User Guide for tandem models including: 004629, T-Slim Insulin Delivery Pump System
User Guide
UNITS OF MEASURE MMOL/L
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY USER GUIDE Software Version: Control-IQ (7.4)
Congratulations on the purchase of your new t:slim X2TM insulin pump with Control-IQTM technology. This user guide is designed to assist you with the features and functions of the t:slim X2 insulin pump with Control-IQ technology. It provides important warnings and cautions on proper operation as well as technical information to ensure your safety. It also provides step-by-step instructions on how to properly program, manage and care for your t:slim X2 insulin pump with Control-IQ technology. Changes in equipment, software, or procedures occur periodically; information describing these changes will be included in future editions of this user guide. No part of this publication may be reproduced, stored in a retrieval system, nor transmitted in any form or by any means, electronic or mechanical, without the prior written permission of Tandem Diabetes Care. Please contact Customer Technical Support to obtain a replacement copy of the user guide that is the correct version for your pump. For contact information in your region see the back cover of this user guide. Tandem Diabetes Care, Inc. 11075 Roselle Street San Diego, CA 92121 USA tandemdiabetes.com
WARNINGS: Control-IQ technology should not be used in anyone under the age of six years old. Control-IQ technology should also not be used in patients who require less than a total daily insulin dose of 10 units per day or who weigh less than 55 pounds (25 kilograms), as those are the required minimum values needed in order for Control-IQ technology to operate safely.
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TABLE OF CONTENTS
Section 1: Before You Begin
Chapter 1 · Introduction 1.1 Conventions of This Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 1.2 Explanation of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 1.3 System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 1.4 About this User Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 1.5 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 1.6 Compatible CGMs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 1.7 Important User Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 1.8 Important Pediatric User Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 1.9 Emergency Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Section 2: t:slim X2 Insulin Pump Features
Chapter 2 · Important Safety Information 2.1 t:slim X2 Insulin Pump Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 2.2 Radiology and Medical Procedures and Your t:slim X2 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 2.3 Magnetic Resonance Imaging Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 2.4 t:slim X2 Insulin Pump Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 2.5 Potential Benefits From Using Your Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 2.6 Possible Risks From Using Your Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 2.7 Working with your Healthcare Provider . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 2.8 Verification of Proper Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
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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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 3.2 Pump Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 3.3 Explanation of t:slim X2 Insulin Pump Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 3.4 Explanation of Pump Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 3.5 Lock Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 3.6 Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 3.7 Current Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 3.8 Bolus Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 3.9 Options Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 3.10 My Pump Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 3.11 Device Settings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 3.12 Number Keypad Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 3.13 Letter Keypad Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Chapter 4 · Getting Started 4.1 Charging the t:slim X2 Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 4.2 Turning the Pump On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 4.3 Using the Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 4.4 Turning the t:slim X2 Pump Screen On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 4.5 Selecting Your Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 4.6 Turning the Pump Screen Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 4.7 Turning the Pump Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 4.8 Unlocking the t:slim X2 Pump Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 4.9 Edit Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 4.10 Edit Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 4.11 Basal Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 4.12 Display Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 4.13 Mobile Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
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4.14 Mobile Connection Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 4.15 Sound Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 4.16 Turn Security PIN On or Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Chapter 5 · Insulin Delivery Settings 5.1 Personal Profiles Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 5.2 Creating a New Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 5.3 Programming a New Personal Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 5.4 Editing or Reviewing an Existing Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 5.5 Duplicating an Existing Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74 5.6 Activating an Existing Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74 5.7 Renaming an Existing Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74 5.8 Deleting an Existing Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 5.9 Starting a Temporary Basal Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 5.10 Stopping a Temp Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Chapter 6 · Infusion Site Care and Loading Cartridge 6.1 Infusion Site Selection and Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 6.2 Cartridge Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 6.3 Filling and Loading a t:slim Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 6.4 Filling Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 6.5 Filling Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 6.6 Setting Site Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Chapter 7 · Manual Bolus 7.1 Manual Bolus Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 7.2 Correction Bolus Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 7.3 Bolus Override . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 7.4 Food Bolus Using Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 7.5 Food Bolus Using Grams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
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7.6 Extended Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 7.7 Max Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 7.8 Quick Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 7.9 Canceling or Stopping a Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Chapter 8 · Start, Stop, or Resume Insulin 8.1 Starting Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 8.2 Stopping Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 8.3 Resuming Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 8.4 Disconnecting When Using Control-IQ Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Chapter 9 · t:slim X2 Insulin Pump Information and History 9.1 t:slim X2 Pump Info . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 9.2 t:slim X2 Pump History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Chapter 10 · t:slim X2 Insulin Pump Reminders 10.1 Low BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 10.2 High BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 10.3 After Bolus BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 10.4 Missed Meal Bolus Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 10.5 Site Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Chapter 11 · User Settable Alerts and Alarms 11.1 Low Insulin Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 11.2 Auto-Off Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 11.3 Max Basal Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Chapter 12 · t:slim X2 Insulin Pump Alerts 12.1 Low Insulin Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115 12.2 Low Power Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
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12.3 12.4 12.5 12.6 12.7 12.8 12.9 12.10 12.11 12.12 12.13 12.14 12.15
Incomplete Bolus Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118 Incomplete Temp Rate Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Incomplete Load Sequence Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120 Incomplete Setting Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123 Basal Rate Required Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124 Max Hourly Bolus Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125 Max Bolus Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126 Max Basal Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128 Min Basal Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Connection Error Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131 Pairing Code Timeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132 Power Source Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133 Data Error Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Chapter 13 · t:slim X2 Insulin Pump Alarms
13.1 Resume Pump Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137 13.2 Low Power Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138 13.3 Empty Cartridge Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139 13.4 Cartridge Error Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140 13.5 Cartridge Removal Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141 13.6 Temperature Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142 13.7 Occlusion Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143 13.8 Screen On/Quick Bolus Button Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145 13.9 Altitude Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146 13.10 Reset Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Chapter 14 · t:slim X2 Insulin Pump Malfunction 14.1 Malfunction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
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Chapter 15 · Taking Care of Your Pump 15.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
Chapter 16 · Lifestyles Issues and Travel 16.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Section 3: CGM Features
Chapter 17 · Important CGM Safety Information 17.1 CGM Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160 17.2 CGM Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161 17.3 Potential Benefits From Using the t:slim X2 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163 17.4 Possible Risks From Using the t:slim X2 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Chapter 18 · Getting to Know Your CGM System 18.1 CGM Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166 18.2 Explanation of CGM Pump Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168 18.3 CGM Lock Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170 18.4 CGM Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172 18.5 My CGM Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
Chapter 19 · CGM Overview 19.1 CGM System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178 19.2 Receiver (t:slim X2 Insulin Pump) Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178 19.3 Transmitter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178 19.4 Sensor Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
Chapter 20 · CGM Settings 20.1 About Bluetooth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
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20.2 Disconnecting from the Dexcom Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182 20.3 Entering Your Transmitter ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182 20.4 Setting CGM Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183 20.5 CGM Info . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Chapter 21 · Setting CGM Alerts 21.1 Setting Your High Glucose Alert and Repeat Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188 21.2 Setting Your Low Glucose Alert and Repeat Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189 21.3 Rate Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190 21.4 Setting Your Rise Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190 21.5 Setting Your Fall Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191 21.6 Setting Your Out of Range Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
Chapter 22 · Start or Stop a CGM Sensor Session 22.1 Start the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194 22.2 Sensor Startup Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195 22.3 Automatic Sensor Shut-Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197 22.4 Ending a Sensor Session Before Automatic Shut-Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197 22.5 Removing the Sensor and Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Chapter 23 · Calibrating Your CGM System 23.1 Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200 23.2 Startup Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200 23.3 Calibration BG Value and Correction Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202 23.4 Reasons You May Need to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
Chapter 24 · Viewing CGM Data on Your t:slim X2 Insulin Pump 24.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204 24.2 CGM Trend Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205 24.3 Rate of Change Arrows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
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24.4 CGM History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209 24.5 Missed Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
Chapter 25 · CGM Alerts and Errors 25.1 Startup Calibration Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213 25.2 Second Startup Calibration Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214 25.3 12 Hour Calibration Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215 25.4 Incomplete Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216 25.5 Calibration Timeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217 25.6 Wait 15 Minute Calibration Error Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218 25.7 Calibration Required Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219 25.8 CGM High Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220 25.9 CGM Low Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221 25.10 CGM Fixed Low Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222 25.11 CGM Rise Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223 25.12 CGM Rapid Rise Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224 25.13 CGM Fall Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225 25.14 CGM Rapid Fall Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226 25.15 Unknown Sensor Glucose Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227 25.16 Out of Range Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228 25.17 Low Transmitter Battery Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229 25.18 Transmitter Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230 25.19 Failed Sensor Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231 25.20 CGM Unavailable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232 25.21 CGM System Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233
Chapter 26 · CGM Troubleshooting 26.1 CGM Pairing Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236 26.2 Calibration Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236 26.3 Unknown Sensor Reading Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
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26.4 Out of Range/No Antenna Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237 26.5 Failed Sensor Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238 26.6 Sensor Inaccuracies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238
Section 4: Control-IQ Technology Features
Chapter 27 · Control-IQ Technology Important Safety Information 27.1 Control-IQ Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242 27.2 Control-IQ Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
Chapter 28 · Getting to Know Control-IQ Technology 28.1 Responsible Use of Control-IQ Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246 28.2 Explanation of Control-IQ Technology Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247 28.3 Control-IQ Lock Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248 28.4 Control-IQ Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250 28.5 Control-IQ Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252
Chapter 29 · Introduction to Control-IQ Technology 29.1 Control-IQ Technology Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256 29.2 How Control-IQ Technology Works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256 29.3 Control-IQ Technology and Activity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 265
Chapter 30 · Configure and Use Control-IQ Technology 30.1 Required Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268 30.2 Set Control-IQ Technology Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268 30.3 Set Total Daily Insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269 30.4 Turn Control-IQ Technology On or Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269 30.5 Schedule Sleep . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270 30.6 Activate or Deactivate a Sleep Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 271
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30.7 Manually Start or Stop Sleep . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272 30.8 Manually Start or Stop Exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273 30.9 Control-IQ Technology Information on Your Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273
Chapter 31 · Control-IQ Technology Alerts 31.1 Out of Range Alert Control-IQ Technology Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279 31.2 Out of Range Alert Control-IQ Technology On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 280 31.3 Control-IQ Technology Low Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281 31.4 Control-IQ High Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282 31.5 Max Insulin Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283
Chapter 32 · Overview of Control-IQ Technology Clinical Studies 32.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 286 32.2 Clinical Study Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 286 32.3 Demographics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 288 32.4 Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292 32.5 Intervention Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 296 32.6 Primary Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300 32.7 Secondary Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303 32.8 Insulin Delivery Differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 308 32.9 Control-IQ Technology High and Low Alert Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 310 32.10 Additional Analysis of Glucose Value Auto-Population with CGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 312
Section 5: Technical Specifications and Warranty
Chapter 33 · Technical Specifications 33.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 316 33.2 t:slim X2 Pump Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 316
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33.3 33.4 33.5 33.6 33.7 33.8 33.9 33.10 33.11 33.12 33.13 33.14 33.15
t:slim X2 Pump Options and Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 322 t:slim X2 Pump Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 324 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 329 Wireless Co-existence and Data Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 329 Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 330 Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 331 Distances Between the t:slim X2 Pump and RF Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334 Quality of Wireless Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 336 FCC Notice Concerning Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 336 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 337 Returned Goods Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341 t:slim X2 Insulin Pump Event Data (Black Box) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341 Product List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 342
Index
344
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1 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
Italic Text
Numbered Items
Blue Text
Text that is in bold in a sentence or step indicates an on-screen icon or physical button name. Text that is in italics indicates the name of a screen or menu on the pump display. Numbered items are step-by-step instructions for how to perform a specific task. Calls out a reference to a separate user guide location or website link.
Terminology Definitions
Term
Definition
Touchscreen Tap Press Hold Menu Icon
The front glass screen of your pump, which displays all programming, operating, and alarm/alert information. Quickly and lightly touch the screen with your finger. Use your finger to depress a physical button (the Screen On/Quick Bolus button is the only physical/hardware button on your pump). Keep pressing a button or touching an icon or menu until its function is complete. A list of options on your touchscreen that allow you to perform specific tasks. 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.
14
Symbol Definitions Symbol Definition
Calls out an important note regarding the use or operation of the system. Calls out safety precautions which, if ignored, could result in minor or moderate injury. Calls out critical safety information which, if ignored, could result in serious injury or death. Indicates how the pump responds to the previous instruction.
CHAPTER 1 · Introduction
15
CHAPTER 1 · Introduction
1.2 Explanation of Symbols
The following are symbols (and their descriptions), which you may find on your pump, pump supplies and/or their packaging. These symbols tell you about the proper and safe use of the pump. Some of these symbols may not be relevant in your region, and are listed for informational purposes only.
Explanation of t:slim X2 Insulin Pump Symbols
Symbol Definition Caution
Symbol
Definition
Type BF Applied Part (patient isolation, not defibrillator protected)
Follow instructions for use
Consult instructions for use
For sale by or on the order of a physician only (U.S.)
Non-ionizing Radiation
Catalogue number
Serial number
Batch code
Magnetic Resonance (MR) Unsafe; keep away from magnetic resonance imaging (MRI) equipment
Authorized Representative in the European Community
Medical device Manufacturer number CE marking of conformity
Manufacturer
Date of manufacture
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CHAPTER 1 · Introduction
Explanation of t:slim X2 Insulin Pump Symbols (Continued) Symbol Definition
International Protection (IP) Code
Direct Current (DC) voltage Separate collection for waste electrical and electronic equipment Electric equipment designed primarily for indoor use
IEC Class II equipment
Wall power USB adapter
Cartridge removal tool
USB cable
Symbol
Definition Regulatory Compliance Mark
Humidity limitation
Temperature limit
Keep Dry
Outlet adapter
Pump case
User guide
17
CHAPTER 1 · Introduction
1.3 System Description
The t:slim X2TM insulin pump is made up of the t:slim X2 insulin pump, the t:slim X2 3mL (300 units) cartridge, and a compatible infusion set. In this user guide, the t:slim X2 insulin pump may be referred to as the "pump" or the "t:slim X2 pump." The combination of the t:slim X2 pump with Control-IQTM 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 4872 hours.
The t:slim X2 pump comes preloaded with Control-IQ technology, or can be updated to include this feature. The addition of this feature enables the t:slim X2 System to automatically adjust the delivery of insulin based on CGM sensor readings; however, the feature is not a substitute for your own active diabetes management. Control-IQ technology utilizes the CGM sensor readings to calculate a predicted glucose value 30 minutes into the future. For more information on how Control-IQ technology is activated, see Chapter 29 Introduction to Control-IQ Technology. The pump can be used for basal and bolus insulin delivery with or without a CGM. If a CGM is not used, sensor glucose readings will not be sent to the pump display and you will not be able to use Control-IQ technology. The sensor is a disposable device that is inserted under the skin to continuously monitor glucose levels. The transmitter connects to the sensor pod and wirelessly sends readings to the pump, which acts as a receiver for the therapeutic CGM, every 5 minutes.
The pump shows sensor glucose readings, a trend graph, as well as the direction and rate of change arrows. The sensor measures glucose in the fluid under the skin--not in blood, and sensor readings are not identical to readings from a blood glucose (BG) meter.
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 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 Control-IQ technology on your pump.
18
CHAPTER 1 · Introduction
Section 5 provides information on the technical specifications of your pump. The pump screens used in this user guide demonstrate how to use features and are examples only. They should not be considered as suggestions for your individual needs. Additional product information, including electronic versions of the user guide, and a CGM training tutorial, are available at tandemdiabetes.ca.
1.5 Indications for Use
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 pump is able to reliably and securely communicate with compatible, digitally connected devices. The pump is indicated for use in persons six years of age and greater. The pump is intended for single patient use.
The pump is indicated for use with NovoRapid or Humalog U-100 insulin. Control-IQ technology is intended for use with a compatible continuous glucose monitor (CGM) and the t:slim X2 insulin pump to automatically increase, decrease, and suspend delivery of basal insulin based on CGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons six years of age and greater. Control-IQ technology is intended for single patient use. Control-IQ technology is indicated for use with NovoRapid or Humalog U-100 insulin.
1.6 Compatible CGMs
Compatible CGMs include the following: · 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 or their local distributors.
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.
19
CHAPTER 1 · Introduction
1.7 Important User Information
Review all instructions in this user guide before using the System. If you are not able to use the System according to the instructions in this user guide and other applicable user guides, you may be putting your health and safety at risk. If you are new to using CGM, continue using your BG meter until you are familiar with CGM usage. If you are currently using the pump without Dexcom G6 CGM, or if you are currently using Dexcom G6 CGM, it is still very important that you review all instructions in this user guide before using the combined System. Pay special attention to Warnings and Precautions in this user guide. Warnings and Precautions are identified with a or symbol. If you still have questions after reading this user guide, contact Customer Technical Support 24 hours a day, 7 days a week.
1.8 Important Pediatric User Information
The following recommendations are meant to help younger users and their caregivers program, manage, and care for the System. Younger children may inadvertently press or tap the pump, leading to unintentional delivery of insulin. It is the responsibility of the healthcare provider and caregiver to determine if the user is appropriate for treatment with this device. We recommend reviewing the Quick Bolus and Security PIN capabilities of the pump and determining how they best fit with your care plan. These features are detailed in Chapters 7 Manual Bolus and 4 Getting Started. Inadvertent dislodgement of the infusion site may occur more frequently with children so consider securing the infusion site and tubing.
WARNING Control-IQ technology should not be used by people who use less than 10 units of insulin per
day or weigh less than 25 kilograms (55 pounds), which are the minimum inputs required to initiate Control-IQ technology and for it to operate safely.
WARNING The t:slim X2 insulin pump with Control-IQ technology should not be used in children under the age of six years old.
WARNING DO NOT allow small children (either pump users or non-users) to ingest small parts, such as the rubber USB port cover and cartridge components. Small parts could pose a choking hazard. If ingested or swallowed, these small component pieces may cause internal injury or infection.
WARNING The pump includes parts (such as the USB cable and infusion set tubing) that could pose a strangulation or asphyxiation hazard. Always use the appropriate length of infusion set tubing and arrange cables and tubing to minimize the risk of strangulation. ENSURE that these parts are stored in a secure place when not in use.
20
CHAPTER 1 · Introduction
WARNING
For patients who do not self-manage their disease, the Security PIN function should ALWAYS be on when the pump is not being used by a caregiver. The Security PIN function is intended to prevent inadvertent screen taps or button presses that may lead to insulin delivery or changes in the pump settings. These changes can potentially lead to hypoglycemia (low BG) or hyperglycemia (high BG) events. See Section 4.16 Turn Security PIN On or Off for details on how to turn the Security PIN function on.
WARNING
For patients whose insulin administration is managed by a caregiver, ALWAYS turn off the Quick Bolus feature to avoid inadvertent bolus delivery. If the Security PIN is turned on, the Quick Bolus feature is automatically disabled. Inadvertent screen taps, button presses, or tampering with the insulin pump could result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. See Section 4.16 Turn Security PIN On or Off for details on how to turn the Security PIN function off.
1.9 Emergency Kit
Make sure that you always have an insulin syringe and vial of insulin or a prefilled insulin pen with you as a backup for emergency situations. You should also always have an appropriate emergency kit with you. Talk with your healthcare provider regarding what items this kit should include. Supplies to carry every day: · BG testing supplies: meter, strips,
control solution, lancets, meter batteries · Fast-acting carbohydrate to treat low BG · Extra snack for longer coverage than fast-acting carbohydrate · Glucagon emergency kit · Rapid-acting insulin and syringes or a prefilled insulin pen · Infusion sets (minimum of 2) · Insulin pump cartridges (minimum of 2)
· Infusion site preparation products (antiseptic wipes, skin adhesive)
· Diabetes identification card or jewelry
21
CHAPTER 1 · Introduction
This Page is Intentionally Left Blank
22
2 t:slim X2 Insulin Pump Features
CHAPTER 2
Important Safety Information
CHAPTER 2 · Important Safety Information
The following includes important safety information related to your t:slim X2TM pump and its components. The information presented in this chapter does not represent all warnings and precautions related to the System. Pay attention to other warnings and precautions listed throughout this user guide as they relate to special circumstances, features, or users.
2.1 t:slim X2 Insulin Pump Warnings
WARNING DO NOT start to use your pump before reading the user guide. Failure to follow the instructions in this user guide can result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. If you have questions or need further clarification on your pump use, ask your healthcare provider or call Customer Technical Support.
WARNING DO NOT start to use your pump before you have been appropriately trained on its use by a certified trainer or through the training materials available online if you are updating your pump.
Consult with your healthcare provider for your individual training needs for the pump. Failure to complete the necessary training on your pump could result in serious injury or death.
WARNING Only U-100 Humalog and NovoRapid have been tested and found to be compatible for use with the pump. The use of lower or higher concentration may cause over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.
WARNING DO NOT put any other drugs or medications in the pump. The pump has only been tested for continuous subcutaneous insulin infusion (CSII) with U-100 Humalog or U-100 NovoRapid insulin. The pump may be damaged if other medicines are used and an infusion may result in damage to health.
WARNING The pump is not intended for anyone unable or unwilling to:
» Use the pump, CGM, and all other system components in accordance with their respective instructions for use
» Test BG levels as recommended by a healthcare provider
» Demonstrate adequate carbohydrate-counting skills
» Maintain sufficient diabetes self- care skills
» See a healthcare provider(s) regularly
The user must also have adequate vision and/or hearing in order to recognize all functions of your pump, including alerts, alarms, and reminders.
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.
24
CHAPTER 2 · Important Safety Information
WARNING ALWAYS be prepared to inject insulin with an alternative method if delivery is interrupted for any reason. Your pump is designed to deliver insulin reliably, but because it uses only rapid-acting insulin, you will not have long-acting insulin in your body. Failure to have an alternative method of insulin delivery can lead to very high BG or Diabetic Ketoacidosis (DKA).
WARNING ONLY use cartridges and infusion sets with matching connectors and follow their instructions for use. Failure to do so may result in over delivery or under delivery of insulin and may cause hypoglycemia (low BG) or hyperglycemia (high BG) events.
WARNING DO NOT place your infusion set on any scars, lumps, moles, stretch marks or tattoos. Placing your infusion set in these areas can cause swelling, irritation or infection. This can affect insulin absorption and cause high or low BG.
WARNING ALWAYS carefully follow the instructions for use accompanying your infusion set for proper insertion and infusion site care, as failure to do
so could result in over delivery or under delivery of insulin or infection.
WARNING NEVER fill your tubing while your infusion set is connected to your body. Always ensure that the infusion set is disconnected from your body before filling the tubing. Failure to disconnect your infusion set from your body before filling the tubing can result in over delivery of insulin. This can cause hypoglycemia (low BG) events.
WARNING DO NOT change your infusion set before bedtime or if you will not be able to test your BG 12 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.
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. If the connection comes loose, disconnect the infusion set from your body before tightening. 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).
25
CHAPTER 2 · Important Safety Information
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 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 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. 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.
2.2 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 There is no need to disconnect for electrocardiograms (EKGs) or colonoscopies. If you have questions, contact Customer Technical Support.
WARNING DO NOT use the pump if you have a condition which, in the opinion of your healthcare provider, would put you at risk. Examples of individuals who should not use the pump include those with uncontrolled thyroid disease, renal failure (e.g. dialysis or eGFR <30), hemophilia, or another major bleeding disorder, or unstable cardiovascular disease.
2.3 Magnetic Resonance Imaging Safety
The System is magnetic resonance (MR) unsafe. You must take off your pump, transmitter, and sensor and leave them outside the procedure
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CHAPTER 2 · Important Safety Information
room if you are going to have any of the following procedures.
» X-ray » Computed Tomography (CT) scan » Magnetic Resonance Imaging (MRI) » Positron Emission Tomography (PET)
scan » Other exposure to radiation
WARNING DO NOT expose your pump, transmitter, or sensor to:
» Pacemaker/Automatic Implantable Cardioverter Defibrillator (AICD) placement or reprogramming
» Cardiac Catheterization » Nuclear Stress Test
You must take off your pump, transmitter, and sensor and leave them outside the procedure room if you are going to have any of the above medical procedures.
WARNING There are other procedures where you should proceed with caution:
» Laser Surgery Your System can usually be worn during the procedure. However, some lasers can create interference and cause the System to alarm.
» General Anesthesia Depending on the equipment being used, you may or may not need to remove your System. Be sure to ask your healthcare provider.
2.4 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.
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CHAPTER 2 · Important Safety Information
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 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 using the 12 hour clock. AM is to be used from midnight until 11:59 AM. PM is to be used from noon until 11:59 PM.
PRECAUTION CONFIRM that the screen display turns on, you can hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On/Quick Bolus button when you connect a power source to the USB port. These features are used to notify you about alerts, alarms, and other conditions that require your attention. If these features are not working, discontinue use of the pump and contact Customer Technical Support.
PRECAUTION CHECK your pump regularly for potential alarm conditions that may display. It is important to be aware of conditions that may affect insulin delivery and require your attention so you can respond as soon as possible.
PRECAUTION DO NOT use the vibrate feature for alerts and alarms during sleep unless otherwise directed by your healthcare provider. Having the volume for alerts and alarms set to high will help ensure that you do not 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 5°C (41°F) or above 37°C (99°F). 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 0.91 m (3 feet) or for more than 30 minutes (IPX7 rating). If your pump has been
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CHAPTER 2 · Important Safety Information
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 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 BG meter following a gradual elevation change of up to each 305 meters (1,000 feet), 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 305 meters (1,000 feet). 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 16.3 cm (6.4 inches) apart.
PRECAUTION ALWAYS dispose of used components such as cartridges, syringes, needles, infusion sets, and CGM sensors following the instructions from
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CHAPTER 2 · Important Safety Information
your healthcare provider. Wash your hands thoroughly after handling used components.
2.5 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 six 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 carbohydrates entered, which can help eliminate guesswork.
· The 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.
2.6 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,
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CHAPTER 2 · Important Safety Information
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 or dislodged cannula, which can affect insulin delivery. If your BG does not decrease after initiating a bolus, or you have other unexplained high BG, it is recommended that you check your infusion set for an occlusion or air bubbles, and verify that the cannula has not dislodged. 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 or software anomaly.
· 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, software anomaly, or infusion set failure. Having a backup method of insulin delivery greatly reduces your risk of severe hyperglycemia or DKA.
2.7 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 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), 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.
2.8 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:
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CHAPTER 2 · Important Safety Information
· 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
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 your pump and contact Customer Technical Support.
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2 t:slim X2 Insulin Pump Features
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 X2TM insulin pump 2. pump case 3. t:slim X2 Insulin Pump with
Control-IQTM 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. The t:slim X2 3 mL cartridge with t:lockTM connector consists of the reservoir chamber and a micro-delivery chamber for the delivery of very small amounts of insulin. A variety of compatible infusion sets with the t:lock connector are available from Tandem Diabetes Care, Inc. The t:lock connector allows a secure connection between the cartridge and the infusion set. Use only t:slim X2 cartridges and compatible infusion sets with t:lock connectors manufactured for Tandem Diabetes Care, Inc. 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 BG is the abbreviation for blood glucose, which is the level of glucose in the blood, measured in mmol/L. BG Target BG target is a specific BG or glucose value 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.
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CHAPTER 3 · Getting to Know Your t:slim X2 Insulin Pump
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. Carb Ratio The Carb Ratio is the number of grams of carbohydrate that 1 unit of insulin will cover. Also known as insulin-to-carbohydrate 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.
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CHAPTER 3 · Getting to Know Your t:slim X2 Insulin Pump 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.
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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 The amount of charge left in the pump battery.
A system reminder, alert, error, or alarm is active.
All insulin deliveries are stopped.
Basal insulin is programmed and being delivered.
Bluetooth® wireless technology 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.
Delete. Tap to delete characters or digits on a keypad.
Symbol Definition Amount of insulin remaining in the cartridge. A temporary Basal Rate is active. A Basal Rate of 0 u/hr is active. A temporary Basal Rate of 0 u/hr is active. A bolus is being delivered.
Cancel. Tap to cancel the current operation. Decline. Tap to exit the screen or answer no to a message on the pump screen. Back. Tap to navigate to the previous screen. Total. Tap to total values on a keypad.
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CHAPTER 3 · Getting to Know Your t:slim X2 Insulin Pump
Pump Icon Definitions (Continued) Symbol Definition
Space. Tap to enter a space on the character keypad.
The associated setting is turned on. Security PIN has been enabled. See Section 4.16 Turn Security PIN On or Off.
Symbol
OK
Definition
OK. Tap to confirm the current instruction or setting on the screen.
The associated setting is turned off.
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CHAPTER 3 · Getting to Know Your t:slim X2 Insulin Pump 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 123 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. 123: 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.
8. Insulin Level: Displays the current amount of insulin in the cartridge.
9. Tandem Logo: Returns to the Home screen.
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CHAPTER 3 · Getting to Know Your t:slim X2 Insulin Pump
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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, start/stop activities, 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.
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CHAPTER 3 · Getting to Know Your t:slim X2 Insulin Pump
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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.
: Returns to the Home screen.
2. Profile: Displays current active Personal Profile.
3. Basal Rate: Displays current Basal Rate being delivered in units/hr. If a Temp Rate is active, this row will change to display current Temp Rate being delivered in units/hr.
