Tandem Tslim X2 with Basil IQ User Manual

Download

400

INSULIN ON BOARD: 1.1 u | 1:09 hrs

10:20

14 Nov 2019

100%

235 u

350 300 250 200 150 100

mg/dL

HRS

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

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

Table of Contents

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

Table of Contents

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

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

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

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

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

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

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.

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.

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)

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

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

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

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.

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

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

Chapter 1 – Introduction

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Section 2

t:slim X2 Insulin Pump

Before You Begin

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

t:slim X2 Insulin Pump

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

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 rapidacting 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

Chapter 2 – Important Safety Information

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

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

Chapter 2 – Important Safety Information

changes can potentially lead to hypoglycemic or hyperglycemic events.

WARNING

For patients whose insulin administration is managed by a caregiver, ALWAYS turn off the Quick Bolus feature to avoid inadvertent bolus delivery.

WARNING

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.

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

WARNING

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.

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

WARNING

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.

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 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),

Chapter 2 – Important Safety Information

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 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.

Chapter 2 – Important Safety Information

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 of explosion. Remove your pump if you need to enter these areas.

PRECAUTION

MAKE SURE to not move further than the length of the USB cable when you are connected to the pump and to a charging source. Moving further than the length of the USB cable may cause the cannula to be pulled out of the infusion site. For this reason it is recommended not to charge the pump while sleeping.

PRECAUTION

DISCONNECT your infusion set from your body while on high-speed/high gravity amusement park thrill rides. Rapid changes in altitude or gravity can affect insulin delivery and cause injury.

PRECAUTION

DISCONNECT your infusion set from your body before flying in an aircraft without cabin pressurization or in planes used for aerobatics or combat simulation (pressurized or not). Rapid

Chapter 2 – Important Safety Information

changes in altitude or gravity can affect insulin delivery and cause injury.

PRECAUTION

CONSULT your healthcare provider about lifestyle changes such as weight gain or loss, and starting or stopping exercise. Your insulin needs may change in response to lifestyle changes. Your basal rate(s) and other settings may need adjustment.

PRECAUTION

CHECK your BG using a blood glucose meter following a gradual elevation change of up to each 1,000 feet (305 meters), such as when snow skiing or driving on a mountain road. Delivery accuracy can vary up to 15% until 3 units of total insulin have been delivered or elevation has changed by more than 1,000 feet (305 meters). Changes in delivery accuracy can affect insulin delivery and cause injury.

PRECAUTION

ALWAYS check with your healthcare provider for specific guidelines if you want or need to disconnect from the pump for any reason. Depending on the length of time and reason you are disconnecting, you may need to replace missed basal and/or bolus insulin. Check your BG before disconnecting from the pump and again when you reconnect, and treat high BG

levels as recommended by your healthcare provider.

PRECAUTION

ENSURE that your personal insulin delivery settings are programmed into the pump before use if you receive a warranty replacement. Failure to enter your insulin delivery settings could result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. Consult your healthcare provider as needed.

PRECAUTION

Interference with your pump’s electronics by cell phones can occur if worn in close proximity. It is recommended that your pump and cell phone be worn at least 6.4 inches (16.3 cm) apart.

PRECAUTION

ALWAYS dispose of used components such as cartridges, syringes, needles, infusion sets, and CGM sensors following the instructions from your healthcare provider. Wash your hands thoroughly after handling used components.

2.3 Potential Benefits From Using Your Pump

• The pump provides an automated way to deliver basal and bolus

insulin. Delivery can be fine-tuned based on up to 6 customizable Personal Profiles, each with up to 16 time-based settings for basal rate, carb ratio, correction factor, and target BG. In addition, the temp rate feature allows you to program a temporary basal rate change for up to 72 hours.

• The pump gives you the option of delivering a bolus all at once, or delivering a percentage over an extended period of time without navigating to different menus. You can also program a bolus more discreetly using the Quick Bolus feature, which can be used without looking at the pump, and can be programmed in increments of either units of insulin or grams of carbohydrate.

• From the Bolus screen, the “calculator within a calculator” feature allows you to enter multiple carbohydrate values and add them together. The insulin pump’s bolus calculator will recommend a bolus based on the entire amount of

Chapter 2 – Important Safety Information

carbohydrates entered, which can help eliminate guesswork.

• The insulin pump keeps track of the amount of active insulin from food and correction boluses (IOB). When programming additional food or correction boluses, the pump will subtract the amount of IOB from the recommended bolus if your BG is below the target set in your active Personal Profile. This can help prevent insulin stacking, which can lead to hypoglycemia (low BG).

• You can program a number of reminders that will prompt you to retest your BG after a low or high BG is entered, as well as a “Missed Meal Bolus Reminder” which will alert you if a bolus isn’t entered during a specified period of time. If activated, these can help reduce the likelihood that you will forget to check your BG or bolus for meals.

• You have the ability to view a variety of data right on your screen, including the time and amount of your last bolus, your total insulin delivery by day, as well as broken

into basal, food bolus, and correction bolus.

2.4 Possible Risks From Using Your Pump

As with any medical device, there are risks associated with using your pump. Many of the risks are common to insulin therapy in general, but there are additional risks associated with continuous insulin infusion and continuous glucose monitoring. Reading your user guide and following the Instructions for Use are critical for the safe operation of your System. Consult your healthcare provider about how these risks may impact you.

Inserting and wearing an infusion set might cause infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring or skin discoloration).

There is a remote chance that an infusion set cannula fragment could remain under your skin if the cannula breaks while you are wearing it. If you think a cannula has broken under your

skin, contact your healthcare provider and call Customer Technical Support.

Other risks associated with infusion sets include occlusions and air bubbles in the tubing, which can affect insulin delivery. If the condition persists, call Customer Technical Support or seek medical attention as required.

Risks that could result from pump failure include the following:

• possible hypoglycemia (low BG) from over-delivery of insulin due to a hardware defect.

• hyperglycemia (high BG) and ketosis possibly leading to Diabetic Ketoacidosis (DKA) due to pump failure resulting in cessation of insulin delivery due to either a hardware defect or software anomaly.

2.5 Working with your Healthcare Provider

Any clinical language presented in this user guide is based on the assumption that you have been educated by your healthcare provider on certain terms

Chapter 2 – Important Safety Information

and how they apply to you in your diabetes management. Your healthcare provider can help you establish diabetes management guidelines that best fit your lifestyle and needs.

Consult your healthcare provider before using the pump to determine which features are most appropriate for you. Only your healthcare provider can determine and help you adjust your basal rate(s), insulin-to-carbohydrate ratio(s), correction factor(s), BG target, 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.

2.6 Verification of Proper Functionality

A power supply (AC adapter with micro-USB connector) is provided with your pump. Before using your pump, ensure that the following occur when you connect a power supply into the USB port of your pump:

• You hear an audible alert

• You see the green light illuminate

from the edge around the Screen On/Quick Bolus button

• You feel a vibratory alert

• You see a charge symbol (lightning bolt) on the battery level indicator

In addition, before using your pump, ensure the following:

• Press the Screen On/Quick Bolus button to turn the screen on so that you can see the display

• When the display screen is on, the touchscreen responds to your finger tap

PRECAUTION

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Before You Begin

Chapter 3

Getting to Know Your t:slim X2

Insulin Pump

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

3.1 What your t:slim X2 Pump Package Includes

Your pump package should include the following items:

1. t:slim X2 insulin pump

2. pump case

3. t:slim X2 Insulin Pump with Basal-IQ Technology User Guide

4. USB cable

5. wall power USB adapter

6. cartridge removal tool

If any of these items are missing, contact Customer Technical Support.

If you use a CGM, the Dexcom G6 sensors and transmitters are sold and shipped separately by Dexcom.

Your pump is shipped with a clear screen protector. Do not remove the screen protector.

Your pump comes with a protective cover in the place where the cartridge is normally inserted. This cover must be

removed and replaced with a cartridge prior to initiating insulin delivery.

Your pump also includes consumable components that may require replacement during the life of your pump, including:

• pump case(s)/clip(s)

• screen protector

• USB rubber door

• USB cable

Supply Reordering

To order cartridges, infusion sets, supplies, accessories, screen protectors, please contact Customer Technical Support or your usual supplier of diabetes products.

