Tandem Tslim X2 with Control IQ User Manual

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User Guide

UNITS OF MEASURE MG/DL

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY USER GUIDE

Software Version: Moonlight (7.4)

Congratulations on the purchase of your new t:slim X2™ insulin pump with Control-IQ™ technology.

This user guide is designed to assist you with the features and functions of the t:slim X2 insulin pump with Control-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 Control-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

WARNINGS:

Control-IQ technology should not be used in anyone under the age of six years old. Control-IQ technology should also not be used in patients who require less than a total daily insulin dose of 10 units per day or who weigh less than 55 pounds, as those are the required minimum values needed in order for Control-IQ technology to operate safely.

TABLE OF CONTENTS

Section 1: Before You Begin

Chapter 1 • Introduction

1.1 Conventions of This Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

1.2 Explanation of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

1.3 System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

1.4 About this User Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

1.5 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

1.6 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

1.7 Compatible iCGMs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

1.8 Important User Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

1.9 Important Pediatric User Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

1.10 Emergency Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Section 2: t:slim X2 Insulin Pump Features

Chapter 2 • Important Safety Information

2.1 t:slim X2 Insulin Pump Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

2.2 t:slim X2 Insulin Pump Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

2.3 Potential Benefits From Using Your Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

2.4 Possible Risks From Using Your Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

2.5 Working with your Healthcare Provider . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

2.6 Verification of Proper Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Chapter 3 • Getting to Know Your t:slim X2 Insulin Pump

3.1 What your t:slim X2 Pump Package Includes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

3.2 Pump Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

3.3 Explanation of t:slim X2 Insulin Pump Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

3.4 Explanation of Pump Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

3.5 Lock Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

3.6 Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

3.7 Current Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

3.8 Bolus Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

3.9 Options Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

3.10 My Pump Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

3.11 Device Settings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

3.12 Number Keypad Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

3.13 Letter Keypad Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Chapter 4 • Getting Started

4.1 Charging the t:slim X2 Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

4.2 Turning the Pump On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

4.3 Using the Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

4.4 Turning the t:slim X2 Pump Screen On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

4.5 Turning the Pump Screen Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

4.6 Turning the Pump Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

4.7 Unlocking the t:slim X2 Pump Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

4.8 Edit Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

4.9 Edit Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

4.10 Basal Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

4.11 Display Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

4.12 Mobile Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

4.13 Mobile Connection Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

4.14 Sound Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

4.15 Turn Security PIN On or Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Chapter 5 • Insulin Delivery Settings

5.1 Personal Profiles Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

5.2 Creating a New Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

5.3 Programming a New Personal Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

5.4 Editing or Reviewing an Existing Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

5.5 Duplicating an Existing Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

5.6 Activating an Existing Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

5.7 Renaming an Existing Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

5.8 Deleting an Existing Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

5.9 Starting a Temporary Basal Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

5.10 Stopping a Temp Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Chapter 6 • Infusion Site Care and Loading Cartridge

6.1 Infusion Site Selection and Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

6.2 Cartridge Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

6.3 Filling and Loading a t:slim Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

6.4 Filling Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

6.5 Filling Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

6.6 Setting Site Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Chapter 7 • Manual Bolus

7.1 Manual Bolus Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

7.2 Correction Bolus Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

7.3 Bolus Override . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

7.4 Food Bolus Using Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

7.5 Food Bolus Using Grams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

7.6 Extended Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

7.7 Max Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

7.8 Quick Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

7.9 Canceling or Stopping a Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Chapter 8 • Start, Stop, or Resume Insulin

8.1 Starting Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

8.2 Stopping Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

8.3 Resuming Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

8.4 Disconnecting When Using Automated Insulin Dosing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Chapter 9 • t:slim X2 Insulin Pump Information and History

9.1 t:slim X2 Pump Info . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

9.2 t:slim X2 Pump History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Chapter 10 • t:slim X2 Insulin Pump Reminders