4. Last Bolus: Displays amount, date and time of last bolus.
5. Control-IQ Status: Displays Control-IQ technology status.
6. Up/Down Arrow: Indicates there is more information.
7. Correction Factor: Displays current Correction Factor used to calculate a bolus.
8. Carb Ratio: Displays current Carb Ratio used to calculate a bolus.
9. Target BG: Displays current BG target used to calculate a bolus.
10. Insulin Duration: Displays current insulin duration setting used to calculate insulin on board.
11. Last Calibration: Displays date and time of last calibration.
12. Time Sensor Started: Displays date and time of last time sensor started.
13. Transmitter Battery: Displays CGM transmitter battery status.
14. 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.
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CHAPTER 3 · Getting to Know Your t:slim X2 Insulin Pump
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CHAPTER 3 · Getting to Know Your t:slim X2 Insulin Pump
3.8 Bolus Screen
The Bolus screen will default to use units of insulin in calculating a bolus. You may change this setting in your Personal Profile to use grams of carbohydrate instead. Both screens are shown on the next page as examples.
1.
: Returns to the Home screen.
2. Insulin: Enter units of insulin. You may change this setting to use grams of carbohydrate. See Section 5.2 Creating a New Profile for more information.
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 glucose level. This value is populated automatically by the System if:
Control-IQ technology is turned on and available
A CGM session is active
A CGM value is present
A CGM trend arrow is available on the CGM Home screen
NOTE
For more information about CGM trend arrows and how to use them for treatment decisions, see the CGM manufacturer's user guide. You can also see Section 24.3 Rate of Change Arrows.
You can choose to use this value or enter another value from an alternate testing method.
6.
: Moves to next step.
7. Carbs: Enter grams of carbohydrate. You may change this setting to use units of insulin. See Section 5.2 Creating a New Profile for more information.
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CHAPTER 3 · Getting to Know Your t:slim X2 Insulin Pump
Using Units
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Using Grams
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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. Activity: Turns on Exercise, Sleep, and programs sleep schedules and temporary Basal Rates.
5. My Pump: Personal Profiles, Control-IQ, Alerts & Reminders, 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.
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CHAPTER 3 · Getting to Know Your t:slim X2 Insulin Pump
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CHAPTER 3 · Getting to Know Your t:slim X2 Insulin Pump
3.10 My Pump Screen
1.
: Returns to the Options
screen.
2. Personal Profiles: A group of settings that define basal and bolus delivery.
3. Control-IQ: Turn on/off Control-IQ technology and enter required values.
4. Alerts & Reminders: Customize Pump Reminders and Pump Alerts.
5. Pump Info: Displays pump serial number, Customer Technical Support contact information website, and other technical information.
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CHAPTER 3 · Getting to Know Your t:slim X2 Insulin Pump
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CHAPTER 3 · Getting to Know Your t:slim X2 Insulin Pump
3.11 Device Settings Screen
1.
: Returns to the Options
screen.
2. Display Settings: Customize the Screen Timeout settings.
3. Bluetooth Settings: Turn on/off mobile connection. The mobile connection may not yet be available in your region.
4. Time and Date: Edit the time and date that will be displayed on the pump.
5. Sound Volume: Customize the sound volume for pump alarms, pump alerts, reminders, keypad, bolus, quick bolus, fill tubing, and CGM alerts.
6. Security PIN: Turn on/off the Security PIN.
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CHAPTER 3 · Getting to Know Your t:slim X2 Insulin Pump
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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 the 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.
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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.
: 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.
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2 t:slim X2 Insulin 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. If you utilize CGM your battery is designed to 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 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).
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.
The pump continues to operate normally while charging. You do not need to disconnect from the pump while charging.
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.
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.
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CHAPTER 4 · Getting Started
To charge the pump using a car power USB adapter (sold separately):
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 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.
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 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 t:slim X2TM pump and contact Customer Technical Support.
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 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 123 in
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sequence. On all screens, if three non-active 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 4.16 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 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 Arrow to see additional language selections.
Tap to save the selection and continue with pump setup. 4.6 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.
4.7 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.
4.8 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.
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CHAPTER 4 · Getting Started
3. Tap 2.
4. Tap 3.
The pump screen is now unlocked. The last screen that was viewed will be displayed.
You must tap 123 in sequential order to unlock the pump. If you do not tap 123 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 using the 12 hour clock. 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 . 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
.
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CHAPTER 4 · Getting Started
Tap the Tandem logo to return to the Home screen.
4.11 Basal Limit
The Basal Limit setting allows you to set a limit to the Basal Rate that is set in the Personal Profiles, as well as the amount of insulin that will be delivered when sing a Temp Rate.
You are unable to set any Basal Rates or temp Basal Rates that exceed the Basal Limit. You can set Basal Limit from 0.2 to 15 units per hour. Work with your healthcare provider to set the proper Basal Limit.
NOTE Basal Limit and Personal Profiles: If you are setting your Basal Limit after you have set any of your Personal Profiles, you cannot set your Basal Limit lower than any of your existing Basal Rates.
The default Basal Limit is 3 units per hour. If you are updating your pump from a version that did not previously have the Basal Limit setting, the Basal Limit will be set to a value two times the
highest Basal Rate setting in your pump. 1. From the Home screen, tap
OPTIONS. 2. Tap My Pump. 3. Tap Personal Profiles. 4. Tap Pump Settings. 5. Tap Basal Limit.
6. Using the on-screen keypad, enter a Basal Limit amount that is between 0.2 15 units.
7. Tap .
8. Review the new Basal Limit value and tap .
9. Confirm settings and tap . A SETTING SAVED screen is
temporarily displayed.
4.12 Display Settings
The display settings for your t:slim X2 pump includes Screen Timeout. You can set the Screen Timeout to the length of time you want the screen to stay on before it automatically turns off. The default for the Screen Timeout is 30 seconds. The options are 15, 30, 60, and 120 seconds. You can always turn the screen off before it automatically times out by pressing the Screen On/Quick Bolus button. 1. From the Home screen, tap
OPTIONS. 2. Tap the Down Arrow. 3. Tap Device Settings.
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CHAPTER 4 · Getting Started
4. Tap Display Settings. 5. Tap Screen Timeout.
6. Select preferred time and tap . 7. Tap the Tandem logo to return to
the Home screen.
4.13 Mobile Connection
The Tandem Diabetes Care mobile app may not yet be available in your region. Do not turn the mobile connection on if you are not using or do not have access to the Tandem Diabetes Care mobile app.
NOTE CGM Bluetooth Connection: This Mobile Connection setting is not related to your CGM Bluetooth connection. For CGM Bluetooth information, see Section 20.1 About Bluetooth.
4.14 Mobile Connection Security
Only one phone and mobile app may pair with your pump. When pairing your pump to a mobile app, a unique code
will be generated and used to secure communications between the pump and mobile phone. All transmissions between the pump and phone are encrypted. Any unauthorized or unrecognized connections are denied by the pump.
4.15 Sound Volume
The Sound Volume is preset to high. Sound Volume can be personalized for Alarms, Alerts, Reminders, Keypad, Bolus, Quick Bolus, and Fill Tubing. Options for Sound Volume include high, medium, low, and vibrate.
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 do not miss an alert or alarm.
1. From the Home screen, tap OPTIONS.
2. Tap the Down Arrow.
3. Tap Device Settings.
4. Tap Sound Volume. 5. Tap desired option. Use Up/Down
Arrow to view additional options. 6. Select preferred volume. 7. Continue to make changes for all
Sound Volume options by repeating steps 5 and 6. 8. Tap when all changes are complete. 9. Tap the Tandem logo to return to the Home screen.
4.16 Turn Security PIN On or Off The Security PIN is preset to off. With the Security PIN turned on, you cannot unlock and use the pump without entering the Security PIN. To turn on the Security PIN, follow these steps. 1. From the Home screen, tap
OPTIONS. 2. Tap the Down Arrow.
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CHAPTER 4 · Getting Started
3. Tap Device Settings.
4. Tap the Down Arrow.
5. Tap Security PIN.
6. Tap Security PIN to toggle the feature on.
7. Tap PIN.
to create your Security
8. Using the keypad, enter a number between four and six digits. A PIN may not begin with the number zero.
9. Tap .
10. Tap OK to verify your Security PIN.
11. Use the keypad to repeat and verify the new Security PIN.
12. Tap .
A PIN CREATED screen is displayed.
13. Tap on.
to turn the Security PIN
14. Tap .
It is possible to change your Security PIN or override an old Security PIN if you forget your Security PIN. 1. From the Home screen, tap
OPTIONS.
2. Tap the Down Arrow.
3. Tap Device Settings.
4. Tap the Down Arrow.
5. Tap Security PIN.
6. Tap Change Security PIN.
7. Tap . OK
8. Using the keypad, enter the current Security PIN. If you forget your Security PIN, use the override code 314159.
» The override PIN can be used as many times as needed and never resets or changes to another PIN. It can be used to unlock the pump when the Security PIN feature is on. If desired, you may use this as a valid Security PIN.
9. Tap .
10. Tap OK to enter a new Security PIN.
11. Use the keypad to enter a new Security PIN.
12. Tap .
13. Tap OK to verify your new Security PIN.
14. Use the keypad to repeat and verify the new Security PIN.
15. Tap .
A PIN UPDATED screen is displayed.
16. Tap .
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2 t:slim X2 Insulin Pump Features
CHAPTER 5
Insulin Delivery Settings
CHAPTER 5 · Insulin Delivery Settings
5.1 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 and Carbohydrates setting (on/off).
NOTE Control-IQ Technology Settings: In order to turn on Control-IQ technology, the Timed Settings must be complete for every time segment, and the Carbohydrates setting must be turned on in the Bolus Settings.
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.
NOTE Control-IQ Technology: Some of the Personal Profile settings are overridden when Control-IQ technology is turned on. See Chapter 29 Introduction to Control-IQ Technology.
5.2 Creating a New Profile
Creating Personal Profiles
You can create up to six Personal Profiles; however, only one 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)
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CHAPTER 5 · Insulin Delivery Settings
· Target BG (your ideal BG level, measured in mmol/L)
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.
The ranges you can set for Timed Settings are:
· Basal (range: 0 and 0.1 to 15 units/ hr)
NOTE Basal Rate Setting: The Basal Rate may not exceed the Basal Limit set in Pump Settings (see Section 4.11 Basal Limit). If you set up your Basal Limit after you have set any of your Personal Profiles, you cannot set your Basal Limit lower than any of your existing Basal Rates.
NOTE Control-IQ Technology and Basal Rates Greater than 3 Units/Hour: If Control-IQ technology is on and your CGM is out of range for more than 20 minutes, the system will automatically limit your Basal
Rate to a maximum of 3 units/hour. If you enter a value for your Basal Rate that is higher than 3 units/hour, you will receive less insulin than expected during an out of range event.
WARNING Control-IQ technology limits Basal Rate to 3 units/hour when the pump has not received a CGM reading for 20 minutes. For example, when the pump and CGM are out of range, during the sensor startup period, when a sensor session ends, or when there is a transmitter or sensor error. In order to receive more than 3 units/hour during these scenarios, turn Control-IQ technology off.
· Correction Factor (range: 1 unit:0.1 mmol/L to 1 unit:33.3 mmol/L)
· 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 gram. For example a Carb Ratio of 1:8.2 can be programmed.
· Target BG (range: 3.9 mmol/L to 13.9 mmol/L)
In addition, you can set any or all of the following Bolus Settings:
· Insulin Duration (how long a bolus lowers your BG)
· Carbs (ON indicates entering grams of Carb; OFF indicates entering units of insulin)
The default settings and ranges for Bolus Settings are as follows:
· Insulin Duration (default: 5 hrs; range: 2 to 8 hrs)
NOTE Control-IQ Technology Insulin Duration: When using Control-IQ technology, the insulin duration is set to five hours and cannot be changed. This duration is used for all bolus deliveries as well as for basal adjustments made by Control-IQ technology.
· Carbs (default: dependent on pump history)
NOTE Carbs Default Setting: If you received a new pump with Control-IQ technology, the default setting will be on. If you updated
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CHAPTER 5 · Insulin Delivery Settings
your pump, the default setting will be the same as what you set up on your pump previously. Check to ensure that the Carbs setting is on in order to use Control-IQ technology.
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. 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 adjusts the calculated bolus if necessary.
The insulin duration time is displayed on the Home screen when Control-IQ technology is not enabled.
Consult your healthcare provider to accurately set your insulin duration. If you have Control-IQTM technology enabled, IOB includes all basal delivered above and below the programmed Basal Rate, in addition to all bolus insulin delivered. The insulin duration time is not displayed on the Home screen. Insulin duration is set to 5 hours when Control-IQ technology is enabled and cannot be changed. 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, two quick taps for middle letter; and three quick taps for the third letter.
6. Tap Press to Set Up to begin setting insulin delivery settings.
5.3 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 have Carbs turned on, and you must set a Basal Rate, Correction Factor, Carb Ratio, and Target BG in order to turn Control-IQ technology on.
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· 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.
2. Using the on-screen keypad, enter your Basal Rate and tap .
NOTE Basal Limit Pump Setting: If you have previously set a Basal Limit in the Pump Settings, then the Basal Rate entered here must be lower then the Basal Limit entered in the Pump Settings.
3. Tap Correction Factor.
4. Using the on-screen keypad, enter your Correction Factor (the mmol/L that 1 unit of insulin will lower BG) and tap .
5. Tap Carb Ratio.
6. 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 .
7. Tap Target BG.
8. Using the on-screen keypad, enter your Target BG and tap .
NOTE Control-IQ Technology and Target BG: Once Control-IQ technology is turned on,
the default Target BG is set to 6.1 mmol/L. For details about target ranges and how Control-IQ technology works, see Chapter 29 Introduction to Control-IQ Technology.
9. Review entered values and tap .
10. Confirm Settings.
Tap if entered data is correct.
Tap to make changes.
11. Tap to set the Bolus Settings, or tap to create additional time segments.
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CHAPTER 5 · Insulin Delivery Settings
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 10 from Section 5.2 Creating a New Profile 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.
2. Tap Insulin Duration.
3. Using the on-screen keypad, enter the desired time for the duration of insulin action (28 hrs) and tap .
4. Review entered values and tap .
5. Confirm Settings. Tap if entered data is correct. Tap to make changes.
6. Tap the Tandem logo to return to the Home screen.
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CHAPTER 5 · Insulin Delivery Settings
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: The Carbohydrates option is turned on by default, but a ratio will still need to be defined. The Carbohydrates option must be used if Control-IQ technology is enabled.
5.4 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 on-screen 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 or Carbohydrates as needed. Use the on-screen keypad to enter desired changes. Tap . 14. Confirm Settings. Tap if entered data is
correct. Tap and make changes. 15. Tap the Tandem logo to return to the Home screen.
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CHAPTER 5 · Insulin Delivery Settings
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 X to the left of the time segment and tap to confirm.
5.5 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.
5.6 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 one 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.
5.7 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.
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CHAPTER 5 · Insulin Delivery Settings
6. Using the on-screen keypad, rename the profile name (up to 16 characters) and tap .
7. Tap the Tandem logo to return to the Home screen.
5.8 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.
5.9 Starting a Temporary Basal Rate
A Temp Rate is used to increase or decrease (by percentage) the current Basal Rate for a period of time. This feature can be helpful for situations such as exercise or illness. When you enter the Temp Rate screen, the default values are 100% (current Basal Rate) and a Duration of 0:15 min. The Temp Rate can be set from a minimum of 0% of current Basal Rate to a maximum of 250% of current Basal Rate in increments of 1%. Duration can be set from a minimum of 15 minutes to a maximum of 72 hours in increments of 1 minute. If you program a Temp Rate greater than 0% but less than the minimum allowable Basal Rate of 0.1 units/hr, you will be notified that the selected rate is too low and that it will be set to the minimum allowable rate for delivery.
If you program a Temp Rate more than the maximum allowable Basal Rate of 15 units/hr, or more than your Basal Limit set up in the Pump Settings, you will be notified that the selected rate is too high and that it will be set to the maximum allowable rate for delivery.
NOTE Temp Rate with Control-IQ Technology: In order to use Temp Rates, Control-IQ technology must be turned off.
1. From the Home screen, tap OPTIONS.
2. Tap Activity.
3. Tap Temp Rate.
4. Tap Temp Rate again.
5. Using the on-screen keypad enter desired percentage. The current rate is 100%. An increase is greater than 100% and decrease is less than 100%.
6. Tap .
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CHAPTER 5 · Insulin Delivery Settings
7. Tap Duration. Using the on-screen keypad enter desired length of time for Temp Rate. Tap .
You can always tap View Units to see the actual units to be delivered.
8. Verify settings and tap .
The TEMP RATE STARTED screen is temporarily displayed.
The Lock screen will be displayed with the icon indicating a Temp Rate is active.
An T in an orange box means a Temp Rate is active.
A T in a red box means a Temp Rate of 0 u/hr is active.
NOTE Temp Rate While Insulin is Stopped: If a Temp Rate is active when you stop insulin, including when you change a cartridge or infusion set, the Temp Rate timer will remain active. The Temp Rate will be resumed when insulin delivery is resumed as long as there is time remaining on the Temp Rate timer.
5.10 Stopping a Temp Rate To stop an active Temp Rate: 1. From the Home screen, tap
OPTIONS. 2. Tap Activity. 3. On the Activity screen, tap on
the right side of Temp Rate. 4. On the confirmation screen, tap
. The TEMP RATE STOPPED screen
appears before returning to the Activity screen.
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2 t:slim X2 Insulin Pump Features
CHAPTER 6
Infusion Site Care and Loading Cartridge
CHAPTER 6 · Infusion Site Care and Loading Cartridge
6.1 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 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 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.
WARNING DO NOT change your infusion set before bedtime or if you will not be able to test your BG
12 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 CHECK your infusion site daily for proper placement and leaks. REPLACE your infusion set if you notice leaks around the site, or if you suspect your infusion set cannula may have become dislodged. Improperly placed sites or leaks around the infusion site can result in under delivery of insulin.
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 5 cm (2 inches) around your belly button.
Any scars, moles, stretch marks, or tattoos.
Areas within 7.6 cm (3 inches) of your CGM sensor site.
Site Rotation
PRECAUTION CHANGE your infusion set every 4872 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.
78
· The infusion set must be replaced and rotated every 4872 hours, or more often if needed.
· With experience, you will find areas 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 6 · Infusion Site Care and Loading Cartridge Areas of Body for Infusion Set Insertion
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CHAPTER 6 · Infusion Site Care and Loading Cartridge
6.2 Cartridge Instructions for Use
For complete cartridge labeling, consult the cartridge instructions for use included in the t:slim X2TM cartridge box.
6.3 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 insulins in your pump. Only U-100 Humalog and NovoRapid have been tested and found to be compatible for use with the pump. The use of insulin with lower or higher concentration insulin may cause over delivery or under 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.
Start by preparing the following:
· 1 unopened cartridge
· 3.0 mL syringe and fill needle
· one vial of compatible 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 4.15 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.
NOTE Control-IQ Technology While Filling Cartridge: Control-IQTM technology will continue to make calculations based on CGM values while the cartridge is being filled. Since there is no insulin delivered during the cartridge fill process, there will be no actual Basal Rate adjustments until the cartridge is filled and loaded back onto the pump. Control-IQ technology will then immediately begin to operate normally.
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The illustration identifies the connector and insulin fill port used in the cartridge filling process.
Insulin Fill Port
Connector Tail of the Cartridge
PRECAUTION
CHANGE your cartridge every 4872 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.
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
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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.
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.
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CHAPTER 6 · 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.
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.
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
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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 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. A screen will display to notify you 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 the 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
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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 OK to fill the tubing. 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).
6.4 Filling Tubing
Filling the Infusion Set Tubing with Insulin
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.
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.
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 4.15 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 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.
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. Be careful to keep the tubing connector away from unclean areas.
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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.
while the tubing is being filled, depending on your Sound Volume settings.
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) events.
5. Hold the pump vertically to ensure any air in the cartridge will be dispelled first. Tap START. The pump will beep and vibrate regularly
Starting Fill screen is displayed. The following are approximate amounts of insulin to fill different tubing lengths: 1520 units for 60 cm (23 inch) tubing 2025 units for 80 cm (32 inch) tubing 2530 units for 110 cm (42 inch) 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 5 and 6 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
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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 + 60 u + 120 u + 180 u + 240 u
More than 40 units detected in the cartridge
More than 60 units detected in the cartridge
More than 120 units detected in the cartridge
More than 180 units detected in the cartridge
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 example, you will see 40, 39, 38, 37) until there is 1 unit remaining.
A screen will display to instruct you to insert a new infusion set and connect to the filled tubing.
6.5 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 START. The STARTING FILL screen is displayed.
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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).
6.6 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 (13).
The default for the Site Reminder is set for 3 days
3. Tap Remind Me At. Use the on-screen keypad to enter time and tap .
4. Tap Time of Day to change AM or PM, if applicable. Tap .
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 Control-IQ Technology: Control-IQ technology will continue to operate while changing a cartridge. If you complete a cartridge change and resume insulin while Control-IQ technology is adjusting insulin, insulin will resume until the next five-minute CGM reading. At this time the pump will resume normal operation.
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2 t:slim X2 Insulin Pump Features
CHAPTER 7
Manual Bolus
CHAPTER 7 · Manual Bolus
7.1 Manual 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.
WARNING Delivering large boluses or delivering multiple boluses back-to-back may cause hypoglycemia (low BG) or hyperglycemia (high BG) events. Pay attention to IOB and the bolus calculator recommended dose before delivering large or multiple boluses.
WARNING If you do not see a reduction in BG after initiating a bolus, it is recommended that you check your infusion set for an occlusion, air bubbles, or for leaks or cannula dislodgement. If the condition persists, call Customer Technical Support or seek medical attention as required.
NOTE Automatic Bolus Delivery and Control-IQ Technology: The information in this chapter does NOT apply to boluses delivered automatically by Control-IQ technology. For information Automatic Bolus Delivery, see Automatic Correction Bolus Delivery in Section 29.2 How Control-IQ Technology Works.
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 Carbs 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 you are not using Control-IQ technology and Carbs is turned off in your active Personal Profile, you will enter units of insulin to request the bolus.
NOTE Manual Bolus and Automatic Correction Bolus: If you deliver a manual bolus, Control-IQ technology will not be able to deliver an automatic correction bolus until 60 minutes after the manual bolus has completed.
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, either from the CGM or from manual entry, it will determine whether to recommend that a correction bolus to be added to any other bolus requested on the Bolus screen.
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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 is subtracted only from the correction portion of the bolus. · Between 3.9 mmol/L 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 3.9 mmol/L: 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 Auto-Population with CGM
PRECAUTION PAY ATTENTION to the trend information on the CGM Home screen, as well as your symptoms, before using CGM values to calculate and deliver a correction bolus. Individual CGM values may not be as accurate as BG meter values.
NOTE Making Treatment Decisions with your CGM: With a CGM that is approved for non-adjunctive use, there is no need to take a fingerstick to make a treatment decision, as long as your symptoms match the CGM readings. The t:slim X2 insulin pump can automatically use CGM readings in the bolus calculator when Control-IQ technology is enabled and there is a valid reading and trend arrow available from the CGM. If your CGM readings do not match your symptoms, it is recommended that you wash your hands thoroughly and use your BG meter to replace the CGM reading in the bolus calculator if the BG meter value matches your symptoms. If you want to align your CGM with your BG meter, you should follow the instructions to calibrate your CGM. Sometimes you should not treat at all, but rather watch and wait, including stacking insulin. Do not take insulin doses too close together. If you have recently given a
bolus, you might wait 60 minutes to see if your readings respond to the bolus.
NOTE Automatically Using CGM Readings in the Bolus Calculator vs. Manual Entry: Retrospective analysis of the pivotal study results indicated that there was an increased incidence of CGM values <3.9 mmol/L five hours after a bolus was delivered when glucose values were auto-populated. See Section 32.10 Additional Analysis of Glucose Value Auto-Population with CGM for more information.
Your glucose value is automatically entered into the GLUCOSE field on the Bolus screen when the following conditions are true:
· Control-IQTM technology is turned on and available
· A CGM session is active
· A CGM value is present
· A CGM trend arrow is available on the CGM Home screen
NOTE For more information about CGM trend arrows and how to use them for treatment
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decisions, see the CGM manufacturer's user guide. You can also see Section 24.3 Rate of Change Arrows.
To access the Correction Bolus confirmation screen, tap BOLUS from the CGM Home screen.
If you are not using a CGM, or if your CGM value or trend arrow are not available on the Home screen, the Correction Bolus confirmation screen is displayed if appropriate after you manually enter your BG value on the Bolus screen.
When the CGM reading is automatically populated into the bolus calculator, only the current CGM reading is used to calculate the correction bolus. The trend arrow is not used in the dose calculation. Speak with your healthcare provider for recommendations on how best to utilize the arrows for your correction bolus dosing.
If your healthcare provider has advised you to use the trend arrow to adjust your correction dose, or if you want to change the glucose value used to calculate your correction dose, you can
manually override the glucose value auto-populated from your CGM. To change the glucose value auto-populated from your CGM you can tap on the glucose value on the Bolus screen.
NOTE Changing the Glucose Value: If the glucose value auto-populated from your CGM was above or below your Target BG, your pump will present you with the Above Target or Below Target Correction Bolus confirmation screen. Correction Bolus Confirmation Screens You cannot tap the Current BG value on these Correction Bolus confirmation
screens to change the glucose value auto-populated from your CGM. Tap either or and proceed to the Bolus screen to change the glucose value as described above. Once the value is changed, if the manually inputted value is above or below your Target BG, your pump will again present you with the Above Target or Below Target confirmation screen where you can choose to accept the correction bolus or decline it. Above Target If your glucose value is above your Target BG, the pump presents you with the option for the pump to calculate and add a correction bolus to any other bolus you request.
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· 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.
· 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. BG Value Manual Entry If your glucose value was not auto-populated on the Bolus screen based on the conditions needed for that feature, you will need to enter your BG value into the pump manually before advancing to the Correction Bolus confirmation screens. The conditions needed for the auto-populate feature are: · Control-IQ technology is turned on and available · A CGM session is active · A CGM value is present
· A CGM trend arrow is available on the CGM Home screen NOTE For more information about CGM trend arrows and how to use them for treatment decisions, see the CGM manufacturer's user guide. You can also see Section 24.3 Rate of Change Arrows.
The Correction Bolus confirmation screens are displayed, if appropriate, after you manually enter your BG value on the Bolus screen. 1. From the Home screen tap BOLUS. 2. Tap Add BG.
3. Using the on-screen keypad, enter your BG value and tap . Once
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is tapped, the BG value is saved in your pump history whether or not a bolus is delivered. 4. Follow the steps in the appropriate Target section above depending on the results of your BG value. 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 an available option.
7.4 Food Bolus Using Units
If you are using Control-IQ technology, skip to Section 7.5 Food Bolus Using Grams. 1. From the Home screen, tap
BOLUS.
2. Tap 0 units on the left side of the screen.
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.
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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 . 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).
NOTE Control-IQ Technology and Extended Bolus: When Control-IQ technology is enabled, the default, and maximum limit for duration is two hours for extended bolus.
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. 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.
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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. The default maximum duration for extended bolus delivery is 8 hours. The default maximum duration for extended bolus delivery changes to 2 hours when Control-IQ technology is enabled.
11. Use the on-screen keypad to adjust the length of time the bolus is to be delivered, then tap .
12. Tap . 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 one 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. 7.7 Max Bolus The Max Bolus setting allows you to set a limit to the maximum insulin delivery amount for a single bolus.
The default setting for Max Bolus is 10 units but can be set to any value between 1 to 25 units. To adjust the Max Bolus setting, follow these steps. 1. From the Home screen, tap
OPTIONS. 2. Tap My Pump. 3. Tap Personal Profiles. 4. Tap Pump Settings. 5. Tap Max Bolus.
6. Using the on-screen keypad, enter the desired amount for maximum bolus (125 units) and tap .
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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 12.9 Max Bolus Alerts). If you are using Control-IQ technology, a reminder screen will not appear, but you will still have the option to deliver the remaining bolus as needed.
7.8 Quick Bolus
The Quick Bolus function enables you to deliver a bolus by simply pressing a button. It is a way to deliver a bolus by following beep/vibration commands without navigating through or viewing the pump screen.
Quick Bolus can be configured to correspond to either units of insulin or grams of carbohydrate. When Control-IQ technology is enabled, it will use the Quick Bolus as a correction bolus if configured as units of insulin, or as a food bolus if configured as grams of carbohydrate. Control-IQ technology
uses the information about carbohydrate intake to optimize insulin delivery after eating.
Configure Quick Bolus
The default for the Quick Bolus function is off. Quick Bolus can be set to either units of insulin or grams of carbohydrate. The increment options are 0.5, 1.0, 2.0, and 5.0 units; or 2, 5, 10 and 15 grams.
NOTE Control-IQ Technology and Carbs: It is required to use grams of carbohydrate in a bolus delivery whenever eating and using Control-IQ technology. The model used to make predictions and insulin dosing is more accurate when informed when you eat.
