Paradigm 515, 715 User Manual

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Paradigm

515 and 715 Infusion Pumps

User Guide

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, Dickinson and Company. The Link™ is a trademark of Becton, Dickinson and Company (Canada only).

Energizer

is a registered trademark of Eveready Battery Company.

Glucagon Emergency Kit

is a registered trademark of Eli Lilly and Company.

6025020-015 110805

REF MMT-515

MMT-715

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 v

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

vi Contents

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

Contents vii

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

viii Contents

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

Recommended follow-up .............................................................................107

Everyday ............................................................................................ 107

Every month ........................................................................................ 107

Every 3 months ..................................................................................... 107

Laboratory tests .................................................................................... 108

Every visit ........................................................................................... 108

Annually ............................................................................................. 108

Contents ix

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

xContents

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

Contents xi

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

xii Contents

xiii

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

xiv

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

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

Glossary xvii

Glossary

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.

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.

xviii Glossary

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.

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.

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.”)

Daily totals - Shows the total insulin delivered

(basal and bolus) in the last 24-hours. Maximum records: 14 days

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.

Glossary xix

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.

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.)

Express bolus - Method of delivery for any bolus

type using the express bolus button .

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

current blood glucose levels is above your target range.

Gastroparesis - A condition of the digestive

system that slows down the emptying of food from the stomach.

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.

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.

Kilopascal (kPa) - A unit of measurement for

quantifying force. Used to measure atmospheric pressure. Equivalent to 10,000 dynes per square centimeter.

xx Glossary

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.

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.

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.

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.

Glossary xxi

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.

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)

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.)

Special mode - Operating mode that indicates

one or more special functions is active or a condition exists that requires attention.

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.

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.

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.

µL - microliter

xxii Glossary

xxiii

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

Start time

Basal rate

(units per

hour)

#1 midnight #2 #3

Additional basal rates

#4 #5 #6 #7 #8

xxiv

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.

Pattern A

Basal rate

number

Start time

Basal rate

(units per hour)

#1 midnight #2 #3

(additional basal rates)

#4 #5 #6 #7 #8

Patter n B

Basal rate

number

Start time

Basal rate

(units per hour)

#1 midnight #2 #3

(additional basal rates)

#4 #5 #6 #7 #8

When Start time

(grams/u or

u/exch)

breakfast

lunch dinner snacks

Introduction 1

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)

800.646.4633

(800.MiniMed)

24-hour Product Help Line (calls outside the United States)

818.576.5555

2Chapter: 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

➠ Glucagon Emergency Kit

➠ Extra Paradigm infusion set and Paradigm

reservoir

➠ Extra AAA alkaline batteries (Energizer

brand

is recommended)

➠ Insulin syringe and fast-acting insulin (with

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).

Introduction 3

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.

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

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.

4Chapter: 1

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.

Introduction 5

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.

6Chapter: 1

How to use this guide

NOTE -

This User Guide shows sample screens only. Your pump screens may be slightly different.

For step-by-step instructions, refer to the appropriate sections in this guide. 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”

To choose an item in a list on the pump screen using the / buttons

“Exit the menus”

To leave the current pump menu and return to the HOME screen by pressing

the ESC button until the HOME screen appears Pump Buttons Always bold and uppercase (for example, ESC, ACT) Screen and menu names Always uppercase; for example, MAIN MENU, REWIND screen Menu selections Always bold; for example, 12-Hour Setup, On, Off flashing (blinking)

screen item

You can change the value for that item with the

buttons

NOTE and TIP Additional helpful information CAUTION:

Warns of a potential hazard which, if not avoided, may result in minor or

moderate damage 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 screen, the path to that screen is

shown. For example:

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.

Go to the ALARM MENU.

Main > Utilities > Alarm

Introduction 7

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.

8Chapter: 1

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.

Introduction 9

Notice

Insulin pump and RF accessories

The pump, Paradigm Link meter, and remote control comply with the United States Federal Communications Commission and international standards for electromagnetic compatibility.

Do not use the RF meter to send your blood glucose reading to the pump while on an aircraft. Manually enter your blood glucose levels.

These devices comply with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesirable operation. It does not interfere with any RF signals transmitted from outside sources.

These standards are designed to provide reasonable protection against excessive radio frequency interference and prevent undesirable operation of the device from unwanted electromagnetic interference. Operation is subject to the following two conditions:

1 This device has been tested and found to comply with the regulations governing such devices in your

area. For the specific regulation and test results for your area, please contact the Medtronic

MiniMed 24-hour Product Help Line.

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/Paradigm Link meter

➠ Increase the separation between the insulin pump/remote control/Paradigm Link meter and the

device that is receiving/emitting interference

The Paradigm Link meter transmits 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. See Chapter 9, “Troubleshooting” to

correct interference problems you may have.

If you have questions, please contact the Medtronic MiniMed 24-hour Product Help Line.

CAUTION: Any changes or modifications to the devices not expressly approved by

Medtronic MiniMed could void your ability to operate the equipment.

10 Chapter: 1

The basics 11

Chapter: 2

The basics

Your pump

Take a look at your pump. The reservoir window allows you to view the insulin in the reservoir. The reservoir, with the tubing connector attached, is inserted into the reservoir compartment of the pump.

CAUTION: Never use sharp objects to press the buttons on your Paradigm pump as this

can damage the buttons or compromise the seal of the pump. Some examples of sharp objects that may damage your keypad are fingernail files, pens or pencils, paper clips, knives, scissors, and keys.

ACT

ESC

ACT

ESC

battery

compartment

tubing

connector

reservoir

compartment

buttons

reservoir

window

screen

12 Chapter: 2

Install battery

Medtronic MiniMed designed the pump to only accept a NEW battery. As a safety measure, if you

install a battery that does not have full power, the “weak battery” or “failed batt test” alarms may sound. If a “weak battery” alarm happens, respond to the alarm and continue. The pump will still operate normally, but with a decreased battery life. The pump uses one AAA alkaline battery.

1 Make sure all the following apply:

➠ Clear (ESC, ACT) any alarms and/or alerts before removing and replacing the battery ➠ Make sure the pump is at the HOME (idle) screen when you remove the battery. ➠ Do NOT remove the battery during a bolus or prime delivery.

2 Use the edge of a coin to remove the battery cap. Turn the cap in a counter-clockwise direction. 3 Remove the old battery and dispose of it per the

disposable requirements of your state or country. Put the new battery in the pump with the negative end [(-) symbol] going in first. Check the label on the back of the pump to make sure the battery is inserted correctly.

NOTE -

Do not use batteries that have been in cold storage (i.e., in the refrigerator or your car in

the winter).

4 Place the battery cap in the pump and tighten so the slot is

aligned horizontally with the pump as shown here:

Do NOT apply force when you turn the cap.

CAUTION: Do not use a rechargeable or carbon zinc battery in your pump. For best

results, a new AAA Energizer alkaline battery is recommended.

CAUTION: Do NOT over-tighten the battery cap.

You should not turn the cap more than four half turns. If you over-tighten the cap you may not be able to remove it, and you can damage your pump.

Battery cap

Battery

one half-turn

The basics 13

5 While the pump turns on, it will show various screens until the HOME screen appears.

NOTE -

If you are replacing a battery for a pump that has very recently been in use, the only

screen you will see before the HOME screen is the one displaying the version number.

If the HOME screen does not appear, do these steps:

a. Check that the battery is inserted correctly. If the battery has been installed backwards,

remove the battery and install it properly.

b. If your pump still does not turn on or you get a FAILED BATT TEST alarm, remove and replace

the battery with a new one.

c. If the pump is still not on, call the Medtronic MiniMed 24-hour Product Help Line.

6 Check to make sure the time and date are correct. If this is the first battery installed, or if more

than 5 minutes have passed since you removed the battery, you will be prompted to check the time

and date. See “Setting the time and date” on page 23 for programming instructions.

7 Press ESC to view the STATUS screen, making sure no alarms are active. If an alarm is active, follow

the instructions on the screen.

NOTE -

Make sure that you dispose of the battery per your local battery disposal regulations.

Ver X.XX

HOME screen

14 Chapter: 2

Pump buttons

The buttons on the pump are used to navigate through the menus and screens, and to program the features of the pump.

From the HOME screen

EASY BOLUS button—Shortcut to set and deliver an Easy Bolus.

From the menus and programming screens

Increases / decreases the value of a flashing item. Scrolls up and down the items in a list.

Turns the backlight on/off from the HOME screen.

Accepts a selected menu item or activates a selected setting.

Opens the MAIN MENU. Returns to previous screen. Backs

out of unintentional menu selections if the ACT button has not been pressed yet.

Opens the pump STATUS screen. EXPRESS BOLUS button: Short-cut

to the SET BOLUS MENU or Bolus Wizard screen to set up a bolus.

Press simultaneously with to turn on backlight when in the menus, or press as a “shift” button in combination with another button to access certain features.

DOWN button

UP button

(From the HOME screen, this is the EASY

BOLUS button.)

ACT

button

ESC

button

EXPRESS BOLUS

button

The basics 15

The pump screen

The screen shows five lines of text at one time. The first is the operating mode. The second is the current open menu or function. The last three lines show either information or text that you can select for the current function.

NOTE -

The screen text in the examples used in this guide might not exactly match the text on your pump screen. Please follow your pump screen instructions. If you have any questions, call the Medtronic MiniMed 24-hour Product Help Line.

HOME screen

The HOME screen serves as the starting point to access the programming screens. When no buttons are pressed for about 30 seconds, the pump returns to this screen.

When you press ACT from the HOME screen, the MAIN ME N U will appear.

When the pump is on, the following icons always appear across the top of the screen: reservoir volume icon, the time (12 or 24 hr), and the battery icon. If these do not appear, the pump is not operating.

Screen icons

There are various icons that appear at the top of your pump screen, like the time, battery and reservoir icons mentioned above. The meaning of the icons are described below.

Battery

The battery icon tells you how much usable life is left in your battery. There are four segments in the icon. Each segment represents approximately 25 percent of the usable battery life you have left until you reach Low Battery point. So if you only have one segment left you want to make sure you have a new battery available.

in the HOME screen, the area below the icons is blank.

Battery Indicator icons

At least 75% left

Low battery

16 Chapter: 2

Time display

The current time of day is displayed across the top of the pump screen in the format you select—12-hour or 24-hour. The AM or PM is only displayed for the 12-hour format. For instructions on setting the time on your pump, see “Setting the time and date” on page 23.

