Medtronic Paradigm 515, Paradigm 715 User Manual
User Guide
INSULIN PUMP
Paradigm
®
515 and 715 Insulin Pumps
User Guide
©2008 Medtronic MiniMed, Inc. All rights reserved.
This product is covered by U.S. Patent Nos. 6,551,276; 6,554,798; 6,872,200; 6,936,029; 6,979,326; 6,997,920 and
7,025,743. Other U.S. and/or foreign patents may be pending.
Bolus Wizard
®
, Dual Wave®, Guardian®, Guardian RT®, Paradigm®, Paradigm Link®, Quick-serter®, Quick-set®, Sof-set®, and
Square Wave
®
are registered trademarks of Medtronic MiniMed, Inc.
CareLink™ Personal and Easy Bolus™ are trademarks of Medtronic MiniMed, Inc.
Energizer
®
is a registered trademark of Eveready Battery Company.
Glucagon Emergency Kit
®
is a registered trademark of Eli Lilly and Company.
6025020-018_b
REF MMT-515 MMT-715
Important Safety Information
Regarding Your Paradigm Insulin Infusion Pump
(includes all models)
Avoid Immersing Your Pump In Water
The pump was tested and met requirements for IPX7 at time of manufacture. For more information about
IPX7, see the Glossary on page 165. Be aware that drops and bumps that occur over time will affect the
integrity of the pump case and make it more vulnerable to damage from water. Lotions, sunscreens and
insect repellent can also damage the pump case. It is not known how much water is needed to damage
your pump. You should avoid getting your pump wet. To shower, bathe, swim, or participate in water
activities, always disconnect from your pump and reconnect after you are out of the water.
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 Selftest 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 HelpLine
at 1 800 646 4633 for further assistance. Symptoms of high blood glucose include fatigue, excessive thirst
and nausea. 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 A-13 alarm although, under
certain circumstances, high level ESD exposure can cause A-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 A-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 HelpLine at 1-800-MINIMED (1-800-646-4633) to report any error alarms or
other problems that occur with your pump.
Contents
Chapter 1: Introduction ..................................................................... 1
Assistance ...................................................................................................... 1
Emergency kit ................................................................................................. 2
Consumables .................................................................................................. 2
Accessories .................................................................................................... 3
How to wear your pump ..................................................................................... 3
How to use this guide ........................................................................................ 4
User safety ..................................................................................................... 5
Indications .................................................................................................. 5
Pump ...................................................................................................... 5
Contraindications .......................................................................................... 5
Warnings .................................................................................................... 5
Pump ...................................................................................................... 5
Reservoir and infusion sets ............................................................................ 5
Tubing Connector ....................................................................................... 6
Magnetic fields .......................................................................................... 6
X-rays, MRIs and CT scans .............................................................................. 7
Precautions ................................................................................................. 7
Avoid extreme temperatures .......................................................................... 7
Infusion sets and sites .................................................................................. 7
Notice .......................................................................................................... 7
Insulin pump and RF accessories ........................................................................ 7
RF interference from other devices ..................................................................... 8
Chapter 2: Introduction to pump therapy .............................................. 11
Theory of insulin pump therapy ........................................................................... 11
Understanding pump therapy ............................................................................. 12
Basal rate .................................................................................................. 12
Contents v
Meal bolus ................................................................................................. 12
Gram counting ......................................................................................... 12
Exchange counting ..................................................................................... 12
BG targets ................................................................................................. 12
Insulin sensitivity ......................................................................................... 13
Active Insulin .............................................................................................. 13
Blood glucose and A1C testing ............................................................................ 13
BG testing ................................................................................................. 13
A1C ......................................................................................................... 13
Low blood glucose (hypoglycemia) ....................................................................... 15
Hypoglycemia protocol: the rule of 15 ................................................................ 16
High blood glucose (hyperglycemia) ..................................................................... 16
Hyperglycemia protocol ................................................................................. 17
Diabetes ketoacidosis (DKA) ............................................................................... 17
Preventing DKA ........................................................................................... 17
Sick day management ...................................................................................... 18
Sick day protocol ......................................................................................... 18
Sick day supplies .......................................................................................... 19
Nutrition ...................................................................................................... 19
Carbohydrate counting .................................................................................. 20
Carbohydrate gram counting ......................................................................... 20
Carbohydrate exchange system ..................................................................... 20
Reading a food label ..................................................................................... 21
Fat and blood glucose ................................................................................... 22
Protein and blood glucose .............................................................................. 22
Other things that affect blood glucose ............................................................... 23
Healthy eating habits .................................................................................... 23
Exercise ....................................................................................................... 23
Chapter 3: The basics ...................................................................... 25
Your pump .................................................................................................... 25
Install battery ................................................................................................ 26
Pump buttons ................................................................................................ 28
The pump screen ............................................................................................ 29
HOME screen ................................................................................................. 29
Screen icons ............................................................................................... 30
