Medtronic Paradigm Link Owner's Manual

Download

Page 1

BD Consumer Healthcare 1 Becton Drive Franklin Lakes, New Jersey 07417

Lancets manufactured by BD. Lancet device and control solution(s) manufactured for BD.

Paradigm, Solutions, Paradigm Link, Bolus Wizard and MiniMed are registered trademarks of Medtronic MiniMed.

Monitor and test strips manufactured for BD by Nova Biomedical Corporation, Waltham, MA 02454.

U.S. Patent No. 6,258,229 and other U.S. and foreign patents pending.

P80122

Owner’s Guide

BD Logic

™

Technology

Page 2

Page 3

Thank you for choosing the Paradigm Link™ Blood Glucose Monitor. This Owner’s Guide contains important information on the meter and how it works. Please read it carefully before using your new blood glucose meter. The Paradigm Link™ Blood Glucose Monitor, developed by Medtronic MiniMed and BD, is designed to be convenient and easy to use. It is the first blood glucose meter designed for wireless communication with Paradigm

Model 512 or higher Insulin Infusion Pumps. Your blood glucose result is automatically sent to your insulin pump and placed into the pump’s Bolus Wizard™. Then the Bolus Wizard™ can easily suggest an insulin dosage, if needed, to bring your blood glucose back to normal (refer to your Paradigm®Model 512 or higher Infusion Pump User Guide for setting up and using the Bolus Wizard™).

The Paradigm Link™ Blood Glucose Monitor gives accurate results in just 5 seconds using a very small blood sample. This small blood sample allows you to use a thinner lancet because not as much blood is needed to do a blood sugar test. BD offers the thinnest lancet available with its BD Ultra-Fine™ 33 Lancet, resulting in 50% less pain*. In addition, the new Paradigm Link™ Blood Glucose Monitor has memory that stores your blood glucose test results and has optional features, such as mealtime averaging, to help you and your healthcare professional manage your diabetes care. Your Paradigm Link™ Blood Glucose Monitor can also be used to download your Paradigm®Model 511, 512 or higher pump settings and pump data when connected to a computer using a special USB cable.

Medtronic MiniMed and BD are partners dedicated to improving the lives of people with diabetes. The Paradigm Link™ Blood Glucose Monitor is partnered with Paradigm®Insulin Infusion Pumps to provide the comfort and convenience you need for managing your diabetes.

If you have any questions about your meter, please call BD Consumer Services toll-free, 24 hours a day, 7 days a week, in the US at 1.888.BDCARES (1.888.232.2737)**or visit our website at www.BDdiabetes.com. If you have any questions about your insulin infusion pump, please call Medtronic MiniMed toll-free, 24 hours a day, 7 days a week, in the US at 1.800.MINIMED (1.800.646.4633) or visit our website at www.minimed.com.

In BD™ Lancet Device when compared to 28-gauge lancets in other lancet devices. Data on file at BD.

** NOT FOR EMERGENCY OR MEDICAL INFORMATION.

Welcome

Page 4

•Before you begin using your new Paradigm LinkTMBlood Glucose Monitor, please read all of the instructions provided in this Owner’s Guide.

•Use the meter only if the protective seal on the box containing your Paradigm Link™ Blood Glucose Monitor is unbroken.

•Perform all quality control checks recommended in your Owner’s Guide.

•Consult with your diabetes healthcare professional and follow his or her guidance for your blood glucose monitoring routine.

•These recommendations apply to all blood glucose meters and are supported by the American Association of Diabetes Educators (AADE),

the American Diabetes Association (ADA), the US Food and Drug Administration (FDA), and the Advanced Medical Technology Association (AdvaMed).

For the Blood Glucose Meter with radio frequency (RF) turned on:

This device complies with the United States Federal Communications Commission and international standards for Electromagnetic Compatibility regarding its use.

This device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesirable operation.

Your Paradigm Link

Blood Glucose Monitor

• Is intended for use outside the body (in vitro diagnostic use).

•Should only be used with BD™ Test Strips and BD™ Control Solution.

•Should be used for testing glucose (sugar) and only with fresh capillary whole blood samples.

•Should not be used to diagnose diabetes or to test newborns.

•Should not be stored in the refrigerator or in the car.

CAUTION:

The Paradigm LinkTMBlood Glucose Monitor contains

small parts. Keep the meter out of reach of small children and pets.

Important Information

These standards are designed to provide reasonable protection against excessive radio frequency interference and prevent undesirable operation of the device from unwanted electromagnetic interference. Operation is subject to the following two conditions:

1. This device has been tested and found to comply with the regulations governing such devices in your area. For the specific regulation and test results for your area, please contact BD at 1.888.BDCARES (1.888.232.2737)

2. This device generates, uses, and can radiate radio frequency energy and, if installed and used in accordance with the instruction, may cause harmful interference to radio communications. If the device does cause interference to radio or television reception, the user is encouraged to try to correct the interference by one or more of the following measures:

- Reorient or relocate the blood glucose meter

- Increase the separation between the blood glucose meter and the device that is receiving/emitting interference

- If you have questions, please contact BD at 1.888.BDCARES (1.888.232.2737)

* NOT FOR EMERGENCY OR MEDICAL INFORMATION.

Page 5

Mark a Single Blood Glucose Test So It Is Not Sent To Your Paradigm

Model 512 or Higher Pump..................................................................................... 30

Marking for Identification........................................................................................................... 31

Marking a Blood Glucose Test for Identification ............................................................... 32

How to Use Your Meter’s Basic Memory Functions

What Are the Basic Memory Functions? ............................................................................. 34

Memory................................................................................................................................... 34

14-Day Average .................................................................................................................... 34

Reviewing Your Basic Memory Functions............................................................................. 35

How to Use Your Meter’s Optional Functions

........................................................... 36

Setting the Optional Functions ............................................................................................... 37

Reviewing Your Optional Functions........................................................................................ 41

Uses Your Meter’s Optional Functions

7-Day Average................................................................................................................................ 45

Time-Specific Averages...............................................................................................................45

Recording Your Insulin Doses.....................................................................................................48

Marking an Insulin Dose............................................................................................................... 51

Labeling Your Insulin Types....................................................................................................... 53

Summary: How to Review Your Basic and Optional Functions

................................................................................................ 54

Additional Information

Display Messages and Troubleshooting Guide ................................................................... 55

Caring for Your Meter.................................................................................................................. 61

Storing and Cleaning........................................................................................................... 61

Battery ..................................................................................................................................... 61

Healthcare Precautions and Limitations............................................................................... 64

Conditions That May Affect Results..................................................................................... 65

3-Year Warranty............................................................................................................................ 65

Specifications................................................................................................................................. 66

How to Contact Us....................................................................................................................... 67

Getting to Know Your Paradigm Link™ Blood Glucose Monitor

Meter Components .........................................................................................................................2

Kit Contents........................................................................................................................................3

Meter Display .....................................................................................................................................4

Test Strips ...........................................................................................................................................5

Lancet Device.....................................................................................................................................7

Use Paradigm Link™ to Download Paradigm

Model 511, 512 or

Higher Pumps to PC.........................................................................................................................7

Getting Started

Before You Measure Your Blood Glucose Level for the First Time............................... 8

Talking to Your Pump ..................................................................................................................... 8

Setting the Time, Date, and Beeper ........................................................................................ 9

How to Set the Time, Date, and Beeper .................................................................... 10

Coding Your Meter ........................................................................................................................ 13

Why Coding Your Meter Before Testing Is Necessary........................................... 13

How to Code Your Meter.................................................................................................. 14

Running a Control Solution Test................................................................................................15

Why Running a Control Solution Test Is Important................................................ 15

How to Run a Control Solution Test ............................................................................. 17

How to Test Your Blood Glucose

Preparing the Lancet Device .................................................................................................... 22

Inserting the BD™ Test Strip..................................................................................................... 24

Getting and Applying a Blood Sample to the BD™ Test Strip...................................... 25

Understanding Your Test Result ............................................................................................. 27

Sending a Blood Glucose Result to Your Paradigm

Model 512 or Higher Pump........ 29

Table of Contents

Page 6

Kit Contents

Getting to Know Your Paradigm Link™ Blood Glucose Monitor

Getting to Know Your Paradigm LinkTMBlood Glucose Monitor • 3

2•Getting to Know Your Paradigm Link

Blood Glucose Monitor

Meter Components

Monitor Display

Mode Button

Test Strip Slot and Data Port

Insulin Recording Button

Arrow Buttons

Left arrow moves backward; right arrow moves forward

* Accepts a cable to download stored data to a personal computer.

