Medtronic Paradigm Revel User manual

User Guide

U

s

e

r

G

u

id

e

User Guide

Paradigm

®

REAL-Time

Revel™ Insulin Pump

User Guide

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.

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.

6025306-017_a

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

Contacts:

Africa:

Medtronic Africa (Pty) Ltd.

Tel: +27 (0) 11 677 4800

Australia:

Medtronic Australasia Pty. Ltd.

Tel: 1800 668 670 (product orders)

Tel: 1800 777 808 (customer help)

Bangladesh

Sonargaon Healthcare Pvt Ltd

Mobile: (+91)-9903995417

or (+880)-1714217131

België/Belgique:

N.V. Medtronic Belgium S.A.

Tel: 0800-90805

Brasil:

Medtronic Comercial Ltda.

Tel: +(11) 3707-3707

Canada:

Medtronic of Canada Ltd.

Tel: 1-800-284-4416 (toll free/sans-

frais)

China:

Medtronic (Shanghai) Ltd.

Tel: +86 40 0820 1981

or 80 0820 1981

Croatia

Medtronic Adriatic

Tel: +385 1 488 11 20

Fax: +385 1 484 40 60

Danmark:

Medtronic Danmark A/S

Tel: +45 32 48 18 00

Deutschland:

Medtronic GmbH

Geschäftsbereich Diabetes

Telefon: +49 2159 8149-370

Telefax: +49 2159 8149-110

24-Stdn-Hotline: 0800 6464633

Eire:

Accu-Science LTD.

Tel: +353 45 433000

España:

Medtronic Ibérica S.A.

Tel: +34 91 625 05 42

Fax: +34 91 625 03 90

24 horas: +34 901 120 335

Europe:

Medtronic Europe S.A. Europe, Middle

East and Africa Headquarters

Tel: +41 (0) 21-802-7000

France:

Medtronic France S.A.S.

Tel: +33 (0) 1 55 38 17 00

Hellas:

Medtronic Hellas S.A.

Tel: +30 210677-9099

Hong Kong:

Celki International Ltd.

Tel: +852 2332-3366

India:

India Medtronic Pvt. Ltd

Tel: (+91)-80-22112245 / 32972359

Mobile: (+91)-9611633007

Italia:

Medtronic Italia S.p.A.

Tel: +39 02 24137 261

Fax: +39 02 24138 210

Servizio assistenza tecnica: Nº verde

24h: 800 712 712

Japan:

Medtronic Japan Co. Ltd.

Tel: +81-3-6430-2019

Latin America:

Medtronic, Inc.

Tel: 1(305) 500-9328

Fax: 1(786) 709-4244

Latvija:

Ravemma Ltd.

Tel: +371 7273780

Magyarország:

Medtronic Hungária Kft.

Tel: +36 1 889 0697

Malaysia:

Medtronic International Ltd.

Tel: +60-3 7953 4800

Middle East and North Africa:

Regional Office

Tel: +961-1-370 670

Nederland, Luxembourg:

Medtronic B.V.

Tel: +31 (0) 45-566-8291

Toll Free: 0800-3422338

New Zealand:

Medica Pacifica

Tel: +0800 106 100

24-hr After-Hours:

+0800 633 487

Norge:

Medtronic Norge A/S

Tel: +47 67 10 32 00

Fax: +47 67 10 32 10

POCCИЯ:

Medtronic B. V.

Tel: +7 495 580 73 77

24h: 8-800-200-76-36

Polska:

Medtronic Poland Sp. Z.o.o.

Tel: +48 22 465 6934

Portugal:

Medtronic Portugal Lda

Tel: +351 21 7245100

Fax: +351 21 7245199

Puerto Rico:

Medtronic Puerto Rico

Tel: 787-753-5270

Republic of Korea:

Medtronic Korea, Co., Ltd.

Tel: +82.2.3404.3600

Schweiz:

Medtronic (Schweiz) AG

Tel: +41 (0)31 868 0160

24-Stunden-Hotline: 0800 633333

Fax Allgemein: +41 (0)318680199

Serbia & Montenegro:

Epsilon

Tel: +381 11 311 8883

Singapore:

Medtronic International Ltd.

