Insulin pump and continuous glucose monitoring system

Insulin Pump User Guide
INSULIN PUMP AND
CONTINUOUS GLUCOSE MONITORING SYSTEM

Paradigm
®
522 and 722 Insulin Pumps
User Guide

©2008 Medtronic MiniMed, Inc. All rights reserved.
This product is covered by U.S. Patent Nos. 6,551,276; 6,554,798; 6,872,200; 6,936,029; 6,979,326; 6,997,920 and
7,025,743. Other U.S. and/or foreign patents may be pending.
Bolus Wizard
®
, Dual Wave
®
, Guardian
®
, Guardian RT
®
, Paradigm
®
, Paradigm Link
®
, Quick-serter
®
, Quick-set
®
, Sen-serter
®
,
Silhouette
®
, Sof-set
®
, and Square Wave
®
 are registered trademarks of Medtronic MiniMed, Inc.
CareLink™ Personal, Easy Bolus™, and MiniLink™ are trademarks of Medtronic MiniMed, Inc.
Energizer
®
 is a registered trademark of Eveready Battery Company.
LifeScan
®
, OneTouch
®
, OneTouch
®
Ultra
®
 and OneTouch
®
UltraLink™ are trademarks of LifeScan, Inc.
Glucagon Emergency Kit
®
 is a registered trademark of Eli Lilly and Company.
YSI 2300 STAT Plus™ is a trademark of YSI Inc.
6025250-013_b
   
REF MMT-522 MMT-522K MMT-722 MMT-722K

Contacts:
 
Africa:
Medtronic Africa (Pty) Ltd.
Tel: [phone]
Australia:
Medtronic Australasia Pty. Ltd.
Tel: [phone] (product orders)
Tel: [phone] (customer help)
Belgie/Belgique:
N.V. Medtronic Belgium S.A.
Tel: [phone]
Brasil:
Medtronic Comercial Ltda.
Tel: +(11) 3707-3707
Canada:
Medtronic of Canada Ltd.
Tel: [phone] (toll free/sans-
frais)
Ceska Republika:
Medtronic Czechia s.r.o.
Tel: [phone]
China:
Medtronic (Shanghai) Ltd.
Tel: [phone] 
or 80 0820 1981
Danmark:
Medtronic Danmark A/S
Tel: [phone]
Deutschland:
Medtronic GmbH
Geschäftsbereich Diabetes
Telefon: [phone]
Telefax: [phone]
24-Stdn-Hotline: [phone]
East Asia:
Medtronic International Ltd.
Tel: [phone]
Eire:
Accu-Science LTD.
Tel: [phone]
España:
Medtronic Ibérica S.A.
Tel: + 34 91 625 05 42
Fax: [phone]
Europe:
Medtronic Europe S.A. Europe,
Middle East and Africa Headquarters
Tel: [phone]
France:
Medtronic France S.A.S.
Tel: [phone]
Hellas:
Medtronic Hellas S.A.
Tel: [phone]
Italia:
Medtronic Italia S.p.A.
Tel. [phone]
Servizio assistenza tecnica: No verde
24h: 800 712 712
Tel. [phone]
Fax [phone]
Japan:
Medtronic Japan Co. Ltd.
Tel: [phone]
Latin America:
Medtronic, Inc.
Tel. [phone]
Fax [phone]
Latvija:
Ravemma Ltd.
Tel: [phone]
Magyarország:
Medtronic Hungária Kft.
Tel: [phone]
Malaysia:
Medtronic International Ltd.
Tel: [phone]
or ([phone]
Middle East and North Africa:
Regional Office
Tel: [phone]
Nederland, Luxembourg:
Medtronic B.V.
Tel: [phone]
New Zealand:
Medica Pacifica
Tel: [phone]
After-Hours:
+0800 633 487
Norge:
Medtronic Norge A/S
Tel: [phone]
Fax: [phone]
POCCИЯ:
Medtronic B. V.
Tel: [phone]
Polska:
Medtronic Poland Sp. z.o.o.
Tel: [phone]
Portugal:
Medtronic Portugal Lda
Tel: [phone]
Fax: [phone]
Puerto Rico:
Medtronic Puerto Rico
Tel: [phone]
Republic of Korea:
Medtronic Korea, Co., Ltd.
Tel: [phone]

Schweiz:
Medtronic (Schweiz) AG
Tel: + 41 (0)31 868 0160
24-Stunden-Hotline [phone]
Fax Allgemein: [phone]
Serbia & Montenegro:
Novolab Serbia & Montenegro
Epsilon Research Ltd.
Tel: [phone]
Singapore:
Medtronic International Ltd.
Tel: [phone]
or ([phone]
Slovenija:
Zaloker & Zaloker d.o.o.
Tel: [phone]
Slovenská Republika:
Medtronic Slovakia o.z.
Tel: [phone]
Suomi:
Medtronic Finland OY
Tel: [phone]
Sverige:
Medtronic AB
Tel: [phone]
Fax: [phone]
Taiwan:
Medtronic-Mediland Ltd.
Tel: [phone]
Thailand:
Medtronic (Thailand) Ltd.
Tel: [phone]
or ([phone]
Turkiye:
Medtronic Medikal Teknoloji
Ticaret Ltd. Sirketi.
Tel: [phone]
USA:
Medtronic Diabetes Global
Headquarters
Tel: [phone]
24-hour Help Line: [phone]
To order supplies: [phone]
United Kingdom:
Medtronic Ltd.
Tel: [phone]
Yisrael:
Agentek
Tel: [phone]
Österreich:
Medtronic Österreich GmbH
Tel: [phone]
24 – Stunden – Hotline [phone]

Important Safety Information
Regarding Your 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.