10.1 Low BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

10.2 High BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

10.3 After Bolus BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

10.4 Missed Meal Bolus Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

10.5 Site Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

Chapter 11 • User Settable Alerts and Alarms

11.1 Low Insulin Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

11.2 Auto-Off Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

11.3 Max Basal Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Chapter 12 • t:slim X2 Insulin Pump Alerts

12.1 Low Insulin Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

12.2 Low Power Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

12.3 Incomplete Bolus Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

12.4 Incomplete Temp Rate Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

12.5 Incomplete Load Sequence Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

12.6 Incomplete Setting Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

12.7 Basal Rate Required Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

12.8 Max Hourly Bolus Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

12.9 Max Bolus Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

12.10 Max Basal Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

12.11 Min Basal Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

12.12 Connection Error Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

12.13 Pairing Code Timeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

12.14 Power Source Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

12.15 Data Error Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Chapter 13 • t:slim X2 Insulin Pump Alarms

13.1 Resume Pump Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

13.2 Low Power Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

13.3 Empty Cartridge Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

13.4 Cartridge Error Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

13.5 Cartridge Removal Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

13.6 Temperature Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

13.7 Occlusion Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

13.8 Screen On/Quick Bolus Button Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

13.9 Altitude Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

13.10 Reset Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Chapter 14 • t:slim X2 Insulin Pump Malfunction

14.1 Malfunction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

Chapter 15 • Taking Care of Your Pump

15.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Chapter 16 • Lifestyles Issues and Travel

16.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158

Section 3: CGM Features

Chapter 17 • Important CGM Safety Information

17.1 CGM Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

17.2 CGM Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

17.3 Potential Benefits From Using the t:slim X2 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

17.4 Possible Risks From Using the t:slim X2 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Chapter 18 • Getting to Know Your CGM System

