Paradigm 522, 722 User Manual

Paradigm
®
522 and 722 Insulin Pumps
User Guide
©2008 Medtronic MiniMed, Inc. All rights reserved.
Bolus Wizard
®
, Dual Wave®, Guardian®, MiniLink®, Paradigm®, Paradigm Link®, Quick-serter®, Quick-set® , Silhouette®,
Sof-set
®
, and Square Wave® are registered trademarks of Medtronic MiniMed, Inc.
CareLink™ Personal, Enlite™, 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.
6025646-021_a
REF MMT-522 MMT-722
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Important Safety Information
Regarding Your Paradigm Insulin Pump
(includes all models)
Avoid Immersing Your Pump In Water
Although it is unlikely that water damage will occur if your pump is splashed or briefly dunked, you should avoid immersing your Paradigm insulin pump in water. To swim or participate in other water activities, always disconnect from your Paradigm 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 your local help line or representative for further assistance. Symptoms of high blood glucose include fatigue, excessive thirst and nausea. You should always contact your healthcare professional if you experience excessively high or low blood glucose levels, or if you have any questions about your care.
Electrostatic Discharge
Although your Paradigm pump is designed to be unaffected by typical levels of electrostatic discharge (ESD), very high levels of ESD can result in a reset of the pump's software with an associated pump error alarm. In most cases, exposure to high levels of ESD will trigger the pump's 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 your local helpline or representative to report any error alarms or other problems that occur with your pump.
Warranty
Medtronic Diabetes warrants the Medtronic MiniMed Insulin Pump against defects in materials and workmanship for a period of 4 years from the date of purchase.
During the warranty period, Medtronic Diabetes will, at its discretion, either repair or replace (with a new or recertified pump, at Medtronic Diabetes’ discretion) any defective pump or motor, subject to the conditions and exclusions stated herein. In the event that a pump is repaired or replaced, the warranty period will not be extended.
This warranty is valid only if the Medtronic MiniMed Insulin Pump is used in accordance with the manufacturer’s instructions. This warranty will not apply:
If damage results from changes or modifications made to the pump by the user or third persons after
the date of manufacture.
If non-Medtronic infusion sets and/or reservoirs are being used with the pump.
If damage results from service or repairs performed by any person or entity other than the manufacturer.
If damage results from a Force Majeure or other event beyond the control of the manufacturer.
If damage results from negligence or improper use, including but not limited to: improper storage,
submersion in water or physical abuse, such as dropping or otherwise.
This warranty shall be personal to the original user. Any sale, rental or other transfer or use of the product covered by this warranty to or by a user other than the original user shall cause this warranty to immediately terminate. This warranty does not apply to batteries, infusion sets, reservoirs, and other accessories.
The remedies provided for in this warranty are the exclusive remedies available for any breach hereof. Neither Medtronic Diabetes nor its suppliers or distributors shall be liable for any incidental, consequential, or special damage of any nature or kind caused by or arising out of a defect in the product. Notwithstanding the foregoing, the terms of this warranty do not affect the statutory rights of consumers or seek to exclude any liability which is not permitted by law.
All other warranties, other than mandatory statutory warranties, expressed or implied, are excluded, including the warranties of merchantability and fitness for a particular purpose.
