Tandem t:slim X2 User manual

INSULIN ON BOARD (IOB)
Units 1.1 u 1:09 hrsTime Remaining
B
12:31 PM
October 16, 2016 235 u
OPTIONS
BOLUS
100%

Customer Technical Support: [phone] 3
Congratulations on the purchase of
your new t:slim X2 Pump. Your deci-
sion to use insulin pump therapy is a
sign of your commitment to your diabe-
tes care. We recognize and respect the
importance of your decision. We also
recognize that your t:slim X2 Pump
purchase is only the beginning of your
relationship with Tandem. Our commit-
ment goes much deeper than simply
supplying products to help you in your
diabetes management. We pledge to
be here to support you with training
and education through our network of
Clinical Diabetes Specialists. We also
pledge to be here to support you with
our dedicated Customer Technical
Support.
This User Guide is designed to assist
you with the features and functions of
the t:slim X2 Pump. It provides import-
ant warnings and cautions on proper
operation as well as technical infor-
mation to ensure your safety. It also
provides step-by-step instructions on
how to properly program, manage and
care for your t:slim X2 Pump.
Changes in equipment, software, or
procedures occur periodically; informa-
tion describing these changes will be
included in future editions of this User
Guide. Please contact Tandem Diabe-
tes Care Customer Technical Support
at [phone] to obtain a replace-
ment copy of the User Guide that is the
correct version for your pump.
No part of this publication may be
reproduced, stored in a retrieval sys-
tem, nor transmitted in any form or by
any means, electronic or mechanical,
without the prior written permission
of Tandem Diabetes Care, Inc., San
Diego, California, USA.
Tandem Diabetes Care, Inc.
11045 Roselle Street
San Diego, CA 92121 USA
[phone]
www.tandemdiabetes.com
Need help? We are here for you
24 hours a day, 7 days a week
at [phone].
©2016 Tandem Diabetes Care, Inc.
All rights reserved. t:slim, touch sim-
plicity and Tandem Diabetes Care are
registered trademarks, and t:slim X2
is a trademark of Tandem Diabetes
Care, Inc.
Humalog®is a registered trademark of
Eli Lilly and Company.
NovoLog®is a registered trademark of
Novo Nordisk A/S.
Comfort™is a trademark of Unomedical
A/S.
Bluetooth®is a registered trademark of
Bluetooth SIG, Inc.
All other trademarks and copyrights are
the property of their respective owners.
t:slim X2 Insulin Pump User Guide Software Version: Trestles

Table of Contents
Customer Technical Support: (877) 801-69014
Section 1 – Before You Begin
Chapter 1 – Introduction
1.1 System Description .......................................................................................................16
1.2 About this User Guide ...................................................................................................16
1.3 Important User Information ...........................................................................................17
1.4 Important Pediatric User Information ............................................................................17
1.5 Conventions of this Guide.............................................................................................18
Chapter 2 – Important Safety Information
2.1 Indications for Use ........................................................................................................20
2.2 Contraindications ..........................................................................................................20
2.3 Pump Warnings .............................................................................................................20
2.4 System Precautions ......................................................................................................24
2.5 Potential Benefits From Using the Pump ......................................................................27
2.6 Possible Risks From Using the Pump...........................................................................28
2.7 Working with your Healthcare Provider .........................................................................28
2.8 Emergency Kit ...............................................................................................................29
2.9 Verification of Proper Functionality................................................................................30

Table of Contents
Customer Technical Support: [phone] 5
Chapter 3 – Getting to Know Your t:slim X2 Pump
3.1 What your t:slim X2 System Package Includes.............................................................32
3.2 Pump Terminology.........................................................................................................32
3.3 Explanation of Pump Symbols ......................................................................................34
3.4 Explanation of Pump Icons ...........................................................................................35
3.5 Explanation of Pump Colors..........................................................................................36
3.6 Screen Lock ..................................................................................................................38
3.7 Home Screen.................................................................................................................40
3.8 Status Screen ................................................................................................................42
3.9 Bolus Screen .................................................................................................................44
3.10 Options Screen..............................................................................................................46
3.11 My Pump Screen...........................................................................................................48
3.12 Number Keypad Screen ................................................................................................50
3.13 Letter Keypad Screen....................................................................................................52