Quick Reference Guide

BD™ Lancet Device

Monitor

(Battery installed)

Owner’s Guide

BD Ultra-Fine™ 33 Lancet

BD™ Control Solution

Vial of 10 BD™ Test Strips

Getting Started Post er

BD Logb

ook

Day Case

Warranty Card

Page 7

Mem. Avg.

mg/dL

mmol/L

AM PM

Beep Symbol

Beeper is preset to ON

Battery

Appears when

battery should be

repl aced

Test Results Display Area

Blood Drop

Appears when monitor is ready for you to apply sample to test strip

Units

Refers to units of

measurement for

blood glucose

Mem.

Appears when

viewing a test result

or insulin dose

stored in memory

Avg .

Appears when viewing

averages (7-day, 14-day,

or Time-Specific)

Symbols for Optional Memory Functions That Require Setup

A. Time-Specific Averages Symbol B. Marking Symbol

Appears when viewing a marked blood glucose test or marked insulin dose.

C. U Symbol

Appears when units of insulin are entered.

D. Insulin Symbol

Appears when recording or reviewing insulin delivery.

Month

Day

Hour

Minutes

When you turn the Paradigm LinkTMBlood Glucose Monitor on, the “all segments” display appears briefly. This tells you that all the display segments are working properly.

Test StripsMeter Display

Getting to Know Your Paradigm LinkTMBlood Glucose Monitor • 5

4•Getting to Know Your Paradigm Link

Blood Glucose Monitor

Edge to Apply

Blood Drop

End to Insert

Into Meter

BD™ Test Strips are designed for use with your Paradigm Link

Blood Glucose Monitor, BD Logic™ Blood Glucose Monitor or BD Latitude

Diabetes Management System only. Use each test strip only once, then discard. Do not reapply blood to the test strip.

Te st Strips:

• Require a very small blood volume (0.3 µL).

• Automatically draw blood into the test area of the strip.

• Can be handled with clean, dry hands without affecting glucose readings.

Not actual size. Scale is relative.

0.3 µL4 µL10 µL2 µL1 µL

BD™ Test Strip Requires

Other Test Strips Require

NOTE:

This Paradigm Link™ will display in units of mg/dL only.

Page 8

CAUTION:

The test strip vial contains small parts. Keep the

test strip vial away from children and pets.

Important BD™ Test Strip Information

•Use only BD™ Test Strips when testing.

• Remove the test strip from the vial only when ready to test.

•Store test strips at room temperature below 86°F (30°C). Do not refrigerate or freeze.

•Test strips should be stored only in original vial.

• Keep vial cap closed tightly after each use.

•Do not use the test strip if the expiration date has passed, for this may cause inaccurate results.

•Test strips should only be stored for 3 months after opening the vial. When first opening a new vial of test strips, count forward 3 months and write that date on vial. Discard any remaining test strips after the date you have written on the vial.

•Do not tamper with test strip.

6•Getting to Know Your Paradigm Link

Blood Glucose Monitor

Arming

Knob

Depth Penetration Dial

(1 = shallow to 6 = deep)

Body

Trigger Button

Cap

Depth Setting

Lancet Device

The diagram below shows the components of the BD™ Lancet Device.

Getting to Know Your Paradigm LinkTMBlood Glucose Monitor • 7

Use Paradigm Link™ to download Paradigm

Model 511, 512 or Higher Pumps to PC.

• A BD USB cable (included in your Medtronic Minimed Solutions™ software kit) may be used as shown to connect meter to computer.

• Medtronic MiniMed Solutions™ software (not included in meter kit) may be used to download Paradigm

Model 511, 512 or higher pump data through your meter to the PC. Refer to the User Guide provided with your software for using your PC with your meter or your pump.

NOTE:

The meter cannot be used to test blood glucose when connected by the cable to the computer.

Page 9

Getting Started

Having the correct time and date of each blood glucose test result and insulin dose helps you and your healthcare professional track changes in your therapy. It is important to set the correct time and date so you have records of when you test blood glucose and deliver insulin. The correct time and date are needed to coordinate your blood glucose results with your pump data. Solutions™ Pumps and Meters software can be used to review data that you’ve downloaded from your meter and your pump.

When you replace the battery in your meter, your Paradigm Link™ Blood Glucose Monitor automatically displays the date and time screen as a convenience. (Please refer to page 10 for How to Set the Date and Time)

8•Getting Started

Setting the Time, Date, and Beeper

NOTE:

Your Paradigm LinkTMBlood Glucose Monitor offers a beeper function that is preset to “ .” This tells you when enough blood is applied to the test strip, when a test is completed, and prompts you through other steps in using your meter.

Getting Started • 9

Before You Measure Your Blood Glucose Level for the First Time:

1) Program your meter ID number into your Paradigm®Model 512 or higher Pump.

See the Paradigm Pump User Guide or the Paradigm Link™ Getting Started Poster

2) Set your meter to the same time and date as your pump. See page 9.

3) Code your meter. See page 13.

4) Use control solution to test your meter. See page 15.

5) Now you are ready to test your blood glucose level. See page 22.

Talking To Your Pump

Your Paradigm Link™ Blood Glucose Monitor arrives with its “ “ feature already turned on. Every time the meter displays a new blood glucose test result, the meter automatically sends the result to your Paradigm

Model 512 or higher Pump. However, your pump will only listen for a blood glucose test result if you have programmed the pump with the meter’s ID number. The pump will accept up to 3 different meter ID numbers. The Paradigm Link™ is the only meter that can communicate with a Paradigm

Model 512 or higher

Pump. Please refer to your Paradigm

Model 512 or higher Pump User Guide or the Paradigm Link™ Getting Started poster to see how to program your meter’s ID number into your pump.

Page 10

Set Year

(Example)

Set Month

(Example)

Set Day

(Example)

6. Set Year:

Press the right or left arrow button until the correct year appears.

7. Press the Mode button briefly to

confirm your choice and to advance to set the month.

8. Set Month:

Press the right or left arrow button until the correct month appears.

9. Press the Mode button briefly to

confirm your choice and to advance to set the day.

10. Set Day:

Press the right or left arrow button until the correct day appears.

11. Press the Mode button briefly to

confirm your choice and to advance to set the beeper. A long beep will sound.

Getting Started •11

1. Begin Setup:

Press and continue to hold the Mode button until you hear a short beep and see the flashing hour displayed. Release the Mode button.