Contents
Chapter 1: Introduction ..................................................................... 1
Assistance ...................................................................................................... 1
Emergency kit ................................................................................................. 1
Consumables .................................................................................................. 2
Accessories .................................................................................................... 2
How to wear your pump ..................................................................................... 3
How to use this guide ........................................................................................ 3
User safety ..................................................................................................... 4
Indications .................................................................................................. 4
Contraindications .......................................................................................... 5
Warnings .................................................................................................... 5
Reservoir and infusion sets ............................................................................ 5
Sensor ..................................................................................................... 5
Transmitter .............................................................................................. 5
Magnetic fields .......................................................................................... 5
X-rays, MRIs and CT scans .............................................................................. 6
Precautions ................................................................................................. 6
Avoid extreme temperatures .......................................................................... 6
Infusion sets and sites .................................................................................. 7
Sensor ..................................................................................................... 7
Adverse reactions .......................................................................................... 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
Contents vii
Basal rate .................................................................................................. 12
Meal bolus ................................................................................................. 12
Gram counting ......................................................................................... 12
Exchange counting ..................................................................................... 12
BG targets ................................................................................................. 12
Insulin sensitivity ......................................................................................... 12
Active Insulin .............................................................................................. 13
Blood glucose and A1C testing ............................................................................ 13
BG testing ................................................................................................. 13
A1C ......................................................................................................... 13
Low blood glucose (hypoglycemia) ....................................................................... 14
Hypoglycemia protocol: the rule of 15 ................................................................ 15
High blood glucose (hyperglycemia) ..................................................................... 16
Hyperglycemia protocol ................................................................................. 16
Diabetes ketoacidosis (DKA) ............................................................................... 17
Preventing DKA ........................................................................................... 17
Sick day management ...................................................................................... 18
Sick day protocol ......................................................................................... 18
Sick day supplies .......................................................................................... 18
Nutrition ...................................................................................................... 19
Carbohydrate counting .................................................................................. 19
Carbohydrate gram counting ......................................................................... 19
Carbohydrate exchange system ..................................................................... 19
Reading a food label ..................................................................................... 20
Fat and blood glucose ................................................................................... 21
Protein and blood glucose .............................................................................. 21
Other things that affect blood glucose ............................................................... 22
Healthy eating habits .................................................................................... 22
Exercise ....................................................................................................... 22
Chapter 3: The basics ...................................................................... 25
Your pump .................................................................................................... 25
Install battery ................................................................................................ 26
Pump buttons ................................................................................................ 27
The pump screen ............................................................................................ 29
HOME screen ................................................................................................. 29
Screen icons ............................................................................................... 29
Contentsviii
Battery .................................................................................................. 29
Time display ............................................................................................ 30
Reservoir volume ...................................................................................... 30
Alert and alarm icons ................................................................................. 30
Sensor icons ............................................................................................ 30
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 ............................................................................................... 33
SENSOR ..................................................................................................... 33
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 .......................................................................................................... 39
Setting the Normal bolus ................................................................................ 40
Normal meal bolus using the exchange system ...................................................... 41
Bolus practice: ............................................................................................ 41
Normal meal bolus practice using exchanges ........................................................ 42
Normal meal bolus using carbohydrate counting .................................................... 42
Normal meal bolus practice using carbohydrates ................................................... 43
Meal bolus, correction bolus and insulin sensitivity ................................................ 43
Practice: Meal bolus ..................................................................................... 44
Review your bolus deliveries .............................................................................. 44
Bolus details ............................................................................................... 45
Contents ix
Maximum bolus limit ........................................................................................ 47
Example 1: Max bolus .................................................................................... 47
Example 2: Max bolus .................................................................................... 47
BG Reminder ................................................................................................. 47
Basal .......................................................................................................... 48
Start and stop times ..................................................................................... 49
Your basal settings ....................................................................................... 50
Basal programming and delivery .................................................................... 50
Current basal delivery ................................................................................... 51
Daily basal rate(s) ........................................................................................ 51
Setting the Max basal rate ................................................................................. 52
Example 1: Max basal .................................................................................... 52
Example 2: Max basal .................................................................................... 53
Stopping your pump ........................................................................................ 53
Resume pump delivery ..................................................................................... 54
Example: Suspend function ............................................................................. 54
Practice: Suspend function ............................................................................. 55
Practice: Resume basal delivery after a suspend ................................................... 55
Chapter 5: Starting on insulin ............................................................ 57
Prepare your pump for use ................................................................................ 57