3.2 Pump Terminology

Basal

Basal is a slow continuous delivery of insulin, which keeps glucose levels stable between meals and during sleep. It is measured in units per hour (units/ hr).

BG is the abbreviation for blood glucose, which is the level of glucose in the blood, measured in mg/dL.

BG Target

BG target is a specific blood glucose goal, an exact number, not a range. When a glucose value is entered in the pump, the calculated insulin bolus will be adjusted up or down as needed to attain this target.

Bolus

A bolus is a quick dose of insulin that is usually delivered to cover food eaten or correct high glucose. With the pump it can be delivered as a Standard, a Correction, an Extended, or a Quick Bolus.

Cannula

The cannula is the part of the infusion set that is inserted under the skin through which insulin is delivered.

Carb

Carb or Carbohydrate refers to sugars and starches that the body breaks down into glucose and uses as an energy source, measured in grams.

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

Carb Ratio

The carb ratio is the number of grams of carbohydrate that 1 unit of insulin will cover. Also known as insulin-tocarbohydrate ratio.

Correction Bolus

A correction bolus is given to correct high glucose.

Correction Factor

A correction factor is the amount of glucose that is lowered by 1 unit of insulin. Also known as the Insulin Sensitivity Factor (ISF).

Extended Bolus

An extended bolus is a bolus that is delivered over a period of time. It is commonly used to cover food that takes longer to digest. When administering an extended bolus with your pump, enter the DELIVER NOW portion to dose a percentage of insulin immediately and the remaining percentage over a period time.

Grams

Grams are the measurement for a carbohydrate.

Insulin Duration

Insulin duration is the amount of time that insulin is active and available in the body after a bolus has been delivered. This also relates to the calculation for Insulin on Board (IOB).

Insulin On Board (IOB)

IOB is the insulin that is still active (has the ability to continue to lower the glucose) in the body after a bolus has been delivered.

Load

Load refers to the process of removing, filling, and replacing a new cartridge and infusion set.

Personal Profile

A personal profile is a personalized group of settings that defines the delivery of basal and bolus insulin within specific time segments throughout a 24 hour period.

Quick Bolus Quick bolus (using the Screen On/ Quick Bolus button) is a way to deliver

a bolus by following beep/vibration commands without navigating through or viewing the pump screen.

Temp Rate

Temp rate is an abbreviation for a temporary basal rate. It is used to increase or decrease the current basal rate for a short period of time to accommodate special situations. 100% is the same basal rate as programmed. 120% means 20% more and 80% means 20% less than the programmed basal rate.

Units

Units are the measurement for insulin.

USB Cable

USB is the abbreviation for Universal Serial Bus. The USB cable connects into the pump’s micro USB port.

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

3.3 Explanation of t:slim X2 Insulin Pump Icons

The following icons may appear on your pump screen:

Pump Icon Definitions

Symbol Definition Symbol Definition

The amount of charge left in the pump battery. Amount of insulin remaining in the cartridge.

CGM sensor session is active, and the transmitter is communicating with the pump.

CGM sensor session is active, but the transmitter is not communicating with the pump.

CGM calibration is required. A temporary basal rate of 0 u/hr is active.

A system reminder, alert, error, or alarm is active. A bolus is being delivered.

Basal insulin is programmed and being delivered. All insulin deliveries are stopped.

Accept. Tap to continue to the next screen or to answer yes to a message on the pump screen.

Save. Tap to save settings on the screen.

New. Tap to add a new item. Back. Tap to navigate to the previous screen.

A temporary basal rate is active.

A basal rate of 0 u/hr is active.

Cancel. Tap to cancel the current operation.

Decline. Tap to exit the screen or answer no to a message on the pump screen.

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

Pump Icon Definitions (Continued)

Symbol Definition Symbol Definition

Delete. Tap to delete characters or digits on a keypad. Total. Tap to total values on a keypad.

Space. Tap to enter a space on the character keypad.

The associated setting is turned on. The associated setting is turned off.

Bluetooth

OK. Tap to confirm the current instruction or setting on the screen.

Security PIN has been enabled. See Section 11.6 Turn

Security PIN On or Off.

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

12:00

Basal

0.75 u/hr

Correction Factor Press to Set Up

Carb Ratio Press to Set Up

Target BG Press to Set Up

3.4 Explanation of Pump Colors

Red LED

1 red blink every 30 seconds indicates a malfunction or alarm condition.

Yellow LED

1 yellow blink every 30 seconds indicates an alert or reminder condition.

Green LED

• 1 green blink every 30 seconds indicates the pump is functioning normally.

• 3 green blinks every 30 seconds indicate the pump is charging.

Orange Highlight

When editing settings, changes are highlighted in orange for review before saving.

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

3.5 Lock Screen

The Lock screen appears anytime you turn on the screen. You must tap 1–2–3 in sequential order to unlock the pump.

1. Time and Date Display: Displays the current time and date.

2. Alert Icon: Indicates a reminder, alert or alarm is active behind the Lock screen.

3. Battery Level: Displays the level of battery power remaining. When connected for charging, the charging icon (lightning bolt) will display.

4. 1–2–3: Unlocks pump screen.

5. Insulin On Board (IOB): Amount and time remaining of any active insulin on board.

6. Active Bolus Icon: Indicates a bolus is active.

7. Status: Displays current system settings and insulin delivery status.

9. Tandem Logo: Returns to the

Home screen.

8. Insulin Level: Displays the current amount of insulin in the cartridge.

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

10:20

14 Nov 2019

INSULIN ON BOARD (IOB)

Units 1.1 u 1:09 hrsTime Remaining

235 u

100%

2 31

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

3.6 Home Screen

1. Battery Level: Displays the level of battery power remaining. When connected for charging, the charging icon (lightning bolt) will display.

2. USB Port: Port to charge your pump battery. Close the cover when not in use.

3. Bolus: Program and deliver a bolus.

4. Options: Stop/Resume insulin delivery, manage pump and CGM settings, program a temp rate, load a cartridge, and view history.

5. Insulin On Board (IOB): Amount and time remaining of any active insulin on board.

6. Time and Date Display: Displays the current time and date.

7. Status: Displays current system settings and insulin delivery status.

8. Insulin Level: Displays the current amount of insulin in the cartridge.

9. Tandem Logo: Returns to the

Home screen.

10. Cartridge Tubing: Tubing that is

attached to the cartridge.

11. Tubing Connector: Connects the

cartridge tubing to the infusion set tubing.

12. Screen On/Quick Bolus button:

Turns the pump screen on/off or programs a Quick Bolus (if activated).

13. LED Indicator: Illuminates when

connected to a power supply and indicates proper functionality.

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

10:20

14 Nov 2019

INSULIN ON BOARD (IOB)

Units 1.1 u 1:09 hrsTime Remaining

235 u

100 %

OPTIONS

BOLUS

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

3.7 Current Status Screen

The Current Status screen can be accessed from the Lock screen and the Home screen by tapping the insulin level symbol. It is for display only; no changes can be made from this screen.

1. Profile: Displays current active Personal Profile.

2. Basal Rate: Displays current basal rate being delivered in units/hr. If a Temp Rate is active, this row will change to display current temporary basal rate being delivered in units/hr.)

3. Last Bolus: Displays amount, date and time of last bolus.

4. Basal-IQ Status: Displays Basal-IQ technology status.

5. Up/Down Arrow: Indicates there is more information.

6. Correction Factor: Displays current correction factor used to calculate a bolus.

7. Carb Ratio: Displays current carb

ratio used to calculate a bolus.

8. Target BG: Displays current BG

target used to calculate a bolus.

9. Insulin Duration: Displays current

insulin duration setting used to calculate insulin on board.

10. Last Calibration: Displays date and

time of last calibration.

11. Time Sensor Started: Displays date

and time of last time sensor started.

12. Transmitter Battery: Displays

transmitter battery status.

13. Mobile Connection: Displays

whether the mobile connection is turned on or off, whether a mobile device is paired with the pump, and if so whether the mobile device is actively connected to the pump.

The mobile connection may not yet be available in your region.

