400
INSULIN ON BOARD: 1.1 u | 1:09 hrs
10:20
14 Nov 2019
100%
235 u
350
300
250
200
150
100
84
mg/dL
3
HRS
50
with Basal-IQ™ Technology
User Guide
1 2 3
t:slim X2 Insulin Pump with Basal-IQ Technology User Guide Software Version: Carlsbad
Congratulations on the purchase of
your new t:slim X2 insulin pump with
Basal-IQ technology.
This user guide is designed to assist
you with the features and functions of
the t:slim X2 insulin pump with Basal-IQ
technology. It provides important
warnings and cautions on proper
operation as well as technical
information to ensure your safety. It also
provides step-by-step instructions on
how to properly program, manage and
care for your t:slim X2 insulin pump with
Basal-IQ technology.
Changes in equipment, software, or
procedures occur periodically;
information describing these changes
will be included in future editions of this
user guide.
No part of this publication may be
reproduced, stored in a retrieval
system, nor transmitted in any form or
by any means, electronic or
mechanical, without the prior written
permission of Tandem Diabetes
Care™.
Please contact Customer Technical
Support to obtain a replacement copy
of the user guide that is the correct
version for your pump. For contact
information in your region see the back
cover of this user guide.
Tandem Diabetes Care, Inc.
11075 Roselle Street
San Diego, CA 92121 USA
tandemdiabetes.com
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Table of Contents
Chapter 1 – Introduction
1.1 Conventions of this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
1.2 Explanation of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
1.3 System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
1.4 About this User Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
1.5 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
1.6 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
1.7 Compatible iCGMs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
1.8 Important User Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
1.9 Important Pediatric User Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
1.10 Emergency Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Chapter 2 – Important Safety Information
2.1 t:slim X2 Insulin Pump Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
2.2 t:slim X2 Insulin Pump Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
2.3 Potential Benefits From Using Your Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
2.4 Possible Risks From Using Your Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
2.5 Working with your Healthcare Provider . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
2.6 Verification of Proper Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
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Chapter 3 – Getting to Know Your t:slim X2 Insulin Pump
3.1 What your t:slim X2 Pump Package Includes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
3.2 Pump Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
3.3 Explanation of t:slim X2 Insulin Pump Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
3.4 Explanation of Pump Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
3.5 Lock Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
3.6 Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
3.7 Current Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
3.8 Bolus Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
3.9 Options Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
3.10 My Pump Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
3.11 Device Settings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
3.12 Number Keypad Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
3.13 Letter Keypad Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Chapter 4 – Getting Started
4.1 Charging the t:slim X2 Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
4.2 Turning the Pump On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
4.3 Using the Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
4.4 Turning the t:slim X2 Pump Screen On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
4.5 Turning the Pump Screen Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
4.6 Turning the Pump Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
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4.7 Selecting Your Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
4.8 Unlocking the t:slim X2 Pump Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
4.9 Edit Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
4.10 Edit Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Chapter 5 – Infusion Site Care and Loading Cartridge
5.1 Infusion Site Selection and Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
5.2 Cartridge Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
5.3 Filling and Loading a t:slim Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
5.4 Filling Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
5.5 Filling Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
5.6 Setting Site Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Chapter 6 – Personal Profiles
6.1 Personal Profiles Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
6.2 Creating a New Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
6.3 Programming a New Personal Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
6.4 Editing or Reviewing an Existing Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
6.5 Duplicating an Existing Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
6.6 Activating an Existing Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
6.7 Renaming an Existing Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
6.8 Deleting an Existing Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
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Chapter 7 – Bolus
7.1 Bolus Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
7.2 Correction Bolus Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
7.3 Bolus Override . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
7.4 Food Bolus Using Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
7.5 Food Bolus Using Grams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
7.6 Extended Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
7.7 Canceling or Stopping a Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Chapter 8 – Stop/Resume Insulin
8.1 Stopping Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
8.2 Resuming Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Chapter 9 – Temporary Basal Rate
9.1 Setting a Temp Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
9.2 Stopping a Temp Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Chapter 10 – Quick Bolus
10.1 Setting Up Quick Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
10.2 Delivering Quick Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
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Chapter 11 – Device Settings
11.1 Display Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
11.2 Mobile Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
11.3 Mobile Connection Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
11.4 Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
11.5 Sound Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
11.6 Turn Security PIN On or Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Chapter 12 – t:slim X2 Insulin Pump Information and History