Filling the reservoir ......................................................................................... 57
Filling the reservoir ...................................................................................... 58
Changing your infusion set ................................................................................. 60
Removing the reservoir .................................................................................. 60
Rewinding your pump .................................................................................... 60
Inserting the reservoir in your pump .................................................................. 62
Manual prime .............................................................................................. 63
Inserting the infusion set ................................................................................ 64
Quick-set infusion set (with Quick-serter
®
) .......................................................... 66
Fixed prime ................................................................................................ 66
Prime history .............................................................................................. 67
Disconnecting Quick-set ................................................................................. 68
Reconnecting Quick-set ................................................................................. 68
Record keeping for diabetes management .............................................................. 69
Determining your pump settings .......................................................................... 69
Contentsx
Chapter 6: Using the Bolus Wizard feature ............................................ 71
What is it? .................................................................................................... 71
Carbohydrate counting .................................................................................. 71
Your blood glucose reading ............................................................................. 71
Your personal Bolus Wizard feature settings ......................................................... 71
How the Bolus Wizard feature works ..................................................................... 74
Bolus Wizard warnings ...................................................................................... 75
HIGH BG .................................................................................................... 75
LOW BG .................................................................................................... 75
MAX BOLUS EXCEEDED ................................................................................... 75
How to program the Bolus Wizard feature .............................................................. 75
Turning on the Bolus Wizard feature .................................................................. 76
Selecting the Carb units ................................................................................. 76
Setting the Carb/Exch ratios ........................................................................... 77
Setting the BG units ...................................................................................... 78
Insulin sensitivity ......................................................................................... 78
Setting the BG Targets .................................................................................. 79
About active insulin ...................................................................................... 80
Active insulin time ..................................................................................... 81
Review your Bolus Wizard feature settings ............................................................. 81
Meter option ................................................................................................. 82
Meter rules ................................................................................................ 82
Add, delete, review meter IDs ......................................................................... 83
Normal bolus using Bolus Wizard feature ................................................................ 84
Bolus Wizard feature examples ........................................................................... 85
Example 1: Blood glucose on target (normal blood glucose) and no active insulin ............ 86
Example 2: Blood glucose above target (high blood glucose) and no active insulin ........... 87
Example 3: Blood glucose below target (low blood glucose) and no active insulin ............ 88
Example 4: Blood glucose above target (high blood glucose) with active insulin .............. 89
Example 5: Blood glucose below target (low blood glucose) with active insulin ............... 90
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
Square Wave bolus practice ............................................................................ 94
Dual Wave bolus practice ............................................................................... 95
Contents xi
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
Example 1: Easy bolus ................................................................................... 99
Your turn: Easy bolus practice ........................................................................ 100
Basal patterns .............................................................................................. 100
Turning on the patterns ................................................................................ 101
Programming a pattern ................................................................................ 101
Select a pattern ......................................................................................... 102
Example 1: Basal patterns ............................................................................. 102
Example 2: Basal patterns ............................................................................. 103
Your turn: ................................................................................................ 103
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: Sensor features .............................................................. 111
Entering your sensor settings ............................................................................ 111
Turning on the sensor .................................................................................. 111
Selecting the BG units .................................................................................. 112
High Glucose Alert ...................................................................................... 112
Setting the High Snooze ................................................................................ 112
Low Glucose Alert ....................................................................................... 113
Setting the Low Snooze ................................................................................ 114
Setting the Alarm Snooze .............................................................................. 114
Setting the Cal Reminder .............................................................................. 115
Entering the transmitter ID ............................................................................ 115
Setting up the Missed Data feature .................................................................. 116
Reviewing your settings ................................................................................ 116
The transmitter ............................................................................................ 117
Transmitter charger ....................................................................................... 117
Installing a battery in the gray charger ............................................................. 117
Installing a battery in the blue charger ............................................................. 118
Contentsxii
Charging the transmitter ................................................................................. 118
Starting the sensor ........................................................................................ 119
Inserting the Enlite™ sensor .............................................................................. 119
Connecting the transmitter to the sensor ............................................................. 124
Preparing the sensor for communication .............................................................. 125
Calibrating the sensor ..................................................................................... 125
Entering meter BG ......................................................................................... 126
Re-starting the sensor after three days ................................................................ 127
Chapter 9: Using your sensor ........................................................... 129
Status screens .............................................................................................. 129
Reading the sensor glucose graphs ...................................................................... 130
Opening and viewing the graphs ...................................................................... 131
The graphs ............................................................................................... 132
Examples of continuous sensor glucose graphs ..................................................... 133
3-hour graph .......................................................................................... 133
24-hour graph ......................................................................................... 134
How to check for rapid changes in sensor glucose ................................................... 135
The rapid change arrows ............................................................................... 135
Calibration history ......................................................................................... 136
Sensor alarm history ....................................................................................... 136
Disconnecting the transmitter and removing the sensor ............................................ 136
Disconnecting the sensor from the transmitter .................................................... 136
Removing the sensor ................................................................................... 137
Storage ...................................................................................................... 137
