Medtronic Revel, Paradigm REAL-Time Revel Minimed User Manual

User Guide

User Guide

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.

6025306-019_a

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

Contacts:
Africa:

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

Australia:

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

Azerbaijan:

Albatros Health Care
Tel: [phone]

Bangladesh

Sonargaon Healthcare Pvt Ltd.
Mobile: [phone]
or ([phone]

Belarus:

Badgin Ltd
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België/Belgique:

N.V. Medtronic Belgium S.A.
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Bosnia and Herzegovina

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Tel: [phone]
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Brasil:

Medtronic Comercial Ltda.
Tel: +(11) 3707-3707

Bulgaria

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Tel: [phone]

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Medtronic of Canada Ltd.
Tel: [phone] (toll free/sans­frais)

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Medtronic (Shanghai) Ltd.
24 Hour Help (Cell): +86
400-820-1981
24 Hour Help (Landline): +86
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Croatia

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Croatia

Medtronic B.V.
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Danmark:

Medtronic Danmark A/S
Tel: [phone]

Deutschland:

Medtronic GmbH
Geschäftsbereich Diabetes
Telefon: [phone]
Telefax: [phone]
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Eire:

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Medtronic Ibérica S.A.
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Medtronic Europe S.A. Europe,
Middle East and Africa Headquarters
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Medtronic France S.A.S.
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Medtronic Hellas S.A.
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Medtronic International Ltd.
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To order supplies: [phone]
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India Medtronic Pvt. Ltd
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Indonesia:

Medtronic International Ltd.
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or [phone]

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Agentek
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Italia:

Medtronic Italia S.p.A.
Tel: [phone]
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Servizio assistenza tecnica: Nº verde
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Kazakhstan:

Medtronic Kazakhstan B.V.
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Latin America:

Medtronic, Inc.
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Latvija:

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Malaysia:

Medtronic International Ltd.
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Middle East and North Africa:

Regional Office
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Montenegro:

Glosarij
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Nederland, Luxembourg:

Medtronic B.V.
Tel: [phone]
Gratis: 0800-3422338

New Zealand:

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Phone: [phone]
Free Phone: [phone]

Norge:

Medtronic Norge A/S
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POCCИЯ:

Medtronic B. V.
Tel: [phone]
24h: 8-800-200-76-36

Philippines:

Medtronic International Ltd.
Tel: [phone]
or [phone]

Polska:

Medtronic Poland Sp. Z.o.o.
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Portugal:

Medtronic Portugal Lda
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Fax: [phone]

Puerto Rico:

Medtronic Puerto Rico
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Republic of Korea:

Medtronic Korea, Co., Ltd.
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Romania:

Trustmed SRL
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Schweiz:

Medtronic (Schweiz) AG
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24-Stunden-Hotline: [phone]
Fax Allgemein: [phone]

Serbia

Epsilon
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Singapore:

Medtronic International Ltd.
Tel: [phone]
or [phone]

Slovenija:

Zaloker & Zaloker d.o.o.
Tel: [phone]
Fax: [phone]

Slovenská republika:

Medtronic Slovakia o.z.
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Fax: [phone]

Sri Lanka

Swiss Biogenics Ltd.
Mobile: [phone]
or ([phone]

Suomi:

Medtronic Finland Oy
Tel: [phone]
Help line: [phone]

Sverige:

Medtronic AB
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Fax: [phone]

Taiwan:

Medtronic-Taiwan Ltd.
Tel: [phone]
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

The pump was tested and met requirements for IPX7 at time of manufacture. For more information about
IPX7, see the Glossary on page 229. Be aware that drops and bumps that occur over time will affect the
integrity of the pump case and make it more vulnerable to damage from water. Lotions, sunscreens and
insect repellent can also damage the pump case. It is not known how much water is needed to damage
your pump. You should avoid getting your pump wet. To shower, bathe, swim, or participate in water

activities, always disconnect from your 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. 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 ................................................................................................. 2

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 ...................................................................................................... 6

Contraindications .......................................................................................... 6

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

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

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

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

Transmitter .............................................................................................. 7

Tubing Connector ....................................................................................... 8

Magnetic fields .......................................................................................... 8

X-rays, MRIs and CT scans .............................................................................. 9

Precautions ................................................................................................. 9

Avoid extreme temperatures .......................................................................... 9

Infusion sets and sites .................................................................................. 9

Sensor .....................................................................................................

9

Adverse reactions ..........................

