Energizer 515 User guide

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Energizer 515 User guide | Manualzz

Paradigm ®

515 and 715 Infusion Pumps

User Guide

© 2005, Medtronic MiniMed. All rights reserved.

This product is covered by U.S. Patent Nos. 6,551,276 and 6,554,798. Other U.S. and/or foreign patents may be pending.

Paradigm ® , Quick-serter ® , Quick-set ® , Silhouette ® , and Sof-set ® , are registered trademarks of Medtronic MiniMed.

CareLink™, Bolus Wizard™, Dual Wave™, Easy Bolus™, Paradigm Link™, ParadigmPAL™, and Square Wave™ are trademarks of

Medtronic MiniMed.

BD Logic™ is a trademarks of Becton, 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

Glossary .............................................................. xvii

Your personal information .......................................... xxiii

Basal rate ............................................................................................... xxiii

Carb ratios (meal bolus information) ............................................................. xxiv

Chapter 1 Introduction .................................................1

Availability ................................................................................................. 1

Assistance .................................................................................................. 1

Emergency kit ............................................................................................. 2

Disposables ................................................................................................. 3

Accessories ................................................................................................. 3

Download pump and meter data ...................................................................... 4

ParadigmPAL ............................................................................................... 5

How to wear your pump ................................................................................. 5

How to use this guide .................................................................................... 6

User safety ................................................................................................. 7

Indications ............................................................................................. 7

Contraindications ..................................................................................... 7

Warnings ............................................................................................... 7

Reservoir and infusion sets ...................................................................... 7

X-rays, MRIs and CT scans ........................................................................ 7

Precautions ............................................................................................ 8

Avoid extreme temperatures .................................................................... 8

Infusion sets and sites ............................................................................ 8

Notice ....................................................................................................... 9

Insulin pump and RF accessories ................................................................... 9

Chapter 2 The basics ................................................ 11

Your pump ............................................................................................... 11

Install battery ........................................................................................... 12

Pump buttons ............................................................................................ 14

The pump screen ....................................................................................... 15

Contents v

HOME screen ............................................................................................. 15

Screen icons ..........................................................................................15

Battery .............................................................................................15

Time display .......................................................................................16

Reservoir volume .................................................................................16

Alert and alarm icons ............................................................................16

Scroll bar ..............................................................................................16

Screen backlight .....................................................................................17

Beep/vibrate ............................................................................................. 17

Operating modes ........................................................................................ 17

Menus ..................................................................................................... 19

STATUS screen .......................................................................................... 20

If you remove your pump ............................................................................. 21

Pump settings ........................................................................................21

Insulin ..................................................................................................21

Chapter 3 Basic programming ........................................ 23

Setting the time and date ............................................................................. 23

Bolus insulin delivery types .......................................................................... 24

Normal bolus .........................................................................................24

Review your bolus deliveries ......................................................................... 29

Bolus details ..........................................................................................30

Maximum bolus limit ................................................................................... 31

BG reminder ............................................................................................. 32

Basal ....................................................................................................... 33

Start and stop times .................................................................................33

Your basal settings ..................................................................................34

Basal programming and delivery ..................................................................34

Basal review ..........................................................................................36

Current basal delivery ...........................................................................36

Daily basal rate(s) ................................................................................36

Max basal rate ........................................................................................... 38

Stopping your pump .................................................................................... 39

Resume pump delivery ................................................................................ 40

vi Contents

Chapter 4 Starting on insulin ........................................ 43

Prepare your pump for use ........................................................................... 43

Filling the reservoir .................................................................................... 44

Changing your infusion set ............................................................................ 46

Removing the reservoir .............................................................................46

Rewinding your pump ...............................................................................47

Inserting the reservoir in your pump .............................................................48

Manual prime .........................................................................................49

Insert the infusion set ...............................................................................50

Quick-set infusion set (with Quick-serter®) .................................................51

Connecting Quick-set .......................................................................54

Disconnecting Quick-set ...................................................................54

Fixed prime ...........................................................................................55

Prime history ............................................................................................ 55

Record keeping for diabetes management ........................................................ 56

Determining your pump settings .................................................................... 56

Using your daily journal ............................................................................... 57

Chapter 5 Using the Bolus Wizard feature ......................... 59

What is it? ................................................................................................ 59

Information you need .................................................................................. 59

Food entry ............................................................................................59

Your blood glucose (BG) reading ..................................................................59

Your personal Bolus Wizard feature settings ....................................................59

How the Bolus Wizard feature works ............................................................... 62

More about the Bolus Wizard feature ............................................................63

About high or low blood glucose levels .......................................................63

About maximum delivery .......................................................................63

About active insulin ..............................................................................64

How to program the Bolus Wizard feature ........................................................ 66

Bolus Wizard feature on/off .......................................................................66

Carb units .............................................................................................67

Carb/Exch ratios .....................................................................................67

BG (blood glucose) units ............................................................................69

Insulin sensitivity ....................................................................................69

BG (blood glucose) target range ...................................................................70

Active insulin time ...................................................................................72

Contents vii

Review your Bolus Wizard feature settings ....................................................... 73

Meter option ............................................................................................. 73

Meter rules ............................................................................................74

Add, delete, review meter IDs .....................................................................74

Normal bolus using Bolus Wizard feature .......................................................... 76

Bolus Wizard feature examples ...................................................................... 78

Chapter 6 Optimizing pump therapy ................................. 83

Square Wave and Dual Wave boluses ............................................................... 83

Dual/Square Wave bolus on-off ...................................................................84

Square Wave or Dual Wave bolus without Bolus Wizard feature .............................84

Using the Bolus Wizard feature for a Square Wave or Dual Wave bolus .....................89

Easy bolus ................................................................................................ 91

Easy bolus setup .....................................................................................91

Step value setup ..................................................................................92

Delivering an Easy bolus ............................................................................92

Basal patterns ........................................................................................... 95

Patterns on/off ......................................................................................95

Program a pattern ...................................................................................96

Select a pattern ......................................................................................97

Temp (temporary) basal rates ....................................................................... 99

How does temp basal work? ........................................................................99

Temp basal types .................................................................................. 100

Insulin rate ...................................................................................... 100

Percent of basal ................................................................................ 101

Selecting temp basal type ........................................................................ 103

Delivering a temp basal ........................................................................... 103

Verifying temp basal delivery .................................................................... 104

Canceling a temp basal ........................................................................... 105

Chapter 7 Insulin pump therapy follow-up ......................... 107

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

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

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

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

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

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

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

viii Contents

Chapter 8 Utilities .................................................. 109

Alarm review ...........................................................................................109

Alarm details ....................................................................................... 109

Setting your alert type ...............................................................................109

Auto-off ..................................................................................................110

Low resv alert (Low reservoir warning) ...........................................................110

Review daily insulin totals ...........................................................................112

Pump data management .......................................................................... 113

Days to average ................................................................................. 115

Personal reminders ....................................................................................116

Alarm clock ......................................................................................... 116

Remote control option ................................................................................117

Turn on remote control option .................................................................. 118

Add, delete, review remote control IDs ....................................................... 118

Block feature ...........................................................................................119

Turn block on ....................................................................................... 119

Lock keypad feature ..................................................................................121

To lock keypad ..................................................................................... 121

To unlock keypad .................................................................................. 121

Selftest ...................................................................................................121

User settings ............................................................................................123

Saving pump settings .............................................................................. 123

Restoring pump settings .......................................................................... 124

Clear settings ....................................................................................... 125

History ............................................................................................... 126

Language setting .......................................................................................127

Chapter 9 Troubleshooting .......................................... 129

My pump has a no delivery alarm... ............................................................ 129

What happens if I leave the battery out too long? ........................................... 130

Why doesn’t my pump battery last very long? ................................................ 130

What is a CHECK SETTINGS alarm? .............................................................. 130

My screen appears distorted ..................................................................... 131

I cannot get out of the priming loop ............................................................ 131

The pump is asking me to rewind ............................................................... 131

My bolus stopped .................................................................................. 132

My pump buttons are not acting right during a bolus ........................................ 132

My pump won’t display my blood glucose reading from my meter ........................ 132

Contents ix

I dropped my pump ................................................................................ 133

I submerged my pump in water .................................................................. 133

I cannot get to the User Settings menu ........................................................ 134

Alert conditions ........................................................................................134

What to do .......................................................................................... 134

Low reservoir alert ............................................................................. 135

Low battery alert ............................................................................... 135

Alarms ....................................................................................................135

What to do .......................................................................................... 136

Alarm conditions .......................................................................................137

A (Alarm) ............................................................................................ 137

Auto off ............................................................................................. 137

Batt out limit ....................................................................................... 137

Bolus stopped ....................................................................................... 137

Button error ........................................................................................ 138

Check settings ...................................................................................... 138

E (Error) ............................................................................................. 138

Empty reservoir .................................................................................... 138

Failed batt test .................................................................................... 138

Is priming complete? .............................................................................. 139

Max delivery ........................................................................................ 139

Motor error ......................................................................................... 139

No delivery .......................................................................................... 139

No reservoir ......................................................................................... 139

Off no power ....................................................................................... 140

Reset ................................................................................................. 140

Weak Battery ....................................................................................... 140

Chapter 10 Pump maintenance ...................................... 141

Battery ...................................................................................................141

Storage ...................................................................................................141

Cleaning your pump ...................................................................................142

Chapter 11 Pump specifications .................................... 143

Alarms and error messages ..........................................................................143

Alarm history ...........................................................................................143

Backlight .................................................................................................143

Basal ......................................................................................................143

x Contents

BG (blood glucose) target ............................................................................144

Bolus delivery ..........................................................................................144

Bolus history ............................................................................................144

Bolus units ..............................................................................................144

Bolus Wizard feature ..................................................................................144

Carb ratios ..............................................................................................144

Carb units ...............................................................................................144

Daily totals ..............................................................................................144

Default screen ..........................................................................................144

Pump motor .............................................................................................145

Dual Wave bolus .......................................................................................145

Easy bolus ...............................................................................................145

Infusion pressure ......................................................................................145

(Insulin) sensitivity ....................................................................................145

Low resv (reservoir) warning ........................................................................145

Meter value .............................................................................................146

Normal bolus ............................................................................................146

Occlusion detection ...................................................................................146

Percent temp basal ....................................................................................146

Power supply ...........................................................................................146

Prime function .........................................................................................146

Prime history ...........................................................................................146

Program safety checks ................................................................................147

Pump size ...............................................................................................147

Pump weight ............................................................................................147

Remote control .........................................................................................147

Reservoir ................................................................................................147

Square Wave bolus ....................................................................................147

Temporary (temp) basal rate ........................................................................147

Time and date screen .................................................................................147

Status screen ...........................................................................................148

Bolus Wizard feature specifications ...............................................................150

Bolus Wizard feature examples .................................................................. 152

Default (factory) settings ............................................................................154

Icon table ................................................................................................157

Index ................................................................. 159

Contents xi

xii Contents

Practice lessons and examples

Bolus examples

Meal bolus

Normal meal bolus using the exchange system ..................................................25

Bolus practice .........................................................................................26

Normal meal bolus practice using exchanges ....................................................26

Normal meal bolus using carbohydrate counting ................................................26

Correction bolus

Meal bolus, correction bolus and insulin sensitivity ............................................27

Practice: Meal bolus .................................................................................28

Max bolus

Example 1: Max bolus ................................................................................31

Example 2: Max bolus ................................................................................31

Basal examples

Basal programming

Practice: Basal programming .......................................................................35

Max basal

Example 1: Max Basal ................................................................................38

Example 2: Max Basal ................................................................................38

Suspend/Resume examples

Example: Suspend function .........................................................................40

Practice: Suspend function .........................................................................41

Practice: Resume basal delivery after a suspend ...............................................41

xiii

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

A

Accept - Pressing the ACT button to approve the selection or setting.

Active insulin - Insulin that has been delivered to your body, but has not yet been used.

Alarm - Audible or vibrating (silent) notice that indicates the pump is in Attention mode and immediate attention is required. Alarms are prefixed in the alarm history with the letter A.

Alarm clock - The feature you can use like any alarm clock. You can set the pump to send you an alarm at certain times of the day as reminders. For example, you can set the pump to send you an alarm every four hours to remind you to check your blood glucose level.

ALARM HISTORY screen - The screen that displays the last twelve alarms or errors that have occurred on your pump.

Alert - An audible ‘beep’ or vibration from the pump to notify you that the pump needs attention soon. You may need to replace a low battery, or the pump may be sending you a reminder of something (for example, that you need to check your blood glucose level). An alert does not affect insulin delivery.

Attention mode - The operating mode that stops all current insulin delivery. This mode indicates an alarm or condition exists that requires immediate attention.

B

Backlight - Pump screen light. Turns on whenever the button is pressed or in combination with the button if not on the HOME screen. The backlight also appears during an alarm (except

LOW BATT).

Basal rate - The pump setting that provides a continuous infusion of insulin to keep the blood glucose stable between meals and during the night. Basal insulin mimics pancreatic insulin delivery - which meets all the body’s non-food related insulin needs.

BASAL REVIEW screen - The screen that shows the basal insulin delivery rates programmed in the pump. This includes the total amount of insulin delivered by the pump every 24 hours at each delivery rate.

BG - (Blood glucose) The main sugar that your body makes from food (especially carbohydrates). Glucose is the major source of energy for your body and is carried in the bloodstream.

BG (blood glucose) reminder - The feature that you can use to remind you to check your blood glucose level after a bolus insulin dose.

Glossary xvii

BG (blood glucose) target range - The range of your normal or desirable blood glucose levels.

You can set up the pump so that you receive an alarm when your blood glucose level is below or above your target range.

BG (blood glucose) units - Blood glucose unit of measure (mg/dL or mmol/L).

Block - The feature that restricts access to all programming except suspend, selftest and the delivery of a bolus with the remote control.

Bolus - A dose of insulin given in addition to your base (basal) insulin dose to bring your blood glucose level down to your target range. The two basic types of bolus insulin doses are

‘correction’ boluses (see page xviii), and ‘food’

boluses (see page xix).

BOLUS HISTORY screen - The screen that shows the last twenty-four (24) boluses delivered by your pump.

Bolus Wizard® feature - A feature of the pump that automatically calculates the amount of insulin you need bring your blood glucose level back down to your target range.

C

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.”)

D

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. xviii Glossary

Dual Wave™ bolus - Combination of a normal bolus that is delivered immediately, then followed by a Square Wave bolus. The Square

Wave portion is delivered evenly over a period of time.

Duration - Amount of time it takes to administer a bolus or basal delivery. Also, length of time for an action or condition.

E

Easy bolus™ - Method of delivery for a Normal bolus using the Easy Bolus button .

Exch ratio - (Exchange ratio) Used when counting carbohydrates as exchanges. The amount of insulin needed to cover one (1) carbohydrate exchange. (Also see carb ratio.)

Express bolus - Method of delivery for any bolus type using the express bolus button .

F

Fixed prime - To fill (prime) the cannula with insulin. This is done after you insert the infusion set into your body and remove the introducer needle.

Food bolus - A type of bolus insulin dose given before meals or snacks to keep your blood glucose level from going above your target range. The amount of insulin needed is calculated using your insulin sensitivity

(page xix), the amount of active insulin in your

body (page xvii), the amount of carbohydrates

in the meal or snack, and how much your current blood glucose levels is above your target range.

G

Gastroparesis - A condition of the digestive system that slows down the emptying of food from the stomach.

H

HbA1c - (Glycosylated hemoglobin)

HDL - (High-density lipoprotein) A complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood.

Hold - To push and keep pressure on a pump button.

I

Idle - The pump is at the HOME screen.

Ins sensitivity - (Insulin sensitivity) The amount that your blood glucose level is reduced by one unit of insulin.

K

Kilopascal (kPa) - A unit of measurement for quantifying force. Used to measure atmospheric pressure. Equivalent to 10,000 dynes per square centimeter.

Glossary xix

L

LDL - (Low-density lipoprotein) A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood.

Link - To turn on and setup the meter option that allows the pump to receive blood glucose readings from the Paradigm Link meter.

Low resv warning - Programmable warning that notifies you with an alert when either a specified number of units remain in the reservoir or a specified amount of time remains before the reservoir will be empty.

M

Manual bolus - Selectable item available in the

BOLUS MENU when the Bolus Wizard feature is active. One method of programming a bolus without the Bolus Wizard feature (see “Set

bolus” on page xxi).

Manual prime - Fills the infusion set tubing with insulin before you insert the set into your body.

This function is available after a rewind.

Max bolus - The maximum amount of bolus insulin that the pump can deliver at one time

(set by the user).

Max basal rate - The maximum amount of basal insulin that the pump will deliver at one time

(set by the user).

Meter - The Paradigm Link Blood Glucose Monitor

Powered by BD Logic™ Technology (Paradigm Link meter). Your pump can be programmed to receive your blood glucose readings from this meter.

Meter option - Feature that allows the pump to receive blood glucose readings from the

Paradigm Link meter.

N

Normal mode - Regular operating mode. No special features are active, no alert or alarm conditions exist. Insulin delivery is normal during this mode.

Normal bolus - One of three types of bolus insulin deliveries where all the insulin is delivered at once. This is usually used to bring your blood glucose level back down to your blood glucose target range when you are fasting, and the high blood glucose is unexpected. The other types of bolus insulin deliveries are Dual Wave (see

page xix), and Square Wave (see page xxi).

Now portion - The “Normal” portion of a Dual

Wave bolus. The now portion is delivered all at once, followed by the Square portion.

P

Pattern feature - Extended pump feature that allows you to program optional basals (Pattern

A, Pattern B) that support activities that are not a part of your day-to-day routine, but are usual in your lifestyle. Such activities could be a sport that you do once a week or a change in your sleep pattern over the weekend. xx Glossary

Pattern, standard - Your normal basal that supports your usual day-to-day activity. When the Patterns feature is off, the pump uses your standard (basal) pattern.

Press - To push and release a pump button.

Prime - To fill (prime) the cannula with insulin.

This can be done automatically by the pump (a

“Fixed prime”), or manually (a “Manual prime.”

See Fixed prime (page xix) or Manual prime

(page xx).

PSI - Pound-force per square inch.

R

Resume - Continue basal insulin delivery after the pump is suspended.

Rewind - The pump drive moves back to its starting position to prepare the pump for a new reservoir.

RF - (Radio frequency)

S

Scroll - Press the up or down arrow buttons to move through the screen text.

Select - Pressing the up or down arrow buttons to highlight a desired screen item.

Set bolus - Selectable item available in the

BOLUS MENU when the Bolus Wizard feature is inactive. One method of programming a bolus without the Bolus Wizard feature. (See “Manual

bolus” on page xx.)

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.

T

Temp - Temporary

Temp basal - (Tmp basal) Temporary one-time basal insulin with a specified amount and duration. Used to support insulin needs for special activities or conditions that are not part of the normal daily routine.

