Energizer 715, 515 User Manual
®
Paradigm
515 and 715 Infusion Pumps
User Guide
© 2005, Medtronic MiniMed. All rights reserved.
This product is covered by U.S. Patent Nos. 6,551,276 and 6,554,798. Other U.S. and/or foreign patents may be pending.
Paradigm
®
, Quick-serter®, Quick-set®, Silhouette®, and Sof-set®, are registered trademarks of Medtronic MiniMed.
CareLink™, Bolus Wizard™, Dual Wave™, Easy Bolus™, Paradigm Link™, ParadigmPAL™, and Square Wave™ are trademarks of
Medtronic MiniMed.
BD Logic™ is a trademarks of Becton, Dickins on and Company.
The Link™ is a trademark of Becton, Dickinson and Company (Canada only).
Energizer
Glucagon Emergency Kit
®
is a registered trademark of Eveready Battery Company.
®
is a registered trademark of Eli Lilly and Company.
REF MMT-515
MMT-715
6025020-015 110805
Important Safety Information
Regarding Your Paradigm Insulin Infusion Pump
(includes all models)
Avoid Immersing Your Pump In Water
Although it is unlikely that water damage will occur if your pump is splashed or briefly dunked, you
should avoid immersing your Paradigm infusion pump in water. To swim or participate in other water
activities, always disconnect from your Paradigm pump and reconnect after water play.
If you inadvertently submerge your pump in water, dry the pump quickly using a soft, clean towel and
verify that it is working properly by selecting “self test” from the pump’s Utilities Menu. If you believe
that water has entered your pump or you observe any other possible pump malfunction, please check
your blood glucose, treat high blood glucose (if necessary) with an injection and contact our 24-Hour
Help Line at 1-800-MINIMED (1-800-646-4633) for further assistance. Symptoms of high blood glucose
include fatigue, excessive thirst and nausea. You should always contact your healthcare professional if
you experience excessively high or low blood glucose levels, or if you have any questions about your
care.
Electrostatic Discharge
Although your Paradigm pump is designed to be unaffected by typical levels of electrostatic discharge
(ESD), very high levels of ESD can result in a reset of the pump’ s software with an associated pump error
alarm. In most cases, exposure to high levels of ESD will trigger the pump’s 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 Chapter 9, “Troubleshooting” for more details regarding what to do if
your pump displays an error alarm or other alert message.
Please contact our 24-Hour Help Line at 1-800-MINIMED (1-800-646-4633) to report any error alarms or
other problems that occur with your pump.
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Contents
Glossary .............................................................. xvii
Your personal information .......................................... xxiii
Basal rate ............................................................................................... xxiii
Carb ratios (meal bolus information) ............................................................. xxiv
Chapter 1 Introduction .................................................1
Availability ................................................................................................. 1
Assistance ..................................................................................................1
Emergency kit .............................................................................................2
Disposables .................................................................................................3
Accessories ................................................................................................. 3
Download pump and meter data ......................................................................4
ParadigmPAL ............................................................................................... 5
How to wear your pump .................................................................................5
How to use this guide ....................................................................................6
User safety .................................................................................................7
Indications ............................................................................................. 7
Contraindications ..................................................................................... 7
Warnings ............................................................................................... 7
Reservoir and infusion sets ...................................................................... 7
X-rays, MRIs and CT scans ........................................................................ 7
Precautions ............................................................................................ 8
Avoid extreme temperatures .................................................................... 8
Infusion sets and sites ............................................................................ 8
Notice ....................................................................................................... 9
Insulin pump and RF accessories ................................................................... 9
Chapter 2 The basics ................................................ 11
Your pump ............................................................................................... 11
Install battery ........................................................................................... 12
Pump buttons ............................................................................................ 14
The pump screen ....................................................................................... 15
Contents v
HOME screen ............................................................................................. 15
Screen icons ..........................................................................................15
Battery .............................................................................................15
Time display .......................................................................................16
Reservoir volume .................................................................................16
Alert and alarm icons ............................................................................16
Scroll bar ..............................................................................................16
Screen backlight .....................................................................................17
Beep/vibrate ............................................................................................. 17
Operating modes ........................................................................................ 17
Menus ..................................................................................................... 19
STATUS screen .......................................................................................... 20
If you remove your pump ............................................................................. 21
Pump settings ........................................................................................21
Insulin ..................................................................................................21
Chapter 3 Basic programming ........................................ 23
Setting the time and date ............................................................................. 23
Bolus insulin delivery types .......................................................................... 24
Normal bolus .........................................................................................24
Review your bolus deliveries ......................................................................... 29
Bolus details ..........................................................................................30
Maximum bolus limit ................................................................................... 31
BG reminder ............................................................................................. 32
Basal ....................................................................................................... 33