18.1 CGM Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

18.2 Explanation of CGM Pump Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170

18.3 CGM Lock Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172

18.4 CGM Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

18.5 My CGM Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Chapter 19 • CGM Overview

19.1 CGM System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180

19.2 Receiver (t:slim X2 Insulin Pump) Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180

19.3 Transmitter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180

19.4 Sensor Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182

Chapter 20 • CGM Settings

20.1 About Bluetooth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

20.2 Disconnecting from the Dexcom Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

20.3 Entering Your Transmitter ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

20.4 Setting CGM Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185

20.5 CGM Info . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

Chapter 21 • Setting CGM Alerts

21.1 Setting Your High Glucose Alert and Repeat Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190

21.2 Setting Your Low Glucose Alert and Repeat Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

21.3 Rate Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

21.4 Setting Your Rise Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

21.5 Setting Your Fall Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

21.6 Setting Your Out of Range Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

Chapter 22 • Start or Stop a CGM Sensor Session

22.1 Start the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196

22.2 Sensor Startup Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

22.3 Automatic Sensor Shut-Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

22.4 Ending a Sensor Session Before Automatic Shut-Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

22.5 Removing the Sensor and Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

Chapter 23 • Calibrating Your CGM System

23.1 Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202

23.2 Startup Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202

23.3 Calibration BG Value and Correction Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204

23.4 Reasons You May Need to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204

Chapter 24 • Viewing CGM Data on Your t:slim X2 Insulin Pump

24.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

24.2 CGM Trend Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207

24.3 Rate of Change Arrows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208

24.4 CGM History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211

24.5 Missed Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211

Chapter 25 • CGM Alerts and Errors

25.1 Startup Calibration Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215

25.2 Second Startup Calibration Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

25.3 12 Hour Calibration Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

25.4 Incomplete Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218

25.5 Calibration Timeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219

25.6 Wait 15 Minute Calibration Error Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220

25.7 Calibration Required Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

25.8 CGM High Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222

25.9 CGM Low Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223

25.10 CGM Fixed Low Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224

25.11 CGM Rise Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

25.12 CGM Rapid Rise Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

25.13 CGM Fall Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227

25.14 CGM Rapid Fall Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228

25.15 Unknown Sensor Glucose Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229

25.16 Out of Range Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230

25.17 Low Transmitter Battery Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231

25.18 Transmitter Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232

25.19 Failed Sensor Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233

25.20 CGM Unavailable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234

25.21 CGM System Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235

Chapter 26 • CGM Troubleshooting

26.1 CGM Pairing Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238

26.2 Calibration Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238

26.3 Unknown Sensor Reading Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238

26.4 Out of Range/No Antenna Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239

26.5 Failed Sensor Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240

26.6 Sensor Inaccuracies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240

Section 4: Control-IQ Technology Features

Chapter 27 • Control-IQ Technology Important Safety Information

27.1 Control-IQ Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244

27.2 Control-IQ Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244

Chapter 28 • Getting to Know Control-IQ Technology

28.1 Responsible Use of Control-IQ Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248

28.2 Explanation of Control-IQ Technology Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249

28.3 Control-IQ Lock Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250

28.4 Control-IQ Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252

28.5 Control-IQ Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254

Chapter 29 • Introduction to Control-IQ Technology

29.1 Control-IQ Technology Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258

29.2 How Control-IQ Technology Works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258

29.3 Control-IQ Technology and Activity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267

Chapter 30 • Configure and Use Control-IQ Technology

30.1 Required Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270

30.2 Set Control-IQ Technology Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270

30.3 Set Total Daily Insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 271

30.4 Turn Control-IQ Technology On or Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 271

30.5 Schedule Sleep . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272

30.6 Activate or Deactivate a Sleep Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273

30.7 Manually Start or Stop Sleep . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 274

30.8 Manually Start or Stop Exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275

30.9 Control-IQ Technology Information on Your Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275

Chapter 31 • Control-IQ Technology Alerts

31.1 Out of Range Alert – Control-IQ Technology Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281

31.2 Out of Range Alert – Control-IQ Technology On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282

31.3 Control-IQ Technology Low Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283

31.4 Control-IQ High Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284

31.5 Max Insulin Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285

Chapter 32 • Overview of Control-IQ Technology Clinical Studies

32.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 288

32.2 Clinical Study Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 288

32.3 Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290

32.4 Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 294

32.5 Intervention Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 298

32.6 Primary Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303

32.7 Secondary Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 306

32.8 Insulin Delivery Differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 311

32.9 Control-IQ Technology High and Low Alert Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313

32.10 Additional Analysis of Sensor Glucose Value Auto-Population with CGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 315

Section 5: Technical Specifications and Warranty

Chapter 33 • Technical Specifications

33.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 320

33.2 t:slim X2 Pump Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 320

33.3 t:slim X2 Pump Options and Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 326

33.4 t:slim X2 Pump Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 328

33.5 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 333

33.6 Wireless Co-existence and Data Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 333

33.7 Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334

33.8 Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 335

33.9 Distances Between the t:slim X2 Pump and RF Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 338

33.10 Quality of Wireless Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 340

33.11 FCC Notice Concerning Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 340

33.12 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341

33.13 Returned Goods Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 344

33.14 t:slim X2 Insulin Pump Event Data (Black Box) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 345

33.15 Product List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 345

Index 348

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

Numbered items are step-by-step instructions for how to perform a specific task.

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.

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.

Symbol Definitions

Symbol Definition

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.

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 Definition Symbol Definition

Caution

Follow instructions for use Consult instructions for use

For sale by or on the order of a physician only (U.S.) Non-ionizing Radiation

Catalogue number Serial number

Batch code Medical device

International Protection (IP) Code Authorized Representative in the European Community

Manufacturer CE marking of conformity

Date of manufacture Regulatory Compliance Mark

Type BF Applied Part (patient isolation, not defibrillator protected)

Explanation of t:slim X2 Insulin Pump Symbols (Continued)

Symbol Definition Symbol Definition

Direct Current (DC) voltage Humidity limitation

CHAPTER 1 • Introduction

Separate collection for waste electrical and electronic equipment

Electric Equipment Designed Primarily for Indoor Use

Temperature limit

Keep Dry

IEC Class II Equipment Outlet Adapter

Wall Power USB Adapter Pump Case

Cartridge Removal Tool User Guide

USB Cable

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 Control-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 an automated insulin dosing feature, or can be updated to include an automated insulin dosing feature. The addition of this feature enables the t:slim X2 System to automatically adjust the delivery of insulin based on CGM sensor readings; however, the feature is not a substitute for your own active diabetes management. The automated insulin dosing feature utilizes the CGM sensor readings to calculate a predicted sensor glucose value 30 minutes into the future. For more information on how the automated insulin dosing feature is activated, see

Chapter 29 Introduction to Control-IQ Technology.

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 the automated insulin dosing feature.

The sensor is a disposable device that is inserted under the skin to continuously monitor glucose levels. 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 (BG) 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

CHAPTER 1 • Introduction

program, manage, and care for the System. It also provides important warnings and cautions on proper 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 the automated insulin dosing feature on your pump. Section 5 provides information on the technical specifications of your pump.

The pump screens used in this user guide demonstrate how to use features, and are examples only. They should not be considered as suggestions for your individual needs.

For customers in the United States, product information, including electronic versions of the user guide, t:connect Getting Started Guide, t:connect user guides, and a CGM training tutorial, are available at

tandemdiabetes.com. Product

information for users outside the United States can be provided by your local Tandem distributor.