Battery .................................................................................................. 30
Contentsvi
Time display ............................................................................................ 30
Reservoir volume ...................................................................................... 30
Alert and alarm icons ................................................................................. 31
Scroll bar .................................................................................................. 31
Screen backlight .......................................................................................... 31
Beep/vibrate ................................................................................................. 31
Operating modes ............................................................................................ 31
Normal mode .............................................................................................. 32
Special mode .............................................................................................. 32
Attention mode ........................................................................................... 32
Menus ......................................................................................................... 33
MAIN MENU ................................................................................................ 33
BOLUS MENU ............................................................................................... 33
SUSPEND ................................................................................................... 33
BASAL MENU ............................................................................................... 34
PRIME MENU ............................................................................................... 34
UTILITIES MENU ........................................................................................... 34
STATUS screen ............................................................................................... 34
If you remove your pump .................................................................................. 35
Chapter 4: Basic programming ............................................................ 37
Setting the time and date ................................................................................. 37
Selecting the language ..................................................................................... 39
Bolus .......................................................................................................... 40
Setting the Normal Bolus ................................................................................ 40
Review your bolus deliveries .............................................................................. 44
Bolus details ............................................................................................... 46
Maximum bolus limit ........................................................................................ 47
BG reminder ................................................................................................. 47
Basal .......................................................................................................... 48
Start and stop times ..................................................................................... 48
Your basal settings ....................................................................................... 49
Basal programming and delivery .................................................................... 50
Current basal delivery ................................................................................... 51
Daily basal rate(s) ..................................................................................... 51
Setting the Max basal rate ................................................................................. 52
Stopping your pump ........................................................................................ 53
Contents vii
Resume pump delivery ..................................................................................... 54
Chapter 5: Starting on insulin ............................................................ 57
Prepare your pump for use ................................................................................ 57
Filling the reservoir ......................................................................................... 58
Changing your infusion set ................................................................................. 61
Removing the reservoir ................................................................................. 61
Rewinding your pump ................................................................................... 62
Inserting the reservoir in your pump ................................................................. 62
Manual prime .............................................................................................. 64
Inserting the infusion set ................................................................................ 65
Quick-set infusion set (with Quick-serter
®
) .......................................................... 67
Fixed prime ................................................................................................ 69
Prime history .............................................................................................. 69
Disconnecting Quick-set ................................................................................. 70
Reconnecting Quick-set ................................................................................. 71
Record keeping for diabetes management .............................................................. 71
Determining your pump settings .......................................................................... 72
Chapter 6: Using the Bolus Wizard feature ............................................ 73
What is it? .................................................................................................... 73
Carbohydrate counting .................................................................................. 73
Your blood glucose reading ............................................................................. 73
Your personal Bolus Wizard feature settings ......................................................... 74
How the Bolus Wizard feature works ..................................................................... 77
Bolus Wizard warnings ................................................................................... 77
High or low blood glucose levels ................................................................... 77
About maximum delivery ............................................................................ 77
How to program the Bolus Wizard feature .............................................................. 78
Turning on the Bolus Wizard feature ................................................................. 78
Selecting the Carb units ................................................................................ 78
Setting the Carb/Exch ratios ........................................................................... 79
Setting the BG units ..................................................................................... 79
Insulin sensitivity ........................................................................................ 80
Setting the BG targets .................................................................................. 81
About active insulin ...................................................................................... 82
Active insulin time ....................................................................................... 83
Contentsviii
Review your Bolus Wizard feature settings ............................................................. 83
Meter option ................................................................................................. 83
Meter rules ............................................................................................... 84
Add, delete, review meter IDs ........................................................................ 85
Normal bolus using Bolus Wizard feature ................................................................ 85
Bolus Wizard feature examples ........................................................................... 87
Chapter 7: Optimizing pump therapy ................................................... 91
Square Wave and Dual Wave bolus ....................................................................... 91
Turning on the Dual Wave/Square Wave option .................................................... 92
Square Wave or Dual Wave bolus without Bolus Wizard feature ................................. 92
