Medtronic MiniMed 511 Paradigm Infusion Pump, Model MMT-511 User Manual manual

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Date Submitted	2001-05-17 00:00:00
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Paradigm” Infusion Pump
User Guide
© 2001, MiniMed Inc. All rights reserved.
MiniMed® is a trademark of MiniMed Inc.
ParadigmTM is a trademark of MiniMed Inc.
Glucagon Emergency Kit® is a trademark of Eli Lilly Industries
U.S., international, and foreign patent applications are pending.
/ o 0 ®
MMmiMed
USA: Northridge, CA 91325
EUROPE: MiniMed S.A., Paris, France
D9195890-0U1 5/01
Table of Contents
Chapter 1 Introduction .................. 1
For your records .............................. 1
Assistance ................................... 2
Availability .................................. 2
Keep an emergency kit with you at all times ..... 3
Pump and user guide conventions ............... 4
Your pump .................................. 5
Chapter 2 Remote Transmitter ............. 6
Using your remote ............................ 7
Remote Transmitter Buttons .................. 8
Deliver a bolus using the remote ................. 8
Suspend/resume using the remote ............. 9
Installing a new remote battery ............... 10
Cleaning your remote transmitter ............. 11
If the remote transmitter is dropped ........... 11
If the remote transmitter falls in water ......... 11
Chapter 3 Pump User Safety ............. 12
Indications ................................. 12
Contraindications ............................ 12
Warnings ................................... 13
Diabetic ketoacidosis (DKA) .................. 13
Hypoglycemia ............................. 13
Skin infections ............................ 13
Notices .................................... 14
For the remote transmitter .................. 14
For the insulin pump ....................... 15
Chapter4lconTabIe......’H..........17
Table of Contents
Chapter 1
Introduction
Whether you are beginning pump therapy for the first time,
or upgrading from a previous model. we are pleased that you
have chosen 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, menufdriven pro-
gramming of the MiniMed ParadigmTM pump, will provide
many benefits.
This User Guide is designed to help you learn to use your
pump, however, working with your healthcare provider 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 and purchase date in the table
below.
Serial Number Purchase Date
Assistance
The Clinical Service help line provides technical support If you
need to order a product (i. e., pump supplies) call the Customer
Service number.
MiniMed provides a 24—hour help line for assistance in the
United States The help line is staffed with Clinical Service tech~
nicians, who are trained in the set—up and operation of the Para—
digm pump and are able to answer pump—related questions.
When calling the help line of your local MiniMed office, please
have your pump and serial number available The Clinical Ser»
Vices help line is also listed on the back of your pump.
Telephone Numbers
800.826.2099
Department
Clinical Services (24-hour Help Line)
if calling from inside the United States
Clinical Services (24—hour Help Line) 818.576.5555
if calling from outside of the United
States
80084313687
www.minimedicom
Customer Service (sales)
MiniMed web site
Availability
CAUTION: US. law restricts the Paradigm insulin pump and
system components to sale by or on the order of a physician.
The Paradigm insulin pump and its components are available
through MiniMed and from authorized MiniMed distributors.
Introduction 2
Keep an emergency kit with you at all times
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 batteries (AAA Alkaline)
- Paradigm Quick Reference Card
. Glucagon Emergency Kit®
Inform a family member, co-worker. and/or friend where this
emergency kit is kept.
Quick
g/ m
Mort Acting Insulin—
Please refer to the Pump User Safely/chapter for more informa—
tion on pump safety.
Introduction
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 icon is preceded by the word “caution,” indi-
cates damage to the pump may occur if instruc—
tions are not followed.
The icon is preceded by the word “warning, " indi-
cates that the person wearing the pump could be
harmed if instructions are not followed.
Introduction 4
Your pump
Take a look at your pump.
display
screen
battery
compartment
reservoir
compartment
EXPRESS button
BOLUS
button
The pump is smart. It remembers _
your settings and stores a record of
its actions.
Turn your pump on its side. reservoir
Look at the reservoir compartment wmdow
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 connec-
tor are inserted into the compartment.
UP
arrow
and
EASY BOLUS
DOWN
arrow
and
BACKLIGHT
Introduction
Chapter 2
Remote Transmitter
CAUflON: The remote transmitter should not be used
aboard an aircraft. Operate your pump using its
integral display and keyboard Wh/le the a/rcraft doors
0 are dosed
The Model 503 Remote Transmitter (remote) is an accessory
item for your Paradigm insulin pump that allows you to pro-
gram a bolus or suspend and restart your pump without
pressing any of the pump buttons.
The remote transmitter sends signals to a receiver in your
pump. This is designed to add more freedom and flexibility to
your daily activities. Of course, you can still program your
pump by using the five buttons on the keypad.