Start and stop times .................................................................................33
Your basal settings ..................................................................................34
Basal programming and delivery ..................................................................34
Basal review ..........................................................................................36
Current basal delivery ...........................................................................36
Daily basal rate(s) ................................................................................36
Max basal rate ........................................................................................... 38
Stopping your pump .................................................................................... 39
Resume pump delivery ................................................................................ 40
vi Contents
Chapter 4 Starting on insulin ........................................ 43
Prepare your pump for use ........................................................................... 43
Filling the reservoir .................................................................................... 44
Changing your infusion set ............................................................................ 46
Removing the reservoir .............................................................................46
Rewinding your pump ...............................................................................47
Inserting the reservoir in your pump .............................................................48
Manual prime .........................................................................................49
Insert the infusion set ...............................................................................50
Quick-set infusion set (with Quick-serter®) .................................................51
Connecting Quick-set .......................................................................54
Disconnecting Quick-set ...................................................................54
Fixed prime ...........................................................................................55
Prime history ............................................................................................ 55
Record keeping for diabetes management ........................................................ 56
Determining your pump settings .................................................................... 56
Using your daily journal ............................................................................... 57
Chapter 5 Using the Bolus Wizard feature ......................... 59
What is it? ................................................................................................ 59
Information you need .................................................................................. 59
Food entry ............................................................................................59
Your blood glucose (BG) reading ..................................................................59
Your personal Bolus Wizard feature settings ....................................................59
How the Bolus Wizard feature works ............................................................... 62
More about the Bolus Wizard feature ............................................................63
About high or low blood glucose levels .......................................................63
About maximum delivery .......................................................................63
About active insulin ..............................................................................64
How to program the Bolus Wizard feature ........................................................ 66
Bolus Wizard feature on/off .......................................................................66
Carb units .............................................................................................67
Carb/Exch ratios .....................................................................................67
BG (blood glucose) units ............................................................................69
Insulin sensitivity ....................................................................................69
BG (blood glucose) target range ...................................................................70
Active insulin time ...................................................................................72
Contents vii
Review your Bolus Wizard feature settings ....................................................... 73
Meter option ............................................................................................. 73
Meter rules ............................................................................................74
Add, delete, review meter IDs .....................................................................74
Normal bolus using Bolus Wizard feature .......................................................... 76
Bolus Wizard feature examples ...................................................................... 78
Chapter 6 Optimizing pump therapy ................................. 83
Square Wave and Dual Wave boluses ............................................................... 83
Dual/Square Wave bolus on-off ...................................................................84
Square Wave or Dual Wave bolus without Bolus Wizard feature .............................84
Using the Bolus Wizard feature for a Square Wave or Dual Wave bolus .....................89
Easy bolus ................................................................................................ 91
Easy bolus setup .....................................................................................91
Step value setup ..................................................................................92
Delivering an Easy bolus ............................................................................92
Basal patterns ........................................................................................... 95
Patterns on/off ......................................................................................95
Program a pattern ...................................................................................96
Select a pattern ......................................................................................97
Temp (temporary) basal rates ....................................................................... 99
How does temp basal work? ........................................................................99
Temp basal types .................................................................................. 100
Insulin rate ...................................................................................... 100
Percent of basal ................................................................................ 101
Selecting temp basal type ........................................................................ 103
Delivering a temp basal ........................................................................... 103
Verifying temp basal delivery .................................................................... 104
Canceling a temp basal ........................................................................... 105
Chapter 7 Insulin pump therapy follow-up ......................... 107
viii Contents
Recommended follow-up .............................................................................107
Everyday ............................................................................................ 107
Every month ........................................................................................ 107
Every 3 months ..................................................................................... 107
Laboratory tests .................................................................................... 108
Every visit ........................................................................................... 108