Reservoir volume

The reservoir volume icon tells you how much insulin is in your pump. This icon is also divided into four segments. Each segment represents approximately 25 percent of the reservoir volume you have left until you reach the Low Reservoir point. This allows you to be aware of how much insulin you have left in your pump. Check your STATUS screen to view the number of units left in the reservoir.

NOTE -

If using the Paradigm 715, your reservoir icon will only

appear full if using a filled 300 unit Paradigm reservoir.

Alert and alarm icons

An open circle (alert) or a closed circle (alarm) are displayed in the upper part of your pump screen only when there is an alert or alarm condition on your pump. For alarm and alert information, see “Alarms” on page 135 and “Alarm conditions” on page 137.

Scroll bar

If there is more text than the screen can show, a scroll bar appears in the right side of the screen. Press to

view any additional text.

Time Display

12-Hr

Reservoir Volume Indicator icons

Empty

75 to 100 percent left

Alert icon

Alarm icon

scroll bar

The basics 17

Screen backlight

When you press from the HOME screen, the light on the screen turns on or off. During

programming, the backlight can be turned on by pressing the and the together. The light will stay on while you are pressing any of the pump buttons. It will stay on as long as the current screen is

active.

To conserve your battery, the backlight will turn off automatically while the pump is vibrating. After the vibration is finished, the light will turn back on. The backlight cannot be turned on in a Low Battery condition.

Beep/vibrate

Your pump will beep or vibrate to indicate activity. See “Setting your alert type” on page 109 for setup instructions.

Operating modes

The screen lets you know when a special feature is active or if there is a condition that needs your attention. The active features and pump status will determine the operating mode. The screens for the three modes are shown below.

Normal - mode for standard pump operations for normal basal and

bolus delivery. No special features are active (i.e., basal patterns, temp basal, etc.). No alarms and no alerts exist.

WARNING: When the pump is in “Attention mode,” all insulin deliveries are stopped.

Normal Mode

18 Chapter: 2

Special - indicates a special feature is active or an alert condition(s)

exists. Special mode does not restrict any of the pump functions. When the pump is in Special mode, an open circle appears at the top of the screen and it will beep/vibrate periodically to remind you of the condition. The conditions and features that will put the pump in Special mode are:

Attention - indicates insulin delivery has stopped. This can mean

that the pump is in Suspend mode. It can also mean an alarm is active or an alarm condition exists that needs immediate attention for insulin delivery to resume. A solid circle appears at the top of the screen and the pump will beep periodically until the either the pump is taken out of Suspend mode or the condition is cleared. The screen will show text describing the condition that put the pump in Attention mode. For example, if the reservoir is empty, “Empty Reservoir” will appear on the screen.

When the pump is in Attention mode, it will beep/vibrate periodically to remind you of the condition. The beep/vibrate frequency varies depending on the condition that put the pump in Attention mode. See “Alarm conditions” on page 137 for alarm conditions that will trigger the Attention mode. See “Stopping your pump” on page 39 to learn about Suspend mode.

➠ Low Reservoir condition ➠ Low Battery condition ➠ Block feature is on

➠ Dual or Square Wave bolus

delivery

➠ Basal pattern A or B is active

➠ Temporary basal

delivery

Special Mode

Attention Mode

The basics 19

Menus

The MAIN MENU is the highest level menu. There are submenus, functions, status and programming screens in the lower menu levels. The menus are described in the following paragraphs.

TIP -

If a screen item is flashing (blinking), during programming, press

to change the

value.

MAIN MENU - Highest menu level in the menu system. When you press ACT from the HOME screen,

the MAIN MENU will appear.

BOLUS MENU - Contains the settings and functions for bolus deliveries. The button allows

direct access to the BOLUS MENU or to the Bolus W izard feature without having to navigate through the menus. See Chapter 3, “Basic programming” for the manual bolus information, or to Chapter 5, “Using the Bolus Wizard feature” for delivering bolus insulin using the Bolus Wizard feature.

SUSPEND - Stops all current insulin deliveries (basal, bolus and fixed prime). See “Stopping your

pump” on page 39 for more information.

BASAL MENU - Contains the functions to setup and deliver your basal. See Chapter 3, “Basic

programming” for more information.

PRIME MENU - Contains the functions required to change your reservoir and fill the infusion set with

insulin. See “Changing your infusion set” on page 46 for more information.

UTILITIES MENU - Contains features for your safety and convenience. See Chapter 8, “Utilities”

for more information.

20 Chapter: 2

STATUS screen

The STATUS screen shows information about what your pump is doing. The information that shows

on the STATUS screen depends on the current activities and conditions of your pump.

➠ To open the STATUS screen, press ESC until the STATUS screen appears. ➠ To view more text on STATUS screen, press / to scroll and view all of the information.

➠ To exit the STATUS screen, press ESC until the STATUS screen disappears.

The screen includes information about:

NOTE -

Only check your pump status (press

ESC

) when you are not programming your

pump. If you press

ESC

during programming, you will cancel the settings you are trying to enter.

See Chapter 11, “Pump specifications” for a comp let e list of the information that is available in the

STATUS screen.

➠ recent insulin deliveries (basal and

bolus)

➠ reservoir status ➠ time and date

➠ special features that are turned on ➠ battery status

Sample

STATUS screen

STATUS U100 Last Bolus: N 3.8U

9:07A 18 MAR Basal 1: 0.15U/H Reservoir Started:

13MAR, 12:44P

Units left: 144.0U

Time left: > 24 Hours BG Reminder in 2:04h Meter: On Battery: Normal Auto Off - 12HR Fri 21 MAR 2004 S/N# 123456 Paradigm 515 VER X.XX X.X

The basics 21

If you remove your pump

Pump settings

You may have an occasion when you need or want to remove your pump. If you have to remove and store your pump, it is recommended that you store it with the battery in place. Keep a record of your current basal rates. To preserve battery life, reset the basal rates to 0 (zero), turn off the RF options (meter, remote), and set Auto-off to dashes or zeroes.

NOTE -

Your pump keeps a record of the basal and bolus insulin it delivers. Setting your basal to

0.0 while you are disconnected ensures the insulin delivery records in your pump are accurate.

Insulin

Remember, your body still needs insulin while your pump is removed.

It is important that you consult with your healthcare professional to determine an alternate method of receiving your insulin. You can remove your pump for up to one (1) hour without taking insulin. If you remove your pump for more than an hour, you will have to use another way to take your insulin, such as injections of fast-acting insulin, or reconnecting your pump to take boluses. Take the injection or bolus approximately every four (4) hours. Calculate the amount of insulin to take based on the total of your basal insulin in four (4) hours. Include the amount you need for meal and correction boluses. If you will have your pump off for several days, you will need to return to a multiple injection regimen.

22 Chapter: 2

Basic programming 23

Chapter: 3

Basic programming

Setting the time and date

Setting the correct time and date in your pump is necessary for accurate basal insulin delivery and allows you to keep an accurate record of your insulin delivery and other pump functions. You can select a 12-hour or 24-hour clock. You must reset the time and date if you receive a CHECK SETTINGS alarm or you clear your settings (Clear Settings function).

1 Go to the TIME/DATE SETUP screen.

Main > Utilities > Time/Date

2 Select 12-Hour Setup or 24-Hour Setup and

press ACT.

3 Press ACT again to change the settings. 4 Change each of the settings as follows:

Hour Minutes Year Month Day

Change the hour. Press ACT.

For 12-hour setups, press

until the correct A (am) or P (pm) appears.

Change the minutes. Press ACT.

Change the year. Press ACT.

Change the month. Press ACT.

Change the day. Press ACT.

12:00A 01JAN2004 Press ACT to change

ACT

TIME/DATE SETUP

24 Hour Setup

12 Hour Setup

TIME/DATE SET

SET HOUR

12:00A

SET MINUTES

9:00A

SET YEAR

2004

SET MONTH

SET DAY

24 Chapter: 3

5 The TIME SET AT screen will show the settings that you programmed.

Press ACT and exit the menus. Your time/date settings are complete.

Bolus insulin delivery types

This section provides information on the basic bolus insulin delivery types and instructions on using

the Express bolus feature for giving yourself a ‘Normal’ bolus insulin delivery.

A bolus insulin delivery is a dose of insulin given in addition to your base (basal) insulin to bring your

blood glucose down to your target range. A bolus insulin delivery can be used when:

➠ You are fasting and you notice an unexpected rise in your blood glucose. ➠ Before a meal or a snack and you want to prevent your blood glucose from rising above your target

range.

There are three bolus insulin delivery types: normal, Square Wave, and Dual Wave.The normal bolus insulin delivery is described below. For information about Square Wave and Dual Wave boluses, see Chapter 6, “Optimizing pump therapy.”)

Normal bolus

For this type of insulin delivery, all of the bolus insulin is given all at once (all of the insulin in the dose is given at one time). Normal bolus deliveries can be used to cover an expected rise in your blood glucose caused by eating a meal or snack, or to correct an unexpected rise in blood glucose.

During a Normal bolus, most pump features are disabled until after all the bolus insulin has been delivered. The Suspend function and the STATUS screen, however, are always available.

The following instructions are for a Normal bolus when the Bolus Wizard feature is turned off.

from the menu, or using the EXPRESS BOLUS button

1 Go to the BOLUS

MENU.

Main > Bolus

Select Set Bolus and

press ACT. Go to

Step 2.

Press the button. Go to Step 2.

TIME SET AT

8:33 AM

26FEB2004

Set Bolus Bolus History Bolus Wizard Setup Max Bolus Dual/Square Bolus Easy Bolus BG Reminder

BOLUS MENU

Set Bolus

Basic programming 25

NOTE -

If you have the BG Reminder feature turned On, a screen displays allowing you to accept or modify the length of time after this bolus before you are reminded to check your blood glucose. See “BG reminder” on page 32 for information about this feature.

4 Press ACT to accept and deliver the bolus. The Normal

bolus will start. As the bolus delivers, the amount shown on the screen will increase until the entire bolus has been delivered.

The pump will beep/vibrate at the start of the bolus. When the bolus is finished, the pump will beep/vibrate again and the HOME screen will appear.

Below are some practice lessons that will help you understand this pump feature.

2 If the SET BOLUS

screen appears:

(Dual/Square option is off) Go to Step 3.

If the BOLUS TYPE screen

appears: (Dual/Square

Wave is on) Select Normal

Bolus

and press ACT. Go

to Step 3.

3 Enter your bolus amount

and press ACT.