Using your system in water ............................................................................... 137
Chapter 10: Utilities ...................................................................... 139
Alarm review ............................................................................................... 139
Setting your alert type .................................................................................... 139
Auto-off ..................................................................................................... 140
LOW RESV WARNING (Low reservoir warning) ......................................................... 140
Review daily insulin totals ............................................................................... 141
Pump data management .................................................................................. 142
Meter blood glucose information ..................................................................... 142
Personal reminders ........................................................................................ 145
Alarm clock .............................................................................................. 145
Contents xiii
Remote control option .................................................................................... 145
Turn on remote control option ....................................................................... 146
Add, delete, review remote control IDs ............................................................. 146
Block feature ............................................................................................... 147
Turning block on ........................................................................................ 147
Example 1: Block ........................................................................................ 147
Example 2: Block ........................................................................................ 147
Lock keypad feature ...................................................................................... 148
Locking the keypad ..................................................................................... 148
Unlocking the keypad .................................................................................. 148
Selftest ...................................................................................................... 148
User settings ................................................................................................ 149
Saving the settings ...................................................................................... 150
Restoring the settings .................................................................................. 150
Clearing the settings ................................................................................... 151
History .................................................................................................... 151
Chapter 11: Therapy management software ........................................ 153
CareLink Personal Software .............................................................................. 153
Reports ................................................................................................... 153
Logbook ................................................................................................... 154
Chapter 12: Insulin pump therapy follow-up ........................................ 155
Recommended follow-up ................................................................................. 155
Everyday .................................................................................................. 155
Every month ............................................................................................. 155
Every three months ..................................................................................... 155
Laboratory tests ......................................................................................... 156
Every visit ................................................................................................ 156
Annually .................................................................................................. 156
Chapter 13: Troubleshooting, alerts and alarms ................................... 157
My pump has a NO DELIVERY alarm ..................................................................... 157
What happens if I leave the pump battery out too long? ............................................ 158
Why doesn't my pump battery last very long? ......................................................... 158
What is a CHECK SETTINGS alarm? ...................................................................... 159
My screen appears distorted ............................................................................. 159
Contentsxiv
I cannot get out of the priming loop .................................................................... 159
The pump is asking me to rewind ....................................................................... 160
My bolus stopped .......................................................................................... 160
My pump buttons are not acting right during a bolus ................................................ 160
My pump will not display my blood glucose reading from my meter .............................. 160
I dropped my pump ........................................................................................ 161
I submerged my pump in water ......................................................................... 161
I cannot get to the USER SETTINGS screen ............................................................ 162
Alerts ........................................................................................................ 162
Example: ................................................................................................. 163
What to do ............................................................................................... 163
Pump alert conditions .................................................................................. 163
LOW RESERVOIR ...................................................................................... 163
LOW BATTERY ......................................................................................... 163
Sensor alert conditions ................................................................................. 164
WEAK SIGNAL .......................................................................................... 164
LOST SENSOR .......................................................................................... 164
LOW TRANSMTR ....................................................................................... 165
BAD TRANSMTR ....................................................................................... 165
BAD SENSOR ........................................................................................... 165
SENSOR END ........................................................................................... 165
CAL ERROR ............................................................................................ 166
METER BG NOW ....................................................................................... 166
METER BG BY .......................................................................................... 166
LOW X.X MMOL/L (XX MG/DL) ...................................................................... 166
HIGH XX.X MMOL/L (XXX MG/DL) .................................................................. 167
SENSOR ERROR ........................................................................................ 167
Alarms ....................................................................................................... 167
What to do ............................................................................................... 168
Alarm conditions ........................................................................................... 168
A (ALARM) ................................................................................................ 168
AUTO OFF ................................................................................................ 168
BATT OUT LIMIT ......................................................................................... 168
BOLUS STOPPED ......................................................................................... 168
BUTTON ERROR .......................................................................................... 169
CHECK SETTINGS ........................................................................................ 169
E (ERROR) ................................................................................................ 169
Contents xv
EMPTY RESERVOIR ....................................................................................... 169
FAILED BATT TEST ...................................................................................... 169
MAX DELIVERY ........................................................................................... 170
MOTOR ERROR ........................................................................................... 170
NO DELIVERY ............................................................................................. 170
NO RESERVOIR ........................................................................................... 170
OFF NO POWER .......................................................................................... 170
RESET ..................................................................................................... 170
WEAK BATTERY .......................................................................................... 170
Testing the transmitter ................................................................................... 171
Connecting the tester .................................................................................. 171
Disconnecting the tester ............................................................................... 172
Troubleshooting sensor features ........................................................................ 172
Reconnect old sensor ................................................................................... 172
Find lost sensor .......................................................................................... 173