................................................................ 9

Notice ......................................................................................................... 10

Insulin pump and RF accessories ....................................................................... 10

RF interference from other devices ................................................................... 11

Contents ix

Chapter 2: The basics ...................................................................... 13

Your pump .................................................................................................... 13

Install battery ................................................................................................ 14

Pump buttons ................................................................................................ 15

The pump screen ............................................................................................ 17

HOME screen ................................................................................................. 17

Screen icons ............................................................................................... 17

Battery .................................................................................................. 17

Time display ............................................................................................ 18

Reservoir volume ...................................................................................... 18

Alert and alarm icons ................................................................................. 18

Sensor icons ............................................................................................ 18

Scroll bar .................................................................................................. 19

Screen backlight .......................................................................................... 19

Beep/vibrate ................................................................................................. 19

Operating modes ............................................................................................ 19

Normal mode .............................................................................................. 20

Special mode .............................................................................................. 20

Attention mode ........................................................................................... 20

Menus ......................................................................................................... 21

MAIN MENU ................................................................................................ 21

BOLUS MENU ............................................................................................... 21

SUSPEND ................................................................................................... 21

SENSOR ..................................................................................................... 21

C

A

PTURE EVENT .......................................................................................... 22

BASAL MENU ............................................................................................... 22

RESERVOIR + SET ......................................................................................... 22

UTILITIES MENU ........................................................................................... 22

STATUS screen ............................................................................................... 22

If you remove your pump .................................................................................. 23

Chapter 3: Basic programming ............................................................ 25

Setting the time and date ................................................................................. 25

Selecting the language ..................................................................................... 27

Bolus .......................................................................................................... 27

Setting the Normal bolus ................................................................................ 27

Normal meal bolus using the exchange system ...................................................... 29

Contentsx

Bolus practice: ............................................................................................ 29

Normal meal bolus practice using exchanges ........................................................ 30

Normal meal bolus using carbohydrate counting .................................................... 30

Normal meal bolus practice using carbohydrates ................................................... 31

Meal bolus, correction bolus and insulin sensitivity ................................................ 31

Practice: Meal bolus ..................................................................................... 32

Review your bolus deliveries .............................................................................. 32

Bolus details ............................................................................................... 33

Maximum bolus limit ........................................................................................ 35

Example 1: Max bolus .................................................................................... 35

Example 2: Max bolus .................................................................................... 35

Scroll rate .................................................................................................... 35

Example: Scroll rate ..................................................................................... 36

BG Reminder ................................................................................................. 36

Capturing Events ............................................................................................ 37

Turning on the Capture Event feature ................................................................ 38

Entering BG measurements ............................................................................. 38

Entering insulin injection information ................................................................ 39

Entering carbohydrate information .................................................................... 40

Entering exercise information .......................................................................... 41

Entering Other markers .................................................................................. 41

Viewing Capture Event history ......................................................................... 42

Basal .......................................................................................................... 42

Sta

r

t and stop times ..................................................................................... 42

Your basal settings ....................................................................................... 44

Basal programming and delivery .................................................................... 44

Current basal delivery ................................................................................... 45

Daily basal rate(s) ........................................................................................ 45

Setting the Max basal rate ................................................................................. 46

Example 1: Max basal .................................................................................... 46

Example 2: Max basal .................................................................................... 47

Stopping your pump ........................................................................................ 47

Resume pump delivery ..................................................................................... 48

Example: Suspend function ............................................................................. 48

Practice: Suspend function ............................................................................. 49

Practice: Resume basal delivery after a suspend ................................................... 49

Contents xi

Chapter 4: Starting on insulin ............................................................ 51

Prepare your pump for use ................................................................................ 51

Setting up the reservoir .................................................................................... 52

Filling the reservoir ...................................................................................... 52

Changing your infusion set ................................................................................. 54

Removing the reservoir .................................................................................. 54

Rewinding your pump .................................................................................... 55

Inserting the reservoir in your pump .................................................................. 55

Filling the tubing ......................................................................................... 56

Inserting the infusion set ................................................................................ 57

Quick-set infusion set (with Quick-serter

®

) .......................................................... 59

Filling the cannula ....................................................................................... 60

Disconnecting Quick-set ................................................................................. 60

Reconnecting Quick-set ................................................................................. 61

Record keeping for diabetes management .............................................................. 61

Determining your pump settings .......................................................................... 62

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 ............................................................. 74

Contentsxii

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 .......................................................................................... 88

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

Delivering Easy Bolus .................................................................................... 89

Example 1: Easy bolus ................................................................................... 90

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

Missed Bolus Reminder ..................................................................................... 91

Add, delete, and review bolus reminders ............................................................ 91

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

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

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

Basal patterns ............................................................................................... 92

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

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

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

Example 1: Basal patterns .............................................................................. 94

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

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

Temp basal ra

tes ..............................

