This product is covered by U.S. Patent Nos. 6,551,276 and 6,554,798. Other U.S.
and/or foreign patents may be pending.
Bolus Wizard
®
is a registered trademark of Medtronic MiniMed.
Dual Wave™ is a trademark of Medtronic MiniMed.
Easy Bolus™ is a trademark of Medtronic MiniMed.
Square Wave™ is a trademark of Medtronic MiniMed.
BD Logic™ is a trademark of Becton, Dickinson and Company
Energizer
Glucagon Emergency Kit
Paradigm
®
is a registered trademark of Eveready Battery Company.
®
is a registered trademark of Eli Lilly and Company.
®
is a registered trademark of Medtronic MiniMed.
Paradigm Link™ is a trademark of Medtronic MiniMed.
The Link™ is a trademark of Becton, Dickinson and Company (Canada only)
Quick-serter
Quick-set
Silhouette
Sof-set
®
is a registered trademark of Medtronic MiniMed.
®
is a registered trademark of Medtronic MiniMed.
®
is a registered trademark of Medtronic MiniMed.
®
is a registered trademark of Medtronic MiniMed
U.S., international, and foreign patent applications are pending.
D9195890-015 040705
Important Safety Information Regarding Your
Paradigm Insulin Infusion Pump (includes all models)
Avoid Immersing Your Pump In Water
Although it is unlikely that water damage will occur if your pump is splashed
or briefly dunked, you should avoid immersing your Paradigm infusion pump
in water. To swim or participate in other water activities, always disconnect
from your Paradigm pump and reconnect after water play.
If you inadvertently submerge your pump in water, dry the pump quickly
using a soft, clean towel and verify that it is working properly by selecting
“self test” from the pump’s Utilities Menu. If you believe that water has
entered your pump or you observe any other possible pump malfunction,
please check your blood glucose, treat high blood glucose (if necessary) with
an injection and contact our 24-Hour Help Line at 1-800-MINIMED
(1-800-646-4633) for further assistance. Symptoms of high blood glucose
include fatigue, excessive thirst and nausea. You should always contact your
healthcare professional if you experience excessively high or low blood
glucose levels, or if you have any questions about your care.
Electrostatic Discharge
Although your Paradigm pump is designed to be unaffected by typical levels
of electrostatic discharge (ESD), very high levels of ESD can result in a reset
of the pump’s software with an associated pump error alarm. In most cases,
exposure to high levels of ESD will trigger the pump’s E-13 alarm although,
under certain circumstances, high level ESD exposure can cause E-44, Bolus
Stopped or Max Delivery alarms. High levels of ESD are more likely in
situations where the relative humidity is very low, such as inside a heated
building during the winter in areas where it is cold outside.
If your pump experiences an E-13 or other error alarm, press the “ESC” and
“ACT” buttons to clear the alarm. If you are unable to clear the alarm by
pressing “ESC” and “ACT”, you may need to remove and replace the pump’s
battery to clear the alarm. After clearing the alarm, you should always verify
that your pump is set to the correct date and time and that all other settings
(basal rate, max basal and bolus limits, etc.) are programmed to the desired
values, since the software reset could erase your previously programmed
settings. Please see the Alarms and Alerts section of this User Guide for
more details regarding what to do if your pump displays an error alarm or
other alert message.
Please contact our 24-Hour Help Line at 1-800-MINIMED (1-800-646-4633)
to report any error alarms or other problems that occur with your pump.
Whether you are beginning pump therapy for the first time, or
upgrading from a previous model, we are pleased that you have
chosen Medtronic MiniMed as your partner to help you gain better control of your diabetes. We believe that the combination of
state-of-the-art technology and the simple, menu-driven programming of the Paradigm pump will provide many benefits.
This User Guide is designed to help you use your pump; however,
working with your healthcare professional is strongly recommended for your safety and to simplify your familiarity with the
pump and pump therapy.
For your records
The pump serial number is located on the back of your pump.
Please enter the serial number, purchase date, and pump start
date in the table below.
Serial NumberPurchase Date
Pump start date:
1
Assistance
Medtronic MiniMed provides a 24-hour help line for assistance in
the United States. The help line is staffed with technicians who are
trained in the set-up and operation of the Paradigm pump and are
able to answer pump-related questions. When calling the help-line,
please have your pump and serial number available. The help-line
telephone number is also on the back of your pump.