U

µ L - microliter

Glossary xxi

xxii Glossary

Your personal information

You may need the following information from your healthcare professional before going to your pump start appointment. If you are unsure, contact your healthcare professional or pump trainer 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

#1

#2 midnight

#3

Additional basal rates

#4

#5

#6

#7

#8

Basal rate

(units per hour) xxiii

Pattern A

Basal rate number

#1

#2

#3

Start time midnight

(additional basal rates)

#4

#5

#6

#7

#8

Basal rate

(units per hour)

Pattern B

Basal rate number

#1

#2

#3

Start time midnight

(additional basal rates)

#4

#5

#6

#7

#8

Basal rate

(units per hour)

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.

When breakfast lunch dinner snacks xxiv

Chapter: 1

Introduction

Thank you for choosing Medtronic MiniMed as your partner in helping you gain better control of your diabetes. Whether you are beginning pump therapy for the first time or upgrading from a previous model, we believe that the combination of state-of-the-art technology and the simple, menu-driven programming of the pump will provide many benefits.

This User Guide is designed to help you to understand pump therapy and the operation of your pump. We strongly recommend that you work closely with your healthcare professional for a safe and complete pump start.

Your pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus for persons requiring insulin. Based on your settings, the pump delivers your custom basal automatically and continuously 24-hours a day. It also provides bolus deliveries to support your immediate insulin needs for food intake and/or high blood glucose. The Bolus

Wizard feature can calculate the amount of bolus insulin you need.

Availability

The pump and accompanying products are available from Medtronic MiniMed and authorized distributors.

Assistance

Medtronic MiniMed provides a 24-hour

Product Help Line for assistance. The Help Line is staffed with technicians who are trained in the set-up and operation of the pump and are able to answer pump-related questions. When calling the Help Line or your local Medtronic

MiniMed office, please have your pump and serial number available. The phone number for the 24-hour Product Help Line is also on the back of your pump.

Department

24-hour Product Help Line

(calls within the United

States)

24-hour Product Help Line

(calls outside the United

States)

Telephone number

800.646.4633

(800.M i n i M e d )

818.576.5555

Introduction 1

Emergency kit

Keep an emergency kit with you at all times to make sure that you always have necessary supplies.

Inform a family member, co-worker, and/or friend where this emergency kit is kept. Please refer to

“User safety” on page 7 for more information on pump safety. Your emergency kit should include these

items:

➠ Fast-acting glucose tablets

➠ Blood glucose monitoring supplies

➠ Urine ketone monitoring supplies

➠ Extra Paradigm infusion set and Paradigm reservoir

➠ Insulin syringe and fast-acting insulin (with dosage instructions from your healthcare professional)

➠ Paradigm Quick Reference Card

➠ Dressing and adhesive

➠ Glucagon Emergency Kit

®

➠ Extra AAA alkaline batteries (Energizer

® is recommended)

brand

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).

2 Chapter: 1

Disposables

The pumps use disposable reservoirs and infusion sets for insulin delivery. Installation instructions

for Paradigm reservoir and infusion sets are provided in Chapter 4, “Starting on insulin.”

Reservoirs: The 515 pump is intended for use with a 176-unit Paradigm reservoir (MMT-326). The

715 pump is intended for use with a 300-unit Paradigm reservoir (MMT-332), however it can also use the MMT-326 as well.

Infusion sets: Medtronic MiniMed provides a variety of Paradigm infusion sets to fit your needs.

Contact your healthcare professional who will assist you to choose an infusion set that fits your needs.

WARNING: For your protection the pump has undergone extensive testing to confirm appropriate operation when used with Paradigm reservoirs and Paradigm infusion sets manufactured or distributed by Medtronic MiniMed. We recommend using Medtronic MiniMed infusion sets and reservoirs as we cannot guarantee appropriate operation if the pump is used with reservoirs or infusion sets offered by third-parties and therefore we are not responsible for any injury or malfunctioning of the pump that may occur in association with such use.

Accessories

Meter: Your pump can be used with the optional Paradigm Link™ Blood Glucose Monitor powered by

BD Logic™ Technology. You can program your pump to automatically receive your blood glucose readings from this meter.

Remote control: The optional Paradigm remote control can be used with the pump to deliver normal boluses and suspend the pump from a distant location. (This User Guide provides programming instructions for the remote control. See the remote control User Guide for operating instructions.

To order supplies, call 800-646-4633 (1-800-MiniMed) or 818-362-5958 (outside U.S.) www.minimed.com

Introduction 3

Download pump and meter data

The Medtronic CareLink™ Therapy Management System for Diabetes Web site is designed to help you take information from all of your diabetes management tools—your insulin pump, blood glucose meters, and logbook—and organize it into easy-to-read charts, graphs, and tables.

These reports can help you and your healthcare professional discover trends and other information that can lead to improved therapy management for greater control of your diabetes.

Reports show you data gathered from your pump, meter, plus information you enter directly into the system. Examples of reports you can create include:

➠ Pump operation, such as alarm settings and maximum allowed bolus amount

➠ Insulin delivery rates, types, and times

➠ Blood glucose reading levels and times

➠ Bolus Wizard or online logbook entry data.

Reports display in PDF format, which you can view online, print out, and download and save to your computer.

You can share your reports with your healthcare professional. They can use report results to determine if and how your treatment regimen should be adjusted.

The logbook feature allows you to keep track of facts such as:

➠ Carbohydrates eaten,

➠ Exercise activity,

➠ Urine ketone results,

➠ HbA1c results, and

➠ Infusion set changes.

This data from your logbook is used in the reports you create. For instance, you can see how your carbohydrate intake compares to blood glucose levels for the same day or time. You can also use your logbook as an online diary of your diabetes management.

The CareLink system is accessed through a Web site at http://carelink.minimed.com

. From there, you can follow the on-screen instructions and help.

NOTE -

Medtronic CareLink™ Therapy Management System for Diabetes is not available in all locations.

4 Chapter: 1

ParadigmPAL

With ParadigmPAL™ you can do the following with your pump settings:

See your pump settings on your PC screen.

Backup, or save, pump settings to diskette or the hard drive of your PC.

Quickly change your pump settings in case your healthcare professional needs to make a change to your pump therapy.

Print copies of your pump settings for your records.

How to wear your pump

There are a different ways to wear your pump. Medtronic MiniMed has accessories that can hide, protect, and add to the convenience of wearing a pump. See the accessories catalog or the website

( www.minimed.com

) for more information.

Holster: Used to wear the pump on your belt.

Pump clip: Used to wear the pump underneath your clothing.

Activity guard: If you are active in sports, or you are a child, use the guard to protect the pump from disconnecting.

Leather case: Fine leather lined with nylon. Styling complements business and formal wear. Velcro flap provides easy access to pump for programming. Wear it vertically with the built-in belt clip.

Introduction 5

How to use this guide

NOTE -

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

“Press”

“Hold”

Meaning

To push and release the pump button

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

NOTE and TIP

CAUTION:

WARNING:

“Go to the...screen.”

You can change the value for that item with the

/

1.

From the MAIN MENU, select Utilities and press ACT .

2.

In the UTILITIES MENU, select Alarm and press ACT .

buttons

Additional helpful information

Warns of a potential hazard which, if not avoided, may result in minor or moderate damage to the equipment

Notifies you of a potential hazard which, if not avoided, could result in death or serious injury. It may also describe potential serious adverse reactions and safety hazards

When a step instructs you to “Go to” a screen, the path to that screen is shown. For example:

Go to the ALARM MENU.

Main > Utilities > Alarm

3.

The ALARM MENU appears.

6 Chapter: 1

User safety

Indications

The Paradigm 515/715 pump system is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Contraindications

Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four (4) blood glucose tests per day and to maintain contact with their healthcare professional.

Successful insulin pump therapy requires sufficient vision or hearing to allow recognition of the pump signals and alarms.

Warnings

Reservoir and infusion sets

Standard Luer sets are not compatible with the Medtronic Minimed Paradigm pump. Medtronic

MiniMed Paradigm reservoir and Paradigm infusion sets are specifically designed for use with the pump.

Do not modify your Paradigm reservoir or Paradigm infusion set.

Do not put any other drugs/medications inside your reservoir to use with this pump. Only insulin that has been prescribed by your physician can be used in this pump.

X-rays, MRIs and CT scans

If you are going to have an X-ray, CT scan, MRI or other type of exposure to radiation, TAKE OFF

YOUR PUMP, METER AND REMOTE CONTROL and remove them from the area.

The Paradigm pump is designed to withstand common electromagnetic interference, including airport security systems. Be sure to carry the Airport Card provided, when you are traveling.

Introduction 7

Precautions

Although the pump has multiple safety alarms, it cannot notify you if the set is leaking or the insulin has lost its potency. It is essential, therefore, that you test your blood glucose levels at least four

times per day. If your blood glucose is out of range, check the pump and the infusion set to ensure that the necessary amount of insulin is being delivered.

Avoid extreme temperatures

1 Avoid exposure of your pump and remote control to temperatures above 108°F (42°C) or below 34°F

(1°C).

2 Insulin solutions freeze near 32°F (0°C) and degrade at high temperatures. If you are outside in cold weather, wear your pump close to your body and cover it with warm clothing. If you are in a warm environment, take measures to keep your pump and insulin cool.

3 Do not steam, sterilize or autoclave your pump or remote control.

Infusion sets and sites

Avoid using an infusion site that will be irritated by clothing and accessories, or by rigorous stretching and exercise.

8 Chapter: 1

Notice

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

Medtronic MiniMed could void your ability to operate the equipment.

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.

Introduction 9

10 Chapter: 1

Chapter: 2

The basics

Your 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.

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. screen battery compartment reservoir window tubing connector

ESC

ACT buttons reservoir compartment

The basics 11

Install battery

CAUTION: Do not use a rechargeable or carbon zinc battery in your pump. For best results, a new AAA Energizer alkaline battery is recommended.

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.

Battery cap

Battery

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.

one half-turn

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. one half-turn

12 Chapter: 2

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

7

Ver X.XX

HOME screen

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.

The basics 13

Pump buttons

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

UP button

(From the

HOME screen, this is the EASY

BOLUS button.)

EXPRESS

BOLUS button

DOWN button

ESC button

From the HOME screen

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

ACT button

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.

Opens the MAIN MENU.

Opens the pump STATUS screen.

Accepts a selected menu item or activates a selected setting.

Returns to previous screen. Backs out of unintentional menu selections if the ACT button has not been pressed yet.

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.

14 Chapter: 2

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 MENU will appear.

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

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.

At least 75% left

Battery

Indicator icons

Low battery

The basics 15

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.

Time Display

12-Hr

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.

75 to 100 percent left

Empty

Alert icon

Reservoir

Volume

Indicator icons

Alarm icon

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.

scroll bar

16 Chapter: 2

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.

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

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.

Normal Mode

The basics 17

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:

Low Reservoir condition

Low Battery condition

Block feature is on

Special Mode

➠ Dual or Square Wave bolus delivery

➠ Basal pattern A or B is active

➠ Temporary basal delivery

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.

Attention Mode

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.

18 Chapter: 2

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 -

value.

If a screen item is flashing (blinking), during programming, press / to change the

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 Wizard 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.

The basics 19

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:

➠ recent insulin deliveries (basal and bolus)

➠ reservoir status ➠ time and date

➠ special features that are turned on ➠ battery status

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.

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

Sample

STATUS screen

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

STATUS screen.

20 Chapter: 2

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.

The basics 21

22 Chapter: 2

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 TIME/DATE SETUP

ACT

TIME/DATE SET

12 Hour Setup

24 Hour Setup

12:00A

01JAN2004

Press ACT to change

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

SET HOUR

12:00A

SET MINUTES

9:00A

SET YEAR

2004

SET MONTH

01

SET DAY

01

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 A CT.

Change the month.

Press ACT .

Change the day.

Press ACT .

Basic programming 23

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

Press ACT and exit the menus. TIME SET AT

8:33 AM

26FEB2004 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.

using the EXPRESS BOLUS button from the menu, or

1 Go to the BOLUS

MENU.

Main > Bolus

Select Set Bolus and press ACT. Go to

Step 2

.

BOLUS MENU

Bolus History

Bolus Wizard Setup

Max Bolus

Dual/Square Bolus

Easy Bolus

BG Reminder

Press the

button. Go to Step 2.

24 Chapter: 3

2 If the SET BOLUS screen appears:

(Dual/Square option is

off) Go to Step 3.

SET BOLUS

0.0

U

If the BOLUS TYPE screen

appears: (Dual/Square

Wave is on) Select Normal

Bolus and press

to Step 3.

ACT . Go

BOLUS TYPE

Normal Bolus

Square Wave Bolus

Dual Wave Bolus

3 Enter your bolus amount and press ACT .

SET BOLUS*

0.0

U

/

* “SET NORMAL BOLUS” will show if Dual/Square option is on.

SET BOLUS*

2.5

U

ACT

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.

BOLUS DELIVERY

11:53A

Normal

0.1

U

BOLUS DELIVERY

11:53A

Normal

2.5

U

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.

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.

Basic programming 25

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).

26 Chapter: 3

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

3a

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:

1

30 mg/dL (1.7 mmol/L)

3b

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.)

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

2

) 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.

Basic programming 27

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 _________ .

28 Chapter: 3

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

BOLUS HISTORY

Last 12:48P 0.7N

05SEP 01:05P 0.2N

05SEP 06:30P 4.8S

(with the Bolus

Wizard feature)

BOLUS HISTORY

Last 12:48P 0.7N

CH: 13 BG: 150

05SEP 01:05P 0.2N

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.

date time amount/type carb value blood glucose

(BG) value

N = Normal

S = Square Wave

D = Dual Wave

DN = Normal part of Dual Wave bolus

DS = Square part of Dual Wave bolus

Basic programming 29

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:

(without the Bolus

Wizard feature)

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.

BOLUS HISTORY

Last 05:45P 0.7N

05SEP 01:05P

05SEP 06:30P

ACT

02N

4.8S

(delivery is active)

BOLUS DETAIL

Type: Normal

User Entry:

Delivered:

4.0U

0.7U

If the Bolus Wizard feature calculated your bolus, this information will also appear in the

BOLUS DETAIL screen.

(delivery stopped)

BOLUS DETAIL

Type:

Normal

User Entry:

4.0U

Stopped at:

0.7U

(delivery completed)

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

(values shown are for example only)

BOLUS DETAIL

Type:

Delivered:

Normal

4.0U

30 Chapter: 3

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:

2 Set your maximum bolus limit and press ACT .

3 Your maximum bolus is set. Exit the menus.

1 Go to the MAX BOLUS SETUP screen.

Main > Bolus > Max Bolus

MAX BOLUS SETUP

0-25

10.0

U

(flashing)

x __ MAX BOLUS SETUP

0-25

15.0

U

ACT

BOLUS MENU

Bolus Wizard Setup

Max Bolus

Dual/Square Bolus

ESC

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.

Basic programming 31

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.

BG REMINDER SETUP

Off

On

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.

BG REMINDER DURATION

2:00

NOTE -

If you press ESC when the BG Reminder Duration

(flashing)

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.

12:40P

CHECK

This is a reminder

BG

to check your BG

ESC, ACT to clear

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).

STATUS U100

BG Reminder in 0:18h

Battery: Normal

Tues 08 MAR 2004

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.

32 Chapter: 3

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.

Basal rate 1 start #1 stop #1

(midnight)

*12:00 a.m. or

00:00

Basal rate 2

7:00 a.m. or

7:00 start #2 stop #2

Basal rate 3

3:00 p.m. or

15:00 start #3 stop #3

(midnight)

12:00 a.m. or

00:00

* 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.

Basic programming 33

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.

BASAL MENU

Set/Edit Temp Basal

Set/Edit Basal

Basal Review

ACT

(If using patterns, you will first select the basal you want, then the SET BASAL

RATE 1 screen will appear.)

1 Go to the BASAL MENU.

Main > Basal

2 Select Set/Edit Basal and press ACT .

ACT

EDIT BASAL

Standard

Pattern A

Pattern B

4.40U

0.00U

-.- -U

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.

34 Chapter: 3

SET BASAL RATE 1

12:00A

0.

ACT

00

SET START TIME 2

- -: - -

_._ _

H

H

(flashing) start time 2

Do not set. Press

ACT or ESC.

rate 1 (flashing) press

/

to set

BASAL RATE

Current Rate 0.45U/H

Started #1 - 12:00A

24 HR. Total 10.80U

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.).

SET START TIME 2

- -: - -

_. _ _

U

H start time (flashing)

/

to set 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.

ACT

NOTE -

When you have finished programming your pump you can save your

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

SET BASAL RATE 2

7:30A

_. _ _

U

H

ACT rate (flashing)

/

to set

SET START TIME 3

- -: - -

ESC

_. _ _

U

H

BASAL RATE

Current Rate

Started #1 -

24 Hr. Total

0.60U/H

12:00A

14.40U

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)

Basic programming 35

Basal review

Temporary basal information is only available in the STATUS screen.

Current basal delivery

The STATUS screen shows your current basal information. 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

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

BASAL MENU

Select Patterns

Set/Edit Basal

Basal Review

36 Chapter: 3

2 If you do not use patterns:

The delivery details for your standard basal will appear.

STANDARD

1) 12:00A

2) 11:30A

3) 12:00P

16.80 U

0.60U/H

1.00U/H

0.80U/H basal rate start times basal delivery rates

(24-hour total) basal insulin from 12:00A to 12:00A

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 REVIEW

Standard

Pattern A

Pattern B

16.80 U

24.50 U

19.60 U

ACT

PATTERN A

1) 12:00A

24.50 U

2.20U/H

2) 10:30A 1.80U/H

3) 6:30P 2.60U/H basal rate start times basal delivery rates

3 Exit the menus when you are done.

Basic programming 37

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

MAX BASAL RATE

2.

00

U

H

(flashing)

2 Change the rate and press ACT . 3 Your maximum basal rate is now set. Exit the menus.

MAX BASAL RATE

x

ACT

15.

00

U

H‘

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.

38 Chapter: 3

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:

1 Select Suspend from the MAIN MENU, and press ACT .

MAIN MENU

Bolus

Suspend

Basal

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.

ACT

SUSPEND

Press ACT to Stop Pump

Stopped at 1:05P

SUSPEND

(flashing)

NOTE -

Press

ESC

to view the STATUS screen and verify your pump is suspended.

STATUS U100

Suspended at 01:05P

Last Bolus N 3.8U

7:58A 22 FEB

Basic programming 39

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.

ACT

Stopped at 1:05P

RESUME

ACT - Restart Basal

ACT

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.

40 Chapter: 3

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.

Basic programming 41

42 Chapter: 3

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

Starting on insulin 43

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. plunger rod

2 Swab vial with alcohol.

3 Making sure you do not push down on the plunger, press the transfer guard onto the vial.

reservoir transfer guard vial

4 Push down on the plunger to pressurize the vial.

44 Chapter: 4

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”

Starting on insulin 45

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.

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.

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.

tubing connector

1/2 turn counter-clockwise

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.

46 Chapter: 4

Rewinding your pump

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

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.

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.

REWIND

Disconnect from Body

Press ACT to Rewind

ACT

REWINDING

Wait for notification

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.

PRIMING STOPPED

Continue Priming

Rewind Pump

Status Screen

ACT

ESC

ACT

PREPARING TO PRIME

Disconnect from Body

Insert/Lock Reservoir

Hold ACT to Prime time out

(HOME screen)

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.

Starting on insulin 47

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.

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.