Normal meal bolus using the exchange system

Fred has been taught that he needs to take 1 unit of insulin for every carbohydrate exchange that he eats (every milk, every starch or every fruit). For lunch today he will eat:

Turkey sandwich with two slices of bread 2 starches

1 small apple 1 fruit

1 cup of non-fat milk 1 milk

_________

Total carbohydrate exchanges = 4

Fred's lunch has a total of 4 carbohydrate exchanges so he will take a meal bolus of 4 units for his lunch.

SET BOLUS

0.0

BOLUS TYPE

Normal Bolus

Square Wave Bolus Dual Wave Bolus

* “SET NORMAL BOLUS” will

show if Dual/Square option is on.

SET BOLUS*

0.0

SET BOLUS*

2.5

ACT

BOLUS DELIVERY

11:53A

Normal

0.1

BOLUS DELIVERY 11:53A

Normal

2.5

26 Chapter: 3

Bolus practice:

Going through the menus, program a 2.0 unit Normal bolus now. Check here if you were able to program it.

Using the express bolus button , program a 2.0 unit Normal bolus now. Check here if you were able to program it.

Normal meal bolus practice using exchanges: Choose a meal you might eat and fill in the blanks.

Food: __________ exchange: ____________

__________ exchange: ____________ __________ exchange: ____________

total exchanges: ____________

You will take _______units of insulin for each exchange. Your total bolus is _______ for this meal.

Normal meal bolus using carbohydrate counting

Lydia has been taught that she needs to take 1 unit of insulin for every 10 grams of carbohydrate. This is her insulin to carbohydrate ratio. For dinner she will have:

4 oz. broiled chicken 0 grams

2/3 cup of rice 30 grams

½ cup cooked broccoli 5 grams

1 oz. dinner roll 15 grams

1 tsp margarine 0 grams

____________

total grams of carbohydrates = 50 grams

Lydia's dinner totals 50 grams of carbohydrate. Her insulin to carbohydrate ratio is 1 unit: 10 grams. She will take a meal bolus of 5 units for her dinner. She determined this by dividing 50 (total grams of carbohydrate) by 10 (insulin to carbohydrate ratio).

Basic programming 27

1. Insulin sensitivity should equal the amount (in mg/dL or mmol/L) that blood glucose will be lowered after taking 1 unit of insulin.

To determine insulin sensitivity, divide 1700 by Total Daily Dose (TDD

) of Insulin. The answer is your

“Correction Factor” (1700 Rule). As always, consult with your healthcare professional for guidance.

2. TDD = Total amount of basal and bolus insulin delivered in a 24-hour day.

Choose a meal you might eat and fill in the blanks.

Food: ________ grams of carbohydrate: ______________

________ grams of carbohydrate: ______________ ________ grams of carbohydrate: ______________

total grams of carbohydrate: ________________

Your insulin to carbohydrate ratio: 1 unit of insulin for _______ grams carbohydrate. Divide your total carbohydrates by your insulin to carbohydrate ratio and take _____units of insulin for your meal.

Meal bolus, correction bolus and insulin sensitivity

Jason is ready to eat his breakfast. He has calculated that he will need 4.0 units for his food. He tests his blood glucose and finds that it is 200 mg/dl (11 mmol/L). Jason knows that his blood glucose

level is above his high blood glucose target and will need more insulin before he eats.

Jason's healthcare professional has determined the following for him:

High blood glucose target: 110 mg/dL (6.1 mmol/L)

Insulin sensitivity:

30 mg/dL (1.7 mmol/L)

Jason determines that he will need a correction bolus of 3.0 units insulin to lower his elevated blood glucose. The 3.0 correction bolus will lower his current blood glucose of 200 mg/dL (11 mmol/L) down to his high blood glucose target of 110 mg/dL (6.1 mmol/L).

elevated blood glucose: 200 - 110 = 90 mg/dL (11 - 6.1 = 5 mmol/L)

correction bolus: 90 / 30 (insulin sensitivity) = 3.0 units

(He will add this 3.0 correction bolus to the 4.0 units of insulin that he will need for his meal bolus. Jason will take a total bolus of 7.0 units.)

28 Chapter: 3

Practice: Meal bolus

You have determined your meal bolus as: _______ units. Your target blood glucose range is: _______ to _______ (average is _______). Your current blood glucose level is: _________. Your correction factor is: 1 unit of insulin will drop your blood glucose _________. You will take ________ unit(s) of insulin to correct your high blood glucose. Your total bolus (meal bolus plus correction bolus) is _________.

Basic programming 29

Review your bolus deliveries

You can view a list of your bolus deliveries in the BOLUS HISTORY screen. This screen shows a list of the dates, times, units, and types for your last 24 boluses. This feature is helpful for record keeping or to check if you bolused for your last meal.

If a bolus was stopped before delivery was complete, the BOLUS HISTORY screen will show only the amount actually delivered. See “Bolus details” on page 30 for instructions about viewing bolus details.

Do the following steps to view the BOLUS HISTORY screen:

1 Go to the BOLUS HISTORY screen and scroll through

the bolus deliveries.

Main > Bolus > Bolus History

If you used the Bolus Wizard feature to deliver any of

these boluses, the screen shows the

carbohydrate/food (CH) and blood glucose values

that the Bolus Wizard feature used to calculate the

boluses.

2 Follow the instructions in “Bolus details” on page 30

to see the details for any of these boluses.

N = Normal S = Square Wave D = Dual Wave DN = Normal part of Dual Wave bolus DS = Square part of Dual Wave bolus

BOLUS HISTORY Last 12:48P 0.7N 05SEP 01:05P 0.2N 05SEP 06:30P 4.8S

BOLUS HISTORY Last 12:48P 0.7N

CH: 13

BG: 150

05SEP 01:05P 0.2N

date

time

amount/type

carb value

blood glucose

(BG) value

(with the Bolus Wizard feature)

30 Chapter: 3

Bolus details

You can view the details for any of the deliveries in the BOLUS HISTORY screen. The details include:

➠ bolus types: normal, square, and dual ➠ programmed bolus amount ➠ delivered bolus amount ➠ Bolus Wizard feature information (if you are using the feature)

To see the details for any bolus, do these

steps:

1 In the BOLUS HISTORY screen, select the

bolus that you want to review and press

ACT.

2 The details for that bolus will appear on

the screen. Scroll through the details.

3 Exit when you are done.

If the Bolus Wizard

feature calculated your

bolus, this information will also appear in the

BOLUS DETAIL screen.

ACT

(values shown are

for example only)

BOLUS HISTORY

Last 05:45P 0.7N

05SEP 05SEP

01:05P 06:30P

02N

4.8S

BOLUS DETAIL Type: User Entry: Delivered:

4.0U

0.7U

BOLUS DETAIL Type: User Entry: Stopped at:

4.0U

0.7U

BOLUS DETAIL Type:

Delivered:

4.0U

Bolus Wizard:

Est total: Food intake: (Meter) BG: Food: Correction: Active Ins: Est time:

4.0U 45gr 160

3.0U

2.0U

1.0U 12:03P

Normal

(delivery is active)

(delivery stopped)

(delivery completed)

(without the Bolus Wizard feature)

Basic programming 31

Maximum bolus limit

The maximum bolus (max bolus) is a safety feature that you can use to set a limit on the amount of insulin that can be delivered in a single bolus. The factory setting is 10.0 units. You can reset the limit to anywhere between 0.0 units up to 25.0 units. It is important to discuss this feature with your healthcare professional to determine your maximum bolus limit.

To set the maximum bolus limit, do these steps:

1 Go to the MAX BOLUS SETUP

screen.

Main > Bolus > Max Bolus

2 Set your maximum bolus limit

and press ACT.

3 Your maximum bolus is

set. Exit the menus.

Example 1: Max bolus

Shelby takes very small doses of insulin for her meal boluses. As a safety limit, she and her healthcare professional reset her pump with a maximum bolus of 5.0 units.

Example 2: Max bolus

David is a growing teenager. He loves to eat big meals and requires very large doses of insulin for his food. He reset his pump with a maximum bolus of 20.0 units so he can take more insulin when he needs to.

(flashing)

MAX BOLUS SETUP 0-25

10.0

x __

MAX BOLUS SETUP 0-25

15.0

ACT

BOLUS MENU

Bolus Wizard Setup

Max Bolus

Dual/Square Bolus

ESC

32 Chapter: 3

BG reminder

When you deliver a bolus you may want to check your blood glucose afterwards. The BG reminder is

an optional feature that you can use to have the pump send you a reminder you to check your blood glucose after a bolus. You can set the pump to remind you with an audible ‘beep’ or by vibrating. Your pump is set at the factory with this feature turned off. If the BG reminder feature is turned on when you are programming your pump, you will be asked to set the amount of time between the bolus insulin delivery and the reminder. This amount of time is called the ‘BG Reminder Duration.’ The amount of time you set can be from 30 minutes to 5 hours, or NONE. If you do not want to use the BG Reminder at all, set the option to off (BG Reminder is not available after an Easy Bolus).

1 Go to the BG REMINDER SETUP screen.

Main > Bolus > BG Reminder

2 Select On and press ACT. The BG reminder feature

is now enabled (turned on). Exit the menus.

Now, the next time you program a bolus, your pump will ask

you for the amount of time after your bolus before you want to be reminded to check your blood glucose.

NOTE -

If you press ESC when the BG Reminder Duration screen appears, your pump will begin delivering the bolus without setting a reminder. If you program another bolus with a BG reminder before a previously scheduled BG reminder goes off, the previous BG reminder will be cancelled.

Your pump will beep or vibrate and the message “CHECK BG” will appear on the screen. Your pump will continue to beep or vibrate periodically until you clear the reminder (ESC,

ACT).

The STATUS screen will show the amount of time remaining before the BG reminder notice will happen. In this example, the BG reminder notice will happen in 18 minutes.

BG REMINDER SETUP

Off

(flashing)

BG REMINDER DURATION

2:00

12:40P

CHECK

This is a reminder to check your BG ESC, ACT to clear

STATUS BG Reminder in 0:18h Battery: Normal Tues 08 MAR 2004

U100

Basic programming 33

Basal

Basal insulin is required to maintain your target glucose values when you are not eating. Your healthcare professional will calculate this rate for you. Your basal insulin should account for approximately one half of the body’s total daily insulin requirements. Your pump mimics your pancreas by delivering insulin continuously over 24-hours.

You can set your insulin pump to change rates during the day to match your needs. Your needs depend on your lifestyle and insulin requirements. Some people only use one rate throughout the day, while others find they need more. Your basal rates are made up of insulin deliveries that have start and stop times. Once set, these rates make up your 24-hour basal pattern and are repeated daily.