24-hour Product Help-line
if calling from inside the United States
if calling from outside of the United
States
Web sitewww.minimed.com
800.646.4633
(800-MiniMed)
818.576.5555
Availability
The Paradigm insulin pump and its components are available
through Medtronic MiniMed and from authorized distributors.
2Chapter 1
Emergency kit
Keep an emergency kit with you at all times to make sure that you
always have necessary supplies. This kit should include:
■
Fast-acting glucose tablets
■
Blood glucose monitoring supplies
■
Urine ketone monitoring supplies
■
Short acting insulin and insulin syringe with directions from
your healthcare professional regarding how much insulin to
take
■
An extra Paradigm infusion set and Paradigm reservoir
■
Dressing and adhesive
■
Extra AAA Alkaline and A23 batteries (Energizer
recommended)
■
Paradigm Quick Reference Card
■
Glucagon Emergency Kit
Inform a family member, co-worker, and/or friend where this
emergency kit is kept.
Please refer to Chapter 10, User Safety for more information on
pump safety.
Introduction 3
Pump and user guide conventions
The following terms and icons are used to describe the pump in
this User Guide.
“Press” means to push and release the button.
“Hold” means to push and maintain pressure on the button.
Flashing words or numbers on the screen indicate information
that can be changed in the pump.
Information that cannot be changed appears on the screen in characters that do not flash.
“Select” means to use the arrow buttons to access a pump
feature.
Buttons and screen names are always uppercase; for example, ESC
and HOME.
A note is additional, helpful information.
The word “CAUTION,” warns you of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury
to the user or damage to the equipment.
The word “WARNING,” alerts you about a situation which, if not
avoided, could result in death or serious injury. It may also describe
potential serious adverse reactions and safety hazards.
4Chapter 1
Your pump
Take a look at your pump.
battery
compartment
display
screen
tubing
connector
reservoir
compartment
The pump is smart. It remembers
your settings and stores a record of
its actions.
Turn your pump on its side.
Look at the reservoir compartment
window. This window lets you see the
reservoir. You can also find the
approximate remaining reservoir volume by looking at the STATUS
screen.
The reservoir compartment only
accepts the Paradigm reservoirs. The
reservoir and tubing connector are
inserted into the compartment.
buttons
reservoir
window
Introduction 5
Installing the battery the first time
The Paradigm pump uses a AAA alkaline battery. As a safety measure, Medtronic MiniMed has designed the pump to only accept a
NEW battery. The pump is very particular, if you insert a used battery, an alarm will be triggered.
If your batteries have been in a cold place, (i.e., your car in the
winter), allow the battery to warm to room temperature (up to 30
minutes) before inserting into the pump.
CAUTION: It is highly recommended that you use an AAA alkaline
Energizer battery. Do not use a carbon zinc battery in the
pump.
1. Use the edge of a coin
and unscrew the battery cap in a counterclockwise manner.
Insert a new AAA alkaline battery. Insert the
battery with the negative (-) symbol going
into the battery compartment first. Check the label on the back
of the pump to make sure you are inserting the battery correctly.
battery
cap
battery
o-ring
2. Replace the battery cap by inserting the cap into the pump,
turning it clockwise until it is fully closed.
6Chapter 1
3. Numbers will appear on the pump screen as the pump turns
on. Then the following screen will appear.
MiniMed
4. If this does not happen:
a. Check to see if the battery is inserted properly. If the battery
has been installed backwards, discard the battery and install
a NEW battery.
b. If the battery is inserted properly and your pump still does
not turn ON, try a new battery (repeat steps 1 through 4).
c. If the pump is still not ON, call the 24-hour Product Help-
line.
5. The software version screen will appear and then the HOME
screen.
MiniMed
6. You can now explore your pump by pressing the buttons and
scrolling through the menus. Refer to Chapter 2: Getting
Started for instructions for programming your pump for use.
If you perform the Rewind function, program your pump or the
Check Settings alarm will occur.
Introduction 7
Home screen
The HOME screen serves as the starting point to access the programming
screens by pressing ACT, or to access
the STATUS screen by pressing ESC.
