wireless blood glucose monitoring system bef dl front view ...€¦ · bayer healthcare contour...

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Enter this Meter ID Enter this Meter ID into your pump: into your pump: 123456 123456 ? OK OK Go Back Go Back CONNECT TO PUMP CONNECT TO PUMP Automatically send results to the Pump? Always Always Ask me Ask me Never Never SEND OPTIONS SEND OPTIONS 70–130 70–130 70–180 70–180 METER ID MENU Add ID Delete ID Review ID REVIEW METER ID 1. 123456 2. ------ 3. ------ 10/10/10 10/10/10 10:30 AM 10:30 AM Accept Accept Change Change CURRENT DATE & TIME CURRENT DATE & TIME CONNECT TO PUMP CONNECT TO PUMP CONNECT TO PUMP CONNECT TO PUMP ? OK OK Go Back Go Back ? OK OK Go Back Go Back Connect to a Medtronic Pump? Enter this Meter ID into your Pump: 123456 ? Accept Accept Turn Off Turn Off AUTOLOG AUTOLOG AutoLog is on. ? Accept Accept Change Change CURRENT TARGET CURRENT TARGET Initial Setup is complete. Initial Setup is complete. HIGH AND LOW LIMITS HIGH AND LOW LIMITS ? Accept Accept Change Change High: 250 High: 250 mg/dL mg/dL Low: 70 Low: 70 mg/dL mg/dL OK OK OK ® QUICK REFERENCE GUIDE ® ® 93 mg dL Before Meal Before Meal 01:33PM l 11/10 01:33PM l 11/10 Reminder Reminder Notes Notes Uses Bayer’s CONTOUR ® NEXT Blood Glucose Test Strips Initial Setup of the Meter and Connection to Compatible Medtronic MiniMed Device 1 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 light will flash. You cannot do a blood glucose test while the battery is charging. When charging is finished, the test strip port light will turn off. Unplug your CONTOUR NEXT LINK meter to test. 2 To begin setup, hold down Menu button for several seconds until the meter turns on. 3 Choose your language and press OK. 4 Press OK on the next screen to begin the connection process. NOTE: Pump refers to your compatible Medtronic MiniMed device. 5 STOP. Do NOT press ANY buttons. This screen displays the meter ID number (in the bottom left corner). This ID is needed to complete the connection process. Put down your meter. Pick up the compatible Medtronic MiniMed device and continue with Step 6. 6 Press ACT to go to the MAIN MENU. Scroll to Utilities by pressing the down arrow. Press ACT. 7 Scroll to Connect Devices from the UTILITIES MENU and press ACT. Then scroll to Meters and press ACT. 8 Select On and press ACT. If you are replacing a meter, go to Step 9. If you are adding a new meter, go to Step 11. 9 To replace a meter, select Delete ID and press ACT. 10 If you have multiple meter IDs, repeat Step 9 for each one. 11 To add a new meter, select Add ID and press ACT. Refer to Step 5 (or see meter back) to find meter ID. Use the up and down arrow buttons to enter the six character meter ID shown on the meter screen. Press ACT after each character entry. 13 Return to your CONTOUR NEXT LINK meter. After you have entered the meter ID into your compatible Medtronic MiniMed device, press OK. 12 Select Review on your compatible Medtronic MiniMed device to confirm that your CONTOUR ® NEXT LINK meter ID has been correctly entered. If incorrect, go back to Step 9. NOTE: For detailed instructions, see your compatible Medtronic MiniMed device user guide. 14 SEND OPTIONS controls how your meter will send blood glucose readings to your compatible Medtronic MiniMed device. Choose the SEND OPTION that is best for you. Always = Meter will always send results. Ask Me = Meter will ask you before sending results. Never = Meter will never send results. 16 Choose your AUTOLOG settings. AUTOLOG allows you to mark a test as Before Meal, After Meal or No Mark. 17 The meter comes preset with the default target ranges as shown. Accept the default target ranges or Change them after talking to your health care professional. 18 Follow the display prompts to set your High and Low Limits. Choose Accept to use the default setting (250 mg/dL for the high limit and 70 mg/dL for the low limit). Choose Change if you wish to use different limits. Connecting Meter to Medtronic MiniMed Paradigm ® REAL-Time Revel™ insulin pump Choosing Meter Send Options Set Meter Date/Time to Match Medtronic Device Additional Meter Settings SETUP IS NOW COMPLETE! Setting Up the Meter  ? = Help MAIN MENU Basal Prime Utilities METER OPTION Off On METER ID MENU Add ID Delete ID Review ID METER ID MENU Add ID Delete ID Review DELETE METER ID 1. aaaaaa 2. bbbbbb 3. ------ ADD METER ID 123456 STAT STAT STAT STA STA STA STA ST STATUS US US US U100 U100 U100 U100 0 00 Batt t Batt Batt Batt t t Ba ery: ery: ery e ery: Nor r Nor Nor r Nor r r N r r rmal mal mal mal l l l l m S/N# S/N# S/N# N S/N# S/N# S/N# S/N# N N# N# N N 454 454 454 454 454 454 454 454 454 4 4 4 4056 056 056 056 56 056 056 56 056 56 056 056 USB Connector Charging the Meter 15 The date and time on your meter must match the date and time on your Medtronic device. Pick up Medtronic device. Check the date and time: Press ACT, Scroll to Utilities. Press ACT, Scroll to Time/Date. Press ACT, Look at Time/Date. Put down Medtronic device. Pick up meter. Change the Time/Date on your meter to match your Medtronic device. Follow instructions on your meter to make the changes. 10:30 10:30 AM A A M Mon n n 10 OCT 2 2 2 2 2 2 2 C 0 0 010 Gather all your CONTOUR ® NEXT LINK kit components and your compatible Medtronic MiniMed device before you begin setup. Remove the meter cap with the Bayer logo on it to reveal the USB connector. TOP VIEW Selection/ Scrolling Buttons Test Strip Port Display Screen Top Menu Button Protective USB Cap Note: Check the units of measure of your meter. See your meter user guide for complete instructions. FRONT VIEW 84497186 Rev. 05/12 Wireless Blood Glucose Monitoring System 12:24 PM METER BG Mg/dL 93 UTILITIES MENU Alarm Clock Connect Devices Block DEVICE OPTIONS Meters Remotes Other Devices 10:30 AM l 3/11 10:30 AM l 3/11 Reminder Reminder Notes Notes 93 mg dL Before Meal English Espanol LANGUAGE LANGUAGE to test.