1.5 Indications for Use

The t:slim X2 insulin pump with interoperable technology (the 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 Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

The Pump is intended for single patient, home use and requires a prescription.

The Pump is indicated for use with NovoLog or Humalog U-100 insulin.

The Pump is indicated for use in individuals six years of age and greater.

Control-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE)

pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.

Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons six years of age and greater.

Control-IQ technology is intended for single patient use and requires a prescription.

Control-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin.

1.6 Contraindications

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.

CHAPTER 1 • Introduction

1.7 Compatible iCGMs

Compatible CGMs include the following 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 and other applicable user guides, you may be putting your health and safety at risk.

If you are new to using CGM, continue using your BG 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.

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 7

Manual Bolus and 4 Getting Started.

CHAPTER 1 • Introduction

Inadvertent dislodgement of the infusion site may occur more frequently with children so consider securing the infusion site and tubing.

WARNING

Control-IQ technology should not be used by people who use less than 10 units of insulin per day or weigh less than 55 pounds (24.9 kilograms), which are the minimum inputs required to initiate Control-IQ technology and for it to operate safely.

WARNING

The t:slim X2 insulin pump with Control-IQ technology should not be used in children under the age of six years old.

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 4.15 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

4.15 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

• 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

CHAPTER 1 • Introduction

• Infusion sets (minimum of 2)

• Insulin pump cartridges (minimum of 2)

• Infusion site preparation products (antiseptic wipes, skin adhesive)

• Diabetes identification card or jewelry

t:slim X2 Insulin Pump Features

CHAPTER 2

Important Safety Information

CHAPTER 2 • Important Safety Information

The following includes important safety information related to your t:slim X2™ pump and its components. The information presented in this chapter does not represent all warnings and precautions related to the System. Pay attention to other warnings and precautions listed throughout this user guide as they relate to special circumstances, features, or users.

2.1 t:slim X2 Insulin Pump Warnings

WARNING

DO NOT start to use your pump before reading the user guide. Failure to follow the instructions in this user guide can result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. If you have questions or need further clarification on your pump use, ask your healthcare provider or call Customer Technical Support.

WARNING

DO NOT start to use your pump before you have been appropriately trained on its use by a certified trainer or through the training materials available online if you are updating your pump.

Consult with your healthcare provider for your individual training needs for the pump. Failure to complete the necessary training on your pump could result in serious injury or death.

WARNING

ONLY use U-100 Humalog or U-100 NovoLog with your pump. Only U-100 Humalog and NovoLog have been tested and found to be compatible for use in the pump. Use of insulin with lesser or greater concentration can result in under delivery or over delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.

WARNING

DO NOT put any other drugs or medications inside your pump cartridge. The pump is designed only for continuous subcutaneous insulin infusion (CSII) using U-100 Humalog or U-100 NovoLog insulin. Use of other drugs or medications can damage the pump and result in injury if infused.

WARNING

The pump is not intended for anyone unable or unwilling to:

» Test blood glucose (BG) levels as

recommended by a healthcare provider

» Demonstrate adequate

carbohydratecounting skills

» Maintain sufficient diabetes self-care

skills

» See a healthcare provider(s) regularly

The user must also have adequate vision and/or hearing in order to recognize pump alerts.

WARNING

DO NOT start to use your pump before consulting with your healthcare provider to determine which features are most appropriate for you. Only your healthcare provider can determine and help you adjust your basal rate(s), carb ratio(s), correction factor(s), target BG, and duration of insulin action. In addition, only your healthcare provider can determine your CGM settings and how you should use your sensor trend information to help you manage your diabetes. Incorrect settings can result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.

WARNING

ALWAYS be prepared to inject insulin with an alternative method if delivery is interrupted for any reason. Your pump is designed to deliver insulin reliably, but because it uses only rapid-

CHAPTER 2 • Important Safety Information

acting insulin, you will not have long-acting insulin in your body. Failure to have an alternative method of insulin delivery can lead to very high BG or Diabetic Ketoacidosis (DKA).

WARNING

ONLY use cartridges and infusion sets with matching connectors and follow their instructions for use. Failure to do so may result in over delivery or under delivery of insulin and may cause hypoglycemia (low BG) or hyperglycemia (high BG) events.