2. Set Hour:

Press the right or left arrow button until the correct hour (with

or PM)

appears.

3. Press the Mode button briefly to confirm

your choice and to advance to set the minutes.

4. Set Minutes:

Press the right or left arrow button until the correct minutes appear.

5. Press the Mode button briefly to confirm

your choice and to advance to set the year.

10 • Getting Started

HOW TO SET THE TIME, DATE, AND BEEPER

Meter is off, with no test strip inserted in the test strip slot.

Flashing Hour

Display

Set Hour

(Example)

Set Minutes

(Example)

(Continued on next page.)

Page 11

Getting Started • 13

WHY CODING YOUR METER BEFORE TESTING IS NECESSARY

Your Paradigm LinkTMBlood Glucose Monitor must be manually “coded” to match the vial of test strips you will be using in order to provide accurate blood glucose test results.

Coding Your Meter

IMPORTANT:

If the code number on the display does not match the code number on the test strip vial, the test results may not be accurate.

You should code your meter:

• When you first receive your new meter, before you test your blood glucose.

•If the meter display shows flashing “– – –” as pictured.

•Before using each new box of test strips.

Set Beeper

(Example)

End of Setup

(Example)

12 • Getting Started

NOTE:

Instructions in this guide assume the beeper is set to “ .” If you have set the beeper to “,” you will not hear the beep as described throughout the guide.

12. Set Beeper:

Beeper is preset to “ .” Press the right or left arrow button to select the beeper setting (ON or OFF).

13. Press the Mode button briefly to

confirm your choice and to advance to the end of setup.

14. End Setup:

The display shows your set time and date. Setup is complete.

15. Return to Setup:

Press the Mode button briefly to return to start of setup. The flashing hour that you set is displayed.

16. Turn Off Meter:

Press and hold the Mode button until the meter turns off, OR the meter will turn off automatically after 1 minute.

Page 12

3. When the codes match, press the Mode

button. A blinking blood drop shows that the meter is ready for you to test. To run a

control solution test, refer to page 15. To run a blood glucose test, refer to page 22.

To turn off the meter, remove and discard the used test strip. The meter turns off automatically.

Getting Started • 15

Finish Coding

1. Insert a BD™ Test Strip into the test strip slot.

The meter turns on and briefly displays the “All Segments” display.

2. While the flashing code number appears on

the display, code the meter to match the test strip being used. Press the right or left

arrow button (within 3 seconds) to match the code printed on the test strip vial.

When you first use your meter, the display shows “– – –.” This means the meter is not coded and needs to be coded.

14 • Getting Started

HOW TO CODE YOUR METER

Meter is off, with no test strip inserted in the test strip slot.

NOTE:

If your meter advances to the blinking blood drop before you coded your meter to match the test strips being used, remove the test strip from the test strip slot and reinsert to start again.

Insert Test Strip

Code the Meter

(Continued on next page.)

The control solution test confirms that your meter and test strips are working correctly. A control solution test is similar to a blood glucose test, except you use BD™ Control Solution and not a blood sample

You Should Run a Control Solution Test:

•Before using your meter for the first time and at least once a week thereafter.

•Each time you open a new box of BD™ Test Strips.

• If you leave the test strip vial cap open.

• If you drop your meter.

• If your results do not match the way you feel, or you think your results are higher or lower than expected.

•To check the performance of the meter and test strips.

Running a Control Solution Test

WHY RUNNING A CONTROL SOLUTION TEST IS IMPORTANT

Page 13

1. Insert a BD™ Test Strip into the test strip slot.

The meter turns on and displays the code number.

2. Match the code number on the display with

the code on the test strip vial.

If the codes match, you are ready to begin testing.

If the codes do not match, review “Coding Your Meter” (refer to page 13).

Getting Started • 17

HOW TO RUN A CONTROL SOLUTION TEST

Meter is off, with no test strip inserted in the test strip slot.

Insert Test Strip

Match Codes

(Example)

16 • Getting Started

CAUTION:

The BD™ Control Solution range printed on the test strip vial is for control solution only. It is used to test the performance of the meter and test strip. It is not a recommended range for your blood glucose level.

Important Control Solution Information

•Use only the BD™ Control Solution for the test.

• Check the expiration date on the control solution vial.

Do not use the control solution if the expiration date has passed.

•Store only for 3 months after first opening. When you open a new

vial of control solution, count forward 3 months and write that date on the label of the control solution vial. Discard any remaining solution after the date you have written on the vial.

•Store the control solution tightly closed at room temperature below

86°F (30°C). Do not refrigerate or freeze.

• Shake control solution well before using.

Page 14

5. Shake the control solution vial and discard a

drop before use. Squeeze a drop of control solution onto a clean, hard, dry surface.

6. While holding the meter, touch the edge of

the inserted test strip to the drop of control solution. A short beep sounds and the meter begins to count down from 5 to 1.

Getting Started • 19

Correct

Incorrect

Squeeze Drop of

Control Solution

Touch Edge of Test

Strip to Control

Solution

IMPORTANT:

It is important to mark a control solution test prior to applying blood to the test strip, so the test result does not appear to be one of your blood glucose test results, and also to prevent it from being included in your blood glucose average.

Also, this will prevent the meter from sending a control solution test result to your Paradigm

Model 512 or higher Insulin Pump.

3. A blinking blood drop tells you that the

meter is ready for the next step.

4. Mark as a control solution test by pressing

the right or left arrow button until a

“” appears.

18 • Getting Started

Blinking

Blood Drop

Mark as Control

Solution Test

(Continued on next page.)

Page 15

Getting Started • 21

Out-of-range results may be caused by the following:

•You may not be doing the test properly. Retest and follow the instructions carefully.

• The Paradigm Link

Blood Glucose Monitor may not be coded properly to

match the test strips being used.

• The control solution may have expired or may have been contaminated. Check the expiration date on the control solution vial. Control solution is good for only 3 months after opening. Make sure the control solution vial is closed when not in use.

• The test strip may have expired. Check the expiration date on the test strip vial.

• The test strip may have been damaged. This can be caused by extreme temperatures or by leaving the test strip vial cap open. Retest using a new test strip.

• The Paradigm Link™ Blood Glucose Monitor may not be working properly.

NOTE:

If the control solution test result is outside the range (is either higher or lower), your meter and test strip may not be working as a system. Repeat the test using a new test strip.

Do not use the meter until test results fall within the appropriate range. If the problem continues, call BD Consumer Services tollfree, 24 hours a day, 7 days a week, in the US at 1.888.BDCARES (1.888.232.2737)* for help.

* NOT FOR EMERGENCY OR MEDICAL INFORMATION.

7. The display counts down from

5 seconds as the meter performs the test.

8. When the test is finished, a long

beep sounds and the meter displays the result.

9. Compare the result on the display with the

range printed on the test strip vial. If the result falls within the range, your meter and test strips are working correctly.

10. Remove and discard the used test strip. The

meter turns off automatically.

20 • Getting Started

Test Countdown

(Continued on next page.)

Range 80-120

mg/dL

(Example)

NOTE:

Results that are marked as control solution will not flash

because they are not sent to your pump.

Test Result

(Example)

Page 16

5. Screw the cap back onto the lancet device.

6. Pull out the arming knob as far as it will go

and then release it. The lancet device is now armed.

Screw Cap Back On

How to Test Your Blood Glucose • 23

Insert Lancet

Remove Lancet

Cover

3. Insert a BD Ultra-FineTM33 Lancet into the

lancet holder.

4. Remove the lancet cover while holding the

base of the lancet.