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

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.

tubing connector

ESC

ACT

4 Attach the activity guard, if desired.

5 You must now do a manual prime as described in the next section.

48 Chapter: 4

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.

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.

1 After you rewind your pump, the PREPARING

TO PRIME screen will appear.

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

Hold ACT

DISCONNECT

ACT

(hold)

PRIMING – HOLD ACT

ESC if done

0.3

U

ACT

(hold)

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.

Starting on insulin 49

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.

IS PRIMING

COMPLETE?

Disconnect from body

See user guide for instruction.

ESC, ACT to clear

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 .

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

WARNING: While the infusion set is connected to your body, do not unscrew and retighten the tubing connector on the reservoir.

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.

50 Chapter: 4

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

4 5 6

Starting on insulin 51

7

9

8

10

52 Chapter: 4

11

13

12

Starting on insulin 53

Connecting Quick-set

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.

Infusion set Infusion set connected

Connector part

Disconnecting Quick-set

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

Remove the connector from the site. Squeeze the side grips of the connector part with your fingers.

Side grips

54 Chapter: 4

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.

1 Go to the PRIME MENU.

Main > Prime

2 Select Fixed Prime and press ACT .

PRIME MENU

Fixed Prime

Rewind

Prime History

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.

FIXED PRIME

0.

3

U

ACT

PRIME DELIVERY

6:26P

0.

2

U

Prime history

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

1 Go to the PRIME MENU.

Main > Prime

2 Select Prime History and press ACT .

PRIME MENU

Fixed Prime

Rewind

Prime History

ACT

3 The PRIME HISTORY screen will appear.

M manual prime

PRIME HISTORY

01JAN 12:05p

03JAN 01:15p

03JAN 01:17p

22.5M

0.5F

1.2M

F fixed prime

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.

Starting on insulin 55

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:

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

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.

56 Chapter: 4

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.

Starting on insulin 57

58 Chapter: 4

Chapter: 5

Using the Bolus Wizard feature

What is it?

A feature that calculates an estimated bolus:

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

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.

Blood glucose

(BG) readings

Paradigm Link

Meter

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.)

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)

Using the Bolus Wizard feature 59

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

Carb units:

Information Setting

_____ 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

#1: _________

#2: _________ start time

(midnight)

#3: _________

(additional settings, if needed)

#4: _________

#5: _________

#6: _________

#7: _________

NOTE -

Your carb ratios may vary throughout the day.

Your pump allows you to program up to eight (8) different carb ratios.

BG units: (how you measure your blood glucose)

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)

(mmol/L)

10 - 400

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.

#8: _________

_____ mg/dL or _____ mmol/L

BG units reduced / 1 unit of insulin

#1: _________ start time

(midnight)

#2: _________

#3: _________

(additional settings, if needed)

#4: _________

#5: _________

#6: _________

60 Chapter: 5

Bolus Wizard feature settings

Information Setting

#1: ____-_____ 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.

#2: ____-_____

#3: ____-_____

(midnight)

(additional settings, if needed) range: (mg/dL)

(mmol/L)

60 - 250

3.3 - 13.9

#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 Hours: _________

Using the Bolus Wizard feature 61

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 (refer to “Meter option” on page 73)

or

➠ 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.

62 Chapter: 5

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.

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

EST: 30.0U

MAX: 25.0U

ESC to cancel

ENTER BG

- - mg/dL*

*or mmol/L

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.

Using the Bolus Wizard feature 63

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.

ESTIMATE DETAILS

Est total: 4.0U

Food intake:

(Meter) BG:

45gr

160

Food:

Correction:

3.0U

2.0U

Active Ins:

ACT to proceed,

1.0U

ESC to back up

If there is no active insulin, this will show

“N/A”

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.

(values shown are for example only)

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

64 Chapter: 5

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

Active Insulin Curve

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

0 1 2 3 4

Time (hours)

5 6 7

8 Hour

7 Hour

6 Hour

5 Hour

4 Hour

3 Hour

2 Hour

8 9

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

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.

Using the Bolus Wizard feature 65

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

2 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

Carb Units:

BG Units:

Off

- - -

- - -

ACT

Off

WIZARD ON/OFF

On

ACT

EDIT SETTINGS

Wizard: On

Carb Units:

BG Units:

- - -

- - -

ACT

66 Chapter: 5

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.

1 In the EDIT SETTINGS screen, select Carb Units and press ACT .

EDIT SETTINGS

Wizard: On

Carb Units:

BG Units:

- - -

- - -

2 Select Grams or

Exchanges and press ACT .

CARB UNITS

Grams

Exchanges

3 The screen will return to the EDIT SETTINGS screen so you can set your carb ratios next.

EDIT SETTINGS

Wizard: On

Carb Units: grams

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). using grams

EDIT SETTINGS

Wizard: On

Carb Units: grams

Carb Ratios: - - -

ACT using exchanges

EDIT SETTINGS

Wizard:

Carb Units:

Carb Ratios:

On exch

ACT

Set your first ratio and press ACT. (The start time for your first ratio is midnight (12:00A) and cannot be changed.)

SET CARB RATIO 1

12:00A

15 grams

/U

(flashing) set, then press

ACT

SET EXCH RATIO 1

12:00A

1.0

U/exch

Using the Bolus Wizard feature 67

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)

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: a.

Press ESC .

using grams using exchanges

SET START TIME 2

_: _ __ grams

/U

(flashing)

SET START TIME 2

_: _ __

(flashing)

U/exch

To set more than one carb ratio: a.

Set the start time for the next ratio and press

ACT . using grams

SET START TIME 2

_: _ __ grams

/U b.

Set the value for the next ratio and press ACT .

using exchanges

SET START TIME 2

_: _

(flashing) set then press

ACT

__

U/exch c.

Repeat steps a and b to set more ratios.

d.

Press ESC when you are done.

SET CARB RATIO 2*

7:00A __ grams

/U

SET EXCH RATIO 2*

7:00A __

U/exch

* Depending on how many ratios you set, this number can be 2 through 8.

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.

EDIT SETTINGS

Wizard: On

Carb Units: grams

Carb Ratios: - >

68 Chapter: 5

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.

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: - - -

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.

EDIT SETTINGS

Carb Ratios:

BG Units:

---> mg/dL

Sensitivity: - - -

ACT

INS SENSITIVITY 1

12:00A

_ _ mg/dL per unit insulin

NOTE -

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

(flashing) set,

Using the Bolus Wizard feature 69

3 The SET START TIME 2 screen will appear.

4 To set just one insulin sensitivity: To set more than one insulin sensitivity:

Press ESC .

SET START TIME 2

_: _

_ _ _

mg/dL per unit insulin a.

Set the start time for the next insulin sensitivity and press

ACT .

SET START TIME 2*

7:30A

_ _ _

mg/dL per unit insulin

(flashing) set, then press

ACT

(flashing) b.

Set the value for the next insulin sensitivity and press ACT .

c.

Repeat steps a and b to set more values.

INS SENSITIVITY 2*

7:30A

50

mg/dL per unit insulin

(flashing) set, then press ACT d.

Press ESC when you are done.

* Depending on how many values you set, this number can be 2 through 8.

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.

(mmol/L)

22.2

13.9

5.5

3.8

Target Range

(mg/dL)

400

250

100

70

Correct down to upper limit

(mg/dL) 100

(mmol/L) 5.5

Correct up to the lower limit

(mg/dL)

(mmol/L)

70

3.8

70 Chapter: 5

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.

EDIT SETTINGS

BG Units: mg/dL

Sensitivity: ->

BG Target: - - -

ACT

TARGET RANGE 1

12:00A mg/dL

100 - 100 first BG Target

Range

(flashing)

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: a.

Press ESC .

SET START TIME 2

_: _

_ - _

mg/dL

To set more than one BG Target: a.

Set the start time for the next BG target range and press ACT .

SET START TIME 2*

_: _

- - -

(flashing) set, then press

ACT

(flashing) press ESC 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.

TARGET RANGE 2*

7:30A mg/dL

100 - 100

(flashing) set, then press

ACT

* Depending on how many targets you set, this number can be 2 through 8.

Using the Bolus Wizard feature 71

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:

1 In the EDIT

SETTINGS screen, select Active Ins

Time and press

ACT .

EDIT SETTINGS

Sensitivity

BG Target:

Active Ins Time:

->

->

- - -

2 Set the number of hours for the active insulin time and press

ACT .

ACTIVE INS TIME

6 hr

(flashing) set, then 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: 6

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.

72 Chapter: 5

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.

WIZARD SETUP

Edit Settings

Review Settings

ACT

REVIEW SETTINGS

Wizard On

Carb Units: grams

Carb Ratios:

12:00A

6:00A

BG Units:

Sensitivity:

15

10 mg/dL

12:00A

6:00A

BG Target:

30

35

90-120

12:00A

6:00A 100-140

Active Ins Time: 6

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.

Blood glucose

(BG) Readings

Paradigm Link meter

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.

Using the Bolus Wizard feature 73

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.

CAUTION: The pump will not receive signals from the Paradigm Link meter 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.)

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. METER OPTION

Off

On

ACT

METER ID MENU

Add ID

Delete ID

Review ID

74 Chapter: 5

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

Add a.

Select

ACT .

Add ID and press b.

Use the up and down arrow buttons to enter each of the six ID numbers. Press ACT after each entry.

Delete a.

Select Delete ID and press

ACT .

b.

Select the meter ID that you want to delete and press

ACT .

Review a.

Select Review ID and press ACT . b.

The programmed IDs will show in the REVIEW

METER ID screen.

ADD METER ID

- - - - - -

(flashing) c.

After you set the last number of the ID, the screen will return to the

METER ID MENU.

DELETE METER ID

1 111111

2 222222

3 - - - - - c.

The selected ID is now deleted.

DELETE METER ID

1 - - - - - -

2 222222

3 - - - - - -

REVIEW METER ID

1 - - - - - -

2 222222

3 - - - - - -

METER ID MENU

Add ID

Delete ID

Review ID

3 Exit the menus when your are done.

Using the Bolus Wizard feature 75

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 using the Paradigm Link meter: If you are NOT 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 .

ENTER BG

- - mg/dL*

* or mmol/L

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

ENTER BG meter this BG value, if necessary.) Continue to step 4 .

XXX

mg/dL*

* or mmol/L

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.

76 Chapter: 5

4 In the ENTER FOOD screen, if this is a food bolus: enter the food value you will eat and press ACT .

if this is a correction bolus: select 0 (zero) as the value and press ACT .

ENTER FOOD

45 grams* * or exch

(flashing)

ENTER FOOD

0 grams* * or exch

(flashing)

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.

ESTIMATE DETAILS

Est total: 4.0U

Food intake: 45gr

(Meter) BG:

Food:

160

3.0U

Correction: 2.0U

Active Ins: 1.0U

ACT to proceed,

ESC to back up

ACT to continue

(values shown are for example only)

ESC returns to the

ENTER BG screen

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.

SET BOLUS

Estimate

4.0

U

ACT to accept

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.

BOLUS DELIVERY

3:24P

NORMAL

0.

1 U

Using the Bolus Wizard feature 77

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

= 4 + 0

= 4 units estimate = 4 units

+

78 Chapter: 5

Example 2: Blood glucose above target range and no active insulin

The next day, Michael wakes up before school. Before eating the same breakfast, he tests his blood glucose with his Paradigm Link meter and finds it to be 200 mg/dL (11.1 mmol/L), which is above his

High BG target of 120 mg dL (6.7 mmol/L). His blood glucose reading is automatically sent to his pump.

When prompted by the Bolus Wizard feature, he enters his carbohydrate amount of 60 grams in the

ENTER FOOD screen. Based on his settings, the pump will suggest that he take 6.0 units of insulin.

(food estimate)

= 4 + 2

= 6 units estimate = 6 units

60g

15g/u

= 4 units + (correction)

200mg/dL - 120mg/dL

40mg/dL/u

= 2 units

Example 3: Blood glucose below target range and no active insulin

On another morning, Michael sits down before eating the same breakfast. He tests his blood glucose with his Paradigm Link meter and finds it at 70 mg/dL (3.9 mmol/L), which is below his Low BG target of 90 mg/dL (5.0 mmol/L). His reading is automatically sent to his pump.

When prompted by the Bolus Wizard feature, he enters his carbohydrate amount of 60 grams in the

ENTER FOOD screen. Based on his settings, the pump will suggest that he only take 3.5 unit of insulin.

(food estimate)

60g

15g/u

= 4 units

= 4 + (-0.5)

= 3.5 unit estimate = 3.5 unit

+ (correction)

70mg/dL - 90mg/dL

40mg/dL/u

=

-20mg/dL

= -0.5 unit

40mg/dL

Using the Bolus Wizard feature 79

Example 4: Blood glucose above target range with active insulin

Michael is at school and wants to eat a snack in the late morning. He tests his blood glucose with his

Paradigm Link meter and finds it to at 200 mg/dl (11.1 mmol/L), which is above his High BG target of 120 mg/dL (6.7 mmol/L). He estimates that his snack contains 60 grams of carbohydrate, so he enters 60 into the pump when prompted by the Bolus Wizard feature. Based on his settings, and as a result of 1.5 units of active insulin, his pump will suggest that he take 4.5 units.

(food estimate)

60g

15g/u

= 4 units

+

(correction)

200mg/dL - 120mg/dL

40mg/dL/u

-1.5 units (active insulin)= 2 - 1.5 = 0.5

= 4 + 0.5

= 4.5 units estimate = 4.5 units

80 Chapter: 5

Example 5: Blood glucose below target range with active insulin

Another day at school, Michael is getting ready to eat lunch. He tests his blood glucose with his Paradigm

Link meter and finds it at 70 mg/dL (3.9 mmol/L), which is below his Low BG target of 90 mg/dL (5.0 mmol/L). His reading is automatically sent to his pump.

When prompted by the Bolus Wizard feature, he enters his carbohydrate amount of 60 grams in the

ENTER FOOD screen. Based on his settings, and despite 1.5 units of active insulin, his pump will suggest that he take 3.5 units of insulin.

(food estimate) (correction)

60g

15g/u

= 4 units +

70mg/dL - 90mg/dL

40mg/dL/u

=

-20mg/dL

40mg/dL

(-0 active insulin*) = -0.5 unit

= 4 + (-0.5)

= 3.5 unit estimate = 3.5 unit

*Note: When the current blood glucose is below the Low BG target, an active insulin amount that is greater than the correction estimate is not considered in the Bolus Wizard feature calculations.

Using the Bolus Wizard feature 81

82 Chapter: 5

Chapter: 6

Optimizing pump therapy

Square Wave and Dual Wave boluses

Square Wave bolus delivers a bolus evenly over a period of time (30 minutes to 8-hours). This bolus can be used for insulin delivery when you have eaten a long meal with extended snacking. It can also be useful if you have delayed food digestion due to gastroparesis or meals high in fat. A Square Wave bolus can be useful if a normal bolus drops your blood glucose too quickly. Since the Square Wave portion extends over a period of time, the insulin is more likely to be available to match your individual needs.

NOTE -

During delivery of a Square Wave bolus, you will not be able to do the following pump functions: change the max bolus amount, disable or deliver dual and Square Wave boluses, do a fixed prime or rewind, change the active insulin time, run a self-test, or access the User Settings menu. All other pump functions are still available during the Square Wave bolus.

Dual Wave bolus delivers a combination of an immediate normal bolus followed by a Square Wave bolus. The Square Wave portion is delivered evenly over a period of time. A Dual Wave bolus is useful for meals with both rapidly and slowly absorbed carbohydrates. For example, a Dual Wave bolus would be appropriate for fruit and crackers followed by pasta. The Dual Wave option meets both immediate and extended insulin needs. A Dual Wave bolus is also useful for correcting elevated blood glucose before a meal.

This graphic shows: See the following graphic for a description of the different bolus types:

Entire bolus amount delivered immediately.

Bolus amount delivered evenly over specified time period.

Part of the bolus amount delivered immediately. Remainder delivered evenly over time period

NORMAL

BOLUS

1

SQUARE WAVE

BOLUS

2

Now

Portion

DUAL WAVE

BOLUS

3

Square

Portion

TIME

Optimizing pump therapy 83

Dual/Square Wave bolus on-off

NOTE -

It is important that you consult with your healthcare professional before using a Square

Wave or Dual Wave bolus. You should be familiar with the basic functions of your pump before exploring these options.

To set up a Dual Wave or Square Wave bolus, you must first turn on the Dual/Square bolus option. If the option is off, a Dual Wave or Square Wave bolus cannot be programmed or delivered.

1 Go to the DUAL/SQUARE OPTION screen.

Main > Bolus > Dual/Square Bolus

2 Select On and press ACT . The feature is now on. Exit the menus.

DUAL/SQUARE OPTION

Off

On

Square Wave or Dual Wave bolus without Bolus Wizard feature

1 Make sure the dual/square option is on.

2 Calculate your food and/or correction bolus amount.

3 Press on your pump, or go to the BOLUS MENU and select Set Bolus (or Manual Bolus ), then press ACT .

4 The BOLUS TYPE (or MANUAL BOLUS TYPE) screen will appear.

84 Chapter: 6

For a

Square Wave bolus

do these steps: a.

Select Square Wave Bolus . Press ACT .

The SET SQUARE BOLUS screen will appear. b.

Enter the desired amount for the Square Wave bolus units and press

ACT .

c.

Continue to step 5 .

SET SQUARE BOLUS

1.2U

For a

Dual Wave bolus

do these steps: a.

Select Dual Wave Bolus and press ACT. The SET

DUAL BOLUS TOTAL screen will appear.

b.

Enter the desired amount for the total dual bolus units. Press ACT .

SET DUAL BOLUS TOTAL

1.2U

NOTE -

The number of units you enter for the SET DUAL BOLUS TOTAL is a total of both the normal and Square Wave bolus units.

c.

In the next screen, press

/ to change the

Now:

50% normal (Now) and Square portions of the Dual Wave bolus. Press ACT . Notice the screen also shows the

Square:

50% percentage amount for each portion.

0.6U

0.6U

ACT d.

Continue to step 5.

5 The SQUARE DURATION screen will appear. Enter the amount of time you want the Square Wave bolus to last and press ACT . SQUARE DURATION

Sq: 1.2U

0:30

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.

6 The BOLUS DELIVERY screen will appear. The pump will beep or vibrate at the start and end of the bolus. As the bolus is delivered, the screen will show the bolus type and amount until the total units have been delivered.

Optimizing pump therapy 85

Example 1: Square Wave bolus -

Use of a Square Wave bolus while eating a meal high in fat

Conner loves pizza. When he was using insulin shots, he began to avoid pizza because he always had high blood glucose readings several hours after eating this high fat meal. Now that Conner is using the Paradigm pump, he can use the Square Wave bolus feature to help with this problem. With frequent blood glucose testing and many pizza meals, he and his healthcare professional have determined the length of time (duration) he needs to set his Square Wave bolus to prevent the high blood sugars after eating pizza. He set it for 3-hours.

Example 2: Square Wave bolus (gastroparesis)

Lisa has had diabetes for many years. She has been diagnosed with gastroparesis, a condition of the digestive system that slows down the emptying of food from her stomach. This makes her carbohydrate digestion unpredictable. Because of this, Lisa has had a lot of trouble with blood glucose control. It has been suggested to her that she use the Square Wave bolus feature before meals to more evenly match her insulin with her carbohydrate digestion.