1. From the Home screen, tap OPTIONS.
2. Tap My Pump.
3. Tap Personal Profiles.
4. Tap Pump Settings.
5. Tap Quick Bolus.
6. Tap Increment Type.
7. Tap units of insulin or grams of carbohydrate to select. Tap
8. Tap Increment Amount.
9. Select the preferred increment amount.
NOTE Incrementing Amount: The increment amount is added with each press of the Screen On/Quick Bolus button when delivering a quick bolus.
10. Review entered values and tap .
11. Confirm Settings.
Tap if entered data is correct.
Tap to go back to make changes.
12. Tap the Tandem logo to return to the Home screen.
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Delivering a Quick Bolus
If the Quick Bolus function is turned on, you can deliver a bolus without having to look at the t:slim X2 pump screen. Simply use the Screen On/Quick Bolus button to deliver your bolus. Quick boluses are delivered as standard boluses (there is no glucose value entry or extended bolus).
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.
1. Press and hold the Screen On/Quick Bolus button. The Quick Bolus screen will appear. Listen for two beeps (if sound volume is set to beep) or feel for vibrations (if sound volume is set to vibrate).
2. Press the Screen On/Quick Bolus button for each increment until desired amount is reached. The pump will beep/vibrate for each button press.
3. Wait for the pump to beep/vibrate once for each increment pressed to confirm desired amount.
4. After the pump beeps/vibrates, press and hold the Screen On/Quick Bolus button for several seconds to deliver the bolus.
NOTE Safety Features: If you want to cancel the bolus and return to the Home screen, tap
on the Quick Bolus screen.
If more than 10 seconds have passed with no input, the bolus is canceled and never delivered.
You cannot exceed the Max Bolus setting defined in your active Pump Settings when using the Quick Bolus feature. Once you reach the Max Bolus amount, a different tone will sound to notify you (if Quick Bolus is set to vibrate, the pump will stop vibrating in response to additional button presses to notify you). Look at the screen to confirm the bolus amount.
You cannot exceed 20 button presses when using the Quick Bolus feature. Once you reach 20 button presses, a different tone
will sound to notify you (if Quick Bolus is set to vibrate, the pump will stop vibrating in response to additional button presses to notify you). Look at the screen to confirm the bolus amount.
If you hear a different tone at any point during programming or the pump stops vibrating in response to button presses, look at the screen to confirm the bolus amount. If the Quick Bolus screen does not display the correct bolus amount, use the touchscreen to enter bolus information.
The BOLUS INITIATED screen is temporarily displayed.
NOTE Quick Bolus During Insulin Adjustment: If Control-IQ technology is on and has adjusted insulin delivery during a Quick Bolus, the remaining Quick Bolus insulin will be delivered.
7.9 Canceling or Stopping a Bolus
Canceling a Bolus if delivery HAS NOT STARTED:
1. Tap 123 to access the Home screen.
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2. Tap to cancel the bolus.
The BOLUS STOPPED screen is displayed and the units delivered are calculated.
Units requested and delivered are shown.
4. Tap . OK
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 123 to access the Home
screen. 2. Tap to stop delivery. 3. Tap .
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2 t:slim X2 Insulin Pump Features
CHAPTER 8
Start, Stop, or Resume Insulin
CHAPTER 8 · Start, Stop, or Resume Insulin
8.1 Starting Insulin Delivery Insulin delivery starts once you have a Personal Profile configured and activated. See Chapter 5 Insulin Delivery Settings for instructions on creating, configuring, and activating a Personal Profile. 8.2 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 Control-IQ Technology: If you manually stop insulin delivery, you must manually resume insulin delivery. Control-IQ technology does not automatically resume insulin if you decide to stop it manually.
8.3 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 123.
2. Tap .
The RESUMING INSULIN screen is temporarily displayed.
OR 1. From the Home screen, tap
OPTIONS.
2. Tap RESUME INSULIN.
3. Tap . The RESUMING INSULIN screen is temporarily displayed. 8.4 Disconnecting When Using
Control-IQ Technology When you need to disconnect your pump from your body, stop insulin delivery. Stopping insulin delivery tells the system that you are not actively delivering insulin, which also stops Control-IQ technology so that it does not continue to calculate insulin delivery adjustments.
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CHAPTER 9
t:slim X2 Insulin Pump Information and History
CHAPTER 9 · t:slim X2 Insulin Pump Information and History
9.1 t:slim X2 Pump Info Your t:slim X2TM pump allows access to information about your pump. In the Pump Info screen you have access to items such as your pump Serial Number, Customer Technical Support contact information, website, and software/hardware versions. 1. From the Home screen, tap
OPTIONS. 2. Tap My Pump. 3. Tap Pump Info. 4. Scroll through the Pump Info using
the Up/Down Arrows. 5. Tap the Tandem logo to return to
the Home screen.
9.2 t:slim X2 Pump History Pump History displays a historical log of pump events. At least 90 days of data can be viewed in History. When the maximum number of events is reached,
the oldest events are removed from the history log and replaced with the most recent events. The following can be viewed in Pump History: Delivery Summary, Total Daily Dose, Bolus, Basal, Load, BG, Alerts and Alarms, Control-IQ, and Complete. Delivery Summary breaks down total insulin delivery by basal and bolus types into units and percentages. It can be viewed by the selected time period of: Today, 7 Day, 14 Day and 30 Day Average. Total Daily Dose breaks down basal and bolus delivery into units and percentages for each individual day. You can scroll through each individual day to see your total insulin delivery. The Bolus, Basal, Load, BG, and Alerts and Alarms are categorized by date. The event details in each report are listed by time. The Complete section includes all information from each section as well as any changes to settings. The letter "D" (D: Alert) before an Alert or Alarm indicates the time it was
declared. The letter "C" (C: Alert) indicates the time it was cleared. Bolus history shows the bolus request, the bolus start time, and the bolus completion time. The Control-IQ history shows the historical log of the Control-IQTM technology status, including when the feature is enabled or disabled, when Basal Rate changes were made, and when Control-IQ technology boluses were delivered. The rate of insulin delivery may change as frequently as every five minutes. 1. From the Home screen, tap
OPTIONS. 2. Tap the Down Arrow. 3. Tap History. 4. Tap Pump History. 5. Tap desired option. 6. Tap the Tandem logo to return to
the Home screen.
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CHAPTER 10
t:slim X2 Insulin Pump Reminders
CHAPTER 10 · t:slim X2 Insulin Pump Reminders
Your pump lets you know important information about the System with Reminders, Alerts, and Alarms. Reminders are displayed to notify you of an option that you have set (for example, a reminder to check your BG after a bolus). Alerts display automatically to notify you about safety conditions that you need to know (for example, an alert that your insulin level is low). Alarms display automatically to let you know of an actual or potential stopping of insulin delivery (for example, an alarm that the insulin cartridge is empty). Pay special attention to Alarms. If multiple Reminders, Alerts, and Alarms happen at the same time, Alarms will be displayed first, Alerts will be displayed second, and Reminders will be displayed third. Each must be confirmed separately until all have been acknowledged. Information in this section will help you learn how to respond to Reminders. Reminders notify you with a single sequence of three notes or a single vibration depending on the volume/vibrate setting in Sound Volume. They repeat every 10 minutes
until acknowledged. Reminders do not escalate.
10.1 Low BG Reminder The Low BG Reminder prompts you to re-test your BG after a low glucose value is read. When turning this reminder on, you need to set a low glucose value that triggers the reminder, as well as how much time should pass before the reminder occurs. The default for this reminder is preset to off. If on, the defaults are Remind Me Below 3.9 mmol/L, and Remind Me After 15 min, but you can set these values from 3.9 to 6.7 mmol/L and 10 to 20 min. 1. From the Home screen, tap
OPTIONS. 2. Tap My Pump. 3. Tap Alerts & Reminders. 4. Tap Pump Reminders. 5. Tap Low BG.
6. Low BG is set to on; to turn off, tap Low BG. a. Tap Remind Me Below and using the on-screen keypad, enter a Low BG value (from 3.9 to 6.7 mmol/L) that you want to trigger the reminder, then tap . b. Tap Remind Me After and using the on-screen keypad, enter the time (from 10 to 20 min), then tap . c. Tap when all changes are complete. d. Tap the Tandem logo to return to the Home screen.
To Respond to the Low BG Reminder To clear the reminder, tap OK and then check your glucose. 10.2 High BG Reminder The High BG Reminder prompts you to re-test your BG after a high glucose
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CHAPTER 10 · t:slim X2 Insulin Pump Reminders
value is read. When you turn this reminder on, you need to set a high glucose value that triggers the reminder, as well as how much time should pass before the reminder occurs. The default for this reminder is preset to off. If on, the defaults are Remind Me Above 11.1 mmol/L, and Remind Me After 120 min, but you can set these values from 8.3 to 16.7 mmol/L and 1 3 hours. 1. From the Home screen, tap
OPTIONS. 2. Tap My Pump. 3. Tap Alerts & Reminders. 4. Tap Pump Reminders. 5. Tap High BG. 6. High BG is set to on; to turn off, tap
High BG. a. Tap Remind Me Above and
using the on-screen keypad, enter a High BG value (from 8.3
to 16.7 mmol/L) that you want to trigger the reminder, then tap
. b. Tap Remind Me After and using
the on-screen keypad, enter the time (from 1 to 3 hours), then tap . c. Tap when all changes are complete. 7. Tap the Tandem logo to return to the Home screen. To Respond to the High BG Reminder To clear the reminder tap OK and then check your glucose. 10.3 After Bolus BG Reminder The After Bolus BG Reminder prompts you to test your BG at a selected time after bolus delivery. When turning this reminder on, you need to set how much time should pass before the reminder occurs. The default is 1 hour and 30 minutes. It can be set from 1 to 3 hours.
1. From the Home screen, tap OPTIONS.
2. Tap My Pump. 3. Tap Alerts & Reminders. 4. Tap Pump Reminders. 5. Tap After Bolus BG. 6. After Bolus BG is set to on; to turn
off, tap After Bolus BG. 7. Tap Remind Me After and using the
on-screen keypad, enter the time (from 1 3 hours) that you want to trigger the reminder, then tap . 8. Tap when all changes are complete. 9. Tap the Tandem logo to return to the Home screen. To Respond to the After Bolus BG Reminder To clear the reminder tap OK and then check BG using your BG meter.
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CHAPTER 10 · t:slim X2 Insulin Pump Reminders
10.4 Missed Meal Bolus Reminder The Missed Meal Bolus Reminder lets you know if a bolus was not delivered during a specified time period. Four separate reminders are available. When programming this reminder you need to select the Days, the Start Time, and End Time for each reminder. 1. From the Home screen, tap
OPTIONS. 2. Tap My Pump. 3. Tap Alerts & Reminders. 4. Tap Pump Reminders. 5. Tap Missed Meal Bolus. 6. On the Missed Meal Bolus screen,
tap which reminder you want to set (Reminder 1 to 4) and do the following: a. Tap Reminder 1 (or 2, 3, 4). b. Reminder 1 is set to on; to turn
off, tap Reminder 1.
c. Tap Selected Days and tap the day(s) you want the reminder to be on, then tap .
d. Tap Start Time, tap Time and using the on-screen keypad enter the start time, then tap .
e. Tap Time of Day to select AM or PM, if applicable, then tap .
f. Tap End Time, tap Time and using the on-screen keypad enter the end time, then tap .
g. Tap Time of Day to select AM or PM, if applicable, then tap .
h. Tap when all changes are complete.
7. Tap the Tandem logo to return to the Home screen.
To Respond to the Missed Meal Bolus Reminder To clear the reminder tap OK and deliver a bolus if necessary.
10.5 Site Reminder
The Site Reminder prompts you to change your infusion set. The default for this reminder is preset to off. If on, the reminder can be set for 1 3 days and at a time of day selected by you. For detailed information on the Site Reminder feature, see Section 6.6 Setting Site Reminder. To Respond to the Site Reminder To clear the reminder tap OK and change your infusion set.
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CHAPTER 11
User Settable Alerts and Alarms
CHAPTER 11 · User Settable Alerts and Alarms
11.1 Low Insulin Alert Your t:slim X2 pump keeps track of how much insulin remains in the cartridge and alerts you when it is low. The default for this alert is preset to 20 units. You can set this alert setting anywhere between 10 and 40 units. When the insulin amount reaches the set value, the Low Insulin Alert beeps/ vibrates and appears on the screen. After the alert is cleared, the low insulin indicator (a single red bar on the insulin level display on the Home screen appears). 1. From the Home screen, tap
OPTIONS. 2. Tap My Pump. 3. Tap Alerts & Reminders. 4. Tap Pump Alerts. 5. Tap Low Insulin. 6. Using the on-screen keypad, enter
the number of units (from 10 to 40 units) that you want the Low Insulin
Alert value to be set to, and tap .
7. Tap when all changes are complete.
To Respond to the Low Insulin Alert To clear the alert, tap . OK
11.2 Auto-Off Alarm Your pump can stop insulin delivery and alert you (or whoever is with you) if there has been no interaction with the pump within a specified period of time. The default for this alarm is preset to 12 hours. You can set it anywhere between 5 and 24 hours, or off. This alarm notifies you that there has been
no interaction with the pump in the specified number of hours and the pump will shut down after 60 seconds. When the number of hours since you have pressed the Screen On/Quick Bolus button and tapped any interactive screen option or delivered a Quick Bolus passes the set value, the Auto-Off Alarm beeps and appears on the screen, and insulin delivery stops. 1. From the Home screen, tap
OPTIONS. 2. Tap My Pump. 3. Tap Alerts & Reminders. 4. Tap Pump Alerts. 5. Tap Auto-Off. 6. Tap Auto-Off. A confirmation
screen will appear. Tap to continue. Tap to go back.
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CHAPTER 11 · User Settable Alerts and Alarms
7. Verify Auto-Off is set to on, then tap Time.
8. Using the on-screen keypad, enter the number of hours (from 5 24 hours) that you want the Auto-Off Alarm to be triggered, and tap .
9. Tap , then tap when all changes are complete.
10. Tap the Tandem logo to return to the Home screen.
To Respond to Auto-Off Warning Tap DO NOT SHUT DOWN.
If you do not clear the warning within the 60-second countdown period, the Auto-Off Alarm occurs, accompanied by an audible alarm. This alarm notifies you that your pump has stopped delivering insulin. Auto-Off Alarm Screen Tap . OK
The warning clears and the pump returns to normal operation.
The Home screen appears, indicating a status of All Deliveries Stopped.
You must resume delivery to continue therapy, see Section 8.3 Resuming Insulin Delivery.
11.3 Max Basal Alert
Your pump allows you to set a limit to the Basal Rate that the pump will not allow you to exceed during a Temp Rate. Once the Basal Limit in the Pump Settings has been set up (Section 4.11 Basal Limit), you will receive an alert if the following scenarios occur. 1. A Temp Rate was requested that
exceeds the Basal Limit. 2. A Temp Rate is in progress, and a
new Personal Profile time segment has begun, causing the Temp Rate to exceed the Basal Limit. To Respond to Max Basal Alert Tap OK to accept the reduced Temp Rate. The reduced Temp Rate value is
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CHAPTER 11 · User Settable Alerts and Alarms the same Basal Limit value that was set up in Personal Profiles.
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CHAPTER 12
t:slim X2 Insulin Pump Alerts
CHAPTER 12 · t:slim X2 Insulin Pump Alerts
Your pump lets you know important information about the System with Reminders, Alerts, and Alarms. Reminders are displayed to notify you of an option that you have set (for example, a reminder to check you BG after a bolus). Alerts display automatically to notify you about safety conditions that you need to know (for example, an alert that your insulin level is low). Alarms display automatically to let you know of an actual or potential stopping of insulin delivery (for example, an alarm that the insulin cartridge is empty). Pay special attention to Alarms. If multiple Reminders, Alerts, and Alarms happen at the same time, Alarms will be displayed first, Alerts will be displayed second, and Reminders will be displayed third. Each must be confirmed separately until all have been confirmed. Information in this section will help you learn how to respond to Alerts. Alerts notify you with 2 sequences of 3 notes or 2 vibrations depending on the volume/vibrate setting selected in Sound Volume. They repeat regularly
until acknowledged. Alerts do not escalate.
NOTE CGM Alerts: There is an additional list of alerts and errors related to CGM use in Chapter 25 CGM Alerts and Errors.
NOTE Control-IQ Technology Alerts: There is an additional list of alerts related to Control-IQ technology use in Chapter 31 Control-IQ Technology Alerts.
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12.1 Low Insulin Alert
Screen What will I see on the screen?
CHAPTER 12 · t:slim X2 Insulin Pump Alerts
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
5 units or less of insulin remain in the cartridge.
2 sequences of 3 notes or 2 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 5 minutes until acknowledged.
How should I respond?
Tap OK . Change your cartridge as soon as possible to avoid the EMPTY CARTRIDGE ALARM and running out of insulin.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
12.2 Low Power Alerts Low Power Alert 1
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
Less than 25% of battery power remains.
2 sequences of 3 notes or 2 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 5 minutes until acknowledged.
How should I respond?
Tap OK . Charge your pump as soon as possible to avoid the second LOW POWER ALERT.
NOTE
Low Battery Display: Once the LOW POWER ALERT occurs, the low-power indicator (a single red bar on the battery level display on the Home and Lock screens) appears.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
Low Power Alert 2
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me? How should I respond?
Less than 5% of battery power remains. Insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop.
2 sequences of 3 notes or 2 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 5 minutes until acknowledged.
Tap OK . Charge your pump immediately to avoid the LOW POWER ALARM and pump power off.
NOTE
Low Battery Display: Once the LOW POWER ALERT occurs, the low-power indicator (a single red bar on the battery level display on the Home and Lock screens) appears.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
12.3 Incomplete Bolus Alert
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
You started a bolus request but did not complete the request within 90 seconds.
2 sequences of 3 notes or 2 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 5 minutes until acknowledged.
How should I respond?
Tap OK . The Bolus screen will appear. Continue with your bolus request.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
12.4 Incomplete Temp Rate Alert
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
How should I respond?
You started to set up a Temp Rate but did not complete the request within 90 seconds.
2 sequences of 3 notes or 2 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 5 minutes until acknowledged.
1. Tap OK . The Temp Rate screen will appear. Continue setting up your Temp Rate.
2. Tap if you do not want to continue setting up your Temp Rate.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
12.5 Incomplete Load Sequence Alerts Incomplete Cartridge Change Alert
Screen What will I see on the screen?
Explanation What does it mean?
How will the System notify me? Will the System re-notify me?
You selected Change Cartridge from the Load menu but did not complete the process within 3 minutes.
2 sequences of 3 notes or 2 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 5 minutes until acknowledged.
How should I respond?
Tap OK . Complete the cartridge change process.
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Incomplete Fill Tubing Alert
Screen What will I see on the Screen?
CHAPTER 12 · t:slim X2 Insulin Pump Alerts
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
You selected Fill Tubing from the Load menu but did not complete the process within 3 minutes.
2 sequences of 3 notes or 2 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 5 minutes until acknowledged.
How should I respond?
Tap OK . Complete the fill tubing process.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
Incomplete Fill Cannula Alert
Screen What will I see on the Screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
You selected Fill Cannula from the Load menu but did not complete the process within 3 minutes.
2 sequences of 3 notes or 2 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 5 minutes until acknowledged.
How should I respond?
Tap OK . Complete the cannula fill process.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
12.6 Incomplete Setting Alert
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me? How should I respond?
You started to set up a new Personal Profile or Control-IQ Technology setting but did not save or complete the programming within 5 minutes.
2 sequences of 3 notes or 2 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 5 minutes until acknowledged.
Tap OK . Complete programming the Personal Profile or Control-IQ Technology setting.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
12.7 Basal Rate Required Alert
Screen What will I see on the screen?
Explanation
What does it mean? How will the System notify me? Will the System re-notify me?
You did not enter a Basal Rate in a time segment in Personal Profiles. A Basal Rate must be entered in each time segment (rate can be 0 u/hr).
Prompt screen only.
No, a Basal Rate must be entered to save the time segment.
How should I respond?
Tap OK . Enter a Basal Rate in the time segment.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
12.8 Max Hourly Bolus Alert
Screen What will I see on the screen?
Explanation
What does it mean? How will the System notify me? Will the System re-notify me?
In the previous 60 minutes, you requested total bolus delivery that is more than 1.5 times your Max Bolus setting.
Prompt screen only.
No, you must tap or to deliver the bolus.
How should I respond?
· Tap to return to the Bolus screen and adjust the bolus delivery amount.
· Tap to confirm the bolus.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
12.9 Max Bolus Alerts Max Bolus Alert 1
Screen What will I see on the screen?
Explanation
What does it mean? How will the System notify me? Will the System re-notify me?
You requested a bolus larger than the Max Bolus setting in your active Personal Profile.
Prompt screen only.
No, you must tap or to deliver the bolus.
How should I respond?
· Tap to return to the Bolus screen and adjust the bolus delivery amount.
· Tap to deliver the amount of your Max Bolus setting.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
Max Bolus Alert 2 The following applies only if Control-IQTM technology is turned off, Carbs are turned on in your active Personal Profile, and your Max Bolus amount is set to 25 units.
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
How should I respond?
Your Max Bolus is set to 25 units and you requested a bolus larger than 25 units.
Prompt screen only.
No, you must tap or the bolus request.
to deliver the remaining amount of
Before responding to this Alert, always consider whether your bolus insulin needs have changed since you requested the original bolus.
· Tap to deliver the remaining amount of the bolus request. A confirmation screen will appear.
· Tap if you do not want to deliver the remaining amount of the bolus request.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
12.10 Max Basal Alert
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me? How should I respond?
An active Temp Rate exceeds your Basal Limit setting due to a new timed segment activation within Personal Profiles. This alert will only display once your timed segment changes.
2 sequences of 3 notes or 2 vibrations, depending on the volume/vibration setting selected in Sound Volume.
No, you must tap OK to move forward.
Tap OK to accept the new Temp Rate. The reduced Temp Rate value is the same Basal Limit value that was set up in Pump Settings.
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12.11 Min Basal Alerts Min Basal Alert 1
Screen What will I see on the screen?
CHAPTER 12 · t:slim X2 Insulin Pump Alerts
Explanation
What does it mean? How will the System notify me? Will the System re-notify me?
When entering a Basal Rate or requesting a Temp Rate, you requested a Basal Rate less than half of the lowest Basal Rate defined in your Personal Profile.
Prompt screen only.
No, you must tap or to move forward.
How should I respond?
· Tap · Tap
to return to the previous screen to adjust the amount. to dismiss the alert and continue with the request.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
Min Basal Alert 2
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
An active Temp Rate dropped below half of your lowest basal setting defined in your Personal Profile.
2 sequences of 3 notes or 2 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 5 minutes until acknowledged.
How should I respond?
Tap OK and review your current Temp Rate in the Activity menu.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
12.12 Connection Error Alert
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
You connected pump to a computer with the USB cable to charge it and a connection could not be made.
2 sequences of 3 notes or 2 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 5 minutes until acknowledged.
How should I respond?
Tap OK . Disconnect and reconnect the USB cable to try again.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
12.13 Pairing Code Timeout
Screen What will I see on the screen?
Explanation What does it mean?
How will the System notify me? Will the System re-notify me?
You attempted to connect a mobile device to the pump, but the pairing process took too long (more than 5 minutes) and was unsuccessful.
2 sequences of 3 notes or 2 vibrations depending on the volume/vibrate setting selected in Sound Volume.
No.
How should I respond?
Tap OK . Try to pair the mobile device again.
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12.14 Power Source Alert
Screen What will I see on the screen?
CHAPTER 12 · t:slim X2 Insulin Pump Alerts
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
You connected your pump to a power source that does not have enough power to charge the pump.
2 sequences of 3 notes or 2 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 5 minutes until acknowledged.
How should I respond?
Tap OK . Connect the pump to a different power source to charge.
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CHAPTER 12 · t:slim X2 Insulin Pump Alerts
12.15 Data Error Alert
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
How should I respond?
Your pump encountered a condition that could potentially result in a loss of data.
2 sequences of 3 notes or 2 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 5 minutes until acknowledged.
Tap OK . Check your Personal Profiles and pump settings to verify that they are accurate. See Section 5.4 Editing or Reviewing an Existing Profile.
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CHAPTER 13
t:slim X2 Insulin Pump Alarms
CHAPTER 13 · t:slim X2 Insulin Pump Alarms
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.
Your t:slim X2TM pump lets you know important information about the System with Reminders, Alerts, and Alarms. Reminders are displayed to notify you of an option that you have set (for example, a reminder to check you BG after a bolus). Alerts display automatically to notify you about safety conditions that you need to know (for example, an alert that your insulin level is low). Alarms display automatically to let you know of an actual or potential stopping of insulin delivery (for example, an alarm that the insulin cartridge is empty). Pay special attention to Alarms.
If multiple Reminders, Alerts, and Alarms happen at the same time, Alarms will be displayed first, Alerts will be displayed second, and Reminders will be displayed third. Each must be confirmed separately until all have been confirmed.
Information in this section will help you learn how to respond to Alarms.
Alarms notify you with 3 sequences of 3 notes or 3 vibrations depending on the volume/vibrate setting selected in Sound Volume. If not acknowledged, alarms escalate to highest volume and vibe. Alarms repeat regularly until the condition that caused the alarm is corrected.
NOTE CGM Alerts: There is a list of alerts and errors related to CGM use in Chapter 25 CGM Alerts and Errors.
NOTE Control-IQ Technology Alerts: There is a list of alerts related to Control-IQ technology use in Chapter 31 Control-IQ Technology Alerts.
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CHAPTER 13 · t:slim X2 Insulin Pump Alarms
13.1 Resume Pump Alarm
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me?
Will the System re-notify me?
How should I respond?
You selected STOP INSULIN in the Options menu and insulin delivery has been stopped for more than 15 minutes.
3 sequences of 3 notes or 3 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes.
· If not acknowledged by tapping OK , the System will re-notify you every 3 minutes at highest volume and vibrate.
· If acknowledged by tapping OK , the System will re-notify you in 15 minutes.
To resume insulin, from the Options menu, tap RESUME INSULIN and tap to confirm.
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CHAPTER 13 · t:slim X2 Insulin Pump Alarms
13.2 Low Power Alarm
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
How should I respond?
Your pump detected a power level of 1% or less remaining and all deliveries have stopped.
3 sequences of 3 notes or 3 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 3 minutes until no power remains and the pump shuts down.
Tap OK . Charge your pump immediately to resume insulin delivery.
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CHAPTER 13 · t:slim X2 Insulin Pump Alarms
13.3 Empty Cartridge Alarm
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
How should I respond?
Your pump detected that the cartridge is empty and all deliveries have stopped.
3 sequences of 3 notes or 3 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 3 minutes until you change the cartridge.
Tap OK . Change your cartridge immediately by tapping OPTIONS from the Home screen, then Load and follow the instructions in Section 6.3 Filling and Loading a t:slim Cartridge.
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CHAPTER 13 · t:slim X2 Insulin Pump Alarms
13.4 Cartridge Error Alarm
Screen What will I see on the screen?
Explanation What does it mean?
How will the System notify me? Will the System re-notify me? How should I respond?
Your pump detected that the cartridge could not be used and all deliveries have stopped. This can be caused by cartridge defect, not following the proper procedure to load the cartridge, or over filling the cartridge (with more than 300 units of insulin).
3 sequences of 3 notes or 3 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 3 minutes until you change the cartridge.
Tap OK . Change your cartridge immediately by tapping OPTIONS from the Home screen, then Load and follow the instructions in Section 6.3 Filling and Loading a t:slim Cartridge.
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CHAPTER 13 · t:slim X2 Insulin Pump Alarms
13.5 Cartridge Removal Alarm
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
How should I respond?
Your pump detected that the cartridge has been removed and all deliveries have stopped.
3 sequences of 3 notes or 3 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 3 minutes until you reconnect the current cartridge or change the cartridge.
Tap CONNECT to reattach the current cartridge. Tap INSTALL to load a new cartridge.
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13.6 Temperature Alarm
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me? How should I respond?
Your pump detected an internal temperature below 2ºC (35ºF) or above 45ºC (113ºF) or a battery temperature below 2ºC (35ºF) or above 52ºC (125ºF) and all deliveries have stopped.
3 sequences of 3 notes or 3 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 3 minutes until a temperature in the operating range is detected.
Tap OK . Remove the pump from the extreme temperature and then resume insulin delivery.
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13.7 Occlusion Alarms Occlusion Alarm 1
Screen What will I see on the screen?
Explanation What does it mean?
How will the System notify me? Will the System re-notify me? How should I respond?
Your pump detected that insulin delivery is blocked and all deliveries have stopped. See Section 33.4 t:slim X2 Pump Performance Characteristics for more information on how long it can take the system to detect an occlusion.
3 sequences of 3 notes or 3 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 3 minutes until you resume insulin delivery.
Tap OK . Check the cartridge, tubing, and infusion site for any sign of damage or blockage and correct the condition. To resume insulin, from the Options menu, tap RESUME INSULIN and tap to confirm.
NOTE
Occlusion During Bolus: If the occlusion alarm occurs during bolus delivery, after tapping OK , a screen will appear letting you know how much of the requested bolus was delivered before the occlusion alarm. When the occlusion is cleared, some or all of the previously requested insulin volume may be delivered. Test your BG at the time of alarm and follow your healthcare provider's instructions for managing potential or confirmed occlusions.