Annually ............................................................................................. 108
Chapter 8 Utilities ..................................................109
Alarm review ...........................................................................................109
Alarm details ....................................................................................... 109
Setting your alert type ...............................................................................109
Auto-off ..................................................................................................110
Low resv alert (Low reservoir warning) ...........................................................110
Review daily insulin totals ...........................................................................112
Pump data management .......................................................................... 113
Days to average ................................................................................. 115
Personal reminders ....................................................................................116
Alarm clock ......................................................................................... 116
Remote control option ................................................................................117
Turn on remote control option .................................................................. 118
Add, delete, review remote control IDs ....................................................... 118
Block feature ...........................................................................................119
Turn block on ....................................................................................... 119
Lock keypad feature ..................................................................................121
To lock keypad ..................................................................................... 121
To unlock keypad .................................................................................. 121
Selftest ...................................................................................................121
User settings ............................................................................................123
Saving pump settings .............................................................................. 123
Restoring pump settings .......................................................................... 124
Clear settings ....................................................................................... 125
History ............................................................................................... 126
Language setting .......................................................................................127
Chapter 9 Troubleshooting ..........................................129
My pump has a no delivery alarm... ............................................................ 129
What happens if I leave the battery out too long? ........................................... 130
Why doesn’t my pump battery last very long? ................................................ 130
What is a CHECK SETTINGS alarm? .............................................................. 130
My screen appears distorted ..................................................................... 131
I cannot get out of the priming loop ............................................................ 131
The pump is asking me to rewind ............................................................... 131
My bolus stopped .................................................................................. 132
My pump buttons are not acting right during a bolus ........................................ 132
My pump won’t display my blood glucose reading from my meter ........................ 132
Contents ix
I dropped my pump ................................................................................ 133
I submerged my pump in water .................................................................. 133
I cannot get to the User Settings menu ........................................................ 134
Alert conditions ........................................................................................134
What to do .......................................................................................... 134
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 ........................................................................................ 138
Check settings ...................................................................................... 138
E (Error) ............................................................................................. 138
Empty reservoir .................................................................................... 138
Failed batt test .................................................................................... 138
Is priming complete? .............................................................................. 139
Max delivery ........................................................................................ 139
Motor error ......................................................................................... 139
No delivery .......................................................................................... 139
No reservoir ......................................................................................... 139
Off no power ....................................................................................... 140
Reset ................................................................................................. 140
Weak Battery ....................................................................................... 140
Chapter 10 Pump maintenance ...................................... 141
Battery ...................................................................................................141
Storage ...................................................................................................141
Cleaning your pump ...................................................................................142
Chapter 11 Pump specifications .................................... 143
Alarms and error messages ..........................................................................143
Alarm history ...........................................................................................143
Backlight .................................................................................................143
Basal ......................................................................................................143
xContents
BG (blood glucose) target ............................................................................144
Bolus delivery ..........................................................................................144
Bolus history ............................................................................................144
Bolus units ..............................................................................................144
Bolus Wizard feature ..................................................................................144
Carb ratios ..............................................................................................144
Carb units ...............................................................................................144
Daily totals ..............................................................................................144
Default screen ..........................................................................................144
Pump motor .............................................................................................145
Dual Wave bolus .......................................................................................145
Easy bolus ...............................................................................................145
Infusion pressure ......................................................................................145
(Insulin) sensitivity ....................................................................................145