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

Current Status

Weekday

Basal Rate 0.75 u/hr

Last Bolus

5.5 u

14 Nov - 10:20

Current Status

Insulin Duration

5 hours

Target BG

120 mg/dL

Carb Ratio

1u: 10 g

Correction Factor

1u: 50 mg/dL

Current Status

14 Nov 2019

10:02

Time Sensor Started

14 Nov 2019

12:15

Last Calibration

Transmitter Battery

Basal-IQ

Mobile Connection

OFF

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

3.8 Bolus Screen

1. : Returns to the Home screen.

2. Carbs: Enter grams of carbohydrate. See Section 10.1

Setting Up Quick Bolus for details

on how to set the Increment Type.

3. Units: Displays total units calculated. Tap to enter a bolus request or change (override) a calculated bolus.

4. View Calculation: Displays how the insulin dose was calculated using the current settings.

5. Glucose: Enter blood glucose level.

6. : Moves to next step.

7. Insulin: Enter units of insulin. See

Section 10.1 Setting Up Quick Bolus for details on how to set the

Increment Type.

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

units

2 7

63 54

Using Grams Using Units

CARBS

grams

GLUCOSE

Add BG

View Calculation

INSULIN

units

View Calculation

GLUCOSE

Add BG

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

3.9 Options Screen

1. : Returns to the Home screen.

2. Stop Insulin: Stops insulin delivery. If insulin delivery is stopped, RESUME INSULIN will be displayed.

3. Load: Change Cartridge, Fill Tubing, Fill Cannula, and Site Reminder.

4. Temp Rate: Programs a temporary basal rate.

5. My Pump: Personal Profiles, Alerts & Reminders, Basal-IQ, Pump Settings, and Pump Info.

6. Up/Down Arrow: Indicates there is more information.

7. My CGM: Start/Stop Sensor, Calibrate CGM, CGM Alerts, Transmitter ID, and CGM Info.

8. Device Settings: Display settings, Bluetooth settings, Time and Date, Sound Volume, and Security PIN.

9. History: Displays historical log of pump and CGM events.

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

Options

Temp Rate

Load

STOP INSULIN

My Pump

Options

My CGM

Device Settings

History

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

3.10 My Pump Screen

1. : Returns to the Home screen.

2. Personal Profiles: A group of settings that define basal and bolus delivery.

3. Basal-IQ: Turn on/off Basal-IQ technology, and Basal-IQ Alerts.

4. Alerts & Reminders: Customize Pump Reminders and Pump Alerts.

5. Pump Settings: Customize Quick Bolus.

6. Pump Info: Displays pump serial number, Customer Technical Support contact information, website, and other technical information.

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

My Pump

Alerts & Reminders

Basal-IQ

Personal Profiles

Pump Settings

My Pump

Pump Info

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

3.11 Device Settings Screen

1. Display Settings: Customize the Screen Timeout settings.

2. Bluetooth Settings: Turn on/off mobile connection. The mobile connection may not yet be available in your region.

3. Time and Date: Edit the time and date that will be displayed on the pump.

4. Sound Volume: Customize the sound volume for pump alarms, pump alerts, reminders, keypad, bolus, quick bolus, fill tubing, and CGM alerts.

5. Security PIN: Turn on/off the Security PIN.

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

Device Settings

Time and Date

Display Settings

Sound Volume

Device Settings

Security PIN

Bluetooth Settings

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

3.12 Number Keypad Screen

1. Value Entered.

2. : Returns to previous screen.

3. Keypad Numbers.

4. : Allows numbers to be added on gram screen. If in units, this displays as a decimal point.

5. : Completes task and saves information entered.

6. Units/Grams: Unit of measure associated with the value entered.

7. : Deletes last number entered.

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

grams

21 3

87 9

54 6

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

3.13 Letter Keypad Screen

1. Name of Profile.

2. : Returns to previous screen.

3. Space: Enters a space.

4. 123: Changes keypad mode from letters (ABC) to numbers (123).

5. : Saves entered information.

6. Letters: Tap once for first letter displayed, 2 quick taps for middle letter, and 3 quick taps for third letter.

7. : Deletes last letter or number entered.

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

name

defabc ghi

vwxstu yz

mnojkl pqr

Weekday

123

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

THIS PAGE IS

INTENTIONALLY

LEFT BLANK

Key Pump Features

Chapter 4

Getting Started

Chapter 4 – Getting Started

4.1 Charging the t:slim X2 Pump

The pump is powered by an internal lithium polymer rechargeable battery. A full charge will typically last between 4 and 7 days, depending on your use of CGM and the t:connect mobile app (if available in your region) features. If you utilize both CGM and the t:connect mobile app, your battery life will last up to 4 days. Please be aware that the battery life on a single charge can vary considerably depending on individual usage, including insulin delivered, display-on time, and frequency of reminders, alerts and alarms.

Accessories for charging from wall and automobile outlets, as well as from a computer USB port, are included with the pump. Use only the accessories provided to charge your pump. If you lose any of the accessories, or need a replacement, contact Customer Technical Support.

The battery level indicator is displayed in the upper left portion of the Home screen. The charge amount will increase or decrease by 5% at a time (for example, you will see 100%, 95%,

90%, 85%). When the charge amount is less than 5%, it will begin decreasing 1% at a time (for example, you will see 4%, 3%, 2%, 1%).

When you first receive your pump, you will need to connect it to a charging source before it can be used. Charge the pump until the battery level indicator on the upper left portion of the Home screen reads 100% (initial charge can take up to 2.5 hours).

The pump continues to operate normally while charging. You do not need to disconnect from the pump while charging.

PRECAUTION

If you choose to disconnect from the pump while charging, check with your healthcare provider for specific guidelines. Depending on the length of time you are disconnected, you may need to

replace missed basal and/or bolus insulin. Check your BG before disconnecting from the pump and again when you reconnect.

To charge the pump from an AC Power Outlet:

1. Plug the included USB cable into the AC power adapter.

2. Plug the AC power adapter into a grounded AC power outlet.

3. Plug the other end of the cable into the micro USB port on the pump.

To charge the pump using the optional Car Power USB Adapter:

1. Plug the USB cable into the Car Power USB Adapter.

2. Plug the Car Power USB Adapter into a grounded auxiliary power outlet.

3. Plug the other end of the cable into the micro USB port on the pump.

WARNING

When using an optional Car Power USB Adapter, the charger must be connected to an isolated, battery powered 12 Volt system, such as an

Chapter 4 – Getting Started

automobile. Connecting the DC vehicle adapter charger to 12 Volt DC that is generated by a power supply connected to alternating current (AC) mains is prohibited.

To charge the pump using a USB port on a computer:

Ensure that the computer complies with the IEC 60950-1 (or equivalent) safety standard.

1. Plug the included USB cable into your computer.

2. Plug the other end of the cable into the micro USB port on the pump.

NOTE: For Customers Using the t:connect Web Application

Before using a computer to charge the pump, it is recommended that a driver be installed on the computer by downloading the t:connect uploader software from our website at tandemdiabetes.com. This will also allow communication between the pump, the computer, and the t:connect web application. The t:connect web application may not yet be available in your region.

Depending on your computer, charging time will vary. The pump will display a

CONNECTION ERROR ALERT message if it is not charging properly.

When you charge the pump, you will notice the following:

• The screen illuminates

• An audible alert

• The LED (edge around the Screen On/Quick Bolus button) blinks green

• A vibrating alert

• A charge symbol (lightning bolt) on the battery level indicator appears

PRECAUTION

Charging Tips

Tandem Diabetes Care recommends that you periodically check the battery level indicator, charge the pump for a short period of time every day (10 to 15 minutes), and avoid frequent full discharges.

NOTE: Fully Discharged Battery

If the battery is fully discharged, the screen may not power on immediately when connected to a charging source. The LED around the Screen On/Quick Bolus button will blink green until there is enough charge to power on the touchscreen.

4.2 Turning the Pump On

Plug in your pump to a charging source. The pump will make an audible noise when it has turned on and is ready for use.

4.3 Using the Touchscreen

To turn on your pump screen, first press the Screen On/Quick Bolus button, then use the pad of your finger to quickly and lightly tap on the screen. Do not use your fingernail or other

Chapter 4 – Getting Started

object to interact with the screen. It will not activate the screen or its functions.

Your pump is designed to give you quick and easy access to the functions that you will use in your day-to-day diabetes management whether basic or advanced.