Using the Bolus Wizard feature for a Square Wave or Dual Wave bolus ........................ 95
Easy bolus .................................................................................................... 97
Easy bolus setup .......................................................................................... 97
Step value setup ......................................................................................... 98
Delivering Easy Bolus .................................................................................... 98
Basal patterns .............................................................................................. 100
Turning on the patterns ............................................................................... 100
Programming a pattern ................................................................................ 101
Select a pattern ........................................................................................ 102
Temp basal rates .......................................................................................... 103
How does temp basal work? ........................................................................... 103
Temp basal types ....................................................................................... 104
Insulin rate (U/H) .................................................................................... 104
Percent of basal ...................................................................................... 105
Chapter 8: Utilities ....................................................................... 111
Alarm review ............................................................................................... 111
Setting your alert type .................................................................................... 111
Auto-off ..................................................................................................... 112
LOW RESV WARNING (Low reservoir warning) ......................................................... 112
Review daily insulin totals ............................................................................... 113
Pump data management .................................................................................. 114
Meter blood glucose information ..................................................................... 114
Personal reminders ........................................................................................ 117
Alarm clock .............................................................................................. 117
Remote control option .................................................................................... 117
Contents ix
Turn on remote control option ....................................................................... 118
Add, delete, review remote control IDs ............................................................ 118
Block feature ............................................................................................... 119
Turning block on ....................................................................................... 119
Lock keypad feature ...................................................................................... 120
Locking the keypad ..................................................................................... 120
Unlocking the keypad .................................................................................. 120
Selftest ...................................................................................................... 120
User settings ................................................................................................ 121
Saving the settings ..................................................................................... 122
Restoring the settings ................................................................................. 122
Clearing the settings ................................................................................... 123
History ................................................................................................... 123
Chapter 9: Therapy software ............................................................ 125
CareLink Personal™ ........................................................................................ 125
Reports ................................................................................................... 125
Logbook ................................................................................................... 126
Chapter 10: Insulin pump therapy follow-up ......................................... 127
Recommended follow-up ................................................................................. 127
Everyday .................................................................................................. 127
Every month ............................................................................................. 127
Every 3 months .......................................................................................... 127
Laboratory tests ......................................................................................... 128
Every visit ................................................................................................ 128
Annually .................................................................................................. 128
Chapter 11: Troubleshooting and alarms ............................................. 129
My pump has a NO DELIVERY alarm ..................................................................... 129
What happens if I leave the pump battery out too long? ............................................ 130
Why doesn't my pump battery last very long? ......................................................... 130
What is a CHECK SETTINGS alarm? ...................................................................... 131
My screen appears distorted ............................................................................. 131
I cannot get out of the priming loop .................................................................... 131
The pump is asking me to rewind ....................................................................... 132
My bolus stopped .......................................................................................... 132
Contentsx
My pump buttons are not acting right during a bolus ................................................ 132
My pump will not display my blood glucose reading from my meter .............................. 132
I dropped my pump ........................................................................................ 133
I submerged my pump in water ......................................................................... 133
I cannot get to the User Settings screen ............................................................... 133
Alert conditions ............................................................................................ 134
What to do ............................................................................................... 135
LOW RESERVOIR ALERT ............................................................................. 135
LOW BATTERY ALERT ................................................................................ 135
Alarms ....................................................................................................... 135
What to do ............................................................................................... 136
Alarm conditions ........................................................................................... 137
A (ALARM) ............................................................................................... 137
AUTO OFF ................................................................................................ 137
BATT OUT LIMIT ........................................................................................ 137
BOLUS STOPPED ........................................................................................ 137
BUTTON ERROR .......................................................................................... 137
CHECK SETTINGS ....................................................................................... 137
E (ERROR) ............................................................................................... 138
EMPTY RESERVOIR ...................................................................................... 138
FAILED BATT TEST ...................................................................................... 138
MAX DELIVERY .......................................................................................... 139
MOTOR ERROR .......................................................................................... 139