Low resv (reservoir) warning ........................................................................145
Meter value .............................................................................................146
Normal bolus ............................................................................................146
Occlusion detection ...................................................................................146
Percent temp basal ....................................................................................146
Power supply ...........................................................................................146
Prime function .........................................................................................146
Prime history ...........................................................................................146
Program safety checks ................................................................................147
Pump size ...............................................................................................147
Pump weight ............................................................................................147
Remote control .........................................................................................147
Reservoir ................................................................................................147
Square Wave bolus ....................................................................................147
Temporary (temp) basal rate ........................................................................147
Time and date screen .................................................................................147
Status screen ...........................................................................................148
Bolus Wizard feature specifications ...............................................................150
Bolus Wizard feature examples .................................................................. 152
Default (factory) settings ............................................................................154
Icon table ................................................................................................157
Index .................................................................159
Contents xi
xii Contents
Practice lessons and examples
Bolus examples
Meal bolus
Normal meal bolus using the exchange system ..................................................25
Bolus practice .........................................................................................26
Normal meal bolus practice using exchanges ....................................................26
Normal meal bolus using carbohydrate counting ................................................26
Correction bolus
Meal bolus, correction bolus and insulin sensitivity ............................................27
Practice: Meal bolus .................................................................................28
Max bolus
Example 1: Max bolus ................................................................................31
Example 2: Max bolus ................................................................................31
Basal examples
Basal programming
Practice: Basal programming .......................................................................35
Max basal
Example 1: Max Basal ................................................................................38
Example 2: Max Basal ................................................................................38
Suspend/Resume examples
Example: Suspend function .........................................................................40
Practice: Suspend function .........................................................................41
Practice: Resume basal delivery after a suspend ...............................................41
xiii
Bolus Wizard feature examples
Example 1: BG on target (normal BG) and no active insulin ...................................78
Example 2: BG above target (high BG) and no active insulin ..................................79
Example 3: Blood glucose below target (low BG) and no active insulin .....................79
Example 4: Blood glucose above target (high BG) with active insulin .......................80
Example 5: Blood glucose below target (low BG) with active insulin ........................81
Square Wave bolus examples
Example 1: Use of a Square Wave bolus while eating a meal high in fat ....................86
Example 2: Square Wave bolus, (gastroparesis) .................................................86
Dual Wave bolus examples
Your turn: Square Wave bolus practice ...........................................................87
Example 1: Set a Dual Wave bolus for a barbecue style dinner ...............................87
Example 2: Set a Dual Wave bolus for correcting elevated BG before a meal ..............88
Your turn: Dual Wave bolus practice ..............................................................88
Easy bolus examples
Example #1: Easy bolus ..............................................................................94
Your turn: Easy bolus practice .....................................................................94
xiv
Basal patterns examples
Example 1: Basal patterns ..........................................................................98
Example 2: Basal patterns ..........................................................................98
Your turn ...............................................................................................98
Example 1: Temp Basal for a decreased temporary basal rate ............................. 105
Temp Basal examples
Example 2: Temp Basal for an increased temporary basal rate ............................. 106
Your turn ............................................................................................. 106
Block examples
Example 1: Block ................................................................................... 120
Example 2: Block ................................................................................... 120
A
Accept - Pressing the ACT button to approve the
selection or setting.
Active insulin - Insulin that has been delivered to
your body, but has not yet been used.
Alarm - Audible or vibrating (silent) notice that
indicates the pump is in Attention mode and
immediate attention is required. Alarms are
prefixed in the alarm history with the letter A.
Alarm clock - The feature you can use like any
alarm clock. You can set the pump to send you
an alarm at certain times of the day as
reminders. For example, you can set the pump
to send you an alarm every four hours to remind
you to check your blood glucose level.
ALARM HISTORY screen - The screen that
displays the last twelve alarms or errors that
have occurred on your pump.
Alert - An audible ‘beep’ or vibration from the
pump to notify you that the pump needs
attention soon. You may need to replace a low
battery, or the pump may be sending you a
reminder of something (for example, that you
need to check your blood glucose level). An
alert does not affect insulin delivery.
Attention mode - The operating mode that stops
all current insulin delivery. This mode indicates
an alarm or condition exists that requires
immediate attention.
Glossary
B
Backlight - Pump screen light. Turns on whenever
the button is pressed or in combination with
the button if not on the HOME screen. The
backlight also appears during an alarm (except
LOW BATT).
Basal rate - The pump setting that provides a
continuous infusion of insulin to keep the blood
glucose stable between meals and during the
night. Basal insulin mimics pancreatic insulin
delivery - which meets all the body’s non-food
related insulin needs.
BASAL REVIEW screen - The screen that shows
the basal insulin delivery rates programmed in
the pump. This includes the total amount of
insulin delivered by the pump every 24 hours at
each delivery rate.
BG - (Blood glucose) The main sugar that your
body makes from food (especially
carbohydrates). Glucose is the major source of
energy for your body and is carried in the
bloodstream.