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Page 1: Wireless Blood Glucose Monitoring System Bef dL FRONT VIEW ...€¦ · Bayer HealthCare Contour Next LINK PMA Version C QRG - English 908938 N/A 16.5" (H) x 8.0" (W) 10000010027 REV

DATE:CLIENT:

DESCRIPTION:

SCHAWK JOB#:SKU#:

DIMENSIONS:PRINTER SPEC:

RELEASE: V-0 LANGUAGE(S): ENGLISHINTERNAL: R-X

18211 NE 68th Street, E120 Redmond, WA 98052 T: 425-881-5454

BAN#:84497186 Rev. 05/12Contour Next LINK PMA Version C QRG - US

May 30, 2012Bayer HealthCareContour Next LINK PMA Version C QRG - English908938N/A16.5" (H) x 8.0" (W)10000010027 REV. -

FONTS: Helvetica, Helvetica Neue, Zapf Dingbats, Arial, Skinny Mini, Mini Micra, COLORS: Cyan Magenta Yellow Black

NOTE: THIS COLOR PROOF INDICATES COLOR BREAK ONLY AND MAY NOT ACCURATELY REFLECT ACTUAL PRODUCTION COLOR.Regional Master Template No: XXXXClinical Trial / Global Master Template No: M-QRG-0062_R0002

Enter this Meter IDEnter this Meter IDinto your pump:into your pump:123456123456

?

OKOK

Go BackGo Back

CONNECT TO PUMPCONNECT TO PUMP

Automatically sendresults to the Pump?

AlwaysAlways

Ask meAsk me

NeverNever

SEND OPTIONSSEND OPTIONS

70–130 70–130

70–180 70–180

METER ID MENUAdd IDDelete IDReview ID

REVIEW METER ID1. 1234562. ------3. ------

10/10/1010/10/10

10:30 AM10:30 AMAcceptAccept

ChangeChange

CURRENT DATE & TIMECURRENT DATE & TIME

CONNECT TO PUMPCONNECT TO PUMP

CONNECT TO PUMPCONNECT TO PUMP

?

OKOK

Go BackGo Back

?

OKOK

Go BackGo Back

Connect to a Medtronic Pump?

Enter this Meter IDinto your Pump:123456

?

AcceptAccept

Turn OffTurn Off

AUTOLOGAUTOLOG

AutoLog is on.