86 Chapter: 6

Your turn: Square Wave bolus practice

Your target pre-meal blood glucose range is ______ to _______.

Check your pre-meal blood glucose. Are you within your target? _____ If yes, continue. If no, wait to try the following test until your pre-meal blood glucose is within your target range:

TEST:

Choose a meal that is high in fat (e.g. hot dogs, pizza, cheese enchiladas). Determine your meal bolus amount. Set the Square Wave bolus to deliver the determined amount of insulin over 2-hours*.

(* This duration time is an example. As always, consult with your healthcare professional for guidance.)

Check your blood glucose and record: Pre-meal ________

1 hour post meal ________

2 hours post meal ________

3 hours post meal ________

4 hours post meal ________

Did your blood glucose return to your pre-meal target within 4 hours post meal? ________*

* If you answered yes, then repeat this test with the same meal on another day to verify your results.

* If you answered no, discuss this with your healthcare professional for guidance.

Example 1: Dual Wave bolus

Set a Dual Wave bolus for a barbecue style dinner

Carol is going to a barbecue at a friend's house. Her meal consists of: mixed green salad fruit salad a dinner roll and margarine potato salad baked beans pork ribs with barbecue sauce.

She calculates her total carbohydrates and determines her total meal bolus amount. She knows that she will need some insulin immediately for the fruit, barbecue sauce and dinner roll and some insulin spread out over time for the high fat and high fiber content of the rest of the meal. Carol will program her pump to deliver a Dual Wave bolus with ½ of the total bolus to be given immediately and the other half over a 2- hour* duration.

(* This particular duration of time and bolus proportions is an example. As always, you should consult with your healthcare professional for your individual needs.)

Optimizing pump therapy 87

Example 2: Dual Wave bolus -

Set a Dual Wave bolus for correcting elevated blood glucose before a meal

Marsha uses the Square Wave bolus for the majority of her meals. She tests her pre-meal blood glucose and finds that it is above her target level. Marsha would like to correct her elevated blood glucose before she eats. The Dual Wave bolus can be used to deliver some insulin now to help correct her blood glucose elevation, and then deliver her Square Wave bolus to cover her meal.

Your turn:

Dual Wave bolus practice

Can you think of any meals where this feature would help you with blood glucose control?

Your target pre-meal blood glucose range is ______ to _______

Check your pre-meal blood glucose. Are you within your target? _____ If yes, continue. If no, try this test when your pre-meal blood glucose is within your target range:

TEST:

Choose a meal that has a combination of both rapidly absorbed and slowly absorbed carbohydrates. Determine your meal bolus amount. Set the Dual Wave bolus to deliver the determined amount of insulin. Program your pump to deliver ½ over 2-hours*, and the other half immediately

(* This duration of time and ratio is an example. As always, consult with your healthcare professional for guidance.)

Check blood glucose and record: Pre-meal________

1 hour post meal________

2 hours post meal________

3 hours post meal________

4 hours post meal________

Did your blood glucose return to your pre-meal target within 4 hours post meal? ________*

* If you answered yes, repeat this test with the same meal on another day to verify results.

* If you answered no, discuss this with your healthcare professional for guidance.

88 Chapter: 6

Using the Bolus Wizard feature for a Square Wave or Dual Wave bolus

If you are using the Bolus Wizard feature to calculate your Square Wave or Dual Wave bolus amounts, you will be prompted to enter your blood glucose reading and/or the (carb or exchange) units you will eat. The Bolus Wizard feature will use this input to calculate your suggested correction and/or food bolus amount. If you do not want to use the Bolus Wizard feature estimate, you can change it, if desired.

1 The Bolus Wizard feature must be turned on and the settings must be programmed. Also, make sure the dual/square option is turned on.

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.

2 After you enter your blood glucose and/or food entry, review the information in the ESTIMATE DETAILS screen.

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

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

(values shown are for example only)

3 In the next screen, select Square Wave Bolus or Dual Wave Bolus as desired and press ACT .

(using the Bolus

Wizard feature)

(without the Bolus

Wizard feature)

BOLUS EST: 4.0U

Normal Bolus

Square Wave Bolus

Dual Wave Bolus

ACT

BOLUS TYPE

Normal Bolus

Square Wave Bolus

Dual Wave Bolus

ACT

NOTE -

If you are using the Bolus Wizard feature and it calculates that your bolus includes a portion to correct your high blood glucose, the Square Wave bolus will not be available. This helps you to select a bolus type

(Normal or Dual Wave) that has an immediate delivery option to cover your high blood glucose.

BOLUS EST: 4.0U

Normal Bolus

Dual Wave Bolus

Optimizing pump therapy 89

4 For a

Square Wave bolus

: For a

Dual Wave bolus

do these steps:

The SET SQUARE BOLUS screen will appear.

Change the amount if desired. Press ACT to accept.

SET SQUARE BOLUS

Estimate

4.

0U

ACT

NOTE -

The number of units you program for the

SET DUAL BOLUS TOTAL is a total of both the

Normal and Square Wave bolus units.

a.

The SET DUAL BOLUS TOTAL screen will appear. Change the amount if desired. Press

ACT to accept.

SET DUAL BOLUS TOTAL

Estimate 4.0U

ACT b.

In the next screen, notice the screen shows the Normal

(Now) and Square portions of the Dual Wave bolus. Press

ACT to accept the portions suggested by the Bolus Wizard feature, or press

/

to change these portions then press ACT.

Now:

50%

Square:

50%

2.5U

1.5U

ACT

NOTE -

The Bolus Wizard feature recommends splitting the food portion of your bolus

50/50 between the Square and Now portions. The entire correction amount is always recommended to the Now portion.

5 The SQUARE DURATION screen will appear. Enter the amount of time you want the Square Wave bolus to last and press ACT .

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.

Square Duration

Sq: 1.2 u

0:30

ACT

90 Chapter: 6

6 Press ACT to accept and deliver the bolus. The BOLUS DELIVERY appears. The pump beeps or vibrates at the start and end of the bolus. Shortly after bolus delivery begins, the screen defaults to the HOME screen. If you want to see the progress of the delivery, press ESC to see the status screen.

BOLUS DELIVERY

3:24P

NORMAL

0.

1U

ACT

Easy bolus

The EASY BOLUS button allows a quick way to deliver a Normal bolus. You will pre-set the settings for this feature in the EASY BOLUS OPTION screen in the BOLUS MENU. Your pump is sent from the factory with the Easy Bolus feature set to on. If you do not want to use Easy Bolus, turn it off.

After you set up Easy Bolus, with each press, you can increase the Normal bolus amount by a fixed amount, called a “step.” Before you can deliver an Easy Bolus, you must set the amount in the

EASY BOLUS ENTRY screen. This amount equals the number of units of insulin for each step. The maximum number of steps can equal up to your maximum bolus limit.

NOTE -

When using vibrate mode, EASY BOLUS is limited to 20 steps or maximum bolus, whichever comes first.

Once you set your step amount, you can program your Easy Bolus. When you are in the HOME screen, each time you press the Easy Bolus amount increases by one “step.” You will hear a beep or feel a vibration for each step increase. Each beep is a different tone. This makes it easy for you to count the beeps while you are programming your Easy Bolus.

Easy bolus setup

1 Go to the EASY BOLUS OPTION screen.

Main > Bolus > Easy Bolus

EASY BOLUS OPTION

Off

On/Set

Select On/Set and press ACT. If you do not want to use Easy Bolus, select Off and press ACT.

NOTE -

If you are using the remote control, the Easy Bolus must be set to on.

Optimizing pump therapy 91

Step value setup

You can set the step value from 0.1 to 2.0 units (factory setting: 0.1). Set the step to a number that is convenient to use and easy to multiply.

Total # Steps = 4

Total # Button Presses = 4

4

1 Step = 0.5 units

3

1 Step = 0.5 units

2

1 Step = 0.5 units

1

1 Step = 0.5 units

0

0 0.5

1.0

Total # Units

1.5

2

Example:

2.0 unit Easy bolus with a step amount set at 0.5 units

2 In the EASY BOLUS ENTRY screen, the “step” value will appear flashing. Change the value and press ACT (The step value is the increment you will use for your Easy bolus.)

EASY BOLUS ENTRY

0.

1 U

/ EASY BOLUS ENTRY

0.

5 U

ACT

3 The screen will return to the BOLUS MENU.

Your step amount is now programmed and

Easy Bolus is ready to use. Exit the menus.

(flashing)

BOLUS MENU

Dual/Square Bolus

Easy Bolus

BG Reminder

ESC

Delivering an Easy bolus

Practice using the Easy Bolus feature while looking at the pump screen as you count the beeps. After you are familiar with Easy Bolus, you can use the audible tones for bolus delivery without having to look at the screen.

NOTE -

Easy bolus only works from the HOME screen.

92 Chapter: 6

1 From the HOME screen, press . The SET EASY BOLUS screen will appear. The single “step” value will be flashing. SET EASY BOLUS

0.1

(flashing)

U

2 Press the number of times needed for your bolus amount. Watch the amount change on the screen with each press. When your total bolus amount appears on the screen, press ACT . The pump will vibrate or sound a different tone for each press. Listen/feel to count the steps without looking at the screen.

x 10

SET EASY BOLUS

1.0

U

ACT

For example: You need to deliver a 1.0 unit bolus, and your step size is set to 0.1. Each time you press , the units increase by the “step” amount. To deliver 1.0 units, you need to press the button 10 times. (10 X 0.1 = 1.0) The screen will show 1.0 units.

NOTE -

Pressing or will cancel the Easy bolus. For your safety you cannot use the to select the Easy Bolus values.

3 If this amount is correct, press ACT to start the

Easy Bolus delivery. The BOLUS DELIVERY screen will show the units being delivered. When the total bolus is finished, the pump will beep or vibrate.

SET EASY BOLUS

1.0

U

ESC

ACT to accept

BOLUS DELIVERY

1:32P

Normal

0.1

U

to cancel

If this amount is wrong, press ESC or to start over. The pump will return to the HOME screen.

Optimizing pump therapy 93

Example 1: Easy bolus

Alexander is a busy executive with an accounting firm. He wears his Paradigm pump on his belt and does not want to take it off to give himself a bolus. Alex can easily reach down and feel for the Easy

Bolus button to give a bolus.

He previously programmed his pump to deliver an Easy Bolus in steps of 0.5 unit increments. From the HOME screen, with each press of the , the pump will sound a different tone so he can keep track of the number of button presses.

He wants to give himself 2.0 units for a snack, so he will press 4 times (4 presses x 0.5 units/press = 2.0 units) and then press the ACT button. The pump counts back 4 beeps because he pressed 4 times. He simply presses ACT to confirm the amount, and his pump delivers the 2.0 units.

When Alexander wants to be more discrete, or does not want his pump to beep in an important

meeting, he can set the pump to “vibrate” mode (see “Setting your alert type” on page 109) and feel

for vibrations rather than listening for the tones.

Your turn: Easy bolus practice

The factory default setting for the Easy Bolus feature is 0.1 unit steps. You can change the step level as necessary to a value that is more convenient for you to use and easier to multiply.

Give your next bolus by using the Easy Bolus feature on your pump.

How many units did you give? _______

How many tones did you count? _______

It might be a good idea to look at your pump's screen to see the bolus amount as well as counting the steps the first few times you try this until you become familiar and comfortable with the feature.

Your step level is

________.

94 Chapter: 6

Basal patterns

The Basal Patterns feature is optional for pump users. You can set your pump to deliver a standard basal and two additional basal patterns to meet your individual daily, weekly, or monthly needs. Keep a paper copy of your programmed patterns with you at all times in case you need to reprogram your pump. To select and use pattern A or pattern B, the patterns option must be on and programmed.

Basal patterns are useful to establish different sets of basal rates to match different needs such as:

➠ Changes in time of sleep (for example, work shift)

➠ Different schedules during the week versus weekend

➠ Extended periods of higher or lower activity

➠ Softball games every Saturday morning, etc.

➠ Menses

NOTE -

You may want to explore this option after you become familiar with the basic pump functions. It is important that you consult your healthcare professional before using a pattern other than your standard pattern.

Standard pattern: Your normal basal that supports your usual day-to-day activity. When the

Patterns feature is off, the pump uses your standard basal pattern.

Pattern A/B: Basal pattern that supports activity levels that are not a part of your dayto-day routine, but are normal 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.

Patterns on/off

Your pump is set at the factory with the basal patterns feature turned off. After you turn on patterns, you still have to program and select a pattern (A or B), as described in the next sections, before the patterns feature is active. If you turn off the patterns feature, your pump will automatically select your standard basal pattern.

1 Go to the PATTERNS OPTION screen.

Main > Basal > Patterns PATTERNS OPTION

ACT

Select On or Off and press ACT .

Off

On

2 The screen will go back to the BASAL MENU. The patterns feature is now on. Exit the menus.

Optimizing pump therapy 95

Program a pattern

Your pump will keep your pattern settings even when the Patterns option is turned off. The patterns feature must be on to program a basal pattern.

NOTE -

Be aware. When you make changes to a pattern, the pump will use that pattern as the current basal. Make sure the basal you want is selected in the SELECT PATTERNS screen.

Do these steps to program your patterns:

1 Go to the EDIT BASAL screen.

Main > Basal > Set/Edit Basal

2 Select the basal pattern you want to program and press ACT .

EDIT BASAL

Standard 16.80U

Pattern A ---.-- U

Pattern B ---.-- U

ACT

3 The SET BASAL RATE 1 screen will appear. The basal rate will flash indicating that it can be changed. Set your first rate and press ACT .

NOTE -

The first basal rate starts at midnight and cannot be changed.

A

SET BASAL RATE 1

12:00A

_.

- U

H rate

(flashing)

H indicates programming is for Pattern A

4 The SET START TIME 2 screen will appear. The start time will flash. If you want to use the same rate for the whole day, press ESC and go to step 5 .

If you want to program more rates, do these steps: a.

Set the start time for this rate and press ACT . b.

The rate will start flashing. Set the rate and press

ACT .

c.

Repeat steps a and b for each additional rate you want to program for that pattern. Each rate will have a different number (RATE 2, RATE 3, etc.).

Press ESC when you are done. Continue to step 5 .

A

SET START TIME 2

- -: - -

_.

- -

A

- -: - -

_.

- U

H set time

(flashing)

U

H time

(flashing)

A

SET BASAL RATE 2

7:30A

_.

- -

U

H rate will flash after you set the start time

96 Chapter: 6

5 After you press ESC , the BASAL RATE screen appears. The screen will show:

➠ the current basal pattern and basal rate,

➠ time it started, and

➠ the 24-hour basal total. indicates

Pattern A is the active pattern

BASAL RATE A

Current Rate 0.80 U/H

Started #1 - 12:00A

24 Hr. Total 19.20

Select a pattern

Before you try to select a pattern to be active, make sure the Patterns feature is on. After your standard pattern and/or pattern A or B are set, do these steps to select a pattern to be the active one:

1 Go to the SELECT PATTERN screen.

Main > Basal > Select Patterns

2 Select the desired pattern, press ACT .

SELECT PATTERN

Standard 16.80U

Pattern A

19.60 U

Pattern B - -. - this pattern is not programmed

3 The screen will return to the BASAL MENU. Your basal pattern is now active. Exit the menus.

NOTE -

If pattern A or B is active, the pump is in “Special mode” (an open circle appears at the top of the screen).

BASAL MENU

Set/Edit Temp Basal

Select Patterns

Set/Edit Basal

ACT

Optimizing pump therapy 97

Example 1:

Basal patterns

Ken has had his insulin pump for about a month. He tests his blood glucose 4 - 6 times a day and records his results in his logbook. He is happy with his glucose control during the week but on the weekends, he noticed that he has to eat more food to prevent his blood glucose from running too low.

Ken has realized that during the week while he is at work, he is very inactive and sits at a desk most of the time. On the weekends, though, he is busy with yard work, running errands and playing with his kids. He determines that he needs to have lower basal settings to receive less insulin during active times, such as his weekend.

He can use the Basal Patterns feature to support his weekend change in activity. During the week, he can set his pump to deliver in the standard setting, and on Saturday morning, he can switch over to Pattern A, which he can set with lower basal rates for the weekend. On Monday morning, he can return his pump to the Standard setting for his weekday insulin needs.

Example 2:

Basal patterns

Cynthia has had diabetes for about 12 years and has been on her Paradigm pump for several weeks.

Every Monday, Wednesday and Friday, Cynthia goes on a 2-mile walk in the morning. To prevent hypoglycemia on these days, she uses the patterns feature. For those days, she simply switches over to Pattern A, which she has programmed with a lower set of basal rates. Before she learned to use the patterns feature, she would have to eat more food throughout the day to keep her blood glucose at a safe level. Cynthia has also noticed that a few days prior to menstruation, her blood glucose levels seem to rise, requiring more insulin. She has programmed Pattern B on her Paradigm pump with higher basal rates for this time. For her usual schedule, she uses the standard basal pattern.

Your turn:

Can you think of situations where you might require different basal rate settings on different days?

98 Chapter: 6

Temp (temporary) basal rates

The temp (temporary) basal rate feature is useful to manage blood glucose levels during unusual short-term activities or conditions. These conditions could be an illness or unplanned physical activity that is not part of your daily routine.

A temporary basal rate allows an immediate short-term change to your basal insulin for a specified period of time (30 minutes to 24-hours). This rate can be up to your maximum basal rate setting. It offers an easy way to immediately meet short-term insulin needs for temporary activities or situations.

When your blood glucose is temporarily high or low, a temp basal rate allows you to set a temporarily higher or lower basal to accommodate your blood glucose.

NOTE -

Temp Basal is useful for a temporary condition or period of increased or decreased activity

(i.e. a cold or physical activity) that is not usually part of your lifestyle. For ongoing periods of increased or decreased activity, the patterns feature may be more suitable.

How does temp basal work?

During a temp basal delivery, all other basal programming is temporarily overridden. After the temp basal delivery is completed, your pump will return to the programmed basal. A temp basal is delivered only once and does not repeat. If you want another temp basal, you must program the temp basal again. This feature may be useful to temporarily increase or decrease basal insulin during illness, exercise or the similar situations.

Optimizing pump therapy 99

Temp basal types

Based on your preference, you can select either Percent of Basal or Insulin Rate.

Insulin rate

Insulin rate is a fixed basal in units per hour (U/H). This temp basal type is independent of your current basal. When you select Insulin rate (U/H) for your temp basal type, your pump will deliver the fixed amount you have set for the duration as set. The amount of your temp basal insulin rate can be set up to your maximum basal rate setting.

If you make changes to your normal basal rate, your U/H temp basal is not affected and will continue to deliver as programmed.

temp basal settings temp basal type: Insulin rate (U/H) duration: 4:00 hours (1:05p - 5:05p) rate: 3.50 U/H

1.50 U/H

(rate 1)

2.55 U/H

(rate 2)

3.50 U/H

NOTE -

Temp Basal rate cannot exceed maximum basal rate.

.

(07:00)

3:00 p.m.

(15:00)

1:05 p.m.