BG (blood glucose) reminder - The feature that
you can use to remind you to check your blood
glucose level after a bolus insulin dose.
Glossary xvii
BG (blood glucose) target range - The range of
your normal or desirable blood glucose levels.
You can set up the pump so that you receive an
alarm when your blood glucose level is below or
above your target range.
BG (blood glucose) units - Blood glucose unit of
measure (mg/dL or mmol/L).
Block - The feature that restricts access to all
programming except suspend, selftest and the
delivery of a bolus with the remote control.
Bolus - A dose of insulin given in addition to your
base (basal) insulin dose to bring your blood
glucose level down to your target range. The
two basic types of bolus insulin doses are
‘correction’ boluses (see page xviii), and ‘food’
boluses (see page xix).
BOLUS HISTORY screen - The screen that
shows the last twenty-four (24) boluses
delivered by your pump.
Bolus Wizard® feature - A feature of the pump
that automatically calculates the amount of
insulin you need bring your blood glucose level
back down to your target range.
C
CH - (Carbohydrate) A source of energy in food.
Most carbohydrates are sugars and starches that
your body turns into glucose for energy. After
you eat carbohydrates, your blood glucose rises.
Correction bolus - A type of bolus insulin dose
given to bring your blood glucose level back
down to your blood glucose target range when
your blood glucose is unexpectedly higher than
your target range, and the rise in blood glucose
is not related to eating. The amount of insulin
that is needed is called the “corr bolus
amount” and is calculated using this formula:
[blood glucose] – [blood glucose target) = X.
X ÷ (corr bolus factor) = corr bolus amount
Correction bolus factor - How much 1.0 unit of
insulin will lower your blood glucose level. This
information is used to calculate the amount of
bolus insulin you need when your blood glucose
is above your blood glucose target range. (See
“Correction bolus.”)
D
Daily totals - Shows the total insulin delivered
(basal and bolus) in the last 24-hours. Maximum
records: 14 days
Carb ratio - (Carbohydrate ratio) The amount of
carbohydrates covered by one unit of insulin.
(Also see exch ratio.)
Carb units - The food entry when using the Bolus
Wizard feature. Entered as (carbohydrate)
grams or exchanges.
xviii Glossary
DKA - (Diabetic Ketoacidosis) A complication of
diabetes mellitus that is caused by the
accumulation of fat metabolism by-products
(ketones). This happens when glucose is not
available as fuel in the body. DKA is also
referred to as ketoacidosis or diabetic coma.
Dual Wave™ bolus - Combination of a normal
bolus that is delivered immediately, then
followed by a Square Wave bolus. The Square
Wave portion is delivered evenly over a period
of time.
Duration - Amount of time it takes to administer
a bolus or basal delivery. Also, length of time
for an action or condition.
E
Easy bolus™ - Method of delivery for a Normal
bolus using the Easy Bolus button .
Exch ratio - (Exchange ratio) Used when
counting carbohydrates as exchanges. The
amount of insulin needed to cover one (1)
carbohydrate exchange. (Also see carb ratio.)
current blood glucose levels is above your
target range.
G
Gastroparesis - A condition of the digestive
system that slows down the emptying of food
from the stomach.
H
HbA1c - (Glycosylated hemoglobin)
HDL - (High-density lipoprotein) A complex of
lipids and proteins in approximately equal
amounts that functions as a transporter of
cholesterol in the blood.
Hold - To push and keep pressure on a pump
button.
Express bolus - Method of delivery for any bolus
type using the express bolus button .
F
Fixed prime - To fill (prime) the cannula with
insulin. This is done after you insert the infusion
set into your body and remove the introducer
needle.
Food bolus - A type of bolus insulin dose given
before meals or snacks to keep your blood
glucose level from going above your target
range. The amount of insulin needed is
calculated using your insulin sensitivity
(page xix), the amount of active insulin in your
body (page xvii), the amount of carbohydrates
in the meal or snack, and how much your
I
Idle - The pump is at the HOME screen.
Ins sensitivity - (Insulin sensitivity) The amount
that your blood glucose level is reduced by one
unit of insulin.