Arm Lancet Device

22 • How to Test Your Blood Glucose

How to Test Your Blood Glucose

Preparing the Lancet Device

Before testing, wash your hands with soap and warm water. Dry thoroughly.

1. Unscrew the cap from the

BD™ Lancet Device.

2. Select the penetration depth by turning

the cap dial from 1 (shallow) to 6 (deep). Find the lowest setting that gets you enough blood, by starting at the lowest setting (1). Increase the setting if you do not get enough blood.

Unscrew Cap

Select Penetration

Depth

(Continued on next page.)

Page 17

How to Test Your Blood Glucose • 25

Getting and Applying a Blood Sample to the BD™ Test Strip

1. Place the armed BD™ Lancet Device securely

on the side of your finger and press the trigger button to activate the device. If necessary, gently squeeze your finger to help form a drop of blood.

Correct Blood Drop

Lance Finger

NOTE:

Lancets are for one-time use only. Use a new, sterile lancet each time you test. Test different areas on your fingertips to avoid developing calluses. After completing the blood test, remove the cap from the BD™ Lancet Device, carefully place the lancet cover on the lancet and remove the lancet. Dispose of the used lancet per your local disposal regulation where applicable.

CAUTION:

Your BD™ Lancet Device and BD™ Lancets are for your personal use only. DO NOT share with others. Sharing the lancet device or lancets can transmit serious, even grave infections. To avoid accidental sticks, do not store used lancets in the device after testing or arm lancet device with a new sterile lancet unless ready to use.

24 • How to Test Your Blood Glucose

Inserting the BD™ Test Strip

Meter is off, with no test strip inserted in the test strip slot.

1. Insert a BD™ Test Strip into the test strip

slot. The meter turns on and briefly displays “All Segments.”

2. Match the code number on the display

with the code on the test strip vial. If the codes do not match, press the right or left arrow button to match the code printed on the test strip vial. When the codes match, press the

Mode button briefly (refer to page 13 for “Coding Your Meter”).

3. A blinking blood drop tells you that the meter is

ready for the next step.

Insert Test Strip

Match Codes

(Example)

Blinking Blood

Drop

Edge to Apply

Blood Drop

End to Insert

Into Meter

NOTE:

Use only BD™ Test Strips when testing.

Page 18

How to Test Your Blood Glucose • 27

Understanding Your Test Result

Your blood glucose test result is displayed on the meter.

Test Result

(Example)

mg/dL

Test Result

(Example)

5. Remove and discard the used test strip. The meter turns

off automatically.

6. Remove the used lancet from the lancet device. Follow

your local disposal regulations where applicable.

mg/dL

Countdown

Completely Filled

Not Completely

Filled

2. Apply blood drop to the edge of the test

strip. The blood is drawn into the test strip. Hold your finger to the edge of the test strip until you hear a short beep or see the meter display begin to count down.

Correct

Incorrect

Apply Blood Drop

26 • How to Test Your Blood Glucose

NOTE:

If you are not using a pump, then you may choose to

set " " to " " to save battery power.

NOTE:

Your meter arrives from the factory with " " set to " ". If the glucose result does not flash and the pump does not receive the glucose result, then set " " to " ". See Optional Functions on page 37.

(Continued on next page.)

The glucose result will flash while meter is transmitting the glucose result to the insulin pump. Removing the strip will not automatically turn off the meter while RF transmission is in progress (flashing). You can stop the transmission by manually turning off the meter or inserting a new test strip. The glucose result will stop flashing(transmitting) when the pump receives the glucose result or after 60 seconds.

3. The display counts down from 5 seconds as

the meter performs the test.

4. A long beep sounds and the result is

displayed and stored in the meter’s memory.

(Continued on next page.)

Page 19

How to Test Your Blood Glucose • 29

If the test result is lower than 20 mg/dL, the meter sounds 3 quick beeps and the display will read

“.”You may have

low blood sugar. Retest your blood glucose immediately using a new test strip. If your reading is still low, you should treat as prescribed by your healthcare professional and/or contact your healthcare professional immediately. The meter will not transmit when the glucose result is " ".

28 • How to Test Your Blood Glucose

Blood Glucose Test

Lower Than

20 mg/dL

NOTE:

Hi and Lo values will not transmit to insulin pump even if

“” is " " in optional setup.

Test results greater than 240 mg/dL may mean high blood sugar (hyperglycemia). Test results lower than 60 mg/dL may mean low blood sugar (hypoglycemia). If you get results in these ranges, retest your blood glucose. If your reading is still in these ranges, you should treat as prescribed by your healthcare professional and/or contact your healthcare professional immediately.

Blood Glucose Test

Higher Than

600 mg/dL

If the test result is higher than 600 mg/dL, the meter sounds 3 quick beeps and the display will read

“.”Yo u

may have high blood sugar. Retest your blood glucose immediately using a new test strip. If your reading is still high, you should treat as prescribed by your healthcare professional and/or contact your healthcare professional immediately. The meter will not transmit when the glucose result is " ".

Sending a Blood Glucose Result to Your Paradigm

Model 512 or Higher Pump

Your Paradigm Link™ Blood Glucose Monitor arrives with " " turned " ." Thus, when a new blood glucose result is displayed, the meter will send the result to your pump. The new result will flash on the meter display while the meter is sending the result to your Paradigm

Model 512 or higher Pump. The

meter will stop flashing when the pump receives the result, or after 60 seconds.

A pump is only capable of receiving a blood glucose result if you have entered the meter’s ID number into the pump. No one else’s pump can receive your blood glucose result, unless they enter your meter’s ID number into their pump. Please refer to your Pump User Guide or the Paradigm Link™ Getting Started Poster to learn how to enter the meter’s ID number into your pump.

NOTE:

If the meter displays " " or " ," no blood glucose

result is sent to the pump.

(Continued on next page.)

The meter uses radio frequency (RF) signals to send the blood glucose result to the pump. If you set " " to " " your meter will not send a RF signal to your pump. You may want to turn off the " " feature, to save battery power, if you do not have a pump.

NOTE:

To set up the “ “ function, refer to page 37.

Page 20

How to Test Your Blood Glucose • 31

30 • How to Test Your Blood Glucose

Mark a Single Blood Glucose Test So It Is Not Sent To Your Paradigm

Model 512 or Higher Pump

If you want to take a single blood glucose measurement and not have that result sent to your Paradigm

Model 512 or higher Pump, you can mark it as a

control solution test.

1. Insert a BD™ Test Strip into the test strip slot.

2. Match the code number on the display with the code on the test

strip vial.

3. A blinking blood drop tells you that the meter is ready for the

next step.

4. Press one of the arrow keys BEFORE applying blood to the test strip.

5. "C" will appear on the display indicating that the result is a control

solution test. After you apply blood or control solution to the test strip, the result will not be sent to your pump. You may want to mark a result as a control test if:

• you are using control solution on a test strip to test your meter

• you lend your meter to someone else and you do not want their result to appear on your pump.

• you do not want to generate an RF signal, such as if you’ve been asked to turn-off electronic devices on an aircraft.

A blood glucose result may only be marked for identification immediately after the result appears on the display. Once the meter is turned off, the result cannot be marked later. Marking allows you to identify specific blood glucose test results or insulin doses in the meter’s memory.

• The Marking for Identification function is turned off when you receive your new meter. To set up the Marking for Identification function, refer to page 37.

• For how to mark a blood glucose test, refer to page 32.

• For how to mark an insulin dose, refer to page 51.