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Occlusion Alarm 2
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
How should I respond?
Your pump detected a second occlusion alarm shortly after the first occlusion alarm and all deliveries have stopped.
3 sequences of 3 notes or 3 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 3 minutes until you resume insulin delivery.
Tap OK . Change the cartridge, tubing, and infusion site to ensure proper delivery of insulin. Resume insulin after changing the cartridge, tubing, and infusion site.
NOTE
Occlusion During Bolus: If the second occlusion alarm occurs during bolus delivery, after tapping OK , a screen will appear letting you know that the amount of bolus delivery could not be determined and was not added to your IOB.
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13.8 Screen On/Quick Bolus Button Alarm
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
The Screen On/Quick Bolus button (on the top of your pump) is stuck or not functioning properly and all deliveries have stopped.
3 sequences of 3 notes or 3 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 3 minutes until the condition is corrected.
How should I respond?
Tap OK . Contact Customer Technical Support.
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13.9 Altitude Alarm
Screen What will I see on the screen?
Explanation What does it mean?
How will the System notify me? Will the System re-notify me? How should I respond?
Your pump detected a pressure difference between inside the cartridge and the surrounding air within the validated operating range of -396 meters to 3,048 meters (-1,300 feet to 10,000 feet) and all deliveries have stopped.
3 sequences of 3 notes or 3 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 3 minutes until the condition is corrected.
Tap OK . Remove the cartridge from the pump (this will allow the cartridge to fully vent) and then reconnect the cartridge.
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13.10 Reset Alarm
Screen What will I see on the screen?
CHAPTER 13 · t:slim X2 Insulin Pump Alarms
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
Your pump detected that one if its micro-processors experienced a reset and all deliveries have been stopped.
3 sequences of 3 notes or 3 vibrations depending on the volume/vibrate setting selected in Sound Volume.
Yes, every 3 minutes until you tap . OK
How should I respond?
Tap OK . Contact Customer Technical Support.
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CHAPTER 14
t:slim X2 Insulin Pump Malfunction
CHAPTER 14 · t:slim X2 Insulin Pump Malfunction
14.1 Malfunction If your pump detects a system error, the MALFUNCTION screen appears and all deliveries are stopped. Contact Customer Technical Support. Malfunctions notify you with 3 sequences of 3 notes at highest volume and 3 vibrations. They repeat at regular intervals until acknowledged by tapping SILENCE ALARM.
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 and low BG levels as recommended by your healthcare provider.
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Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
How should I respond?
Your pump detected a system error and all deliveries have been stopped.
3 sequences of 3 notes at highest volume and 3 vibrations.
Yes, every 3 minutes until you acknowledge the malfunction by tapping SILENCE ALARM.
· Write down the Malfunction Code number that appears on the screen.
· Tap SILENCE ALARM. The MALFUNCTION screen will remain on the pump even though the alarm is silenced.
· Contact Customer Technical Support and provide the Malfunction Code number that you wrote down.
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CHAPTER 15
Taking Care of Your Pump
CHAPTER 15 · Taking Care of Your Pump
15.1 Overview
This section provides information on caring for and maintaining your pump. Cleaning Your Pump When cleaning your pump, use a damp lint-free cloth. Do not use household or industrial cleaners, solvents, bleach, scouring pads, chemicals, or sharp instruments. Never submerge the pump in water or use any other liquid to clean it. Do not place the pump in the dishwasher or use hot water to clean it. If needed, use only a very mild detergent, such as a bit of liquid soap with warm water. When drying your pump, use a soft towel; never place your pump in a microwave oven or baking oven to dry it. Wipe the outside of the transmitter with a damp lint-free cloth or isopropyl alcohol wipe between uses. Maintaining Your Pump The pump requires no preventative maintenance.
Inspecting Your Pump for Damage
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.
If you drop your pump or it has been hit against something hard, ensure that it is still working properly. Check that the touchscreen is working and clear, and that the cartridge and infusion set are properly in place. Check for leaks around the cartridge and at the tubing connector to the infusion set. Immediately contact Customer Technical Support if you notice any cracks, chips, or other damage.
Storing Your Pump
If you need to stop using your pump for a long period of time, you can place the
pump in storage mode. To place the pump in storage mode, connect the pump to a power source and then press and hold down the Screen On/Quick Bolus button for 30 seconds. The pump will beep 3 times before going into storage mode. Disconnect the pump from the power source. Keep the pump protected when not in use. Store at temperatures between -20°C (-4°F) and 60°C (140°F) and at relative humidity levels between 20% and 90%. To bring the pump out of storage mode, simply connect the pump to a power source. Disposing of System Components Consult your healthcare provider for instructions for disposal of devices containing electronic waste such as your pump, and for instructions for disposal of potentially biohazardous materials such as used cartridges, needles, syringes, infusion sets, and sensors.
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CHAPTER 16
Lifestyles Issues and Travel
CHAPTER 16 · Lifestyles Issues and Travel
16.1 Overview
While the convenience and flexibility of the pump allow most users to participate in a variety of activities, some lifestyle changes may be required. Additionally, your insulin needs may change in response to lifestyle changes.
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.
Physical Activity
The pump can be worn during most forms of exercise, such as running, cycling, hiking, and resistance training. During exercise, the pump can be worn in the provided case, your pocket, or other third-party "sport cases."
For activities where contact is a concern, such as baseball, hockey, martial arts, or basketball, you can disconnect from your pump for short
periods of time. If planning to disconnect from your pump, discuss a plan with your healthcare provider to compensate for any basal insulin delivery you miss while disconnected, and be sure to continue to check your BG levels. Even if you disconnect your tubing from your infusion site, the pump should continue to receive data from the transmitter as long as it is within the 6 meter (20 foot) range without obstruction.
Aquatic Activities
PRECAUTION AVOID submerging your pump in fluid beyond a depth of 0.91 meters (3 feet) 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.
Your pump is watertight to a depth of 0.91 meters (3 feet) for up to 30 minutes (IPX7 rating), but it is not waterproof. Your pump should not be worn while swimming, scuba diving, surfing, or during any other activities that could submerge the pump for an
extended period of time. Your pump should not be worn in hot tubs or Jacuzzis.
Extreme Altitudes
Some activities, such as hiking, skiing or snowboarding, could expose your pump to extreme altitudes. The pump has been tested at altitudes up to 3,048 meters (10,000 feet) at standard operating temperatures.
Extreme Temperatures
You should avoid activities which could expose your pump to temperatures below 5ºC (41ºF) or above 37ºC (98.6ºF), as insulin can freeze at low temperatures or degrade at high temperatures.
Other Activities Which Require Removing Your Pump
PRECAUTION If you remove your pump for a period of time, up to 30 minutes or longer, it is recommended that you turn off Control-IQTM technology to potentially save insulin. The feature will continue to operate while the pump is removed and will
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continue to dose insulin if transmitted glucose values rise.
There are other activities, such as bathing and intimacy, when it may be more convenient for you to remove your pump. It is safe to do so for short periods of time. If planning to disconnect from your pump, discuss a plan with your healthcare provider for compensating for any basal delivery you miss while disconnected, and be sure to check your BG levels frequently. Missing basal delivery could cause your BG to rise. Travel The flexibility afforded by an insulin pump can simplify some aspects of travel, but it still requires planning. Be sure to order your pump supplies before your trip so that you have enough supplies with you while you're away from home. In addition to pump supplies, you should also always bring the following items: · The items listed in the Emergency
Kit described in Section 1.9 Emergency Kit.
· A prescription for both rapid-acting and long-acting insulin of the type recommended by your healthcare provider in case you need to take insulin by injection.
· A letter from your healthcare provider explaining the medical need for your insulin pump and other supplies.
Traveling by Air
PRECAUTION DO NOT expose your pump to X-ray screening used for carry-on and checked luggage. Newer full body scanners used in airport security screening are also a form of X-ray and your pump should not be exposed to them. Notify the security agent that your pump cannot be exposed to X-ray machines and request an alternate means of screening.
Your pump has been designed to withstand common electromagnetic interference including airport metal detectors.
The pump is safe for use on commercial airlines. The pump is a Medical Portable Electronic Device (M-PED). The system complies with
radiated emissions requirements defined in RTCA/DO-160G, Section 21, Category M. Any M-PED which meet the requirements of this standard in all modes of operation may be used on board aircraft without the need for further testing by the operator. Pack your pump supplies in your carry-on luggage. DO NOT pack your supplies in checked luggage as it could get delayed or lost. If traveling, contact Customer Technical Support prior to your trip to obtain a travel loaner pump in case your pump malfunctions outside of Tandem's replacement area.
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CHAPTER 17
Important CGM Safety Information
CHAPTER 17 · Important CGM Safety Information
The following includes important safety information related to your CGM and its components. The information presented in this chapter does not represent all warnings and precautions related to the CGM. Visit the CGM manufacturer's website for applicable user guides that also present warnings and precautions.
17.1 CGM Warnings
Using Dexcom G6 with Your t:slim X2TM Insulin Pump
WARNING DO NOT ignore symptoms of high and low glucose. If your sensor glucose alerts and readings do not match your symptoms, measure your BG with a BG meter even if your sensor is not reading in the high or low range.
WARNING DO NOT ignore sensor wire fractures. Sensors may fracture on rare occasions. If a sensor wire breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation (redness, swelling, or pain) at the insertion site. If you experience a
broken sensor wire, please report this to Customer Technical Support.
WARNING DO NOT use Dexcom G6 CGM in pregnant women or persons on dialysis. The System is not approved for use in pregnant women or persons on dialysis and has not been evaluated in these populations. Sensor glucose readings may be inaccurate in these populations and could result in you missing severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
WARNING DO NOT use Dexcom G6 CGM in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect the performance of the System. Sensor glucose readings may be inaccurate in critically ill patients, and solely relying on the sensor glucose alerts and readings for treatment decisions could result in you missing severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
WARNING DO NOT insert the sensor in sites other than the abdomen (belly) or upper buttocks (for ages 6 17 only). Other sites have not been studied and are not approved. Use in other sites might cause
sensor glucose readings to be inaccurate and could result in you missing severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
WARNING DO NOT expect CGM alerts until after the 2-hour startup. You will NOT get any sensor glucose readings or alerts until after the 2-hour startup ends. During this time you might miss severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
WARNING DO NOT use your transmitter if it is damaged/cracked. This could create an electrical safety hazard or malfunction, which might cause electrical shocks.
WARNING STORE the Dexcom G6 CGM sensor at temperatures between 2.2°C (36°F) to 30°C (86°F) for the length of the sensor's shelf life. You may store the sensor in the refrigerator if it is within this temperature range. The sensor should not be stored in a freezer. Storing the sensor improperly might cause the sensor glucose readings to be inaccurate, and you might miss severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
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WARNING DO NOT allow young children to hold the sensor, transmitter or transmitter kit box without adult supervision. The sensor and transmitter include small parts that may pose a choking hazard.
17.2 CGM Precautions
Using Dexcom G6 CGM with Your t:slim X2 Insulin Pump
PRECAUTION DO NOT open the sensor package until you have washed your hands with soap and water, and let them dry. You may contaminate the insertion site and suffer an infection if you have dirty hands while inserting the sensor.
PRECAUTION DO NOT insert the sensor until you have cleaned the skin with a topical antimicrobial solution, such as isopropyl alcohol, and allowed the skin to dry. Inserting into unclean skin might lead to infection. Do not insert the sensor until the cleaned area is dry so the sensor adhesive will stick better.
PRECAUTION AVOID using the same spot repeatedly for sensor insertion. Rotate your sensor placement sites, and do not use the same site for two sensor sessions in a row. Using the same site might cause scarring or skin irritation.
PRECAUTION AVOID inserting the sensor in areas that are likely to be bumped, pushed or compressed, or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose. Insertion in those areas might affect accuracy and could result in you missing severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
PRECAUTION AVOID injecting insulin or placing an infusion set within 7.6 cm (3 inches) of the sensor. The insulin might affect sensor accuracy and could result in you missing severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
PRECAUTION DO NOT use the sensor if its sterile package has been damaged or opened. Using an unsterile sensor might cause infection.
PRECAUTION PAY ATTENTION to the trend information on your CGM Home screen, as well as your symptoms, before using CGM values to calculate and deliver a correction bolus. Individual CGM values may not be as accurate as BG meter values.
PRECAUTION To calibrate the Dexcom G6 CGM, ALWAYS enter the exact BG value that your BG meter displays within 5 minutes of a carefully performed BG measurement. Do not enter sensor glucose readings for calibration. Entering incorrect BG values, BG values obtained more than 5 minutes before entry, or sensor glucose readings might affect sensor accuracy and could result in you missing severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
PRECAUTION DO NOT calibrate if your BG is changing at a significant rate, typically more than 0.1 mmol/L per minute. Do not calibrate when your receiver screen is showing the rising or falling single arrow or double arrow, which indicates that your BG is rapidly rising or falling. Calibrating during significant rise or fall of BG may affect sensor accuracy and could result in you missing severe
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hypoglycemia (low BG) or hyperglycemia (high BG) events.
PRECAUTION The Dexcom G6 CGM accuracy may be affected when your glucose is changing at a significant rate (i.e., 0.1 to 0.2 mmol/L/min or more than 0.2 mmol/L each minute), such as during exercise or after a meal.
PRECAUTION AVOID separating the transmitter and pump by more than 6 meters (20 feet). The transmission range from the transmitter to the pump is up to 6 meters (20 feet) without obstruction. Wireless communication does not work well through water so the range is reduced if you are in a pool, bathtub, or on a water bed, etc. To ensure communication, it is suggested that you face your pump screen out and away from the body, and wear the pump on the same side of the body that you wear your CGM. Types of obstruction differ and have not been tested. If your transmitter and pump are farther than 6 meters (20 feet) apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter and result in you missing severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
PRECAUTION DO NOT use alternative BG site testing (blood from your palm or forearm, etc.) for calibration. Alternative site BG values may be different than those taken from a fingerstick BG value and may not represent the timeliest BG value. Use a BG value taken only from a fingerstick for calibration. Alternative site BG values might affect sensor accuracy and result in you missing severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
PRECAUTION ENSURE that your transmitter ID is programmed into the pump before you use the System if you receive a warranty replacement pump. The pump cannot communicate with the transmitter unless the transmitter ID is entered. If the pump and transmitter are not communicating, you will not receive sensor glucose readings and you might miss severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
PRECAUTION DO NOT discard your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter battery life.
PRECAUTION
The Dexcom G6 sensor is not compatible with older versions of transmitters or receivers. Do not mix transmitters, receivers, and sensors from different generations.
PRECAUTION
Hydroxyurea is a medication used in the treatment of diseases including cancer and sickle cell anemia. It is known to interfere with glucose readings from the Dexcom sensor. The use of hydroxyurea will result in sensor glucose readings that are higher than actual glucose values. The level of inaccuracy in sensor glucose readings is based on the amount of hydroxyurea in the body. Relying on sensor glucose results while taking hydroxyurea could result in missed hypoglycemia alerts or errors in diabetes management, such as giving a higher dose of insulin than necessary to correct falsely high sensor glucose values. It can also result in errors when reviewing, analyzing and interpreting historical patterns for assessing glucose control. Do not use the Dexcom CGM readings to make diabetes treatment decisions or assess glucose control when taking hydroxyurea.
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17.3 Potential Benefits From Using the t:slim X2 System
· When paired with Dexcom G6 transmitter and sensor, your pump can receive CGM readings every 5 minutes, which are displayed as a trend graph on the CGM Home screen. You can also program your pump to alert you when your CGM readings are above or below a given level, or are rising or falling quickly. Unlike the readings from a standard BG meter, CGM readings allow you to view trends in real time, as well as capture information when you would otherwise be unable to check your blood sugar, such as while you are asleep. This information can be useful for you and your healthcare provider when considering changes to your therapy. In addition, the programmable alerts can help you to spot potential low or high BG sooner than you would using a only a BG meter.
· In some studies, CGM was shown to increase time in the target glucose range. Subjects in these
studies had better diabetes control (lowered A1C values, reduced glycemic variability and time spent in low and high BG ranges)1, 2, 3 which can help reduce diabetes related complications.4, 5 These benefits can be seen especially with using real-time CGM at least six days per week2 and were sustained over time.6 In some cases, patients perceived an increase in their quality of life and peace of mind when using real-time CGM as well as reporting a high satisfaction with CGM.7 1 Garg S, Zisser H, Schwartz S, et al. Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. Diabetes Care. 2006; 29(1):44-50. 2 JDRF CGM Study Group. Continuous glucose monitoring and intensive treatment of type 1 diabetes. NEJM. 2008; 359:1464-76. 3 Battelino T, Phillip M, Bratina N, et al. Effect of continuous glucose monitoring of hypoglycemia in type 1 diabetes. Diabetes Care 2011; 34(4):795-800.
4 The Diabetes Control and Complications Research Group. The effect of intensive treatment of diabetes on the development and progression of long- term complications of insulin-dependent diabetes mellitus. NEJM. 1993; 329:997-1036. 5 Ohkubo Y, Kishikawa H, Araki E, et al. Intensive insulin therapy prevents progression of diabetic microvascular complications in Japanese patients with non-insulin dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract. 1995; 28(2):103-117. 6 JDRF CGM Study Group. Sustained benefit of continuous glucose monitoring on A1c, glucose profiles, and hypoglycemia in adults with type 1 diabetes, Diabetes Care 2009; 32(11):2047-2049. 7 JDRF CGM Study Group. Quality-of-Life measures in children and adults with type 1 diabetes. Diabetes Care 2010; 33(10):2175-2177.
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17.4 Possible Risks From Using the t:slim X2 System
Inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain and skin irritations (readiness, swelling, bruising, itching, scarring, or skin discoloration). There is a remote chance that a sensor wire fragment could remain under your skin if the sensor wire breaks while you are wearing it. If you think a sensor wire has broken under your skin, contact your healthcare provider and call Customer Technical Support. Other risks associated with CGM use include the following: · You will not get sensor glucose
alerts when the alert function is turned off, your transmitter and pump are out of range, or when your pump is not showing sensor glucose readings. You might not notice alerts if you are unable to hear them or feel the vibration. · There are a number of risks as a result of the fact that the Dexcom
G6 CGM takes readings from fluid below the skin (interstitial fluid) instead of blood. There are differences in how glucose is measured in the blood compared to how it is measured in interstitial fluid, and glucose is absorbed into the interstitial fluid slower than it is absorbed into the blood, which can cause CGM readings to lag behind readings from a BG meter.
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CHAPTER 18
Getting to Know Your CGM System
CHAPTER 18 · Getting to Know Your CGM System
18.1 CGM Terminology
Alternate Site BG Testing Alternate site BG testing is when you take a BG value on your BG meter using a blood sample from an area on your body other than your fingertip. Do not use alternate site testing to calibrate your sensor. Applicator The applicator is a disposable piece that comes attached to the sensor pod and inserts the sensor under the skin. There is a needle inside the applicator that is removed after you insert the sensor. Calibration Calibration is when you enter BG values from a BG meter into the System. Calibrations may be needed for your System to show continuous glucose readings and trend information. CGM Continuous glucose monitoring.
Glucose Data Gaps Glucose data gaps occur when your System is unable to provide a sensor glucose reading. Glucose Trends Glucose trends let you see the pattern of your glucose levels. The trend graph shows where your glucose levels have been during the time shown on the screen and where your glucose levels are now. HypoRepeat HypoRepeat is an optional alert setting that keeps repeating the fixed low alert every 5 seconds until your sensor glucose value rises above 3.1 mmol/L or you confirm it. This alert can be helpful if you want extra awareness for severe lows. mmol/L Millimoles per liter. The standard unit of measure for sensor glucose readings. Receiver When the Dexcom G6 CGM is used with the pump to display CGM readings, the insulin pump replaces the receiver for the therapeutic CGM. A smartphone with the Dexcom app may
be used in addition to the pump to receive sensor readings. Rise and Fall (Rate of Change) Alerts Rise and fall alerts occur based on how much and how fast your glucose levels rise or fall. RF RF is the abbreviation for radio frequency. RF transmission is used to send glucose information from the transmitter to the pump. Sensor The sensor is the part that of the CGM includes an applicator and wire. The applicator inserts the wire under your skin, and the wire measures glucose levels in your tissue fluid. Sensor Pod The sensor pod is the small plastic base of the sensor attached to your skin that holds the transmitter in place. Startup Period The startup period is the 2-hour period after you tell the System you inserted a new sensor. Sensor glucose readings are not provided during this time.
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System Reading A System reading is a sensor glucose reading shown on your pump. This reading is in mmol/L units and is updated every 5 minutes. Transmitter The transmitter is the part of the CGM that snaps into the sensor pod and wirelessly sends glucose information to your pump. Transmitter ID The transmitter ID is a series of numbers and/or letters that you enter into your pump to let it connect and communicate with the transmitter. Trend (Rate of Change) Arrows Trend arrows show how fast your glucose levels are changing. There are seven different arrows that show when your glucose direction and speed change.
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18.2 Explanation of CGM Pump Icons
The following CGM icons may appear on your pump screen: CGM Icon Definitions
Symbol Meaning
mmol/L
Unknown sensor reading.
CGM sensor session is active, but the transmitter and pump are out of range.
The CGM sensor has failed.
The CGM sensor session has ended.
Wait 15 minutes calibration error.
Startup calibration is required (2 BG values).
Additional startup calibration is required.
CGM calibration is required.
Symbol Meaning
Transmitter error. 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. Sensor startup 030 minutes.
Sensor startup 3160 minutes.
Sensor startup 6190 minutes.
Sensor startup 91119 minutes.
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18.3 CGM Lock Screen The CGM Lock screen appears anytime you turn on the screen and you are using your pump with a CGM. 1. Time and Date Display: Displays
the current time and date. 2. Antenna: Indicates communication
status between pump and transmitter. 3. Battery Level: Displays the level of battery power remaining. When connected for charging, the charging icon (lightning bolt) will display. 4. High Glucose Alert Setting. 5. Glucose Target Range. 6. Low Glucose Alert Setting. 7. Plot of Most Recent Sensor Glucose Readings. 8. 123: Unlocks pump screen.
9. Active Bolus Icon: Indicates a bolus is being delivered.
10. Status: Displays current system settings and insulin delivery status.
11. Insulin Level: Displays the current amount of insulin in the cartridge.
12. Most Recent 5-Minute Glucose Reading.
13. Trend Arrow: Indicates direction and rate of change.
14. Trend Graph Time (HRS): 1, 3, 6, 12 and 24 hour views available.
15. Insulin On Board (IOB): Amount and time remaining of any active insulin on board.
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18.4 CGM Home Screen 1. Time and Date Display: Displays
the current time and date. 2. Antenna: Indicates communication
status between pump and transmitter. 3. Battery Level: Displays the level of battery power remaining. When connected for charging, the charging icon (lightning bolt) will display. 4. High Glucose Alert Setting. 5. Glucose Target Range. 6. Low Glucose Alert Setting. 7. Plot of Most Recent Sensor Glucose Readings. 8. Options: Stop/Resume insulin delivery, manage pump and CGM settings, start/stop activities, load a cartridge, and view history. 9. Bolus: Program and deliver a bolus.
10. Status: Displays current system settings and insulin delivery status.
11. Insulin Level: Displays the current amount of insulin in the cartridge.
12. Most Recent 5-Minute Glucose Reading.
13. Trend Arrow: Indicates direction and rate of change.
14. Trend Graph Time (HRS): 1, 3, 6, 12 and 24 hour views available.
15. Insulin On Board (IOB): Amount and time remaining of any active insulin on board.
To view CGM information on the full screen: From the CGM Home screen tap anywhere on the CGM trend graph. Tap the "minimize" icon to return to the CGM Home screen.
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CHAPTER 18 · Getting to Know Your CGM System 18.5 My CGM Screen 1. Start Sensor: Starts a CGM
session. If sensor is active, STOP SENSOR will be displayed. 2. Calibrate CGM: Enter a calibration BG value. Only active when sensor session is active. 3. CGM Alerts: Customize CGM Alerts. 4. Transmitter ID: Enter the transmitter ID. 5. CGM Info: View the CGM information.
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CHAPTER 18 · Getting to Know Your CGM System
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CHAPTER 19
CGM Overview
CHAPTER 19 · CGM Overview
19.1 CGM System Overview
This section of the user guide covers instructions for using a CGM with your t:slim X2 pump. Use of a CGM is optional, but in order to use Control-IQ technology, CGM is required. When used, CGM allows readings from your sensor to be displayed on your pump screen. To make treatment decisions during a new sensor startup period, you will also need a commercially available BG meter to use with your System.
As an example, a compatible CGM is the Dexcom G6 CGM System, which consists of a sensor, transmitter, and a receiver.
NOTE Device Connections: The Dexcom G6 CGM only allows pairing with one medical device at a time (either the t:slim X2TM pump or the Dexcom receiver), but you can still use the Dexcom G6 CGM app and your pump simultaneously using the same transmitter ID.
The Dexcom G6 sensor is a disposable device that is inserted under the skin to continuously monitor glucose levels.
The Dexcom G6 transmitter connects to the sensor using Bluetooth wireless technology communication and sends readings to the pump display every 5 minutes. The pump display shows sensor glucose readings, a trend graph, and the direction and rate of change arrows. For information about inserting a Dexcom G6 CGM sensor, placing a Dexcom G6 transmitter, and Dexcom G6 product specifications, visit the manufacturer's website for applicable user guides and training information. You can also program your pump to alert you when your CGM readings are above or below a given level, or are rising or falling quickly. If CGM readings become 3.1 mmol/L or lower, the CGM Fixed Low Alert will sound. This alert is not customizable. Unlike the readings from a standard BG meter, CGM readings allow you to view trends in real time, as well as capture information when you would otherwise be unable to check your BG, such as while you are asleep. This information can be useful for you and your healthcare provider when considering changes to your therapy. In addition,
the programmable alerts can help you to spot potential low or high glucose sooner than you would using a only a BG meter. 19.2 Receiver (t:slim X2 Insulin
Pump) Overview To review the icons and controls displayed on the Home screen with CGM enabled, see Section 18.4 CGM Home Screen. 19.3 Transmitter Overview This section provides information about CGM devices that have a separate transmitter. The information contained in this section is specific to the Dexcom G6 CGM and is provided as an example. For information about the Dexcom G6 transmitter, visit the manufacturer's website for applicable user guides. Snapping into the transmitter holder, the transmitter wirelessly sends glucose information to your pump. If you have a new transmitter, only open the package when you are ready to use it.
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CHAPTER 19 · CGM Overview
Even if you disconnect your tubing from your infusion site, the pump should continue to receive data from the transmitter as long as it is within the 6 meter (20 foot) range without obstruction. If your transmitter is damaged or cracked, do not use it. Immediately contact Customer Technical Support if you notice any cracks or other damage. Do not use the sensor if its sterile package has been damaged or opened. Transmitter features: · Reusable
Do not discard after sensor session.
Only for you, do not share a transmitter.
· Water resistant · Can transmit data to your pump for
up to 6 meters (20 feet). Range is less if you are in or under water. · Battery lasts approximately 90 days. Pump or smart device
prompts you when battery is running low.
· Serial number is on the back
· M-PED designation
Emission levels meet IATA standards.
May be used on board aircraft without any further testing by the operator.
PRECAUTION DO keep your transmitter and pump within 6 meters (20 feet) with no obstacles (like walls or metal) between them. Otherwise, they may not be able to communicate. If water is between your transmitter and the pump (for example, if you're showering or swimming) keep them closer to each other. The range is reduced because Bluetooth doesn't work as well through water. To ensure communication, it is suggested that you face your pump screen out and away from the body, and wear the pump on the same side of the body that you wear your CGM.
The transmitter battery will last 90 days. Once you see the Low Transmitter Battery Alert, replace the transmitter as soon as possible. Your transmitter battery may drain as quickly as 7 days after this alert occurs.
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CHAPTER 19 · CGM Overview 19.4 Sensor Overview This section provides information about CGM devices that have a separate sensor. The information contained in this section is specific to the Dexcom G6 CGM and is provided as an example. For information about the Dexcom G6 sensor, visit the manufacturer's website for applicable user guides. The Dexcom G6 sensor is water resistant when showering, bathing or swimming if the transmitter is fully snapped in. The sensor has been tested to be water resistant when submerged for up to 2.4 meters (8 feet) and up to 24 hours. Underwater use will affect the ability to communicate with the pump, so the range will be much less than during normal use. Extended contact with water could weaken the adhesive used by your infusion sets and Dexcom CGM sensors and cause them to fall off prematurely.
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CHAPTER 20
CGM Settings
CHAPTER 20 · CGM Settings
20.1 About Bluetooth Bluetooth Low Energy technology is a type of wireless communication used in cell phones and many other devices. Your t:slim X2 pump and a CGM transmitter wirelessly pair together with other devices using Bluetooth wireless technology communication. This allows the pump and transmitter paired devices to communicate securely and only with each other. 20.2 Disconnecting from the
Dexcom Receiver The Dexcom G6 CGM only allows pairing with one medical device at a time. Ensure your transmitter is not connected to the receiver before pairing with the pump by doing the following: Before entering your CGM transmitter ID into the pump, turn off the Dexcom G6 receiver and wait 15 minutes. This allows the Dexcom G6 transmitter to forget the connection currently in place with the Dexcom G6 receiver.
