Medtronic Paradigm Revel User Manual

Paradigm® REAL-Time

Revel™ Insulin Pump

User Guide

©2009 Medtronic MiniMed, Inc. All rights reserved.
This product is covered by U.S. Patents. Other U.S. and/or foreign patents may be pending. Please visit

http://www.medtronicdiabetes.com/patents for a listing of patents covering this product.
Bolus Wizard

®

, CareLink®, Dual Wave®, Guardian®, Guardian RT®, MiniLink®, Paradigm®, Paradigm Link®, Quick-serter®,

Quick-set

®

,Sen-serter®,Silhouette®,Sof-set®, and Square Wave® are registered trademarks of Medtronic MiniMed, Inc.
Easy Bolus™ and Revel™ are trademarks of Medtronic MiniMed, Inc.
CONTOUR

®

is a registered trademark of Bayer.

Energizer

®

is a registered trademark of Eveready Battery Company.

Glucagon Emergency Kit

®

is a registered trademark of Eli Lilly and Company.

YSI 2300 STAT Plus™ is a trademark of YSI Inc.

OneTouch

®

, OneTouch® Ultra®, and OneTouch® UltraLink® are registered trademarks of

LifeScan, Inc

.

6025306-018_d

REF MMT-523 MMT-723 MMT-523K MMT-723K

Contacts:
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Medtronic Africa (Pty) Ltd.
Tel: [phone]

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Medtronic Australasia Pty. Ltd.
Tel: [phone] (product orders)
Tel: [phone] (customer help)

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or ([phone]

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Medtronic of Canada Ltd.
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Medtronic (Shanghai) Ltd.
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Medtronic B.V.
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Medtronic Danmark A/S
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Deutschland:

Medtronic GmbH
Geschäftsbereich Diabetes
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Telefax: [phone]
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Medtronic Europe S.A. Europe, Middle
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To order supplies: [phone]
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Medtronic International Ltd.
Tel: [phone]
or [phone]

Polska:

Medtronic Poland Sp. Z.o.o.
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Medtronic Portugal Lda
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or [phone]

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Sri Lanka

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or ([phone]

Suomi:

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Help line: [phone]

Sverige:

Medtronic AB
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Taiwan:

Medtronic-Taiwan Ltd.
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Toll Free: +886.0800.005.285

Thailand:

Medtronic (Thailand) Ltd.
Tel: [phone]

Turkiye:

Medtronic Medikal Teknoloji
Ticaret Ltd. Sirketi.
Tel: [phone]

USA:

Medtronic Diabetes Global
Headquarters
Tel: [phone]
24 Hour HelpLine: [phone]
To order supplies: [phone]

Ukraine:

Med EK Service Ltd.
Tel: [phone]

United Kingdom:

Medtronic Ltd.
Tel: [phone]

Österreich:

Medtronic Österreich GmbH
Tel: [phone]
24 – Stunden – Hotline: [phone]

Česká republika:

Medtronic Czechia s.r.o.
Tel: [phone]
Non-stop help line:
[phone]

Important Safety Information

Regarding Your Paradigm Insulin Pump

(includes all models)

Avoid Immersing Your Pump In Water

Although it is unlikely that water damage will occur if your pump is splashed or briefly dunked, you should
avoid immersing your Paradigm insulin pump in water. To swim or participate in other water activities,
always disconnect from your Paradigm pump and reconnect after you are out of the water.

If you inadvertently submerge your pump in water, dry the pump quickly using a soft, clean towel and verify
that it is working properly by selecting Selftest from the pump's Utilities Menu. If you believe that water has
entered your pump or you observe any other possible pump malfunction, please check your blood glucose,
treat high blood glucose (if necessary) with an injection and contact our 24 Hour HelpLine at 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
the Alarms and Alerts section of this User Guide for more details regarding what to do if your pump displays
an error alarm or other alert message.

Please contact our 24 Hour HelpLine at 1-800-646-4633 to report any error alarms or other problems that
occur with your pump.

Warranty

Medtronic Diabetes warrants the Medtronic MiniMed Insulin Pump against defects in materials and
workmanship for a period of 4 years from the date of purchase.

During the warranty period, Medtronic Diabetes will, at its discretion, either repair or replace (with a new
or recertified pump, at Medtronic Diabetes’ discretion) any defective pump or motor, subject to the
conditions and exclusions stated herein. In the event that a pump is repaired or replaced, the warranty period
will not be extended.

This warranty is valid only if the Medtronic MiniMed Insulin Pump is used in accordance with the
manufacturer’s instructions. This warranty will not apply:

• If damage results from changes or modifications made to the pump by the user or third persons after

the date of manufacture.

• If damage results from use of non-Medtronic reservoirs and/or infusion sets.