The pump has several safety features to prevent unintentional interaction with the touchscreen. The screen must be unlocked by tapping 1–2–3 in sequence. On all screens, if three nonactive areas of the touchscreen are tapped before an active area is tapped, the screen will turn off to prevent accidental screen interactions. There is also a Security PIN feature that can be set up to prevent unintentional access (see Section 11.6 Turn Security PIN On

or Off).

NOTE: Touchscreen Tips

When using the pump, tap the Tandem logo to return to the Home screen or tap to return to the previous screen.

4.4 Turning the t:slim X2 Pump Screen On

To turn on your pump screen, press the Screen On/Quick Bolus button, located on the top of the pump, once.

 The Lock screen will be displayed.

4.5 Turning the Pump Screen Off

To turn the pump screen off, press and release the Screen On/Quick Bolus button. This turns off the screen, but not the pump.

NOTE: Turning off the Pump Screen

Turn off the pump screen by pressing the Screen On/Quick Bolus button before placing the pump back in its case or any pocket/ clothing. Always position the pump screen away from the skin when worn under clothing.

The pump continues to function normally when the screen is not on.

4.6 Turning the Pump Off

To turn the pump off completely, plug the pump into a power source and hold the Screen On/ Quick Bolus button down for 30 seconds.

4.7 Selecting Your Language

The Language Selection screen displays when you unlock the pump screen for the first time, or when you unlock the screen after turning the pump off.

To select your language:

1. Tap the circle next to the language

you want to display. Tap the Down

Chapter 4 – Getting Started

Language

Français (Canada)

Español

English

Italiano

Arrow to see additional language selections.

2. Tap to save the selection and continue with pump setup.

4.8 Unlocking the t:slim X2 Pump Screen

The Lock screen appears anytime you turn on the screen, and after a bolus or temp rate is requested. To unlock the screen:

1. Press Screen On/Quick Bolus

button.

2. Tap 1.

3. Tap 2.

4. Tap 3.

 The pump screen is now unlocked.

The last screen that was viewed will be displayed.

You must tap 1–2–3 in sequential order to unlock the pump. If you do not tap 1–2–3 in sequential order, the pump will force you to restart the unlock sequence from the beginning.

If the Security PIN feature is enabled, you will need to enter your PIN after unlocking the screen.

4.9 Edit Time

After powering up your pump for the first time, set the current time and date. Refer back to this section if you need to edit the time for either traveling in a different time zone or adjusting for Daylight Savings Time.

PRECAUTION

ALWAYS make sure that the correct time and date are set on your 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.

1. From the Home screen, tap

OPTIONS.

2. Tap the Down Arrow.

3. Tap Device Settings.

4. Tap Time and Date.

5. Tap Edit Time.

6. Tap Time.

7. Using the on-screen keypad, enter the hour and minutes. Verify and tap .

8. Tap Time of Day to set AM or PM, or tap 24-hour Time to toggle that setting on.

9. Verify the correct time is set and tap

Any edits to Time or Date will not be saved until you tap .

Chapter 4 – Getting Started

4.10 Edit Date

1. From the Time and Date screen tap

Edit Date.

2. Tap Day.

3. Using the on-screen keypad enter the current day. Verify and tap .

4. Tap Month.

5. Find and tap the current month displayed on the right. Use Up/ Down Arrow to view months not displayed.

6. Tap Year.

7. Using the on-screen keypad enter the current year. Verify and tap

8. Verify the correct date is set and tap

 Tap the Tandem logo to return to

the Home screen.

Key Pump Features

Chapter 5

Infusion Site Care and Loading

Cartridge

Chapter 5 – Infusion Site Care and Loading Cartridge

5.1 Infusion Site Selection and Care

WARNING

ALWAYS use only cartridges and insulin 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 hypoglycemia (low BG) or hyperglycemia (high BG) events.

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

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.

General Guidelines

Site Selection

• Your infusion set can be worn anywhere on your body that you would normally inject insulin. Absorption varies from site to site. Discuss options with your healthcare provider.

• The most commonly used sites are the abdomen, upper buttocks, hips, upper arms, and upper legs.

• The abdomen is the most popular site because of access to fatty

tissue. If using the abdominal area, AVOID:

 Areas that would constrict the

site such as the belt line, waistline, or where you would normally bend.

 Areas 2 inches (5 cm) around

your belly button.

 Any scars, moles, stretch marks,

or tattoos.

 Areas within 3 inches (7.6 cm) of

your CGM sensor site.

Site Rotation

PRECAUTION

CHANGE your infusion set every 48–72 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.

• The infusion set must be replaced and rotated every 48–72 hours, or more often if needed.

• With experience, you will find areas

Areas of Body for Infusion Set Insertion

that not only provide better absorption, but are more comfortable. Keep in mind, using the same areas may cause scarring or lumps which can affect insulin absorption.

• Consult your healthcare provider to establish a rotation schedule that best fits your needs.

Keep it Clean

• When changing your infusion set, use clean techniques to avoid an infection.

• Wash your hands, use antiseptic wipes or infusion site preparation products, and keep the area clean.

• Site preparation products that have both an antiseptic and an adhesive are encouraged.

Chapter 5 – Infusion Site Care and Loading Cartridge

5.2 Cartridge Instructions for Use

For complete cartridge labeling, consult the cartridge Instructions for Use included in the t:slim cartridge box.

Chapter 5 – Infusion Site Care and Loading Cartridge

Connector Tail of the Cartridge

Insulin Fill Port

5.3 Filling and Loading a t:slim Cartridge

This section describes how to fill the cartridge with insulin and load the cartridge into your t:slim X2 pump. The single-use disposable cartridge can hold up to 300 units (3.0 mL) of insulin.

WARNING

ONLY use U-100 Humalog or 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

ALWAYS use cartridges manufactured by Tandem Diabetes Care. Use of any other cartridge brand may result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.

WARNING

DO NOT reuse cartridges. Reuse of cartridges may result in over delivery or under delivery of

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

Before you begin, make sure you have the following items:

• 1 unopened cartridge

• 3.0 mL syringe and fill needle

• Vial of U-100 Humalog or U-100 NovoLog insulin

• Alcohol prep swab

• 1 new infusion set

• Infusion set Instructions for Use

NOTE: Fill Tubing Sound Volume

The pump will beep or vibrate, depending on your pump settings, while the tubing is filling with insulin. To change the Fill Tubing sound setting, see Section 11.5 Sound Volume.

NOTE: Removing the Cartridge

DO NOT remove the used cartridge from the pump during the load process until prompted on the pump screen.

The illustration identifies the connector and insulin fill port used in the cartridge filling process.

PRECAUTION

CHANGE your cartridge every 48–72 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.

Chapter 5 – Infusion Site Care and Loading Cartridge

Instructions for Drawing Insulin from Vial into Syringe

PRECAUTION

ALWAYS remove all air bubbles from the cartridge 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.

The fill estimate displayed on the pump is the amount of insulin available for delivery. It does not include insulin needed to fill the tubing (up to 30 units) and a small amount of insulin that is not available for delivery. When filling the syringe, add approximately 45 units to the amount of insulin you want available for delivery.

For example, the pump requires a minimum of 50 units available for delivery after fill tubing has been completed. Fill the syringe with approximately 95 units to have enough to fill your tubing and still have 50 units available for delivery.

1. Inspect the needle and syringe package for any signs of damage. Discard any damaged product.

2. Wash your hands thoroughly.

3. Wipe the rubber septum of the insulin vial with an alcohol swab.

4. Remove the needle and syringe from their packaging. Securely twist needle onto syringe. Safely remove protective cap from needle by pulling outward.

5. Draw air into syringe up to the amount of insulin desired.

6. With insulin vial upright, insert needle into vial. Inject air from

syringe into vial. Maintain pressure on syringe plunger.

7. With needle still inserted into vial, turn vial and syringe upside down. Release syringe plunger. Insulin will begin to flow from the vial into the syringe.

Chapter 5 – Infusion Site Care and Loading Cartridge

8. Slowly pull back the plunger to the desired amount of insulin.

9. While the filling needle is still in the vial and upside down, tap the syringe so that any air bubbles rise to the top. Then slowly push the plunger upwards, forcing any air bubbles back into the vial.