(13:05)

3.50 U/H temp basal rate

1.95 U/H

(rate 3)

5:05 p.m.

(17:05)

12:00 a.m.

(00:00)

100 Chapter: 6

Percent of basal

The temp basal type is dependent on your current basal rates. Percent temp basal is a percentage increase or decrease of your current basal (0 - 200 percent limited to your maximum basal rate setting).

The maximum percent limit is based on the largest basal rate segment with your programmed temp basal rate time.

For example: It is 6:00AM and your current basal rate is 1.50 U/H. You want to set a temp basal rate of 130 percent for seven (7) hours. The maximum percent temp basal rate you can set is 125 percent.

Anything larger would make #2 segment exceed your maximum basal setting of 2.0 U/H.

Your current basal rates:

Segment #1: 12:00A

Segment #2: 11:00A

Segment #3: 4:00P

Your maximum basal rate setting: 2.0 U/H

1.50 U/H

1.60 U/H (largest)

1.30 U/H

If your current basal changes (i.e. from rate 1 to rate 2), your percent temp basal amount will also change. The pump will deliver the percentage for the duration that you have set.

You cannot make changes to your normal basal rate while a percent temp basal is active. You must either wait until the temp basal is finished or cancel the temp basal in order to reprogram your normal basal rate setting(s).

Optimizing pump therapy 101

NOTE -

The pump delivers basal amounts in 0.05 U/H increments. Because of this, your temp basal amount will be rounded down to the next 0.05 U/H increment.

temp basal settings temp basal type: Percent of basal duration: 4 hours (1:05p - 5:05p) rate: 120 percent (%)

(120% x rate 2 = 3.06)

3.06 rounded down to the next 0.05 increment is 3.05 U/H

(120% x rate 3 = 2.34)

2.34 rounded down to the next 0.05 increment is 2.30 U/H

3.05

U/H 2.30

U/H

1.50 U/H

(rate 1)

2.55 U/H

(rate 2)

1.95 U/H

(rate 3)

7:00a.m.

(07:00) temp basal start time

3:00 p.m.

(15:00)

1:05 p.m.

(13:05)

5:05 p.m.

(17:05) temp basal stop time

12:00 a.m.

(00:00)

102 Chapter: 6

Selecting temp basal type

Your pump will remember the temp basal type setting. Once the type is set, you do not have to set it again. To select a temp basal type, do these steps:

1 Go to the BASAL MENU.

Main > Basal > Temp Basal Type

Select Temp Basal Type and press ACT .

BASAL MENU

Max Basal Rate

Patterns

Temp Basal Type

ACT

2 The SET TEMP BASAL AS screen will appear. Select Insulin Rate or Percent of

Basal and press ACT .

SET TEMP BASAL AS

Insulin Rate <U/H>

Percent of Basal

ACT

3 The screen will return to the BASAL MENU. The temp basal type is now set. Exit the menus.

NOTE -

Be aware. If your temp basal type is set to “Percent of Basal,” changes to your basal rate are not allowed until after temp basal is completed or cancelled.

Delivering a temp basal

NOTE -

A temp basal cannot exceed your programmed max basal rate.

1 Go to the BASAL MENU.

Main > Basal > Set/Edit Temp Basal

Select Set/Edit Temp Basal and press ACT .

BASAL MENU

Max Basal

Rate Patterns

Temp Basal Type

ESC

BASAL MENU

Set/Edit Temp

Basal Set/Edit

Basal Review

ACT

2 The SET DURATION screen will appear. The duration* will flash. Enter the desired minutes or hours (30 minutes to 24-hours), then press ACT .

NOTE -

* Duration is the amount of time it will take for the pump to deliver the temporary basal.

SET DURATION

Temp

3:00

ACT

Optimizing pump therapy 103

3 In the SET TEMP BASAL screen, the temporary basal rate will flash. Enter your temp basal rate, then press ACT .

SET TEMP BASAL U/H

3:00P

0.05

appears if

U

H

Temp Basal Type is set to “Insulin rate (U/H)”

OR

SET TEMP BASAL%

3:00P

60% appears if

Temp Basal Type is set to “Percent of basal”

4 The BASAL MENU will appear. Your temp basal is now set and delivering.

Exit the menus.

BASAL MENU

Set/Edit Temp Basal

Cancel Temp Basal

Select Patterns pump is in Special mode during a temp basal

Verifying temp basal delivery

Temporary basal information is available in the STATUS screen only.

During a temporary (temp) basal, the pump is in Special mode (an open circle appears). This open circle will remind you that a temp basal is active.

Additionally, your pump will beep/vibrate three times every hour during delivery. During delivery, the

STATUS screen will show the current temp basal information.

indicates a U/H temp basal of

0.6 units per hour is now active temp basal delivery will last 30 minutes time remaining before temp basal delivery is finished regular programmed basal rate that will resume after the temp basal delivery is finished

STATUS U100

Tmp Basal 0.60 U/H

Duration 0:30

Time left 0:22

Last Bolus N 3.8U

9:07A 11 JAN

Basal 1: 0.80 U/H

Reservoir Started:

09JAN, 6:03P

Units left: 128U

Time left: 24 Hours

Battery: Normal

Tue 11 JAN 2004

S/N# 000000

104 Chapter: 6

Canceling a temp basal

Use the cancel temp basal function in the BASAL MENU to cancel a temporary basal. This function immediately stops the temp basal and resumes the regular programmed basal delivery. To cancel a temp basal, do these steps:

1 Go to the BASAL MENU.

Main > Basal > Cancel Temp Basal

2 Select Cancel Temp Basal and press ACT to accept.

BASAL MENU

Set/Edit Temp Basal

Cancel Temp Basal

Select Patterns

ACT

BASAL MENU

Set/Edit Temp Basal

Select Patterns

Set/Edit Basal

The screen will return to the BASAL MENU. Your temp basal is cancelled and the programmed basal is now active again. Exit the menus.

Example 1:

Temp Basal for a decreased temporary basal rate

Ramon and his friends got together for an unplanned game of soccer. Before using the pump, he was taking shots to manage his diabetes. Ramon experienced frequent low blood glucose reactions sometimes during, and very often after, he played games with his friends. Now that he is using his

Paradigm pump, he can use the Temporary Basal Rate feature to help prevent low blood glucose. He simply programs his pump to temporarily deliver less basal insulin during the time that he is playing, and often for several hours after play, as well.

Ramon was able to determine how to set his Temporary Basal rates by frequent blood glucose testing, both during and after activity, and recording his results. The first time he tried using the pump, his healthcare professional advised him to program his pump to deliver ½ his usual basal rate for the amount of time that he was playing and for an hour after he was done. He made small adjustments of the temporary basal rate and the duration of time, each time he tried to use the feature. After several different attempts with similar activity for the same amount of time, (such as his soccer game that lasted 2 hours), he found a temporary basal rate that worked well for him.

Optimizing pump therapy 105

Example 2:

Temp Basal for an increased temporary basal rate

Gail has had a cold with a cough for a couple of days. Because she is not feeling well, she tests her blood glucose more frequently. She finds that her blood glucose levels are running above target range before meals and she has needed several correction boluses to keep her blood glucose levels within her normal limits. Gail decides to use the Temporary Basal Rate to increase her basal rate during the day today. As advised by her healthcare professional, she will continue to check her blood glucose more frequently until she is feeling well.

Your turn:

Think of an activity where you might need to use a Temporary Basal Rate.

At what rate is your current basal rate running? ____________

What Temporary Basal Rate would you try using at this time? ___________________

How long will you be active?___________________

What duration will you set for the Temporary Basal Rate?________________

Test your blood glucose before and during activity and several times after as well. What are your blood glucose results?

Pre- activity______________

During activity______________

1 hour after activity______________

Several hours after activity______________

What Temporary Basal Rate changes will you make for the next time you try this?

106 Chapter: 6

Chapter: 7

Insulin pump therapy follow-up

We hope that you are now comfortable using the pump and your blood glucose values have improved through insulin pump therapy. Diabetes management requires much more than blood glucose control.

You need to take care of your complete physical and mental health. This includes seeking treatment for any condition both directly related to and not related to diabetes. The following recommendations apply to general diabetes as well as insulin pump therapy follow-up. Remember, your healthcare professional is your best resource for successful diabetes management.

Recommended follow-up

Everyday

Check your blood glucose 4 to 6 times a day and always before bed

Test before driving and have a fast-acting carbohydrate with you when you drive

If your blood glucose is above 250 mg/dl (13.9 mmol/L) twice in a row, take an injection and change the infusion set

Every month

Review DKA prevention guidelines

Check 3:00AM blood glucose at least once during the month

Check 2-hour post-meal blood glucose for all meals on a given day

Every 3 months

Visit your healthcare professional, even if you feel well and your blood glucose values are within your target range

Review your blood glucose log and insulin pump settings with your healthcare professional

Make sure you have an HbA1c test done

Insulin pump therapy follow-up 107

Laboratory tests

Test for HbA1c four or more times a year

Test for cholesterol, HDL, LDL, triglyceride yearly

Test for microalbuminuria yearly

Every visit

Blood pressure check

Foot exam

Review goals for blood glucose, meal plan and exercise

Annually

Dilated eye exam by a qualified opthalmologist

Annual flu shot

Regular dental visits

Nerve function tests

EKG test over age 35

Prostate exam for men, breast exam for women

Diabetes education review

Replace Glucagon Emergency Kit

(new prescription from healthcare professional)

108 Chapter: 7

Chapter: 8

Utilities

Alarm review

You can review alarms in the ALARM HISTORY screen. This screen shows up to 36 past alarms and/or errors. You can also review the details for each alarm when you are in the ALARM HISTORY screen.

1 Go to the ALARM HISTORY screen

Main > Utilities > Alarm > Alarm History

ALARM HISTORY

2 Scroll through your past alarms.

3 If you want to review the details for an alarm, continue to

“Alarm details” below. Exit the menus if you are done.

11OCT 10:35P LoRes

08OCT 04:08P ChkSet

05OCT 11:35A LoBat

Alarm details

4 In the ALARM HISTORY screen, select the alarm you want to review and press ACT . The details for that alarm will appear on the screen.

5 Press ESC to return to the ALARM HISTORY screen. Select another alarm to review, or exit the menus if you are done.

LOW RESERVOIR

11OCT 10:35P

>

24-hours remaining

0.25 units remaining

Setting your alert type

You can select the type of alert your pump uses (for alarms, special conditions and programming).

You can select a vibrate (silent) alert, or an audible beep alert. There are three beep types: long, medium and short tones. The factory setting for this feature is beep-medium.

The vibrate alert type is disabled if you use the block feature, and vibrate must be set again once block is turned off. If your alert type is set to vibrate and you get a LOW BATTERY alert, your pump will use the beep alert type instead to conserve battery power.

NOTE -

Vibrate uses more battery power than the beep alert type and may shorten battery life.

Utilities 109

1 Go to the ALERT TYPE screen.

Main > Utilities > Alarm > Alert Type

2 Select your alert type and press ACT . That alert type is now active. Exit the menus.

ALERT TYPE

Beep Long

Beep Medium

Beep Short

Vibrate

Auto-off

The factory setting for this feature is off (set to 0 hours). This is a safety feature that stops insulin delivery after a defined time period (from 1 to 24-hours). If the pump detects that no buttons have been pressed for the selected amount of time, insulin delivery will stop and an alarm will sound. You may choose to program this feature into your pump based on the numbers of hours that you usually sleep at night. Discuss what uses and settings are best for you with your healthcare professional.

1 Go to the AUTO OFF DURATION screen.

Main > Utilities > Alarm > Auto Off

AUTO OFF DURATION

(flashing)

2 Set the number of hours you want to set and press

ACT .

0

Hours

NOTE -

If you do not want to use the Auto Off feature, make sure the hour is set to zero (0).

3 The screen will return to the ALARM MENU. The Auto Off feature is now set. Exit the menus.

Low resv alert (Low reservoir warning)

Allows you to program the pump to sound an alert before your reservoir is empty. You can select one of these warning types:

➠ a specified number of units that remain in the reservoir a specified maximum amount of time that remains before the reservoir will be empty

The factory setting for this feature is (20) insulin units.

1 Go to the RESV WARNING TYPE screen.

Main > Utilities > Alarm > Low Resv Warning

2 Select Insulin units or Time and press ACT .

RESV WARNING TYPE

Insulin Units

Time

WARNING: When the pump detects a low reservoir condition during a bolus or prime delivery, the alert will go off after the delivery is finished. Make sure to check the volume of your reservoir to ensure enough insulin is available.

110 Chapter: 8

For “Insulin units”:

Enter the number of units you want remaining when the first warning will go off. Press ACT .

WARNING UNITS

(flashing) can be 5.0 – 50.0

20 U

The pump will alarm first when the specified units remain, then again when half that remaining amount is used.

For “Time”:

Enter the amount of remaining time you want for the first warning. Press ACT .

WARNING TIME

(flashing) can be 2 –24

8:00

Hours

The pump will alarm first when the specified time remains, then again one hour before empty.

NOTE -

If you use “time” as the low resv warning type and you deliver large boluses, the actual time remaining could be less than the warning time. “Time” low resv warning types are intended to let you know if you will have enough insulin while you are sleeping.

Utilities 111

Review daily insulin totals

The DAILY TOTALS screen provides a day-by day history of the total amount of insulin that delivered for the past 31 days. This screen includes all bolus and basal amounts delivered midnight-to midnight for each of the past 31 days. The today line in the DAILY TOTALS screen shows the amount of insulin you delivered so far that day.

NOTE -

The amount of insulin used to prime your pump is not included in the DAILY TOTALS screen. This amount is counted separately and shown in the PRIME HISTORY screen.

Why should I review my daily totals?

Comparing your daily insulin deliveries to your blood glucose records helps you and your healthcare professional identify your optimal daily insulin rate(s).

What is included in the daily totals?

Daily totals include all basal and bolus insulin deliveries, but they do not include insulin used for priming your pump. Each total reflects all basal and bolus insulin delivered for that day.

NOTE -

If an asterisk (*) is displayed next to a total, that means the day for which the total is being reported was not a full day. Anything, such as a time or date change, that shortens a day an hour and twelve minutes or more will cause the asterisk to display.

Where is the daily totals screen?

Main > Utilities > Daily Totals

DAILY TOTALS

Daily Average

Today

09Nov

08Nov

26.5U

48.5U

54.5U

Daily Average date (total) basal and bolus deliveries

112 Chapter: 8

Pump data management

The pump data management feature allows you and your healthcare professional to view and manage your basal and bolus insulin delivery, blood glucose information, and food intake with averages up to 31 days. You can view the details of each day individually. You can also average the data over a specified time period that you select up to (up to 31 days). This is done in the DAYS

TO AVERAGE screen as explained in “Days to average” on page 115.

To view the details of one day:

1 Select a date and press ACT . The following example shows the details for February 27th.

Main > Utilities > Daily Totals > 27 FEB 48.5U

2 The BG AVG (Blood Glucose Average) screen is displayed. This screen shows:

➠ your average blood glucose for the day your high and low blood glucose levels for the day total number of blood glucose values you entered into the pump for the day

To view more data, press .

DAILY TOTALS

Daily Average

Today

Today

26.5U

48.5U

ACT

27FEB BG AVG 128

BG Low/Hi 92/178

Number BGs 6

27FEB INSULIN 112.30U

Basal 60.20/54%

Bolus

Carbs

52.10/46%

253gr

27FEB BOLUS 52.10U

Food 36.50/70%

Corr

Manual

10.30/20%

5.30/10%

3 The INSULIN screen is displayed. This screen shows:

➠ total insulin delivered for the day

27FEB NUM BOLUS 8

Food/Corr 2/ 1

Food + Corr

Manual Bolus

1

4 total Basal and Bolus insulin delivered for the day total percentage of each (Basal and Bolus) delivered for the day total carbohydrates entered into the pump for the day (entered using the Bolus Wizard feature)

To view more data, press

.

4 The BOLUS screen is displayed. This screen shows:

➠ total bolus insulin delivered for the day

➠ total food bolus insulin delivered for the day and total percentage of food bolus insulin delivered for the day total Corr (correction) bolus insulin delivered for the day and total percentage of corr bolus insulin delivered for the day

Utilities 113

➠ total man (manual) bolus insulin delivered for the day and total percentage of manual boluses delivered for the day

To view more data, press

.

5 The NUM BOLUS screen is displayed. This screen shows:

➠ total number of boluses delivered for the day

➠ total number of food only and correction only boluses delivered for the day

➠ total number of food plus correction boluses delivered for the day

➠ total number of manual boluses delivered for the day

To get back to the HOME screen, press four times.

114 Chapter: 8

Days to average

The DAYS TO AVERAGE screen allows you to choose the number of days to average. This example shows the previous 12 days as the number of days to be averaged

DAILY TOTALS

Daily Average

Today

27Feb

26Feb

26.5U

48.5U

54.5U

12

NOTE -

Any day marked with an (*) asterisk is excluded from the average.

ACT

1 Select Daily Average and press ACT .

Main > Utilities > Daily Totals > Daily

Average

DAYS TO AVERAGE

2 The DAYS TO AVERAGE screen is displayed. Select the number of days you want to average by pressing the and the

.

Press ACT.

3 The AVG BG screen is displayed. This screen shows:

➠ the average of all blood glucose values entered into the pump for the previous 12 days the average high and low blood glucose values for the previous 12 days the average number of blood glucose values entered into the pump per day for the previous

12 days

ACT

AVG BG 128 mg/dL

BG Low/Hi 92/178

Number BGs 6.1

AVG INS 112.30U

Basal 60.20/ 54%

Bolus 52.10/ 46%

Carbs 253gr

The flashing number will be the number of days you have available to average (up to

31 days).

AVG BOLUS52.10U

Food 36.50/70%

Corr 10.30/20%

Manual 5.30/10%

To view more data, press

.

4 The AVG INS (average insulin) screen is displayed.

This screen shows:

➠ the average total insulin delivered per day for the previous 12 days

NUM BOLUS 4.2

Food/Corr

Food + Corr

2.1/1

1.1

Manual Bolus 1.0

the average total basal and bolus insulin delivered and total percentage of basal and bolus insulin delivered per day for the previous 12 days the average total carbs entered into the pump per day (entered using the Bolus Wizard feature) for the previous 12 days

To view more data, press

.

5 The AVG BOLUS screen is displayed. This screen shows:

➠ the average total bolus insulin delivered per day for the previous 12 days

Utilities 115

➠ the total average percentage of bolus insulin delivered for the previous 12 days the average total correction bolus insulin delivered per day the total average percentage of bolus insulin delivered per day for the previous 12 days the average total manual bolus insulin delivered per day

To view more data, press .

6 The NUM BOLUS screen is displayed. This screen shows:

➠ the average total number of boluses delivered per day for the previous 12 days

➠ the average total number of food only boluses delivered per day for the previous 12 days

➠ the average total number of correction only boluses delivered per day for the previous 12 days

➠ the average total number of food plus correction boluses delivered per day for the previous 12 days

➠ the average total number of manual boluses delivered per day for the previous 12 days

To get back to the HOME screen, press four times.