Table of Contents
Customer Technical Support: (877) 801-69016
Section 2 – Key Pump Features
Chapter 4 – Getting Started
4.1 Charging the t:slim X2 Pump.........................................................................................56
4.2 Using the Touch Screen ................................................................................................58
4.3 Turning on the t:slim X2 Pump Screen..........................................................................58
4.4 Unlocking the t:slim X2 Pump Screen...........................................................................58
4.5 Edit Time .......................................................................................................................59
4.6 Edit Date........................................................................................................................59
Chapter 5 – Infusion Site Care and Loading Cartridge
5.1 Infusion Site Selection and Care ...................................................................................62
5.2 Cartridge Instructions for Use .......................................................................................64
5.3 Filling and Loading a t:slim Cartridge............................................................................64
5.4 Filling Tubing .................................................................................................................70
5.5 Filling Cannula ...............................................................................................................72
5.6 Setting Site Reminder ...................................................................................................73

Table of Contents
Customer Technical Support: [phone] 7
Chapter 6 – Personal Profiles
6.1 Personal Profiles Overview............................................................................................76
6.2 Creating a New Profile...................................................................................................76
6.3 Programming a New Personal Profile ...........................................................................78
6.4 Editing or Reviewing an Existing Profile........................................................................81
6.5 Duplicating an Existing Profile.......................................................................................82
6.6 Activating an Existing Profile.........................................................................................82
6.7 Renaming an Existing Profile.........................................................................................83
6.8 Deleting an Existing Profile............................................................................................83
Chapter 7 – Bolus
7.1 Bolus Overview .............................................................................................................86
7.2 Food Bolus Using Units.................................................................................................86
7.3 Food Bolus Using Grams ..............................................................................................87
7.4 Correction Bolus............................................................................................................88
7.5 Extended Bolus .............................................................................................................89
7.6 Canceling or Stopping a Bolus......................................................................................90

Table of Contents
Customer Technical Support: (877) 801-69018
Chapter 8 – Stop/Resume Insulin
8.1 Stopping Insulin Delivery...............................................................................................94
8.2 Resuming Insulin Delivery .............................................................................................94
Section 3 – Additional Pump Operations
Chapter 9 – Temporary Basal Rate
9.1 Setting a Temp Rate ......................................................................................................98
9.2 Stopping a Temp Rate...................................................................................................99
Chapter 10 – Quick Bolus
10.1 Setting Up Quick Bolus ...............................................................................................102
10.2 Delivering Quick Bolus ................................................................................................102
Chapter 11 – t:slim X2 Pump Settings
11.1 t:slim X2 Pump Volume ...............................................................................................106
11.2 Screen Options............................................................................................................106

Table of Contents
Customer Technical Support: [phone] 9
Chapter 12 – t:slim X2 Pump Info and History
12.1 t:slim X2 Pump Info .....................................................................................................110
12.2 t:slim X2 Pump History................................................................................................110
Chapter 13 – t:slim X2 Pump Reminders
13.1 Low BG Reminder .......................................................................................................112
13.2 High BG Reminder ......................................................................................................113
13.3 After Bolus BG Reminder ............................................................................................114
13.4 Missed Meal Bolus Reminder......................................................................................114
13.5 Site Reminder..............................................................................................................115
Chapter 14 – User Settable Alerts and Alarms
14.1 Low Insulin Alert ..........................................................................................................118
14.2 Auto-Off Alarm ............................................................................................................118

Table of Contents
Customer Technical Support: (877) 801-690110
Section 4 – t:slim X2 Pump Safety Alerts and Alarms
Chapter 15 – t:slim X2 Pump Alerts
15.1 Low Insulin Alert ..........................................................................................................123
15.2 Low Power Alerts ........................................................................................................124
15.3 Incomplete Bolus Alert ................................................................................................126
15.4 Incomplete Temp Rate Alert ........................................................................................127
15.5 Incomplete Load Sequence Alerts ..............................................................................128
15.6 Incomplete Setting Alert..............................................................................................131
15.7 Basal Rate Required Alert ...........................................................................................132
15.8 Max Hourly Bolus Alert................................................................................................133
15.9 Max Bolus Alerts .........................................................................................................134
15.10 Max Basal Alerts .........................................................................................................136
15.11 Min Basal Alerts ..........................................................................................................138
15.12 Connection Error Alert.................................................................................................140
15.13 Power Source Alert......................................................................................................141
15.14 Data Error Alert............................................................................................................142