The word MiniMed is always ON when
the pump is running. When
“MiniMed” does not appear, the pump
is not running.
MiniMed
Area below the line
is blank.
Modes of operation
There are three modes of pump operation: Normal, Special and
Attention.
Normal
In the Normal mode,
the word MiniMed
appears without
circles.
This area
will not have
or
MiniMed
Special
The Special mode indicates certain
features have been activated. Programming of other features is still allowed
when the pump is in the Special mode.
The open circles will appear on top of
all the screens until the pump is returned back to Normal mode or
the Attention mode is triggered.
8Chapter 1
These circles indicate
Special mode.
MiniMed
The following features or alarms turn on the open circles:
■
Dual/square wave bolus delivery
■
Basal patterns A or B
■
Temporary basal delivery
■
Block
■
Low reservoir
■
Low battery
Attention
Solid circles appear when insulin
delivery has stopped. This will happen if operator interaction is
required, an alarm warning is
received, or when the pump is suspended. Alarm text; such as, Empty Reservoir will appear on the
screen if activated. The warnings will be explained on the screen
when programming buttons are pressed. Use the to view all of
the instructions on the screen. Press ESC and then ACT to clear
the alarm. Until the alarm is cleared, the pump is not delivering
insulin.
MiniMed
These circles indicate
Attention mode.
Solid circles indicate that INSULIN DELIVERY HAS BEEN
STOPPED.
The pump will beep/vibrate periodically when in the Attention or
Special modes to remind you of the condition. The beep/vibrate
frequency varies depending on the alarm.
Introduction 9
The screens that will display solid circles are:
■
Suspend
■
Empty Reservoir
■
Rewind
■
Insulin Type
■
Prime
■
Alarms
■
Errors
■
No Reservoir
■
Check Settings
Pump buttons
Five buttons are used to program and access the pump features.
UP
and
DOWN
buttons
EXPRESS
BOLUS
button
ESC
button
ACT
button
■
10 Chapter 1
The UP and DOWN buttons have several functions.
✒ They allow you to scroll through the menus for entry
choices.
✒ When a numerical entry is required, these buttons allow
you to change the number to the value of your choice.
scrolls the number higher and scrolls the
number lower.
■
From the HOME screen, the and buttons have
special functions:
✒ The button lets you set an Easy Bolus.
✒ The button lets you turn the backlight On or Off.
■
The ESC button is used to move backwards in the menu
structure. Use this button to back out of an unintentional
menu selection.
■
The ESC button is used to view the STATUS screen from the
HOME screen.
■
Press the ACT button to select or activate menu items. You
will hear a beep or feel a vibration after you have successfully
activated a change.
■
The EXPRESS BOLUS button provides a shortcut to the
bolus set-up screens.
The pump screen text shown in this User Guide might not exactly
match the text on your pump screen. Please follow the instructions on your pump screen. If you have any questions call the 24hour Product Help-line.
Introduction 11
Main menu
When you press ACT from the HOME screen, the Main menu will
appear.
MiniMed
MAIN MENU
Bolus
Suspend
Basal
Prime
Utilities
* Manual Prime is
only displayed as part
of the rewind process.
ACT
ACT
ACT
ACT
ACT
MiniMed
BOLUS MENU
Set Bolus
Bolus History
Max Bolus
Dual/Square Bolus
Easy Bolus
MiniMed
SUSPEND
Press ACT to Stop Pump
MiniMed
BASAL MENU
Set/Edit Temp Basal
Set/Edit Basal
Basal Review
Max Basal Rate
Patterns
MiniMed
PRIME MENU
Rewind
Manual Prime*
Fixed Prime
Prime History
MiniMed
UTILITIES MENU
Alarm
Daily Totals
Block
Time/Date
Language
RF Options
Clear Pump
Selftest
12 Chapter 1
Five lines of text is always viewable on your pump screen. The top
line will always display the word “MiniMed.” The lines that follow
identify the name of the menu and the choices/information available in that menu.
If there are more choices available in a menu than permitted
by the five-line screen size, a
scroll bar will appear on the
right side of the display. You will
Basal
Prime
Utilities
MiniMed
MAIN MENU
scroll
bar
need to use the and buttons to move through the menu choices.