12.1 t:slim X2 Pump Info . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
12.2 t:slim X2 Pump History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Chapter 13 – t:slim X2 Insulin Pump Reminders
13.1 Low BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
13.2 High BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
13.3 After Bolus BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
13.4 Missed Meal Bolus Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
13.5 Site Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Chapter 14 – User Settable Alerts and Alarms
14.1 Low Insulin Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
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14.2 Auto-Off Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Chapter 15 – t:slim X2 Insulin 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 Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
15.11 Min Basal Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
15.12 Connection Error Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
15.13 Pairing Code Timeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
15.14 Power Source Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
15.15 Data Error Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Chapter 16 – t:slim X2 Insulin Pump Alarms
16.1 Resume Pump Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
16.2 Low Power Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
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16.3 Empty Cartridge Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
16.4 Cartridge Error Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
16.5 Cartridge Removal Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
16.6 Temperature Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
16.7 Occlusion Alarm 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
16.8 Occlusion Alarm 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
16.9 Screen On/Quick Bolus Button Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
16.10 Altitude Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
16.11 Reset Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Chapter 17 – t:slim X2 Insulin Pump Malfunction
17.1 Malfunction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Chapter 18 – Lifestyle Issues and Travel
18.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Chapter 19 – Taking Care of Your Pump
19.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
Chapter 20 – Important CGM Safety Information
20.1 CGM Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
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20.2 CGM Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
20.3 Potential Benefits From Using the t:slim X2 System . . . . . . . . . . . . . . . . . . . . . . . . 174
20.4 Possible Risks From Using the t:slim X2 System . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Chapter 21 – Getting to Know Your CGM System
21.1 CGM Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
21.2 Explanation of CGM Pump Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
21.3 CGM Lock Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
21.4 CGM Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184
21.5 My CGM Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
Chapter 22 – CGM Overview
22.1 CGM System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
22.2 Receiver (t:slim X2 Insulin Pump) Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
22.3 Transmitter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
22.4 Sensor Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192
Chapter 23 – CGM Settings
23.1 About Bluetooth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
23.2 Disconnecting from the Dexcom Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
23.3 Entering Your Transmitter ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
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23.4 Setting CGM Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
23.5 CGM Info . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Chapter 24 – Setting CGM Alerts
24.1 Setting Your High Glucose Alert and Repeat Feature . . . . . . . . . . . . . . . . . . . . . . . 200
24.2 Setting Your Low Glucose Alert and Repeat Feature . . . . . . . . . . . . . . . . . . . . . . . . 201
24.3 Rate Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
24.4 Setting Your Rise Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
24.5 Setting Your Fall Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
24.6 Setting Your Out of Range Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Chapter 25 – Starting a CGM Sensor Session
25.1 Start the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
25.2 Sensor Startup Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208
Chapter 26 – Calibrating Your CGM System
26.1 Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
26.2 Startup Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
26.3 Calibration BG Value and Correction Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214
26.4 24 Hour Calibration Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214
26.5 Other Reasons You May Need to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
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Table of Contents
Chapter 27 – Viewing CGM Data on Your t:slim X2 Insulin Pump
27.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
27.2 CGM Trend Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219
27.3 Rate of Change Arrows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220
27.4 CGM History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222
27.5 Missed Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222
Chapter 28 – Ending Your CGM Sensor Session
28.1 Automatic Sensor Shut-Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224
28.2 Ending a Sensor Session Before Automatic Shut-Off . . . . . . . . . . . . . . . . . . . . . . . 224
28.3 Removing the Sensor and Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224
Chapter 29 – CGM Alerts and Errors
29.1 Startup Calibration Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
29.2 Second Startup Calibration Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230
29.3 12 Hour Calibration Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231
29.4 Incomplete Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232
29.5 Calibration Timeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233
29.6 Wait 15 Minute Calibration Error Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234
29.7 Calibration Required Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
29.8 CGM High Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
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Table of Contents
29.9 CGM Low Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237
29.10 CGM Fixed Low Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238
29.11 CGM Rise Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239
29.12 CGM Rapid Rise Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240
29.13 CGM Fall Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
29.14 CGM Rapid Fall Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242
29.15 Unknown Sensor Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