.............................................................. 95

How does temp basal work? ............................................................................ 95

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

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

Contents xiii

Percent of basal ....................................................................................... 97

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 ................................................................ 105

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

Setting the Low Repeat ................................................................................ 107

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

Setting the Rate of Change Alerts .................................................................... 109

Setting the Cal Repeat ................................................................................. 110

Setting the Cal Reminder .............................................................................. 110

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

Setting up the Weak Signal feature .................................................................. 111

Setting the sensor glucose graph timeout ........................................................... 112

Reviewing your settings ................................................................................ 112

Using the Sensor Demo .............................................................................. 113

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

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

Inserting the sensor ....................................................................................... 114

Removing the sensor ...................................................................................... 114

Preparing the sensor for communication .............................................................. 114

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 ............................................................................................... 121

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

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

6-hour graph .......................................................................................... 123

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

Contentsxiv

24-hour graph ......................................................................................... 124

How to check for rapid changes in sensor glucose ................................................... 125

The rapid change arrows ............................................................................... 125

How to make glucose alerts silent ...................................................................... 126

Calibration history ......................................................................................... 127

Sensor alert history ........................................................................................ 127

Using your system in water ............................................................................... 128

Chapter 9: Utilities ........................................................................ 129

Alarm review ............................................................................................... 129

Setting your alert type .................................................................................... 129

Auto-off ..................................................................................................... 130

LOW RESV WARNING (Low reservoir warning) ......................................................... 130

Review daily insulin totals ............................................................................... 131

Pump data management .................................................................................. 132

Insulin delivery information ........................................................................... 132

Sensor glucose information ............................................................................ 133

Meter blood glucose information ..................................................................... 134

AUC calculation ....................................................................................... 136

Personal reminders ........................................................................................ 138

Alarm clock .............................................................................................. 138

PC connect for change settings .......................................................................... 138

Remote control option .................................................................................... 138

Turn on remote control option ....................................................................... 139

Add, delete, review remote control IDs ............................................................. 139

Other Devices option ...................................................................................... 140

Block feature ............................................................................................... 140

Turning block on ........................................................................................ 140

Example 1: Block ........................................................................................ 140

Example 2: Block ........................................................................................ 141

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

141

Locking the keypad ..................................................................................... 141

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

............................................................ 141

Selftest ...................................................................................................... 141

User settings ................................................................................................ 142

Saving the settings ...................................................................................... 143

Restoring the settings .................................................................................. 143

Contents xv

Clearing the settings ................................................................................... 144

History .................................................................................................... 144

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

Contentsxvi

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 ......................................................................................... 161

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

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

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

CAL ERROR ............................................................................................... 162

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

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

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

HIGH XXX MG/DL (XXX = SG measurement) ......................................................... 163

LOW PREDICTED ......................................................................................... 163

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

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

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

SENSOR ER

ROR ........................

................................................................... 164

Alarms ....................................................................................................... 164

What to do ............................................................................................... 165

Alarm conditions ........................................................................................... 165

A (ALARM) ................................................................................................ 165

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

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

BOLUS STOPPED ......................................................................................... 166

BUTTON ERROR .......................................................................................... 166

CHECK SETTINGS ........................................................................................ 166

E (ERROR) ................................................................................................ 166

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

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

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

MAX FILL REACHED ...................................................................................... 167

Contents xvii

MAX DELIVERY ........................................................................................... 168

MOTOR ERROR ........................................................................................... 168

NO DELIVERY ............................................................................................. 168

NO RESERVOIR ........................................................................................... 168

OFF NO POWER .......................................................................................... 168

RESET ..................................................................................................... 168

WEAK BATTERY .......................................................................................... 169

Testing the transmitter ................................................................................... 169

Connecting the tester .................................................................................. 169

Disconnecting the tester ............................................................................... 170

Troubleshooting sensor features ........................................................................ 170

Reconnect old sensor ................................................................................... 170

Find lost sensor .......................................................................................... 171

Chapter 14: Maintenance ................................................................ 173

Battery ...................................................................................................... 173

Storage ...................................................................................................... 174

Cleaning your pump ....................................................................................... 174

Cleaning the transmitter ................................................................................. 174

Cleaning the Sen-serter ................................................................................... 175

Chapter 15: Pump specifications ....................................................... 177

Alarms and error messages ............................................................................... 177

Alarm history ............................................................................................... 177

Audio frequency ........................................................................................... 177

Backlight .................................................................................................... 178

Basal ......................................................................................................... 178

BG Target ................................................................................................... 178

Bolus delivery .............................................................................................. 178

Maximum bolus ............................................................................................. 178

Bolus history ................................................................................................ 178

Bolus units .................................................................................................. 179