?

AcceptAccept

ChangeChange

CURRENT TARGETCURRENT TARGET

Initial Setup is complete.Initial Setup is complete.HIGH AND LOW LIMITSHIGH AND LOW LIMITS ?

AcceptAccept

ChangeChange

High: 250 High: 250 mg/dLmg/dL

Low: 70 Low: 70 mg/dLmg/dL

OKOK

OK

®

QUICK REFERENCE GUIDE

®®

93 mgdL Before Meal

Before Meal

01:33PM l 11/10

01:33PM l 11/10

ReminderReminderNotesNotes

Uses Bayer’s CONTOUR®NEXT Blood Glucose Test Strips

Initial Setup of the Meter and Connection to Compatible Medtronic MiniMed Device

1 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 light will flash.

You cannot do a blood glucose test while the battery is charging. When charging is finished, the test strip port light will turn off. Unplug your CONTOUR NEXT LINK meter to test.

2 To begin setup, hold down Menu button for several seconds until the meter turns on.

3 Choose your language and press OK.

4 Press OK on the next screen to begin the connection process.

NOTE: Pump refers to your compatible Medtronic MiniMed device.

5 STOP. Do NOT press ANY buttons.

This screen displays the meter ID number (in the bottom left corner). This ID is needed to complete the connection process.

Put down your meter. Pick up the compatible Medtronic MiniMed device and continue with Step 6.

6 Press ACT to go to the MAIN MENU. Scroll to Utilities by pressing the down arrow. Press ACT.

7 Scroll to Connect Devices from the UTILITIES MENU and press ACT.

Then scroll to Meters and press ACT.

8 Select On and press ACT. If you are replacing a meter, go to Step 9. If you are adding a new meter, go to Step 11.

9 To replace a meter, select Delete ID and press ACT.

10 If you have multiple meter IDs, repeat Step 9 for each one.

11 To add a new meter, select Add ID and press ACT. Refer to Step 5 (or see meter back) to find meter ID.

Use the up and down arrow buttons to enter the six character meter ID shown on the meter screen.

Press ACT after each character entry.

13 Return to your CONTOUR NEXT LINK meter. After you have entered the meter ID into your compatible Medtronic MiniMed device, press OK.

12 Select Review on your compatible Medtronic MiniMed device to confirm that your CONTOUR®NEXT LINK meter ID has been correctly entered. If incorrect, go back to Step 9.

NOTE: For detailed instructions, see your compatible Medtronic MiniMed device user guide.

14 SEND OPTIONS controls how your meter will send blood glucose readings to your compatible Medtronic MiniMed device.

Choose the SEND OPTION that is best for you. Always = Meter will always send results.

Ask Me = Meter will ask you before sending results.Never = Meter will never send results.

16 Choose your AUTOLOG settings. AUTOLOG allows you to mark a test as

Before Meal, After Meal or No Mark.

17 The meter comes preset with the default target ranges as shown. Accept the default target ranges or Change them after talking to your health care professional.

18 Follow the display prompts to set your High and Low Limits. Choose Accept to use the default setting (250 mg/dL for the high limit and 70 mg/dL for the low limit). Choose Change if you wish to use different limits.

Connecting Meter to Medtronic MiniMed Paradigm® REAL-Time Revel™ insulin pump

Choosing Meter Send Options

Set Meter Date/Time to Match Medtronic Device

Additional Meter Settings

SETUP IS NOW COMPLETE!

Setting Up the Meter

  ? = Help

MAIN MENUBasalPrimeUtilities

METER OPTIONOffOn

METER ID MENUAdd IDDelete IDReview ID

METER ID MENUAdd IDDelete IDReview

DELETE METER ID1. aaaaaa2. bbbbbb3. ------

ADD METER ID

1 2 3 4 5 6

STATSTATSTATSTASTASTASTASTSTATUSUSUS US U100U100U100U100000BatttBattBattBattttBa ery:ery:eryeery: Norr NorNorrNorrrN rrrmalmalmalmalllllm

S/N#S/N#S/N#NS/N#S/N#S/N#S/N#NN#N#NN 454454454454454454454 454 4544 444056056056056560560565605656056056

USB Connector

Charging the Meter

15 The date and time on your meter must match the date and time on your Medtronic device.

Pick up Medtronic device.

Check the date and time:

Press ACT, Scroll to Utilities.

Press ACT, Scroll to Time/Date. Press ACT, Look at Time/Date. Put down Medtronic device.