• If damage results from service or repairs performed by any person or entity other than the

manufacturer.

• If damage results from a Force Majeure or other event beyond the control of the manufacturer.

• If damage results from negligence or improper use, including but not limited to: improper storage,

submersion in water or physical abuse, such as dropping or otherwise.

This warranty shall be personal to the original user. Any sale, rental or other transfer or use of the product
covered by this warranty to or by a user other than the original user shall cause this warranty to immediately
terminate. This warranty does not apply to batteries, infusion sets, reservoirs, and other accessories.

The remedies provided for in this warranty are the exclusive remedies available for any breach hereof.
Neither Medtronic Diabetes nor its suppliers or distributors shall be liable for any incidental,
consequential, or special damage of any nature or kind caused by or arising out of a defect in the
product.

Pumps purchased through our Pathway Program will assume the warranty stated in our Pathway Program
agreement.

All other warranties, expressed or implied, are excluded, including the warranties of merchantability
and fitness for a particular purpose.

Contents

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

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

Emergency kit ................................................................................................. 1

Consumables .................................................................................................. 2

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

How to wear your pump ..................................................................................... 3

How to use this guide ........................................................................................ 4

User safety ..................................................................................................... 5

Indications .................................................................................................. 5

Paradigm REAL-Time Revel insulin pump ............................................................ 5

Meter ...................................................................................................... 5

Contraindications .......................................................................................... 5

Warnings .................................................................................................... 6

Pump ...................................................................................................... 6

Reservoir and infusion sets ............................................................................ 6

Sensor ..................................................................................................... 6

Transmitter .............................................................................................. 6

Magnetic fields .......................................................................................... 6

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

Precautions ................................................................................................. 7

Avoid extreme temperatures .......................................................................... 7

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

Sensor ..................................................................................................... 8

Adverse reactions .......................................................................................... 8

Notice .......................................................................................................... 8

Insulin pump and RF accessories ........................................................................ 8

RF interference from other devices ..................................................................... 9

Contents

ix

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

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

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

Pump buttons ................................................................................................ 13

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

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

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

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

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

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

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

Sensor icons ............................................................................................ 16

Scroll bar .................................................................................................. 17

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

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

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

Normal mode .............................................................................................. 18

Special mode .............................................................................................. 18

Attention mode ........................................................................................... 18

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

MAIN MENU ................................................................................................ 19

BOLUS MENU ............................................................................................... 19

SUSPEND ................................................................................................... 19

SENSOR ..................................................................................................... 19

CAPTURE EVENT .......................................................................................... 20

BASAL MENU ............................................................................................... 20

RESERVOIR + SET ......................................................................................... 20

UTILITIES MENU ........................................................................................... 20

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

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

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

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

Selecting the language ..................................................................................... 25

Bolus .......................................................................................................... 25

Setting the Normal bolus ................................................................................ 26

Normal meal bolus using the exchange system ...................................................... 27

Contents

x

Bolus practice: ............................................................................................ 27

Normal meal bolus practice using exchanges ........................................................ 28

Normal meal bolus using carbohydrate counting .................................................... 28

Normal meal bolus practice using carbohydrates ................................................... 29

Meal bolus, correction bolus and insulin sensitivity ................................................ 29

Practice: Meal bolus ..................................................................................... 30

Review your bolus deliveries .............................................................................. 30

Bolus details ............................................................................................... 31

Maximum bolus limit ........................................................................................ 33

Example 1: Max bolus .................................................................................... 33

Example 2: Max bolus .................................................................................... 33

Scroll rate .................................................................................................... 33

Example: Scroll rate ..................................................................................... 34

BG Reminder ................................................................................................. 34

Capturing Events ............................................................................................ 35

Turning on the Capture Event feature ................................................................ 35

Entering BG measurements ............................................................................. 36

Entering insulin injection information ................................................................ 37

Entering carbohydrate information .................................................................... 38

Entering exercise information .......................................................................... 38

Entering Other markers .................................................................................. 39

Viewing Capture Event history ......................................................................... 39

Basal .......................................................................................................... 39

Start and stop times ..................................................................................... 40

Your basal settings ....................................................................................... 41

Basal programming and delivery .................................................................... 41

Current basal delivery ................................................................................... 42

Daily basal rate(s) ........................................................................................ 42

Setting the Max basal rate ................................................................................. 43

Example 1: Max basal .................................................................................... 44

Example 2: Max basal .................................................................................... 44

Stopping your pump ........................................................................................ 44

Resume pump delivery ..................................................................................... 45

Example: Suspend function ............................................................................. 46

Practice: Suspend function ............................................................................. 46

Practice: Resume basal delivery after a suspend ................................................... 47

Contents

xi

Chapter 4: Starting on insulin ............................................................ 49