K
Kilopascal (kPa) - A unit of measurement for
quantifying force. Used to measure atmospheric
pressure. Equivalent to 10,000 dynes per square
centimeter.
Glossary xix
L
LDL - (Low-density lipoprotein) A complex of
lipids and proteins, with greater amounts of
lipid than protein, that transports cholesterol in
the blood.
Link - To turn on and setup the meter option that
allows the pump to receive blood glucose
readings from the Paradigm Link meter.
Low resv warning - Programmable warning that
notifies you with an alert when either a
specified number of units remain in the
reservoir or a specified amount of time remains
before the reservoir will be empty.
M
Manual bolus - Selectable item available in the
BOLUS MENU when the Bolus Wizard feature is
active. One method of programming a bolus
without the Bolus Wizard feature (see “Set
bolus” on page xxi).
Manual prime - Fills the infusion set tubing with
insulin before you insert the set into your body.
This function is available after a rewind.
Max bolus - The maximum amount of bolus
insulin that the pump can deliver at one time
(set by the user).
Max basal rate - The maximum amount of basal
insulin that the pump will deliver at one time
(set by the user).
Meter - The Paradigm Link Blood Glucose Monitor
Powered by BD Logic™ Technology (Paradigm Link
meter). Your pump can be programmed to
receive your blood glucose readings from this
meter.
Meter option - Feature that allows the pump to
receive blood glucose readings from the
Paradigm Link meter.
N
Normal mode - Regular operating mode. No
special features are active, no alert or alarm
conditions exist. Insulin delivery is normal
during this mode.
Normal bolus - One of three types of bolus insulin
deliveries where all the insulin is delivered at
once. This is usually used to bring your blood
glucose level back down to your blood glucose
target range when you are fasting, and the high
blood glucose is unexpected. The other types of
bolus insulin deliveries are Dual Wave (see
page xix), and Square Wave (see page xxi).
Now portion- The “Normal” portion of a Dual
Wave bolus. The now portion is delivered all at
once, followed by the Square portion.
P
Pattern feature - Extended pump feature that
allows you to program optional basals (Pattern
A, Pattern B) that support activities that are not
a part of your day-to-day routine, but are usual
in your lifestyle. Such activities could be a sport
that you do once a week or a change in your
sleep pattern over the weekend.
xx Glossary
Pattern, standard - Your normal basal that
supports your usual day-to-day activity. When
the Patterns feature is off, the pump uses your
standard (basal) pattern.
Press - To push and release a pump button.
Prime - To fill (prime) the cannula with insulin.
This can be done automatically by the pump (a
“Fixed prime”), or manually (a “Manual prime.”
See Fixed prime (page xix) or Manual prime
(page xx).
PSI - Pound-force per square inch.
Square Wave™ bolus - Immediate bolus
delivered evenly over a specified time period
(30 minutes to 8 hours).
Square Wave portion - (Sq) The second part of a
Dual Wave bolus. The Square Wave portion
delivers evenly over a period of time after the
NOW portion delivers.
STATUS screen - The screen that displays the
current operations of the pump, including
active functions, the most recent basal and
bolus deliveries, reservoir information, and
battery condition.
R
Resume - Continue basal insulin delivery after the
pump is suspended.
Rewind - The pump drive moves back to its
starting position to prepare the pump for a new
reservoir.
RF - (Radio frequency)
S
Scroll - Press the up or down arrow buttons to
move through the screen text.
Select - Pressing the up or down arrow buttons to
highlight a desired screen item.
Set bolus - Selectable item available in the
BOLUS MENU when the Bolus Wizard feature is
inactive. One method of programming a bolus
without the Bolus Wizard feature. (See “Manual
bolus” on page xx.)
Step - Measurement of insulin that you set and
use for Easy Bolus delivery.
Suspend - Function that stops all insulin delivery.
Any current bolus and/or prime deliveries are
cancelled. The basal delivery is paused until
restarted.
T
Temp - Temporary
Temp basal - (Tmp basal) Temporary one-time
basal insulin with a specified amount and
duration. Used to support insulin needs for
special activities or conditions that are not part
of the normal daily routine.
U
µL - microliter
Special mode - Operating mode that indicates
one or more special functions is active or a
condition exists that requires attention.