Understanding your transmitter, tester, and charger ............................................. 173
Chapter 14: Maintenance ................................................................ 175
Battery ...................................................................................................... 175
Storage ...................................................................................................... 176
Cleaning your pump ....................................................................................... 176
Cleaning the transmitter ................................................................................. 176
Cleaning the Serter ........................................................................................ 177
Chapter 15: Pump specifications ....................................................... 179
Alarms and error messages ............................................................................... 179
Alarm history ............................................................................................... 179
Audio frequency ........................................................................................... 179
Backlight .................................................................................................... 179
Basal ......................................................................................................... 180
BG target .................................................................................................... 180
Bolus delivery .............................................................................................. 180
Bolus history ................................................................................................ 181
Bolus units .................................................................................................. 181
Bolus Wizard feature ...................................................................................... 181
Carb ratios .................................................................................................. 181
Carb units ................................................................................................... 181
Contentsxvi
Daily totals .................................................................................................. 181
Default screen .............................................................................................. 181
Delivery accuracy .......................................................................................... 182
Pump motor ................................................................................................ 182
Dual Wave bolus ........................................................................................... 183
Easy bolus ................................................................................................... 183
Infusion pressure ........................................................................................... 183
Insulin sensitivity .......................................................................................... 183
Low resv (reservoir) warning ............................................................................. 184
Meter value ................................................................................................. 184
Normal bolus ............................................................................................... 184
Occlusion detection ....................................................................................... 184
Percent temp basal ........................................................................................ 184
Power supply ............................................................................................... 185
Prime function ............................................................................................. 185
Prime history ............................................................................................... 185
Program safety checks .................................................................................... 185
Pump size ................................................................................................... 185
Pump weight ................................................................................................ 185
Remote control ............................................................................................ 185
Reservoir .................................................................................................... 186
Square Wave bolus ........................................................................................ 186
Temporary (temp) basal rate ............................................................................ 186
Time and date screen ..................................................................................... 186
Environmental conditions ................................................................................ 186
Status screen ............................................................................................... 186
Bolus Wizard feature specifications .................................................................... 188
Bolus Wizard feature examples .......................................................................... 191
Insulin delivery default settings ......................................................................... 194
Bolus Wizard feature default settings .................................................................. 195
Sensor features default settings ......................................................................... 196
Guidance and manufacturer's declaration ............................................................. 197
Icon table ................................................................................................... 203
Glossary ...................................................................................... 205
Index ......................................................................................... 213
Contents xvii
Contentsxviii
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
Please contact your local help line or representative for assistance. Refer to the Medtronic Diabetes International Contacts list at the beginning of this user guide for the help line or representative in your area.
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)
Introduction 1
Chapter 1
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 522 pump is only used with the 176-unit Paradigm reservoir (MMT-326A). The 722 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.
Introduction2
Sensor — The sensor (MMT-7002/MMT-7003/MMT-7008) 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 (MMT-7305) is used to download
the Paradigm 522 or 722 pump data to the diabetes management software using a USB port on your computer.
Not all devices or accessories are available in all countries where the pump is approved.
To order supplies, contact your local representative. Refer to the enclosed contact card for the Medtronic Diabetes office in your area.
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 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. Velcro
flap provides easy access for programming. Wear it vertically with the built-in belt clip.
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
Introduction 3
Chapter 1
Conventions Meaning
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.
User safety
Indications
The Paradigm 522/722 pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump system is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes. The pump displays continuous glucose values and stores this data so that it can be analyzed to track patterns and improve diabetes management. Pump history can be downloaded to a computer for analysis of historical glucose values.
Introduction4
The continuous glucose values provided by the Paradigm 522/722 pump systems are not intended to be used directly for making therapy adjustments. Rather, they provide an indication that a confirmation fingerstick measurement may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not based on the value displayed by 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
Reservoir and infusion sets
Standard Luer sets are not compatible with the Medtronic MiniMed Paradigm pump. Medtronic Diabetes Paradigm reservoirs 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.
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.
Magnetic fields
Do not use pump cases that have a magnetic clasp.
Do not ex pose you r in sulin pu mp to MRI equipme nt or oth er d evices t hat gene rat e very st rong mag net ic fi elds. 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.
Introduction 5
Chapter 1
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 42°C (108°F) or below 1°C
(34°F).
2 Insulin solutions freeze near 0°C (32°F) 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.
Introduction6
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 your local representative 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.
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 7
Chapter 1
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, alerts and alarms chapter to correct interference problems you may have.
Wireless transmission between the pump and transmitter within the 1.8 meters (6 feet) 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 your local Medtronic Diabetes representative.
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.
The pump includes a programmable WEAK SIGNAL alert that notifies you when one or more expected transmissions were not received as expected by the pump. (The pump will also issue a LOST SENSOR alert if communication is interrupted for an extended period of time.)
Introduction8
Communication problems can usually be resolved by:
ensuring that there is less than 1.8 meters (6 feet) between the receiving device and transmitter, to
include RF glucose meters;
turning off or moving away from other RF transmitting devices; or
reorienting or relocating the transmitter or receiving device, 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 31 cm (12 inches) 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 31 cm (12 inches) away from the receiving device, transmitter 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
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.
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).
Introduction to pump therapy12
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