Start and stop times

When you set your basal rate(s) in the BASAL MENU, your pump prompts you to set the start time for each basal delivery. The stop time is the time that one basal rate stops and the next basal rate starts (see figure).

It is recommended that you record your basal rates on paper. The Quick Reference card is provided with your pump for this purpose. For best results, setting or changing your basal rate(s) should be discussed with your healthcare professional.

* For Basal Rate 1, the start time cannot be changed (only the rate

can be changed). Basal Rate 1 always starts at 12 a.m. or 00:00, depending on the time format selected.

■

The start time of one basal rate is the stop time of the previous rate. This gives you continuous basal insulin through a 24-hour period.

■

You cannot set a start time for one basal rate to overlap the next. basal rate. The addition of a new basal rate will erase any basal rates that follow.

Basal rate 2

Basal rate 3

Basal rate 1

(midnight)

12:00 a.m.

00:00

3:00 p.m.

15:00

7:00 a.m.

7:00

(midnight)

*12:00 a.m.

00:00

start #1

stop #1

start #2

stop #2

start #3

stop #3

34 Chapter: 3

Your basal settings

You must program your basal settings before you can deliver basal insulin. Keep a written record of

your basal settings.

It is recommended that you set your basal rates with the assistance of your healthcare professional. If you plan to take off your pump for an extended period of time, i.e. more than a day, set the basal

rate to 0.00 U/H. This will ensure that the insulin delivery records in your pump are accurate. See “If you remove your pump” on page 21 for more information.

Basal programming and delivery

To set your basal rates, do these steps:

NOTE -

You cannot make changes to your basal rate settings while a percent (%) temp basal is active.

1 Go to the BASAL MENU.

Main > Basal

2 Select Set/Edit Basal and press ACT. 3 The SET BASAL RATE 1 screen will

appear. Enter your first basal rate amount and press ACT.

4 The start time for your first basal rate is midnight

(12:00A) and cannot be changed.

5 The screen will change to SET START TIME 2. If

you only need one basal rate for the entire 24hour day (12:00A to 12:00A), do these steps:

a. Press ACT or ESC without setting a start

time.

b. The BASAL RATE screen will appear with

your basal data. Your daily basal rate is now programmed. It will deliver daily from 12:00A to 12:00A.

c. Exit the menus.

(If using patterns, you will first select the basal you want, then the SET BASAL RATE 1 screen will appear.)

BASAL MENU

Set/Edit Temp Basal

Set/Edit Basal

Basal Review

EDIT BASAL

Pattern A Pattern B

0.00U

-.- -U

ACT

Standard

4.40U

rate 1 (flashing) press

to set

SET BASAL RATE 1 12:00A

ACT

(flashing) start time 2 Do not set. Press ACT or ESC.

SET START TIME 2

- -: - -

_._ _

BASAL RATE

Current Rate 0.45U/H

Started #1 - 12:00A 24 HR. Total 10.80U

Basic programming 35

If you need to program more than one basal rate for the day, do these steps:

a. In the SET START TIME 2 screen,

enter the start time for the next rate and press ACT.

b. The SET BASAL RATE 2 screen will

appear. Enter the rate and press

ACT.

c. Repeat steps a and b for each

additional basal rate. Each rate will have a different number (i.e. Basal Rate 1, Rate 2, Rate 3, etc.).

d. After you program your last basal rate, press ESC. e. The BASAL RATE screen will appear. Your basal rate(s) will now

deliver as programmed. Exit the menus.

NOTE -

When you have finished programming your pump you can save your

settings. See “User settings” on page 123 for instructions.

Practice: Basal programming

Make sure you are NOT connected to your pump while practicing.

Set a basal rate of 0.5 unit per hour. Check here if you were able to set the basal rate:

What is the total basal insulin for 24-hours? ______ (answer: 12 units)

start time (flashing)

to set

rate (flashing)

to set

SET START TIME 2

- -: - -

_. _ _

SET BASAL RATE 2

7:30A

_. _ _

ACT

U H

SET START TIME 3

- -: - -

_. _ _

BASAL RATE Current Rate Started #1 24 Hr. Total

0.60U/H 12:00A

14.40U

ESC

U H

36 Chapter: 3

Basal review

Temporary basal information is only available in the STATUS screen.

Current basal delivery

The STATUS screen shows your current basal information.

Daily basal rate(s)

The BASAL REVIEW screen shows your daily basal rates programmed for delivery from midnight to midnight (12:00A to 12:00A). Compare your daily insulin deliveries to your blood glucose records to help you and your healthcare professional identify your optimal daily basal insulin rate(s).

1 Go to the BASAL MENU. Select Basal Review and

press ACT.

Main > Basal

standard

basal is the

current basal

STATUS U100 Last Bolus N 3.8U

9:07A 11 JAN

Basal 1: 0.80 U/H Units Left: 128.0U Battery: Normal Remote: On Tue 11 JAN 2004 S/N #000000 Paradigm 515 Ver X.XX X.X

BASAL MENU Select Patterns Set/Edit Basal

Basal Review

Basic programming 37

3 Exit the menus when you are done.

2 If you do not use patterns:

The delivery details for your standard basal will appear.

If you use patterns:

The screen will show the basal patterns. The current basal pattern will be highlighted. Select the pattern you want to view. Press ACT.

The start time and units for each delivery rate in that pattern will appear.

(24-hour total)

basal insulin from 12:00A

to 12:00A

basal rate

start times

basal

delivery rates

STANDARD

1) 12:00A

2) 11:30A

3) 12:00P

0.60U/H

1.00U/H

0.80U/H

16.80 U

BASAL REVIEW

Standard

Pattern A

Pattern B

16.80 U

24.50 U

19.60 U

ACT

(24-hour total)

basal insulin from

12:00A to 12:00A)

basal rate

start times

basal

delivery rates

PATTERN A

24.50 U

1) 12:00A

2) 10:30A

3) 6:30P

2.20U/H

1.80U/H

2.60U/H

38 Chapter: 3

Max basal rate

Maximum basal rate is a safety limit for the amount of basal insulin that is able to be delivered per hour. This maximum rate will apply to every basal rate that is set, including a temporary basal. It is important to discuss what your max (maximum) basal rate should be with your healthcare professional.

Once your basal rates have been set, you CANNOT set a maximum basal that is less than any of the programmed basal rates or program a basal rate that is greater than your maximum basal rate - this includes patterns and temporary basal rates. Your pump is sent from the factory with the maximum basal rate set to two (2.0) units per hour.

To set your max basal rate, do these steps:

1 Go to the MAX BASAL RATE screen.

The maximum basal rate will be flashing.

Main > Basal > Max Basal Rate

2 Change the rate and press ACT. 3 Your maximum

basal rate is now set. Exit the menus.

Example 1: Max Basal

Helen has a very low insulin requirement. Her highest basal rate is only 0.4 units per hour. As a safety measure, Helen's healthcare professional set her pump with a Maximum Basal Rate of 1.0 units per hour.

Example 2: Max Basal

Rusty needs large amounts of insulin to control his blood glucose levels. His new pump was delivered from the factory with a Maximum Basal Rate of 2.0 units per hour, but he needs 2.8 units per hour in the early morning. Rusty will reprogram his Maximum Basal to 3.0 units per hour to accommodate his needs.

(flashing)

MAX BASAL RATE

U H

MAX BASAL RATE

15.

ACT

U H‘

Basic programming 39

Stopping your pump

You can stop your pump with the suspend function. Suspend stops all insulin delivery including the current basal and any bolus or prime deliveries that are in progress. While suspended, your pump will not deliver insulin until you Resume your pump. When basal is resumed, the pump is taken out of the Suspend mode.

The pump will beep or vibrate about every 15 minutes on the hour to remind you that it is not delivering insulin. Example: You suspend your pump at 11:20AM. The pump will beep/vibrate at 11:30AM, 11:45AM, 12:00PM, and so on until you resume your pump (basal resumes).

NOTE -

When suspended, your pump is in Attention mode (a solid circle). When in Suspend, you can

only resume your basal or view the STATUS screen. No other functions are available.

Do these steps to suspend your pump:

NOTE -

Press

ESC

to view the STATUS screen

and verify your pump is suspended.

1 Select Suspend from

the MAIN MENU, and press ACT.

2 SUSPEND will flash. Press

ACT to stop your pump.

3 The screen will show that the pump

is suspended and the time that it stopped. After a few minutes, the pump will default to the HOME screen with a solid circle.

MAIN MENU

Bolus

Suspend

Basal

ACT

(flashing)

SUSPEND

Press ACT to Stop Pump

ACT

Stopped at 1:05P

SUSPEND

STATUS U100 Suspended at 01:05P Last Bolus N 3.8U

7:58A 22 FEB

40 Chapter: 3

Resume pump delivery

When the pump is suspended, it defaults to the HOME screen with a solid circle. Do these steps to resume your pump and basal delivery:

1. From any screen, press ACT until the RESUME screen appears. Press ACT

again.

2. Your pump will beep once, then the HOME screen will appear (with no circle).

NOTE -

A bolus or fixed prime that was stopped by suspend will

not

restart when you resume your pump. You must reprogram and activate it to finish delivery.

Example: Suspend function

1 Josh has been on a Medtronic MiniMed pump for several months. He is very active in soccer and

basketball. He and his healthcare professional have determined that he does not need his basal insulin during his games, and that he is able to take the pump off for these short amounts of time. Josh uses the “Suspend” feature on his pump to stop the basal insulin during the time that he is disconnected from his pump. He will “Resume” delivery when he reconnects the pump.

2 Helen is ready to eat her lunch. She has just programmed her pump to deliver a meal bolus when

the phone rings. Helen wants to talk on the phone and not eat her lunch right away. She knows that if she lets the bolus continue and she does not eat her lunch soon, she may be at risk for low blood glucose. Helen “Suspends” delivery of her pump to stop the bolus, but then “Resumes” delivery to restart her basal insulin. When she is off the phone and ready to eat, she checks her STATUS screen to see how much insulin she received from the partially delivered bolus before she suspended her pump. She will reprogram a new bolus for the remainder.

Stopped at 1:05P

RESUME

ACT - Restart Basal

ACT

Basic programming 41

Practice: Suspend function

1 Make sure you are NOT connected to your pump while practicing.

Program your pump to deliver a Normal bolus of 3.0 units. Once the bolus begins, stop the bolus by suspending your pump.

Remember, when you stop the bolus delivery with “Suspend,” ALL insulin delivery will stop.