WARNING

DO NOT place your infusion set on any scars, lumps, moles, stretch marks or tattoos. Placing your infusion set in these areas can cause swelling, irritation or infection. This can affect insulin absorption and cause high or low BG.

WARNING

ALWAYS carefully follow the instructions for use accompanying your infusion set for proper insertion and infusion site care, as failure to do so could result in over delivery or under delivery of insulin or infection.

WARNING

NEVER fill your tubing while your infusion set is connected to your body. Always ensure that the

infusion set is disconnected from your body before filling the tubing. Failure to disconnect your infusion set from your body before filling the tubing can result in over delivery of insulin. This can cause hypoglycemia (low BG) events.

WARNING

NEVER reuse cartridges or use cartridges other than those manufactured by Tandem Diabetes Care. Use of cartridges not manufactured by Tandem Diabetes Care or reuse of cartridges may result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.

WARNING

ALWAYS twist the tubing connector between the cartridge tubing and the infusion set tubing an extra quarter of a turn to ensure a secure connection. A loose connection can cause insulin to leak, resulting in under delivery of insulin. This can cause hyperglycemia (high BG).

WARNING

DO NOT disconnect the tubing connector between the cartridge tubing and the infusion set tubing. If the connection comes loose, disconnect the infusion set from your body before tightening. Failure to disconnect before

tightening can result in over delivery of insulin. This can cause hypoglycemia (low BG).

WARNING

DO NOT remove or add insulin from a filled cartridge after loading onto the pump. This will result in an inaccurate display of the insulin level on the Home screen and you could run out of insulin before the pump detects an empty cartridge. This can cause very high BG, or Diabetic Ketoacidosis (DKA).

WARNING

DO NOT deliver a bolus until you have reviewed the calculated bolus amount on the pump display. If you deliver an insulin amount that is too high or too low, this could cause hypoglycemia (low BG) or hyperglycemia (high BG) events. You can always adjust the insulin units up or down before you decide to deliver your bolus.

WARNING

CHAPTER 2 • Important Safety Information

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

can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.

Radiology and Medical Procedures and Your t:slim X2 System

WARNING

ALWAYS notify the provider/technician about your diabetes and your pump. If you need to discontinue use of the pump for medical procedures, follow your healthcare provider’s instructions to replace missed insulin when you reconnect to the pump. Check your BG before disconnecting from the pump and again when you reconnect and treat high BG levels as recommended by your healthcare provider.

WARNING

DO NOT expose your pump, transmitter, or sensor to:

» X-ray » Computed Tomography (CT) scan » Magnetic Resonance Imaging (MRI) » Positron Emission Tomography (PET)

scan

» Other exposure to radiation

The System is magnetic resonance (MR) unsafe. You must take off your pump, transmitter, and sensor and leave them outside the procedure

room if you are going to have any of the above procedures.

WARNING

In addition to the above, DO NOT expose your pump, transmitter, or sensor to:

» Pacemaker/Automatic Implantable

Cardioverter Defibrillator (AICD)

placement or reprogramming » Cardiac Catheterization » Nuclear Stress Test

You must take off your pump, transmitter, and sensor and leave them outside the procedure room if you are going to have any of the above medical procedures.

WARNING

There are other procedures where you should proceed with caution:

» Laser Surgery – Your System can

usually be worn during the procedure.

However, some lasers can create

interference and cause the System to

alarm. » General Anesthesia – Depending on the

equipment being used, you may or may

CHAPTER 2 • Important Safety Information

not need to remove your System. Be sure to ask your healthcare provider.

WARNING

There is no need to disconnect for electrocardiograms (EKGs) or colonoscopies. If you have questions, contact Customer Technical Support.

WARNING

DO NOT use the pump if you have a condition which, in the opinion of your healthcare provider, would put you at risk. Examples of individuals who should not use the pump include those with uncontrolled thyroid disease, renal failure (e.g. dialysis or eGFR <30), hemophilia, or another major bleeding disorder, or unstable cardiovascular disease.

2.2 t:slim X2 Insulin Pump Precautions

PRECAUTION

DO NOT open or attempt to repair your insulin pump. The pump is a sealed device that should be opened and repaired only by Tandem Diabetes Care. Modification could result in a safety hazard. If your pump seal is broken, the

pump is no longer watertight and the warranty is voided.