Glossary xxi
xxii Glossary
Your personal information
You may need the following information from your healthcare professional before going to your
pump start appointment. If you are unsure, contact your healthcare professional or pump traine r for
instructions.
NOTE -
This information is not for the Bolus Wizard feature. Refer to Chapter 5, “Using the
Bolus Wizard feature” for information on the Bolus Wizard feature.
Basal rate
Basal insulin is required to maintain your target
glucose values when you are not eating. Your pump
can be programmed with up to three (3) basal
patterns (standard, pattern A, pattern B) to
accommodate your varying insulin needs on
different days (example: weekday versus weekend
day). Each pattern can have up to 48 basal rates.
When you first start pump therapy, your healthcare
professional may only have you program one or two
basal rates. Get your basal rate settings from your
healthcare professional.
Standard
Basal rate
number
#1 midnight
#2
#3
Additional basal rates
#4
#5
#6
#7
#8
Start time
Basal rate
(units per
hour)
xxiii
Pattern A
Patter n B
Basal rate
number
#1 midnight
#2
#3
(additional basal rates)
#4
#5
#6
#7
#8
Start time
Basal rate
(units per hour)
Basal rate
number
(additional basal rates)
Carb ratios (meal bolus information)
Your carb ratios are used to calculate your meal boluses.
If you count grams: this ratio is the number of carb
grams covered by one (1) unit of insulin.
If you count exchanges: this ratio is the number of
insulin units you need to cover one carb exchange.
Start time
#1 midnight
#2
#3
#4
#5
#6
#7
#8
When Start time
breakfast
lunch
dinner
snacks
Basal rate
(units per hour)
(grams/u or
u/exch)
xxiv
Chapter: 1
Introduction
Thank you for choosing Medtronic MiniMed 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
pump. We strongly recommend that you work closely with your healthcare professional for a safe and
complete pump start.
Your pump is indicated for the continuous delivery of insulin, at set and variable rates, for the
management of diabetes mellitus for persons requiring insulin. Based on your settings, the pump
delivers your custom basal automatically and continuously 24-hours a day. It also provides bolus
deliveries to support your immediate insulin needs for food intake and/or high blood glucose. The Bolus
Wizard feature can calculate the amount of bolus insulin you need.
Availability
The pump and accompanying products are available from Medtronic MiniMed and authorized
distributors.
Assistance
Medtronic MiniMed provides a 24-hour
Product Help Line for assistance. The Help Line
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 Help Line or your local Medtronic
MiniMed office, please have your pump and
serial number available. The phone number for
the 24-hour Product Help Line is also on the
back of your pump.
Department Telephone number
24-hour Product Help Line
(calls within the United
States)
24-hour Product Help Line
(calls outside the United
States)
800.646.4633
(800.MiniMed)
818.576.5555
Introduction 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
“User safety” on page 7 for more information on pump safety. Your emergency kit should include these
items:
➠ Fast-acting glucose tablets ➠ Paradigm Quick Reference Card
➠ Blood glucose monitoring supplies ➠ Dressing and adhesive
➠ Urine ketone monitoring supplies
➠ Extra Paradigm infusion set and Paradigm
reservoir
➠ Insulin syringe and fast-acting insulin (with
➠ Glucagon Emergency Kit
➠ Extra AAA alkaline batteries (Energizer
is recommended)
®
®
brand
dosage instructions from your healthcare
professional)
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 body. Usually, you
need to wait at least 8 hours after an injection before using the Bolus Wizard
feature to calculate your active insulin. The actual amount of time you need to
wait depends on your active insulin setting (see “About active insulin” on
page 64 for more information).
2Chapter: 1
Disposables
The pumps use disposable reservoirs and infusion sets for insulin delivery. Installation instructions
for Paradigm reservoir and infusion sets are provided in Chapter 4, “Starting on insulin.”
➠ Reservoirs: The 515 pump is intended for use with a 176-unit Paradigm reservoir (MMT-326). The
715 pump is intended for use with a 300-unit Paradigm reservoir (MMT-332), however it can also use
the MMT-326 as well.
➠ Infusion sets: Medtronic MiniMed provides a variety of Paradigm infusion sets to fit your needs.
Contact your healthcare professional who will assist you to choose an infusion set that fits your
needs.