2 Now, “Resume” delivery so that you will continue to receive your basal insulin. 3 Check the STATUS screen. 4 How much insulin did the bolus deliver before you Suspended delivery? _______. 5 If you wanted to take the rest of the bolus later, how much would you take to equal 3.0 units?

_______.

Practice: Resume basal delivery after a suspend

1 Make sure you are NOT connected to your pump while practicing. 2 Give a 3.0 unit bolus now. While it is delivering, suspend the bolus.

Check here if you were able to suspend the bolus.

3 Now restart the pump.

Check here if you were able to restart the pump.

42 Chapter: 3

Starting on insulin 43

Chapter: 4

Starting on insulin

Prepare your pump for use

Before continuing with the steps in this chapter, we recommend that you watch your pump training

CD-ROM and complete your pump start training.

When you are done practicing and ready to use your pump with insulin, you must:

1 Make sure the time and date are correct on your pump, 2 program your settings as instructed by your healthcare professional,

3 install the reservoir, and 4 prime the infusion set.

You will need these items:

➠ Pump ➠ Insulin ➠ Paradigm reservoir ➠ Paradigm reservoir Instructions for Use document (provided with the

reservoir)

➠ Paradigm infusion set

44 Chapter: 4

Filling the reservoir

WARNING: Your pump will not accurately deliver insulin if air bubbles are in the

reservoir or the infusion set. To prevent this, take care to remove air bubbles when filling your reservoir.

1 Remove reservoir from package. Make sure

plunger rod is fully extended.

2 Swab vial with alcohol. 3 Making sure you do not push down on the

plunger, press the transfer guard onto the vial.

4 Push down on the plunger to pressurize the vial.

plunger rod

reservoir

transfer guard

vial

Starting on insulin 45

5 While still holding the

plunger rod, flip the vial over so the vial is up, slowly pull down on the plunger to fill the reservoir.

6 Gently tap the side of the

reservoir to make any air bubbles rise to the top of the reservoir.

7 Slowly push up on the

plunger just enough to remove any air bubbles from the reservoir.

8 Slowly pull down on the

plunger to completely fill the reservoir.

9 While holding the transfer guard, turn the

reservoir counter-clockwise then pull straight up to remove it from the transfer guard.

10 Put the tubing connector on the reservoir. Turn it

clockwise to secure.

“CLICK”

46 Chapter: 4

Changing your infusion set

Removing the reservoir

Each time you remove and replace a reservoir in your pump, you have to rewind and prime your

pump. Priming requires insulin.

11 Tap the side of the

reservoir to remove any air bubbles.

12 To purge air bubbles that have

risen to the top of the reservoir, push up on the plunger until you see insulin in the tubing.

13 Without pulling, turn the

plunger counter-clockwise to remove it from the reservoir.

1 Remove the entire infusion set from your body. 2 If attached, remove the activity guard. 3 Turn the tubing connector 1/2-turn counter

clockwise, then pull the reservoir and connector out from the pump.

4 Safely dispose of the used reservoir and infusion set items. 5 You must now rewind your pump as described in “Rewinding your pump” on page 47.

tubing connector 1/2 turn counter-clockwise

Starting on insulin 47

Rewinding your pump

Before you continue, make sure the pump is NOT connected to your body.

1 If you removed your reservoir and are replacing it, go to the REWIND screen.

Main > Prime > Rewind

2 In the REWIND screen, press ACT to start the

rewind process. The REWINDING screen will appear while the pump rewinds.

3 After the pump rewinds the PREPARING TO PRIME

screen will appear.

NOTE -

If you press ESC or the pump returns to the HOME screen the PRIMING STOPPED screen will appear which guides you back to the priming screens. Once you start a rewind, you cannot cancel it.

If you are practicing, do these steps:

a. Do NOT insert the reservoir in your pump.

Make sure the shipping cap is installed in the reservoir compartment.

b. Continue with the manual prime instructions described in “Manual prime” on page 49.

If you are not practicing, continue to “Inserting the reservoir in your pump” on page 48.

WARNING: Make sure the infusion set is disconnected from your body before you rewind or

prime the pump. Never insert the reservoir into the pump while the tubing is connected to your body. Doing so could result in an accidental infusion of insulin.

Disconnect from Body Press ACT to Rewind

Wait for notification

REWIND

REWINDING

ACT

PRIMING STOPPED

Continue Priming

Rewind Pump

Status Screen

PREPARING TO PRIME Disconnect from Body Insert/Lock Reservoir Hold ACT to Prime

ESC

ACT

time out

(HOME screen)

48 Chapter: 4

Inserting the reservoir in your pump

If your reservoir is already inserted in your pump, continue to “Manual prime” on page 49. You must do these steps in the order described. Your pump screen will show instructions to help you

with these steps. If you are practicing, do NOT insert the reservoir in your pump.

1 If you are using the pump for the first time, remove the shipping cap from the reservoir

compartment.

4 Attach the activity guard, if desired. 5 You must now do a manual prime as described in the next section.

CAUTION: You must rewind your pump before installing a new reservoir. As part of the

pump’s function, it measures the reservoir volume. To ensure correct volume measurements, your pump has been designed to require a rewind before you insert your reservoir.

WARNING: Do not insert the reservoir in the pump if you did not rewind. Doing so could

result in inaccurate insulin delivery. Never insert the reservoir into the pump while the tubing is connected to your

body. Doing so could result in an accidental infusion of insulin.

2 Insert the reservoir into the top of the pump

case.

3 Turn the tubing connector approximately

1/2-turn clockwise until the connector is seated. The tubing connector should be aligned horizontally with the pump case as shown here.

ACT

ESC

tubing connector

Starting on insulin 49

Manual prime

Manual prime fills the infusion set tubing with insulin before you attach it to the infusion site.

Manual prime is only available after you rewind your pump.

1 After you rewind your

pump, the PREPARING TO PRIME screen will appear.

WARNING: Make sure the infusion set is disconnected from your body before you press

ACT to prime the pump. Never insert the reservoir into the pump while the

tubing is connected to your body. Doing so could result in an accidental infusion of insulin.

2 Press and hold ACT to

start the prime. The pump will beep 6 times indicating the prime has started.

3 While you hold ACT, the

pump will beep again 6 times as the screen begins counting the prime units being used.

ATTENTION: If you release the

ACT button:

a. Press ACT. The Manual Prime

screen appears.

b. Press ACT again to continue

the prime sequence (screen shows where you left off), or Press ESC to rewind.

4 Continue to hold ACT until

insulin droplets form on the tip of the infusion set needle, then release. Be sure no bubbles are in the tubing.

PREPARING TO PRIME Disconnect from Body Insert/Lock Reservoir Hold ACT to Prime

The pump may automatically return to the HOME screen while you install the reservoir. Press ACT to return to the PREPARING TO PRIME screen.

ACT

(hold)

PREPARING TO PRIME

DISCONNECT

Hold ACT

ACT

(hold)

PRIMING – HOLD ACT ESC if done

0.3

ACT

(hold)

50 Chapter: 4

5 Press ESC. Your manual prime is complete. 6 You can now insert the infusion set into your body as described in the next section.

Insert the infusion set

After you complete all of the following, you will be ready to insert the infusion set into your body:

➠ fill your reservoir ➠ rewind your pump ➠ and prime the pump (fill the infusion set with insulin)

It is important that you change your infusion set every 2-3 days. Medtronic MiniMed offers a number of different infusion sets for your pump. Instructions for the Quick-set® begin on the next page as an example. Always refer to the instructions that shipped with your infusion set. After your infusion set is inserted, continue to “Fixed prime” on page 55.

WARNING: Your pump will not accurately deliver insulin if there are air bubbles in the

infusion set. Take care to remove any air bubbles during the manual prime.

If your manual prime uses more than 30U insulin, the pump will ask you, “is priming complete?” If you get this message, do these steps:

a. Make sure you are not connected to the pump. b. Read the message on the screen, then press ESC, ACT to clear. a. If your manual prime is complete (you see droplets on the tip of the

infusion set needle), press ESC and continue to step 5. If your manual prime is not complete, press and hold ACT until priming is complete then continue to step 5.

WARNING: While the infusion set is connected to your body, do not unscrew and

retighten the tubing connector on the reservoir.

IS PRIMING

COMPLETE?

Disconnect from body See user guide

for instruction.

ESC, ACT to clear

Starting on insulin 51

Quick-set infusion set (with Quick-serter®)

Always refer to the instructions that shipped with your infusion set.

1 Wash your hands. 2 Clean and dry the infusion site. 3

45 6

52 Chapter: 4

910

Starting on insulin 53

11 12

54 Chapter: 4

Connecting Quick-set

Disconnecting Quick-set

The Quick-set allows you the freedom to temporarily disconnect from your pump without removing the

infusion set from your body.

If you inserted a new reservoir, you should have already done a manual prime. A manual prime is always done to fill the infusion set tubing with insulin after you rewind your pump and insert the reservoir. If you are changing your infusion set without changing your reservoir, do a fixed prime to fill the tubing. See “Fixed prime” on page 55 for instructions.

Place the connector part (flat-side facing down) on the infusion set until it is fully seated. Do not grip the connector part by the flat side-grips.

Squeeze the side grips of the connector part with your fingers.

Remove the connector from the site.

Infusion set connected

Infusion set

Connector part

Side grips

Starting on insulin 55

Fixed prime

A fixed prime fills the soft cannula with insulin and is required after the infusion set is inserted into your body. Additionally, a fixed prime is required if you disconnect your quick release and you need to reprime the infusion set or if you change your infusion set without changing the reservoir.

NOTE -

Prime amounts depend on the type of infusion set you are using. See your infusion set

instructions for your fixed prime amount.

Prime history

Do these steps to see a list of the delivered primes.

1 Go to the PRIME MENU.

Main > Prime

2 Select Fixed Prime and

press ACT.

3 In the FIXED PRIME screen,

enter the amount of insulin for your type of infusion set, then press ACT.

4 Once the prime begins, the PRIME

DELIVERY screen will count up the units as they are delivered. A “beep” will sound when priming is complete.

1 Go to the PRIME MENU.

Main > Prime

2 Select Prime History

and press ACT.

3 The PRIME HI S T O R Y screen

will appear.

4 Scroll through the list of prime

deliveries. The “F” at the end of the text line indicates a fixed prime.

An “M” indicates a manual prime. Exit the menus.