NO DELIVERY ............................................................................................. 139
NO RESERVOIR ........................................................................................... 139
OFF NO POWER .......................................................................................... 139
RESET ..................................................................................................... 139
WEAK BATTERY .......................................................................................... 139
Chapter 12: Pump maintenance ........................................................ 141
Battery ...................................................................................................... 141
Storage ...................................................................................................... 142
Cleaning your pump ....................................................................................... 142
Chapter 13: Pump specifications ....................................................... 143
Alarms and error messages ............................................................................... 143
Alarm history ............................................................................................... 143
Contents xi
Audio frequency ........................................................................................... 143
Backlight .................................................................................................... 143
Basal ......................................................................................................... 143
BG target .................................................................................................... 144
Bolus delivery .............................................................................................. 144
Bolus history ................................................................................................ 144
Bolus units .................................................................................................. 144
Bolus Wizard feature ...................................................................................... 144
Carb ratios .................................................................................................. 145
Carb units ................................................................................................... 145
Daily totals .................................................................................................. 145
Default screen .............................................................................................. 145
Delivery accuracy .......................................................................................... 146
Pump motor ................................................................................................ 147
Dual Wave bolus ........................................................................................... 147
Easy bolus ................................................................................................... 147
Infusion pressure ........................................................................................... 147
Insulin sensitivity .......................................................................................... 147
Low resv (reservoir) warning ............................................................................. 148
Meter value ................................................................................................. 148
Normal bolus ............................................................................................... 148
Occlusion detection ....................................................................................... 148
Percent temp basal ........................................................................................ 149
Power supply ............................................................................................... 149
Prime function ............................................................................................. 149
Prime history ............................................................................................... 149
Program safety checks .................................................................................... 149
Pump size ................................................................................................... 149
Pump weight ................................................................................................ 149
Remote control ............................................................................................ 150
Reservoir .................................................................................................... 150
Square Wave bolus ........................................................................................ 150
Temporary (temp) basal rate ............................................................................ 150
Time and date screen ..................................................................................... 150
Environmental conditions ................................................................................ 150
Status screen ............................................................................................... 151
Bolus Wizard feature specifications .................................................................... 152
Contentsxii
Bolus Wizard feature examples .......................................................................... 155
Insulin delivery default settings ......................................................................... 158
Bolus Wizard feature default settings .................................................................. 160
Icon table ................................................................................................... 161
Warranty .................................................................................................... 163
Glossary ...................................................................................... 165
Index ......................................................................................... 173
Contents xiii
Contentsxiv
Introduction
Thank you for choosing Medtronic Diabetes (legally known as Medtronic MiniMed, Inc.) as your partner in
helping you gain better control of your diabetes. Whether you are beginning pump therapy for the first
time or upgrading from a previous model, we believe that the combination of state-of-the-art technology
and the simple, menu-driven programming of the pump will provide many benefits.
This user guide is designed to help you to understand pump therapy and the operation of your Medtronic
MiniMed Paradigm
®
pump. We strongly recommend that you work closely with your healthcare professional
for a safe and complete pump start.
Assistance
Medtronic Diabetes provides a 24 Hour HelpLine for assistance. The HelpLine is staffed with technicians
who are trained in the set-up and operation of the pump and are able to answer pump-related questions.
When calling the HelpLine or your local Medtronic Diabetes office, please have your pump and serial
number available. The phone number for the 24 Hour HelpLine is also on the back of your pump.
Department Telephone number
24 Hour HelpLine (calls within the United States) 800.646.4633 (800.MiniMed)
24 Hour HelpLine (calls outside the United States) +1.818.576.5555
Web site www.medtronicdiabetes.com
Introduction 1
Chapter 1
Emergency kit
Keep an emergency kit with you at all times to make sure that you always have necessary supplies. Inform
a family member, co-worker, and/or friend where this emergency kit is kept. Please refer to the User
safety section in this chapter for more information on pump safety. Your emergency kit should include
these items:
• Fast-acting glucose tablets
• Blood glucose monitoring supplies
• Urine ketone monitoring supplies
•
Extra Paradigm
®
compatible infusion set and Paradigm reservoir
• Insulin syringe and fast-acting insulin (with dosage instructions from your healthcare professional)
• Paradigm Quick Reference Card
• Dressing and adhesive
•
Glucagon Emergency Kit
®
•
Extra AAA alkaline batteries (Energizer
®
brand is recommended)
CAUTION: If you give yourself insulin by using a syringe, the Bolus Wizard feature will not be able to
correctly determine the active insulin in your system. Consult with your healthcare professional on
how long you need to wait after a manual injection before you can rely on the active insulin
calculation of your Bolus Wizard feature.
Consumables
The pumps use disposable reservoirs and infusion sets for insulin delivery. Installation instructions for
Paradigm reservoir and Paradigm compatible infusion sets are provided in the Starting on insulin chapter.