10. Check the syringe for air bubbles and do one of the following:

 If there are air bubbles present,

repeat step 9.

 If no air bubbles are present,

remove the filling needle from the vial.

Instructions for Filling the Cartridge

1. Inspect the cartridge package for any signs of damage. Discard any damaged product.

2. Open the package and remove the cartridge.

3. Hold the cartridge upright and gently insert the needle into the white insulin fill port on the cartridge. The needle is not intended to go all the way in, so do not force it.

4. Keeping the syringe vertically aligned with the cartridge, and the needle inside the fill port, pull back on the plunger until it is fully retracted. This will remove any residual air from the cartridge. Bubbles will rise toward the plunger.

Chapter 5 – Infusion Site Care and Loading Cartridge

5. Make sure the needle is still in the fill port and release the plunger. Pressure will pull the plunger to its neutral position but it will NOT push any air back inside the cartridge.

6. Withdraw the needle from the fill port.

7. Turn the syringe upright and pull down on the plunger. Flick the barrel to make sure that any air bubbles rise to the top.

8. Gently press on the plunger to remove air bubbles until insulin fills the needle hub and you see a drop of insulin at the tip of the needle.

9. Re-insert the needle in the fill port and slowly fill the cartridge with insulin. It is normal to feel some

back pressure as you slowly press on the plunger.

10. Maintain pressure on the plunger while you remove the needle from the cartridge. Check the cartridge for leaks. If you detect insulin leaking, discard the cartridge and repeat entire process with a new cartridge.

11. Always dispose of used needles, syringes, cartridges, and infusion sets following the instructions from your healthcare provider.

Instructions on How to Install a Cartridge

If this is the very first time you are loading the cartridge, remove the

Chapter 5 – Infusion Site Care and Loading Cartridge

shipping canister (which is not for human use) from the back of the pump.

1. From the Home screen, tap

OPTIONS.

2. Tap Load.

 During the load sequence, the

Tandem logo is disabled.

Tapping it will not return to the Home screen.

3. Tap Change Cartridge.

4. Screen will display that all insulin deliveries will be stopped. Tap to continue.

NOTE: First Time Use

This screen will not be displayed if this is the first time loading a new cartridge and you have not started actively pumping.

5. Disconnect the infusion set from your body and tap to continue.

 Preparing for Cartridge screen is

displayed.

6. Remove the used cartridge. If needed, place the cartridge removal tool or the edge of a coin in the slot

at the bottom of the cartridge and twist to aid in the removal of the cartridge.

7. Place bottom of the cartridge at the end of the pump. Make sure cartridge is lined up to both guide tracks.

8. Push on the circular fill port next to the cartridge tubing to slide the

cartridge onto the pump. Tap the UNLOCK icon when completed.

9. Tap to continue.

 Detecting Cartridge screen is

displayed.

 After completing the cartridge

change, the pump will automatically prompt you to fill the tubing.

10. Tap to fill the tubing.

WARNING

Chapter 5 – Infusion Site Care and Loading Cartridge

cartridge. This can cause very high BG, or Diabetic Ketoacidosis (DKA).

5.4 Filling Tubing

Filling the Infusion Set Tubing with Insulin

WARNING

This section describes how to fill the infusion set tubing with insulin after you change the cartridge. If you just completed step 10 from the previous section, skip to step 5.

NOTE: Fill Tubing Sound Volume

The pump will beep or vibrate, depending on your pump settings, while the tubing is filling with insulin. To change the Fill Tubing sound setting, see Section 11.5 Sound Volume.

To fill the tubing without changing the cartridge, from the Home screen tap OPTIONS, tap Load, tap Fill Tubing and then follow the instructions.

• Tap NEW if you installed a new

cartridge.

• Tap FILL if you did not install a new

cartridge and want to continue with filling the tubing.

PRECAUTION

1. Verify that the infusion set is disconnected from your body.

2. Ensure that the new infusion set package is not damaged, and remove the sterile tubing from the package. If the package is damaged or opened, discard of properly and use another tubing set.

3. Remove the infusion set tubing cap from the tubing connector. Be careful to keep the tubing

connector away from unclean areas.

4. Attach the infusion set tubing to the tubing connector on the cartridge tubing. Twist clockwise until finger tight and then twist another quarter of a turn to ensure a secure connection.

WARNING

5. Hold the pump vertically to ensure any air in the cartridge will be

Chapter 5 – Infusion Site Care and Loading Cartridge

dispelled first. Tap START. The pump will beep and vibrate regularly while the tubing is being filled, depending on your Sound Volume settings.

 Starting Fill screen is displayed.

The following are approximate amounts of insulin to fill different tubing lengths:

 15–20 units for 23 inch (60 cm)

tubing

 20–25 units for 32 inch (80 cm)

tubing

 25–30 units for 42 inch (110 cm)

tubing

6. Tap STOP after 3 drops of insulin

are seen at the end of the infusion set tubing.

 Stopping Fill screen is displayed.

 Detecting Insulin screen is

displayed.

7. Verify that drops are seen and tap

DONE.

• If you do not see drops, tap FILL.

The Fill Tubing screen appears, repeat steps 3 to 5 until you see 3 drops of insulin at the end of the tubing.

• The tubing may be filled with a maximum of 30 units of insulin during each fill cycle. If you do not tap STOP, a notification screen will appear letting you know that the maximum amount has been filled. Do one of the following:

a. If you are finished filling the

tubing, tap DONE.

b. If you want to fill the tubing with

more than 30 units, tap FILL to go back to the Fill Tubing screen.

 Fill Tubing is complete screen is

temporarily displayed.

NOTE: Initial Display of Insulin

After tubing fill is complete, when the pump returns to the Home screen, an estimate of how much insulin is in the cartridge is displayed in the upper right portion of the screen. You will see one of the following on the screen:

+ 40 u More than 40 units detected

in the cartridge

+ 60 u More than 60 units detected

in the cartridge

+ 120 u More than 120 units detected

in the cartridge

+ 180 u More than 180 units detected

in the cartridge

+ 240 u More than 240 units detected

in the cartridge

After 10 units are delivered, an actual number of units remaining in the cartridge will be displayed on the Home screen

The amount of insulin remaining displayed on the Home screen will decrease 5 units at a time (for example, you will see 140, 135, 130, 125). When less than 40 units remain, it will begin decreasing 1 unit at a time (for

Chapter 5 – Infusion Site Care and Loading Cartridge

example, you will see 40, 39, 38, 37) until there is 1 unit remaining.

5.5 Filling Cannula

Filling the Infusion Set Cannula with Insulin

This section describes how to fill the infusion set cannula with insulin after you fill the tubing.

To fill the cannula without filling the tubing, from the Home screen, tap OPTIONS, tap Load, tap Fill Cannula and then follow the instructions below.

If you are using a steel needle infusion set, there is no cannula; skip this section.

To Fill the Cannula:

1. Tap Fill Cannula.

2. Insert a new infusion set and connect filled tubing to site, then tap .

3. Tap Edit Fill Amount.

 The cannula fill amount displayed is

based on your last cannula fill

amount. Filling stops at this amount.

4. Select amount needed for cannula fill.

 See your infusion set instructions

for use for proper cannula fill amount.

 If the amount needed is not

listed, tap Other amount and use the on-screen keypad to enter a value between 0.1 to 1.0 unit.

5. Tap .

 The STARTING FILL screen is

displayed.

 After fill is complete, STOPPING

FILL screen is displayed.

NOTE: Stopping Fill

You can tap STOP at any time during the fill process if you want to stop filling the cannula.

 The screen will return to the Load

menu if the Site Reminder is turned off.

6. Tap to resume insulin if finished. Or tap Site Reminder to

set reminder. If Site Reminder is on, the pump will automatically display the Site Reminder screen (see the next section).

5.6 Setting Site Reminder

This section describes how to set the Site Reminder after you fill the cannula.

To set the Site Reminder without filling the cannula, from the Home screen, tap

OPTIONS, tap Load, tap Site Reminder then follow the instructions

below.