Prepare your pump for use ................................................................................ 49

Setting up the reservoir .................................................................................... 50

Filling the reservoir ...................................................................................... 50

Changing your infusion set ................................................................................. 52

Removing the reservoir .................................................................................. 52

Rewinding your pump .................................................................................... 52

Inserting the reservoir in your pump .................................................................. 53

Filling the tubing ......................................................................................... 54

Inserting the infusion set ................................................................................ 55

Quick-set infusion set (with Quick-serter

®

) .......................................................... 57

Filling the cannula ....................................................................................... 57

Disconnecting Quick-set ................................................................................. 59

Reconnecting Quick-set ................................................................................. 59

Record keeping for diabetes management .............................................................. 60

Determining your pump settings .......................................................................... 60

Chapter 5: Using the Bolus Wizard feature ............................................ 63

What is it? .................................................................................................... 63

Carbohydrate counting .................................................................................. 63

Your blood glucose reading ............................................................................. 63

Your personal Bolus Wizard feature settings ......................................................... 63

How the Bolus Wizard feature works ..................................................................... 66

Bolus Wizard warnings ...................................................................................... 67

HIGH BG .................................................................................................... 67

LOW BG .................................................................................................... 67

MAX BOLUS EXCEEDED ................................................................................... 67

How to program the Bolus Wizard feature .............................................................. 67

Turning on the Bolus Wizard feature .................................................................. 68

Selecting the Carb units ................................................................................. 68

Setting the Carb/Exch ratios ........................................................................... 69

Setting the BG units ...................................................................................... 70

Insulin sensitivity ......................................................................................... 70

Setting the BG Targets .................................................................................. 71

About active insulin ...................................................................................... 72

Active insulin time ..................................................................................... 73

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

Contents

xii

Normal bolus using Bolus Wizard feature ................................................................ 74

Bolus Wizard feature examples ........................................................................... 75

Example 1: Blood glucose on target (normal blood glucose) and no active insulin ............ 76

Example 2: Blood glucose above target (high blood glucose) and no active insulin ........... 77

Example 3: Blood glucose below target (low blood glucose) and no active insulin ............ 78

Example 4: Blood glucose above target (high blood glucose) with active insulin .............. 79

Example 5: Blood glucose below target (low blood glucose) with active insulin ............... 80

Chapter 6: Optimizing pump therapy ................................................... 81

Square Wave and Dual Wave bolus ....................................................................... 81

Turning on the Dual Wave/Square Wave option ..................................................... 82

Square Wave or Dual Wave bolus without Bolus Wizard feature .................................. 82

Square Wave bolus practice ............................................................................ 84

Dual Wave bolus practice ............................................................................... 85

Using the Bolus Wizard feature for a Square Wave or Dual Wave bolus ......................... 85

Easy bolus .................................................................................................... 87

Easy bolus setup .......................................................................................... 87

Step value setup .......................................................................................... 88

Delivering Easy Bolus .................................................................................... 88

Example 1: Easy bolus ................................................................................... 89

Your turn: Easy bolus practice ......................................................................... 90

Missed Bolus Reminder ..................................................................................... 90

Add, delete, and review bolus reminders ............................................................ 90

Add ......................................................................................................... 91

Delete ...................................................................................................... 91

Review ..................................................................................................... 91

Basal patterns ............................................................................................... 91

Turning on the patterns ................................................................................. 92

Programming a pattern .................................................................................. 92

Select a pattern .......................................................................................... 93

Example 1: Basal patterns .............................................................................. 93

Example 2: Basal patterns .............................................................................. 94

Your turn: .................................................................................................. 94

Temp basal rates ............................................................................................ 94

How does temp basal work? ............................................................................ 94

Temp basal types ......................................................................................... 95

Insulin rate (U/H) ...................................................................................... 95

Contents xiii

Percent of basal ....................................................................................... 96

Chapter 7: Sensor features .............................................................. 103

Entering your sensor settings ............................................................................ 103

Turning on the sensor .................................................................................. 103

Turning on the Glucose Alerts ........................................................................ 104

Setting the Glucose Limits ............................................................................. 104

Selecting the BG units .................................................................................. 105

Setting the Glucose Limits start time ................................................................ 106

Setting the High Repeat ................................................................................ 107

Setting the Low Repeat ................................................................................ 108

Setting the Predictive glucose alert ................................................................. 108

Setting the Rate of Change Alerts .................................................................... 110

Setting the Cal Repeat ................................................................................. 111

Setting the Cal Reminder .............................................................................. 111

Entering the transmitter ID ............................................................................ 111

Setting up the Weak Signal feature .................................................................. 112

Setting the sensor glucose graph timeout ........................................................... 113