• Reservoirs — The 515 pump is only used with the 176-unit Paradigm reservoir (MMT-326A). The 715
pump can be used with either the 300-unit Paradigm reservoir (MMT-332A) or the 176-unit reservoir,
depending on your insulin needs.
• Infusion sets — Medtronic Diabetes provides a variety of Paradigm compatible infusion sets to fit your
needs. Contact your healthcare professional who will assist you to choose an infusion set that fits your
needs.
Introduction2
WARNING: For your protection the pump has undergone extensive testing to confirm appropriate
operation when used with Paradigm reservoirs and Paradigm compatible infusion sets manufactured
or distributed by Medtronic Diabetes. We recommend using Medtronic Diabetes infusion sets and
reservoirs as 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.
Accessories
• Meter — Your pump can be used with an optional blood glucose meter powered by MWT1 technology
(where or if available). MWT1 is the wireless Radio Frequency (RF) technology that is used to transmit
information from the meter to the pump. You can program your pump to automatically receive your
BG reading from this meter. All meters referenced in this user guide are blood glucose meters
supported by MWT1 technology.
• Remote control — The optional Paradigm remote control can be used with the pump to deliver normal
boluses and suspend/resume the pump from a distant location. (This User Guide provides programming
instructions for the remote control. Refer to the remote control User Guide for operating
instructions.)
• CareLink USB Upload Device — The Medtronic Diabetes CareLink USB is used to download the
Paradigm 515 or 715 pump data to the diabetes management software using a USB port on your
computer.
To order supplies, call 800-646-4633 (1-800-MiniMed), +1-818-362-5958 (outside U.S.), refer to the
contacts list at the beginning of this user guide, or visit our web site at www.medtronicdiabetes.com.
How to wear your pump
There are different ways to wear your pump. Medtronic Diabetes has optional accessories that can hide,
protect, and add to the convenience of wearing a pump. Refer to the accessories catalog or the website
(www.medtronicdiabetes.com) for more information.
• Holster — To wear the pump on your belt.
• Pump clip — To wear the pump underneath your clothing.
• Activity guard — If you are active in sports, or you are a child, use the guard to protect the pump
from disconnecting.
• Leather case — Fine leather lined with nylon. Styling complements business and formal wear. A flap
with a hook-and-loop fastener provides easy access for programming. Wear it vertically with the builtin belt clip.
Introduction 3
Chapter 1
How to use this guide
NOTE: This user guide shows sample screens only. Your pump screens may be slightly different.
For step-by-step instructions, refer to the appropriate sections in this guide. Refer to the Glossary for
definitions of terms and functions. The terms and symbols used in this guide are in the table below.
Conventions Meaning
Press to push and release the button
Hold to push and keep pressure on the button
Select
to press
or to highlight a screen item you want to select
Exit the menus press ESC until the HOME screen appears
Pump Buttons always bold and uppercase; for example, ESC, ACT
Screen and menu names always uppercase; for example, MAIN MENU, REWIND screen
Menu selections always bold; for example, 24-Hour Setup, On, Off
Flashing (blinking) screen item
you can change the value for that item with the
or buttons
NOTE and TIP additional helpful information
CAUTION
warns of a potential hazard which, if not avoided, may result in
minor or moderate injury to the equipment
WARNING
notifies you of a potential hazard which, if not avoided, could result
in death or serious injury. It may also describe potential serious
adverse reactions and safety hazards
Go to the...screen.
when a step instructs you to go to a certain screen, the path to that
screen is shown. For example:
Go to the ALARM MENU.
Main > Utilities > Alarm
1 From the MAIN MENU, select Utilities and press ACT.
2 In the UTILITIES MENU, select Alarm and press ACT.
3 The ALARM MENU appears.
Introduction4
User safety
Indications
Pump
The Paradigm 515/715 pump system is indicated for the continuous 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 unwilling or unable to perform a minimum of four
blood glucose tests per day and to maintain contact with their healthcare professional. Successful insulin
pump therapy requires sufficient vision or hearing to allow recognition of the pump signals and alarms.
Warnings
Pump
The drive support cap should appear slightly indented at all times
(as shown in the image). If you notice that the cap is loose, or
sticking out, discontinue use of the pump and contact our
24 Hour HelpLine at 1 800 646 4633 to arrange for your pump to
be replaced. Do not press on the drive support cap if it is
sticking out. Pushing on the drive support cap may result in
unintended delivery of insulin, which can cause hypoglycemia.