MARKING FOR IDENTIFICATION FUNCTION

Marking Blood Glucose Test Results:

Some examples of why you may wish to mark blood glucose test results for identification are shown below:

•You may wish to mark a test result to

identify that it was taken after eating.

•You may have retested to confirm a previous

reading and do not want the result added to your averages.

NOTE:

Test results marked for identification are not included

in any averages.

NOTE:

Results that are marked for identification are still sent to

the pump.

Marked Blood

Glucose Test

Result

(Example)

mg/dL

Page 21

How to Test Your Blood Glucose • 33

32 • How to Test Your Blood Glucose

A blood glucose test can be marked for identification after completing a test. For an explanation of situations in which you may wish to mark a blood glucose test, refer to page 31.

1. Te st your blood glucose.

(Refer to page 22 for how to test.)

2. After a blood drop is applied to the

test strip, the display counts down from 5 seconds and shows your test result.

3. To mark your test result, press the right or left arrow button. An

asterisk (*) appears, to confirm that the test result is marked. To unmark the test result, press the right or left arrow button until the asterisk disappears.

Marked Blood Glucose Test Result (Example)

Marking a Blood Glucose Test For Identification

mg/dL

Blood Glucose Test

Result (Example)

(Continued on next page.)

4. To save the marked test result, press the Mode button.

5. The marked test result is stored in the

meter’s memory.

6. To turn off the meter, press and hold the Mode button until the meter turns off,

OR the meter will turn off automatically after 1 minute.

NOTE:

Once a marked test result or manually entered insulin dose is saved, you cannot unmark. Marked tests are not included in averages. Results that are marked for identification are still sent to the pump.

Page 22

The Basic Memory functions help you and your healthcare professional track changes in your blood glucose levels over time.

How to Use Your Meter’s Basic Memory Functions

NOTE:

In computing averages, the meter will use 600 mg/dL

for any

“”results and 20 mg/dL for any “”results.

What Are the Basic Memory Functions?

34 • How to Use Your Meter’s Basic Memory Functions How to Use Your Meter’s Basic Memory Functions • 35

Mem.

mg/dL

Reviewing Your Basic Memory Functions

1. Press the Mode button briefly to turn the meter on.

2. Your Most Recent Blood Glucose Test Result with

date and time of testing is shown on the display.

(To set t

he correct date and time, refer to page 10.)

3. If you wish to review up to 30 stored test results, continue to press the left arrow button.

“”is displayed after the last recorded test result. To return to the most recent test result, press the left arrow button.

4. Press the Mode button briefly to advance

to your 14-Day Blood Glucose Test Average.

5. The display shows the average of all test results

taken in the last 14 days. The average will not include marked or control solution test results.

6. Press the Mode button briefly to return to

your most recent blood glucose test result.

7. To turn off the meter, press and hold the Mode button until the meter turns off, OR the meter will turn off automatically after 1 minute.

Meter is off, with no test strip inserted in the test strip slot.

Most Recent Blood

Glucose Reading

(Example)

End of Stored

Test Results

Mem.

MEMORY

Your Paradigm LinkTMBlood Glucose Monitor has a memory that stores 250 of your blood glucose test results. You can view up to 30 of your most recent test results on your meter display. Once the meter contains 250 test results, new results will replace the oldest results.

14-DAY AVERAGE

You can review the average of all test results taken in the last 14 days.

The average will not include marked test results or control solution test results.

(For information on “Marking for Identification,” refer to page 31 or

How to Mark a Control Solution Test refer to page 18.)

Mem.

mg/dL

Avg.

14-Day Average

(Example)

Page 23

How to Use Your Meter’s Optional Functions • 37

36 • How to Use Your Meter’s Optional Functions

1. Begin Setup:

Press and continue to hold the Mode button. You will hear 2 short beeps and see “ ” and the word “ .” Release the Mode button.

Meter is off, with no test strip inserted in the test strip slot.

NOTE:

If you release the Mode button too soon, turn off your

meter by pressing and holding the Mode button. Repeat step 1.

Glucose Test Result

Tra nsfers to

Insulin Pump

Glucose Test Result

Transfers to

Insulin Pump

Setting the Optional Functions

(Continued on next page.)

2. Set Glucose Test Result Transfer To Insulin Pump:

The Glucose Test Result Transfer to Insulin Pump is preset to “ .” Press the right or left arrow button to select the setting (

“”

or “ ”).

3. Press the Mode button briefly to

confirm your choice and to advance to set Insulin Recording function.

How to Use Your Meter’s Optional Functions

Your Paradigm LinkTMBlood Glucose Monitor has Optional functions that can help you and your healthcare professional manage your diabetes.

The Optional functions allow you to:

1. Turn on or off sending blood glucose results to your Paradigm®Model 512 or higher Insulin Pump.

2. Mark specific blood glucose test results and insulin doses

3. Look at the 7-day average of your blood glucose test results

4. View time-specific averages of your blood glucose test results

5. Record and review your insulin doses

NOTE:

The Optional functions are included with your meter. These functions are turned off, except “ ”, when you receive your new meter and must be manually set up. (Refer to page 37 for setup.)

Page 24

How to Use Your Meter’s Optional Functions • 39

38 • How to Use Your Meter’s Optional Functions

Set Insulin

Recording

4. Set Insulin Recording Function:

The Insulin Recording function is preset to “ .” Press the right or left arrow button to select the setting (

“”

or “ ”).

5. Press the Mode button briefly to confirm

your choice and to advance to set Time-Specific Averages.

6. Set Time-Specific Averages:

The Time-Specific Averages function automatically comes with the 7-Day Average function. The Time-Specific Averages function is preset to “ .” Press the

right or left arrow button to select

the setting (

“”

or “ ”).

7. Press the Mode button briefly to confirm

your choice. If you set Time-Specific Averages to “ ,” skip to step 9. If you set to “ ,” you will advance to set the first of 4 times (A1, A2, A3, A4).

Set Time-Specific

Ave rag es

Avg.

NOTE:

If you set the Time-Specific Averages function to “ ” and do not set the times for A1 through A4, your meter will default the times to 7:00

, 12:00 PM, 6:00 PM, and 10:00 PM.

Set Time for A2

8. Set Time for A1:

Press the right or left arrow button to select the time when you usually do your first blood glucose test. The time will advance in 15-minute steps. The TimeSpecific Average will include test results within a 2-hour range: 1 hour before and 1 hour after the time you select.

9. Press the Mode button briefly to

confirm your choice and to advance to set time for A2.

10. Set Time for A2 Through A4:

Repeat steps 6 and 7. When complete, you will advance to set Marking function.

Set Time for Your

First

Time-Specific

Average (A1)

Avg.

(Continued on next page.)

Page 25

How to Use Your Meter’s Optional Functions • 4140 • How to Use Your Meter’s Optional Functions

11. Set Marking for Identification Function:

The Marking for Identification function is preset to “ .” Press the

right or

left

arrow button to select the

setting (“ ” or “ ”). Press the

Mode

button briefly to confirm your

choice and to advance to end of setup.

12. End of Setup:

Optional Function Setup is complete. The word “ ” will be displayed on your meter.

13. Return to Setup: Press the Mode button

briefly

to return to start of setup. You will see “” and the word

“” or “ ,” indicating whether you set the Insulin Pump Glucose Transfer function to on or off.

14. Turn Off Meter:

Press and hold the Mode button until the meter turns off, OR the meter will turn off automatically after 1 minute.