Reviewing your settings ................................................................................ 113

Using the Sensor Demo .............................................................................. 114

The transmitter ............................................................................................ 114

Starting the sensor ........................................................................................ 114

Inserting the sensor ....................................................................................... 115

Removing the sensor ...................................................................................... 115

Preparing the sensor for communication .............................................................. 115

Calibrating the sensor ..................................................................................... 115

Entering meter BG for calibration ...................................................................... 116

Chapter 8: Using your sensor ........................................................... 119

Status screens .............................................................................................. 119

Reading the sensor glucose graphs ...................................................................... 120

Opening and viewing the graphs ...................................................................... 121

The graphs ............................................................................................... 122

Examples of real-time sensor glucose graphs ....................................................... 123

3-hour graph .......................................................................................... 123

6-hour graph .......................................................................................... 124

12-hour graph ......................................................................................... 124

Contents

xiv

24-hour graph ......................................................................................... 125

How to check for rapid changes in sensor glucose ................................................... 126

The rapid change arrows ............................................................................... 126

How to make glucose alerts silent ...................................................................... 127

Calibration history ......................................................................................... 128

Sensor alert history ........................................................................................ 128

Using your system in water ............................................................................... 129

Chapter 9: Utilities ....................................................................... 131

Alarm review ............................................................................................... 131

Setting your alert type .................................................................................... 131

Auto-off ..................................................................................................... 132

LOW RESV WARNING (Low reservoir warning) ......................................................... 132

Review daily insulin totals ............................................................................... 133

Pump data management .................................................................................. 134

Insulin delivery information ........................................................................... 134

Sensor glucose information ............................................................................ 135

Meter blood glucose information ..................................................................... 136

AUC calculation ....................................................................................... 138

Personal reminders ........................................................................................ 140

Alarm clock .............................................................................................. 140

PC connect for change settings .......................................................................... 140

Remote control option .................................................................................... 140

Turn on remote control option ....................................................................... 141

Add, delete, review remote control IDs ............................................................. 141

Other Devices option ...................................................................................... 142

Block feature ............................................................................................... 142

Turning block on ........................................................................................ 142

Example 1: Block ........................................................................................ 142

Example 2: Block ........................................................................................ 143

Lock keypad feature ...................................................................................... 143

Locking the keypad ..................................................................................... 143

Unlocking the keypad .................................................................................. 143

Selftest ...................................................................................................... 143

User settings ................................................................................................ 144

Saving the settings ...................................................................................... 145

Restoring the settings .................................................................................. 145

Contents xv

Clearing the settings ................................................................................... 146

History .................................................................................................... 146

Chapter 10: Meter option ............................................................... 147

About meters ............................................................................................... 147

Meter rules ............................................................................................... 147

Add, delete, review meter IDs ........................................................................ 148

Chapter 11: Therapy management software ........................................ 149

CareLink® Personal Software ............................................................................ 149

Reports ................................................................................................... 149

Logbook ................................................................................................... 150

Chapter 12: Insulin pump therapy follow-up ........................................ 151

Recommended follow-up ................................................................................. 151

Everyday .................................................................................................. 151

Every month ............................................................................................. 151

Every three months ..................................................................................... 151

Laboratory tests ......................................................................................... 152

Every visit ................................................................................................ 152

Annually .................................................................................................. 152

Chapter 13: Troubleshooting, alerts and alarms ................................... 153

My pump has a NO DELIVERY alarm ..................................................................... 153

What happens if I leave the pump battery out too long? ............................................ 154

Why doesn't my pump battery last very long? ......................................................... 154

What is a CHECK SETTINGS alarm? ...................................................................... 155

My screen appears distorted ............................................................................. 155

The pump is asking me to rewind ....................................................................... 155

My bolus stopped .......................................................................................... 155

My pump buttons are not acting right during a bolus ................................................ 156

My pump will not display my blood glucose reading from my meter .............................. 156

I dropped my pump ........................................................................................ 156

I submerged my pump in water ......................................................................... 157

I cannot get to the USER SETTINGS screen ............................................................ 157

Alerts ........................................................................................................ 157

Example: ................................................................................................. 158

Contents

xvi

What to do ............................................................................................... 158

Pump alert conditions ..................................................................................... 159

LOW RESERVOIR ......................................................................................... 159

LOW BATTERY ........................................................................................... 159

Sensor alert conditions ................................................................................... 159

WEAK SIGNAL ............................................................................................ 159

ALERT SILENCE .......................................................................................... 159

MISSED BOLUS ............................................................................................ 160

LOST SENSOR ............................................................................................ 160

LOW TRANSMTR ......................................................................................... 160

CHARGE TRANSMTR ..................................................................................... 161

CHANGE SENSOR ......................................................................................... 161

SENSOR END .............................................................................................. 161

CAL ERROR ............................................................................................... 161

METER BG NOW .......................................................................................... 162

METER BG BY ............................................................................................. 162

LOW XX MG/DL (XX = SG measurement) ............................................................. 162