Tel: +65 6436-5097

or +65 6436-5090

Slovenija:

Zaloker & Zaloker d.o.o.

Tel: +386 1 542 51 11

Fax: +386 1 542 43 32

Slovenská republika:

Medtronic Slovakia O.Z.

Tel: +421 268 206 944

Fax: +421 268 206 999

Sri Lanka

Swiss Biogenics Ltd.

Mobile: (+91)-9003077499

or (+94)-777256760

Suomi:

Medtronic Finland Oy

Tel: +358 20 7281200

Help line: +358 400 100 313

Sverige:

Medtronic AB

Tel: +46 8 568 585 10

Fax: +46 8 568 585 11

Taiwan:

Medtronic-Taiwan Ltd.

Tel: +886.2.2183.6093

Fax: +886.2.2501.7680

Toll Free: 0800.082.999

Thailand:

Medtronic (Thailand) Ltd.

Tel: +66 2 232 7400 ext 1

Turkiye:

Medtronic Medikal Teknoloji

Ticaret Ltd. Sirketi.

Tel: +90 216 4694330

USA:

Medtronic Diabetes Global

Headquarters

Tel: +1-800-826-2099

24 Hour HelpLine: +1-818-576-5555

To order supplies: +1-800-843-6687

United Kingdom:

Medtronic Ltd.

Tel: +44 1923-205167

Yisrael:

Agentek

Tel: +972 3649 3111

Österreich:

Medtronic Österreich GmbH

Tel: +43 (0) 1 240 44-0

24 – Stunden – Hotline: 0820 820 190

Česká republika:

Medtronic Czechia s.r.o.

Tel: (+420-233) 059401

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 .................................................................................. 7

Sensor ..................................................................................................... 7

Adverse reactions .......................................................................................... 7

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

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

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

Contents vii

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

Contentsviii

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 ................................................... 46

Contents ix

Chapter 4: Starting on insulin ............................................................ 47

Prepare your pump for use ................................................................................ 47

Setting up the reservoir .................................................................................... 48

Filling the reservoir ...................................................................................... 48

Changing your infusion set ................................................................................. 50

Removing the reservoir .................................................................................. 50

Rewinding your pump .................................................................................... 50

Inserting the reservoir in your pump .................................................................. 51

Filling the tubing ......................................................................................... 52

Inserting the infusion set ................................................................................ 53

Quick-set infusion set (with Quick-serter

®

) .......................................................... 55

Filling the cannula ....................................................................................... 55

Disconnecting Quick-set ................................................................................. 57

Reconnecting Quick-set ................................................................................. 57

Record keeping for diabetes management .............................................................. 58

Determining your pump settings .......................................................................... 58

Chapter 5: Using the Bolus Wizard feature ............................................ 61

What is it? .................................................................................................... 61

Carbohydrate counting .................................................................................. 61

Your blood glucose reading ............................................................................. 61

Your personal Bolus Wizard feature settings ......................................................... 61

How the Bolus Wizard feature works ..................................................................... 64

Bolus Wizard warnings ...................................................................................... 65

HIGH BG .................................................................................................... 65

LOW BG .................................................................................................... 65

MAX BOLUS EXCEEDED ................................................................................... 65

How to program the Bolus Wizard feature .............................................................. 65

Turning on the Bolus Wizard feature .................................................................. 66

Selecting the Carb units ................................................................................. 66

Setting the Carb/Exch ratios ........................................................................... 67

Setting the BG units ...................................................................................... 68

Insulin sensitivity ......................................................................................... 68

Setting the BG Targets .................................................................................. 69

About active insulin ...................................................................................... 70

Active insulin time ..................................................................................... 71

Review your Bolus Wizard feature settings ............................................................. 71

Contentsx

Meter option ................................................................................................. 72

Meter rules ................................................................................................ 72

Add, delete, review meter IDs ......................................................................... 73