 
Contents
Chapter 1: Introduction .....................................................................  1
Assistance ...................................................................................................... 1
Emergency kit .................................................................................................  2
Consumables ..................................................................................................  3
Accessories ....................................................................................................  3
How to wear your pump .....................................................................................  4
How to use this guide ........................................................................................  5
User safety ..................................................................................................... 6
Indications: Paradigm 522/722 ..........................................................................  6
Pump ......................................................................................................  6
Sensor and transmitter .................................................................................  6
Indications: Paradigm 522K/722K (pediatric version) ................................................  6
Pump ......................................................................................................  6
Sensor and transmitter .................................................................................  6
Meter ...................................................................................................... 7
Contraindications ..........................................................................................  7
Warnings ..................................................................................................... 7
Pump ......................................................................................................  7
Reservoir and infusion sets ............................................................................  7
Tubing Connector ........................................................................................ 8
Sensor .....................................................................................................  8
Transmitter ............................................................................................... 8
Magnetic fields ..........................................................................................  9
X-rays, MRIs and CT scans .............................................................................. 9
Precautions .................................................................................................  9
Avoid extreme temperatures ..........................................................................  9
Infusion sets and sites ................................................................................. 10
Sensor ...................................................................................................  10
Contents
vii

Adverse reactions ........................................................................................  10
Notice .........................................................................................................  10
Insulin pump and RF accessories .......................................................................  10
RF interference from other devices ...................................................................  11
Chapter 2: Introduction to pump therapy ..............................................  13
Theory of insulin pump therapy ........................................................................... 13
Understanding pump therapy .............................................................................  14
Basal rate ..................................................................................................  14
Meal bolus .................................................................................................  14
Gram counting .........................................................................................  14
Exchange counting ..................................................................................... 14
BG targets .................................................................................................  14
Insulin sensitivity .........................................................................................  15
Active Insulin .............................................................................................. 15
Blood glucose and A1C testing ............................................................................  15
BG testing .................................................................................................  15
A1C .........................................................................................................  15
Low blood glucose (hypoglycemia) .......................................................................  17
Hypoglycemia protocol: the rule of 15 ................................................................ 18
High blood glucose (hyperglycemia) .....................................................................  19
Hyperglycemia protocol .................................................................................  19
Diabetes ketoacidosis (DKA) ...............................................................................  20
Preventing DKA ...........................................................................................  20
Sick day management ......................................................................................  21
Sick day protocol .........................................................................................  21
Sick day supplies .......................................................................................... 22
Nutrition ......................................................................................................  22
Carbohydrate counting ..................................................................................  22
Carbohydrate gram counting ......................................................................... 23
Carbohydrate exchange system .....................................................................  23
Reading a food label .....................................................................................  23
Fat and blood glucose ...................................................................................  24
Protein and blood glucose ............................................................................... 25
Other things that affect blood glucose ...............................................................  25
Healthy eating habits ....................................................................................  26
Exercise ....................................................................................................... 26
Contents
viii

Chapter 3: The basics ......................................................................  27
Your pump ....................................................................................................  27
Install battery ................................................................................................ 28
Pump buttons ................................................................................................  29
The pump screen ............................................................................................  31
HOME screen .................................................................................................  31
Screen icons ...............................................................................................  32
Battery ..................................................................................................  32
Time display ............................................................................................  32
Reservoir volume ......................................................................................  32
Alert and alarm icons .................................................................................  32
Sensor icons ............................................................................................  33
Scroll bar ..................................................................................................  33
Screen backlight ..........................................................................................  33
Beep/vibrate ................................................................................................. 33
Operating modes ............................................................................................  33
Normal mode .............................................................................................. 34
Special mode ..............................................................................................  34
Attention mode ...........................................................................................  34
Menus .........................................................................................................  35
MAIN MENU ................................................................................................  35
BOLUS MENU ............................................................................................... 35
SUSPEND ...................................................................................................  35
BASAL MENU ...............................................................................................  35
SENSOR .....................................................................................................  35
PRIME MENU ...............................................................................................  36
UTILITIES MENU ...........................................................................................  36
STATUS screen ...............................................................................................  36
If you remove your pump ..................................................................................  37
Chapter 4: Basic programming ............................................................ 39
Setting the time and date .................................................................................  39
Selecting the language .....................................................................................  40
Bolus ..........................................................................................................  41
Setting the Normal bolus ................................................................................  41
Review your bolus deliveries ..............................................................................  45
Bolus details ............................................................................................... 47
Contents
ix

Maximum bolus limit ........................................................................................ 48
BG Reminder .................................................................................................  49
Basal ..........................................................................................................  49
Start and stop times .....................................................................................  50
Your basal settings .......................................................................................  51
Basal programming and delivery ....................................................................  51
Current basal delivery ...................................................................................  52
Daily basal rate(s) .....................................................................................  52
Setting the Max basal rate .................................................................................  54
Stopping your pump ........................................................................................  55
Resume pump delivery .....................................................................................  55
Chapter 5: Starting on insulin ............................................................  57
Prepare your pump for use ................................................................................  57
Filling the reservoir .........................................................................................  58
Changing your infusion set ................................................................................. 60
Removing the reservoir  .................................................................................  60
Rewinding your pump  ...................................................................................  62
Inserting the reservoir in your pump  .................................................................  62
Manual prime .............................................................................................. 64
Inserting the infusion set ................................................................................ 65
Quick-set infusion set (with Quick-serter
®
) ..........................................................  66
Fixed prime ................................................................................................ 67
Prime history ..............................................................................................  67
Disconnecting Quick-set .................................................................................  67
Reconnecting Quick-set .................................................................................  68
Record keeping for diabetes management ..............................................................  68
Determining your pump settings .......................................................................... 69