NOTE Turn Receiver Off: It is not enough to Stop the Sensor Session on your Dexcom receiver prior to pairing to the pump. The receiver power must be completely off in order to avoid connection problems.
You may still use a smartphone with the Dexcom G6 CGM app and your pump simultaneously with the same transmitter ID.
20.3 Entering Your Transmitter ID
To activate the Bluetooth wireless technology communication, you need to enter the unique transmitter ID into your pump. Once the transmitter ID has been entered into your pump, the two devices can be paired, allowing your sensor glucose readings to be displayed on your pump.
If you need to replace your transmitter, you will need to enter the new transmitter ID into your pump. If you need to replace your pump, you will need to re-enter the transmitter ID into your pump.
1. Remove the transmitter from its packaging.
2. From the Home screen, tap OPTIONS.
3. Tap the Down Arrow. 4. Tap My CGM. 5. Tap Transmitter ID. 6. Using the on-screen keypad, enter
the unique transmitter ID. The transmitter ID can be found on the bottom of your transmitter. The letters I, O, V, and Z are not used in transmitter IDs and should not be entered. If one of these letters is entered, you will be notified that an invalid ID was entered and prompted to enter a valid ID. 7. Tap . 8. To make sure that the correct transmitter ID is entered, you will be prompted to enter it a second time.
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CHAPTER 20 · CGM Settings
9. Repeat step 6 above, then tap . If the transmitter IDs you entered do not match you will be prompted to start the process again.
Once matching values have been entered, you will be returned to the My CGM screen and the transmitter ID you entered will be highlighted in orange.
20.4 Setting CGM Volume You can set the sound pattern and volume for CGM alerts and prompts to meet your individual needs. Reminders, alerts, and alarms for pump functions are separate from alerts and errors for CGM functions and do not follow the same pattern and volume. To set your sound volume, see Section 4.15 Sound Volume. CGM Volume options: Vibrate You can set your CGM to alert you with vibration rather than sound. The only exception to this is the Fixed Low Alert
at 3.1 mmol/L, which alerts you as a vibration first, followed by beeps 5 minutes later if not confirmed. Soft When you want your alert to be less noticeable. This sets all alerts and alarms to lower volume beeps. Normal The default profile when you receive your pump. This sets all alerts and alarms to higher volume beeps. HypoRepeat Very similar to normal profile, but it continuously repeats the Fixed Low Alert every 5 seconds until your sensor glucose reading rises above 3.1 mmol/L or the alert is confirmed. This can be helpful if you want extra alerts for severe low sensor glucose readings. The CGM volume setting that you choose applies to all CGM alerts, errors, and prompts which have their own unique sound pattern, tone and volume. This allows you to identify each alert and error and its meaning. The Fixed Low Alert at 3.1 mmol/L cannot be turned off or changed.
The Soft, Normal, and HypoRepeat options have the following sequence: · The first alert is vibrate only. · If the alert is not confirmed in 5
minutes, the system vibrates and beeps. · If the alert is not confirmed in 5 more minutes, the system vibrates and beeps louder. This continues at the same volume every 5 minutes until confirmed. · If the alert is confirmed and your sensor glucose readings continue to be at or below 3.1 mmol/L your system repeats the alert sequence in 30 minutes (HypoRepeat option only).
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CHAPTER 20 · CGM Settings
Sound Option Descriptions
CGM Volume
Vibrate
High Alert
2 long vibrates
Low Alert
3 short vibrates
Rise Alert
2 long vibrates
Fall Alert
3 short vibrates
Out of Range Alert
1 long vibrate
Fixed Low Alert
4 short vibrates + 4 medium tone beeps
All Other Alerts
1 long vibrate
Soft
2 long vibrates + 2 low beeps
3 short vibrates + 3 low beeps
2 long vibrates + 2 low beeps
3 short vibrates + 3 low beeps
1 long vibrate + 1 low beep
4 short vibrates + 4 medium tone beeps
1 long vibrate + 1 low beep
Normal
2 long vibrates + 2 medium beeps
3 short vibrates + 3 medium beeps
2 long vibrates + 2 medium beeps
3 short vibrates + 3 medium beeps
1 long vibrate + 1 medium beep
4 short vibrates + 4 medium tone beeps
1 long vibrate + 1 medium beep
HypoRepeat
2 long vibrates + 2 medium beeps
3 short vibrates + 3 medium beeps
2 long vibrates + 2 medium beeps
3 short vibrates + 3 medium beeps
1 long vibrate + 1 medium beep
4 short vibrates + 4 medium tone beeps + pause + repeat sequence
1 long vibrate + 1 medium beep
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To Select Your CGM Volume: 1. From the Home screen, tap
OPTIONS. 2. Tap the Down Arrow. 3. Tap Device Settings. 4. Tap Sound Volume. 5. Tap the Down Arrow. 6. Tap CGM Alerts. 7. Tap Vibrate, Soft, Normal or
HypoRepeat to select. Once a value is selected, the pump
will return to the previous screen. 8. Tap .
20.5 CGM Info CGM Info contains important information about your device. The following an be found in CGM Info: · Firmware Revision
· Hardware Revision · BLE Hardware ID · Software Number You can view this information at any time. 1. From the Home screen, tap
OPTIONS. 2. Tap the Down Arrow. 3. Tap My CGM. 4. Tap the Down Arrow. 5. Tap CGM Info.
CHAPTER 20 · CGM Settings
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CHAPTER 20 · CGM Settings
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CHAPTER 21
Setting CGM Alerts
CHAPTER 21 · Setting CGM Alerts
Setting Your CGM Alerts
You can create personal settings for how and when you want the System to tell you what is happening.
NOTE Setting Separate CGM Alerts: The following applies to setting CGM alerts on the pump. If you are using a CGM app, any alerts that have been set up in the app are not automatically transferred to the pump and must be set up separately.
The High and Low Alerts tell you when your sensor glucose readings are outside your target glucose range.
Rise and Fall (rate of change) Alerts let you know when your glucose levels are changing fast.
The System also has a 3.1 mmol/L Fixed Low Alert that cannot be changed or turned off. This safety feature tells you your glucose level may be dangerously low.
The Out of Range Alert notifies you when the transmitter and pump are not communicating. Keep the transmitter and the pump within 6 meters (20 feet)
of each other without obstruction. When the transmitter and the pump are too far apart, you will not get sensor glucose readings or alerts. High and Low Glucose Alerts You can personalize the High and Low Alerts which tell you when your sensor glucose readings are outside of your target glucose range. When you have both your High and Low Alerts turned on, a gray zone on your trend graph shows your target range. The default for the High Alert is on, 11.4 mmol/L. The default for the Low Alert is on, 4.4 mmol/L. Consult with your healthcare provider before setting the High and Low Glucose Alert setting.
21.1 Setting Your High Glucose Alert and Repeat Feature
1. From the Home screen, tap OPTIONS.
2. Tap the Down Arrow. 3. Tap My CGM. 4. Tap CGM Alerts.
5. Tap High and Low.
6. To Set the High Alert, tap High Alert.
7. Tap Alert Me Above.
The default setting for the High Alert is 11.1 mmol/L.
NOTE Turning the Alert Off: To turn off the High Alert, tap the on/off toggle.
8. Using the on-screen keypad, enter the value above which you want to be notified. It can be set between 6.7 and 22.2 mmol/L in 0.1 mmol/L increments.
9. Tap .
The repeat feature allows you to set a time for the High Alert to sound again and display on your pump as long as your sensor glucose reading remains above the High Alert value. The default value is: Never (the alert will not sound again). You can set the repeat feature to sound again every 15 minutes, 30 minutes, 1
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CHAPTER 21 · Setting CGM Alerts
hour, 2 hours, 3 hours, 4 hours, or 5 hours when your sensor glucose reading remains above the High Alert value. To Set Up the Repeat Feature: 10. Tap Repeat. 11. To select the repeat time, tap the time you want the alert to sound again. For instance, if you select 1 hr, the alert will sound every hour as long as your sensor glucose reading remains above the High Alert value. Use the up and down arrows to view all Repeat options. Once a value is selected, the pump will return to the previous screen. 12. Tap .
21.2 Setting Your Low Glucose Alert and Repeat Feature
1. From the Home screen, tap OPTIONS.
2. Tap the Down Arrow. 3. Tap My CGM. 4. Tap CGM Alerts. 5. Tap High and Low. 6. To Set the Low Alert, tap Low Alert. 7. Tap Alert Me Below.
The default setting for the Low Alert is 4.4 mmol/L.
NOTE Turning the Alert Off: To turn off the Low Alert, tap the on/off toggle. 8. Using the on-screen keypad, enter the value below which you want to be notified. It can be set between 3.3 and 5.6 mmol/L in 0.1 mmol/L increments. 9. Tap . The repeat feature allows you to set a time for the Low Alert to sound again and display on your pump as long as your sensor glucose reading
remains below the Low Alert value. The default value is: Never (the alert will not sound again). You can set the repeat feature to sound again every 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, or 5 hours when your sensor glucose reading remains below the Low Alert value. To Set Up the Repeat Feature: 10. Tap Repeat. 11. To select the repeat time, tap the time you want the alert to sound again. For instance, if you select 1 hr, the alert will sound every hour as long as your sensor glucose reading remains below the Low Alert Value. Use the up and down arrows to view all repeat options. Once a value is selected, the pump will return to the previous screen. 12. Tap .
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CHAPTER 21 · Setting CGM Alerts
21.3 Rate Alerts
Rate alerts tell you when your glucose levels are rising (Rise Alert) or falling (Fall Alert) and by how much. You can choose to be alerted when your sensor glucose reading is rising or falling 0.11 mmol/L or more per minute, or 0.17 mmol/L or more per minute. The default value for both the Fall Alert and the Rise Alert is off. When turned on, the default is 0.17 mmol/L. Consult with your healthcare provider before setting the Rise and Fall Alerts. Examples If you set your Fall Alert to 0.11 mmol/L per minute and your sensor glucose readings fall at this rate or faster, the CGM Fall Alert with one arrow pointing down shows. The pump vibrates or
beeps according to your CGM volume selection. If you set your Rise Alert to 0.17 mmol/L per minute and your sensor glucose readings rise at this rate or faster, the CGM Rise Alert with two arrows pointing up shows. The pump vibrates or beeps according to your CGM volume selection.
21.4 Setting Your Rise Alert
1. From the Home screen, tap OPTIONS.
2. Tap the Down Arrow. 3. Tap My CGM. 4. Tap CGM Alerts. 5. Tap Rise and Fall. 6. Tap Rise Alert. 7. To select the default of 0.17
mmol/L/min, tap . To change your selection, tap Rate.
NOTE Turning the Alert Off: To turn off the Rise Alert, tap the on/off toggle. 8. Tap 0.11 mmol/L/min to select. Once a value is selected, the pump will return to the previous screen. 9. Tap .
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CHAPTER 21 · Setting CGM Alerts
21.5 Setting Your Fall Alert
1. From the Home screen, tap OPTIONS.
2. Tap the Down Arrow. 3. Tap My CGM. 4. Tap CGM Alerts. 5. Tap Rise and Fall. 6. Tap Fall Alert. 7. To select the default of 0.17
mmol/L/min, tap . To change your selection, tap Rate.
NOTE Turning the Alert Off: To turn off the Fall Alert, tap the on/off toggle. 8. Tap 0.11 mmol/L/min to select. Once a value is selected, the pump will return to the previous screen. 9. Tap .
21.6 Setting Your Out of Range Alert
The range from the transmitter to the pump is up to 6 meters (20 feet) without obstruction.
The Out of Range Alert lets you know when your transmitter and pump are not communicating with each other. This alert is on by default.
PRECAUTION We recommend that you keep the CGM Out of Range Alert turned on to notify you if your CGM is disconnected from your pump whenever you are not actively monitoring your pump status. Your CGM is providing the data that Control-IQTM technology requires to make predictions to automate insulin dosing.
Keep the transmitter and the pump within 6 meters (20 feet) of each other without obstruction. To ensure communication, it is suggested that you face your pump screen out and away from the body, and wear the pump on the same side of the body that you wear your CGM. When the transmitter and pump are not communicating, you will not get sensor glucose readings or
alerts. The default value is on and will alert after 20 minutes.
The Out Of Range symbol appears on the pump Home screen and on the Out of Range Alert screen (if turned on) when the transmitter and pump are not communicating. The amount of time out of range also shows on the alert screen. It will continue to re-alert until the transmitter and pump are back in range.
NOTE Out of Range and Control-IQ Technology: Control-IQ technology will continue to operate for the first 15 minutes that the transmitter and pump are out of range. Once the Out of Range condition is present for 20 minutes, Control-IQ technology will stop operation until the two devices are within range.
To Set Your Out of Range Alert:
1. From the Home screen, tap OPTIONS.
2. Tap the Down Arrow.
3. Tap My CGM.
4. Tap CGM Alerts.
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CHAPTER 21 · Setting CGM Alerts 5. Tap Out of Range.
The default is set to on and the time is set to 20 minutes. 6. To change the time, tap Alert After. 7. Using the on-screen keypad, enter the time after which you want to be alerted (between 20 minutes and 3 hours and 20 minutes) then tap
. 8. Tap .
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CHAPTER 22
Start or Stop a CGM Sensor Session
CHAPTER 22 · Start or Stop a CGM Sensor Session
22.1 Start the Sensor To start a CGM session, follow the steps below. 1. From the Home screen, tap
OPTIONS. 2. Tap the Down Arrow. 3. Tap My CGM. 4. Tap START SENSOR. Once you start a sensor session,
the START SENSOR option is replaced with STOP SENSOR. The following screen displays prompting you to either enter the sensor code, or to skip this step. If you choose to enter the sensor code, you will not be prompted to calibrate for the duration of the sensor session. For information about Dexcom G6 CGM sensor
codes, visit the manufacturer's website for applicable user guides.
Tap CODE to enter the 4-digit sensor code. If you do not have a code, or if you have already started a sensor session with the Dexcom G6 CGM app, you can tap SKIP. If you do not enter a code into either the t:slim X2 pump or the Dexcom G6 CGM app you will need to calibrate your sensor every 24 hours. A prompt to calibrate will be displayed on the pump and on the Dexcom G6 CGM app. 5. Tap to confirm.
The SENSOR STARTED screen will appear to let you know your sensor startup has begun.
Your pump will return to the CGM Home screen with the 3 hour trend graph and the sensor startup countdown symbol displayed.
6. Check your pump CGM Home screen 10 minutes after starting your sensor session to make sure your pump and transmitter are communicating. The antenna symbol should be to the right of the battery indicator and should be white.
7. If you see the out of range symbol below the insulin level indicator, and the antenna symbol is grayed out, follow these troubleshooting tips: a. Make sure your pump and transmitter are within 6 meters (20 feet) of each other without obstruction. Re-check in 10 minutes to see if the out of range symbol is still active.
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CHAPTER 22 · Start or Stop a CGM Sensor Session
b. If the pump and transmitter are still not communicating, check the My CGM screen to make sure the correct transmitter ID is entered.
c. If the correct transmitter ID is entered and the pump and transmitter are still not communicating, contact Customer Technical Support.
22.2 Sensor Startup Period
As an example, the Dexcom G6 sensor needs a 2-hour startup period to adjust to being under your skin. You will not get sensor glucose readings or alerts until the 2-hour startup period ends. For information about Dexcom G6 CGM sensor startup periods, visit the manufacturer's website for applicable user guides.
During the startup period, the CGM Home screen on your pump shows a 2-hour countdown symbol in the upper right portion of the screen. The countdown symbol fills in over time to show that you are getting closer to the active sensor session.
WARNING Control-IQ technology limits Basal Rate to 3 units/hour during the sensor startup period. In order to receive more than 3 units/hour during sensor startup, turn Control-IQ technology off.
Sensor Startup Period Timeline Start 030 Minutes 3160 Minutes 6190 Minutes 91120 Minutes
End
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CHAPTER 22 · Start or Stop a CGM Sensor Session
WARNING Continue to use a BG meter and test strips in order to make treatment decisions during the 2-hour startup period.
NOTE Sensor Startup Period and Control-IQ Technology: During the sensor startup period, Control-IQ technology will not affect the Basal Rates or deliver automatic correction boluses. The sensor must be actively providing readings for Control-IQ technology to operate.
Examples
For example, if you started your sensor session 20 minutes ago, you would see this countdown symbol on the CGM Home screen.
If you started your sensor session 90 minutes ago, you would see this countdown symbol on the CGM Home screen. At the end of the 2-hour startup period, the countdown symbol will be replaced with the current CGM reading.
Follow the instructions in the next chapter to calibrate your sensor. Skip the calibration instructions if you entered a sensor code. You may enter a calibration into the System at any time, even if you have already entered sensor code. Pay attention to your symptoms, and if they do not match the current CGM readings, you may choose to enter a calibration.
Ending Your Sensor Session
When the sensor session ends, you will need to replace the sensor and start a new sensor session. In some cases your sensor session may end early. You may also choose to end the sensor session early.
Glucose alerts and alarms do not work after the sensor session ends. Once the sensor session has ended, CGM readings are not available. If you are using Control-IQ technology, it becomes inactive when a CGM sensor session is ended.
WARNING Control-IQ technology limits Basal Rate to 3 units/hour after the sensor session has ended. In order to receive more than 3 units/hour after
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CHAPTER 22 · Start or Stop a CGM Sensor Session
the sensor session has ended, turn Control-IQ technology off.
22.3 Automatic Sensor Shut-Off
Your t:slim X2 pump tells you how much time you have left until your sensor session is complete. The SENSOR EXPIRING SOON screen shows at 6 hours remaining, 2 hours remaining, and 30 minutes remaining before your session ends. You will continue to receive sensor glucose readings after each reminder. When you see the SENSOR EXPIRING SOON screen: 1. Tap OK to return to the previous
screen. The SENSOR EXPIRING SOON
screen will show again when there are 2 hours remaining, and when there are 30 minutes remaining. After the final 30 minutes, the REPLACE SENSOR screen is displayed. 2. Tap . OK
The CGM Home screen will appear with the Replace Sensor icon in the place where sensor glucose readings normally show.
New sensor glucose readings do not show on your pump after your sensor session ends. You must remove your sensor and insert a new sensor. 22.4 Ending a Sensor Session
Before Automatic Shut-Off You can end your sensor session at any time before the automatic sensor shutoff. To end your sensor session early: 1. From the Home screen, tap
OPTIONS. 2. Tap the Down Arrow. 3. Tap My CGM. 4. Tap STOP SENSOR. 5. Tap to confirm. The SENSOR STOPPED screen is
temporarily displayed.
The CGM Home screen will appear with the Replace Sensor icon in the place where sensor glucose readings normally show.
New sensor glucose readings do not show on your pump after your sensor session ends. You must remove your sensor and insert a new sensor.
22.5 Removing the Sensor and Transmitter
WARNING DO NOT ignore broken or detached sensor wires. A sensor wire could remain under your skin. If a sensor wire breaks off under your skin and you can't see it, do not try to remove it. Contact your healthcare provider. Also seek professional medical help if you have symptoms of infection or inflammation (redness, swelling, or pain) at the insertion site. If you experience a broken sensor, please report this to Customer Technical Support.
For information about removing the Dexcom G6 sensor and Dexcom G6 transmitter, visit the manufacturer's website for applicable user guides.
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CHAPTER 23
Calibrating Your CGM System
CHAPTER 23 · Calibrating Your CGM System
23.1 Calibration Overview
If you did not enter a CGM sensor code when starting a sensor session, you will be prompted to calibrate at the following intervals: · 2-hour startup: 2 calibrations 2
hours after you start your sensor session · 12-hour update: 12 hours after the 2 hour start up calibration · 24-hour update: 24 hours after the 2 hour start up calibration · Every 24 hours: every 24 hours after the 24-hour update · When notified On the first day of your sensor session, you must enter four BG values into your pump to calibrate. You must enter one BG value to calibrate every 24 hours after your first startup calibration. The pump will remind you when the System needs these calibrations. In addition, you may be prompted to enter additional BG values to calibrate as needed.
PRECAUTION DO NOT calibrate when your trend arrow is up, double-up, down, or double-down because your BG is changing at more than 0.11 mmol/L per minute.
When calibrating, you must enter your BG values into the pump by hand. You can use any commercially available BG meter. You must calibrate with accurate BG meter values to get accurate sensor glucose readings.
Follow these important instructions when obtaining BG values for calibration:
· BG values used for calibration must be between 2.2 to 22.2 mmol/L and must have been taken within the past 5 minutes.
· Your sensor cannot be calibrated if the glucose value from your meter is less than 2.2 mmol/L. For safety reasons, if your BG is low, first treat your low BG.
· Make sure a sensor glucose reading shows in the upper right portion of the CGM Home screen before calibrating.
· Make sure the antenna symbol is visible to the right of the battery indicator on the CGM Home screen and is active (white, not greyed out) before calibrating.
· Always use the same BG meter to calibrate that you routinely use to measure your BG. Do not switch your BG meter in the middle of a sensor session. BG meter and strip accuracy vary between BG meter brands.
· The accuracy of the BG meter used for calibration may affect the accuracy of sensor glucose readings. Follow your BG meter manufacturer's instructions for BG testing.
23.2 Startup Calibration
If you did not enter a sensor code when starting the sensor session, the system will prompt you to calibrate to provide accurate information.
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CHAPTER 23 · Calibrating Your CGM System
NOTE Sensor Code: The instructions in this section do not apply if you entered the sensor code when you started the sensor session.
Two hours after you start the sensor session, the CALIBRATE CGM screen will appear, letting you know that two separate BG values from your BG meter must be entered. You will not see sensor glucose readings until the pump accepts the BG values. 1. From the CALIBRATE CGM screen,
Tap . OK
The CGM Home screen will appear with two blood drops in the upper right portion of the screen. The two blood drops will stay on the screen until you enter 2 separate BG values to calibrate.
2. Wash and dry your hands, make sure your glucose test strips have been stored properly and are not expired, and make sure your BG meter is properly coded (if required).
3. Take a BG measurement using your BG meter. Carefully apply the blood
sample to the test strip following your BG meter manufacturer's instructions.
PRECAUTION DO use fingertips to calibrate from your BG meter. Blood from other places may be less accurate and not as timely.
4. Tap OPTIONS.
5. Tap the Down Arrow.
6. Tap My CGM.
7. Tap Calibrate CGM.
8. Using the on-screen keypad, enter the BG value from your BG meter.
PRECAUTION To calibrate the System, DO enter the exact BG value displayed on your BG meter within 5 minutes of a carefully performed BG meter. Do not enter the sensor glucose readings for calibration. Entering incorrect BG values, BG values obtained more than 5 minutes before entry, or sensor glucose readings might affect sensor accuracy and could result in you missing severe
hypoglycemia (low BG) or hyperglycemia (high BG) events. 9. Tap . 10. Tap to confirm the calibration. Tap if the BG value does not exactly match the reading from your BG meter. The on-screen keypad will reappear. Enter the exact reading from your BG meter. The CALIBRATION ACCEPTED screen will appear. The My CGM screen will appear. 11. Tap Calibrate CGM to enter your second BG value. The on-screen keypad will appear. 12. Wash and dry your hands, make sure your glucose test strips have been stored properly and are not expired, and make sure your meter is properly coded (if required). 13. Take a BG measurement using your BG meter. Carefully apply the blood
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CHAPTER 23 · Calibrating Your CGM System
sample to the test strip following your BG meter manufacturer's instructions. 14. Follow steps 8 10 to enter your second BG value.
23.3 Calibration BG Value and Correction Bolus
Your t:slim X2 pump uses the BG value entered for calibration to determine if a correction bolus is needed, or to provide other important information about your insulin on board and BG. · If you enter a calibration value that is
above your Target BG in Personal Profiles, the Above Target Correction Bolus confirmation screen will appear. To add a correction bolus, tap . Follow the instructions in Section 7.2 Correction Bolus Calculation to deliver a correction bolus. · If you enter a calibration value that is below your Target BG in Personal Profiles, a message screen will indicate "Your BG is Below Target",
and other important information will appear on the screen.
· If you enter your Target BG as a calibration value, the pump will return to the CCM Home screen.
23.4 Reasons You May Need to Calibrate
You may need to calibrate if your symptoms do not match the glucose values provided by your CGM.
If you see the CALIBRATION ERROR screen, you will be prompted to enter a BG value to calibrate in either 15 minutes or 1 hour, depending on the error.
NOTE Calibrations After Entering a Sensor Code: Although it is not required, and you will not be prompted to calibrate, you may enter a calibration into the System at any time, even if you have already entered a sensor code. Pay attention to your symptoms, and if they do not match the current CGM readings, you may choose to enter a calibration.
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CHAPTER 24
Viewing CGM Data on Your t:slim X2 Insulin Pump
CHAPTER 24 · Viewing CGM Data on Your t:slim X2 Insulin Pump
24.1 Overview
WARNING DO NOT ignore how you feel. If your glucose alerts and readings do not match what you're feeling, use your BG meter to make diabetes treatment decisions or, if needed, seek immediate medical attention.
The pump screens in this section illustrate the screen when Control-IQ technology is off. For information about CGM screens when Control-IQ technology is on, see Section 30.9 Control-IQ Technology Information on Your Screen.
During an active sensor session, CGM readings are sent to your pump every 5 minutes. This section teaches you how to view your sensor glucose readings and trend information. The trend graph provides additional information that your BG meter does not. It shows your current glucose value, the direction it is changing and how fast it is changing. The trend graph can also show you where your glucose has been over time.
Your BG meter measures glucose in your blood. Your sensor measures glucose from interstitial fluid (the fluid under your skin). Because glucose from different fluids is measured, readings from your BG meter and sensor may not match. The greatest benefit you get from using continuous glucose monitoring will come from trending information. It is important that you focus on the trends and rate of change on your receiver or pump rather than the exact glucose reading. Press the Screen On/Quick Bolus button to turn the screen on. If a CGM session is active, you will see the CGM Home screen with the 3 hour trend graph displayed.
· The current time and date are shown at the top of the screen in the middle.
· Each "dot" on the trend graph is a sensor glucose reading reported every 5 minutes.
· Your High Alert setting shows as an orange line across the trend graph.
· Your Low Alert setting shows as a red line across the trend graph.
· The gray zone highlights your target glucose range, between your High and Low Alert settings.
· Sensor glucose readings are shown in millimoles per liter (mmol/L).
· If your sensor glucose reading is between your High and Low Alert settings, it is shown in white.
· If your sensor glucose reading is above your High Alert setting, it is shown in orange.
· If your sensor glucose reading is below your Low Alert setting, it is shown in red.
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· If your glucose reading is 3.1 mmol/L or lower, it is shown in red, regardless of the Low Alert setting.
· The dots on the trend graph display as different colors based on your High and Low Alert settings: white if between High and Low Alert settings, orange if above High Alert setting, red if below Low Alert setting.
24.2 CGM Trend Graphs
You can view your past sensor glucose trend information on your CGM Home screen. 1, 3, 6, 12, and 24 hour trend views can be seen. The 3 hour Trend Graph is the default view and will be shown on the CGM Home screen even if a different trend graph was shown when the screen turned off. Sensor glucose information is only reported for values between 2.2 and 22.2 mmol/L. Your trend graph shows a flat line or dots at 2.2 or 22.2 mmol/L when your glucose is outside this range.
To view different Trend Graph times, tap on the Trend Graph Time (HRS) to cycle through the options. 3 Hour Trend Graph (default view) shows you your current glucose reading along with the last 3 hours of sensor glucose readings.
6 Hour Trend Graph shows you your current glucose reading along with the last 6 hours of sensor glucose readings. 12 Hour Trend Graph shows you your current glucose reading along with the last 12 hours of sensor glucose readings.
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24 Hour Trend Graph shows you your current glucose reading along with the last 24 hours of sensor glucose readings.
LOW shows when your most recent sensor glucose reading is less than 2.2 mmol/L.
24.3 Rate of Change Arrows
Your rate of change arrows add detail about the direction and speed of glucose change over the last 1520 minutes. The trend arrows show below your current sensor glucose reading.
1 Hour Trend Graph shows you your current glucose reading along with the last 1 hour of sensor glucose readings.
HIGH shows when your most recent sensor glucose reading is greater than 22.2 mmol/L.
Do not overreact to the rate of change arrows. Consider recent insulin dosing, activity, food intake, your overall trend graph and your BG value before taking action. If there are missed communications between the sensor and your pump during the last 1520 minutes due to being out of range or due to an error
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condition, an arrow may not display. If the trend arrow is missing, and you are concerned that your BG level may be rising or falling, take a BG measurement using your BG meter.
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CHAPTER 24 · Viewing CGM Data on Your t:slim X2 Insulin Pump
The table below shows the different trend arrows your receiver or pump displays:
Trend Arrow Definitions
Constant: Your glucose is steady (not increasing/decreasing more than 0.06 mmol/L each minute). Your glucose could increase or decrease by up to 0.9 mmol/L in 15 minutes.