Personal reminders

Alarm clock

The alarm clock is a feature that allows you to set daily reminders for various events (8 max). The factory setting for this feature is off. The alarm clock can be useful to remind you when to check your blood glucose, eat, bolus, etc. When the alarm clock goes off, the message, “ALARM

CLOCK” will appear.

12:40P

1 Go to the ALARM OPTION screen.

ALARM

CLOCK

116 Chapter: 8

Main > Utilities > Alarm Clock

2 Select On/Set .

Press ACT .

ALARM OPTION

Off

On/Set

3 Select Add Alarm .

Press ACT .

ALARM CLOCK

Add Alarm

Delete Alarm

Review Alarms

4 Use the or buttons to select the hours (flashing). Press ACT . Use the buttons again to select the minutes

(flashing). Press ACT .

(hours flashing)

ADD ALARM

12:00 (A)

(minutes flashing)

ADD ALARM

3:00 (A)

5

Repeat step 3 and step 4 to program additional alarm clock times. Exit the menus when you are

done.

Remote control option

The factory setting for this feature is off. You may want to explore the remote option after you have become completely familiar with the basic functions of your pump. It is important that you consult with your healthcare professional before using this feature. Remote controls can be purchased from

Medtronic MiniMed.

See the remote control User Guide for operating instructions.

NOTE -

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

To use the remote control, these pump settings must be programmed:

➠ Remote Options = On

➠ Remote control ID code entered in pump (code is on back of remote)

➠ Easy Bolus = On

Utilities 117

Turn on remote control option

WARNING: If there is a “Low Battery” condition, the pump will not receive signals from the remote. To ensure the pump communicates with the remote control, make sure the pump does not have a low battery. (Replacing the low battery with a new battery will restore remote control function.)

1 Go to the REMOTE OPTION screen. Select On and press

ACT .

Main > Utilities > Remote Options

2 The REMOTE ID MENU screen will appear. Add, delete or review your remote ID as described in the next section.

Exit the menus if you are done.

REMOTE OPTION

Off

On

ACT

REMOTE ID MENU

Add ID

Delete ID

Review ID

Add, delete, review remote control IDs

Each remote control has its own unique ID. Up to three (3) different remote control IDs can be programmed in your pump. The remote control programming screens are very similar to those for the meter. Make sure to select “Remote Options” (in the UTILITIES MENU) when programming your remote control.

If you are not sure that your remote control ID is entered in your pump, check the REVIEW REMOTE

ID screen. You have to turn on the remote option to add, delete or review the remote control ID(s) programmed in your pump.

1 In the REMOTE OPTION screen, select On and press ACT .

The REMOTE ID MENU will appear. REMOTE OPTION

ACT

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

Off

On

REMOTE ID MENU

Add ID

Delete ID

Review ID

NOTE -

The remote control RF ID code is on the back of the remote control.

118 Chapter: 8

Add

Select Add ID

ADD REMOTE ID

_ _ _ _ _ _

and press ACT .

Enter each of the six ID numbers.

Press ACT after each.

(flashing)

After you set the last number of the ID, the screen will return to the REMOTE ID MENU.

Delete

Select Delete ID and press

ACT .

Select the remote ID that you want to delete and press ACT .

DELETE REMOTE ID

1 111111

2 222222

3 - - - - - -

The selected ID is now deleted.

REMOTE ID MENU

Add ID

Delete ID

Review ID

Review

Select Review ID and press

ACT .

The programmed IDs will show in the REVIEW REMOTE ID screen.

REVIEW REMOTE ID

1 - - - - -

2 222222

3 - - - - -

3 Exit the menus when your are done.

Block feature

The block allows you to prevent (block) people from changing pump setting that should not be working with the pump s settings. This feature is an important safety feature, especially if the pump user requires someone else to maintain complete control of pump operation. The factory setting for this feature is off. When block is on, the remote control is used to deliver a bolus and suspend the pump. Direct pump programming is limited to suspend, block, and selftest. You can, however, still view status-type screens (STATUS, BOLUS and PRIME HISTORY, BASAL REVIEW, DAILY TOTALS, etc.). Discuss what uses and settings are best for you with your healthcare professional. (You can order the remote control from Medtronic MiniMed.)

Turn block on

NOTE -

The vibrate alert-type is disabled when block is on.

1 Go to the BLOCK OPTION screen.

Main > Utilities > Block

2 Select On and press ACT . The HOME screen will appear with an open circle. The Block option is now on and the pump is in Special mode. Exit the menus.

BLOCK OPTION

Off

On

ACT

Utilities 119

Example 1: Block

Nicholas is a very active toddler who wears a Paradigm pump. His parents don't want to worry that he will play with the pump and accidentally change his programmed settings. They simply activated the Block feature, and now, except for the Suspend and Self-Test, no other features are active when using the pump buttons. When Nicholas needs a bolus, his parents and caregivers simply program it with the Remote Control.

Example 2: Block

Oscar is an elderly man with diabetes who needs assistance with all of his daily living activities. He needs his caregiver or family member to help him with his pump as well. To be sure that Oscar does not change any pump settings, his family programmed his Paradigm pump with the Block feature turned on. They use the Remote Control to give him his boluses when he needs them.

120 Chapter: 8

Lock keypad feature

Lock keypad prevents accidental pump keypad presses. The only button you can press is the to view the STATUS screen. The remote control can be used to give a bolus or put the pump into Suspend.

To lock keypad

1 Go to the Lock Keypad screen

Main > Utilities > Lock Keypad

2 Select Utilities

Press ACT .

MAIN MENU

Basal

Prime

Utilities

ACT

3 Select Lock Keypad

Press ACT .

ACT UTILITIES MENU

Lock Keypad

Alarm

Daily Totals

4 Press ACT to lock keypad.

Press ACT to Lockout

Keypad

ACT

Press ESC to Cancel

KEYPAD LOCKED

To unlock, press B a nd UP keys at the same time

To unlock keypad

1 Press the button and the same time.

button at the

KEYPAD

UNLOCKED

Selftest

Selftest is a safety utility that allows you to check if your pump is operating properly. This selfdiagnostic feature can be used for maintenance or to check your pump if it operates unusually. During selftest, your pump will automatically run internal tests, including a check for proper operation of the beep and vibrate modes. The selftest is additional to the routine tests that run independently while the pump operates.

Contact the Medtronic MiniMed 24-hour Product Help Line if any of the tests do not occur as described here.

NOTE -

If the pump detects a condition such as low battery, the selftest will not finish. A message will appear to show the condition that caused the test to stop.

Utilities 121

1 Go to the UTILITIES MENU. Select Selftest and press ACT .

Main > Utilities > Selftest

2 As part of the selftests, the pump will do these tests:

MAIN MENU

Basal

Prime

Utilities

ACT

UTILITIES MENU

Meter Options

Remote Options

Selftest

NOTE -

Periodically, you will hear beeps as different mechanisms in the pump are being tested. a.

Screen Test:

The screen will appear all black as shown here.

c.

Tone Test:

You should hear beeps.

TONE TEST

3 b.

Selftest:

The pump will count down from 10.

d.

Vibrate Test:

You will feel vibrations.

SELFTEST

10

VIBRATE TEST

1

3 After the selftest is finished, TEST COMPLETE will appear on the screen. The screen will return to the

UTILITIES MENU, then to the HOME screen.

TEST COMPLETE

122 Chapter: 8

User settings

The user settings function allows you to save, restore, and clear all pump settings. You can also view a listing of the dates and times of all recent user settings operations you have done. The Save Settings feature lets you keep a set of pump settings that you can restore to your pump if it is cleared or you need to go back to these settings for any reason.

When you clear your pump, the pump settings are restored to the factory defaults, and you must either use Restore Settings, if you have saved a set of pump settings, or reprogram all your settings before you can use your pump again. The pump does not clear the internal pump memory.

WARNING: Do not clear your pump settings while it is connected to your body.

CAUTION: Do not clear your pump settings unless directed by your healthcare professional or a Medtronic MiniMed representative. If you clear your pump settings, it will be necessary to reprogram all your personal pump settings as directed by your healthcare professional. Additionally, you will have to rewind your pump.

Saving pump settings

Do these steps to save your current pump settings:

1 Go to the Utilities screen and highlight User Settings. Then, hold down and .

Main > Utilities > User Settings

UTILITIES MENU

Selftest

User Settings

Language

ACT

2 The USER SETTINGS screen is displayed with Save Settings highlighted. Press ACT .

USER SETTINGS

Save Settings

Clear Settings

History

ACT

Utilities 123

3 If this is the first time you have saved pump settings, go to step 4 .

If you have previously saved pump settings, a message displays, indicating the date of your last pump settings save. Read the instructions on the screen then press ACT to save your current settings (or press ESC to cancel the save).

Press ACT to over write settings saved

20APR2004 at 9:41A

ESC to CANCEL

ACT

4 The SETTINGS SAVED message displays to confirm that your current pump settings have been saved. Exit the menus.

SETTINGS SAVED

User settings have been saved

920APR2004 at 9:43A

Restoring pump settings

ESC/ACT

Do these steps to restore the most recent pump settings you have saved to your pump.

NOTE -

Regardless of the basal pattern you saved or the current one, Restore Settings always sets patterns to Standard.

1 Go to the Utilities screen and select User Settings. Then, hold down and

Main > Utilities > User Settings

UTILITIES MENU

Selftest

User Settings

Language

ACT

2 The USER SETTINGS screen is displayed. Select Restore Settings and press ACT .

USER SETTINGS

Save Settings

Restore Settings

Clear Settings

ACT

3 A message displays, giving you the option of restoring the pump settings that were saved on the given date and erasing the ones currently on your pump. Read the instructions on the screen then press ACT to restore the settings. (You can press ESC to cancel the restore.)

Press ACT to restore settings saved on

03/10/2004 at 04:15P

ESC to CANCEL

ACT

124 Chapter: 8

4 The SETTINGS RESTORED message displays to confirm that your current pump settings have been replaced with the pump settings you had saved on the given date. Exit the menus and check your pump settings to verify the restore.

SETTINGS RESTORED

User settings have been restored.

PLEASE CHECK SETTINGS

ACT

Clear settings

Take the following steps only if you want to clear your pump to factory default settings.

WARNING: Do not clear your pump settings while it is connected to your body.

CAUTION: Do not clear your pump settings unless directed by your healthcare professional or a Medtronic MiniMed representative.

If you clear your pump settings, it will be necessary to reprogram all your personal pump settings as directed by your healthcare professional. Additionally, you will have to rewind your pump.

1 Go to the Utilities screen and select User Settings. Then, hold down

Main > Utilities > User Settings and press ACT .

UTILITIES MENU

Selftest

User Settings

Language

ACT

2 The USER SETTINGS screen is displayed. Select Clear Settings and press

ACT .

USER SETTINGS

Save Settings

Restore Settings

Clear Settings

ACT

3 A CONFIRM message displays, giving you the option of clearing your pump settings or not. Select YES and press ACT to clear the settings. (You can press ESC to cancel.) No

Yes

CONFIRM

ACT

Utilities 125

4 You will see a RESET screen, and then the pump will go through various screens while it restarts. After the pump clears all of your settings, the screen will go to the TIME/DATE SETUP screen

5

Reset the time and date as described in “Setting the time and date” on page 23.

6 After you set the time and date, you must rewind your pump. See

“Rewinding your pump” on page 47 for instructions. Remember, all your

settings have been cleared and you must either restore or reprogram all your settings.

3:32A

RESET

Settings cleared by user

Reprogram settings

ESC, ACT to clear

History

If you want to view a listing of the dates and times of all recent User Settings operations you have done on your pump, such as saves and restores, take the following steps:

1 Go to the UTILITIES screen and select User Settings. Then, hold down and .

Main > Utilities > User Settings

UTILITIES MENU

Selftest

User Settings

Language

ACT

2 The USER SETTINGS screen is displayed. Select History and press

ACT .

USER SETTINGS

Restore Settings

Clear Settings

History

ACT

3 The SETTINGS HISTORY screen displays, giving you a list of all the dates and times of your most recent User Setting operations. Use the scroll bar to view the entire history. When you are done looking at the history, press ACT / ESC to exit the menu.

SETTINGS HISTORY

15MAR

10MAR

03MAR

12FEB

09:15A

04:15P

10:03A

12:10P

Restor

Save

Save

Restor

ESC/ACT

126 Chapter: 8

Language setting

The language shown on the pump screens can be changed. Some languages will not be available on all pumps. To change the language for your pump, do these steps:

1 Go to the UTILITIES screen, select Language and press

ACT .

Main > Utilities > Language

UTILITIES MENU

Selftest

User Settings

Language

ACT

LANGUAGE MENU

English

Espanol

Francais

2 The LANGUAGE MENU screen is displayed. Select your language and press ACT

3 The language setting is now changed. Exit the menus.

Utilities 127

128 Chapter: 8

Chapter: 9

Troubleshooting

This chapter is designed to help you understand the messages that your pump is giving you when you get an alarm or an alert message. The procedures in the beginning of this chapter are to be used when you get specific alarms or cover a likely condition that might happen. A list of alarms is provided at the end of this chapter.

NOTE -

It is recommended that you read your warranty statement included with your pump for information on what is covered during your warranty period.

My pump has a no delivery alarm...

When a “No Delivery” alarm occurs, it means the pump is working correctly. Your pump is not broken, but it has detected that something is preventing insulin from being delivered. Do the following steps:

1 Check your blood glucose and take an injection if needed.

2 Make sure that there is insulin in your reservoir and the tubing is not kinked. If these are all right, go to step 5 .

3 If necessary unkink the tubing. Clear the alarm by pressing ESC and ACT . A screen will appear with two choices: Resume and Rewind . Select Resume .

4 If the reservoir is empty, clear the alarm by pressing ESC and ACT . Select Rewind and change your

reservoir and infusion set per the instructions in Chapter 4, “Starting on insulin.”

5 Continue troubleshooting by disconnecting at the quick-disconnect, and set a 10 unit Fixed Prime.

6 Does insulin come out of the needle at the quick-disconnect? a.

If yes, change your entire infusion set per the instructions in Chapter 4, “Starting on insulin.”

If NO insulin comes out of the needle at the quick-disconnect, or you receive another No

Delivery alarm, call the 24-hour Product Help Line.

b.

Your pump remembers the last fixed prime you deliver, so make sure to set your fixed prime amount back to your usual setting. To do this, deliver another fixed prime in your normal amount (the amount specified in your infusion set instructions).

Troubleshooting 129

7 Monitor your blood glucose closely.

8 If you followed these steps and you are still receiving a No Delivery alarm, call the 24-hour Product

Help Line.

What happens if I leave the battery out too long?

If you leave the battery out too long (more than five minutes) you may receive a BATT OUT LIMIT alarm message when you install the new battery. Do the following steps:

1 Set your pump clock to the correct time, date, and year.

2 Check to make sure that all your settings, such as basal rate, are set as desired. If need be, reapply your last saved settings to the pump by using the Restore Settings option under User Settings in the

UTILITIES menu as described in chapter 8 (you can only use this option if you have previously saved your pump settings).

3 Check the ALARM HISTORY screen and the STATUS screen for any alarms and/or alerts that may still need attention.

Why doesn’t my pump battery last very long?

A short battery life does not necessarily mean something is wrong with your pump.

Battery life in your pump is variable and based on the conditions below. As a result, your battery life will vary.

The brand of battery you use (we recommend Energizer).

The way the battery was stored and/or handled before use (avoid high or low temperatures).

How you use your pump. For example: how often the buttons are pushed, the number of alerts/alarms and set changes.

How much insulin you are delivering.

➠ Use of some features. The backlight, vibrate, remote control and/or meter options decrease battery life.

What is a CHECK SETTINGS alarm?

This alarm occurs after an E alarm or after you clear your pump. It is advising you to make sure that all your settings are correct. A CHECK SETTINGS alarm occurs after any of these actions:

➠ all user settings were cleared (set back to their defaults) because there was an E-error alarm, the “Clear Settings” function was performed,

130 Chapter: 9

➠ or after you rewind when practicing without a reservoir when your first get your pump. In this case, it is just a reminder to make sure all your settings are programmed before you begin using the pump with insulin.

My screen appears distorted

The screen may appear distorted or have a “rainbow” appearance if you are wearing polarized sunglasses, are in bright sunlight, or in extreme high or low temperatures. If your screen appears distorted:

Take off your sunglasses.

Move into the shade.

➠ Make sure your pump is not in direct heat (i.e., next to a heater) or cold (worn on the outside of your clothing on a very cold day).

Do not return the pump: this is a normal property of this type of screen on any device.

I cannot get out of the priming loop

1 Is the reservoir in the pump full?

➠ If no, place a full reservoir or shipping cap in the pump.

➠ If yes, make sure you are disconnected from the pump.

2 Hold the ACT button until the second set of beeps and the numbers appear on the screen.

If yes, your pump is okay, go to step 4 in the “Manual prime” instructions on page 49 to finish the

manual prime.

➠ If you did not hear a second set of beeps or numbers did not appear on the screen, change your infusion set and repeat this step.

3 If you still do not hear the beeps and see the numbers count up on the screen, call the 24-hour

Product Help Line.

The pump is asking me to rewind

This is normal after any of the following:

1 any E-alarms,

2 the Clear Settings function,

3 or, a “No Delivery” Alarm (during the Prime sequence).

Troubleshooting 131

My bolus stopped

The Bolus Stopped error can occur if the battery cap is loose or the pump was bumped or dropped during a bolus. It can also happen if the pump receives a static shock. As a safety measure, the pump stops the bolus when this happens.

1 If you dropped your pump, visually inspect it to make sure that it is not damaged in any way.

2 Review your bolus history and reprogram the remaining bolus, if needed.

My pump buttons are not acting right during a bolus

If any button is pressed and held down while a bolus is being delivered, the screen will freeze on that amount. Once the button is released, the units will ramp up to the amount delivered so far.

Pressing and holding down the button will not stop the delivery of a bolus.

My pump won’t display my blood glucose reading from my meter

1 Make sure you are using the correct meter (Paradigm Link Blood Glucose Monitor Powered by BD

Logic Technology). Your pump will communicate with this meter only.

2 Make sure your meter is on (set to “snd”) and working correctly.

3 Make sure the meter option in your pump is set to “on” and you have set the meter ID number correctly on the pump.

4 Make sure your pump does not have a low battery alert condition.

5 Make sure the meter is within 4 feet (1.2 meters) of the pump without anything in between such as another person, a wall, etc.

6 Make sure there is no RF (radio frequency) interference from other electronic devices that could prevent communication. These devices can include some cell phones, cordless phones, televisions, computers, radios, other Paradigm pumps meters and pump remote controls. To restore communication, simply move away from these other types of devices, or turn them off.

7 Your pump will not show another reading. Make sure the pump is idle and the HOME screen is blank.

8 If your pump still does not receive your blood glucose reading from the Paradigm Link meter, use the up/down buttons to manually enter your blood glucose (in the ENTER BG screen).

132 Chapter: 9

I dropped my pump

Take care to protect your pump from being dropped.