PRIME MENU

Fixed Prime

Rewind Prime History

ACT

FIXED PRIME

ACT

PRIME DELIVERY

6:26P

PRIME MENU

Rewind

Prime History

Fixed Prime

ACT

PRIME HISTORY

01JAN 12:05p 03JAN 01:15p 03JAN 01:17p

22.5M

0.5F

1.2M

M manual prime

F fixed prime

56 Chapter: 4

Record keeping for diabetes management

Now that you are using the pump with insulin, we will be asking you to test your blood glucose regularly. The information from your blood glucose journal is your healthcare professional's only method of making adjustments in your pump settings. It is important to test often and write down your blood glucose readings, the food you eat, any exercise you perform and any other notes to explain your blood glucose results.

You must test at the recommended times and any other time that you feel your blood glucose is high or low. Be sure to include your meal boluses, correction boluses, the amount of carbohydrate you eat, basal rate and any other information that will be helpful in assisting your healthcare professional in adjusting your pump settings.

It is very important to look at your blood glucose readings as feedback regarding your diabetes management, not as statements about you or your self-worth. Try not to have an emotional reaction to the numbers and do not judge them too harshly. You will soon learn how to modify the numbers easily and precisely through insulin pump therapy.

TEST AT LEAST 4-6 TIMES A DAY.

These are the recommended times to test to determine control:

Determining your pump settings

Your healthcare professional will use your daily blood glucose journal records to program your pump. It is very important to keep good records during the first weeks after you start on pump therapy. Not only must you record your blood glucose readings, but it will be important to eat regularly scheduled meals and to keep your activity as consistent as possible.

Until you and your healthcare professional determine the pump settings that will work best for you, it is important to eat meals for which it is easy to count the carbohydrates. After your correct basal rate is determined, you will be able to experiment with varied food choices and amounts.

After you and your healthcare professional are satisfied with your initial pump settings, you may begin to experiment with different food choices, meal times and exercise schedules.

➠ Overnight (occasionally, at approximately 2 - 3 AM) ➠ Pre-breakfast (fasting) ➠ Post-breakfast (approximately 2 hours after eating) ➠ Pre-lunch ➠ Post-lunch (approximately 2 hours after eating)

➠ Pre-dinner ➠ Post-dinner (approximately 2 hours

after eating)

➠ Bedtime ➠ Before driving

Starting on insulin 57

Using your daily journal

To use the daily journal that came with your pump, follow these easy steps:

1 Write the day and date in the spaces provided on the top of the page.

2 Find the time of the entry you are making. Test your blood glucose and enter the value in the space

labeled “blood glucose.”

3 If you are eating at this time, write the grams of carbohydrates in the space labeled

“carbohydrates.”

4 If you are taking a correction and/or meal bolus, record it in the space labeled “meal bolus” and/or

“correction bolus.” Even if you have added these together to take one bolus, write the separate amounts in the corresponding spaces.

5 Record your basal rate in the space labeled “basal rate.” If you have more than one rate, be sure to

record the rate in the space corresponding to the correct time for each rate.

6 When you exercise, write the minutes in the space labeled “exercise.” If you test your urine

ketones, write the result in the space labeled “urine ketones.” Each time you test your ketones, write the result even if it is negative.

7 Record the time you change your infusion set in the space labeled “set change.” This notation will

help you to evaluate any changes in your blood glucose readings due to changing your infusion set.

8 Record the food you eat in the “breakfast,” “lunch,” and “dinner” columns.

9 In the “notes” section, write down any information that may explain your blood glucose values or

diabetes management decisions. Use this section as you would a personal journal.

10 At the end of the journal, there are blood glucose graphs. To draw your blood glucose graph for the

day, find the time you tested and follow the line up until you reach the corresponding blood glucose on the left. Once you find it, mark a dot on the graph that corresponds to the correct time and blood glucose value. At the end of the day, connect the marks and draw your graph. This graph will be helpful in looking at patterns in your blood glucose values from day to day.

58 Chapter: 4

Using the Bolus Wizard feature 59

Chapter: 5

Using the Bolus Wizard feature

What is it?

A feature that calculates an estimated bolus:

Information you need

Food entry

You need to know how many exchanges or grams of carbohydrates you are going to eat. (You need to

know what foods contain carbohydrate and understand carbohydrate counting.)

Your blood glucose (BG) reading

You need to know your blood glucose levels. When using the Bolus Wizard feature, the pump can work with the Paradigm Link Blood Glucose Monitor Powered by BD Logic Technology (Paradigm Link meter) to automatically receive your blood glucose readings. The section “Meter option” on page 73 has more information. If you are not using this meter, you will manually enter your blood glucose levels.

Your personal Bolus Wizard feature settings

In addition to your blood glucose readings and/or your food entry, the Bolus Wizard feature uses personal settings that you program into the pump. (See “How to program the Bolus Wizard feature” on page 66 for instructions.)

➠ to support your food intake AND/OR ➠ to correct high blood glucose

➠ carb units (grams or exchanges) ➠ carb (food) ratios (in carbohydrate grams/unit of

insulin or insulin units/carb exchanges)

➠ BG units (mg/dL or mmol/L) ➠ insulin sensitivity ➠ blood glucose target range ➠ active insulin time (hours)

Blood glucose (BG) readings

Paradigm Link

Meter

60 Chapter: 5

Get this information from your healthcare professional, and, for best results, talk to your healthcare

professional before making any changes. Keep a record of your settings in the “Bolus Wizard feature settings table,” on this page and the next page.

Bolus Wizard feature settings

Information Setting

Carb un i t s : _____ grams or ____ exchanges Carb ratios:

Bolus Wizard feature uses this for your food bolus calculations.

If you count carbs:

This ratio is the amount of carbohydrate grams covered by one (1) unit of insulin.

range: 3 – 150 grams per unit If you count exchanges:

This ratio is the amount of insulin you need to cover one (carb) exchange.

range: 0.1 – 5.0 units per exchange

NOTE -

Your carb ratios may vary throughout the day. Your pump allows you to program up to eight (8) different carb ratios.

start time

#1: _________ (midnight) #2: _________ #3: _________

(additional settings, if needed)

#4: _________

#5: _________ #6: _________ #7: _________

#8: _________

BG units: (how you measure your blood glucose) _____ mg/dL or _____ mmol/L

Insulin sensitivity:

This ratio is used for your correction bolus calculations. This ratio is the BG units reduced by 1.0 units of insulin.

range: (mg/dL) 10 - 400

(mmol/L) 0.5 - 22.2

NOTE -

Your insulin sensitivity may vary throughout the day. Your pump allows you to program up to eight (8) different insulin sensitivities.

BG units reduced / 1

unit of insulin

start time

#1: _________ (midnight) #2: _________ #3: _________

(additional settings, if needed)

#4: _________ #5: _________ #6: _________

Using the Bolus Wizard feature 61

BG target range:

If your current BG is above the BG Target Range, the Bolus Wizard feature will calculate a correction dose. If your current BG is below the BG Target Range, the Bolus Wizard feature will calculate a negative correction and subtract it from your food bolus.

range: (mg/dL) 60 - 250

(mmol/L) 3.3 - 13.9

#1: ____-_____ (midnight) #2: ____-_____ #3: ____-_____

(additional settings, if needed)

#4: ____-_____

NOTE -

Your pump will allow you to program up to eight

(8) different BG target ranges.

#5: ____-_____ #6: ____-_____ #7: ____-_____ #8: ____-_____

Active insulin time:

The Bolus Wizard feature uses this time to calculate the active insulin in your system (see “About active insulin” on page 64). Use your healthcare professional’s recommendation for the active insulin time that best represents the insulin type you use and your physiological insulin absorption rate.

range: 2 – 8 hours

Number of Ho u r s : _________

Bolus Wizard feature settings

Information Setting

62 Chapter: 5

How the Bolus Wizard feature works

If you are going to eat and you want the Bolus Wizard feature to estimate your food bolus:

1 Enter your blood glucose reading.

➠ automatically from the Paradigm Link meter

efer to “Meter option” on page 73)

➠ manually by selecting the button.

2 Enter your food amount in carbs or exchanges. 3 The Bolus Wizard feature will calculate an estimated food bolus for you. An ESTIMATE DETAILS

screen will appear with your estimated total food bolus amount.

NOTE -

If you are using the Paradigm Link meter, you can program your pump to automatically receive your meter readings. The Bolus Wizard feature will use the blood glucose readings when calculating your bolus amount. See “Meter option” on page 73 for instructions. If you are not using this meter, you will manually enter your blood glucose levels.

Using the Bolus Wizard feature 63

More about the Bolus Wizard feature

About high or low blood glucose levels

If your blood glucose is less than 60 mg/dL (3.3 mmol/L), or more than 250 mg/dL (13.9 mmol/L), the Bolus Wizard screen will notify you and give you instructions. Read the instructions and press ACT or ESC to clear the message. You can continue programming and deliver your bolus.

About maximum delivery

The Bolus Wizard feature will not deliver more than the limit set for your maximum bolus. If the Bolus Wizard feature calculates a bolus amount that is larger than your max bolus limit setting, the message, “MAX BOLUS EXCEEDED” will appear. If this happens, do these steps:

1 In the MAX BOLUS EXCEEDED screen, press ACT to continue your

bolus programming. The estimate and maximum bolus amounts

will appear for your information. Continue to step 2.

If you do not want to continue, press ESC to cancel and the screen

will return to the ENTER BG screen.

2 In the EST: MAX screen, press ACT again to continue your bolus

programming. If desired, press ESC to cancel and the screen will

return to the ENTER BG screen.

NOTE -

Your pump will only deliver up to your maximum bolus limit setting. For example: The Bolus Wizard feature estimate is 30 units and your max bolus limit is 25 units. When you press ACT, your pump will only deliver 25 units, and will notify you that your bolus estimate exceeds your max bolus.

LOW BG DO NOT BOLUS UNTIL BG IS NORMAL. Treat low BG.

Monitor BG.

HIGH BG Check for occlusion Check ketones. Consider insulin injection. Monitor BG.

ACT or ESC

- - -

MAX BOLUS

EXCEEDED

ACT

ESC

to cancel

EST: 30.0U MAX: 25.0U

ENTER BG

mg/dL*

*or mmol/L

64 Chapter: 5

About active insulin

Active insulin is the bolus insulin that has already been delivered to your body, but has not yet been used. The Bolus Wizard feature considers your active insulin time setting in determining any active insulin still in your body from prior boluses. This may help prevent hypoglycemia caused by over correcting for high blood glucose.

