Insulin pump and continuous glucose monitoring system

Appendix A: Sensor accuracy ............................................................ 207
Performance results in adults ............................................................................ 208
Accuracy of Guardian RT readings ......................................................................  209
Precision of Guardian RT readings ......................................................................  213
Low and High Alerts in adults ............................................................................ 214
The Low Glucose Alert .................................................................................  214
The High Glucose Alert ................................................................................. 215
Guardian RT sensor performance and calibration stability as a function of time ...............  216
Effects of calibration frequency ......................................................................... 219
Time-elapsed plots ...................................................................................... 220
Performance results in children and adolescents ..................................................... 223
Accuracy of Guardian RT readings .................................................................... 223
Low and High Alerts in children and adolescents .....................................................  227
The Low Glucose Alert .................................................................................  227
The High Glucose Alert ................................................................................. 228
Glossary ......................................................................................  229
Index .........................................................................................  237
Contents
xvii

Contents
xviii

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
representatives 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
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)
•
Wallet 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.
Introduction
2

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 522/522K pump is only used with the 176-unit Paradigm reservoir (MMT-326A). The
722/722K 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 for help in choosing an infusion set that fits your needs.
Change your infusion set every two to three days.
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.)
•
Medtronic MiniLink™ Transmitter — The transmitter (MMT-7703) is a small device that connects to the
sensor. It comes with a tester and a charger. When connected to a sensor that is inserted in the body,
the transmitter automatically initializes the sensor and begins to periodically send glucose data to the
pump using a radio signal.
•
Sensor — The sensor (MMT-7002/MMT-7003) continuously converts tiny amounts of glucose from your
fatty layer under the skin into an electronic signal. This signal is sent to the transmitter.
•
CareLink USB Upload Device — The Medtronic Diabetes CareLink USB is used to download your pump
data to the diabetes management software using a USB port on your computer. 
Introduction
3
Chapter 1

Not all devices or accessories are available in all countries where the pump is approved.
To order supplies, call 800-646-4633, [phone] (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 built-
in belt clip.
Introduction
4

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.
Introduction
5
Chapter 1

User safety
Indications: Paradigm 522/722
Pump
The Paradigm MMT-522 and MMT-722 pumps are indicated for the continuous delivery of insulin, at set and
variable rates, for the management of diabetes mellitus in persons requiring insulin.
Sensor and transmitter
The sensor and transmitter components are indicated for continuous or periodic monitoring of glucose
levels in the fluid under the skin, and possible low and high blood glucose episodes in adults (ages 18 and
older). It alerts if a glucose level falls below or rises above preset values. Values are not intended to be
used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick
may be required. All therapy adjustments should be based on measurements obtained using a blood
glucose meter and not on Paradigm 522/722 pump system values.
Indications: Paradigm 522K/722K (pediatric version)
Pump
The Paradigm MMT-522K and MMT-722K insulin infusion pumps are indicated for the continuous delivery of
insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Sensor and transmitter
The Paradigm REAL-Time system (pediatric version) consists of the Paradigm MMT-522K or MMT-722K insulin
infusion pumps, the MMT-7002 or MMT-7003 glucose sensor, and the MMT-7703 transmitter. Use of the
MMT-522K and MMT-722K insulin pumps with the optional sensor and transmitter components is indicated
for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and
high blood glucose episodes in children and adolescents (ages 7 through 17). The system provides an alert
if glucose levels fall below or rise above preset values. Glucose values provided by the system are not
intended to be used directly for making therapy adjustments, but rather to provide an indication of when
a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a
blood glucose meter and not on the sensor glucose readings provided by the Paradigm REAL-Time system.
Introduction
6

Meter
The Paradigm REAL-Time insulin pump can be programmed to receive fingerstick blood glucose values
transmitted from the LifeScan OneTouch
®
 UltraLink™ Meter or the BD Paradigm Link
®
 Meter for use in the
Bolus Wizard calculator and for use as calibration values for the glucose sensor. Glucose values from other
glucose meters must be manually entered into the pump.
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
7
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 60.
Tubing
connector
Top of
reservoir
Sensor
The sensor may create special needs regarding your medical conditions or medications. Please discuss
these conditions and medications with your doctor before using the sensor.
Bleeding, swelling, irritation and/or infection at the insertion site are possible risks associated with
inserting the sensor and sometimes result from improper insertion and maintenance of insertion site.
Transmitter
Product contains small parts and may pose a choking hazard for young children.
Optional occlusive dressing should be removed if irritation or reaction to this develops.
The transmitter should be disconnected from the sensor while traveling on an aircraft, or if it interferes
with another transmitting device.
Introduction
8

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 your local
help line or representative for further assistance.
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,
sensor, transmitter, meter and remote control before entering a room containing any of these
equipment.
The Paradigm pump is designed to withstand common electromagnetic interference, including airport
security systems. Be sure to carry the Emergency Card provided, when you are traveling. This card
provides airport information.
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.
Introduction
9
Chapter 1

Infusion sets and sites
Avoid using an infusion set insertion site that will be irritated by clothing and accessories, or by rigorous
stretching and exercise.
Sensor
Prior to exercising, make sure the sensor is firmly attached.
Adverse reactions
Operation of the sensor feature requires the insertion of a glucose sensor into the skin. Bleeding, swelling,
bruising, or infection at the sensor insertion site are possible risks of sensor use. The sensor should be
removed if redness, pain, tenderness or swelling develop at the insertion site. The optional occlusive
dressing should be removed if irritation or a reaction to this develops. Contact your doctor and the 24
Hour HelpLine in the event of any adverse reaction.
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, transmitter 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. Do not use the sensor feature while on an aircraft. 
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.
Introduction
10

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 your local
representative.
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/transmitter/meter
•
Increase the separation between the insulin pump/remote control/transmitter/meter and the
device that is receiving/emitting interference
The meter and the transmitter send 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.
Wireless transmission between the pump and transmitter within the two-meter operating range may
be interrupted due to the transmitter orientation and the pump position on the body. Move the pump
closer to the transmitter or to another position. If a Lost Sensor alarm has occurred retry:
Main > Sensor > Sensor Start > Find Lost Sensor
If you have questions, please contact the 24 Hour HelpLine.
RF interference from other devices
Common consumer electronic devices that transmit in the same frequency band used by the MMT-7703
MiniLink transmitter may prevent the pump from receiving the glucose information sent by the
transmitter. Most cellular (mobile) phones and 900 MHz cordless phones, when transmitting or receiving,
may cause significant interruption of transmitter-receiver 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 transmitter.
Introduction
11