The RF Options feature is not essential for pump users. You
may want to explore this option after you have become com-
pletely familiar with the basic functions of your pump. It is
important that you consult with your healthcare professional
before using this feature.
Using your remote
To use the remote transmitter, this feature must be turned ON,
and the Easy Bolus feature must be ON. You will need to pro»
gram a radio frequency code (RF ID) to link your pump with
your remote. Your pump is programmed at the factory with this
feature OFF. Discuss what uses and settings are best for you
with your healthcare professional.
When the remote is in “sleep mode," the green LED light will be
off. The remote transmitter will operate within 24 inches from
your pump.
Your pump "looks" for a signal from the remote every two to
three seconds. This is why you need to press and hold the ACT
button on the remote before you can program. Continuing to
hold the ACT button, however, after the pump wakes up may
result in the pump returning to sleep mode.
After you have awakened your pump by pressing and holding
the ACT button, the green LED light will glow and flash rapidly.
When the battery is low, the LED will blink in a series of three
quick flashes until the battery is replaced. When this happens,
replace the battery in the remote transmitter as soon as possi—
ble. If the wrong button is pressed, simply wait 30 seconds for
the command to time out (do not press any buttons).
Remote Transmitter 1
Remote Transmitter Buttons
Back of Remote Transmitter
B button
for
5 I B Bolus
3 button for Suspend
1 l RF IDcode
green ACT
light ACT
button
Deliver a bolus using the remote
Allows you to deliver an easy bolus using the remote transmit—
ter.
1. Turn ON Easy Bolus on the pump.
2. Add the RF ID code from your remote transmitter via the
Utililities menu on the pump.
3. Press and hold ACT on the remote transmitter for at least
three seconds to “wake up" the pump. Do not press ACT for
longer than 10 seconds. When the pump is awake, it will
beep or vibrate. You will now be able to program an easy
bolus.
4. Press the B button as many times as you want to select the
bolus step amount. Each press will result in a step beep or
vibration. The beeps will change in pitch to assist your
counting.
RemoteTransmitter 8
5. Press ACT. The pump will beep or vibrate back the amount
you just selected. Count the beeps/vibrations. If this amount
correctly equates to the desired bolus amount, press ACT to
deliver the bolus.
If the amount is incorrect, let the pump “time out." (Do not
press any buttons.) To restart programming, you will need
to wake up the pump again.
Suspend/resume using the remote
1. Press and hold the ACT button on the remote transmitter
for at least three seconds to “wake up” the pump. When the
pump is awake, it will beep or vibrate.
2. To suspend pump delivery. press the S button, then press
ACT. Three audible beeps/vibrations will confirm that the
pump is in suspend mode.
3. T0 resume basal delivery, press and hold ACT on the remote
transmitter for three seconds. This will “wake up" the
pump. Next, press the S button, then press ACT. The pump
will beep/vibrate once and then will resume basal delivery.
RemoteTransrnitter
Installing a new remote battery
The battery in the remote transmitter needs to be changed
approximately every six months, depending on how often you
use the remote.
1.
Unsnap the rear panel by twisting a coin or screwdriver
between the key ring. Remove the used battery and discard
properly.
Insert a new A23 bat—
tery according to the
diagram on the remote
transmitter case.
When inserting the
new battery, do not
touch any of the
exposed electronics.
3. Replace the rear panel
and snap the panels together to connect remote transmitter
case.
> Your remote transmitter should be able to transmit to the pump as
soon as the battery is inserted. If this does not happen:
1.
2.
Check to see if the battery is inserted properly.
If the battery is inserted properly and the remote transmit»
ter LED/green light does not flash, install a new battery.
> If the remote transmitter does not “wake up" the pump:
1.
2.
3.
Make sure the easy bolus and RF transmitter options are
turned ON.
Make sure the RF ID is correctly entered.
Call MiniMed for assistance.
RemoteTransmitter 10
Cleaning your remote transmitter
1.
Use a damp cloth and mild soap to clean the outside of your
remote transmitter.
Never use organic solvents, such as nail polish remover or
paint thinner, to clean your remote transmitter.
If the remote transmitter is dropped
1‘
Check that the remote transmitter panels (front and rear)
are still attached
Press and hold the ACT button on the remote transmitter to
check communication with the pump.
If the remote transmitter falls in water
Pat the outside of the case with a cloth until dry.
Following the battery installation procedure, unsnap the
rear panel, and allow the two sections to dry out. Do not use
hot air to dry your remote transmitter as this may damage
internal electronics
Call MiniMed for assistance.