HIGH XXX MG/DL (XXX = SG measurement) ......................................................... 162

LOW PREDICTED ......................................................................................... 162

HIGH PREDICTED ........................................................................................ 163

RISE RATE ................................................................................................ 163

FALL RATE ................................................................................................ 163

SENSOR ERROR ........................................................................................... 163

Alarms ....................................................................................................... 163

What to do ............................................................................................... 164

Alarm conditions ........................................................................................... 164

A (ALARM) ................................................................................................ 164

AUTO OFF ................................................................................................ 165

BATT OUT LIMIT ......................................................................................... 165

BOLUS STOPPED ......................................................................................... 165

BUTTON ERROR .......................................................................................... 165

CHECK SETTINGS ........................................................................................ 165

E (ERROR) ................................................................................................ 165

EMPTY RESERVOIR ....................................................................................... 166

FAILED BATT TEST ...................................................................................... 166

FINISH LOADING ......................................................................................... 166

MAX FILL REACHED ...................................................................................... 166

Contents xvii

MAX DELIVERY ........................................................................................... 167

MOTOR ERROR ........................................................................................... 167

NO DELIVERY ............................................................................................. 167

NO RESERVOIR ........................................................................................... 167

OFF NO POWER .......................................................................................... 167

RESET ..................................................................................................... 167

WEAK BATTERY .......................................................................................... 167

Testing the transmitter ................................................................................... 168

Connecting the tester .................................................................................. 168

Disconnecting the tester ............................................................................... 169

Troubleshooting sensor features ........................................................................ 169

Reconnect old sensor ................................................................................... 169

Find lost sensor .......................................................................................... 170

Chapter 14: Maintenance ................................................................ 171

Battery ...................................................................................................... 171

Storage ...................................................................................................... 172

Cleaning your pump ....................................................................................... 172

Cleaning the transmitter ................................................................................. 172

Cleaning the Sen-serter ................................................................................... 173

Chapter 15: Pump specifications ....................................................... 175

Alarms and error messages ............................................................................... 175

Alarm history ............................................................................................... 175

Audio frequency ........................................................................................... 175

Backlight .................................................................................................... 176

Basal ......................................................................................................... 176

BG Target ................................................................................................... 176

Bolus delivery .............................................................................................. 176

Maximum bolus ............................................................................................. 176

Bolus history ................................................................................................ 176

Bolus units .................................................................................................. 177

Bolus Wizard feature ...................................................................................... 177

Carb ratios .................................................................................................. 177

Carb units ................................................................................................... 177

Daily totals .................................................................................................. 177

Default screen .............................................................................................. 177

Contents

xviii

Delivery accuracy .......................................................................................... 178

Pump motor ................................................................................................ 178

Dual Wave bolus ........................................................................................... 179

Easy bolus ................................................................................................... 179

Filling the infusion set .................................................................................... 179

Infusion pressure ........................................................................................... 179

Insulin sensitivity .......................................................................................... 179

Low resv (reservoir) warning ............................................................................. 180

Meter value ................................................................................................. 180

Normal bolus ............................................................................................... 180

Occlusion detection ....................................................................................... 180

Percent temp basal ........................................................................................ 180

Power supply ............................................................................................... 181

Reservoir + Set history .................................................................................... 181

Program safety checks .................................................................................... 181

Pump size ................................................................................................... 181

Pump weight ................................................................................................ 181

Remote control ............................................................................................ 181

Reservoir .................................................................................................... 181

Square Wave bolus ........................................................................................ 182

Temporary (temp) basal rate ............................................................................ 182

Time and date screen ..................................................................................... 182

Environmental conditions ................................................................................ 182

Radio frequency (RF) communication specifications ................................................. 182

Quality of service .......................................................................................... 182

Data security ............................................................................................... 182

Status screen ............................................................................................... 183

Bolus Wizard feature specifications .................................................................... 185

Bolus Wizard feature examples .......................................................................... 188

Insulin delivery default settings ......................................................................... 190

Bolus Wizard feature default settings .................................................................. 192

Sensor features default settings ......................................................................... 193

Guidance and manufacturer's declaration ............................................................. 196

Icon table ................................................................................................... 202

Appendix A: Sensor accuracy ........................................................... 203

Performance results in adults ........................................................................... 204

Contents xix

Accuracy of Guardian RT readings ...................................................................... 205

Precision of Guardian RT readings ...................................................................... 209

Low and High alerts in adults ............................................................................ 210

The Low Glucose alert ................................................................................. 210