29.16 Out of Range Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244
29.17 Low Transmitter Battery Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245
29.18 Transmitter Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246
29.19 Failed Sensor Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247
29.20 CGM System Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248
Chapter 30 – CGM Troubleshooting
30.1 CGM Pairing Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250
30.2 Calibration Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250
30.3 Unknown Sensor Reading Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250
30.4 Out of Range/No Antenna Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
30.5 Failed Sensor Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
30.6 Sensor Inaccuracies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252
12
Table of Contents
Chapter 31 – Getting to Know Basal-IQ Technology
31.1 Responsible Use of Basal-IQ Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256
31.2 Explanation of Basal-IQ Technology Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256
31.3 Basal-IQ Lock Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258
31.4 Basal-IQ Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260
31.5 Basal-IQ Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262
Chapter 32 – Basal-IQ Technology Overview
32.1 Basal-IQ Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266
32.2 How Basal-IQ Works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266
32.3 Turn Basal-IQ On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269
Chapter 33 – Viewing Basal-IQ Technology Status on Your t:slim X2 Pump
33.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272
33.2 Basal-IQ Status Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272
33.3 Basal-IQ History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273
Chapter 34 – Basal-IQ Alerts
34.1 Out of Range Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277
34.2 Suspend Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
34.3 Resume Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279
13
Table of Contents
Chapter 35 – Basal-IQ Technology Clinical Study Overview
35.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282
35.2 Clinical Study Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282
35.3 Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283
35.4 Intervention Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284
35.5 Primary Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 286
35.6 Secondary Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 288
35.7 Insulin Delivery Differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290
35.8 Basal-IQ Technology Performance Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292
Chapter 36 – Technical Specifications
36.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 296
36.2 t:slim X2 Pump Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297
36.3 t:slim X2 Pump Options and Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303
36.4 t:slim X2 Pump Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 305
36.5 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 310
36.6 Wireless Co-existence and Data Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 310
36.7 Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 311
36.8 Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 312
36.9 Distances Between the t:slim X2 Pump and RF Equipment . . . . . . . . . . . . . . . . . . 316
36.10 Quality of Wireless Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 318
36.11 FCC Notice Concerning Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 318
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Table of Contents
36.12 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 319
36.13 Returned Goods Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 322
36.14 t:slim X2 Insulin Pump Event Data (Black Box) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 323
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .324
15
Section 1
Overview
Before You Begin
Chapter 1
Introduction
Chapter 1 – Introduction
1.1 Conventions of this Guide
The following are conventions used in this user guide (such as terms, icons, text formatting, and other conventions) along with their
explanations.
Formatting Conventions
Convention Explanation
Bolded Text Text that is in bold in a sentence or step indicates an on-screen icon or physical button name.
Italic Text Text that is in italics indicates the name of a screen or menu on the pump display.
Numbered
Items
Blue Text Calls out a reference to a separate user guide location or website link.
Terminology Definitions
Term Definition
Touchscreen 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 pump).
Hold Keep pressing a button or touching an icon or menu until its function is complete.
Menu A list of options on your touchscreen that allow you to perform specific tasks.
Numbered items are step-by-step instructions for how to perform a specific task.
18
Chapter 1 – Introduction
Terminology Definitions (Continued)
Term Definition
Icon An image on your touchscreen that indicates an option or item of information, or a symbol on the back of your pump or its packaging.
Calls out an important note regarding the use or operation of the system.
Calls out safety precautions which, if ignored, could result in minor or moderate injury.
Calls out critical safety information which, if ignored, could result in serious injury or death.
Indicates how the pump responds to the previous instruction.
19
Chapter 1 – Introduction
1.2 Explanation of Symbols
The following are symbols (and their descriptions), which you may find on your pump, pump supplies and/or their packaging. These
symbols tell you about the proper and safe use of the pump. Some of these symbols may not be relevant in your region, and are
listed for informational purposes only.
Explanation of t:slim X2 Insulin Pump Symbols
Symbol Meaning Symbol Meaning
Caution; Consult Manual for Important Safety
Documentation
Follow Instructions for Use Use By Date
See Instructions for Use Do Not Re-Use
Serial Number of Device Non-ionizing Radiation
Part Number
Lot Number Sterile by Radiation
Manufacturer Number Sterile by Ethylene Oxide
Watertight Equipment (protected against the effects of
temporary immersion in water)
20
Type BF Applied Part (patient isolation, not defibrillator
protected)
Non-pyrogenic
For sale by or on the order of a physician only (U.S.)
Explanation of t:slim X2 Insulin Pump Symbols (Continued)
Symbol Meaning Symbol Meaning
Chapter 1 – Introduction
Authorized Representative in the European Community
Manufacturer Keep Dry
Direct Current (DC) voltage Two-Sided Humidity Limits
European Union WEEE Directive 2006/66/EC Two-sided Temperature Limits
Electric Equipment Designed Primarily for Indoor Use IEC Class II Equipment
Wall Power USB Adapter Outlet Adapter (for regions outside the U.S. only)
Cartridge Removal Tool Pump Case
USB Cable User Guide
Marking Certifies That the Device Meets the European
Council Directive 93/42/EEC
21
Chapter 1 – Introduction
1.3 System Description
The t:slim X2 insulin pump is made up
of the t:slim X2 insulin pump, the t:slim
3mL (300 units) cartridge, and a
compatible infusion set. In this user
guide, the t:slim X2 insulin pump may
be referred to as the “pump” or the
“t:slim X2 pump.”