Pick up meter. Change the Time/Date on your meter to match your Medtronic device. Follow instructions on your meter to make the changes.

10:3010:30AMAAA

MMon nn 10 OCT 2222222C 000100

Gather all your CONTOUR®NEXT LINK kit components and your compatible Medtronic MiniMed device before you begin setup. Remove the meter cap with the Bayer logo on it to reveal the USB connector.

TOP VIEW

Selection/Scrolling Buttons

Test Strip Port

Display Screen

Top Menu Button

Protective USB Cap

Note: Check the units of measure of your meter.See your meter user guide for complete instructions.

FRONT VIEW 8449

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5/12

Wireless Blood Glucose Monitoring System

12:24 PMMETER BG

Mg/dL93

UTILITIES MENUAlarm ClockConnect DevicesBlock

DEVICE OPTIONSMetersRemotesOther Devices

10:30 AM l 3/1110:30 AM l 3/11

ReminderReminder

NotesNotes93 mg

dL

Before Meal

EnglishEspanol

LANGUAGELANGUAGE

to test.

84497186_CntrNextLINK_QRG_EN_FpBp_v0 05/30/12 11:04 AM

FC: 13mm BC: 11.5mmFooter: N/A 1/3rd of the Cross clear space has been applied.7mm min.

Page 2: Wireless Blood Glucose Monitoring System Bef dL FRONT VIEW ...€¦ · Bayer HealthCare Contour Next LINK PMA Version C QRG - English 908938 N/A 16.5" (H) x 8.0" (W) 10000010027 REV

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.

• Always wash your hands well with soap and water before and after testing, handling the meter, lancing device, or test strips.

For complete instructions on cleaning and disinfecting your meter and lancing device, please see your meter user guide.

References1 FDA Public Health Notification: Use of Fingerstick

Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens; Initial Communication (2010).http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm

2 CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens (2010).http://www.cdc.gov.injectionsafety/Fingerstick-DevicesBGM.html

93 mgdL

Sent, Sent, Before... Before...

10:30AM l 11/1010:30AM l 11/10

93 mgdL

Sent, Sent, Before... Before...

RESULTS SENTRESULTS SENT

ReminderReminder

NotesNotes

AUTOLOG AUTOLOG Before Meal Before Meal

After Meal After Meal

No MarkNo Mark

OK

2 Remove lancing device endcap.

Insert lancet into lancing device and twist off protective cap.

1 Insert test strip and wait for APPLY BLOOD message.

3 Re-cap and dial to desired lancing depth.

4 Obtain your blood drop.

5 Touch the tip of the test strip to the drop of blood.

If the first blood drop is not enough, the meter may beep twice and display STRIP UNDERFILLED. You have about 30 seconds to apply more blood onto the same strip.

8 Select Reminder to set a reminder for your next test. Select Notes to add more information to the result. Remove test strip.

9 Remove the test strip and the meter will turn off in 3 minutes. Or hold down the Menu button to turn off the meter.

Obtaining the Blood Drop

Testing the Blood Drop

Sending Results to Your Compatible Medtronic MiniMed Device

Reminder and Notes

Turn Meter Off

See your CONTOUR®NEXT LINK user guide, MICROLET®2 insert and compatible Medtronic MiniMed device user guide for full instructions.

Call 800-348-8100 (available 24 hours a day, 7 days a week) with any questions

or visit www.bayerdiabetes.com/usFor In Vitro Diagnostic Use

Bayer, the Bayer Cross, CONTOUR, MICROLET and the No Coding logo are registered trademarks of Bayer.

© 2012 Bayer. All rights reserved.

Paradigm and Guardian are registered trademarks and Revel is a trademark of Medtronic MiniMed, Inc.

8449

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Bayer HealthCare LLCMishawaka, IN 46544 USA

7 If Ask Me or Always was selected in Send Options during Setup, results can be sent to your compatible Medtronic MiniMed device. Press OK to move to the next screen.

6 If AUTOLOG is on, you can choose to record your result as: Before Meal, After Meal or No Mark for the test result.

Testing Your Blood

Materials for Testing

Bayer’s MICROLET®2 Lancing Device

Bayer’s CONTOUR®NEXTTest Strip

Bayer’s MICROLET® Lancet

Bayer’s CONTOUR®NEXT LINK Blood Glucose Meter

84497186_CntrNextLINK_QRG_EN_FpBp_v0 05/30/12 11:04 AM