Slowly falling: Your glucose is falling 0.060.11 mmol/L each minute. If it continued falling at this rate, your glucose could decrease up to 1.7 mmol/L in 15 minutes.
Slowly rising: Your glucose is rising 0.060.11 mmol/L each minute. If it continued rising at this rate, your glucose could increase up to 1.7 mmol/L in 15 minutes.
Falling: Your glucose is falling 0.110.17 mmol/L each minute. If it continued falling at this rate, your glucose could decrease up to 2.5 mmol/L in 15 minutes.
Rising: Your glucose is rising 0.110.17 mmol/L each minute. If it continued rising at this rate, your glucose could increase up to 2.5 mmol/L in 15 minutes.
Rapidly falling: Your glucose is falling more than 0.17 mmol/L each minute. If it continued falling at this rate, your glucose could decrease more than 2.5 mmol/L in 15 minutes.
Rapidly rising: Your glucose is rising more than 0.17 mmol/L each minute. If it continued rising at this rate, your glucose could increase more than 2.5 mmol/L in 15 minutes.
No No rate of change information: The System cannot calculate Arrow how fast your glucose is rising or falling at this time.
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24.4 CGM History
CGM History displays the historical log of CGM events. At least 90 days of data can be viewed in History. When the maximum number of events is reached, the oldest events are removed from the history log and replaced with the most recent events. The following history sections can be viewed: · Sessions and Calibrations · Alerts and Errors · Complete Each section above is organized by date. If there are no events associated with a date, the day will not be shown in the list. The Sessions and Calibrations section includes the start time and date for each Sensor Session, the stop time and date for each Sensor Session, and all calibration BG values entered. The Alerts and Errors section includes the date and time for all Alerts and Errors that occurred. The letter "D" (D: Alert) before an Alert or Alarm indicates
the time it was declared. The letter "C" (C: Alert) indicates the time it was cleared. The Complete section includes all information from the Sessions and Calibrations and Alerts and Errors sections as well as any changes to settings. 1. From the Home screen, tap
OPTIONS. 2. Tap the Down Arrow. 3. Tap History. 4. Tap CGM History. 5. Tap section you want to view. Each
section is organized by date. Tap the date to view events from that day. Use the Down Arrow to scroll to more dates.
24.5 Missed Readings If your pump misses CGM readings for a period of time, you will see three dashes where the CGM reading typically displays on the CGM Home
screen and on the CGM Lock screen. The system will automatically attempt to backfill missing data points up to 6 hours in the past when connectivity is restored and readings begin to appear. If the sensor glucose number or trend arrow is missing, and you are concerned that your BG level may be rising or falling, take a BG measurement using your BG meter.
NOTE
Control-IQ Technology and Missing CGM Data: Control-IQ technology will continue to operate for the first 15 minutes after CGM readings become unavailable. If connectivity is not restored after 20 minutes, Control-IQ technology will stop operation until CGM readings are available. While Control-IQ technology is not operating, your pump will continue to deliver insulin according to your Personal Profile settings. Once CGM readings are available, Control-IQ technology will automatically resume. For more information, see Chapter 29 Introduction to Control-IQ Technology.
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3 CGM Features
CHAPTER 25
CGM Alerts and Errors
CHAPTER 25 · CGM Alerts and Errors
Information in this section will help you learn how to respond to CGM alerts and errors. It applies only to the CGM portion of your System. CGM alerts and errors do not follow the same pattern of vibration and beeps as insulin delivery reminders, alerts, and alarms.
For information on insulin delivery reminders, alerts, and alarms, see Chapters 12 t:slim X2 Insulin Pump Alerts, 13 t:slim X2 Insulin Pump Alarms, and 14 t:slim X2 Insulin Pump Malfunction.
For information on Control-IQ Technology alerts, see Chapter 31 Control-IQ Technology Alerts.
WARNING If a sensor session is ended, either automatically or manually, Control-IQTM technology is unavailable and will not adjust insulin. In order for Control-IQ technology to be enabled, a sensor session must be started and transmitting sensor values to the pump based on a sensor code or sensor calibration.
PRECAUTION You must customize the CGM alert settings on your t:slim X2 pump and the Dexcom G6 CGM
app separately. The alert settings apply to the phone and pump separately.
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CHAPTER 25 · CGM Alerts and Errors
25.1 Startup Calibration Alert
Screen What will I see on the screen?
Explanation
What does it mean? How will the System notify me? Will the System re-notify me?
2-hour CGM startup period is complete. This will only appear if you did not enter a sensor code.
1 vibration, then vibration/beep every 5 minutes until confirmed.
Yes, every 15 minutes until you calibrate.
How should I respond?
Tap OK and enter 2 separate BG values to calibrate the system and start your CGM session.
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25.2 Second Startup Calibration Alert
Screen What will I see on the screen?
Explanation
What does it mean? How will the System notify me? Will the System re-notify me?
The System needs an additional BG value to complete startup calibration. This will only appear if you did not enter a sensor code.
1 vibration, then vibration/beep every 5 minutes until confirmed.
Yes, every 15 minutes until second calibration is entered.
How should I respond?
Tap OK and enter a BG value to calibrate the System and start your CGM session.
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25.3 12 Hour Calibration Alert
Screen What will I see on the screen?
Explanation
What does it mean? How will the System notify me? Will the System re-notify me?
The System needs a BG value to calibrate. This will only appear if you did not enter a sensor code.
On screen only with no vibration or beep.
Yes, every 15 minutes.
How should I respond?
Tap OK and enter a BG value to calibrate the system.
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CHAPTER 25 · CGM Alerts and Errors
25.4 Incomplete Calibration
Screen What will I see on the screen?
Explanation
What does it mean? How will the System notify me? Will the System re-notify me?
If you start to enter a calibration value using the keypad and do not complete the entry within 90 seconds, this screen appears.
2 beeps or vibrations depending on Sound Volume selected.
Yes, every 5 minutes until confirmed.
How should I respond?
Tap OK and complete your calibration by entering the value using the on-screen keypad.
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25.5 Calibration Timeout
Screen What will I see on the screen?
CHAPTER 25 · CGM Alerts and Errors
Explanation
What does it mean? How will the System notify me? Will the System re-notify me?
If you start to enter a calibration value using the keypad and do not complete the entry within 5 minutes, this screen appears.
2 beeps or vibrations depending on Sound Volume selected.
Yes, every 5 minutes until confirmed.
How should I respond?
Tap OK and obtain a new BG value using your BG meter. Enter the value using the on-screen keypad to calibrate the System.
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CHAPTER 25 · CGM Alerts and Errors
25.6 Wait 15 Minute Calibration Error Alert
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
The sensor cannot calibrate. 1 vibration, then vibration/beep every 5 minutes until confirmed. No.
How should I respond?
Tap OK to confirm. Wait 15 minutes then enter 1 more BG value. Wait 15 more minutes. If error screen still appears, enter 1 more BG value. Wait 15 minutes. If no sensor glucose readings appear, the sensor needs to be replaced.
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CHAPTER 25 · CGM Alerts and Errors
25.7 Calibration Required Alert
Screen What will I see on the screen?
Explanation
What does it mean? How will the System notify me? Will the System re-notify me?
The System needs a BG value to calibrate. Sensor glucose readings will not be displayed at this time.
1 vibration, then vibration/beep every 5 minutes until confirmed.
Yes, every 15 minutes.
How should I respond?
Tap OK and enter a BG value to calibrate the System.
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CHAPTER 25 · CGM Alerts and Errors
25.8 CGM High Alert
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
Your most recent sensor glucose reading is at or above the High Alert setting.
2 vibrations, then 2 vibrations/beeps every 5 minutes until confirmed or your glucose value drops below the Alert level.
Only if you have turned on the Repeat feature.
How should I respond?
Tap OK to confirm.
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25.9 CGM Low Alert
Screen What will I see on the screen?
CHAPTER 25 · CGM Alerts and Errors
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
Your most recent sensor glucose reading is at or below the Low Alert setting.
3 vibrations, then 3 vibrations/beeps every 5 minutes until confirmed or your glucose value goes above the Alert level.
Only if you have turned on the Repeat feature.
How should I respond?
Tap OK to confirm.
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CHAPTER 25 · CGM Alerts and Errors
25.10 CGM Fixed Low Alert
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me?
Will the System re-notify me?
Your most recent sensor glucose reading is at or below 3.1 mmol/L.
4 Vibrations, then 4 vibrations/beeps every 5 minutes until confirmed or your glucose value goes above 3.1 mmol/L.
Yes, 30 minutes after each confirmation until your glucose value goes above 3.1 mmol/L.
How should I respond?
Tap OK to confirm.
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25.11 CGM Rise Alert
Screen What will I see on the screen?
CHAPTER 25 · CGM Alerts and Errors
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
Your glucose levels are rising at 0.11 mmol/L per minute or faster (at least 1.7 mmol/L in 15 minutes).
2 vibrations, then 2 vibrations/beeps every 5 minutes or until confirmed.
No.
How should I respond?
Tap OK to confirm.
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CHAPTER 25 · CGM Alerts and Errors
25.12 CGM Rapid Rise Alert
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
Your glucose levels are rising at 0.17 mmol/L per minute or faster (at least 2.5 mmol/L in 15 minutes).
2 vibrations, then 2 vibrations/beeps every 5 minutes or until confirmed.
No.
How should I respond?
Tap OK to confirm.
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25.13 CGM Fall Alert
Screen What will I see on the screen?
CHAPTER 25 · CGM Alerts and Errors
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
Your glucose levels are falling at 0.11 mmol/L per minute or faster (at least 1.7 mmol/L in 15 minutes).
3 vibrations, then 3 vibrations/beeps every 5 minutes or until confirmed.
No.
How should I respond?
Tap OK to confirm.
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CHAPTER 25 · CGM Alerts and Errors
25.14 CGM Rapid Fall Alert
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
Your glucose levels are falling at 0.17 mmol/L per minute or faster (at least 2.5 mmol/L in 15 minutes).
3 vibrations, then 3 vibrations/beeps every 5 minutes or until confirmed.
No.
How should I respond?
Tap OK to confirm.
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CHAPTER 25 · CGM Alerts and Errors
25.15 Unknown Sensor Glucose Reading
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
How should I respond?
The sensor is sending sensor glucose readings that the System does not understand. You will not receive sensor glucose readings.
On screen only with no vibration or beep.
The 3 dashes will remain on the screen until a new glucose reading is received and displayed in their place. If no sensor glucose readings are received after 20 minutes, the CGM Unavailable Alert will trigger. See Section 25.20 CGM Unavailable.
Wait 30 minutes for more information from the system. Do not enter BG values for calibration. The system will not use BG values for calibration when "- - -" appears on the screen.
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CHAPTER 25 · CGM Alerts and Errors
25.16 Out of Range Alert
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me? How should I respond?
The transmitter and pump are not communicating. The pump will not receive sensor glucose readings, and Control-IQ technology is not able to predict glucose levels or adjust insulin delivery.
1 vibrate, then vibration/beep every 5 minutes until the transmitter and pump are back in range.
Yes, if the transmitter and pump remain out of range.
Tap OK to confirm and move the transmitter and pump closer together, or remove the obstruction between them.
WARNING
Control-IQ technology can only adjust insulin delivery when your CGM is in range. If you go out of range during insulin adjustment, your basal insulin delivery will revert to the Basal Rate settings in your active Personal Profile, limited to 3 units/hr. In order to receive more than 3 units/hour while the sensor is not communicating with the pump, turn Control-IQ technology off.
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CHAPTER 25 · CGM Alerts and Errors
25.17 Low Transmitter Battery Alert
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me?
Will the System re-notify me?
Transmitter battery is low.
1 vibration, then vibration/beep every 5 minutes until confirmed.
Yes, the alarm will notify you when there are 21, 14, and 7 days of transmitter battery life remaining.
How should I respond?
Tap OK to confirm. Replace the transmitter as soon as possible.
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CHAPTER 25 · CGM Alerts and Errors
25.18 Transmitter Error
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
The transmitter has failed and the CGM session has stopped. 1 vibration, then vibration/beep every 5 minutes. No.
How should I respond?
Tap MORE INFO. A screen notifying you that your CGM session has stopped but insulin delivery continues will appear.
Replace the transmitter immediately.
WARNING
Control-IQ technology limits Basal Rate to 3 units/hour in the event of a transmitter error. In order to receive more than 3 units/hour during a transmitter error, turn Control-IQ technology off.
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CHAPTER 25 · CGM Alerts and Errors
25.19 Failed Sensor Error
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
How should I respond?
The sensor is not working properly and the CGM session has stopped. 1 vibration, then vibration/beep every 5 minutes. No.
Tap MORE INFO. A screen notifying you that your CGM session has stopped but insulin delivery continues will appear.
Replace the sensor and begin a new CGM session.
WARNING
Control-IQ technology limits Basal Rate to 3 units/hour in the event of a failed sensor. In order to receive more than 3 units/hour when a sensor fails, turn Control-IQ technology off.
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CHAPTER 25 · CGM Alerts and Errors
25.20 CGM Unavailable
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me?
How should I respond?
Your CGM session has been stopped for more than 20 minutes and the CGM can no longer be used.
2 vibrations, then 2 vibrations/beeps every 5 minutes or until confirmed.
Yes, every 20 minutes until the CGM session is available. If the condition persists for 3 hours, the Failed Sensor alert will be displayed. See Section 25.19 Failed Sensor Error.
Tap OK and contact Customer Technical Support.
WARNING
Control-IQ technology limits Basal Rate to 3 units/hour in the event that the CGM is unavailable. In order to receive more than 3 units/hour when the CGM is unavailable, turn Control-IQ technology off.
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CHAPTER 25 · CGM Alerts and Errors
25.21 CGM System Error
Screen What will I see on the screen?
Explanation
What does it mean? How will the System notify me? Will the System re-notify me?
Your CGM System is not working properly; the CGM session has stopped and the CGM can no longer be used.
1 vibration, then vibration/beep every 5 minutes.
No.
How should I respond?
Tap MORE INFO. A screen notifying you that your CGM System cannot operate but insulin delivery continues will appear. Call Customer Technical Support.
WARNING
Control-IQ technology limits Basal Rate to 3 units/hour in the event of a CGM error. In order to receive more than 3 units/hour during a CGM error, turn Control-IQ technology off.
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3 CGM Features
CHAPTER 26
CGM Troubleshooting
CHAPTER 26 · CGM Troubleshooting
This chapter provides helpful tips and instructions to help you fix issues you may have while using the CGM portion of your System. If the troubleshooting steps in this chapter do not fix your issue, contact Customer Technical Support. The following tips are specific to troubleshooting the Dexcom G6 CGM connected to your pump. For more information about Dexcom G6 CGM troubleshooting, visit the manufacturer's website for applicable user guides.
26.1 CGM Pairing Troubleshooting
Possible issue: Difficulty pairing your Dexcom G6 CGM with your t:slim X2TM insulin pump. Troubleshooting tip: The Dexcom G6 CGM only allows pairing with one medical device at a time. Ensure your CGM is not connected to the Dexcom receiver before pairing with the pump. You may still use a smartphone with the Dexcom
G6 CGM app and your t:slim X2 insulin pump simultaneously with the same transmitter ID. See Section 20.2 Disconnecting from the Dexcom Receiver.
26.2 Calibration Troubleshooting
To ensure proper calibration of your CGM, follow these important tips. Before you take a BG value for calibration, wash your hands, make sure your glucose test strips have been stored properly and are not expired, and make sure that your meter is properly coded (if required). Carefully apply the blood sample to the test strip following the instructions that came with your BG meter or test strips. Do not calibrate if you see the Out of Range symbol in the place where your sensor glucose readings are normally shown on the screen. Do not calibrate if you see "- - -" in the place where you sensor glucose readings are normally shown on the screen.
Do not calibrate if your BG value is below 2.2 mmol/L or above 22.2 mmol/L.
26.3 Unknown Sensor Reading Troubleshooting
When your CGM cannot provide a sensor glucose reading "- - -" shows in the place where your sensor glucose is normally shown on the screen. This means that the System does not understand the sensor signal temporarily. Often the System can correct the problem and continue providing sensor glucose readings. If it has been at least 3 hours since your last sensor glucose reading, contact Customer Technical Support. Do not enter any BG values for calibration when you see "- - -" on your screen. The System will not use a BG value for calibration when this symbol is on your screen. If you see "- - -" often during a sensor session, follow the troubleshooting tips below before inserting another sensor.
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CHAPTER 26 · CGM Troubleshooting
· Make sure your sensor is not expired.
· Make sure your sensor pod is not dislodged or peeling up.
· Make sure your transmitter is snapped in completely.
· Make sure nothing is rubbing the sensor pod (e.g., clothing, seat belts, etc.).
· Make sure to select a good insertion site.
· Make sure your insertion site is clean and dry before sensor insertion.
· Wipe the bottom of the transmitter with a damp cloth or isopropyl alcohol wipe. Place the transmitter on a clean, dry cloth and air dry for 23 minutes.
26.4 Out of Range/No Antenna Troubleshooting
WARNING Control-IQTM technology can only adjust insulin delivery when your CGM is in range. If you go
out of range during insulin adjustment, your basal insulin delivery will revert to the Basal Rate settings in your active Personal Profile, limited to 3 units/hr. In order to receive more than 3 units/hour while the sensor is not communicating with the pump, turn Control-IQ technology off.
PRECAUTION AVOID separating the transmitter and the pump by more than 6 meters (20 feet). The transmission range from the transmitter to the pump is up to 6 meters (20 feet) without obstruction. Wireless communication does not work well through water so the range is much less if you are in a pool, bathtub, or on a water bed, etc. Types of obstruction differ and have not been tested. If your transmitter and pump are farther than 6 meters (20 feet) apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter and result in you missing severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
If you see the Out of Range icon on your screen in the place where your sensor glucose reading normally shows, then your t:slim X2 pump is not communicating with your transmitter and sensor glucose readings will not
show on your screen. Each time you start a new sensor session, wait 10 minutes for your t:slim X2 pump to start communicating with your transmitter. When a sensor session is active, you may sometimes experience loss of communication for 10 minutes at a time. This is normal. If you see the Out of Range icon for more than 10 minutes, move your t:slim X2 Pump and CGM transmitter closer together and remove any obstructions. Wait 10 minutes and communication should be restored. You must enter your transmitter ID correctly into your pump to receive sensor glucose readings (see Section 20.3 Entering Your Transmitter ID). Make sure you have removed your sensor and stopped your sensor session before checking or changing your transmitter ID. You cannot change your transmitter ID during a sensor session. If you are still having trouble getting sensor glucose readings, contact Customer Technical Support.
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CHAPTER 26 · CGM Troubleshooting
26.5 Failed Sensor Troubleshooting
The System may detect issues with your sensor where it cannot determine your glucose reading. The sensor session ends and the FAILED SENSOR screen shows on your t:slim X2 pump. If you see this screen, it means your CGM session has ended. · Remove your sensor and insert a
new sensor. · To help improve future sensor
performance, follow the troubleshooting tips below. · Make sure your sensor is not expired. · Make sure your sensor pod is not dislodged or peeling up. · Make sure your transmitter is snapped in completely. · Make sure nothing is rubbing the sensor pod (e.g., clothing, seat belts, etc.). · Make sure you have selected a good insertion site.
26.6 Sensor Inaccuracies
Inaccuracies are usually related to your sensor only and not to your transmitter or pump. Your sensor glucose readings are meant to be used for trending purposes only. The sensor measures glucose in the fluid under the skin--not in blood, and sensor glucose readings are not identical to readings from your BG meter.
PRECAUTION To calibrate the System, DO enter the exact BG value that your BG meter displays within 5 minutes of a carefully performed BG measurement. Do not enter sensor glucose values for calibration. Entering incorrect BG values, BG values obtained more than 5 minutes before entry, or sensor glucose readings might affect sensor accuracy and could result in you missing severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
If the difference between your sensor glucose reading and BG value is greater than 20% of the BG value for sensor readings >4.4 mmol/L or greater than 1.1 mmol/L for sensor readings <4.4 mmol/L, wash your hands and
take another BG measurement. If the difference between this second BG measurement and the sensor is still greater than 20% for sensor readings >4.4 mmol/L or greater than 1.1 mmol/L for sensor readings <4.4 mmol/L, recalibrate your sensor using the second BG value. The sensor glucose reading will correct over the next 15 minutes. If you see differences between your sensor glucose readings and BG values outside of this acceptable range, follow the troubleshooting tips below before inserting another sensor: · Make sure your sensor is not
expired. · Make sure you do not calibrate
when "- - -" or the Out of Range icon are on the screen. · Do not use alternative BG site testing (blood from your palm or forearm, etc.) for calibration as alternative site readings may be different than those from a BG value. Use a BG value only from your fingers for calibration.
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· Use only BG values between 2.2 22.2 mmol/L for calibration. If one or more of your values is outside of this range, the receiver will not calibrate.
· Use the same BG meter you routinely use to measure your BG to calibrate. Do not switch your BG meter in the middle of a sensor session. BG meter and strip accuracy vary between BG meter brands.
· Before taking a BG measurement for calibration, wash your hands, make sure your glucose test strips have been stored properly and are not expired, and make sure that your BG meter is properly coded (if required). Carefully apply the blood sample to the test strip following the instructions provided with your BG meter or test strips.
· Make sure you are using your BG meter following the manufacturer's instructions to get accurate BG values for calibration.
CHAPTER 26 · CGM Troubleshooting
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4 Control-IQ Technology Features
CHAPTER 27
Control-IQ Technology Important Safety Information
CHAPTER 27 · Control-IQ Technology Important Safety Information
The following includes important safety information related to Control-IQTM technology. 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.
27.1 Control-IQ Warnings
WARNING Control-IQ technology should not be used by people who use less than 10 units of insulin per day or weigh less than 25 kilograms (55 pounds), which are the minimum inputs required to initiate Control-IQ technology and for it to operate safely.
WARNING The t:slim X2 insulin pump with Control-IQ technology should not be used in children under the age of six years old.
WARNING DO NOT use Control-IQ technology in pregnant women or persons on dialysis. The System is not approved for use in pregnant women or
persons on dialysis and has not been evaluated in these populations. Sensor glucose readings may be inaccurate in these populations and could result in you missing severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
WARNING DO NOT use Control-IQ technology in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect the performance of the System. Sensor glucose readings may be inaccurate in critically ill patients, and solely relying on the sensor glucose alerts and readings for treatment decisions could result in you missing severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
WARNING Control-IQ technology can only adjust insulin delivery when your CGM is in range. If you go out of range during insulin adjustment, your basal insulin delivery will revert to the Basal Rate settings in your active Personal Profile, limited to 3 units/hr. In order to receive more than 3 units/hour while the sensor is not communicating with the pump, turn Control-IQ technology off.
WARNING If a sensor session is ended, either automatically or manually, Control-IQ technology is unavailable and will not adjust insulin. In order for Control-IQ technology to be enabled, a sensor session must be started and transmitting sensor values to the pump based on a sensor code or sensor calibration.
WARNING AVOID using manual injections, or inhaled insulins, while using Control-IQ technology. Using insulin not provided by the pump while using closed loop therapy can cause the system to over delivery or under delivery of insulin, which can lead to severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
WARNING DO NOT use Control-IQ technology if you are taking hydroxyurea, a medication used in the treatment of diseases including cancer and sickle cell anemia. The use of hydroxyurea will result in sensor glucose readings that are higher than actual glucose levels. The level of inaccuracy in sensor glucose readings is based on the amount of hydroxyurea in the body. Control-IQ technology relies on sensor glucose readings to adjust insulin, provide automatic correction boluses, and provide high and low
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glucose alerts. If Control-IQ technology receives sensor readings that are higher than actual glucose values, it could result in missed hypoglycemia alerts and errors in diabetes management, such as delivery of excess basal insulin and correction boluses, including automatic correction boluses. Hydroxyurea can also result in errors when reviewing, analyzing and interpreting historical patterns for assessing glucose control.
27.2 Control-IQ Precautions
PRECAUTION If you remove your pump for a period of time, up to 30 minutes or longer, it is recommended that you turn off Control-IQ technology to potentially save insulin. The feature will continue to operate while the pump is removed and will continue to dose insulin if transmitted glucose values rise.
PRECAUTION We recommend that you keep the CGM Out of Range Alert turned on to notify you if your CGM is disconnected from your pump whenever you are not actively monitoring your pump status. Your CGM is providing the data that Control-IQ technology requires to make predictions to automate insulin dosing.
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4 Control-IQ Technology Features
CHAPTER 28
Getting to Know Control-IQ Technology
CHAPTER 28 · Getting to Know Control-IQ Technology 28.1 Responsible Use of Control-IQ
Technology Systems like the t:slim X2 insulin pump with Control-IQTM technology are not substitutes for the active management of diabetes, including manually bolusing for meals. There are common scenarios in which automated systems cannot prevent a hypoglycemic event. Control-IQ technology relies on current CGM sensor readings to function and will not be able to predict sensor glucose values and suspend insulin delivery if a patient's CGM is not functioning properly or their pump is unable to receive the CGM signal. Patients should be instructed to always use the components of the pump system (pump, cartridges, CGM, and infusion sets) according to the applicable instructions for use and check them regularly to make sure they are functioning as expected. Patients should always pay attention to their glucose values, actively monitor and manage blood glucose, and treat accordingly.
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28.2 Explanation of Control-IQ Technology Icons
If you have a CGM session active and are using Control-IQ technology, you may see the following additional icons on your pump screen: Control-IQ Technology Icon Definitions
Symbol
Meaning
Control-IQ technology is enabled but not actively increasing or decreasing basal insulin delivery.
Symbol Meaning Basal insulin is programmed and being delivered.
Control-IQ technology is increasing basal insulin delivery.
Control-IQ technology is increasing basal insulin delivery.
Control-IQ technology is decreasing basal insulin delivery.
Control-IQ technology has stopped basal insulin delivery.
BOLUS
Control-IQ: 2.8 u
Control-IQ technology is delivering an automatic correction bolus (or an automatic bolus).
The Sleep Activity is enabled.
Control-IQ technology is decreasing basal insulin delivery.
Basal insulin delivery is stopped and a Basal Rate of 0 u/hr is active. Control-IQ technology is delivering an automatic correction bolus (or an automatic bolus).
The Exercise Activity is enabled.
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CHAPTER 28 · Getting to Know Control-IQ Technology 28.3 Control-IQ Lock Screen The Control-IQ Lock screen appears any time you turn on the screen and you are using your pump with a CGM and Control-IQ technology enabled. The Control-IQ Lock screen is the same as the CGM Lock screen, with the following additions. See Section 18.3 CGM Lock Screen. 1. Control-IQ Technology Status:
Indicates the status of Control-IQ technology. 2. CGM Graph Shading: Red shading indicates Control-IQ technology is, or was, delivering 0 units of for the period indicated.
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CHAPTER 28 · Getting to Know Control-IQ Technology 28.4 Control-IQ Home Screen The Home screen with Control-IQ technology enabled is identical to the CGM Home screen, with the following additions. See Section 18.4 CGM Home Screen. 1. Control-IQ Technology Status:
Indicates the status of Control-IQ technology. 2. Control-IQ Activity Status: Indicates an Activity has been enabled. 3. CGM Graph Shading: Red shading indicates Control-IQ technology is, or was, delivering 0 units of insulin for the period indicated.
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28.5 Control-IQ Screen
1. Control-IQ Technology on/off: Turns on, or off, Control-IQ technology.
2. Weight: Displays your current weight. This value is manually entered in on the numerical keypad.
NOTE Control-IQ Weight: Your weight should be representative of what you weigh when you start the system. Weight can be updated when you visit your healthcare provider. The minimum value for weight is 25 kgs (55 lbs).
3. Total Daily Insulin: Displays your current total daily insulin value in units. This value is manually entered in on the numerical keypad.
NOTE Control-IQ Total Daily Insulin: If you do not know your Total Daily Insulin (TDI), speak with your healthcare provider to get this value. The minimum value for TDI is 10 u.
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4 Control-IQ Technology Features
CHAPTER 29
Introduction to Control-IQ Technology
CHAPTER 29 · Introduction to Control-IQ Technology
29.1 Control-IQ Technology Overview
Control-IQTM technology is a feature of the t:slim X2TM pump that automatically adjusts insulin delivery rates and amounts in response to readings from a CGM. The pump can be used with or without Control-IQ technology enabled. The following sections describe how Control-IQ technology works and how it responds to CGM values while you are awake, sleeping, and exercising.
PRECAUTION You must continue to take boluses to cover food eaten or to correct a high glucose value. Read all Control-IQ technology instructions before activating Control-IQ technology.
NOTE Target CGM Ranges: The target CGM ranges used by Control-IQ technology are not customizable.
NOTE Control-IQ Technology and Temp Basal Rate: Before activating a Temp Rate (see Section 5.9 Starting a Temporary Basal Rate), you must turn off Control-IQ technology.
NOTE Insulin On Board (IOB) Time Remaining: The Insulin On Board (IOB) Time Remaining, which indicates how long the total units of insulin from food and correction boluses will be active in the body, is not displayed when Control-IQ technology is enabled due to the variability of insulin delivery when automatically responding to CGM values. The IOB units will always be displayed on the Home and Lock screens.