Reservoir and infusion sets
Standard Luer sets are not compatible with the Medtronic MiniMed Paradigm pump. Medtronic Diabetes
Paradigm reservoir and Paradigm compatible infusion sets are specifically designed for use with the pump.
Do not modify your Paradigm reservoir or Paradigm compatible infusion set.
Do not put any other drugs/medications inside your reservoir to use with this pump. Only insulin that has
been prescribed by your physician can be used in this pump.
drive support cap
Introduction 5
Chapter 1
Tubing Connector
If insulin, or any liquid, gets inside the tubing connector, it can temporarily block the vents that allow the
pump to properly prime the infusion set. This may result in the delivery of too little or too much insulin,
which can cause hypoglycemia or hyperglycemia. To prevent liquid from getting inside the tubing
connector, after you fill the reservoir make sure you hold the insulin vial upright when you remove the
reservoir from the transfer guard. If you do not hold the insulin vial upright, insulin can get on the top of
the reservoir and could transfer liquid into the tubing connector. If any liquid gets on the top of the
reservoir or inside the tubing connector when you change your infusion set, start over with a new reservoir
and infusion set. For instructions on setting up your reservoir, see Filling the reservoir, on page 58. For
instructions on changing your infusion set, see Changing your infusion set, on page 61.
Tubing
connector
Top o f
reservoir
Magnetic fields
Do not use pump cases that have a magnetic clasp.
Do not expose your insulin pump to MRI equipment or other devices that generate very strong magnetic
fields. The magnetic fields in the immediate vicinity of these devices can damage the part of the pump’s
motor that regulates insulin delivery, possibly resulting in over-delivery and severe hypoglycemia.
Your pump must be removed and kept outside the room during magnetic resonance imaging (MRI)
procedures.
If your pump is inadvertently exposed to a strong magnetic field, discontinue use and contact our 24 Hour
HelpLine for further assistance.
Introduction6
X-rays, MRIs and CT scans
If you are going to have an X-ray, CT scan, MRI or other type of exposure to radiation, take off your
pump, meter and remote control before entering a room containing any of this equipment.
The Paradigm pump is designed to withstand common electromagnetic interference, including airport
security systems. Be sure to carry the Airport Card provided, when you are traveling.
Precautions
Although the pump has multiple safety alarms, it cannot notify you if the set is leaking or the insulin has
lost its potency. It is essential, therefore, that you test your blood glucose levels at least four times per
day. If your blood glucose is out of range, check the pump and the infusion set to ensure that the
necessary amount of insulin is being delivered.
Avoid extreme temperatures
1 Avoid exposure of your pump and remote control to temperatures above 108°F (42°C) or below 34°F
(1°C).
2 Insulin solutions freeze near 32°F (0°C) and degrade at high temperatures. If you are outside in cold
weather, wear your pump close to your body and cover it with warm clothing. If you are in a warm
environment, take measures to keep your pump and insulin cool.
3 Do not steam, sterilize or autoclave your pump or remote control.
Infusion sets and sites
Avoid using an infusion site that will be irritated by clothing and accessories, or by rigorous stretching and
exercise.
Notice
CAUTION: Any changes or modifications to the devices not expressly approved by Medtronic Diabetes
could void your ability to operate the equipment.
Insulin pump and RF accessories
The pump, meter and remote control comply with the United States Federal Communications Commission
and international standards for electromagnetic compatibility.
Do not use the RF meter to send your blood glucose reading to the pump while on an aircraft. Manually
enter your blood glucose.
Introduction 7
Chapter 1
These devices comply 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. It does not interfere with any RF
signals transmitted from outside sources.
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 our 24 Hour HelpLine.
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, you are encouraged to try to correct
the interference by one or more of the following measures:
• Reorient or relocate the insulin pump/remote control/ meter
• Increase the separation between the insulin pump/remote control/meter and the device that is
receiving/emitting interference
The meter sends information to the pump using radio frequency. If other devices that use radio
frequency are in use, such as cell phones, cordless phones and wireless networks, they may prevent
communication between the pump and the meter. This interference will not cause any incorrect data
to be sent and will not cause any harm to your pump or meter. Moving away from or turning off these
other devices may allow communication. Refer to the Troubleshooting and alarms chapter to correct
interference problems you may have.
If you have questions, please contact our 24 Hour HelpLine.