1. Tap if correct. Tap Edit Reminder if settings need to be changed.

2. Tap Remind Me In and select the number of days (1–3).

 The default for the Site Reminder is

set for 3 days

3. Tap Remind Me At. Use the onscreen keypad to enter time and tap .

4. Tap Time of Day to change AM or PM, if applicable. Tap .

Chapter 5 – Infusion Site Care and Loading Cartridge

5. Verify Site Reminder is set correctly and tap .

 Setting Saved screen is displayed.

 Load screen is displayed.

6. Tap .

 A reminder to test BG in 1 to 2

hours will display.

7. Tap .

NOTE: First Time Use

If this is the first time using your pump and a Personal Profile has not been defined, a screen will notify you that a profile must be activated to resume insulin. Tap CLOSE.

 RESUMING INSULIN screen is

temporarily displayed.

NOTE: Changing Cartridge with Basal-IQ Technology

Basal-IQ technology will continue to operate while changing a cartridge. If you complete a cartridge change and resume insulin while Basal-IQ technology is suspending insulin, insulin will resume until the next five minute CGM reading. At this time the pump will resume normal operation.

Key Pump Features

Chapter 6

Personal Profiles

Chapter 6 – Personal Profiles

6.1 Personal Profiles Overview

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.

A Personal Profile is a group of settings that define basal and bolus delivery within specific time segments throughout a 24-hour period. Each profile can be personalized with a name. Within a Personal Profile the following can be set:

• Timed Settings: Basal Rate, Correction Factor, Carb Ratio and Target BG.

• Bolus Settings: Insulin Duration,

Max Bolus and Carbohydrates setting (on/off).

The t:slim X2 pump uses the settings in your active profile to calculate the delivery of basal insulin, food boluses and correction boluses based on your target BG. If you only define a basal rate in Timed Settings, your pump will only be able to deliver basal insulin and standard and extended boluses. Your pump will not calculate correction boluses.

Up to six different Personal Profiles can be created and up to 16 different time segments can be set in each Personal Profile. Having several Personal Profiles provides more flexibility for your body and lifestyle. For example, you could have “Weekday” and “Weekend” profiles if you have different insulin delivery needs on weekdays and weekends, based on schedule, food intake, activity, etc.

6.2 Creating a New Profile

Creating Personal Profiles

You can create up to six Personal Profiles; however, only 1 can be active at a time. In the Personal Profiles screen, the active profile is positioned at the top of the list and is marked as ON. When you create a Personal Profile, you can set any or all of the following Timed Settings:

• Basal Rate (your basal rate in units/ hr)

• Correction Factor (amount 1 unit of insulin lowers BG)

• Carb Ratio (grams of carbohydrate covered by 1 unit of insulin)

• Target BG (your ideal BG level, measured in mg/dL)

Although you do not need to define every setting, some pump features require certain settings to be defined and activated. When you are creating a new profile, your pump prompts you to set up any required settings before you can continue.

Chapter 6 – Personal Profiles

The ranges you can set for Timed Settings are:

• Basal (range: 0 and 0.1 to 15 units/ hr)

• Correction Factor (range: 1 unit:1 mg/dL to 1 unit:600 mg/dL)

• Carb Ratio (range: 1 unit:1 gram to 1 unit:300 grams)

Below a carb ratio of 1:10, increments can be entered in 0.1 g. For example a carb ratio of 1:8.2 can be programmed.

• Target BG (range: 70 mg/dL to 250 mg/dL)

In addition, you can set any or all of the following Bolus Settings:

• Carbs (ON indicates entering grams of Carb; OFF indicates entering units of insulin)

• Insulin Duration (how long a bolus lowers your BG)

• Max Bolus (the maximum amount for a single bolus)

The default settings and ranges for Bolus Settings are as follows:

• Carbs (default: off if no Carb Ratio is defined)

• Insulin Duration (default: 5 hrs; range: 2 to 8 hrs)

• Max Bolus (default: 10 units; range: 1 to 25 units)

Insulin Duration and Insulin on Board (IOB)

Your pump remembers how much insulin you have taken from previous boluses. It does this by relying on the insulin duration. The insulin duration reflects the amount of time that insulin is actively lowering your BG.

Consult your healthcare provider to accurately set your insulin duration.

While the insulin duration setting reflects how long insulin from previous boluses lowers your BG, the IOB feature reflects how much insulin is remaining in your body from previous boluses. IOB is always displayed on the Home screen and is used in bolus delivery calculations when applicable.

When a glucose value is entered during bolus programming, your pump will consider any active IOB and calculate an adjusted bolus if necessary.

1. From the Home screen, tap

OPTIONS.

2. Tap My Pump.

3. Tap Personal Profiles.

4. Tap to create a new profile.

5. Using the on-screen keypad, enter a profile name (up to 16 characters) and tap .

To use the letter keypad, tap once for first letter displayed, 2 quick taps for middle letter; and 3 quick taps for the third letter.

Chapter 6 – Personal Profiles

Weekday

Press to Set Up

5 hrs

DURATION

10 u

MAX BOLUS

OFF

CARBS

12:00

Basal Press to Set Up

Correction Factor Press to Set Up

Carb Ratio Press to Set Up

Target BG Press to Set Up

6. Tap Press to Set Up to begin

setting insulin delivery settings.

Timed Settings

Bolus Settings

6.3 Programming a New Personal Profile

Once the Personal Profile has been created, the settings must be programmed. The first time segment will start at midnight.

• You must program a basal rate in order to have a Personal Profile that you can activate.

• You must set a basal rate, correction factor, carb ratio, and target BG in order to turn Basal-IQ technology on.

• Be sure to tap after entering or changing a value.

PRECAUTION

ALWAYS confirm that the decimal point placement is correct when entering your Personal Profile information. Incorrect decimal point placement can prevent you from getting the proper insulin amount that your healthcare provider has prescribed for you.

Timed Settings

1. Once the new profile has been created, Tap Basal.

Using the on-screen keypad, enter your basal rate and tap .

2. Tap Correction Factor.

3. Using the on-screen keypad, enter your correction factor (the mg/dL that 1 unit of insulin will lower BG) and tap .

4. Tap Carb Ratio.

5. Using the on-screen keypad, enter your insulin-to-carbohydrate ratio (the grams of carbohydrate to be covered by 1 unit of insulin) and tap

6. Tap Target BG.

7. Using the on-screen keypad, enter your target BG and tap .

8. Review entered values and tap

9. Confirm Settings.

 Tap if entered data is

correct.

 Tap to make changes.

10. Tap to set the Bolus Settings.

Chapter 6 – Personal Profiles

Timed Settings

12:00

0.75

BASAL

1:50

CORRECT

1:10

CARB TARGET BG

120

Weekday

5 hrs

DURATION

10 u

MAX BOLUS

OFF

CARBS

0.75

BASAL

1:50

CORRECT

120

TARGET BG

1:10

CARB

Insulin Duration

5 hrs

Max Bolus

10 u

Bolus Settings

Carbohydrates

Tap to create additional time segments.

Adding More Time Segments

When adding more time segments, any settings that you entered in the previous time segment are copied and appear in the new segment. This allows you to simply adjust only the specific settings you want, rather than have to enter them all over again.

1. On the Add Segment screen, tap

Start Time.

2. Using the on-screen keypad, enter the time (hour and minutes) that you want the segment to begin, and tap

3. On the Add Segment screen, tap

Time of Day to select AM or PM, if applicable.

 Once a time segment is set beyond

12:00 PM, the default will change to PM.

4. Tap .

5. Repeat steps 1 to 6 from the

Creating a New Profile section

above for each segment you want to create (up to 16).

To find time segments in the list that are not displayed on the first screen, tap the Down Arrow.

Bolus Settings

1. Tap the Bolus Settings panel.

Timed Settings 12:00 - 00:00

Bolus Settings

2. Tap Insulin Duration.

3. Using the on-screen keypad, enter the desired time for the duration of insulin action (2–8 hrs) and tap .

4. Tap Max Bolus.

5. Using the on-screen keypad, enter the desired amount for maximum bolus (1–25 units) and tap .

NOTE: 25 Unit Max Bolus

If you set the max bolus to 25 units and a bolus larger than 25 units is calculated using your carb ratio or correction factor, after the bolus is delivered a reminder screen will appear. The option of delivering the remaining amount of the bolus up to an additional 25 units will be given (see

Section 15.9 Max Bolus Alerts).