The combination of the t:slim X2 pump
with Basal-IQ technology and a
compatible continuous glucose monitor
(CGM) may be referred to as the
“System.”
The Dexcom G6 transmitter may be
referred to as the “transmitter.” The
Dexcom G6 sensor may be referred to
as the “sensor.” Together, the Dexcom
G6 transmitter and Dexcom G6 sensor
may be referred to as the “CGM.”
The pump delivers insulin in two ways:
basal insulin delivery (continuous) and
bolus insulin delivery. The disposable
cartridge is filled with up to 300 units of
U-100 insulin and attached to the
pump. The cartridge is replaced every
48–72 hours.
The t:slim X2 pump comes preloaded
with Basal-IQ technology, or can be
updated to include Basal-IQ
technology. The addition of this feature
enables the t:slim X2 System to
automatically suspend and resume the
delivery of insulin based on CGM
sensor readings. The Basal-IQ
technology utilizes the CGM sensor
readings to calculate a predicted
glucose value 30 minutes into the
future. For more information on how
Basal-IQ technology is activated, see
Chapter 32 Basal-IQ Technology
Overview.
The pump can be used for basal and
bolus insulin delivery with or without a
CGM. If a CGM is not used, sensor
glucose readings will not be sent to the
pump display and you will not be able
to use Basal-IQ technology.
The sensor is a disposable device that
is inserted under the skin to
continuously monitor glucose levels for
up to 10 days. The transmitter
connects to the sensor pod and
wirelessly sends readings to the pump,
which acts as a receiver for the
therapeutic CGM, every 5 minutes. The
pump shows sensor glucose readings,
a trend graph, as well as the direction
and rate of change arrows.
The sensor measures glucose in the
fluid under the skin—not in blood, and
sensor readings are not identical to
readings from a blood glucose meter.
The t:connect™ mobile app enables
you to connect a mobile device to the
pump using Bluetooth wireless
technology to display your pump
information on the mobile device. The
t:connect mobile app may not yet be
available in your region.
PRECAUTION
Federal (USA) law restricts this device to sale by
or on the order of a physician.
1.4 About this User Guide
This user guide covers important
information on how to operate your
System. It provides step-by-step
instructions to help you properly
program, manage and care for the
System. It also provides important
warnings and cautions on proper
22
Chapter 1 – Introduction
operation and technical information to
ensure your safety.
The user guide is organized into
sections. Section 1 provides important
information you need to know before
you start using the System. Section 2
covers instructions for using the t:slim
X2 pump. Section 3 covers instructions
for using CGM with your pump. Section
4 covers instructions for using Basal-IQ
technology on your pump. Section 5
provides information on the technical
specifications of your pump.
Pump screens used in this user guide
to demonstrate how to use features are
examples only. They should not be
considered suggestions for your
individual needs.
For customers in the United States,
product information, including
electronic versions of the user guide,
Guide to Successful Pumping,
t:connect Getting Started Guide,
t:connect user guides, and a CGM
training tutorial, are available at
tandemdiabetes.com
information for users outside the United
. Product
States can be provided by your local
Tandem distributor.
1.5 Indications for Use
The t:slim X2 System with Basal-IQ
technology consists of the t:slim X2
insulin pump which contains Basal-IQ
technology (the System), and a
continuous glucose monitor (CGM). The
t:slim X2 insulin pump is intended for
the subcutaneous delivery of insulin, at
set and variable rates, for the
management of diabetes mellitus in
persons requiring insulin. The t:slim X2
insulin pump can be used solely for
continuous insulin delivery and as part
of the t:slim X2 insulin pump with BasalIQ technology System.
When the System is used with a
compatible integrate Continuous
Glucose Monitor (iCGM), Basal-IQ
technology can be used to suspend
insulin delivery based on CGM sensor
readings.
Compatible iCGMs are listed in the
labeling for this device.
The System is indicated for use in
individuals 6 years of age and greater.
The System is intended for single
patient use and requires a prescription.
Federal (USA) law restricts this device
to sale by or on the order of a
physician.
The System is indicated for use with
NovoLog or Humalog U-100 insulin.
1.6 Contraindications
The pump is not intended for anyone
unable or unwilling to:
• Test blood glucose (BG) levels as
recommended by a healthcare
provider
• Demonstrate adequate
carbohydrate-counting skills
(preferred, not required)
• Maintain sufficient diabetes selfcare skills
• See a healthcare provider(s)
regularly
23
Chapter 1 – Introduction
The user must also have adequate
vision and/or hearing in order to
recognize pump alerts.