Bolus Wizard feature ...................................................................................... 179

Carb ratios .................................................................................................. 179

Carb units ................................................................................................... 179

Daily totals .................................................................................................. 179

Default screen .............................................................................................. 179

Contentsxviii

Delivery accuracy .......................................................................................... 180

Pump motor ................................................................................................ 180

Dual Wave bolus ........................................................................................... 181

Easy bolus ................................................................................................... 181

Filling the infusion set .................................................................................... 181

Infusion pressure ........................................................................................... 181

Insulin sensitivity .......................................................................................... 181

Low resv (reservoir) warning ............................................................................. 182

Meter value ................................................................................................. 182

Normal bolus ............................................................................................... 182

Occlusion detection ....................................................................................... 182

Percent temp basal ........................................................................................ 182

Power supply ............................................................................................... 183

Reservoir + Set history .................................................................................... 183

Program safety checks .................................................................................... 183

Pump size ................................................................................................... 183

Pump weight ................................................................................................ 183

Remote control ............................................................................................ 183

Reservoir .................................................................................................... 183

Square Wave bolus ........................................................................................ 184

Temporary (temp) basal rate ............................................................................ 184

Time and date s

c

reen ..................................................................................... 184

Environmental conditions ................................................................................ 184

Radio frequency (RF) communication specifications ................................................. 184

Quality of service .......................................................................................... 184

Data security ............................................................................................... 184

Status screen ............................................................................................... 185

Bolus Wizard feature specifications .................................................................... 187

Bolus Wizard feature examples .......................................................................... 190

Insulin delivery default settings ......................................................................... 192

Bolus Wizard feature default settings .................................................................. 194

Sensor features default settings ......................................................................... 194

Guidance and manufacturer's declaration ............................................................. 198

Icon table ................................................................................................... 204

Appendix A: Sensor accuracy ........................................................... 207

Performance results in adults ........................................................................... 208

Contents xix

Accuracy of Guardian RT readings ...................................................................... 209

Precision of Guardian RT readings ...................................................................... 213

Low and High alerts in adults ............................................................................ 214

The Low Glucose alert ................................................................................. 214

The High Glucose alert ................................................................................. 215

Guardian RT sensor performance and calibration stability as a function of time ............... 216

Effects of calibration frequency ......................................................................... 219

Time-elapsed plots ..................................................................................... 220

Performance results in children and adolescents ..................................................... 223

Accuracy of Guardian RT readings ................................................................... 223

Low and High alerts in children and adolescents ..................................................... 227

The Low Glucose alert ................................................................................. 227

The High Glucose alert ................................................................................. 228

Glossary ...................................................................................... 229

Index ......................................................................................... 237

Contentsxx

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 pump­related 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

Introduction 1

Chapter 1

Emergency kit

Keep an emergency kit with you at all times to make sure that you always have necessary supplies. Inform
a family member, co-worker, and/or friend where this emergency kit is kept. Please refer to 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

• 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
176-unit 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.

Introduction2

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.

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.

Introduction 3

Chapter 1

• 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.

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

Introduction4

Conventions Meaning

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.

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.

Introduction 5

Chapter 1

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.

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.

The drive support cap should appear slightly indented at all times
(as shown in the image). If you notice that the cap is loose, or
sticking out, discontinue use of the pump and contact our
24 Hour HelpLine at 1 800 646 4633 to arrange for your pump to
be replaced. Do not press on the drive support cap if it is

sticking out. Pushing on the drive support cap may result in
unintended delivery of insulin, which can cause hypoglycemia.

drive support cap

Introduction6

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.

Introduction 7

Chapter 1

Tubing Connector

If insulin, or any liquid, gets inside the tubing connector, it can temporarily block the vents that allow the
pump to properly prime the infusion set. This may result in the delivery of too little or too much insulin,
which can cause hypoglycemia or hyperglycemia. To prevent liquid from getting inside the tubing
connector, after you fill the reservoir make sure you hold the insulin vial upright when you remove the
reservoir from the transfer guard. If you do not hold the insulin vial upright, insulin can get on the top of
the reservoir and could transfer liquid into the tubing connector. If any liquid gets on the top of the
reservoir or inside the tubing connector when you change your infusion set, start over with a new reservoir
and infusion set. For instructions on setting up your reservoir, see Setting up the reservoir, on page 52.
For instructions on changing your infusion set, see Changing your infusion set, on page 54.

Tubing
connector

Top of

reservoir

Magnetic fields

Do not use pump cases that have a magnetic clasp.

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.

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 our 24 Hour
HelpLine for further assistance.

Introduction8

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.

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.

Introduction 9

Chapter 1