RF interference from other devices
Common consumer electronic devices that transmit in the same frequency band used by the optional RF
glucose meters may prevent the pump from receiving the glucose information sent by those meters. Most
cellular (mobile) phones and 900 MHz cordless phones, when transmitting or receiving, may interrupt RF
glucose meter-pump communication. It is likely that other devices operating in similar frequency ranges
will have a similar effect. This interference, however, will not cause any incorrect data to be sent and will
not cause any harm to your RF glucose meter.
Introduction8
Communication problems can usually be resolved by:
• ensuring that there is less than 6 feet (1.8 meters) between the pump and the RF glucose meter;
• turning off or moving away from other RF transmitting devices; or
• reorienting or relocating the RF glucose meter or pump, or both.
Communications problems may also occur due to cellular telephone interference. Testing conducted with
several different cellular telephones indicates that, while a glucose value is being transmitted, using a cell
phone within 12 inches (31 cm) of receiving devices, transmitters or RF glucose meters can interfere with
reception of the transmitted values. In the event of such interference, normal communication can be reestablished by:
• turning the cell phone off; or
• keeping the cell phone at least 12 inches away from the pump or glucose meter when a glucose
measurement is being transmitted.
If you have questions, please contact your local Medtronic Diabetes representative.
Introduction 9
Chapter 1
Introduction10
Introduction to pump therapy
Theory of insulin pump therapy
Insulin pumps deliver insulin closer to the way the human pancreas delivers insulin than any other method
of treating diabetes.
All people, with or without diabetes, need background insulin for normal functions of the body without
food. They also need a dose of insulin on demand - when food is eaten. People without diabetes can trust
that their pancreas will produce this insulin for them. People with diabetes need to take insulin in a way
that is most like the way a pancreas produces it.
Most people with diabetes who take more than one daily injection, use long-acting insulin. This takes care
of their background insulin needs. They take fast-acting insulin for food. When using an insulin pump, only
fast-acting insulin is used. You control when and at what rate your insulin is delivered.
Insulin pump therapy allows you to set a basal rate, or background insulin. This is delivered all throughout
the day and night for normal body function without food. When you exercise, you can reduce the basal
rate so that your blood glucose (BG) does not drop too low. When you are sick or have an infection, you
can increase the basal rate. This will keep your BG from going up too high.
Insulin pump therapy allows you to give a bolus, or dose of insulin on demand - when you eat. You can also
increase or decrease your meal bolus based on the foods you choose to eat. A bolus may also be used to
lower an elevated BG. This is called a correction bolus.
The Paradigm pump also contains an optional feature called the Bolus Wizard. This does the math for the
required bolus amount based on your personal settings. The Bolus Wizard will use your BG reading,
carbohydrate intake, and active insulin when coming up with your bolus amount.
Remember, the pump uses only fast-acting insulin. This means you will not need to follow as rigid a
schedule as you did before. There is no long-acting insulin telling you when you should eat or when you
will need more insulin.
Sound exciting? It is exciting because not only can you manage your blood glucose more easily, your
lifestyle can be easier too.
Introduction to pump therapy 11
Chapter 2
As long as you are ready to learn how to use the pump, the pump can work for you.
Understanding pump therapy
If you are new to pump therapy, you will need the following data from your healthcare professional.
Gather this before going to your pump start appointment. If you are unsure, contact your healthcare
professional or pump trainer for guidance.
Basal rate
Basal insulin is needed to maintain your target glucose values when you are not eating. Your pump allows
up to 48 basal rates to be programmed. Your healthcare professional may only have you program one or
two basal rates when you start pump therapy.
Meal bolus
Deliver a meal bolus before eating carbohydrates. Your insulin to carbohydrate ratio is the amount of
insulin required to cover a given number of carbohydrates or exchanges. This ratio gives you an idea of
how much of an insulin bolus you should take when eating carbohydrates.
Gram counting
1.0 unit of insulin for __________ grams of carbohydrate
Or
Exchange counting
__________ units of insulin for each carbohydrate exchange
BG targets
The Bolus Wizard will use your BG targets to calculate a correction dose. Keeping your BG within target
range is key to living well with diabetes. Your healthcare professional should help you decide these
targets.
Introduction to pump therapy12
Insulin sensitivity
Insulin sensitivity is used to decide a correction bolus for a high BG. This is how much your blood glucose
will be dropped with 1 unit of insulin.
1 unit of insulin will lower BG __________ mmol/L (mg/dL).
Active Insulin
Active insulin is the bolus insulin that has already been delivered to your body, but has not yet been used.