29.2 How Control-IQ Technology Works
WARNING Control-IQ technology is not a substitute for understanding and being ready at any time to take over manual control of your current or future diabetes therapy.
WARNING Control-IQ technology is not designed to prevent all hypoglycemia (low BG) or hyperglycemia (high BG).
WARNING Control-IQ technology adjusts the delivery of insulin, but does not treat low BG. Always pay attention to your symptoms, manage your BG
level, and treat according to the recommendations of your healthcare provider.
WARNING Do not use Control-IQ technology unless recommended by your healthcare provider.
WARNING Do not use Control-IQ technology until you have received training.
WARNING Control-IQ technology relies on current CGM sensor readings and will not be able to accurately predict BG levels and adjust insulin delivery if for any reason your CGM is not functioning properly or does not transmit three of the last four sensor values to your pump.
PRECAUTION We recommend that you enable the High Glucose Alert and the Low Glucose Alert when using Control-IQ technology so that you will be notified if sensor glucose readings are outside of your target range, and you can treat high or low BG according to your healthcare provider's recommendations.
Control-IQ technology responds to the actual CGM readings as well as
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predicts CGM values 30 minutes in the future. Insulin delivery is automatically adjusted based on the predicted CGM value, your active Personal Profile, and whether or not a Control-IQ technology Activity is enabled.
NOTE Enabling Control-IQ Technology Activity: Control-IQ technology Activity types are not automatically enabled and must be set up as a scheduled occurrence or turned on as needed. For more information, see sections 30.5 Schedule Sleep, 30.7 Manually Start or Stop Sleep, and 30.8 Manually Start or Stop Exercise.
Control-IQ technology adjusts insulin delivery in several ways. It will decrease or suspend insulin delivery when predicted glucose values are below the target, increase insulin delivery when predicted glucose values are above target, and automatically deliver up to 60% of a correction bolus once per hour, as needed. There are maximum insulin delivery limits based on your Personal Profile settings. These different insulin delivery actions are described below. Each of the insulin delivery adjustments occurs in different ways depending on whether you are
sleeping, exercising, or neither. For more detail on how insulin adjustments are made for different activities see Sections Control-IQ Technology With No Activity Enabled, Control-IQ Technology During Sleep, and Control-IQ Technology During Exercise in this chapter. Personal Profile Basal Rate Delivery When the predicted CGM value is within the target range, the pump will deliver insulin at the rate determined by the active Personal Profile settings. All Personal Profile settings must be completed in order to use Control-IQ technology. See Chapter 5 Insulin Delivery Settings for more information about Personal Profiles. Decreased Insulin Delivery When Control-IQ technology predicts that your glucose value will be at or below the target range 30 minutes in the future, the rate of insulin delivered will begin to decrease to attempt to keep the actual glucose values within the target range. The following diagrams depict how the system uses
30 minute predictions to gradually decrease insulin delivery compared to the personal profile Basal Rate. The diagram on the left depicts the prediction, the diagram on the right depicts how the insulin and CGM readings might look if the CGM graph continued on the trend.
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Current Reading
30-minute Prediction
6.25 CGM SENSOR READINGS
6.25 CGM SENSOR READINGS
INSULIN DELIVERY
INSULIN DELIVERY
5-minute Interval
CGM Prediction
Personal Profile Basal Rate
Control-IQ Decreased Basal Rate
NOTE Diagrams are Illustrative: Diagrams are for illustrative purposes only and are not intended to reflect actual results.
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Insulin Decreased or Delivering 0 Units per Hour
Control-IQ technology can reduce the basal delivery to a percent of the Basal Rate in addition to completely suspending. When Control-IQ technology predicts that your glucose value will be lower than the target range 30 minutes in the future, insulin delivery will decrease and may set the Basal Rate at 0 units per hour if necessary, to attempt to keep the actual glucose values within the target range. Manual boluses can still be delivered when Control-IQ technology is decreasing or suspending insulin. The following diagrams depict an illustration of when Control-IQ technology might set the insulin delivery rate to 0 units per hour, and when it will resume at a decreased rate after the 30 minute prediction is above the target glucose value.
NOTE When Control-IQ technology sets the Basal Rate to 0 units per hour, bolus deliveries will continue. This includes starting a new bolus and any remaining bolus from an extended bolus delivery.
CHAPTER 29 · Introduction to Control-IQ Technology
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CHAPTER 29 · Introduction to Control-IQ Technology
Current Reading
30-minute Prediction
Delivery at 0 u/hr
Delivery Resumed
30-minute Prediction
3.9 CGM SENSOR READINGS
3.9 CGM SENSOR READINGS
INSULIN DELIVERY
5-minute Interval
INSULIN DELIVERY
CGM Prediction
Control-IQ Decreased Basal Rate
NOTE Diagrams are Illustrative: Diagrams are for illustrative purposes only and are not intended to reflect actual results.
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Increasing Insulin Delivery When Control-IQ technology predicts that your glucose value will be above the upper limit of the targeted range 30 minutes in the future, the rate of insulin delivered will begin to increase to attempt to keep the actual CGM values within the target CGM range. The following diagrams depict when Control-IQ technology might be increasing and delivering at the maximum increased Basal Rate. Maximum Insulin Delivery When Control-IQ technology predicts that your glucose value will be above the upper limit of the target range 30 minutes in the future, but the maximum rate of insulin delivery has been reached, Control-IQ technology stops increasing the insulin delivery rate. The maximum insulin delivery rate is a calculated value that is dependent on an individual's Correction Factor setting (found in the active Personal Profile), the Total Daily Insulin estimated by Control-IQ technology based on actual total daily insulin values, and the current insulin on board (IOB).
CHAPTER 29 · Introduction to Control-IQ Technology
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Current Reading
30-minute Prediction
Current Reading
8.9 CGM SENSOR READINGS
8.9 CGM SENSOR READINGS
INSULIN DELIVERY
INSULIN DELIVERY
Personal Profile Basal Rate
5-minute Interval
CGM Prediction
Control-IQ Increased Basal Rate
Control-IQ Max Basal Rate
NOTE Diagrams are Illustrative: Diagrams are for illustrative purposes only and are not intended to reflect actual results.
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30-minute Prediction
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Automatic Correction Bolus Delivery When Control-IQ technology predicts that your CGM value will be at or above 10 mmol/L 30 minutes in the future, and when Control-IQ technology is either Increasing Insulin Delivery or delivering Maximum Insulin Delivery, the pump will automatically deliver correction boluses to attempt achieve the target range. The automatic correction bolus will deliver 60% of the total correction bolus calculated based on the Personal Profile Correction Factor and predicted CGM reading. The target glucose for the automatic correction bolus is 6.1 mmol/L. Automatic bolus delivery occurs at most once every 60 minutes and will not be delivered within 60 minutes of the start, cancellation, or completion of an automatic bolus or a manual bolus. For an extended bolus, this 60 minutes does not start until the DELIVER NOW duration has completed. The percentage and duration between boluses are designed to avoid insulin stacking that may cause unsafe reductions in glucose values.
NOTE Automatic Correction Bolus Delivery: Each automatic correction bolus delivery can be manually canceled or stopped during the delivery in the same way that a manual bolus can be stopped. See Section 7.9 Canceling or Stopping a Bolus.
NOTE Maximum Automatic Correction Bolus: The maximum amount of insulin that an automatic correction bolus will deliver is 6 units. This value cannot be increased, but you may choose to deliver a manual bolus after the automatic correction bolus delivery is complete.
PRECAUTION The pump does not activate sound or vibration to indicate when an automatic correction bolus delivery has started. The following pump screen
icon and message indicate that an automatic correction bolus is being delivered.
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10.0
Current Reading
30-minute Prediction
CGM SENSOR READINGS INSULIN DELIVERY
5-minute Interval
CGM Prediction
Personal Profile Basal Rate
Control-IQ Increased Basal Rate
Control-IQ Max Basal Rate
Automatic Correction Bolus
NOTE Diagrams are Illustrative: Diagrams are for illustrative purposes only and are not intended to reflect actual results.
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29.3 Control-IQ Technology and Activity
When Control-IQ technology is turned on you can choose to activate Sleep Exercise to help the System adjust Control-IQ technology settings as described in previous sections. If you have not started either Sleep or Exercise, the System will use the settings described in the following section. Control-IQ Technology With No Activity Enabled The CGM range targeted by Control-IQ technology with no Activity enabled is 6.258.9 mmol/L. This range is wider than the Sleep Activity and Exercise Activity ranges to account for the variability of factors that affect CGM values while people are awake and not exercising. Decreasing Insulin With No Activity Enabled Insulin is decreased when Control-IQ technology predicts a CGM reading of 6.25 mmol/L 30 minutes in the future.
Suspended Insulin With No Activity Enabled Insulin is set to 0 units/hour when Control-IQ technology predicts a CGM reading 3.9 mmol/L 30 minutes in the future. Increasing Insulin With No Activity Enabled Insulin is increased when Control-IQ technology predicts a CGM reading of 8.9 mmol/L 30 minutes in the future. Automatic Correction Bolus With No Activity Enabled When no Activity is enabled, Control-IQ technology will deliver automatic correction boluses as described in the Automatic Correction Bolus Delivery section of this chapter. Control-IQ Technology During Sleep The Control-IQ technology Sleep Activity range is targeted during scheduled sleep times and when the Sleep Activity is manually started (until it is stopped). See Chapter 30 Configure and Use Control-IQ Technology and see Section Activate a Sleep Schedule for instructions on setting the hours you
plan to sleep and Section Manually Start Sleep for starting Sleep manually in that chapter. The CGM range targeted by Control-IQ technology during the Sleep Activity is 6.25 mmol/L6.7 mmol/L. This range is smaller than the target range with no Activity enabled since there are fewer variables that affect CGM values while you are sleeping. During the Sleep Activity, Control-IQ technology will not deliver automatic boluses. Decreasing Insulin During Sleep Insulin is decreased when Control-IQ technology predicts a CGM reading of 6.25 mmol/L 30 minutes in the future. Suspended Insulin During Sleep Insulin is set to 0 units/hour when Control-IQ technology predicts a CGM reading 3.9 mmol/L 30 minutes in the future. Increasing Insulin During Sleep Insulin is increased when Control-IQ technology predicts a CGM reading of 6.7 mmol/L 30 minutes in the future.
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Automatic Correction Bolus During Sleep Activity
Automatic correction boluses will not be delivered while Sleep is enabled.
NOTE Sleep Duration: The ability for Control-IQ technology to achieve the sleep target CGM range is partially dependent on how long you sleep. In order for Control-IQ technology to operate ideally, you should start Sleep (or schedule sleep) when you plan to sleep at least 5 consecutive hours. For example, you do not need to start Sleep if you plan to nap for less than five hours.
NOTE Sleeping Less than Five Hours: If you sleep less than 5 hours, Control-IQ technology may not be able reach or maintain actual CGM values within the sleep target range. However, if you wake up intermittently during your sleep period, do not feel the need to turn off Sleep.
When Control-IQ technology switches back to the settings with no Activity enabled, whether according to scheduled wake time or due to manually stopping Sleep, the transition from the targeted sleep CGM range to
targeted settings with no Activity enabled CGM range occurs slowly and can take 30-60 minutes. This helps ensure that actual CGM values transition gradually. Control-IQ Technology During Exercise During the Exercise Activity, Control-IQ technology uses the target CGM range 7.8 mmol/L8.9 mmol/L. This target range is smaller and higher than the target range with no Activity enabled to accommodate the likely natural drop in glucose following exercise. If the Exercise Activity is on when a Sleep Schedule is due to begin, the Sleep Schedule does not start. In this scenario you must manually start Sleep once you turn Exercise off. Decreasing Insulin During Exercise Insulin is decreased when Control-IQ technology predicts a CGM reading of 7.8mmol/L 30 minutes in the future. Suspended Insulin During Exercise Insulin is set to 0 units/hour when Control-IQ technology predicts a CGM
reading 4.4 mmol/L 30 minutes in the future. Increasing Insulin During Exercise Insulin is increased when Control-IQ technology predicts a CGM reading of 8.9 mmol/L 30 minutes in the future. Automatic Correction Bolus During Exercise Activity When the Exercise Activity is enabled, Control-IQ technology will deliver automatic correction boluses as described in the Automatic Correction Bolus Delivery section of this chapter. See Chapter 30 Configure and Use Control-IQ Technology for instructions on starting or stopping Exercise.
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CHAPTER 30
Configure and Use Control-IQ Technology
CHAPTER 30 · Configure and Use Control-IQ Technology
30.1 Required Settings
Required Personal Profile Settings In order to use Control-IQTM technology, the following Personal Profile settings must be configured. See Chapter 5 Insulin Delivery Settings for instructions about setting these values. · Basal Rate · Correction Factor · Carb Ratio · Target BG · Carbohydrates turned on in Bolus
Settings Required Control-IQ Technology Pump Settings In addition to the required Personal Profile settings, there are two values specific to Control-IQ technology that must be set. These are: · Weight · Total Daily Insulin
Recommended Control-IQ Technology Pump Settings Although Sleep can be started and stopped manually, it is recommended that you schedule Sleep. This chapter explains how to do both. The following settings are required to schedule Sleep: · Selected Days · Start Time · End Time
30.2 Set Control-IQ Technology Weight
Control-IQ technology cannot be turned on unless Weight is entered. The Weight value may be updated when you visit your healthcare provider. 1. From the Home screen, tap
OPTIONS. 2. Tap My Pump. 3. Tap Control-IQ. The Control-IQ screen is displayed.
4. Tap Weight. 5. Tap Pounds or Kilograms to set
the unit of weight. 6. Tap . 7. Enter the weight value on the
numeric keypad. 8. Tap . 9. If you are done with the Control-IQ
settings, tap . The SETTING SAVED screen is
temporarily displayed.
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30.3 Set Total Daily Insulin
Control-IQ technology cannot be turned on unless Total Daily Insulin is entered. The Total Daily Insulin value is used by Control-IQ technology to calculate the maximum insulin delivery rate and to maintain a safe and effective increase in insulin dose.
The Total Daily Insulin value may be updated when you visit your healthcare provider.
NOTE Total Daily Insulin: Once you have used Control-IQ technology, it will maintain and use the actual total insulin delivered, including the adjustments made to basal and all types of boluses while using the System. It is important to update the Total Daily Insulin setting in the Control-IQ screen when you visit your healthcare provider. This value is used for the 2-hour maximum insulin alert.
An estimate of Total Daily Insulin should be entered. Include all types of insulin (basal and bolus) delivered in a 24-hour period. Consult your healthcare
provider if you need assistance estimating your insulin requirements. Enter your Total Daily Insulin Value 1. From the Home screen, tap
OPTIONS. 2. Tap My Pump. 3. Tap Control-IQ. 4. Tap Total Daily Insulin. 5. Use the numeric keypad to enter
the total units of insulin typically required in a 24-hour period. 6. Tap . 7. If you are done with the Control-IQ settings, tap . The SETTING SAVED screen is temporarily displayed. 8. When you are done setting up Control-IQ, tap the Tandem logo to return to the CGM Home screen.
30.4 Turn Control-IQ Technology On or Off
1. From the Home screen, tap OPTIONS.
2. Tap My Pump.
3. Tap Control-IQ.
4. To turn Control-IQ on, tap the toggle next to Control-IQ.
NOTE Active Temp Rate or Extended Bolus: If an active Temp Rate or extended bolus is active when you turn Control-IQ technology on, you will be notified that if you continue the Temp Rate or extended bolus will be stopped.
5. To turn Control-IQ off, tap the toggle next to Control-IQ.
Tap to confirm and turn Control-IQ off.
Tap to leave Control-IQ on.
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30.5 Schedule Sleep
Control-IQ technology operates differently during Sleep than with no Activity or Exercise enabled. Sleep can be scheduled to turn on and off automatically, or it can be turned on and off manually. This section covers how to set Sleep to turn on and off automatically. For detailed information about how to use Control-IQ technology, see Chapter 29 Introduction to Control-IQ Technology.
You can configure two different Sleep Schedules to account for changes in lifestyle, such as a weekday Sleep Schedule and a weekend Sleep Schedule.
NOTE Manual Sleep Start/Stop: If you manually start Sleep before a Sleep Schedule begins, it does not impact the scheduled wake time. For example, if your Sleep Schedule is set from 22:00 to 6:00 (10pm to 6am), and you start Sleep manually at 21:00 (9pm), Sleep will end at 6:00 (6am) as scheduled; unless manually stopped.
NOTE Scheduled Sleep and Exercise: If Exercise is active at the time Sleep is scheduled to start, Sleep will not begin. Once Exercise is turned off, you need to manually start Sleep or wait until the next scheduled sleep cycle.
NOTE Sleeping Less than 5 Hours: If you sleep less than five hours, Control-IQ technology may not be able reach or maintain CGM values within the sleep target range. Do not turn Sleep on if you will be sleeping for less than five hours. However, if you wake up intermittently during your sleep period, do not feel the need to turn off Sleep.
1. From the Home screen, tap OPTIONS.
2. Tap Activity.
3. Tap Sleep Schedules.
4. Select which Sleep Schedule to configure.
If no Sleep Schedules are configured, tap Sleep Schedule 1.
If you are editing an existing schedule, tap the schedule summary that displays to the right of the Sleep Schedule you want to edit.
5. On the Sleep Schedule screen, tap Selected Days. The default is the current day of the week only, according to the day of the week set on the pump.
6. On the Select Days screen, tap the checkmark to the right of each day of the week that you want included in the Sleep Schedule. When a checkmark is green, the corresponding day of the week is active. To deactivate a day, tap the
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associated checkmark again so that it turns gray. Tap the Down Arrow to see more days of the week.
7. When you are finished selecting the days, tap . NOTE No Days Selected: If no days are selected when you tap , the schedule is set to off and the remaining Sleep Schedule settings are not displayed. The remaining instructions do not apply to an incomplete schedule.
8. Tap Start Time.
9. Tap Time. The numbered keypad is displayed.
10. Enter the time you would like the Sleep Schedule to start by entering the number(s) for the hour followed by the minutes. For example, tap 9 3 0 to set the time to 9:30 or 2 1 0 0 to set the time to 21:00.
11. Tap . You are returned to the Start Time screen.
12. Tap AM or PM to set the Time of Day, if applicable.
13. Tap . You are returned to the Sleep Schedule 1 screen.
14. Tap End Time. 15. Tap Time. The numbered keypad is
displayed. 16. Enter the time you would like the
Sleep Schedule to end and tap . You are returned to the End
Time screen. 17. Tap AM or PM to set the Time of
Day, if applicable.
18. Tap . The Sleep Schedule 1 screen is displayed.
19. Tap to save the schedule. The SETTING SAVED screen is
temporarily displayed, followed by the Sleep Schedules screen. 20. When you are done configuring sleep, press to return to the Activity screen or tap the Tandem logo to return to the Home screen.
30.6 Activate or Deactivate a Sleep Schedule
Once a Sleep Schedule is configured, it is activated by default when it is saved. If you have multiple Sleep Schedules configured, you can change the active Sleep Schedule or turn them off completely. Activate a Sleep Schedule 1. From the Home screen, tap
OPTIONS. 2. Tap Activity.
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3. Tap Sleep Schedules. 4. Tap the schedule summary next to
the name of the Sleep Schedule you want to activate. (If no sleep schedules are configured, see Section 30.5 Schedule Sleep.) 5. Tap the toggle next to the schedule name. 6. Tap . Deactivate a Sleep Schedule 1. From the Home screen, tap OPTIONS. 2. Tap Activity. 3. Tap Sleep Schedules.
Tap the schedule summary next to the Sleep Schedule you want to deactivate.
4. Tap the toggle. 5. Tap . 30.7 Manually Start or Stop Sleep In addition to scheduling Sleep, Sleep can be manually started and/or stopped. Sleep time determines when Control-IQ technology, if enabled, switches to the Sleep Activity. Control-IQ technology must be on and a CGM session must be active to start Sleep.
Manually Start Sleep 1. From the Home screen, tap
OPTIONS. 2. Tap Activity. 3. Tap the START text next to Sleep.
A SLEEP STARTED screen is temporarily displayed. The Sleep icon is displayed on the Home screen.
Manually Stop Sleep 1. From the Home screen, tap
OPTIONS. 2. Tap Activity.
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3. Tap the STOP text next to Sleep.
A SLEEP STOPPED message is temporarily displayed. The Sleep icon is removed from the Home screen.
30.8 Manually Start or Stop Exercise
Start Exercise 1. From the Home screen, tap
OPTIONS. 2. Tap Activity. 3. Tap the START text next to
Exercise.
CHAPTER 30 · Configure and Use Control-IQ Technology
An EXERCISE STARTED message is temporarily displayed. The Exercise icon is displayed on the Home screen.
Stop Exercise 1. From the Home screen, tap
OPTIONS. 2. Tap Activity. 3. Tap the STOP text next to
Exercise. An EXERCISE STOPPED message
is temporarily displayed. The Exercise icon is removed from the Home screen.
30.9 Control-IQ Technology Information on Your Screen
Control-IQ Technology Status Icon When Control-IQ technology is on, the CGM Trend Graph displays a diamond icon in the top left corner. This icon uses different colors to communicate information about how Control-IQ technology is operating. Each different
color and its meaning can be found in Section 28.2 Explanation of Control-IQ Technology Icons. When Control-IQ technology is on but not active (i.e. insulin is being delivered normally), the diamond icon is gray as depicted below. Regardless of the color, the icon always appears in the same place.
Exercise and Sleep Icons When Exercise or Sleep is turned on, the respective icon displays in the same place on the screen, since they can never be active at the same time. The following image shows the Sleep icon
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active on the CGM Trend Graph screen.
The following image highlights where the basal status icons display.
appearing below BOLUS indicates that there is an automatic correction bolus delivered by Control-IQ technology. The amount of the bolus is also displayed.
When Exercise is on, the Exercise icon is displayed in the same location. Basal Status Icons There are several basal status icons that display in different colors, each of which communicates information about how Control-IQ technology is operating. Each different color and its meaning can be found in Section 28.2 Explanation of Control-IQ Technology Icons.
Automatic Correction Bolus Status Icon
When Control-IQ technology is on and delivering an automatic correction bolus, an icon displays to the left of the basal status icon. (The manual bolus icon displays in the same place on the screen; see the Section 3.3 Explanation of t:slim X2 Insulin Pump Icons for the manual bolus icon image.) The following image shows the location of the bolus icon.
NOTE Control-IQ Technology Bolus Indicator: The text BOLUS followed by 3 ellipses displays below the CGM graph. The Control-IQ text
CGM Trend Graph Insulin Delivery Suspended Portions of the CGM Trend Graph that display a red band in the background indicate the times when Control-IQ technology was delivering 0 units/hour.
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Each dot on the CGM graph represents a five-minute increment.
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CHAPTER 31
Control-IQ Technology Alerts
CHAPTER 31 · Control-IQ Technology Alerts Information in this section will help you learn how to respond to Control-IQTM technology alerts and errors. It applies only to the Control-IQ technology within your System. The Control-IQ technology alerts follow the same pattern as other pump alerts according to your Sound Volume selection. For information on insulin delivery reminders, alerts, and alarms see Chapters 12 t:slim X2 Insulin Pump Alerts, 13 t:slim X2 Insulin Pump Alarms, and 14 t:slim X2 Insulin Pump Malfunction. For information on CGM Alerts and Errors, see Chapter 25 CGM Alerts and Errors.
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31.1 Out of Range Alert Control-IQ Technology Off
Screen What will I see on the screen?
Explanation What does it mean? How will the System notify me? Will the System re-notify me? How should I respond?
The transmitter and pump are not communicating. The pump will not receive sensor glucose readings, and Control-IQ technology is not able to predict glucose levels or adjust insulin delivery.
1 vibrate, then vibration/beep every 5 minutes until the transmitter and pump are back in range.
Yes, if the transmitter and pump remain out of range.
Tap OK to confirm and move the transmitter and pump closer together, or remove the obstruction between them.
WARNING
Control-IQ technology can only adjust insulin delivery when your CGM is in range. If you go out of range during insulin adjustment, your basal insulin delivery will revert to the Basal Rate settings in your active Personal Profile, limited to 3 units/hr. In order to receive more than 3 units/hour while the sensor is not communicating with the pump, turn Control-IQ technology off.
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31.2 Out of Range Alert Control-IQ Technology On
Screen What will I see on the screen?
Explanation
What does it mean?
How will the System notify me? Will the System re-notify me? How should I respond?
Control-IQ technology is turned on, but the transmitter and pump are not communicating. The pump will not receive sensor glucose readings. Control-IQ technology will continue to adjust Basal Rates and deliver automatic correction boluses for the first 20 minutes that the transmitter and pump are out of range. Control-IQ technology will resume automated insulin dosing once the transmitter and pump are back within range.
1 vibrate, then vibration/beep every 5 minutes until the transmitter and pump are back in range.
Yes, if the transmitter and pump remain out of range.
Tap OK to confirm and move the transmitter and pump closer together, or remove the obstruction between them.
WARNING
Control-IQ technology can only adjust insulin delivery when your CGM is in range. If you go out of range during insulin adjustment, your basal insulin delivery will revert to the Basal Rate settings in your active Personal Profile, limited to 3 units/hr. In order to receive more than 3 units/hour while the sensor is not communicating with the pump, turn Control-IQ technology off.
NOTE
Out Range Alert and Control-IQ Technology: It is recommended that you keep the Out of Range Alert turned on and set to 20 minutes. If your pump and CGM are not connected for 20 minutes, Control-IQ technology will not work. Control-IQ technology will begin working immediately when the transmitter and pump are back within range.
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31.3 Control-IQ Technology Low Alert
Screen What will I see on the screen?
Explanation What does it mean?
How will the System notify me? Will the System re-notify me?
Control-IQ Low Alert has predicted that your glucose reading will drop below 3.9 mmol/L, or below 4.4 mmol/L if Exercise is enabled, in the next 15 minutes.
2 vibrations, then 2 vibrations/beeps every 5 minutes until acknowledged.
Yes, every 5 minutes until acknowledged.
How should I respond?
Eat carbs and test your BG. Tap OK to close the alert screen.
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31.4 Control-IQ High Alert
Screen What will I see on the screen?
Explanation What does it mean?
How will the System notify me? Will the System re-notify me? How should I respond?
Control-IQ technology has three hours of CGM data available and has increased insulin delivery, but detects a glucose reading above 11.1 mmol/L and does not predict that the glucose reading will decrease in the next 30 minutes.
2 vibrations, then 2 vibrations/beeps every 5 minutes until acknowledged.
Yes, every 5 minutes until acknowledged.
Check your cartridge, tubing, and site, and test your BG. Treat your high glucose as necessary. Tap OK to close the alert screen.
282
31.5 Max Insulin Alert
Screen What will I see on the screen?
CHAPTER 31 · Control-IQ Technology Alerts
Explanation
What does it mean?
How will the System notify me? Will the System re-notify me? How should I respond?
The pump has delivered the maximum allowable 2 hour insulin amount based on your Total Daily Insulin setting. You see this alert when Control-IQ technology has delivered 50% of your Total Daily Insulin (through basal and/or bolus deliveries) over the previous rolling 2 hour window, and detects this condition for 20 minutes in a row. Control-IQ technology will suspend insulin delivery for a minimum of 5 minutes, and then resume insulin delivery once the condition is no longer detected.
2 vibrations, then 2 vibrations/beeps every 5 minutes until acknowledged.
Yes, every 5 minutes until acknowledged.