Set Marking

Function

End of Optional

Function Setup

Reviewing Your Optional Functions

1. Press the Mode button briefly

to turn the meter on.

2. Your Most Recent Blood Glucose Test Result

with date and time of testing is shown on the display. (To set the correct date and time, refer

to page 10.)

Meter is off, with no test strip inserted in the test strip slot.

Most Recent

Glucose Reading

(Example)

Mem.

mg/dL

3. If you wish to review up to 30 stored

test results, continue to press the

left arrow button. “ ” is displayed

after the last recorded test result. To return to your most recent test result, press the left

arrow button.

4. Press the Mode button briefly

to advance to the next function.

If you have set the Insulin Recording function to “ ,” proceed to next step. If you have not set the Insulin Recording function, skip to step 8.

End of Stored

Test Results

Mem.

Page 26

How to Use Your Meter’s Optional Functions • 43

42 • How to Use Your Meter’s Optional Functions

8. If you have set the Time-Specific Averages

function to “ ,” you will automatically get 7-Day Average. If you have not set this function, skip to step 10.

Your 7-Day Blood Glucose Average

is displayed showing the average of all test results taken in the last 7 days. The average will not include marked or control solution test results.

(Continued on next page.)

7-Day Average

(Example)

Mem.

mg/dL

Avg.

5. Your Last Insulin Record with

date and time of recording is shown on the display. The display will alternate between insulin dose and insulin type. (Refer to page 53

for Labeling Your Insulin Types.)

6. If you wish to review up to 30

stored insulin records, continue to press the left arrow button.

“” is displayed after the last insulin record. To return to your most recent insulin record, press the left arrow button.

7. Press the Mode button briefly

to advance to the next function.

Insulin Record

(Example)

Mem.

9. Press the Mode button briefly

to advance to the next function.

10. Your 14-Day Blood Glucose Average

is displayed showing the average of all test results taken in the last 14 days. The average will not include marked or control solution test results.

11. Press the Mode button briefly

to advance to the next function.

If you have set the Time-Specific Averages function to “ ,” proceed to next step. If you have not set the Time-Specific Averages function, skip to step 16.

12. Your first Time-Specific Average

(A1) is displayed. This is the average of 3 tests taken during the 2-hour time period that you set.

Time-Specific

Ave rag e A1

(Example)

Mem.

mg/dL

Avg.

14-Day Average

(Example)

Mem.

mg/dL

Avg.

(Continued on next page.)

Page 27

44 • How to Use Your Meter’s Optional Functions Uses For Your Meter’s Optional Functions • 45

13. To review the individual 3 test results that

make up the A1 average, press the left arrow button. “ ” is displayed after the last test result.

14. Press the Mode button briefly

to advance to your next Time-Specific Average A2. Repeat steps 12 and 13 to review your Averages A2 through A4.

15. Press the Mode button briefly

to return to your most recent blood glucose test result.

16. Memory Review is now complete.

17. To turn off the meter, press and hold the Mode button until the meter turns off,

OR the meter will turn off automatically after 1 minute.

Time-Specific

Ave rag e A2

(Example)

3 Individual Blood Glucose Test Results

(Example)

Mem.

mg/dL

Mem.

mg/dL

Mem.

mg/dL

Mem.

mg/dL

Avg.

Your Paradigm Link™ Blood Glucose Monitor allows you to review the average of all test results taken in the last 7 days. The average will not include marked or control solution test results.

(For information on “Marking for Identification,” refer to page 31 or How to Mark a Control Solution Test refer to page 18.)

The 7-Day Average function is turned off when you receive your new meter. It is automatically turned ON when you set the Time-Specific Average function to ON.

7-DAY AVERAGE

• To set up the 7-Day Average function, refer to page 37.

• After you set up the function, you can review your 7-Day Average. For complete information on how to review this and other Optional functions, refer to page 41.

Uses For Your Meter’s Optional Functions

This function is designed to help you adjust your insulin dose based on a pattern of blood glucose values over 3 to 5 days (“pattern-control” of your insulin). It provides information to help make these insulin adjustments.

You can use the meter to compute the average of 3 blood glucose test results that you took at roughly the same time of day over the last few days. You can select the 2-hour time period that you want this average to be drawn from (ie, before or after meals, before or after exercise).

TIME-SPECIFIC AVERAGES

(Continued on next page.)

Page 28

Uses For Your Meter’s Optional Functions • 47

46 • Uses For Your Meter’s Optional Functions

An example of how you may use the Time-Specific Average function is shown below.

NOTE:

To get a Time-Specific Average, your 3 tests must be

performed on 3 of the last 5 days.

This function lets you and your healthcare professional:

•Choose up to 4 time periods during the day for which you want to track results. The meter labels these times as A1, A2, A3, and A4.

•View your Time-Specific Averages on the meter display.

•View the 3 test results that make up each Time-Specific Average.

Example:

For your next appointment, your doctor wants to know, on average, how high your blood glucose has been running before lunch so you and your doctor can decide whether your diabetes therapy needs adjusting. The Time-Specific Average function will compute that number for you. Say your blood glucose at lunchtime over the last few days has been 191 mg/dL, 218 mg/dL, and 146 mg/dL. The Time-Specific Average function will show you that your blood glucose has been 185 mg/dL for this time of day.

How This Time-Specific Average Was Determined:

In the example, you chose 12:00

for your A2 Average time. This is the time you test your blood glucose before lunch.

Your A2 Average is 185 mg/dL. This value averages the last 3 blood glucose tests taken between 11:00

and 1:00 PM(1 hour before and 1

hour after 12:00

). The 3 boxes represent a Time-Specific Average, the average of 3 test results.

Time-Specific

Average (A2)

(Example)

Mem.

mg/dL

Avg.

The Time-Specific Average function is turned off when you receive your new meter. You must set up this function to turn it on. When you turn on the Time-Specific Average function, you will automatically get the 7-Day Average function.

• To set up the Time-Specific Average function, refer to page 37.

• After you set up the function, you can review your Time-Specific Averages. For complete information on how to review this and other Optional functions, refer to page 41.

NOTE:

In computing averages, the meter will use 600 mg/dL

for any

“”results and 20 mg/dL for any “”results.

You can also view the 3 individual test results, with date and time, that make up the A2 Average. Each flashing box represents one of the 3 test results that makes up the average.

3 Individual Blood Glucose Test Results

(Example)

Mem.

mg/dL

Mem.

mg/dL

Mem.

mg/dL

Page 29

Uses For Your Meter’s Optional Functions • 4948 • Uses For Your Meter’s Optional Functions

Your Paradigm Link™ Blood Glucose Monitor allows you to enter insulin dosing information into its memory. This feature might be used if you inject insulin in addition to the insulin you infuse with your pump.

Yo ur meter allows you to record and review each insulin dose and type that you inject. You can review up to 30 of your 250 stored insulin records on your meter display. An advantage of this function is that you can compare changes in the results of your blood glucose test results to your insulin doses. Once you have set the Insulin Recording function to “ ,” you can record and save your insulin delivery by insulin type and dose.

• The Insulin Recording function is turned off when you receive your new meter. To set up the Insulin Recording function, refer to page 37.

• After you set up the function, you can review your insulin therapy. For complete information on how to review this and other Optional functions, refer to page 41.

Meter is off, with no test strip inserted in the test strip slot.

1. Deliver your insulin.

2. After you deliver your insulin, press and

release the Insulin Recording button. The meter turns on and advances to insulin recording. The and a flashing “1” appear on the display.

3. Press the left or right arrow

button to select the label (P1, P2, P3, or P4) that matches the type of insulin you delivered.