WARNING: For your protection the pump has undergone extensive testing to confirm
appropriate operation when used with Paradigm reservoirs and Paradigm
infusion sets manufactured or distributed by Medtronic MiniMed. We
recommend using Medtronic MiniMed 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 the optional Paradigm Link™ Blood Glucose Monitor powered by
BD Logic™ Technology. You can program your pump to automatically receive your blood glucose
readings from this meter.
➠ Remote control: The optional Paradigm remote control can be used with the pump to deliver
normal boluses and suspend the pump from a distant location. (This User Guide provides
programming instructions for the remote control. See the remote control User Guide for operating
instructions.
To order supplies, call 800-646-4633 (1-800-MiniMed) or 818-362-5958 (outside U.S.)
www.minimed.com
Introduction 3
Download pump and meter data
The Medtronic CareLink™ Therapy Management System for Diabetes Web site is designed to help you
take information from all of your diabetes management tools—your insulin pump, blood glucose meters,
and logbook—and organize it into easy-to-read charts, graphs, and tables.
These reports can help you and your healthcare professional discover trends and other information
that can lead to improved therapy management for greater control of your diabetes.
Reports show you data gathered from your pump, meter, plus information you enter directly into
the system. Examples of reports you can create include:
➠ Pump operation, such as alarm settings and maximum allowed bolus amount
➠ Insulin delivery rates, types, and times
➠ Blood glucose reading levels and times
➠ Bolus Wizard or online logbook entry data.
Reports display in PDF format, which you can view online, print out, and download and save to your
computer.
You can share your reports with your healthcare professional. They can use report results to
determine if and how your treatment regimen should be adjusted.
The logbook feature allows you to keep track of facts such as:
➠ Carbohydrates eaten,
➠ Exercise activity,
➠ Urine ketone results,
➠ HbA1c results, and
➠ Infusion set changes.
This data from your logbook is used in the reports you create. For instance, you can see how your
carbohydrate intake compares to blood glucose levels for the same day or time. You can also use your
logbook as an online diary of your diabetes management.
The CareLink system is accessed through a Web site at http://carelink.minimed.com. From there,
you can follow the on-screen instructions and help.
NOTE -
Medtronic CareLink™ Therapy Management System for Diabetes is not available in all
locations.
4Chapter: 1
ParadigmPAL
With ParadigmPAL™ you can do the following with your pump settings:
➠ See your pump settings on your PC screen.
➠ Backup, or save, pump settings to diskette or the hard drive of your PC.
➠ Quickly change your pump settings in case your healthcare professional needs to make a
change to your pump therapy.
➠ Print copies of your pump settings for your records.
How to wear your pump
There are a different ways to wear your pump. Medtronic MiniMed has accessories that can hide,
protect, and add to the convenience of wearing a pump. See the accessories catalog or the website
(www.minimed.com) for more information.
➠ Holster: Used to wear the pump on your belt.
➠ Pump clip: Used 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 to pump for programming. Wear it vertically with the built-in belt clip.
Introduction 5
How to use this guide
NOTE -
For step-by-step instructions, refer to the appropriate sections in this guide. See the Glossary for
definitions of terms and functions. The terms and symbols used in this guide are in the table below.
Term / symbol Meaning
“Press” To push and release the pump button
“Hold” To push and keep pressure on the pump button
“Select”
“Exit the menus”
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, 12-Hour Setup, On, Off
flashing (blinking)
screen item
NOTE and TIP Additional helpful information
This User Guide shows sample screens only. Your pump screens may be slightly different.
To choose an item in a list on the pump screen using the / buttons
To leave the current pump menu and return to the HOME screen by pressing
the ESC button until the HOME screen appears
You can change the value for that item with the
/
buttons
CAUTION:
WARNING:
“Go to the...screen.”
6Chapter: 1
Warns of a potential hazard which, if not avoided, may result in minor or
moderate damage to the equipment
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
When a step instructs you to “Go to” a 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 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 (4) 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
MiniMed Paradigm reservoir and Paradigm infusion sets are specifically designed for use with the pump.
Do not modify your Paradigm reservoir or Paradigm 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.
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 and remove them from the area.
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.
Introduction 7
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.
8Chapter: 1
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