The High Glucose alert ................................................................................. 211

Guardian RT sensor performance and calibration stability as a function of time ............... 212

Effects of calibration frequency ......................................................................... 215

Time-elapsed plots ..................................................................................... 216

Performance results in children and adolescents ..................................................... 219

Accuracy of Guardian RT readings ................................................................... 219

Low and High alerts in children and adolescents ..................................................... 223

The Low Glucose alert ................................................................................. 223

The High Glucose alert ................................................................................. 224

Glossary ...................................................................................... 225

Index ......................................................................................... 233

Contents

xx

Introduction

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

This user guide is designed to help you to understand pump therapy and the operation of your Medtronic
MiniMed Paradigm

®

REAL-Time Revel™ insulin pump. We strongly recommend that you work closely with your

healthcare professional for a safe and complete pump start.

Assistance

Medtronic Diabetes provides a 24 Hour HelpLine for assistance. The HelpLine is staffed with representatives
who are trained in the set-up and operation of the pump and are able to answer pump-related questions.
When calling the HelpLine or your local Medtronic Diabetes office, please have your pump and serial number
available. The phone number for the 24 Hour HelpLine is also on the back of your pump.

Department

Telephone number

24 Hour HelpLine (calls within the United States) 800.646.4633
24 Hour HelpLine (calls outside the United States) +1.818.576.5555
Web site www.medtronicdiabetes.com

Emergency kit

Keep an emergency kit with you at all times to make sure that you always have necessary supplies. Inform
a family member, co-worker, and/or friend where this emergency kit is kept. Please refer to the User safety
section in this chapter for more information on pump safety. Your emergency kit should include these items:

• Fast-acting glucose tablets

• Blood glucose monitoring supplies

Introduction

1

 Chapter 1

• Urine ketone monitoring supplies

• Extra Paradigm

®

compatible infusion set and Paradigm reservoir

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

• Wallet card

• Dressing and adhesive

• Glucagon Emergency Kit

®

• Extra AAA alkaline batteries (Energizer® brand is recommended)

CAUTION: If you give yourself insulin by using a syringe, the Bolus Wizard feature will not be able to
correctly determine the active insulin in your system. Consult with your healthcare professional on how
long you need to wait after a manual injection before you can rely on the active insulin calculation of
your Bolus Wizard feature.

Consumables

The pumps use disposable reservoirs and infusion sets for insulin delivery. Installation instructions for
Paradigm reservoir and Paradigm compatible infusion sets are provided in the Starting on insulin chapter.

• Reservoirs — The 523 and 523K pumps are only used with the 176-unit Paradigm reservoir (MMT-326A).

The 723 and 723K pumps can be used with either the 300-unit Paradigm reservoir (MMT-332A) or the 176­unit reservoir, depending on your insulin needs.

• Infusion sets — Medtronic Diabetes provides a variety of Paradigm-compatible infusion sets to fit your

needs. Contact your healthcare professional for help in choosing an infusion set that fits your needs.
Change your infusion set every two to three days.

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

Introduction

2

Accessories

• Meter — Your pump can be used with an optional blood glucose meter powered by MWT1 technology

(where or if available). MWT1 is the wireless Radio Frequency (RF) technology that is used to transmit
information from the meter to the pump. You can program your pump to automatically receive your BG
reading from this meter. All meters referenced in this user guide are blood glucose meters supported by
MWT1 technology.

• Remote control — The optional Paradigm remote control can be used with the pump to deliver normal

boluses and suspend/resume the pump from a distant location. (This user guide provides programming
instructions for the remote control. Refer to the remote control user guide for operating instructions.)

• Medtronic MiniLink

®

Transmitter — The transmitter (MMT-7703) is a small device that connects to the

sensor. It comes with a tester and a charger. When connected to a sensor that is inserted in the body,
the transmitter automatically initializes the sensor and begins to periodically send glucose data to the
pump using a radio signal.

• Sensor — The sensor (MMT-7002/MMT-7003) continuously converts tiny amounts of glucose from your

fatty layer under the skin into an electronic signal. This signal is sent to the transmitter.

• CareLink USB Upload Device — The Medtronic Diabetes CareLink USB (MMT-7305) is used to download

the Paradigm 523, 723, 523K or 723K pump data to the diabetes management software using a USB port
on your computer.

To order supplies, call 800-646-4633, [phone] (outside U.S.), refer to the contacts list at the
beginning of this user guide, or visit our web site at www.medtronicdiabetes.com.

How to wear your pump

There are different ways to wear your pump. Medtronic Diabetes has optional accessories that can hide,
protect, and add to the convenience of wearing a pump. Refer to the accessories catalog or the website
(www.medtronicdiabetes.com) for more information.