(Refer to page 53 for labeling your insulin.)

4. Press the Mode button briefly to

confirm your choice and to advance to record your insulin dose.

5. Press the right arrow button

to enter your insulin units. Use the right or left arrow buttons to adjust units up or down.

Recording Your Insulin Doses

NOTE:

The meter will not enter into insulin recording mode if:

• The test strip is in the test strip slot, or

• The Insulin Recording function has not been turned on in the Optional function Setup. (Refer to page 37 for setup.)

(Continued on next page.)

Insulin

Recording

Select Insulin Type

(Continued on next page.)

Select

Insulin Dose

Page 30

Uses For Your Meter’s Optional Functions • 51

50 • Uses For Your Meter’s Optional Functions

6. To save the insulin dose, press the

Mode button briefly, or press the Insulin Recording button. A long

beep sounds to confirm that the insulin dose was saved. (Refer to page 51 for marking your

insulin dose.)

7. If you inject more than one type of

insulin at one time, turn off the meter by pressing and holding the Mode button. Repeat steps 2 through 6 to record your next insulin type.

8. You have finished recording your insulin

information. To turn off your meter, press and hold the Mode button until the meter turns off, OR the meter will turn off automatically after 1 minute.

NOTE:

It is recommended that you record your insulin within 10 minutes after delivery to make sure it is recorded with the correct date and time.

Marking an Insulin Dose

An insulin dose can be marked after an injection is recorded. For an explanation of situations in which you may wish to mark an insulin dose, refer to page 52.

1. Record your insulin dose. (Refer to page

48 for how to record your insulin doses.)

2. After you press the Mode button

briefly or press the Insulin Recording button, a long beep sounds to confirm that the insulin dose was saved.

3. To mark your insulin dose, press the right or left arrow button.

An asterisk (*) appears, to confirm that the dose is marked. Marking is complete.

4. To turn off the meter, press and hold the Mode button until the meter turns off, OR the meter will turn off automatically after 1 minute.

Marked

Insulin Dose

(Example)

Page 31

52 • Uses For Your Meter’s Optional Functions Uses For Your Meter’s Optional Functions • 53

Marking Insulin Doses:

Some examples of how you may use the Marking function to mark an insulin dose are shown below.

•You may wish to mark a dose that you are recording to indicate that you entered the information at a different time than you actually delivered the insulin.

• You may wish to indicate that a dose amount was different than what you normally take at that time.

Marked

Insulin Dose

(Example)

The labels P1, P2, P3, and P4 are used by your meter to identify up to 4 different types of insulin. As an insulin pump wearer you only use 1 type of insulin. However, you may choose to use this feature to maintain a record of those times when insulin injections were necessary. If you inject different types of insulin you can label them. Keep a record of the labels you have chosen for each insulin type.

The chart below shows examples of labeling up to 4 different types of insulin.

Humalog is a trademark of Eli Lilly and Company.

Example 1:

Uses 1 insulin type only

P1 __________

P2 __________

P3 __________

P4 __________

Example 2:

Uses 2 insulin types

P1 __________

P2 __________

P3 __________

P4 __________

Example 3:

Uses 3 insulin types

P1 __________

P2 __________

P3 __________

P4 __________

Example 4:

Uses 4 insulin types

P1 __________

P2 __________

P3 __________

P4 __________

Regular NPH

Humalog

NPH

Humalog

Regular

NPH

Humalog

Regular

70/30

Labeling Your Insulin Types

Page 32

Display Messages and Troubleshooting Guide

Additional Information • 55

This section addresses the messages that appear on your display, what they mean, and what action you need to take.

DISPLAY WHAT IT MEANS WHAT TO DO

* NOT FOR EMERGENCY OR MEDICAL INFORMATION.

Additional Information

Mem. Avg.

mg/dL

mmol/L

AM PM

This is an example of a code number stored in your meter.

Match the code number that appears on the display with the code on the vial of test strips that you are using.

System Check. Verifies that all segments are working. Appears when:

• Meter is turned on for Setup and Memory Review

• Test strip is inserted into the meter

No action required. If all segments are not displayed on meter, call BD toll-free, 24 hours a day, 7 days a week, at

1.888.BDCARES

1.888.232.2737.*

The meter is not coded. Code your meter. Refer

to page 13 for coding your blood glucose meter.

54 • Summary: How to Review Your Basic and Optional Functions

Summary: How to Review Your Basic and Optional Functions

STEPS RESULT DISPLAY SETUP

REQUIRED?

Yes (see page 37)

Press Meter turns

Mode

Press Review up to arrow buttons Last 30 Test

Results

Press Review up to Mode Last 30 Insulin

Doses (if turned ON)

Press Review 7-Day

Mode

Ave rage (if turned ON)

Press Review

Mode

14-Day Average

Press Review Time-

Mode

Specific Average (if turned ON)

Press and hold Meter turns

Mode

OFF

Mem.

mg/dL

Mem.

mg/dL

Avg.

Mem.

mg/dL

Avg.

Mem.

Avg.

mg/dL mmol/L

AM PM

Mem.

mg/dL

Avg.

Page 33

DISPLAY WHAT IT MEANS WHAT TO DO

Mem.

mg/dL

End of Setup or Memory Review.

No action required.

Mem.

An insulin dose record in the meter’s memory. Display shows an example of 8 units of insulin.

No action required.

Your blood glucose reading is lower than 20 mg/dL. You may have low blood sugar.

Retest your blood glucose immediately. If your reading is still “ ,” you should treat as prescribed by your healthcare professional and/or contact your healthcare professional immediately. A “ ” value will not transmit to the pump.

A blood glucose test result in mg/dL stored in the meter’s memory.

No action required.

Battery is getting low but you can still perform a test. Battery will appear on the display when reviewing different screens. Display shown is an example of one type of screen.

We suggest that you replace the battery immediately. There is only enough power to perform approximately 20 tests. Refer to page 62 for replacing your battery.

Mem.

An insulin type record in the meter’s memory. Display shows an example of P1 that refers to the insulin type as labeled by the user.

No action required.

56 • Additional Information

DISPLAY WHAT IT MEANS WHAT TO DO

mg/dL

Meter is ready to accept a blood sample.

Apply a blood sample to the test strip. Refer to page 22 for how to test your blood glucose.

5-second countdown as meter calculates the blood glucose test result.

No action required.

A blood glucose test result in mg/dL.

Record the result in your logbook.

Yo ur blood glucose reading is higher than 600 mg/dL. You may have

high blood sugar.

mg/dL

If “ ” is

“” the result 108 will be flashing during RF transmission to the Paradigm

Model 512 or higher Insulin Pump. It will stop flashing once the meter rece ives an acknowledgement from the insulin pump or after 1 minute

Record the result in your logbook.

Additional Information • 57

Page 34

DISPLAY WHAT IT MEANS WHAT TO DO

Additional Information • 59

mg/dL

A control solution test result.

No action required. A control value will not transmit to the pump.

Temperature Error. Meter is outside the

required temperature range of 59°F - 102°F (15°C - 39°C). Move the meter to a warmer or cooler area.

A marked blood glucose test result.

No action required.

System Error. Call BD toll-free, 24 hours

a day, 7 days a week, at

1.888.BDCARES (1.888.232.2737).*

System Error. Call BD toll-free, 24 hours

a day, 7 days a week, at

1.888.BDCARES (1.888.232.2737).*

A marked insulin dose. No action required.

* NOT FOR EMERGENCY OR MEDICAL INFORMATION.