PRECAUTION

CHANGE your infusion set every 48 to 72 hours as recommended by your healthcare provider. Wash your hands with anti-bacterial soap before handling the infusion set and thoroughly clean the insertion site on your body to avoid infection. Contact your healthcare provider if you have symptoms of infection at your insulin infusion site.

PRECAUTION

ALWAYS remove all air bubbles from the pump before beginning insulin delivery. Ensure there are no air bubbles when drawing insulin into the filling syringe, hold the pump with the white fill port pointed up when filling the tubing, and ensure that there are no air bubbles in the tubing when filling. Air in the system takes space where insulin should be and can affect insulin delivery.

PRECAUTION

CHECK your infusion site daily for proper placement and leaks. REPLACE your infusion set if you notice leaks around the site. Improperly placed sites or leaks around the

infusion site can result in under delivery of insulin.

PRECAUTION

CHECK your infusion set tubing daily for any leaks, air bubbles, or kinks. Air in the tubing, leaks in the tubing, or kinked tubing may restrict or stop insulin delivery and result in under delivery of insulin.

PRECAUTION

CHECK the tubing connection between your cartridge tubing and infusion set tubing daily to ensure it is tight and secure. Leaks around the tubing connection can result in under delivery of insulin.

PRECAUTION

DO NOT change your infusion set before bedtime or if you will not be able to test your BG 1–2 hours after the new infusion set is placed. It is important to confirm that the infusion set is inserted correctly and delivering insulin. It is also important to respond quickly to any problems with the insertion to ensure continued insulin delivery.

PRECAUTION

ALWAYS check that your cartridge has enough insulin to last through the night before going to

CHAPTER 2 • Important Safety Information

bed. If you are sleeping, you could fail to hear the Empty Cartridge Alarm and miss part of your basal insulin delivery.

PRECAUTION

CHECK your pump’s personal settings regularly to ensure they are correct. Incorrect settings can result in over delivery or under delivery of insulin. Consult with your healthcare provider as needed.

PRECAUTION

ALWAYS make sure that the correct time and date are set on your insulin pump. Not having the correct time and date setting may affect safe insulin delivery. When editing time, always check that the AM/PM setting is accurate, if applicable. AM is to be used from midnight until 11:59 AM. PM is to be used from noon until 11:59 PM.

PRECAUTION

CONFIRM that the screen display turns on, you can hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On/Quick Bolus button when you connect a power source to the USB port. These features are used to notify you about alerts, alarms, and other conditions that require your attention. If these features are not working,

discontinue use of the pump and contact Customer Technical Support.

PRECAUTION

CHECK your pump regularly for potential alarm conditions that may display. It is important to be aware of conditions that may affect insulin delivery and require your attention so you can respond as soon as possible.

PRECAUTION

DO NOT use the vibrate feature for alerts and alarms during sleep unless otherwise directed by your healthcare provider. Having the volume for alerts and alarms set to high will help ensure that you don’t miss an alert or alarm.

PRECAUTION

ALWAYS look at the screen to confirm correct programming of the bolus amount when you first use the Quick Bolus feature. Looking at the screen will ensure that you are correctly using the beep/vibration commands to program the intended bolus amount.

PRECAUTION

DO NOT use your pump if you think it might be damaged due to dropping it or hitting it against a hard surface. Check that the pump is working properly by plugging a power source into the

USB port and confirming that the display turns on, you hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On/Quick Bolus button. If you are unsure about potential damage, discontinue use of the pump and contact Customer Technical Support.

PRECAUTION

AVOID exposure of your pump to temperatures below 40°F (5°C) or above 99°F (37°C). Insulin can freeze at low temperatures or degrade at high temperatures. Insulin that has been exposed to conditions outside of the manufacturer’s recommended ranges can affect the safety and performance of the pump.

PRECAUTION

AVOID submerging your pump in fluid beyond a depth of 3 feet (0.91 m) or for more than 30 minutes (IPX7 rating). If your pump has been exposed to fluid beyond these limits, check for any signs of fluid entry. If there are signs of fluid entry, discontinue use of the pump and contact Customer Technical Support.

PRECAUTION

AVOID areas where there may be flammable anesthetics or explosive gases. The pump is not suitable for use in these areas and there is a risk

+ 334 hidden pages

Tandem Tslim X2 with Control IQ User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Before You Begin

Introduction

t:slim X2 Insulin Pump Features

Important Safety Information