RemoteTransmitter 1 1
Chapter 3
Pump User Safety
Indications
The MiniMed Paradigm Insulin Pump is indicated for the con—
tinuous delivery of insulin, at set and variable rates, for the
management of diabetes mellitus in persons requiring
insulin.
Contraindications
Pump therapy is not recommended for people who are unwill—
ing or unable to perform at least four to six blood glucose
tests per day and to maintain contact with their healthcare
professional.
Successful operation of the MiniMed pump requires good
vision and hearing. While features exist to help facilitate
pump usage, MiniMed does not recommend the use of this
product by individuals whose impaired vision or hearing does
not allow full recognition of the pump signals and alarms.
12
Warnings
The following conditions may occur while using an insulin
pump:
Diabetic ketoacidosis (DKA)
Insulin pump therapy uses only regular (short—acting) insulin;
therefore, any interruption in the delivery of insulin may result
in hyperglycemia (high blood glucose) and, subsequently, the
rapid onset of diabetic ketoacidosis.
If your insulin delivery is interrupted for any reason, you must
be prepared to replace the missed insulin immediately. The
quickest way to do so is to check your blood glucose and if ele—
rr hihl l ihnin' infh - -
in in lin r r r’ in r in
Hypoglycemia
The intensive management of diabetes has been associated with
an increase in the incidence of hypoglycemia (low blood sugar).
Skin infections
Infection at the infusion site is a risk of pump therapy.
Pump User Safety 13
Notices
For the remote transmitter
This device complies with the United States Federal Communi—
cations Commission and international standards for Electro-
magnetic 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.
These standards are designed to provide reasonable protection
against excessive radio frequency interference and prevent
undesirable operation of the device from unwanted electromag
netic interference Operation is subject to the following two
conditions:
This device has been tested and found to comply with the regu»
lations governing such devices in your area. For the specific
regulation and test results for you area, please contact your
local MiniMed representative.
This device generates, uses, and can radiate radio frequency
energy and, if installed and used in accordance with the instruc—
tion, may cause harmful interference to radio communications.
If the device does cause interference to radio or television recep-
tion, the user is encouraged to try to correct the interference by
one or more of the following measures:
- Reorient or relocate the remote transmitter
- Increase the separation between the remote transmitter
and the device that is receiving/emitting interference
- If you have questions, please contact MiniMed.
Punp User Safety 1 4
For the insulin pump
This device complies with the United States Federal Communi»
cations Commission and international standards for Electro—
magnetic 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.
These standards are designed to provide reasonable protection
against excessive radio frequency interference and prevent
undesirable operation of the device from unwanted electromag
netic interference. Operation is subject to the following two
conditions:
This device has been tested and found to comply with the regu—
lations governing such devices in your area. For the specific
regulation and test results for you area, please contact your
local MiniMed representative.
This device generates, uses, and can radiate radio frequency
energy and, if installed and used in accordance with the instruc—
tion, may cause harmful interference to radio communications.
If the device does cause interference to radio or television recep—
tion, the user is encouraged to try to correct the interference by
one or more of the following measures:
' Reorient or relocate the insulin pump
- Increase the separation between the insulin pump and
the device that is receiving/emitting interference
- If you have questions, please contact MiniMed.
Pump User Safety 15
CAUT/ON: Any changes or modifications to the devices
not expressly approved by Min/Med could void your
ability to operate the equrpment.
Country
Austria
Current Standard
EN 300 220-1 1997—11
Belgium
Denmark
Finland
France
( )
EN 30022111 (1997.11)
EN 300 220-1 (1997-11)
( )
EN 300 220-1 1997»1l
EN 300 2201 1997-11)
Germany
ETS 300 683 (JUNE 1997)
Ireland EV 300 220-1 (1997— 11)
EV 300 220-1 (1997-11)
EV 300 220-1 (1997-11)
Netherlands EV 300 220-1 (1997-11)
Sweden EV 300220 1 (1997- 11)
United Kingdom E 300 220- 1 (1997-11)
Portugal EV 300 220—1 (1997—11)
EN 300 220—1 1997—11)
Norway EV 300 220-1 1997-11)
Switzerland E 300 220-1 1997-11)
Poland EV 300 220-1 (1997-11)
Pump User Safety
16
Chapter 4
Icon Table
Do not reuse this device:
Attention: See Instructions for Use
Sterilized using Ethylene Oxide:
_@
Date of Manufacture:(year - month)
Lot Number:
Use by: (year — month)
2 2000-06
example:
REF MMT-511
Reference Model Number
Device Serial Number
Storage Temperature Range
Fragile Product:
Type BF: (Protection from Electrical Shock)
Water Resistant:
11

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