Table of Contents
Customer Technical Support: [phone] 11
Chapter 16 – t:slim X2 Pump Alarms
16.1 Resume Pump Alarm ..................................................................................................145
16.2 Low Power Alarms ......................................................................................................146
16.3 Empty Cartridge Alarm................................................................................................148
16.4 Cartridge Error Alarm ..................................................................................................149
16.5 Cartridge Removal Alarm ............................................................................................150
16.6 Temperature Alarm ......................................................................................................151
16.7 Occlusion Alarms ........................................................................................................152
16.8 Screen On/Quick Bolus Button Alarm.........................................................................154
16.9 Altitude Alarm ..............................................................................................................155
16.10 Reset Alarm .................................................................................................................156
Chapter 17 – t:slim X2 Pump Malfunction
17.1 Malfunction..................................................................................................................158

Table of Contents
Customer Technical Support: (877) 801-690112
Section 5 – Living With and Caring for Your t:slim X2 Pump
Chapter 18 – Lifestyle Issues and Travel
18.1 Overview......................................................................................................................162
Chapter 19 – Taking Care of Your t:slim X2 Pump
19.1 Overview......................................................................................................................166

Table of Contents
Customer Technical Support: [phone] 13
Section 6 – Technical Specifications and Warranty
Chapter 20 – Technical Specifications
20.1 Overview......................................................................................................................170
20.2 t:slim X2 Pump Specifications.....................................................................................171
20.3 t:slim X2 Pump Options and Settings .........................................................................176
20.4 t:slim X2 Pump Performance Characteristics .............................................................178
20.5 Electromagnetic Compatibility ....................................................................................180
20.6 Electromagnetic Emissions .........................................................................................181
20.7 Electromagnetic Immunity...........................................................................................182
20.8 Distances Between the t:slim X2 Pump and RF Equipment .......................................184
20.9 FCC Notice Concerning Interference ..........................................................................187
20.10 Warranty Information...................................................................................................188
20.11 Returned Goods Policy ...............................................................................................190
Index

Section 1
Before You Begin

Chapter 1
Introduction

Customer Technical Support: (877) 801-690116
Chapter 1 – Introduction
1.1 System Description
The t:slim X2 System is made up of
the t:slim X2™Insulin Pump and the
t:slim®3mL (300 units) cartridge. The
t:slim X2 Insulin Pump delivers insulin in
two ways: continuous, or basal insulin
delivery, and bolus insulin delivery to
cover carbohydrates eaten (food bolus)
and to lower high blood glucose (cor-
rection bolus). The disposable cartridge
is filled with up to 300 units of U-100
insulin and attached to the pump. The
cartridge is replaced every few days.
CAUTION
Federal (USA) law restricts this
device to sale by or on the order
of a physician.
Product information, including electron-
ic versions of the User Guide, a Guide
to Successful Pumping, t:connect
Getting Started and User Guides are
available at www.tandemdiabetes.com.
1.2 About this User Guide
This User Guide covers important infor-
mation on how to operate your t:slim
X2 Pump. It provides step-by-step
instructions to help you properly pro-
gram, manage and care for the pump.
It also provides important warnings and
cautions on proper operation and tech-
nical information to ensure your safety.
In this Guide, the t:slim X2 Pump may
be referred to as “your pump” or “your
t:slim X2 Pump”. The t:slim cartridge
may be referred to as “your cartridge.”
Together, the t:slim X2 Insulin Pump
and the t:slim cartridge may be referred
to as “your system”.
The User Guide is organized into sec-
tions that allow you to learn to use your
t:slim X2 System.
Pump screens used in this Guide to
demonstrate how to use features are
examples only. They should not be
considered suggestions for your indi-
vidual needs.