• Holster — To wear the pump on your belt.

• Pump clip — To wear the pump underneath your clothing.

• Activity guard — If you are active in sports, or you are a child, use the guard to protect the pump from

disconnecting.

• Leather case — Fine leather lined with nylon. Styling complements business and formal wear. Velcro

flap provides easy access for programming. Wear it vertically with the built-in belt clip.

Introduction

3

 Chapter 1

How to use this guide

NOTE: This user guide shows sample screens only. Your pump screens may be slightly different.

For step-by-step instructions, refer to the appropriate sections in this guide. Refer to the Glossary for
definitions of terms and functions. The terms and symbols used in this guide are in the table below.

Conventions

Meaning

Press to push and release the button
Hold to push and keep pressure on the button

Select

to press or to highlight a screen item you want to select

Exit the menus press ESC until the HOME screen appears
Pump buttons always bold and uppercase; for example, ESC, ACT
Screen and menu names always uppercase; for example, MAIN MENU, REWIND screen
Menu selections always bold; for example, 24-Hour Setup, On, Off

Flashing (blinking) screen item

you can change the value for that item with the or buttons

NOTE and TIP additional helpful information

CAUTION

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

WARNING

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

Go to the...screen.

when a step instructs you to go to a certain screen, the path to that
screen is shown. For example:
Go to the ALARM MENU.

Main > Utilities > Alarm

1

From the MAIN MENU, select Utilities and press ACT.

2

In the UTILITIES MENU, select Alarm and press ACT.

3

The ALARM MENU appears.

Introduction

4

User safety

Indications

Paradigm REAL-Time Revel insulin pump

The Paradigm REAL-Time Revel insulin pumps (523/723/523K/723K) are indicated for the continuous delivery
of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

The Paradigm REAL-Time system consists of the Paradigm MMT-523/723 insulin pumps, or the MMT-523K/723K
pediatric versions of the insulin pumps, the MMT-7002/ MMT-7003 glucose sensor, and the MMT-7703
transmitter. Use of the MMT-523/723 insulin pumps with the optional sensor and transmitter components is
indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low
and high blood glucose episodes in adults (ages 18 and older). Use of the MMT-523K/723K insulin pumps with
the optional sensor and transmitter components is indicated for continuous or periodic monitoring of glucose
levels in the fluid under the skin, and possible low and high blood glucose episodes in children and adolescents
(ages 7 through 17). The pediatric system provides an alert if glucose levels fall below or rise above preset
values. Glucose values provided by the Paradigm 523/723/523K/723K systems are not intended to be used
directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be
required. All therapy adjustments should be based on measurements obtained using a home glucose monitor
and not on the sensor glucose readings provided by the Paradigm 523/723/523K/723K systems.

Meter

The Paradigm pump can be programmed to receive fingerstick blood glucose values transmitted from Bayer's
CONTOUR

®

NEXT LINK Wireless Meter, Bayer's CONTOUR® LINK Wireless Meter, a OneTouch® UltraLink

®

meter, or a BD Paradigm Link® glucose meter for use in the Bolus Wizard calculator and for use as calibration
values for the glucose sensor. Glucose values from other glucose meters must be manually entered into the
pump.

Contraindications

Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four
blood glucose tests per day and to maintain contact with their healthcare professional. Successful insulin
pump therapy requires sufficient vision or hearing to allow recognition of the pump signals and alarms.

Do not expose your insulin pump to MRI equipment or other devices that generate very strong magnetic fields.
The magnetic fields in the immediate vicinity of these devices can damage the part of the pump’s motor
that regulates insulin delivery, possibly resulting in over-delivery and severe hypoglycemia.

Introduction

5

 Chapter 1

Your pump must be removed and kept outside the room during magnetic resonance imaging (MRI)
procedures.

If your pump is inadvertently exposed to a strong magnetic field, discontinue use and contact the 24 Hour
HelpLine for further assistance.

Warnings

Pump

The pump is not suitable for use in the presence of a flammable anaesthetic mixture with air, oxygen or
nitrous oxide.

Reservoir and infusion sets

Standard Luer sets are not compatible with the Medtronic MiniMed Paradigm pump. Medtronic Diabetes
Paradigm reservoirs and Paradigm-compatible infusion sets are specifically designed for use with the pump.
Do not modify your Paradigm reservoir or Paradigm-compatible infusion set.

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

Sensor

Bleeding, swelling, irritation and/or infection at the insertion site are possible risks associated with inserting
the sensor and sometimes result from improper insertion and maintenance of insertion site.

Transmitter

Product contains small parts and may pose a choking hazard for young children.

Optional occlusive dressing should be removed if irritation or reaction to this develops.

Magnetic fields

Do not use pump cases that have a magnetic clasp.