Chapter 6 – Personal Profiles

6. Tap Carbohydrates to turn on and

use the carb ratio when calculating boluses.

7. Review entered values and tap .

8. Confirm Settings.

 Tap if entered data is

correct.

 Tap to make changes.

9. Tap Tandem logo to return to the

Home screen.

Adding More Personal Profiles

1. From the Home screen, tap

OPTIONS.

2. Tap My Pump.

3. Tap Personal Profiles.

4. Tap .

5. Name the new profile and repeat

steps for Timed Settings and Bolus Settings.

NOTE: Carbohydrates Options

If the first profile you created is programmed using a carb ratio, any new profile will also have the Carbohydrates option turned on, but a ratio will still need to be defined.

6.4 Editing or Reviewing an Existing Profile

1. From the Home screen, tap

OPTIONS.

2. Tap My Pump.

3. Tap Personal Profiles.

4. Tap the name of the Personal Profile to edit or review.

5. Tap Edit.

NOTE: Review Settings

To review settings but bypass editing the settings, skip the remaining steps in this section. You can tap to navigate to the Personal Profiles list or tap the Tandem logo to return to the Home screen.

6. Tap Timed Settings panel.

7. Tap the desired time segment to edit.

8. Tap Basal, Correction Factor, Carb Ratio or Target BG to make changes as needed and use the onscreen keypad to enter changes. Tap .

9. View recent changes and tap .

10. Confirm Settings.

 Tap if entered data is

correct.

 Tap to make changes.

11. Edit other time segments within the Timed Settings by tapping on them and using the same steps described above.

12. Tap after editing all of the time segments.

13. Tap the Bolus Settings panel to change Insulin Duration, Max Bolus, or Carbohydrates as needed. Use the on-screen keypad to enter desired changes. Tap .

14. Confirm Settings.

Chapter 6 – Personal Profiles

 Tap if entered data is

correct.

 Tap and make changes.

15. Tap Tandem logo to return to the

Home screen.

NOTE: Adding a Time Segment

To add a time segment, tap and enter the desired start time.

NOTE: Deleting a Time Segment

To delete a time segment, tap on the to the left of the time segment and tap to confirm.

6.5 Duplicating an Existing Profile

1. From the Home screen, tap

OPTIONS.

2. Tap My Pump.

3. Tap Personal Profiles.

4. Tap the name of the Personal Profile to duplicate.

5. Tap Duplicate.

6. Confirm profile to duplicate by tapping .

7. Using the on-screen keypad, enter the name (up to 16 characters) for the new profile and tap .

 Profile Duplicated screen is

displayed.

 A new Personal Profile will be

created with the same settings as the profile copied.

8. Tap the Timed Settings or Bolus Settings panel to make changes to the new profile.

6.6 Activating an Existing Profile

1. From the Home screen, tap OPTIONS.

2. Tap My Pump.

3. Tap Personal Profiles.

4. Tap the name of the Personal Profile to be activated.

 The Activate and Delete options

are disabled for the active profile because the profile is already

activated. You cannot delete a profile until you have activated another profile.

 If you have only 1 profile defined,

you do not need to activate it (that profile is automatically activated).

5. Tap Activate.

 A screen to confirm the activation

request is displayed.

6. Tap .

 Profile Activated screen is

displayed.

6.7 Renaming an Existing Profile

1. From the Home screen, tap

OPTIONS.

2. Tap My Pump.

3. Tap Personal Profiles.

4. Tap the name of the Personal Profile to be renamed.

5. Tap Down Arrow, and then

Rename.

Chapter 6 – Personal Profiles

6. Using the on-screen keypad, rename the profile name (up to 16 characters) and tap .

7. Tap Tandem logo to return to the Home screen.

6.8 Deleting an Existing Profile

1. From the Home screen, tap OPTIONS.

2. Tap My Pump.

3. Tap Personal Profiles.

4. Tap the name of the Personal Profile to be deleted.

NOTE: Active Personal Profile

The active Personal Profile cannot be deleted.

5. Tap Delete.

6. Tap .

 Profile Deleted screen is displayed.

7. Tap the Tandem logo to return to the Home screen.

Key Pump Features

Chapter 7

Bolus

Chapter 7 – Bolus

7.1 Bolus Overview

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 change the amount of insulin before you deliver your bolus.

A bolus is a quick dose of insulin that is usually delivered to cover food eaten or to correct high glucose.

The minimum bolus size is 0.05 units. The maximum bolus size is 25 units. If you attempt to deliver a bolus that is larger than the amount of insulin in the cartridge, a message screen appears indicating that there is not enough insulin to deliver the bolus.

Your t:slim X2 pump offers you the ability to deliver different boluses to cover carbohydrate intake (food bolus) and bring your BG back to target (correction bolus). Food and correction boluses can also be programmed together.

If Carbohydrates is turned on in your active personal profile, you will enter grams of carbohydrate and the bolus will be calculated using your Carb Ratio.

If Carbohydrates is turned off in your active personal profile, you will enter units of insulin to request the bolus.

If Basal-IQ technology is enabled and has suspended insulin delivery during a standard or quick bolus, all bolus deliveries will continue until completed. A new bolus cannot be started until insulin is resumed.

PRECAUTION

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

7.2 Correction Bolus Calculation

Once the pump knows your glucose value it will determine whether or not to recommend a correction bolus.

When your glucose value is:

• Above Target BG: the insulin for the food bolus and the correction bolus will be added together. If IOB is present, it will only be used in the calculation of the correction portion of the bolus.

• Between 70 mg/dL and Target BG: You will be given an option to reduce the food bolus to correct for the lower glucose. In addition, if IOB is present, it will also be used to reduce the bolus calculation.

• Below 70 mg/dL: The food bolus will be reduced to automatically correct for the low glucose value. In addition, if IOB is present, it will also be used to reduce the bolus calculation.

Always treat hypoglycemia (low BG) with fast-acting carbohydrates according to the instructions of your healthcare provider and then re-test your BG to ensure that the treatment was successful.

Glucose Value Manual Entry

You will need to enter your glucose value into the pump manually before

Chapter 7 – Bolus

units

Your BG is Above Target

Add Correction Bolus?

Your BG is Below Target

Reduce Bolus Calculation?

advancing to the Correction Bolus screens. You can use the glucose value from your CGM or from your BG meter.

1. From the Home screen tap BOLUS.

2. Tap Add BG.

CARBS

3. Using the on-screen keypad, enter your glucose value and tap . Once is tapped, the glucose value is saved in your pump history whether or not a bolus is delivered.

4. Follow the steps in the appropriate Target section below depending on the results of your glucose value.

Above Target

If your glucose value is above your Target BG, the pump presents you with

grams

View Calculation

GLUCOSE

Add BG

the option for the pump to calculate and add a correction bolus to any other bolus you request.

Current IOB 0 u

Current BG 280 mg/dL

• To accept the correction bolus press . A correction bolus is calculated and will be added to any food bolus you request on the Bolus screen.

• To decline the correction bolus, press . No correction bolus will be added to any food bolus you request on the Bolus screen.

Below Target

If your glucose value is below your Target BG, the pump presents you with the option for the pump to calculate

and subtract a correction bolus from any other bolus you request.

Current IOB 0 u

Current BG 85 mg/dL

• To accept the correction bolus press . A correction bolus is calculated and will be subtracted from any food bolus you request on the Bolus screen.

• To decline the correction bolus, press . No correction bolus will be subtracted from any food bolus you request on the Bolus screen.

Within Target

If your glucose value is the same value as your Target BG, no Correction Bolus screen is displayed.

Chapter 7 – Bolus

units

2.98

7.3 Bolus Override

You can override the calculated bolus by tapping on the calculated units value and entering the units of insulin you want delivered. The bolus override is always active.

CARBS

grams

GLUCOSE

View Calculation

225

mg/dL

7.4 Food Bolus Using Units

If bolusing using a carb ratio, skip to the section 7.5 Food Bolus Using Grams.

1. From the Home screen, tap

BOLUS.

2. Tap 0 units.

3. Using the on-screen keypad enter units of insulin to be delivered, then tap .

WARNING

ALWAYS confirm that the decimal point placement is correct when entering bolus information. Incorrect decimal point placement can prevent you from getting the proper amount of insulin that your healthcare provider has prescribed for you.