The Bolus Wizard feature automatically tracks active insulin for you, based on your active insulin time, and subtracts the appropriate amount when your blood glucose is above your target range. The details will appear in the ESTIMATE DETAILS screen during the bolus programming steps.

Your Paradigm pump is shipped from the factory with an active insulin time setting of six hours, which most closely matches the published scientific data. If your healthcare professional prescribes a different time for you, the active insulin time setting can be adjusted in one-hour increments from two to eight hours.

You can always choose to override the suggested Bolus Wizard feature estimate and manually enter a different amount.

(values shown are

for example only)

If there is no active insulin, this will show “N/A”

ESTIMATE DETAILS

Est total: Food intake: (Meter) BG: Food: Correction: Active Ins:

ACT to proceed, ESC to back up

4.0U 45gr

160

3.0U

2.0U

1.0U

Using the Bolus Wizard feature 65

For more details about active insulin, see “Bolus Wizard feature specifications” on page 150.

CAUTION: The Bolus Wizard feature cannot correctly determine the active insulin in

your system after you have taken a manual injection of insulin. The manual injection will not be recorded by the pump so your active insulin amount will be read as too little. Usually, you must wait at least 8 hours after an injection before using on your Bolus Wizard feature to calculate your active insulin. The actual length of time you need to wait depends on your active insulin setting in the Bolus Wizard feature. See “About active insulin” on page 64 for more information.

Active Insulin Curve

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0123456789

Time (hours)

% Insulin Remaining

8 Hour 7 Hour 6 Hour 5 Hour 4 Hour 3 Hour 2 Hour

Graph adapted from Mudaliar and colleagues, Diabetes Care, Volume 22, Number 9 September 1999, page 1501

66 Chapter: 5

How to program the Bolus Wizard feature

You need your personal settings from the Bolus Wizard feature settings table to setup the Bolus Wizard feature. Your Bolus Wizard feature settings are programmed in the EDIT SETTINGS screen.

Main > Bolus > Bolus Wizard Setup > Edit Settings

Once the settings are programmed, you do not have to program them again unless the values change. After you program one setting, the screen will automatically go to the next required setting. After you program all your settings, review them as described in this section to make sure they are set correctly.

Instructions for programming the Bolus Wizard feature settings are given below. Program your settings in the order described to make sure you program all the settings.

Bolus Wizard feature on/off

1 Go to the EDIT SETTINGS screen.

Bolus > Bolus Wizard Setup >

Edit Settings

Select

Wizard

and press

ACT

3 Select On or Off and

press ACT.

4 The EDIT SETTINGS

screen will appear. Press ACT to program your settings.

- - -

EDIT SETTINGS

Wizard

Off

Carb Units: BG Units:

ACT

WIZARD ON/OFF Off

ACT

- - -

EDIT SETTINGS

Wizard:

Carb Units:

BG Units:

ACT

Using the Bolus Wizard feature 67

Carb units

The carb unit setting lets the pump know which way to count your carbohydrates (grams or

exchanges). See the “Bolus Wizard feature settings” table on page 60 for your carb ratio settings.

NOTE -

Any time you make changes to the carb units, you must also reprogram the carb ratios.

Carb/Exch ratios

If you use grams as your carb units: Carb ratio is the number of carb grams that are covered by one

unit of insulin.

If you use exchanges as your carb units: Carb ratio is the number of insulin units that are needed to

cover one (1.0) carb exchange.

Because this ratio may vary throughout the day, your pump allows you to set up to eight (8) settings. Your healthcare professional may only have you program one or two carb ratios when you first start using the Bolus Wizard feature.

4 In the EDIT SETTINGS screen, select Carb Ratios and

press ACT.

5 The screen will change to SET CARB RATIO 1 (if you

are using grams) or SET EXCH RATIO 1 (if using

exchanges).

Set your first ratio and press ACT. (The start time for

your first ratio is midnight (12:00A) and cannot be

changed.)

1 In the EDIT SETTINGS

screen, select Carb Units and press ACT.

2 Select Grams or

Exchanges and press ACT.

3 The screen will return to

the EDIT SETTINGS screen so you can set your carb ratios next.

Carb Units:

- - -

EDIT SETTINGS

Wizard:

Carb Units:

BG Units:

CARB UNITS

Grams

Exchanges

- - -

EDIT SETTINGS

Wizard:

Carb Units:

grams

Carb Ratios:

- - -

(flashing) set, then press ACT

using grams

using exchanges

- - -

EDIT SETTINGS

Wizard:

Carb Units:

grams

Carb Ratios:

- - -

EDIT SETTINGS

Wizard:

Carb Units:

exch

Carb Ratios:

ACT

SET CARB RATIO 1

12:00A

grams

SET EXCH RATIO 1

12:00A

1.0

U/exch

68 Chapter: 5

6 The screen will return to the EDIT SETTINGS

screen. Set your BG Units as described in the “BG (blood glucose) units” on page 69.

NOTE -

Carb ratio values are normally between 5–50 grams/u or

0.3–3.0 u/exch. If your ratio value is outside the range, this warning message will appear on the screen.

Press ESC to correct or ACT to continue.

To set just one ratio: To set more than one carb ratio:

a. Press ESC. a. Set the start

time for the next ratio and press

ACT.

b. Set the value for

the next ratio and press ACT.

c. Repeat steps a

and b to set more ratios.

d. Press ESC when

you are done.

WARNING A carb ratio of XX

is valid but outside the usual range of 5-50.* ESC to correct,

ACT to continue

(* 0.3 - 3.0 for exch)

_: _

(flashing)

using grams

(flashing)

using exchanges

SET START TIME 2

grams

_: _

SET START TIME 2

U/exch

(flashing) set then press ACT

using grams using exchanges

* Depending on how many ratios you set,

this number can be 2 through 8.

_: _

SET START TIME 2

grams

_: _

SET START TIME 2

U/exch

7:00A

SET CARB RATIO 2*

grams

7:00A

SET EXCH RATIO 2*

U/exch

- >

EDIT SETTINGS

Wizard:

Carb Units:

grams

Carb Ratios:

Using the Bolus Wizard feature 69

BG (blood glucose) units

You can select mg/dL or mmol/L as your BG units (unit of measurement type).

NOTE -

If you make changes to your BG units setting, you must reprogram your insulin sensitivity

and BG targets.

Insulin sensitivity

Your insulin sensitivity is the amount your blood glucose level is reduced by one unit of insulin. This value (amount) is used to calculate a suggested bolus insulin dose to correct your blood glucose level when it is above your target range. Correcting your blood glucose brings it down to your target range. Since insulin sensitivity amount can change throughout the day, your pump lets you enter up to eight (8) different insulin sensitivity settings. Your healthcare professional may have you enter only one or two insulin sensitivity settings when you first start using the Bolus Wizard feature. Record your settings in the “Bolus Wizard feature settings” table (see page 60).

Insulin sensitivity amounts are normally between 20 – 100 mg/dL (or 1.1 – 5.6 mmol/L). If your amount is outside this range, a warning message will appear on the screen.

1 In the EDIT SETTINGS screen, select Sensitivity and

press ACT.

2 Enter the amount for the first insulin sensitivity

setting and press ACT.

NOTE -

The start time for your first insulin sensitivity is midnight (12:00A) and cannot be changed.

7 In the EDIT SETTINGS

screen, select BG Units and press ACT.

8 Select mg/dL or

mmol/L and press ACT.

9 The screen will return to the

EDIT SETTINGS screen to set your insulin sensitivity next.

EDIT SETTINGS Carb Units:grams Carb Ratios:- >

BG Units:- - -

BLOOD GLUCOSE UNITS

mg/dL

mmol/L

- - -

EDIT SETTINGS

Sensitivity:

BG Target: Active Ins Time:

--->

- - -

(flashing) set, then press

ACT

_ _

EDIT SETTINGS

Carb Ratios: BG Units: mg/dL

Sensitivity:

INS SENSITIVITY 1 12:00A

mg/dL

per unit insulin

ACT

70 Chapter: 5

3 The SET START TIME 2 screen will appear.

5 The screen will return to the EDIT SETTINGS screen. You can now program your BG target(s).

BG (blood glucose) target range

The BG target range setting allows you to set your blood glucose target range. Because your target may vary throughout the day, your pump allows you to set up to eight (8) BG targets each day. If you want to set just one target value, instead of a range, set both the low and high values to the same number.

If your current blood glucose level is above your BG target range, the Bolus Wizard feature will calculate a correction dose. If your current blood glucose level is below the BG target range, the Bolus Wizard feature will calculate a negative correction and subtract it from your food bolus.

4 To set just one insulin sensitivity:

To set more than one insulin sensitivity:

Press ESC.

a. Set the start time for

the next insulin sensitivity and press

ACT.

b. Set the value for the

next insulin sensitivity and press ACT.

c. Repeat steps a and b

to set more values.

d. Press ESC when you

are done.

(flashing)

SET START TIME 2

mg/dL

per unit insulin

_ _ _

_: _

(flashing) set, then press ACT

SET START TIME 2* 7:30A

mg/dL

per unit insulin

_ _ _

(flashing) set, then press ACT

* Depending on how many

values you set, this number can be 2 through 8.

INS SENSITIVITY 2* 7:30A

mg/dL

per unit insulin

Correct up to the lower limit (mg/dL) 70 (mmol/L) 3.8

Correct down to upper limit (mg/dL) 100 (mmol/L) 5.5

22.2

13.9

5.5

3.8

(mmol/L)

400

250

100

(mg/dL)

Target Range

Using the Bolus Wizard feature 71

NOTE -

Pumps are sent from the factory with a BG target range of 90-140 mg/dL (5.0-7.8 mmol/L). If you adjust your BG targets outside of 90-140 mg/dL (5.0-7.8 mmol/L), the pump screen displays a warning that the values are acceptable but outside the normal range.

1 In the EDIT SETTINGS screen, select BG

Target and press ACT.

2 Enter the low end of your BG target range

and press ACT. Then enter the high end of your BG target range and press ACT.

NOTE -

The start time for your first BG target range is midnight (12:00A or 00:00) and cannot

be changed.

3 The screen will display one of these messages: 4 To set just one BG Target:

To set more than one BG Target:

a. Press ESC. a. Set the start time

for the next BG target range and press ACT.

b. Set the low and high

values for the next BG target range and press ACT.

c. Repeat steps a and b

to set more BG target ranges.

d. Press ESC when you

are done.