1 Check that all connections are still tightly in place.

2 Check the LCD, keypad and pump case for cracks or damage.

3 Check infusion set, including the tubing connector and tubing for cracks or damage.

4 Review the status screen, basal rates and other pump settings.

5 Perform the Selftest procedure located in the UTILITIES MENU.

6 Call the Medtronic MiniMed 24-hour Product Help Line for assistance.

I submerged my pump in water

Your pump is designed to resist accidental contact with water. Do not submerge in water during bathing, swimming, or other water activities.

1 Pat the outside of the case until dry.

2 Open the reservoir compartment and check the compartment and reservoir for water. If wet, dry it completely within ten (10) minutes of exposure to water. Exposure to liquids, including water or insulin can corrode the mechanism.

3 Dry the reservoir completely—do NOT place a wet reservoir in the pump.

4 Do not use hot air to dry your pump. This may damage your pump's internal electronics.

5 Check the battery compartment and the battery—if wet, let them dry completely before using the pump.

6 Perform a selftest.

Troubleshooting 133

I cannot get to the User Settings menu

If you do not hold down the button while pressing ACT when you have User Settings highlighted, you will see the following screen:

1 Go to the Utilities screen and highlight User Settings. Then, hold down the button and press ACT.

2

See “User settings” on page 123 for information about the menu

options.

Alert conditions

Your pump has a sophisticated network of safety checks and systems. If it detects an unusual condition that requires your immediate attention, it will beep or vibrate periodically to alert you. The pump will go into Special mode (an open circle will display), and the backlight will illuminate. The alert message will also appear on the screen.

This feature is not normally accessible. To access, consult your

User Guide.

➠ Dual Wave or Square Wave bolus delivery

➠ Pattern A or B is active

➠ Temp basal delivery

➠ Block feature is on

➠ Low reservoir

➠ Low battery

➠ Why are alerts important?

Your pump monitors activities and will alert you if a Special mode is active. Some alerts are a normal part of pump therapy, such as an active temporary basal. There are alerts that indicate a condition that is outside normal pump activity. For example, your pump notifies you with an alert when you need to replace the reservoir (LOW RESERVOIR) or replace your pump battery (LOW BATTERY).

What to do

When your pump beeps or vibrates notifying you that an alert condition exists:

1 Read and follow the instructions on the screen. Press ESC , ACT to silence an alert.

2 Check the STATUS screen to determine what caused the alert.

3 If the condition is due to a low battery, replace the battery.

4 If the condition is due to a low reservoir, monitor the reservoir volume frequently and change the reservoir when appropriate. Make sure you have a new reservoir, infusion set and vial of insulin with you.

134 Chapter: 9

Low reservoir alert

You can program the pump to sound an alert when either a specified number of units remains or a specified amount of time remains before the reservoir will be empty.

3:36P

LOW

RESERVOIR

ESC, ACT to clear

Low battery alert

If you get this alert, DO NOT go to sleep without replacing the battery.

The backlight and the remote and Paradigm Link meter functions are disabled during a LOW BATTERY condition. If the alert type is set to

“vibrate,” the pump will change to the audio alert “beep-medium.” Clear

( ESC , ACT ) this alert before you replace your battery.

10:09A

LOW

BATTERY

Replace battery now

Use 1 AAA

ESC, ACT to clear

Alarms

Your pump has a sophisticated network of safety checks and systems. If the safety network detects anything unusual, your pump notifies you of conditions that require your immediate attention. The backlight illuminates the pump screen and the alarm/alert message displays on the screen.

NOTE -

The STATUS screen shows any alarms and alerts that are active.

➠ Why are alarms important?

Your pump monitors activities and notifies you if there is an unusual pump status or your attention is required. When an attention alarm is active, INSULIN DELIVERY IS STOPPED and immediate operator interaction is required.

An alarm gradually becomes higher in pitch until you turn it off. If the vibrate mode is on, all alarms and alerts start as vibrations and then change to beeps. For your safety, if there is no response after ten

(10) minutes, the beeps change to a siren. The siren continues every minute until the alarm is cleared.

when a solid circle appears, follow the instructions on the screen.

Troubleshooting 135

What to do

When an alarm is triggered, the pump goes into Attention mode and an alarm message shows on the screen. The pump then defaults to the HOME screen. Do these steps when you get an alarm:

1 View the alarm. From the HOME screen, press any button to see the alarm message.

2 Read all of the alarm text. There are instructions on how to fix the alarm condition. (Press to read more text, if available.)

(any button)

ALARM

MESSAGE

/

3 Clear the alarm. Press ESC then ACT after you read the alarm instructions.

Alarm description and instructions show here.

ESC, ACT

4 The HOME screen appears.

5 Follow the instructions that appeared with the alarm to fix the alarm condition.

6 Check your settings (i.e., time/date, basal, etc.) to make sure they are correct.

136 Chapter: 9

Alarm conditions

Alarms put the pump in “Attention” mode.

A (Alarm)

This alarm shows an “A” followed by two numbers. A-alarms cause all insulin delivery to stop. Your pump settings are retained. If this alarm repeats often, call the Medtronic MiniMed 24-hour Product Help Line for assistance.

9:42A

Pump reset

Settings preserved

ESC, ACT to clear

Axx

XX indicates the alarm number

Auto off

Alerts you that no buttons were pressed during the time limit you set for the AUTO OFF DURATION feature, and so insulin delivery has been stopped.

11:17A

Delivery stopped No buttons pushed during time limit

ESC, ACT to resume delivery

AUTO

OFF

Batt out limit

Occurs if the battery has been out of the pump for more than five minutes. Verify that the pump time and date are correct. If not correct, go to the Utilities Menu and reset the date and time.

12:00A

BATT

OUT LIMIT

Batt change too slow

ESC, ACT to clear

Bolus stopped

If this alarm occurs, it is very important to check bolus history to review how much of the bolus was actually delivered. If necessary, reprogram a bolus with the amount not yet delivered.

8:35A

BOLUS

STOPPED

Loose battery cap?

Pump dropped or bumped?

Check bolus history,

Reprogram bolus if required

ESC, ACT to clear

Troubleshooting 137

Button error

Occurs if a button has been continually pressed for more than 3 minutes.

10:05A

BUTTON

ERROR

Button pressed for more than 3 min

ESC, ACT to clear

Check settings

When this alarm is active, you should check and/or reprogram your pump settings, including the time/date.

E (Error)

After receiving this alarm, note the error number then call the

Medtronic MiniMed 24-hour Product Help Line for assistance. An error alarm will show an “E” followed by two numbers. E-alarms cause all insulin delivery to stop, the pump resets, and all your settings are cleared.

Empty reservoir

There is no insulin in the reservoir. Change the reservoir immediately.

Failed batt test

The pump tests the voltage of each battery installed. This test ensures a battery with low voltage is not used. If the battery does not have enough voltage, this alarm will occur. The pump will not function and the battery must be replaced. (Always make sure that you install a NEW battery into the pump.)

8:35A

CHECK

SETTINGS

Delivery stopped

Reprogram settings

ESC, ACT to clear

5:30A

Settings cleared

Reprogram settings

Call help-line for assistance

Exx

ESC, ACT to clear

XX indicates the error number

3:36P

EMPTY

RESERVOIR

Delivery stopped

Change reservoir

ESC, ACT to clear

8:35A

FAILED

BATT TEST

Delivery stopped

Replace battery now

Use 1 AAA

ESC, ACT to clear

138 Chapter: 9

Is priming complete?

If you manually prime your pump with more than 30u insulin, this message appears. Press ESC , ACT to clear the message. If manual prime is complete, press ESC . If the manual prime is not complete, press and hold ACT until manual prime is complete.

Max delivery

This alarm alerts you when you have taken more insulin than expected based on maximum bolus and maximum basal rates.

IS PRIMING

COMPLETE?

Disconnect from body

See user guide for instruction

ESC, ACT to clear

3:25P

MAX

DELIVERY

Exceeded 1 hour max delivery

Check BG

ESC, ACT to clear

Motor error

Insulin delivery has stopped. This alarm occurs if your pump detects a motor error.

3:25P

MOTOR

ERROR

Delivery stopped

Disconnect set

ESC, ACT to clear

No delivery

Insulin delivery has stopped. This alarm occurs if your pump detects a blockage.

11:17A

NO

DELIVERY

Delivery stopped

Change entire set

Check BG

See user guide to troubleshoot

ESC, ACT to clear

No reservoir

The reservoir is not inserted correctly or no reservoir has been inserted.

4:36P

NO

RESERVOIR

Delivery Stopped

Change reservoir set

ESC, ACT to clear

Troubleshooting 139

Off no power

The battery is dead. Replace battery immediately. Follow the directions on the screen. Check to make sure that the time is correct on the screen.

Reset the time if necessary.

04:42

OFF

NO POWER

0% battery life

Delivery stopped

Replace battery now

Use 1 AAA

ESC, ACT to clear

Reset

The Reset alarm triggers when pump settings are cleared because of one of these reasons:

➠ Pump settings were cleared (Clear Settings function) and settings have not been reprogrammed.

8:35A

RESET

Settings cleared by user

Reprogram settings

ESC, ACT to clear

A download attempt from the PC is incomplete. (The download function is applicable to the optional software feature. See the software User Guide for more information.)

Weak Battery

The pump tests the voltage of each battery installed. If the battery voltage is less than full strength, this alarm may occur. The pump will operate normally, but the battery life will be shorter than expected. Always make sure to install a NEW battery in the pump.

11:17A

WEAK

BATTERY

Shorter battery life expected

ESC, ACT to clear

140 Chapter: 9

Chapter: 10

Pump maintenance

It is recommended that you read your warranty statement included with your pump for information about what is covered during your warranty period.

Battery

The Paradigm pump uses a AAA battery. As a safety measure, Medtronic MiniMed has designed the pump to only accept a NEW battery. If you insert a used battery, the “failed batt test” alarm may be

triggered. See “Install battery” on page 12 for instructions.

The use of cold batteries causes erratic pump behavior. To prevent this, do not use batteries that have been in cold storage (i.e., in the refrigerator or your car in the winter). It takes several hours for these batteries to warm to room temperature.

Certain features on the pump use a lot of battery power. Your battery will need to be replaced more frequently if you use these features:

➠ Remote control ➠ Paradigm Link meter ➠ Backlight ➠ Vibrate alert type setting

CAUTION: It is recommended that you use a AAA Energizer battery. Do not use a rechargeable or carbon zinc battery in the pump. Do not remove the battery unless you are changing your battery (installing a NEW battery). Replace it within five (5) minutes. If not replaced within five (5) minutes, the screen may display an alarm message. Follow the instructions in the message and make sure the time and date are set correctly. Install a new battery if the battery was placed backwards in the pump.

Storage

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 remote and meter options, and set the Auto-off to dashes or zeroes.

Pump maintenance 141

Cleaning your pump

1 Use only a damp cloth and mild detergent mixed with water to clean the outside of your pump.

2 Rinse the pump with a clean cloth, dampened with clean water.

3 Dry with a clean cloth.

4 Never use organic solvents, such as lighter fluid, nail polish remover, or paint thinner to clean your pump.

5 Keep the reservoir compartment and battery compartment dry and away from moisture.

6 Do not use any lubricants with your pump.

7 Use a 70 percent alcohol wipe to disinfect your pump.

142 Chapter: 10

Chapter: 11

Pump specifications

This section provides detailed information on specifications related to your pump. The safety features of your pump are individually listed and described.

Alarms and error messages

Indicators: audible tone (beep) or vibration (silent)

All alarms and errors show messages on the pump’s screen and provide instructions on what to do.

Unresolved alarms will escalate to siren mode for added safety.

Alarm history

➠ The maximum records shown is 36

Backlight

Display type Liquid Crystal Display (LCD)

Time-out period is 30 seconds. The backlight will turn off when you do not push any buttons for 30 seconds or more.

Basal

Maximum patterns

3 patterns (with 48 delivery rates for each pattern) delivery rate rate increments: lowest possible rate:

0.05 units/hour

0.05 units/hour highest possible rate: 35.0 units/hour factory maximum rate: 2.0 units/hour warning limits lower limit: upper limit: less than 90 mg/dL greater than 140 mg/dL

Pump specifications 143

BG (blood glucose) target

Maximum BG targets

8

(mg/dL)

(mmol/L)

60 – 250

3.3 – 13.9 lower limit: upper limit: less than 90 mg/dL greater than 140 mg/dL

Bolus delivery

Insulin delivered/stroke Fluid delivered/stroke Time between/delivery strokes Delivery rate (per minute)

0.05u

0.5 µL 2 seconds 1.5u

Bolus history

Maximum records shown: 24

Bolus units

Increments: 0.1 units

Bolus Wizard feature

(See “Bolus Wizard feature examples” on page 152 for information.)

Carb ratios

Maximum ratio settings:

8 3 – 150 grams/u

0.1 – 5.0 u/exch less than 5 or greater than 50 grams/u less than 0.3 or greater than 3.0 u/exch

Carb units

The food entry ranges when using Bolus Wizard feature:

➠ grams: exchanges:

0 – 300 (increments: 1 gram)

0.0 – 20 (increments: 0.5 exch)

Daily totals

Maximum records shown: 31 days of data, maximum display: 999.95 units/day. Accuracy: +0/–0.05 units

Default screen

The HOME screen. If no buttons are pressed for 30 seconds (60 seconds for status type screens), the pump returns to this screen.

144 Chapter: 11

Pump motor

The pump motor has a unique, patented design with an integrated safety check system. The system delivers in precise increments.

Dual Wave bolus

Delivers a normal bolus followed by a Square Wave bolus (limited by maximum bolus).

Easy bolus

Features programming using audible tones (or vibrate pulses) in user-defined increments. Beep mode range: 0 to maximum bolus; Vibrate mode range: 0 to 20 steps or maximum bolus, whichever comes first.

Default step increment:

Step size

0.1 unit

< maximum bolus.

Adjustable step size: 0.1 to 2.0 units per step.

Accessible from the remote control or pump buttons.

Infusion pressure

Maximum infusion pressure and occlusion pressure:

13.7 PSI (pounds per square inch)

94,46 kPa (Kilopascal)

(Insulin) sensitivity

Maximum settings: factory setting:

8 range:

50 mg/dL (2.8 mmol/L) (mg/dL) 10 – 400 mg/dL

(mmol/L) 0.5 – 22.2 mmol/L warning limits: less than 20 or greater than 100 mg/dL less than 1.1 or greater than 5.6 mmol/L

Low resv (reservoir) warning

Values are based on displayed amount, not actual amount. time: units:

2 – 24-hours, and @ 1:00 hour before empty

5 – 50 units, and @ 1/2 amount remaining

08:00 hours (default when time is selected)

20 units (factory default)

Pump specifications 145

Meter value

The blood glucose measurement received from Paradigm Link meter. Appears in the ENTER BG screen during bolus programming. Appears on the screen when the pump is idle at the HOME screen.

Maximum ID entries expiration: range:

3 12 minutes (mg/dL) 20 – 600

(mmol/L) 1.1 – 33.3 less than 20 or greater than 100 mg/dL less than 1.1 or greater than 5.6 mmol/L

Normal bolus

Range 0.1 – 25.0 units of insulin (limited by maximum bolus setting).

Occlusion detection

When occlusion is detected, the “no delivery alarm” will occur. The occlusion alarm is triggered by an average of 2.77 units of “missed” insulin. This table shows occlusion detection for 3 different situations when using U100 insulin.

Rate bolus delivery (1.5 u/minute) basal delivery (1.0 u/hour) basal delivery (0.05 u/hour)

Minimum time before alarm

92 seconds

2.2 hours

37.4 hours

Typical time before alarm

116 seconds

3.09 hours

59.2 hours

Maximum time before alarm

162 seconds

4.47 hours

87 hours

Percent temp basal

Default value: 100% of basal programming

Power supply

The pump is powered by a standard 1.5 V AAA alkaline battery (Energizer brand recommended).

Prime function

Fixed prime range0.1 – 25.0 units (limited by maximum bolus)

Manual prime limit: warning at 30 units, then at each 10 units thereafter.

Fill rate: ........ 1 to 5 units/second.

NOTE -

Prime insulin is not counted in daily totals but is recorded separately in the prime history.

Prime history

Maximum records shown: 20 (manual and fixed)

146 Chapter: 11

Program safety checks

Maximum infusion with single fault condition: 0.0 ml.

Pump size

The dimensions of the pump are:

515 Pump:

715 Pump:

(inches) 2.0 x 3.0 (2.8 at the battery cap) x 0.77

(cm) 5.0 x 7.6 (7.1 at the battery cap) x 2

(inches) 2.1 x 3.7 (3.5 at the battery cap) x 0.8

(cm) 5.3 x 9.4 (8.9 at the battery cap) x 2.0

Pump weight

515 Pump:

715 Pump: approximately 100 grams (with battery installed) approximately 108 grams (with battery installed)

Remote control

Uses radio signals to allow users to program Normal boluses or to suspend/resume their pumps.

Reservoir

The user-filled reservoir is made from impact-resistant, insulin-compatible polypropylene.

515 Pump:

715 Pump: up to 176 units of U100 insulin up to 300 units of U100 insulin

Square Wave bolus

Delivers bolus insulin over a duration of 30 minutes up to 8 hours (limited by the max bolus setting).

Temporary (temp) basal rate

Allows you to temporarily change the current basal rate for a duration of 30 minutes up to 24-hours (limited by maximum basal setting). The temp basal rate can be set to either Percent of basal or Insulin rate.

Time and date screen

12-hour or 24-hour formats. Pump users set the time/date, including the year, month and day. The date/time always appears on the top of the screen and in the status screen.

Pump specifications 147

Status screen

➠ Alarm Clock:*

➠ Auto-off:

➠ Basal pattern information:

➠ Battery Status:

➠ BG meter value: (most recent

BG value received)

➠ BG Reminder:* (Only if enabled)

➠ Current date:

Current temp basal information:

Last bolus information:

Meter Off, Low Batt:

Meter On:

Pump model number:

Remote On:

Reservoir started:

Serial number:

(appears if scheduled to alarm)

(appears if enabled)

(if active)

(always appears)

(appears if BG meter is enabled)

Time remaining before BG reminder is set to go off H:MM h (if less than 1 hour, 0:XXh where XX is minutes remaining)

Time set is displayed.

X HR

Pattern A or B

Normal, Low, Off

XXXmg/dL time and date received

ON

(always appears)

(if active) rate (units per hour), duration, time remaining type and units delivered delivery time and date

(appears if enabled but battery is low or empty)

(appears if enabled)

(always appears)

(appears if enabled)

(always appears)

(always appears)

(‘S’-Square, ‘N’-Normal, ‘D’-Dual) date, time, units left, time left

148 Chapter: 11

➠ Standard basal delivery data: (always appears) current basal rate (basal 1, basal 2, etc.)

➠ Status of pump (i.e., Rewind, Suspended,

Low Reservoir, Set Time, etc.)

*If all Reminders and Alarm Clock are enabled, only the reminder nearest to alarming will appear in the STATUS screen.

Pump specifications 149

Bolus Wizard feature specifications

There are three different formulas the Bolus Wizard feature uses to estimate a bolus, depending on your current blood glucose: food estimate correction estimate

1 If current blood glucose is greater than your High Target BG

= food carb ratio

+ current BG – High BG Target

– active insulin insulin sensitivity

2 If current blood glucose is less than your

Low Target BG

= food estimate food carb ratio

+ correction estimate current BG - Low BG Target insulin sensitivity

= food estimate food carb ratio

+ correction estimate

3 If current BG is between or = High or

Low Target BG

Notes:

If a Dual Wave bolus is less than the estimate due to the max bolus limit or a user change, the square (sq) portion is reduced first.