58 • Additional Information

DISPLAY WHAT IT MEANS WHAT TO DO

Mem.

mg/dL

Avg.

Mem.

mg/dL

Mem.

mg/dL

Avg.

Mem.

mg/dL

Avg.

The average of all blood glucose test results taken in the last 7 days.

No action required.

Mem.

mg/dL

One of the 3 individual blood glucose test results that make up a TimeSpecific Average. Example shows most recent of the 3 test results.

No action required.

Memory is empty. There are no blood glucose test results in the meter’s memory. Averages cannot be calculated.

No action required.

The average of all blood glucose test results taken in the last 14 days.

No action required.

The average of 3 most recent blood glucose test results taken during the first TimeSpecific time period (A1). A similar display will appear for A2, A3, and A4.

No action required.

Page 35

Caring for Your Meter

• Not enough blood sample.

• Te st strip may be

damaged.

• Sample applied after

meter automatically turned off.

• Meter may not be

working properly.

Repeat the test with a new test strip.

Call BD toll-free, 24 hours a day, 7 days a week, at

1.888.BDCARES (1.888.232.2737).*

Meter does not begin test countdown after applying a blood sample.

• Keep your Paradigm LinkTMBlood Glucose Monitor clean and protect it from extremes in temperature. Do not store your meter in the car or in the refrigerator.

• No cleaning is required. If necessary, clean the outside of the meter with a clean cloth dampened with water.

Your Paradigm Link™ Blood Glucose Monitor comes with one installed 2450 3-volt coin cell battery or equivalent. It is important to replace the battery immediately when the battery is low.

(Continued on next page.)

Additional Information • 61

STORING AND CLEANING

BATTERY

* NOT FOR EMERGENCY OR MEDICAL INFORMATION.

60 • Additional Information

DISPLAY WHAT IT MEANS WHAT TO DO

• Battery is dead.

• Battery is installed

incorrectly or there is no battery in the meter.

• Te st strip is inserted upside

down or incompletely.

• Meter may not be

working properly.

Replace the battery. Check that the battery is

correctly installed with the “+” sign facing you.

Insert the test strip correctly with the “BD” name facing up and the correct end inserted into the test strip slot.

Call BD toll-free, 24 hours a day, 7 days a week, at

1.888.BDCARES (1.888.232.2737).*

Meter does not turn on after inserting a test strip.

* NOT FOR EMERGENCY OR MEDICAL INFORMATION.

Incorrect application of blood sample or control solution onto the test strip. Test strip may be damaged.

Insert a new test strip and perform the test again.

DISPLAY WHAT IT MEANS WHAT TO DO

(Continued on next page.)

Page 36

Additional Information • 63

Put in New Battery

Replace Battery Door

Remove Old Battery

Open Battery Door

4. Open the battery door by pushing back on

the opener and lifting up as shown.

5. Remove old battery by pulling on the tab.

6. Put in a new battery with the “+”

side facing up and the tab showing as illustrated in step 5.

7. Replace battery door as shown.

NOTE:

After replacing the battery, meter will enter Basic Setup mode to let you reset the time and date to match the local time. (Refer to page 10 for how to set the time and date.) Follow your local regulations on battery disposal.

62 • Additional Information

How to Replace the Battery

1. The meter display shows when performing a test or reviewing your memory functions.

2. Turn the meter off by pressing and holding the Mode

button, OR the meter will turn off automatically

after 1 minute.

3. Turn the meter around so that the display is facing

away from you.

The meter will tell you the battery is low by displaying when the meter is turned on.

•You can still get accurate test results or review your memory functions. However, when the symbol first appears, there is only enough power to perform approximately 20 tests.

•When the battery runs out, the meter will not turn on. The test result information you have stored in memory will not be lost, however, if the battery is removed from the meter, you may need to reset the date and time.

•Battery life varies depending on how often you use your meter. On average, the battery should last for 1 year with the “ “ function turned off. On average, the battery should last for approximately 2 months with the “ “ function turned on.

Turn Meter

Around

Low Battery

mg/dL

(Continued on next page.)

Page 37

Elevated levels of acetaminophen, tolazamide, uric acid, bilirubin, ephedrine, and methyldopa may affect results.

Conditions That May Affect Results

• If, at any time during the first 3 years after purchase, your Paradigm Link™ Blood Glucose Monitor does not work for any reason (other than for obvious abuse), BD will replace it with a new meter or equivalent product free of charge.

• This warranty policy applies only to the individual who originally purchases the meter, and does not apply to the batteries supplied with the meter.

3-Year Warranty

64 • Additional Information

Additional Information

• 65

•Severe dehydration and excessive water loss may cause false low results. If you think you may be dehydrated, consult your healthcare professional immediately.

•Test results greater than 240 mg/dL may mean high blood sugar (hyperglycemia). Test results lower than 60 mg/dL may mean low blood sugar (hypoglycemia). If you get results in these ranges, retest your blood glucose. If your reading is still in these ranges, you should treat as prescribed by your healthcare professional and/or contact your healthcare professional immediately.

• If your blood glucose test results do not match the way you feel AND you have followed all of the instructions described in your Owner’s Guide, contact your healthcare professional.

Healthcare Precautions and Limitations

Page 38

Additional Information • 67

BD Consumer Services is available to help you 24 hours a day, 7 days a week. If you have any comments or questions about your Paradigm Link™ Blood Glucose Monitor, call BD Consumer Services toll-free, in the US at

1.888.BDCARES (1.888.232.2737).*

* NOT FOR EMERGENCY OR MEDICAL INFORMATION.

How to Contact Us

Please have your Paradigm LinkTMBlood Glucose Monitor and the following information readily available when you call:

•Your meter’s ID Number (located on the back of your meter)

•Test strip information:

Lot Number

Code Number

Expiration Date

Control Solution Range

•Control Solution Information:

Lot Number

Expiration Date

66 • Additional Information

Test Capillary blood glucose referenced to plasma

Assay Method Glucose oxidase biosensor

Test Result Range 20 mg/dL to 600 mg/dL

Tes t Time 5 seconds

Test Strip Volume 0.3 µL*

Radio Frequency (RF) 916.5 MHz

Power Source One replaceable 2450 3-volt coin cell battery or equivalent

Battery Life 500 tests or about 2 months at 8 transmitted blood glucose

results per day when “ “ function is on

Glucose Units mg/dL

Display LCD

Memory Up to 250 Blood Glucose and Control Solution Tests

Up to 250 Insulin Records

•

Sending your blood glucose result to your Paradigm®Model 512 or higher Pump

Functions • Averaging: 7-Day, 14-Day, and 4 Time-Specific Averages

• Insulin Recording

•Marking

Data Port Yes

Automatic Shutoff One (1) minute after last user action**

Size 3.6” x 2.3” x 0.9”

(91.4 mm x 58.4 mm x 22.9 mm)

Weight 2.65 ounces (75 g) (with battery) Operating Ranges:

Altitude Up to 10,000 feet (3,000 m) Temperature 59°F to 102°F (15°C to 39°C) Humidity 10% to 90% relative humidity Hematocrit 25% to 60%

*Blood sample required 0.4 µL **10 minutes in insulin mode or when downloading to a computer.

Specifications

Page 39

Notes

Page 40

Notes

Paradigm Link

™

Blood Glucose Monitor

Paradigm Link™ Blood Glucose Monitor

BD™ Lancet Device

BD™ Control Solution

BD™ Test Strips

BD Ultra-Fine™ 33 Lancets