- - -

first BG Target Range (flashing)

mg/dL

100 - 100

EDIT SETTINGS

BG Units:

mg/dL

Sensitivity:

BG Target:

ACT

TARGET RANGE 1 12:00A

_: _

(flashing) press ESC

_ - _

SET START TIME 2

mg/dL

_: _

(flashing) set, then press

ACT

- - -

SET START TIME 2*

7:30A

(flashing) set, then press

ACT

* Depending on how many

targets you set, this number can be 2 through 8.

mg/dL

100 - 100

TARGET RANGE 2*

72 Chapter: 5

Active insulin time

The active insulin time setting lets the pump know which active insulin time to use in calculating the amount of active insulin to subtract before estimating a bolus. See “About active insulin” on page 64 for more information about this setting.

Your healthcare professional should determine the active insulin time that is best for you. To set the time, take the following steps:

MESSAGE What it means

➠ “Bolus Wizard setup is complete” ...Bolus Wizard feature is on and all settings are programmed.

➠ “Bolus Wizard is off”...................Bolus Wizard feature is off.

➠ “Missing Info” ...........................Bolus Wizard feature is on, but some of the settings are not

programmed. This screen will show instructions and the missing

information. You must program the missing information before you can

use the Bolus Wizard feature.

1 In the EDIT

SETTINGS screen, select Active Ins

Time

and press

ACT.

2 Set the number of hours for the

active insulin time and press

ACT.

3 The screen will return to

the EDIT SETTINGS screen where you can see the new setting.

- - -

EDIT SETTINGS

Sensitivity BG Target:

Active Ins Time:

(flashing) set, then pres

ACT

ACTIVE INS TIME

EDIT SETTINGS

Sensitivity

BG Target:

Active Ins Time:

Using the Bolus Wizard feature 73

Review your Bolus Wizard feature settings

Check your Bolus Wizard feature settings in the REVIEW SETTINGS screen. If necessary, compare this

information with your information in the Bolus Wizard feature settings table.

Bolus > Wizard Setup > Review Settings

1 In the REVIEW SETTINGS screen, scroll through the text

to view your Bolus Wizard settings.

2 Exit the menus when you are done.

Meter option

You can set up your pump to automatically receive your blood glucose readings from the Paradigm Link meter. This meter may not be available in all countries. Check with your local Medtronic MiniMed representative. Your pump is set at the factory with the meter option turned off. Programming your Paradigm Link meter ID, links your pump to the meter. If you do not “link” the meter to your pump, you will enter your blood glucose readings manually. Each Paradigm Link meter has its own unique ID. You can link up to three (3) meters to your pump.

When the pump is idle (at the HOME screen), it will beep or vibrate when it receives a blood glucose reading from the Paradigm Link meter. The reading will appear on the pump screen.

NOTE -

The use of RF (radio frequency) devices with the pump reduces pump battery life.

You have to turn on the meter option to add, delete or review the meter ID(s) programmed in your pump. The meter ID is the serial number printed on the back of the Paradigm Link meter. See the User Guide that came with your Paradigm Link meter for detailed information on how to use it.

ACT

WIZARD SETUP

Edit Settings

Review Settings

REVIEW SETTINGS Wizard

Carb Units:

grams

Carb Ratios:

12:00A

6:00A

15 10

BG Units:

mg/dL

Sensitivity:

12:00A

6:00A

BG Target:

12:00A

90-120

6:00A

100-140

Active Ins Time:

Blood glucose

(BG) Readings

Pump

Paradigm Link

meter

74 Chapter: 5

Meter rules

If you want your pump to communicate with the Paradigm Link meter, the following conditions must

apply:

1 The meter option must be turned on and programmed. See “Meter option” on page 73 for

instructions.

2 Your pump must be within 4 feet (1.22 meters) of your Paradigm Link meter to receive blood glucose

readings.

3 The pump cannot have a LOW BATTERY alert condition. 4 When programming a bolus, the blood glucose measurement from the Paradigm Link meter will

appear as the default blood glucose value in the ENTER BG screen. The pump will not display a reading that is older than 12 minutes on the ENTER BG screen.

5 Make sure the pump’s Meter Option is set to “Off” while onboard aircraft. 6 Do not use the RF meter to send your blood glucose readings to the pump while onboard aircraft.

Manually enter your BG.

Add, delete, review meter IDs

The meter programming screens are very similar to those for the remote control. Make sure to

select “Meter Options” (in the UTILITIES MENU) when programming your Paradigm Link meter.

If you are not sure that your Paradigm Link meter ID is entered in your pump, check the REVIEW

METER ID screen.

You have to turn on the meter option to add, delete or review the Paradigm Link meter ID(s)

programmed in your pump.

Main > Utilities > Meter Options

1 In the METER OPTION screen, select On and

press ACT. The METER ID MENU will appear.

CAUTION: The pump will not receive signals from the Paradigm Link mete r while it has a “Low

Battery” condition. To ensure the meter communicates with the pump, make sure the pump does not have a low battery. (Replacing the low battery with a new battery will restore meter-pump communication.)

METER OPTION Off

ACT

METER ID MENU

Add ID

Delete ID Review ID

Using the Bolus Wizard feature 75

2 Add, delete or review your meter ID(s) as desired.

3 Exit the menus when your are done.

Add Delete Review

a. Select Add ID and press

ACT.

b. Use the up and down

arrow buttons to enter each of the six ID numbers. Press ACT after each entry.

c. After you set the last

number of the ID, the screen will return to the METER ID MENU.

a. Select Delete ID and press

ACT.

b. Select the meter ID that you

want to delete and press

ACT.

c. The selected ID is now

deleted.

a. Select Review ID and

press ACT.

b. The programmed IDs will

show in the REVIEW METER ID screen.

- - - - - -

(flashing)

ADD METER ID

METER ID MENU

Add ID

Delete ID Review ID

DELETE METER ID

1 111111

2 222222 3 - - - - - -

DELETE METER ID

1 - - - - - -

3 - - - - - -

2 222222

REVIEW METER ID

1 - - - - - -

2 222222 3 - - - - - -

76 Chapter: 5

Normal bolus using Bolus Wizard feature

After the Bolus Wizard feature is turned on and programmed, this feature can calculate an estimate of insulin you need for your correction bolus and/or your food bolus. You have the option of using the estimate or changing it as necessary. Additionally, your pump can receive your blood glucose readings from the Paradigm Link meter, if they are linked.

Use to deliver a normal bolus at any time except during another Normal bolus. A normal bolus will temporarily interrupt a Square Wave or Dual Wave bolus that is delivering. After the normal bolus is

finished, the Square Wave or Dual Wave bolus delivery will resume.

NOTE -

If you want to use the pump-to-meter link, make sure the meter option is on. See “Meter

option” on page 73 for instructions.

1 If you want a correction bolus, check your blood glucose with your BG meter and go to step 2. If you

want to bolus for food, go to step 2.

2 Press on your pump, or go to the BOLUS MENU, select Use Bolus Wizard, and press ACT. 3 The ENTER BG screen will appear.

If you are NOT using the Paradigm Link meter: If you are using the Paradigm Link meter:

Enter your BG value. Press ACT and continue to step 4.

If you are not entering a BG and want to bolus for food, select the dashes in the ENTER BG screen. Press ACT and continue to step 4.

NOTE -

Selecting dashes in this screen will make the Bolus Wizard feature calculate the insulin needed for your food entry without considering your blood glucose level.

The meter reading will flash on the pump screen. Press ACT to accept this amount. (You can change this BG value, if necessary.) Continue to step 4.

NOTE -

You must program your bolus within 12 minutes of the pump receiving the reading from the meter. If more than 12 minutes have passed, the reading will no longer be available from the screen and you must enter your blood glucose manually.

- - -

ENTER BG

mg/dL*

* or

mmol/L

XXX

* or

mmol/L

ENTER BG

meter

mg/dL*

Using the Bolus Wizard feature 77

5 Review the information in the ESTIMATE DETAILS screen.

Press ACT to continue to step 6. If you need to make any changes, press ESC to return to the ENTER BG screen (step 3) and make changes as necessary.

6 In the SET BOLUS screen, the estimated bolus amount

shows (flashing). Change the amount if desired. Press ACT to accept and start delivery of the bolus.

NOTE -

If you have BG Reminder turned On, a screen displays allowing you to accept or modify the length of time after this bolus before you are reminded to check your BG. See “BG reminder” on page 32 for information about this feature.

7 The BOLUS DELIVERY screen appears. The pump will beep

or vibrate at the start and end of the bolus. As the bolus is delivered, the screen shows the bolus type and amount until the total units have been delivered. The screen then defaults to the HOME screen.

4 In the ENTER FOOD screen, if this is a food bolus: if this is a correction bolus:

enter the food value you will eat and press ACT.

select 0 (zero) as the value and press ACT.

(flashing)

ENTER FOOD

grams*

* or exch

(flashing)

ENTER FOOD

grams*

* or exch

(values shown are

for example only)

ESTIMATE DETAILS

Est total:

4.0U

Food intake:

45gr

(Meter) BG:

160

Food:

3.0U

Correction:

2.0U

Active Ins:

1.0U ACT to proceed, ESC to back up

ESC

returns to the

ENTER BG screen

ACT

to continue

SET BOLUS Estimate

4.0

ACT

to accept

BOLUS DELIVERY

3:24P

NORMAL

78 Chapter: 5

Bolus Wizard feature examples

For the scenarios that follow, Michael has his Bolus Wizard feature turned on with the following settings:

➠ Carb ratio: 15 grams per unit of insulin ➠ Insulin Sensitivity: 40 mg/dL (2.2 mmol/L) per unit of insulin ➠ BG Target: 90-120 mg/dL (5.0 - 6.7 mmol/L) ➠ Active Insulin Time: 6 hours

NOTE -

If you want to see details of the formulas the Bolus Wizard feature uses to calculate estimate boluses like the ones in the following examples, see “Bolus Wizard feature specifications” on page 150.

Example 1: Blood glucose within target range and no active insulin

Michael awakens in the morning before school and his mother has breakfast waiting for him. Before he begins eating, he tests his blood glucose with his Paradigm Link meter and his blood glucose reading of 120 mg/dl (6.7 mmol/L) is automatically sent to his pump.

He estimates that his meal consists of 60 grams of carbohydrates. When prompted by the Bolus Wizard feature, he enters this amount in the ENTER FOOD screen. Based on his Bolus Wizard feature settings, the pump will suggest that he take 4.0 units of insulin.

(food estimate)

60g

15g/u

= 4 units

(correction)

Correction is 0 because the current blood glucose reading is within his BG Target Range

= 4 + 0 = 4 units

estimate = 4 units

Paradigm 515, 715 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual