIGH AND LOW LIMITS 4. The next screen confirms your choices. Press Done. SETUP ▲ High and Low Limits Language Customer Service High: 251 mg/dL Low: 70 mg/dL 4.
Bayer’s CONTOUR NEXT LINK meter has only been tested for use with Medtronic’s CareLink Personal Therapy Management Software and Bayer’s GLUCOFACTS DELUXE diabetes management software. Bayer is not responsible for any erroneous results from the use of other software. For more information, call our Customer Service Department (1-800-348-8100), or visit our website at www.bayerdiabetes.com/us. 1.
E02 Used Test Strip Remove used strip. Repeat test with new strip. Error Detection and Battery Status/Charging/Removal If there is an error (hardware, software, testing errors) detected by your meter, your meter will beep twice. You will see specific instructions to guide you. The first line of the error screen will tell you what the error is. The next lines describe what you should do. When an error screen has an OK shown, press the button next to it to continue.
Shutting Down Battery is dead. A42 Error Detection and Battery Status/Charging/Removal Plug the meter into your wall charger or computer. Be sure your computer is turned on and not in sleep, hibernate or power save mode. Please be aware that USB ports in some When you plug your meter into your wall charger or computer, it will start to charge immediately. While the battery charges, the strip port light flashes slowly. Press the Menu button at any time to display the charging status.
End of Meter Life/Battery Removal Symptoms of High and Low Blood Sugar 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. You can better understand your test results by being aware of the symptoms of high or low blood sugar. TOP VIEW Pry up rechargeable battery here (A). Disconnect battery by pulling battery connector (B).
Capillary samples may be drawn from fingertip (CONTOUR strip) and fingertip and palm (CONTOUR®NEXT strip). The test provides a quantitative measurement of glucose in whole blood from 20 to 600 mg/dL. CAUTION: • For in vitro diagnostic use only. System Performance Information • Potential Biohazard: The CONTOUR®NEXT LINK meter is intended for use with only one person.
Precision and Accuracy Summary Technical Information This equipment has been tested and found to meet the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
Technical Information (cont’d) Service Information Table 3 — System accuracy results for CONTOUR®NEXT LINK meter using CONTOUR® test strips at glucose concentration < 75 mg/dL If you have a problem and none of the problem solving messages on the meter help, call Bayer Diabetes Care Customer Service. In the USA, call toll free: 1-800-348-8100 (7 days a week/24 hours a day). We have trained specialists to help you. Within ± 15 mg/dL 47/90 (52.2%) 85/90 (94.4%) 89/90 (98.
Batch code Consult instructions for use Symbols Used/System Specifications In Vitro Diagnostic Medical Device System Specifications Technical, Service & Care Test Sample: Capillary whole blood Test Result: Referenced to plasma/serum glucose Sample Volume: 0.6 μL Measuring Range: 20–600 mg/dL Countdown Time: 5 seconds Memory: Stores most recent 1000 test results Battery Type: Non-serviceable, 310mAh rechargeable lithium polymer battery, 3.4v – 4.
Caring for Your Meter REPLACEMENT PARTS • CAUTION: Only connect to a computer or charger that is certified to UL 60950-1, 5V maximum. A charging current of 500 mAh minimum is required. Part Number* Item • Wash hands and dry them well before handling to keep the meter and test strips free of oils and other contaminants. • Handle the meter carefully to avoid damaging the electronics or causing other malfunctions. • Avoid exposing meter and test strips to excessive humidity, heat, cold, dust, or dirt.
Warranty 1. A 90-day warranty only will be extended for consumable parts and/or accessories. Warranty 2. This warranty is limited to replacement due to defects in parts or workmanship. Bayer Diabetes Care shall not be required to replace any units which malfunction or are damaged due to abuse, accidents, alteration, modification, misuse, neglect, maintenance by someone other than Bayer Diabetes Care, or failure to operate the instrument in accordance with instructions.
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Bayer HealthCare LLC Mishawaka, IN 46544 USA Call Toll Free: 1-800-348-8100 www.bayerdiabetes.com/us Bayer, the Bayer Cross, CONTOUR, GLUCOFACTS, MICROLET, and the No Coding logo are registered trademarks and No Coding is a trademark of Bayer. Windows and Vista are registered trademarks of Microsoft. Mac OS is a registered trademark of Apple, Inc. YSI is a registered trademark of YSI Incorporated.