Normal bolus using Bolus Wizard feature ................................................................ 73

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

Example 1: Blood glucose on target (normal blood glucose) and no active insulin ............ 75

Example 2: Blood glucose above target (high blood glucose) and no active insulin ........... 76

Example 3: Blood glucose below target (low blood glucose) and no active insulin ............ 77

Example 4: Blood glucose above target (high blood glucose) with active insulin .............. 78

Example 5: Blood glucose below target (low blood glucose) with active insulin ............... 79

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

Contents xi

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

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

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

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 ...................................................................................... 118

Preparing the sensor for communication .............................................................. 118

Calibrating the sensor ..................................................................................... 118

Entering meter BG for calibration ...................................................................... 119

Chapter 8: Using your sensor ........................................................... 121

Status screens .............................................................................................. 121

Reading the sensor glucose graphs ...................................................................... 122

Opening and viewing the graphs ...................................................................... 123

The graphs ............................................................................................... 124

Examples of real-time sensor glucose graphs ....................................................... 125

Contentsxii

3-hour graph .......................................................................................... 125

6-hour graph .......................................................................................... 126

12-hour graph ......................................................................................... 126

24-hour graph ......................................................................................... 127

How to check for rapid changes in sensor glucose ................................................... 128

The rapid change arrows ............................................................................... 128

How to make glucose alerts silent ...................................................................... 129

Calibration history ......................................................................................... 130

Sensor alert history ........................................................................................ 130

Using your system in water ............................................................................... 131

Chapter 9: Utilities ....................................................................... 133

Alarm review ............................................................................................... 133

Setting your alert type .................................................................................... 133

Auto-off ..................................................................................................... 134

LOW RESV WARNING (Low reservoir warning) ......................................................... 134

Review daily insulin totals ............................................................................... 135

Pump data management .................................................................................. 136

Insulin delivery information ........................................................................... 136

Sensor glucose information ............................................................................ 137

Meter blood glucose information ..................................................................... 138

AUC calculation ....................................................................................... 140

Personal reminders ........................................................................................ 142

Alarm clock .............................................................................................. 142

Remote control option .................................................................................... 142

Turn on remote control option ....................................................................... 143

Add, delete, review remote control IDs ............................................................. 143

Other Devices option ...................................................................................... 143

Block feature ............................................................................................... 144

Turning block on ........................................................................................ 144

Example 1: Block ........................................................................................ 144

Example 2: Block ........................................................................................ 144

Lock keypad feature ...................................................................................... 145

Locking the keypad ..................................................................................... 145

Unlocking the keypad .................................................................................. 145

Selftest ...................................................................................................... 145

User settings ................................................................................................ 146

Contents xiii

Saving the settings ...................................................................................... 147

Restoring the settings .................................................................................. 147

Clearing the settings ................................................................................... 148

History .................................................................................................... 148

Chapter 10: Therapy management software ........................................ 149

CareLink

®

Personal Software ............................................................................ 149

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

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

Chapter 11: 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 12: 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

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

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

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

Contentsxiv

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

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

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

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

Contents xv

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 13: Maintenance ................................................................ 171

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

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

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

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

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

Chapter 14: 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

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

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

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

Contentsxvi

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

Status screen ............................................................................................... 182

Bolus Wizard feature specifications .................................................................... 184

Bolus Wizard feature examples .......................................................................... 187

Insulin delivery default settings ......................................................................... 189

Bolus Wizard feature default settings .................................................................. 191

Sensor features default settings ......................................................................... 191

Guidance and manufacturer's declaration ............................................................. 195

Icon table ................................................................................................... 201

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

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

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

Contents xvii

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

Contentsxviii

Introduction

Thank you for choosing Medtronic Diabetes (legally known as Medtronic MiniMed, Inc.) as your partner in

helping you gain better control of your diabetes. Whether you are beginning pump therapy for the first time

or upgrading from a previous model, we believe that the combination of state-of-the-art technology and the

simple, menu-driven programming of the pump will provide many benefits.

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

MiniMed Paradigm

®

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

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