Do not expose your insulin pump to MRI equipment or other dev ices that ge ner ate very str ong mag netic fi eld s.
The magnetic fields in the immediate vicinity of these devices can damage the part of the pump’s motor
that regulates insulin delivery, possibly resulting in over-delivery and severe hypoglycemia.

Your pump must be removed and kept outside the room during magnetic resonance imaging (MRI)
procedures.

Introduction

6

If your pump is inadvertently exposed to a strong magnetic field, discontinue use and contact our 24 Hour
HelpLine for further assistance.

X-rays, MRIs and CT scans

If you are going to have an X-ray, CT scan, MRI or other type of exposure to radiation, take off your pump,
sensor, transmitter, meter and remote control before entering a room containing any of these

equipment.

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

Precautions

Although the pump has multiple safety alarms, it cannot notify you if the set is leaking or the insulin has lost
its potency. It is essential, therefore, that you test your blood glucose levels at least four times per day. If
your blood glucose is out of range, check the pump and the infusion set to ensure that the necessary amount
of insulin is being delivered.

Avoid extreme temperatures

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

(1°C).

2

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

3

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

Introduction

7

 Chapter 1

Infusion sets and sites

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

Sensor

Prior to exercising, make sure the sensor is firmly attached.

Adverse reactions

Operation of the sensor feature requires the insertion of a glucose sensor into the skin. Bleeding, swelling,
bruising, or infection at the sensor insertion site are possible risks of sensor use. The sensor should be removed
if redness, pain, tenderness or swelling develop at the insertion site. The optional occlusive dressing should
be removed if irritation or a reaction to this develops. Contact your doctor and our 24 Hour HelpLine in the
event of any adverse reaction.

Notice

CAUTION: Any changes or modifications to the devices not expressly approved by Medtronic Diabetes
could void your ability to operate the equipment.

Insulin pump and RF accessories

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

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

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

Introduction

8

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 our 24 Hour HelpLine.

2

This device generates, uses, and can radiate radio frequency energy and, if installed and used in
accordance with the instruction, may cause harmful interference to radio communications. If the device
does cause interference to radio or television reception, you are encouraged to try to correct the
interference by one or more of the following measures:

• Reorient or relocate the insulin pump/remote control/transmitter/meter

• Increase the separation between the insulin pump/remote control/transmitter/meter and the

device that is receiving/emitting interference

The meter and the transmitter send information to the pump using radio frequency. If other devices that
use radio frequency are in use, such as cell phones, cordless phones and wireless networks, they may
prevent communication between the pump and the meter. This interference will not cause any incorrect
data to be sent and will not cause any harm to your pump or meter. Moving away from or turning off
these other devices may allow communication. Refer to the Troubleshooting, alerts and alarms chapter
to correct interference problems you may have.

Wireless transmission between the pump and transmitter within the 6 feet (1.8 meters) operating range
may be interrupted due to the transmitter orientation and the pump position on the body. Move the
pump closer to the transmitter or to another position. If a Lost Sensor alarm has occurred retry:

Main > Sensor > Link to Sensor > Find Lost Sensor

If you have questions, please contact the 24 Hour HelpLine.

RF interference from other devices

Common consumer electronic devices that transmit in the same frequency band used by the MMT-7703
MiniLink transmitter may prevent the pump from receiving the glucose information sent by the transmitter.
Most cellular (mobile) phones and 900 MHz cordless phones, when transmitting or receiving, may cause
significant interruption of transmitter-receiver communication. It is likely that other devices operating in
similar frequency ranges will have a similar effect. This interference, however, will not cause any incorrect
data to be sent and will not cause any harm to your transmitter.

The pump includes a programmable WEAK SIGNAL alert that notifies you when one or more expected
transmissions were not received as expected by the pump. (The pump will also issue a LOST SENSOR alert if
communication is interrupted for an extended period of time.)

Introduction

9

 Chapter 1

Communication problems can usually be resolved by:

• ensuring that there is less than 6 feet (1.8 meters) between the receiving device and transmitter, to

include RF glucose meters;

• turning off or moving away from other RF transmitting devices; or

• reorienting or relocating the transmitter or receiving device, or both.

Communications problems may also occur due to cellular telephone interference. Testing conducted with
several different cellular telephones indicates that, while a glucose value is being transmitted, using a cell
phone within 12 inches (31 cm) of receiving devices, transmitters or RF glucose meters can interfere with
reception of the transmitted values. In the event of such interference, normal communication can be re­established by:

• turning the cell phone off; or

• keeping the cell phone at least 12 inches (31 cm) away from the receiving device, transmitter or glucose

meter when a glucose measurement is being transmitted.

If you have questions, please contact the 24 Hour HelpLine.

Introduction

10