The choices which appear on the Main menu graphic on the previous page show all the choices available in each of the Main
Programming menus.
You will not see items printed in gray unless you use the and
buttons to scroll through the menus.
Bolus menu
The Bolus menu is used to give a meal bolus for food and to program a correction bolus for high blood glucose.
Suspend
The Suspend function will stop all insulin deliveries (Basal, Bolus,
and Fixed Prime) programmed into your pump. You must resume
your pump for Basal insulin delivery to restart.
WARNING: A Bolus and Fixed Prime will not restart automatically,
and will need to be reprogrammed.
Introduction 13
Basal menu
Use the Basal menu to program a continuous amount of insulin 24
hours-a-day. Your basal rate is the amount of insulin required to
maintain your target glucose values when you are not eating. Your
healthcare professional will calculate this rate for you.
Prime menu
Use the Prime menu to fill the infusion set with insulin before use.
Utilities menu
The utilities menu allows you to customize your pump. Utility
features that can be set for your personal lifestyle are:
■
Alarms
■
Daily Totals
■
Block
■
Time/Date
■
Language
■
RF Options
■
Clear Pump
■
Selftest
14 Chapter 1
Initial pump settings
This is the information you need on the day that you begin using
your pump with insulin.
If your pump start is to take place in your healthcare professional’s
office, you will be given the settings that day.
If your pump start is going to take place in another location, make
sure to contact your healthcare professional to determine your
basal rate and bolus amounts. This may require making an
appointment to review your blood glucose logs in order for your
healthcare professional to make an accurate determination.
Enter your settings in the tables on the next page and onto the
Quick Reference Card provided. This card is designed to fit into
your wallet or pocket, so it is always with you.
Introduction 15
Basal rate information
Basal Rate NumberStart TimeUnits per Hour
#1
#2
#3
#4
Most people will only have one basal rate when starting pump
therapy.
Meal boluses
Carbohydrate Ratio:
1.0 unit of insulin for ______ grams of carbohydrate
Correction bolus
1.0 unit of insulin will lower blood glucose by approximately
_______ mg/dl(mmol/l)
Blood glucose targets
Before Meals:between ____ and____mg/dl(mmol/l)
2 hours after meals:less than ________mg/dl(mmol/l)
Bedtime:between ____ and____mg/dl(mmol/l)
2-3 a.m.:more than _______mg/dl(mmol/l)
16 Chapter 1
Chapter 2
Getting Started
• • • • • •
This chapter will guide you through the set-up procedures to get
your pump ready to use. Make sure you have read Chapter 1,
Introduction and are familiar with all the pump features.
Do not continue with this section unless you have watched your
video and completed your pump start training.
Reservoir and infusion sets
WARNING: For your protection the model 511Paradigm infusion
pump has undergone extensive testing to confirm
appropriate operation when used with Paradigm reservoirs and Paradigm infusion sets manufactured or distributed by Medtronic MiniMed. We cannot guarantee
appropriate operation if the pump is used with reservoirs or infusion sets offered by third-parties and therefore we are not responsible for any injury or
malfunctioning of the pump that may occur in association with such use.
The Medtronic MiniMed Paradigm infusion system (MMT-511)
includes the Paradigm pump, reservoir and infusion sets. The
Paradigm pump is intended for use with a Paradigm reservoir and
Paradigm infusion sets. Medtronic MiniMed provides a variety of
Paradigm infusion sets to fit your different needs.
17
Refer to the Instructions for Use included with the Paradigm reservoir and infusion sets you have chosen for detailed information.
Preparing your pump for use
This section guides you through the procedures that you need to
complete to prepare your pump for use. You will need the following
items:
■
Paradigm Pump
■
Insulin
■
Paradigm Infusion Set
■
Paradigm Reservoir
These procedures are sequential. Perform the following procedures
in order.
Setting the time and date
1. From the HOME screen, press ACT. Press the button to
select Utilities. Press ACT.
MiniMed
Basal
Prime
Utilities
MAIN MENU
2. Press the button to select Time/Date. Press ACT.
MiniMed
UTILITIES MENU
Daily Totals
Block
Time/Date
18 Chapter 2
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