Medtronic Paradigm Link Owner's Manual

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.

BD, BD Logo, BD Latitude, BD Logic and BD Ultra-Fine
are trademarks of Becton, Dickinson and Company.
© 2003 BD

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

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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

•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

TM

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.

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

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

TM

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

Mem.
Avg.

mg/dL

mmol/L

AM
PM

A.

B.

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

U

C.

D.

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

TM

Blood Glucose Monitor

Edge to Apply

Blood Drop

End to Insert

Into Meter

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

TM

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

TM

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.

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

TM

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.

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.

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

AM

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.

AM

Flashing Hour

Display

PM

Set Hour

(Example)

Set Minutes

(Example)

(Continued on next page.)

PM

(Continued on next page.)

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.

PM

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