The t:slim X2 pump, transmitter, and
sensor must be removed before
Magnetic Resonance Imaging (MRI),
Computed Tomography (CT) scan, or
diathermy treatment. Exposure to MRI,
CT, or diathermy treatment can
damage the components.
1.7 Compatible iCGMs
Compatible CGMs include the following
integrated continuous glucose monitors
(iCGMs):
• Dexcom G6 CGM
For information about Dexcom G6
CGM product specifications and
performance characteristics, visit the
manufacturer’s website for applicable
user guides.
The Dexcom G6 sensors and
transmitters are sold and shipped
separately by Dexcom.
NOTE: Device Connections
The Dexcom G6 CGM currently allows pairing
with one medical device at a time (either the
t:slim X2 pump or the Dexcom receiver), but you
can still use the Dexcom G6 CGM app and your
t:slim X2 pump simultaneously using the same
transmitter ID.
NOTE: Use of CGM for Treatment
Decisions
Product information for the Dexcom G6 CGM
System includes important information on how
to use the Dexcom G6 CGM information
(including sensor glucose readings, trend graph,
trend arrow, alarm/alerts) to make treatment
decisions. Ensure that you have reviewed this
information and discussed it with your
healthcare provider, who can guide you in
correctly using your Dexcom G6 CGM
information when making treatment decisions.
1.8 Important User Information
Review all instructions in this user guide
before using the System.
If you are not able to use the System
according to the instructions in this user
guide, you may be putting your health
and safety at risk.
If you are new to using CGM, continue
using your blood glucose meter until
you are familiar with CGM usage.
If you are currently using the pump
without Dexcom G6 CGM, or if you are
currently using Dexcom G6 CGM, it is
still very important that you review all
instructions in this user guide before
using the combined System.
Pay special attention to Warnings and
Precautions in this user guide.
Warnings and Precautions are identified
with a or symbol.
If you still have questions after reading
this user guide, contact Customer
Technical Support 24 hours a day, 7
days a week.
24
Chapter 1 – Introduction
1.9 Important Pediatric User Information
The following recommendations are
meant to help younger users and their
caregivers program, manage and care
for the System.
Younger children may inadvertently
press or tap the pump, leading to
unintentional 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 Security PIN capabilities of
the pump and determining how they
best fit with your care plan. These
features are detailed in Chapters 10
Quick Bolus and 11 Device Settings.
Inadvertent dislodgement of the
infusion 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 asphyxiation hazard. Always
use the appropriate length of infusion set tubing
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 Security PIN function should
ALWAYS be on when the pump is not being
used by a caregiver. The Security PIN function is
intended to prevent inadvertent screen taps or
button presses that may lead to insulin delivery
or changes in the pump settings. These
changes can potentially lead to hypoglycemia
(low BG) or hyperglycemia (high BG) events. See
Section 11.6 Turn Security PIN On or Off for
details on how to turn the Security PIN function
on.
WARNING
For patients whose insulin administration is
managed by a caregiver, ALWAYS turn off the
Quick Bolus feature to avoid inadvertent bolus
delivery. If the Security PIN is turned on, the
Quick Bolus feature is automatically disabled.
Inadvertent screen taps, button presses, or
tampering with the insulin pump could result in
over delivery or under delivery of insulin. This
can cause hypoglycemia (low BG) or
hyperglycemia (high BG) events. See Section
11.6 Turn Security PIN On or Off for details on
how to turn the Security PIN function off.
1.10 Emergency Kit
Make sure that you always have an
insulin syringe and vial of insulin or a
prefilled insulin pen with you as a
backup for emergency situations. You
should also always have an appropriate
emergency kit with you. Talk with your
healthcare provider regarding what
items this kit should include.
Supplies to carry every day:
• BG testing supplies: meter, strips,
control solution, lancets, meter
batteries
25
Chapter 1 – Introduction
• Fast-acting carbohydrate to treat
low BG
• Extra snack for longer coverage
than fast-acting carbohydrate
• Glucagon emergency kit
• Rapid-acting insulin and syringes or
a prefilled insulin pen
• Infusion sets (minimum of 2)
• Insulin pump cartridges (minimum
of 2)
• Infusion site preparation products
(antiseptic wipes, skin adhesive)
• Diabetes identification card or
jewelry
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Chapter 1 – Introduction
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Section 2
t:slim X2 Insulin Pump
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