The pump considers your active insulin time setting in determining any active insulin still in your body
from prior boluses. This may help prevent hypoglycemia caused by over-correcting for high blood glucose.
Blood glucose and A1C testing
When you check your blood glucose with a meter, you measure blood glucose at the moment you perform
the test. This number gives you key feedback for making present and day-to-day adjustments in your
diabetes management. The A1C test, done at your doctor's, shows you your average blood glucose over the
last 60 to 90 days. Both blood glucose and A1C testing are necessary for good diabetes management.
BG testing
With any insulin therapy, you must monitor your blood glucose 4 to 6 times a day. With insulin pump
therapy, blood glucose testing gives you correct feedback. It also allows you to make prompt changes
based on the results. It alerts you to high blood glucose readings that need changing. It allows you to
adjust your insulin to carbohydrate ratio for certain foods. Your pump only uses fast-acting insulin; as a
result, you have no long-acting insulin as a back-up. Therefore, if your insulin delivery is disrupted on
pump therapy, your blood glucose can go dangerously high fairly fast. This can happen much faster than it
could when you were using daily injections with long-acting insulin. Blood glucose testing is needed to
alert you to high blood glucose so you can prevent diabetic ketoacidosis (DKA).
A1C
A1C testing also plays a key part in diabetes management. Sustained high BG levels can cause serious longterm problems. These problems may be prevented and/or delayed if you maintain your blood glucose
levels close to normal. The best measure of your overall blood glucose is the A1C test. It has been proven
that an A1C level of 7.0 or less greatly reduces the risk of problems from diabetes. But, any reduction in
A1C is a plus. ADA Clinical Practice Recommendations state that your A1C should be tested at least every 3
months by your healthcare professional.
Introduction to pump therapy 13
Chapter 2
Your healthcare professional will rely on the results of your blood glucose tests to make changes in your
pump settings. The results of your A1C tests are used to assess your overall blood glucose control.
If you are on pump therapy, you must test your BG at least:
• Upon waking up
• Before each meal
• At bedtime
• If you feel nauseous
• One hour after any BG above 250 mg/dL (13.9 mmol/L)
Below are target guidelines from the American Diabetes Association for adults with diabetes. Consult your
healthcare professional to find out what your targets should be.
Summary of recommendations for adults with diabetes mellitus
Glycemic control A1C <7.0 percent
Preprandial plasma glucose (before meals) 90-130 mg/dL (5.0-7.2 mmol/L)
Peak postprandial plasma glucose (1-2 hours after meals) <180 mg/dL (<10.0 mmol/L)
Correlation between A1C level and blood glucose levels
Mean plasma glucose
A1C (percent) mg/dL mmol/L
61357.5
71709.5
820511.5
924013.5
10 275 15.5
11 310 17.5
Introduction to pump therapy14
Correlation between A1C level and blood glucose levels
Mean plasma glucose
A1C (percent) mg/dL mmol/L
12 345 19.5
American Diabetes Association. Diabetes Care. “Tests of Glycemia in Diabetes.” & “Standards of
Medical Care.” Vol. 31, Supplement 1, January 2008. S18.
Low blood glucose (hypoglycemia)
Low blood glucose can occur while using the pump for the same reasons it can while using daily injections.
Not enough food
Too much insulin
More exercise than usual
Drinking alcoholic beverages
As you know, you cannot always avoid low blood glucose. It is important that you create a routine to
follow when your BG is low. If you have a routine, you will have something ready to treat a low BG. This
makes it less likely you will over-treat and cause your blood glucose to go up too much.
It is best to use something that you can always carry with you. Choose a food that is all carbohydrate
because it will be fast acting. Avoid using high fat foods such as chocolate. They will not work fast enough,
and you may also end up over-treating your lows. When treating hypoglycemia, start with 15 grams of fast
acting carbohydrates. Do not keep eating until you feel better. Eat the required amount and stop. The
feelings will pass and you will be grateful that you did not overdo it.
Some people with diabetes know when their blood glucose is low and some do not. If you are not aware of
hypoglycemia, it is important to test your blood glucose more often. Everyone with diabetes should test
before driving a car to assure safety on the road. Blood glucose should be above 100 mg/dL (5.6 mmol/L)
before driving and at bedtime.
Tip: We suggest that you use glucose tablets to treat a low. These tablets contain a known, pre-
measured amount of carbohydrate, and are in handy packages that you can carry in your pocket, purse, or
car.
Introduction to pump therapy 15
Chapter 2
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