Customer Technical Support: [phone] 17
Before You Begin1
Chapter 1 – Introduction
1.3 Important User
Information
Review all instructions in this User
Guide before using the pump.
If you are not able to use the pump ac-
cording to the instructions in this User
Guide, you may be putting your health
and safety at risk.
Pay special attention to Warnings
and Precautions in this User Guide.
Warnings and Precautions are identified
with .
If you still have questions after reading
this User Guide, contact Tandem Dia-
betes Care Customer Technical Sup-
port at [phone]. We are here for
you 24 hours a day, 7 days a week.
1.4 Important Pediatric
User Information
The following recommendations are
meant to help younger users and their
caregivers program, manage and care
for the pump.
Younger children may inadvertently
press or tap the pump, leading to unin-
tentional delivery of insulin.
It is the responsibility of the healthcare
provider and caregiver to determine if
the user is appropriate for treatment
with this device.
We recommend reviewing the Quick
Bolus and Feature Lock capabilities
of the Tandem pump and determining
how they best fit with your care plan.
These features are detailed in Chapters
10 and 11 of this User Guide.
Inadvertent dislodgement of the infu-
sion site may occur more frequently
with children so consider securing the
infusion site and tubing.
WARNING
DO NOT allow small children (either
pump users or non-users) to ingest
small parts, such as the rubber USB
port cover and cartridge components.
Small parts could pose a choking
hazard. If ingested or swallowed, these
small component pieces may cause
internal injury or infection.
WARNING
The Pump includes parts (such as the
USB cable and infusion set tubing) that
could pose a strangulation or asphyxi-
ation hazard. Always use the appropri-
ate length of infusion set and arrange
cables and tubing to minimize the risk
of strangulation. ENSURE that these
parts are stored in a secure place when
not in use.
WARNING
For patients who do not self-manage
their disease, the Feature Lock function
should ALWAYS be ON when the
pump is not being used by a caregiver.
The Feature Lock function is intended
to prevent inadvertent button presses
that may lead to insulin delivery or
changes in the pump settings. These

Customer Technical Support: (877) 801-690118
Chapter 1 – Introduction
1.5 Conventions of this Guide
The following are conventions used in this Guide (such as terms, icons, text format-
ting, and other conventions) along with their explanations.
Convention Explanation
Bolded Text Text that is in bold and in a different font than the rest of the sentence or step
indicates an onscreen or physical button name.
Touch Screen The front glass screen of your pump, which displays all programming, operating,
and alarm/alert information.
Tap Quickly and lightly touch the screen with your finger.
Press Use your finger to depress a physical button (the Screen On/Quick Bolus Button
is the only physical/hardware button on your t:slim X2 Pump).
Hold Keep pressing a button or touching an icon or menu until its function is complete.
Menu A list of options on your touch screen that allow you to perform specific tasks.
Icon An image on your touch screen that indicates an option or item of information,
or a symbol on the back of your t:slim X2 Pump or its packaging.
changes can potentially lead to hypo-
glycemic or hyperglycemic events.
WARNING
For patients whose insulin adminis-
tration is managed by a caregiver, DO
turn off the Quick Bolus feature to
avoid inadvertent bolus delivery. With
the Feature Lock turned on, the Quick
Bolus feature is disabled. Inadvertent
button presses or tampering with
the insulin pump could result in over
delivery or under delivery of insulin. This
can cause very low of very high blood
glucose which could result in serious
injury or death.

Chapter 2
Important Safety Information

Customer Technical Support: (877) 801-690120
Chapter 2 – Important Safety Information
2.1 Indications for Use
Indications for Use
The t:slim X2 Pump is intended for the
subcutaneous delivery of insulin, at set
and variable rates, for the management
of diabetes mellitus in persons requiring
insulin, for individuals 6 years of age
and greater. The device is indicated for
use with NovoLog or Humalog U-100
insulin.
2.3 Pump Warnings
WARNINGS
DO NOT start to use your t:slim X2
Pump before reading the User Guide.
Failure to follow the instructions in the
User Guide can result in over delivery
or under delivery of insulin. This can
cause very low or very high blood glu-
cose which could result in serious injury
or death. If you have questions or need
further clarification on your pump use,
ask your healthcare provider or call our
around-the-clock Customer Technical
Support at [phone].
DO NOT start to use your t:slim X2
Pump before you have been appropri-
ately trained on its use by a certified
Tandem Pump Trainer. Consult with
your healthcare provider for your indi-
vidual training needs for the t:slim X2
Pump. Failure to complete the neces-
sary training on the pump could result
in serious injury or death.
2.2 Contraindications
Contraindications
The t:slim X2 Pump is not intended
for anyone unable or unwilling to:
• Test blood glucose (BG) levels as
recommended by your healthcare
provider
• Demonstrate adequate
carbohydrate-counting skills
(preferred, not required)
• Maintain sufficient diabetes self-
care skills
• See your healthcare provider(s)
regularly
You must also have adequate vision
and/or hearing in order to recognize
your pump alerts.