4. Tap to confirm the units of insulin to be delivered.

5. Confirm Request.

 Tap if entered data is

correct.

 Tap to go back to make

changes or view calculations.

6. Tap .

 The BOLUS INITIATED screen is

temporarily displayed.

7.5 Food Bolus Using Grams

1. From the Home screen, tap BOLUS.

2. Tap 0 grams.

3. Using the on-screen keypad enter grams of carb and tap .

 To add multiple carb values enter

first value, then tap , enter second value, tap . Continue until done.

 To clear the value entered and

start over, tap the back arrow.

4. Check that the grams of carb are entered in the correct location on the screen.

5. Tap to confirm the units of insulin to be delivered.

You can always tap View

Calculation to display the Delivery Calculation screen.

6. Confirm Request.

 Tap if entered data is

correct.

 Tap to go back to make

changes or view calculations.

7. Tap .

Chapter 7 – Bolus

 The BOLUS INITIATED screen is

temporarily displayed.

7.6 Extended Bolus

The Extended Bolus feature allows you to deliver part of the bolus now and part of the bolus slowly over a period of up to 8 hours. This can be helpful for high fat meals such as pizza or if you have gastroparesis (delayed stomach emptying).

When extending a bolus, any correction bolus amount will always be given in the DELIVER NOW portion. Talk with your healthcare provider to determine if this feature is appropriate for you, as well as for recommendations on the split between now and later and the duration for the later portion.

Only 1 extended bolus can be active at any given time. However, if the DELIVER LATER portion of an extended bolus is active, you can request another standard bolus.

1. From the Home screen, tap

BOLUS.

2. Tap 0 grams (or 0 units).

3. Using the on-screen keypad enter grams of carb (or units of insulin). Tap .

4. If desired, tap Add BG and using the on-screen keypad enter a glucose value. Tap .

5. Tap to confirm the units of insulin to be delivered.

You can always tap View

Calculation to display the Delivery Calculation screen.

6. Confirm Request.

 Tap if entered data is

correct.

 Tap to go back to make

changes or view calculations.

7. Tap EXTENDED to turn on the extended feature, then tap .

8. Tap 50% under DELIVER NOW to adjust the percentage of the food bolus that is to be delivered immediately.

The percentage value for DELIVER LATER is automatically calculated

by the pump. The default is 50% NOW and 50% LATER. The default for DURATION is 2 hours.

9. Use the on-screen keypad to enter the percentage of the bolus to DELIVER NOW and tap .

For the DELIVER NOW portion, the minimum amount is .05 units. If the DELIVER NOW portion is less than .05 units, you will be notified and the DELIVER NOW portion will be set to .05 units.

The DELIVER LATER portion of the extended bolus also has minimum and maximum rates. If you program a DELIVER LATER rate outside of these limits, you are notified and the duration of the DELIVER LATER portion is adjusted.

10. Tap 2 hrs under DURATION.

11. Use the on-screen keypad to adjust the length of time the bolus is to be delivered, then tap .

12. Tap .

Chapter 7 – Bolus

INSULIN ON BOARD (IOB)

Units 1.1 u 1:09 hrsTime Remaining

10:20

14 Nov 2019 235 u100%

OPTIONS

BOLUS

You can always tap View Units to display the breakdown of units to be delivered NOW versus LATER.

13. Confirm Request.

 Tap if entered data is

correct.

 Tap to go back to make

changes or view calculations.

14. Tap .

15. The BOLUS INITIATED screen is temporarily displayed.

Only 1 extended bolus can be active at any given time. However, if the DELIVER LATER portion of an extended bolus is active, you can request another standard bolus.

NOTE: Extended Bolus During Insulin Suspension

If Basal-IQ technology is on and has suspended insulin delivery during an extended bolus, all remaining bolus insulin will be canceled. If desired, a new bolus must be initiated after insulin delivery has been resumed.

7.7 Canceling or Stopping a Bolus

Canceling a Bolus If delivery HAS NOT STARTED:

1. Tap 1–2–3 to access the Home

screen.

2. Tap X (stop icon) to cancel the

bolus.

Requesting 10 u Bolus ...

 BOLUS will remain inactive while

the bolus is being canceled.

 Once canceled, BOLUS will

become active again on the Home screen.

Stopping a Bolus if delivery of the BOLUS HAS STARTED:

1. Tap 1–2–3 to access the Home

screen.

2. Tap X (stop icon) to stop delivery.

3. Tap .

 The BOLUS STOPPED screen is

displayed and the units delivered are calculated.

 Units requested and delivered are

shown.

4. Tap .

Key Pump Features

Chapter 8

Stop/Resume Insulin

Chapter 8 – Stop/Resume Insulin

8.1 Stopping Insulin Delivery

You can stop all insulin delivery at any time. When you stop all insulin delivery, any active bolus and any active temp rate are immediately stopped. No insulin delivery can take place while your pump is stopped.

1. From the Home screen, tap

OPTIONS.

2. Tap STOP INSULIN.

3. Tap .

 The All Deliveries Stopped screen

appears before returning to the Home screen showing the status ALL DELIVERIES STOPPED. A red exclamation mark icon also appears to the right of the time and date.

NOTE: Manually Stopping Insulin and Basal-IQ Technology

If you manually stop insulin delivery, you must manually resume insulin delivery. Basal-IQ technology does not automatically resume insulin if you decide to stop it manually.

8.2 Resuming Insulin Delivery

If pump screen is not on, press Screen On/Quick Bolus button once to turn on

your t:slim X2 pump screen.

1. Tap 1–2–3.

2. Tap .

 The RESUMING INSULIN screen is

temporarily displayed.

– OR –

1. From the Home screen, tap

OPTIONS.

2. Tap RESUME INSULIN.

3. Tap RESUME.

 The RESUMING INSULIN screen is

temporarily displayed.

Tandem Tslim X2 with Basil IQ User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Overview

Introduction

1.1 Conventions of this Guide

1.2 Explanation of Symbols

1.3 System Description

1.4 About this User Guide

1.5 Indications for Use

1.6 Contraindications

1.7 Compatible iCGMs

1.8 Important User Information

1.9 Important Pediatric User Information

t:slim X2 Insulin Pump

Important Safety Information

2.1 t:slim X2 Insulin Pump Warnings

2.2 t:slim X2 Insulin Pump Precautions

2.3 Potential Benefits From Using Your Pump

2.4 Possible Risks From Using Your Pump

2.5 Working with your Healthcare Provider

2.6 Verification of Proper Functionality

3.1 What your t:slim X2 Pump Package Includes

3.2 Pump Terminology

3.3 Explanation of t:slim X2 Insulin Pump Icons

3.4 Explanation of Pump Colors

3.5 Lock Screen

3.6 Home Screen

3.7 Current Status Screen

3.8 Bolus Screen

3.9 Options Screen

Getting Started

4.1 Charging the t:slim X2 Pump

4.2 Turning the Pump On

4.3 Using the Touchscreen

4.4 Turning the t:slim X2 Pump Screen On

4.5 Turning the Pump Screen Off

4.6 Turning the Pump Off

4.7 Selecting Your Language

4.8 Unlocking the t:slim X2 Pump Screen

4.9 Edit Time

Edit Date.

5.1 Infusion Site Selection and Care

5.2 Cartridge Instructions for Use

5.3 Filling and Loading a t:slim Cartridge

5.4 Filling Tubing

5.5 Filling Cannula

5.6 Setting Site Reminder

Personal Profiles

6.1 Personal Profiles Overview

6.2 Creating a New Profile

6.3 Programming a New Personal Profile

6.4 Editing or Reviewing an Existing Profile

6.5 Duplicating an Existing Profile

6.6 Activating an Existing Profile

6.7 Renaming an Existing Profile

6.8 Deleting an Existing Profile

Bolus

7.1 Bolus Overview

7.2 Correction Bolus Calculation

7.3 Bolus Override

7.4 Food Bolus Using Units

7.5 Food Bolus Using Grams

7.6 Extended Bolus

7.7 Canceling or Stopping a Bolus

Stop/Resume Insulin

8.1 Stopping Insulin Delivery

8.2 Resuming Insulin Delivery