Based on the Active Insulin Time setting you choose, the pump keeps track of how much insulin is still active in your body. This prevents “stacking” of insulin, and lowers the chances of hypoglycemia.

Active Insulin Curves

0

ESTIMATE DETAILS

Est total:

Food intake:

(Meter) BG:

4.0U

45gr

160

Food:3.0U Correction: 2.0U

Active Ins: 1.0U

(values shown are for example only)

ACT to proceed,

ESC to back up

150 Chapter: 11

Active Insulin Curve

60%

50%

40%

30%

20%

10%

0%

0

100%

90%

80%

70%

8 Hour

7 Hour

6 Hour

5 Hour

4 Hour

3 Hour

2 Hour

1 2 3 4

Time (hours)

5 6 7 8 9

Active insulin only reduces the correction portion of the estimate, not the food portion.

For a current blood glucose that is above the high target, if the active insulin is more than the correction estimate, the correction portion of the estimate is changed to zero (0).

For a current blood glucose that is below the low target, if the active insulin is more than the correction estimate, the active insulin is not considered.

Pump specifications 151

Bolus Wizard feature examples

Settings:

➠ Carb ratio: 30 grams/unit

➠ BG Target: 90-120 mg/dL

➠ Insulin Sensitivity: 40 mg/dL/unit

➠ Active Insulin Time: 6 Hours

#1: No active insulin from previous bolus delivery. User inputs 60 grams of carbs and does not enter blood glucose.

(food estimate)

60g

30g/u

= 2 units estimate = 2 units

#2: No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a blood glucose of 200.

(food estimate)

60g

30g/u

= 2 units

+

(correction)

200mg/dL - 120mg/dL

= 2 units

40mg/dL/u

= 2 + 2

= 4 units estimate = 4 units

152 Chapter: 11

#3: No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a blood glucose of 70.

(food estimate)

60g

30g/u

= 2 units

+

(correction)

70mg/dL - 90mg/dL

40mg/dL/u

=

-20mg/dL

40mg/dL

= -0.5 unit

= 2 + (-0.5)

= 1.5 unit estimate = 1.5 unit

#4: No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a blood glucose of 100.

(food estimate)

60g

30g/u

= 2 units

+

(correction)

Correction is 0 because the current blood glucose reading is between the BG High and Low targets

= 2 + 0

= 2 units estimate = 2 units

#5: Previous bolus activity results in a calculation of 1.5 units unabsorbed (active) insulin. User inputs 60 grams of carbs and a blood glucose of 200.

(correction) (food estimate)

60g

30g/u

= 2 units

+ 200mg/dL - 120mg/dL

40mg/dL/u

- 1.5 units (active insulin) = 2 - 1.5

= 0.5 units

= 2 + 0.5

= 2.5 units estimate = 2.5 units

Pump specifications 153

#6: Previous bolus activity results in a calculation of 3.5 units unabsorbed (active) insulin. User inputs 60 grams of carbs and a blood glucose of 200.

(food estimate) (correction)

60g

30g/u

= 2 units

+ 200mg/dL - 120mg/dL

- 3.5 units (active insulin) = 2 - 3.5

40mg/dL/u

= -1.5 units*

= 2 + 0

= 2 units estimate = 2 units

* This negative number indicates that active insulin is sufficient to cover the correction that is needed. Thus, correction will be 0 units. Active insulin does not reduce the food portion of the estimate.

Default (factory) settings

Menu Item Default Setting Limits

Bolus

Menu:

Bolus Wizard feature: Off

Easy bolus: On

Easy bolus step: 0.1 u/h

Dual/Square bolus: Off

Maximum bolus:

10.0 u/h

BG reminder: Off maximum bolus setting

0 - 25 u (per single bolus)

0:00 - 5:00

Increments Warning

Limits

0:30 (minutes)

Basal

Menu:

Patterns: Off

Maximum basal rate: 2.0 u/h

Basal rate: 0.0 u/h

Temp basal type: U/H

0.00 - 35.00 u/h max basal rate setting

0.05u

0.05u

0.05U/H (or

5%)

(basal rate =

0.0)

154 Chapter: 11

Menu

Utilities

Menu:

Item Default Setting Limits

Lock Keypad: Off

(Alarm) History: (no defaults)

Alert type: audio, beep-med

Auto-off: Off

Low reservoir warning: (20) insulin units 5 - 50 u; 2nd: @ 1\2 amount

(2:00 - 24:00; 2nd: after 1:00)

(Time/Date) Time: 12 a.m. (midnight)

(Time/Date) Date: 1/1/04

(Time/Date) Time format: 12-hour

Block: Off

Alarm clock: Off

Remote option: Off

Meter option: Off

User Settings: (no defaults)

Language: English

Increments Warning

Limits

20 u

(0:30 mins)

Pump specifications 155

Menu Item Default

Setting

Bolus Wizard feature Settings carb units: grams or exchanges ins to carb (or exch) ratio: 15 grams/u or

1 unit/exch

(insulin) sensitivity: 50 mg/dL or

2 .8 mmol/L

BG target: 100- 100 mg/dL or

5.6-5.6 mmol/L

Active Ins Time 6 Hours

Limits none

3 - 150g/u or

0.1 - 5.0 u/exch

10 - 400 mg/dL or

0.5 - 22.2 mmol/L

60 - 250 mg/dL or

3.3- 13.9 mmol/L

2 - 8 Hours

Increments Warning Limits none

1 g/u or

0.1 u/exch

1 mg/dL or

0.1 mmol/L

1 mg/dL or

0.1 mmol/L

1 hour none

5 - 50 g/u or

0.3 - 3.0 u/exch

20 - 100 mg/dL or

1.1 - 5.6 mmol/L

90 - 140 mg/dL or

5.0 - 7.8 mmol/L

156 Chapter: 11

Icon table

Do not reuse

Attention: See Instructions for Use

Method of sterilization using ethylene oxide

Date of manufacture (year - month)

Manufacturer

Batch code

Configuration

Use by (year - month)

Catalogue number

Device serial number

Storage temperature range

Fragile product w r

LOT

REF

SN

Type BF equipment (Protection from electrical shock)

Conforms to IEC60601-1 sub-clause 44.6 and IEC60529 standard

Country

Language of Instructions for Use

Recycle

Radio communication

Pump specifications 157

158 Chapter: 11

Index

Symbols

μL xxi

Numerics

24-hour Product Help Line 1

A

accept xvii

accessories,

activity guard 5 holster 5 leather case 5

meter 3

pump clip 5

remote control 3

ACT button 14

active insulin time, setting 72

active insulin,

definition xvii

information about 64

alarm clock feature xvii

ALARM HISTORY screen xvii, 109

alarm,

conditions 137

definition xvii

alarms,

’A’ alarm 137

’auto off’ 137

’batt out limit’ 137

’bolus stopped’ 137

’check settings’ 130, 138

’E’ (error) 138

’empty reservoir’ 138

’failed batt test’ 138

’max delivery exceeded’ 139

’no delivery’ 129

details 109

maximum number records in history 143

responding to 135

reviewing 109

alert,

conditions 134

definition xvii

setting the type 109 types 109

alerts,

’low battery’ 135

’low reservoir’ 135

alerts, what to do 134

assistance

24-hour Product Help Line 1

Attention mode xvii, 18

auto-off feature 110

B

backlight time-out period 143

backlight,

definition xvii

described 17

basal delivery rate,

current 36 daily 36

maximum limit 38

setting 34

basal delivery,

factory maximum rate 143 highest possible rate 143 lower warning limit 143 lowest possible rate 143 maximum number of patterns 143 rate increments (steps) 143

stopping 39

upper warning limit 143 warning limits 143

Basal menu,

described 19

factory settings 154

basal rate,

definition xvii

patterns 95

standard xxiii

temp (temporary) feature 99

BASAL REVIEW screen xvii

battery,

compartment 11

installation 12

requirements 141

BG (blood glucose) reminder xvii

BG (blood glucose) target range,

definition xviii

setting 70

BG (blood glucose) units,

definition xviii

selecting 69

Index 159

BG (blood glucose),

definition xvii

block feature,

definition xviii

turning on 119

BLOCK OPTION screen 119

blood glucose (BG) target range,

mg/dL 144 mmol/L 144

blood glucose (BG) target warnings,

lower limit 144 upper limit 144

blood glucose (BG) targets,

maximum number of 144

blood glucose meter data,

and Carelink™ 4 downloading 4

bolus xviii

bolus deliveries,

history of 29

viewing details on 30

bolus delivery specifications,

amount of fluid delivered per pump stroke 144 amount of insulin delivered per pump stroke 144 time between pump strokes 144 units delivered per minute 144

bolus delivery stopped, what to do

132

BOLUS HISTORY screen xviii

bolus insulin delivery,

basic types 24

Dual Wave bolus (manually) 84

Dual Wave bolus (using Bolus

Wizard feature) 89

maximum limit 31

normal bolus (using Easy Bolus feature) 92

160 Index normal type,

described 24 procedure (Express Bolus feature) 24 procedure (menu) 24

Square Wave bolus (manually) 84

Square Wave bolus (using Bolus

Wizard feature) 89

stopping 39

types,

Dual Wave 83 normal 83

Square Wave 83

Bolus menu,

described 19

factory settings 154

Bolus Wizard feature,

"Bolus Wizard is off" message 72

"Bolus Wizard setup is complete" message 72

"Missing info" message 72

definition xviii

estimate details 30

How it works 62

information about 59 information needed to use 59

maximum bolus limit 63

on/off 66

review settings 73

settings,

BG units 60

Carb ratios 60

Carb units 60

Insulin sensitivity 60

specifications 150

What is it? 59 your blood glucose (BG) reading

59 your personal settings 59

Bolus Wizard feature, examples 152

Bolus Wizard feature, specifications

150

buttons,

ACT 14

Down 14

Easy Bolus 14

ESC 14

Express Bolus 14

Up 14

C

can’t get out of the priming loop, what to do 131

carb ratio xviii

carb ratios,

calculating meal boluses xxiv

maximum number of settings 144 range (grams/u) 144 range (units/exch) 144

using exchanges as Carb units 67 using grams as Carb units 67

warning limits (grams/u) 144 warning limits (u/exch) 144

carb units,

definition xviii

food entry range (exchanges) 144 food entry range (grams) 144

information about 67 setting 67

CH (Carbohydrate) xviii

CHECK BG message 32

check settings alarm, what to do 130

child block feature 119

cleaning your pump 142

clearing factory settings 125

correction bolus factor xviii

correction bolus,

amount of insulin needed xviii corr bolus amount xviii definition xviii formula for calculating xviii

procedure (Bolus Wizard feature)

77

D

DAILY TOTALS screen,

reviewing daily insulin totals 112

daily totals,

definition xviii

maximum number of records 144

default (factory) pump settings 154

display type (pump) 143

disposable parts 3

DKA (Diabetic Ketoacidosis) xviii

Down button 14

downloading,

blood glucose meter data 4 pump data 4 using Medtronic CareLink™

System 4

dropped my pump, what to do 133

Dual Wave bolus,

definition xix

information about 83

now portion 85

programming (manually) 84

programming (with Bolus Wizard feature) 89

square portion 90

turning on-off 84

duration xix

E

Easy Bolus button 14

Easy bolus,

canceling 93

definition xix

delivering 92 step value 92

emergency kit 2

ESC button 14

using to cancel programming 20

Exch ratio xix

Express bolus xix

Express Bolus button 14

F

factory settings (pump) 154

fixed prime,

amount of insulin needed 55

definition xix

procedure 55

food bolus,

definition xix

how Bolus Wizard feature estimates 62

procedure (Bolus Wizard feature)

77

food entry 59

G

Gastroparesis xix

Glossary xvii

H

HbA1c xix

HDL (High-density lipoprotein) xix

high blood glucose,

Bolus Wizard feature notice 63

history,

maximum number of alarm records 143

maximum number of bolus delivery records 144 maximum number of daily totals records 144

maximum number of prime records (fixed and manual) 146

user setting saves and restores

126

hold xix

HOME screen 15

I

idle xix

information needed to use Bolus

Wizard feature 59

infusion pressure, maximum 145

infusion set,

changing 46

infusion sets 3

installing the battery 12

insulin sensitivity,

definition xix

factory setting 145

information about 69

maximum number of settings 145

normal range 69

range (mg/dL) 145 range (mmol/L) 145

setting 69

warning limits (mg/dL) 145 warning limits (mmol/L) 145

Index 161

L

language setting 127

LDL (Low-density lipoprotein) xx

left the battery out too long, what to do 130

Link xx

lock keypad feature 121

logbook feature data,

downloading 4 including in reports 4 types of 4

low battery alert 135

low battery,

affect on alerts 109

affect on remote control 118

affect on Selftest feature 121

affects on meter readings 74

low blood glucose,

Bolus Wizard feature notice 63

low reserve alert feature 110

low reserve alert types,

insulin units 111 time 111

low reservoir alert 135

Low resv warning xx

M

Main menu 19

manual bolus xx

MANUAL PRIME screen 49

manual prime,

definition xx

procedure 49

Max basal rate xx

Max bolus xx

maximum bolus limit 63

maximum infusion pressure 145

maximum limit,

basal delivery rate 38

maximum meter ID entries 146

maximum number of alarm records in history 143

maximum number of patterns,

basal delivery 143

maximum occlusion pressure 145

Medtronic CareLink™ Therapy

Management System 4

menus,

Basal 19

Bolus 19

Main 19

Prime 19

Utilities 19

meter blood glucose reading,

warning limits (mg/dL) 146 warning limits (mmol/L) 146

meter blood glucose readings,

expiration (minutes) 146 maximum ID entries 146 range (mg/dL) 146 range (mmol/L) 146

meter data, downloading 4

meter IDs,

adding 74 deleting 74 reviewing 74

METER OPTION screen 74

meter option,

definition xx

information about 73

rules 74

meter readings 62

modes,

Attention 18

Normal 17

Special 18

N

no delivery alarm, what to do 129

no display of blood glucose meter readings, what to do 132

no User Settings menu, what to do

134

normal bolus xx

normal bolus range 146

normal bolus,

programming (Bolus Wizard feature) 76

programming (without Bolus

Wizard feature) 24

Normal mode xx, 17

normal type bolus delivery,

using Bolus Wizard feature 76

now portion xx

O

occlusion detection,

maximum time before alarm 146 minimum time before alarm 146 typical time before alarm 146

occlusion pressure, maximum 145

options,

Dual/Square Wave bolus 83

Paradigm Link meter 73

ordering supplies,

phone number 3 web site (URL) 3

162 Index

P

Paradigm Link meter 3, 59

ParadigmPAL,

managing your pump settings 5 pump setting reports 5 types of data you can manage 5

Pattern feature xx

pattern, standard xxi

patterns,

A and B 95 basal 95

programming a basal pattern 96

selecting a basal pattern 97

standard basal pattern 95 turning on/off 95

personal reminders 116

personal settings 59

plunger rod 44

press xxi

Prime menu 19

prime,

definition xxi

fill rate 146

fixed 55

fixed prime range 146

history 55

manual 49

manual prime limit 146 maximum number of records

(fixed and manual) 146

viewing history (fixed) 55 viewing history (manual) 55

PSI xxi

pump (reservoir) volume,

model 515 147 model 715 147

pump buttons 14

pump buttons not working right during bolus, what to do 132

pump data, downloading 4

pump screen appears distorted, what to do 131

pump screen,

language settings 127

pump settings,

clearing them 125

managing on your PC 5 managing using ParadigmPAL 5

restoring 124

saving 123

pump therapy follow-up, recommendations 107

pump,

backlight time-out period 143

battery compartment 11

battery requirements 141

buttons 14

cleaning 142

default (factory) settings 154

display type 143

location of buttons 11

power supply 146

recommendations when removing 21

screen 11, 15

size (model 515) 147 size (model 715) 147

storage requirements 141

weight (model 515) 147 weight (model 715) 147

R

radio frequency (RF) accessories,

use restrictions 9

radio frequency (RF) features,

and Paradigm Link meter 73

remote control 117

recommended therapy follow-up,

annual 108

daily 107

laboratory 108

monthly 107 quarterly (every three months)

107

reminder, alarm clock 116

remote control feature,

turning on 118

remote control IDs,

add, delete, review 118

removing your pump,

recommendations for alternate insulin delivery method 21 recommendations for recording pump settings 21

reports,

blood glucose meter data downloads 4 examples of 4 pump data downloads 4

required items to start using your pump,

infusion set 43 insulin 43 reservoir 43 reservoir Instructions for Use document 43

reservoir for 515 pump (MMT-326) 3 reservoir for 715 pump (MMT-332) 3

reservoir volume,

515 pump (model MMT-326) 147

715 pump (model MMT-332) 147

Index 163

reservoir,

filling 44

inserting into your pump 48

low reservoir alert 110

plunger rod 44

removing the 46

transfer guard 44

tubing connector 11

restores,

history of 126

restoring your pump settings 124

Resume feature xxi

Rewind feature xxi

rewinding your pump 47

S

saves,

history of 126

saving your pump settings 123

screen,

language setting 127

scroll xxi select xxi

Selftest 121, 133

Set bolus xxi

setting,

active insulin time 72

maximum bolus limit 31

Special mode,

definition xxi

information about 18

Square Wave bolus,

definition xxi

information about 83

programming without Bolus

Wizard feature 84 turning on-off 84

Square Wave portion xxi

164 Index

STATUS screen,

Alarm Clock 148

Auto-off 148

Basal pattern 148

Battery Status 148

BG meter value 148

BG Reminder 148

Block 148

Current date 148

Current temp basal 148

definition xxi

information about 20

Last bolus 148

Low Batt 148

Meter Off 148

Meter On 148

Pump model number 148

Remote On 148

Reservoir started 148

Serial number 148

Software version 148

Standard basal delivery 149

Status of pump 149

Time 149

step,

definition xxi

setting the value 92

storage requirements (pump) 141

storage temperature, pump 157

submerged my pump in water, what to do 133

supplies, ordering 3

Suspend feature,

definition xxi

using to stop insulin delivery 39

Suspend menu 19

T

target range, blood glucose (BG) 144

Temp basal 134

temp basal,

canceling 105

definition xxi

delivering 103

rates 99

selecting the type 103

types (insulin rate) 100

types (percent of basal) 101

verifying delivery 104

terms and symbols 6

therapy follow-up, recommendations 107

time and date, setting 23

time-out period (backlight) 143

transfer guard 44

troubleshooting,

alerts 134

bolus delivery has stopped 132

can’t get out of the priming loop

131

check settings alarm 130

dropped my pump 133

left the battery out too long 130

no delivery alarm 129

no display of blood glucose meter readings 132

no User Settings menu 134

pump buttons not working right during bolus 132

pump screen appears distorted

131

submerged my pump in water 133

U

Up button 14

user settings 123

Utilities menu,

described 19

factory settings 155

W

water resistance (pump) 133

Index 165

166 Index

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