Tap . OK
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This Page is Intentionally Left Blank
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4 Control-IQ Technology Features
CHAPTER 32
Overview of Control-IQ Technology Clinical Studies
CHAPTER 32 · Overview of Control-IQ Technology Clinical Studies
32.1 Introduction The following data represents the clinical performance of the t:slim X2TM insulin pump with Control-IQTM technology in two studies. The first pivotal study (the DCLP3) included participants 14 years old. A second pivotal study (the DCLP5) included partipants 6 years to 13 years old. In both studies, the t:slim X2 insulin pump with Control-IQ technology was compared to Sensor Augmented Pump (SAP) therapy alone (the control group). All participants in the both studies used the Dexcom G6 CGM. 32.2 Clinical Study Overview The goal of this study was to assess the safety and efficacy of Control-IQ technology when used 24-hours a day for 4 to 6-months under normal conditions. The system performance was evaluated in these two randomized controlled trials comparing the use of Control-IQ technology to the use of SAP over the same period of time. The two trials were performed in the United
States. The two study protocols were very similar. In the DCLP3, participants (N=168) were randomly assigned to use Control-IQ or SAP of the study in a 2:1 ratio. The Control-IQ group included 112 participants, and the SAP group included 56 participants. All 168 participants completed the trial. The study population consisted of patients with a clinical diagnosis of type 1 diabetes, 14 to 71 years of age, treated with insulin via an insulin pump or injections for at least one year. Females known to be pregnant or breastfeeding were not included. The summary statistics presented here describe the primary outcome measure of the glucose time in range between 3.910 mmol/L, reported by treatment group. Analysis of the secondary endpoints and additional metrics was also performed. In the DCLP5, participants (N=101) were randomly assigned to Control-IQ or SAP in a 3:1 ratio. In this study, the Control-IQ group included 78 participants, and the SAP group included 23 participants. The study population was similar to the DCLP5 in that participants had a clinical diagnosis
of type 1 diabetes, but they were younger; 6 to 13 years of age. They were treated with insulin via an insulin pump or injections for at least one year. They weighed 25 kg and 140 kg and took at least 10 units of insulin/day. Females known to be pregnant or breastfeeding were not included. Participants were required to be living with at least one parent or guardian knowledgeable about diabetes and managing diabetes-related emergencies and willing to participate in all training sessions. No participants with the following conditions were enrolled in the DCLP5 study: · Inpatient psychiatric treatment in
the past 6 months · Presence of a known adrenal
disorder · Untreated thyroid disease · Cystic fibrosis · Severe infectious process not
anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis)
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· Any skin condition in the area of insertion that prevents safe sensor or pump placement (e.g. bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, cellulitis)
· Use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication, or disease in the judgment of the investigator will affect the completion of the protocol
· Abnormal liver function tests (transaminase > 3 times the upper limit of normal)
· Abnormal renal function test results (estimated GFR <60 mL/min/1.73m2)
The safety and/or effectiveness of Control-IQ in pediatric users with the conditions above is unknown. During the clinical study, subjects were given an opportunity to complete a training period to become comfortable with the t:slim X2 insulin pump and CGM prior to being randomized into the
study. Eighty-three (83) participants in the DCLP3 and 68 participants in the DCLP5 declined the training, while 85 participants in the DCLP3 and 33 participants in the DCLP5 completed the training. Those that completed the training were primarily new to either pump or CGM therapy, or both. There was one episode of Diabetic Ketoacidosis (DKA), caused by infusion site failure, observed in the Control-IQ group in the DCLP3. There were no episodes of DKA in the DCLP5. There were no severe hypoglycemic events in either group. Most subjects in both clinical studies had not experienced a severe hypoglycemic event (including seizures and/or loss of consciousness) or diabetic ketoacidosis event in the prior 12 months.
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32.3 Demographics
Baseline characteristics including demographics of the study participants are provided in the table below. Results of all subgroup analyses indicate that the Control-IQ technology treatment effect is similar across the distribution of age, race and income. There is no evidence to suggest that baseline demographics are associated with more or less benefit or risk from the use of the t:slim X2 insulin pump with Control-IQ technology. DCLP3: Baseline Characteristics including Demographics at Enrollment (N=168)
Characteristic Age (years)
Mean ± SD Range <18 years 18 years Sex Female n (%) Race / Ethnicity* White non-Hispanic Black / African American Asian Native Hawaiian / Other Pacific Islander More than one race
Control-IQ (n=112)
33 ± 16 14 to 71 31 (28%) 81 (72%) 54 (48%)
94 (86%) 4 (4%) 3 (3%) 1 (<1%) 7 (6%)
SAP (n=56)
33 ± 17 14 to 63 17 (30%) 39 (70%) 30 (54%)
53 (95%) 0 (0%) 2 (4%) 0 (0%) 1 (2%)
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DCLP3: Baseline Characteristics including Demographics at Enrollment (N=168) (Continued)
Characteristic
Control-IQ (n=112)
SAP (n=56)
Income (United States Dollar)
<$50,000
10 (11%)
2 (4%)
$50,000 <$100,000
24 (27%)
18 (36%)
$100,000 Education
55 (62%)
30 (60%)
High School Diploma
3 (3%)
6 (11%)
Associates Degree or Some College
13 (12%)
7 (13%)
Bachelor's Degree
51 (46%)
21 (38%)
Master's Degree
32 (28%)
17 (30%)
Doctoral or Professional Degree Health Insurance§
13 (12%)
5 (9%)
Private
102 (94%)
50 (91%)
CHP or another government / Medicaid
5 (5%)
5 (9%)
None
2 (2%)
0 (0%)
*Three subjects in the Control-IQ group did not provide race information. Twenty-three subjects in the Control-IQ group and 6 in SAP group did not provide income information. Highest level completed by the subject, or the primary caregiver if the participant was <18 years old. One subject in the Control-IQ group did not provide education information. §Three subjects in the Control-IQ group and one in the SAP group did not provide insurance information.
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DCLP5: Baseline Characteristics including Demographics at Enrollment (N=101)
Characteristic
Control-IQ (n=78*)
Age (years) 6 9 10 13 Median (IQR) Range
Sex Female n (%) Race / Ethnicity
White non-Hispanic Hispanic or Latino Black / African American Asian More than one race Annual Household Income (United States Dollar) <$25,000 $25,000 <$35,000 $35,000 <$50,000 $50,000 <$75,000
21 (27%) 57 (73%) 11 (9, 12) 6 to 13 38 (49%)
64 (82%) 6 (8%) 0 (0%) 1 (1%) 7 (9%)
0 (0%) 2 (3%) 1 (1%) 5 (7%)
290
SAP (n=23*)
8 (35%) 15 (65%) 10 (8, 13) 6 to 13 12 (52%)
18 (78%) 2 (9%) 0 (0%) 1 (4%) 2 (9%)
0 (0%) 0 (0%) 2 (10%) 0 (0%)
CHAPTER 32 · Overview of Control-IQ Technology Clinical Studies
DCLP5: Baseline Characteristics including Demographics at Enrollment (N=101) (Continued)
Characteristic
Control-IQ (n=78*)
SAP (n=23*)
$75,000 <$100,000 $100,000 <$200,000 $200,000
13 (18%) 27 (36%) 26 (35%)
4 (19%) 8 (38%) 7 (33%)
Parent Education High School Diploma Associates Degree or Some College Bachelor's Degree
2 (3%) 5 (6%) 32 (41%)
0 (0%) 1 (4%) 9 (39%)
Master's Degree Doctoral or Professional Degree Health Insurance Private
34 (44%) 5 (6%)
70 (90%)
11 (48%) 2 (9%)
21 (91%)
CHP or another government / Medicaid Military Other None
6 (8%) 2 (3%) 0 (0%) 0 (0%)
1 (4%) 1 (4%) 0 (0%) 0 (0%)
*Missing data (CLC/SAP): annual household income 4 (5%)/2 (9%), total daily insulin 1 (1%)/0 (0%). All other variables have no missing data.
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32.4 Adverse Effects
The following tables provide a full list of adverse events that occurred during the main part of the study for both DCLP3 and DCLP5 study groups. DCLP3: Types of Adverse Events by Treatment Group (N=168)
Number of Events
Adverse Events Related to Insulin Pump or Control-IQ Technology Adverse Events Related to Study Device
Ketosis (Infusion Site Failure) Hyperglycemia (Infusion Site Failure) Hyperglycemia (Defected Cartridge) Diabetic Ketoacidosis (Infusion Set Failure) Adverse Effects Not Related to a Study Device Hyperglycemia (User Error) Hyperglycemia (Respiratory Infection) Coronary Bypass Surgery Otitis Externa Concussion
Control-IQ (n=112) 0
3 4 1 1
3 0 1 1 1
SAP (n=56) 0
0 2 0 0
0 1 0 0 0
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DCLP5: Types of Adverse Events by Treatment Group (N=101)
Number of Events
Adverse Events Related to Insulin Pump or Control-IQ Technology Adverse Events Related to Study Device
Ketosis (Infusion Site Failure) Abscess at Sensor Site (CGM Sensor) Hyperglycemia (Defected Cartridge) Adverse Effects Not Related to a Study Device Hypoglycemia (User Error) Ketosis (User Error) Ketosis (Gastroenteritis) Hyperglycemia (User Error) Accidental Over-Delivery of Insulin (User Error)
Control-IQ (n=78) 0
8 0 1
1 2 1 2 1
SAP (n=23) 0
0 2 0
0 1 0 0 0
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The following tables provide a list of only hyperglycemia or ketosis events during the study for both DCLP3 and DCLP5 study groups. These tables also include the cause of these events. DCLP3: Hyperglycemia/Ketosis Events by Treatment Group (N=168)
Number of Events
Ketosis (Infusion Site Failure) Hyperglycemia (Infusion Site Failure) Hyperglycemia (Defected Cartridge) Diabetic Ketoacidosis (Infusion Set Failure) Hyperglycemia (User Error)* Hyperglycemia (Respiratory Infection) *Discontinued pump, forgot to replace
Control-IQ (n=112) 3 4 1 1 3 0
SAP (n=56) 0 2 0 0 0 1
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DCLP5: Hyperglycemia/Ketosis Events by Treatment Group (N=101)
Number of Events
Ketosis (Infusion Site Failure) Hyperglycemia (Defected Cartridge) Ketosis (User Error)* Ketosis (Gastroenteritis) Hyperglycemia (User Error) *Improper cartridge fill Failed to recharge pump battery
Control-IQ (n=78) 8 1 2 1 2
SAP (n=23) 0 0 1 0 0
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32.5 Intervention Compliance
The following three tables provide an overview of the how often the t:slim X2 insulin pump with Control-IQ technology, Dexcom G6 CGM, BG meters, and infusion sets were used during the study period, respectively. The analysis for Control-IQ technology use is specific to the Control-IQ group, while the analysis for CGM and BG meter use represents both the Control-IQ group and the SAP group. DCLP3: Percentage of t:slim X2 Insulin Pump with Control-IQ Technology Use Over the 6-Month Period (N=112)
Average Pump Use*
Average Time Control-IQ Available
Weeks 14
100%
91%
Weeks 58
99%
91%
Weeks 912
100%
91%
Weeks 1216
99%
91%
Weeks 1720
99%
91%
Weeks 21End
99%
82%
Overall
99%
89%
*The denominator is the total possible time within the 6-month study period. Control-IQ Available is calculated as the percent of time when Control-IQ technology was available and operating normally during the 6-month study period.
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DCLP5: Percentage of t:slim X2 Insulin Pump with Control-IQ Technology Use Over the 4-Month Period (n=78)
Average Time Control-IQ Available*
Weeks 14 Weeks 58 Weeks 912
93.4% 93.8% 94.1%
Weeks 13End Overall
94.4% 92.8%
*Control-IQ Available is calculated as the percent of time when Control-IQ technology was available and operating normally during the 4-month study period.
DCLP3: Percentage of CGM Use Over the 6-Month Period (N=168)
Control-IQ*
Weeks 14
96%
Weeks 58
96%
Weeks 912
96%
Weeks 1216
96%
Weeks 1720
97%
Weeks 21End
95%
Overall
96%
*The denominator is the total possible time within the 6-month study period. CGM use includes warm-up time.
SAP* 94% 93% 91% 90% 91% 90% 91%
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DCLP5: Percentage of CGM Use Over the 4-Month Period (N=101)
Control-IQ*
Weeks 14
98%
Weeks 58
98%
Weeks 912
98%
Weeks 13End
97%
Overall
97%
*The denominator is the total possible time within the 4-month study period. CGM use includes warm-up time.
DCLP3: Daily BG Meter Use Over the 6-Month Period (N=168)
Control-IQ
SAP
BG Meter Use Per Day (average)
0.67
0.73
DCLP5: Daily BG Meter Use Over the 4-Month Period (N=101)
Control-IQ
SAP
BG Meter Use Per Day (average)
0.37
0.36
SAP* 95% 96% 96% 97% 96%
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The duration of infusion set used in both the DCLP3 and the DCLP5 was estimated by reviewing the number of times a t:slim X2 study pump was used to prime tubing. In the DCLP3 study, the average duration of infusion set use was 2.8 days in the SAP group and 3.1 days in the Control-IQ group. In the DCLP5 study, the average duration of infusion set use was 2.6 days in the SAP group and 2.8 days in the Control-IQ group. DCLP3: Average Duration of Infusion Set Use (n=168)
Group
SAP Control-IQ
N (pumps)
12 122
Trial Days
2,412 20,412
Primes
884 7,294
Estimated Average Infusion Set Use
Duration 2.8 Days 3.1 Days
DCLP5: Average Duration of Infusion Set Use (n=101)
Group
N (pumps)
Trial Days
Primes
Estimated Average Infusion Set Use
Duration
SAP Control-IQ
11
1,128
439
2.6 Days
90
15,159
5,379
2.8 Days
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32.6 Primary Analysis
The primary analysis of both the DCLP3 and DCLP5 studies was to compare the CGM sensor values in range between 3.910 mmol/L between the Control-IQ group and the SAP group. The data represents the overall system performance 24-hours per day. DCLP3: Comparison of CGM Values Between Control-IQ and SAP Users (N=168)
Characteristic
Control-IQ
SAP
Difference Between Study Arm and Control Arm
Average Glucose (std dev)
Average % 3.910 mmol/L (std dev)
Average % >10 mmol/L (std dev)
Average % <3.9 mmol/L (std dev)
Average % <3 mmol/L (std dev)
8.7 mmol/L (1.1 mmol/L)
71.4% (11.7%)
27% (12%)
1.59% (1.15%)
0.29% (0.29%)
9.4 mmol/L (1.4 mmol/L)
59.2% (14.6%)
38.5% (15.2%)
2.25% (1.46%)
0.35% (0.32%)
-0.7 mmol/L +11% -10% -0.88% -0.10%
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DCLP5: Comparison of CGM Values Between Control-IQ and SAP Users (N=101)
Characteristic
Average Glucose (std dev)
Average % 3.910 mmol/L (std dev)
Average % >10 mmol/L (std dev)
Average % <3.9 mmol/L (std dev)
Average % <3 mmol/L (std dev)
Control-IQ
9.0 mmol/L (1.0 mmol/L)
71.4% (11.7%)
27% (12%)
1.59% (1.15%)
0.29% (0.29%)
SAP
9.9 mmol/L (1.4 mmol/L)
59.2% (14.6%)
38.5% (15.2%)
2.25% (1.46%)
0.35% (0.32%)
Difference Between Study Arm and Control Arm -0.9 mmol/L +11% -10% -0.88% -0.10%
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The table below describes the average time participants in both the Control-IQ group and the SAP group spent with glucose levels between 3.910 mmol/L by month at baseline and during the study period. DCLP3: Percentage of Time in Range per Study Arm by Month (N=168)
Month
Study Arm (Control-IQ)
Control Arm (SAP)
Baseline
61%
59%
Month 1
73%
62%
Month 2
72%
60%
Month 3
71%
60%
Month 4
72%
58%
Month 5
71%
58%
Month 6
70%
58%
DCLP5: Percentage of Time in Range per Study Arm by Month (N=101)
Month
Control-IQ
SAP
Baseline
53%
51%
Month 1
68%
56%
Month 2
68%
54%
Month 3
67%
56%
Month 4
66%
55%
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32.7 Secondary Analysis
The following table compares the percent of time that participants spent at the indicated glucose levels during the daytime and nighttime.The definitions of daytime and nighttime differ slightly between the two studies and are defined in the tables.
DCLP3: Secondary Analysis by Time of Day (N=168)
Characteristic Unit of Measure
Daytime
Control-IQ
SAP
Nighttime
Control-IQ
SAP
Overall Glucose Control
Average Glucose (std dev)
Average % Glucose 3.9 10 mmol/L (std dev)
8.8 mmol/L (1.1 mmol/L)
69.8% (12.4%)
9.4 mmol/L (1.4 mmol/L)
59.4% (14.6%)
8.3 mmol/L (1.0 mmol/L)
76.1% (12.4%)
9.4 mmol/L (1.5mmol/L)
58.5% (16.2%)
DCLP5: Secondary Analysis by Time of Day (N=101)
Characteristic Unit of Measure
Daytime
Control-IQ
SAP
Nighttime
Control-IQ
SAP
Overall Glucose Control
Average Glucose (std dev)
Average % Sensor Glucose 3.9 10 mmol/L (std dev)
9.3 mmol/L (1.5 mmol/L)
63% (11%)
9.9 mmol/L (1.5 mmol/L)
56% (14%)
8.1 mmol/L (0.9 mmol/L
80% (9%)
10.0 mmol/L (1.5 mmol/L)
54% (16%)
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The following table compares the percent of time spent between 3.910 mmol/L across the different baseline HbA1c values observed in the Control-IQ group and the SAP group. Percentage of Time in Range per Study Arm by Baseline HbA1c (N=168)
Baseline HbA1c
6.5 6.67.0 7.17.5 7.68.0 8.1
Time in Range
Control-IQ
SAP
85%
78%
76%
69%
71%
49%
69%
56%
60%
47%
The following table compares the average HbA1c values for all participants at baseline to, after 13-weeks, and 26-weeks. There was a relative difference of -0.33% between the Control-IQ group and the SAP group. Comparison of HbA1c Values (N=168)
Time Period
Control-IQ
SAP
Baseline
7.40
7.40
After 13 Weeks
7.02
7.36
After 26 Weeks
7.06
7.39
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The following tables compare the change in HbA1c values for both DCLP3 and DCLP5 participants over the course of their respective studies. DCLP3: Change in HbA1c Values from Randomization to 26 Weeks (N=168)
Number of Subjects (% of Subjects) with Change in HbA1c
Baseline Central Lab HbA1c
n
5% HbA1c < 6% Treatment
8
Control
0
6% HbA1c < 7% Treatment
30
Control
19
7% HbA1c < 8% Treatment
45
Control
22
8% HbA1c < 9% Treatment
22
Control
13
9% HbA1c < 10% Treatment
4
Control
1
HbA1c 10%
Treatment
2
Decrease >1%
n
%
Decrease 0 to 1%
n
%
No Change
n
%
Increase 0 to 1%
n
%
Increase >1%
n
%
0
0%
1
13%
0
0%
7
88%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
18
60%
3
10%
9
30%
0
0%
0
0%
10
53%
0
0%
9
47%
0
0%
4
9%
33
73%
2
4%
5
11%
1
2%
0
0%
11
50%
1
5%
8
36%
2
9%
5
23%
15
68%
1
5%
1
5%
0
0%
0
0%
8
62%
0
0%
4
31%
1
8%
1
25%
2
50%
0
0%
1
25%
0
0%
0
0%
0
0%
0
0%
1 100% 0
0%
2
100%
0
0%
0
0%
0
0%
0
0%
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DCLP3: Change in HbA1c Values from Randomization to 26 Weeks (N=168) (Continued)
Overall
Number of Subjects (% of Subjects) with Change in HbA1c
Control
0
0
0%
0
0%
0
0%
0
0%
0
0%
Treatment 111
12
11%
69
62%
6
Control
55
0
0%
29
53%
1
5%
23
21%
1
<1%
2%
22
40%
3
5%
DCLP5: Change in HbA1c Values from Randomization to 16 Weeks (N=101)
Number of Subjects (% of Subjects) with Change in HbA1c
Baseline Central Lab HbA1c
n
5% HbA1c < 6% Treatment
3
Control
0
6% HbA1c < 7% Treatment
18
Control
3
7% HbA1c < 8% Treatment
28
Control
8
8% HbA1c < 9% Treatment
20
Decrease >1%
n
%
Decrease 0 to 1%
n
%
No Change
n
%
0
0%
0
0%
2
67%
0
0%
0
0%
0
0%
0
0%
9
50%
1
6%
0
0%
1
33%
0
0%
3
11%
20
71%
0
0%
0
0%
5
63%
0
0%
11
55%
9
45%
0
0%
Increase 0 to 1%
n
%
Increase >1%
n
%
1
33%
0
0%
0
0%
0
%0
8
44%
0
0%
2
67%
0
0%
5
18%
0
0%
2
25%
1
13%
0
0%
0
0%
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DCLP5: Change in HbA1c Values from Randomization to 16 Weeks (N=101) (Continued)
Number of Subjects (% of Subjects) with Change in HbA1c
Control
10
0
0%
7
70%
0
0%
3
30%
0
0%
9% HbA1c < 10% Treatment
7
5
71%
1
14%
0
0%
1
14%
0
0%
Control
1
0
0%
1
100%
0
0%
0
0%
0
0%
HbA1c 10%
Treatment
1
0
0%
1
100%
0
0%
0
0%
0
0%
Control
1
0
0%
1
100%
0
0%
0
0%
0
0%
Overall
Treatment
77
19
25%
40
52%
3
4%
15
19%
0
0%
Control
23
0
0%
15
65%
0
0%
7
30%
1
4%
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CHAPTER 32 · Overview of Control-IQ Technology Clinical Studies
32.8 Insulin Delivery Differences
The following table compares the insulin delivery statistics between the Control-IQ group and the SAP group in the DCLP3 study. DCLP3: Insulin Delivery Comparison (N=168)
Characteristic
Unit of Measure
Control-IQ
SAP
After 2-weeks Average
50
50
(std dev)
(25)
(21)
Total Insulin Units
After 13-weeks Average (std dev)
54 (27)
50 (19)
After 26-weeks Average
55
51
(std dev)
(27)
(20)
After 2-weeks Average
1.1
1.2
(std dev)
(0.5)
(0.8)
Basal to Bolus Ratio
After 13-weeks Average (std dev)
1.1 (0.6)
1.3 (1.6)
After 26-weeks Average
1.1
1.2
(std dev)
(0.7)
(0.6)
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CHAPTER 32 · Overview of Control-IQ Technology Clinical Studies
The following table compares the insulin delivery statistics between the Control-IQ group and the SAP group in the DCLP5 study. Total daily insulin is reported as Units of insulin per body weight of participant, in kilograms (kg), per day. DCLP5: Insulin Delivery Comparison (N=101)
Characteristic
Timepoint
Control-IQ
SAP
Total Daily Insulin (U/kg/day) Basal to Bolus Ratio
Baseline
After 16-weeks Average (std dev)
Baseline
After 16-weeks Average (std dev)
0.89 (0.24)
0.94 (0.25)
0.73 (0.26)
0.87 (0.30)
0.94 (0.24)
0.98 (0.32)
0.89 (0.33)
0.84 (0.38)
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CHAPTER 32 · Overview of Control-IQ Technology Clinical Studies
32.9 Control-IQ Technology High and Low Alert Accuracy
The following data table characterizes the accuracy of the Control-IQ technology high and low alerts, respectively. This analysis depicts the percent of alerts that were triggered relative to the resulting glucose value achieving the level the alert predicted by evaluating the history log messages compared to actual glucose readings. The Control-IQ technology Low Alert notifies the user when Control-IQ technology predicts that the glucose value will be below 3.9 mmol/L 15 minutes in the future, or 4.4 mmol/L when the exercise activity is enabled. If the glucose value never reached this predicted low reading after 15 minutes, it was considered a false alert. Conversely, if the glucose value did reach the low threshold reading without the pump indicating a Control-IQ technology Low Alert, it was considered a missed alert. The Control-IQ technology High Alert notifies the user when Control-IQ technology predicts that the glucose value will remain above 11.1 mmol/L for 30 minutes or more. If the glucose value never reached above 11.1 mmol/L for more than 30 minutes, it was considered a false alert. Conversely, if the glucose value did reach above 11.1 mmol/L for 30 minutes or more without the pump indicating a Control-IQ technology Low Alert, it was considered a missed alert. DCLP3: Percentage of False and Missed Alerts for Control-IQ Technology Alerts (N=112)
Predictive Alert
False Alerts
Missed Alerts
Control-IQ Technology Low Alert
57%
41%
Control-IQ Technology High Alert
16%
23%
DCLP5: Percentage of False and Missed Alerts for Control-IQ Technology Alerts (n=78)
Predictive Alert
False Alerts
Missed Alerts
Control-IQ Technology Low Alert
50%
54%
Control-IQ Technology High Alert
17%
25%
310
CHAPTER 32 · Overview of Control-IQ Technology Clinical Studies
The tables below depicts the performance of the Control-IQ technology high and low alerts when evaluating the resulting glucose value after 15-minutes and 30-minutes. DCLP3: Percentage of Accurate Control-IQ Technology Alerts (N=112)
Predictive Alert
Control-IQ Technology Low Alert Control-IQ Technology High Alert
15-minutes 49% 75%
Performance
30-minutes 59% 77%
DCLP5: Percentage of Accurate Control-IQ Technology Alerts (n=78)
Predictive Alert
15-minutes
Performance
30-minutes
Control-IQ Technology Low Alert
38%
46%
Control-IQ Technology High Alert
78%
63%
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CHAPTER 32 · Overview of Control-IQ Technology Clinical Studies
32.10 Additional Analysis of Glucose Value Auto-Population with CGM
Upon completion of the pivotal studies, an evaluation of the auto-population of CGM readings into the bolus calculator was performed. The results of the analysis indicate that in the DCLP3 study, when a glucose value was >13.9 mmol/L, there was an increased incidence of CGM values <3.9 mmol/L five hours after a bolus was delivered using auto-populated CGM readings compared to the five hours after the bolus was delivered using manually entered glucose values. These results were not seen in the DCLP5 study. DCLP3: Post-Correction Bolus CGM Readings (5 hours): All Boluses
Entry Type
Automatically Populated (n=17,023) Manually Entered (n=1,905)
One or More CGM Reading <3.0 mmol/L
(95% CI)
4% (3.6, 4.2)%
5% (3.8, 5.7)%
Three Consecutive CGM Readings <3.9 mmol/L
(95% CI)
8% (7.5, 8.3)%
9% (7.4, 10.0)%
Five or More CGM Readings <3.9 mmol/L
(95% CI)
12% (11.2, 12.2)%
12% (10.3, 13.2)%
DCLP5: Post-Correction Bolus CGM Readings (5 hours): All Boluses
Entry Type
Automatically Populated (n=12,323) Manually Entered (n=1,630)
One or More CGM Reading <3.0 mmol/L
(95% CI)
6% (5.7, 6.5)%
6% (4.9, 7.3)%
Three Consecutive CGM Readings <3.9 mmol/L
(95% CI)
15% (14.4, 15.6)%
14% (12.1, 15.5)%
Five or More CGM Readings <3.9 mmol/L
(95% CI)
9% (8.4, 9.4)%
9% (7.4, 10.2)%
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CHAPTER 32 · Overview of Control-IQ Technology Clinical Studies
DCLP3: Post-Correction Bolus CGM Readings (5 hours): Based on Starting Glucose Readings
CGM Reading
Entry Type
One or More CGM Reading <3.0 mmol/L
(95% CI)
Three Consecutive CGM Readings <3.9 mmol/L
(95% CI)
3.910.0 mmol/L 10.113.9 mmol/L >13.9 mmol/L
Automatically Populated (n=8,700)
Manually Entered (n=953)
Automatically Populated (n=6,071)
Manually Entered (n=568)
Automatically Populated (n=2,252)
Manually Entered (n=384)
3% (2.8, 3.5)%
5% (3.2, 5.8)%
4% (3.9, 5.0)%
5% (3.4, 7.1)%
5% (4.0, 5.8)%
4% (2.4, 6.5)%
7% (6.6, 7.6)%
9% (7.4, 11.1)%
9% (8.0, 9.4)%
9% (6.6, 11.3)%
9% (7.5, 9.8)%
7% (4.5, 9.6)%
Five or More CGM Readings <3.9 mmol/L
(95% CI)
11% (10.3, 11.6)%
13% (10.4, 14.6)%
12% (11.3, 13.0)%
12% (9.5, 14.8)%
13% (11.9, 14.7)%
9% (6.5, 12.3)%
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CHAPTER 32 · Overview of Control-IQ Technology Clinical Studies
DCLP5: Post-Correction Bolus CGM Readings (5 hours): Based on Starting Sensor Glucose Readings
CGM Reading
Entry Type
One or More CGM Reading <3.0 mmol/L
(95% CI)
Three Consecutive CGM Readings <3.9 mmol/L
(95% CI)
Five or More CGM Readings <3.9 mmol/L
(95% CI)
3.910.0 mmol/L 10.113.9 mmol/L >13.9 mmol/L
Automatically Populated (n=5,646)
Manually Entered (n=627)
Automatically Populated (n=3,622)
Manually Entered (n=437)
Automatically Populated (n=3,035)
Manually Entered (n=566)
6% (5.5 6.7)%
7% (4.7, 8.7)%
7% (6.0, 7.6)%
6% (3.4, 7.6)%
6% (4.7, 6.3)%
6% (3.9, 7.7)%
16% (15.0, 17.0)%
16% (13.2, 19.0)%
16% (14.4, 16.8)%
14% (10.9, 17.5)%
13% (11.5, 13.9)%
11% (8.4, 13.6)%
9% (8.4, 10.0)%
11% (8.6, 13.4)%
10% (9.1, 11.1)%
7% (4.5, 9.2)%
7% (6.2, 8.0)%
8% (5.6, 10.0)%
314
5 Technical Specifications and Warranty
CHAPTER 33
Technical Specifications
CHAPTER 33 · Technical Specifications
33.1 Overview
This section provides tables of technical specifications, performance characteristics, options, settings, and electromagnetic compliance information for the t:slim X2TM pump. The specifications in this section meet the international standards set forth in IEC 60601-1 and IEC 60601-2-24.
33.2 t:slim X2 Pump Specifications
t:slim X2 Pump Specifications Specification Type
Classification
Size Weight (with full disposable) Operating Conditions
Storage Conditions Atmospheric Pressure Moisture Protection Cartridge Volume Cannula Fill Amount
Specification Details
External PSU: Class II, Infusion Pump. Internally-powered equipment, Type BF applied part. The risk of ignition of flammable anesthetics and explosive gases by the pump is remote. While this risk is remote, it is not recommended to operate the t:slim X2 pump in the presence of flammable anesthetics or explosive gases.
7.95 cm x 5.08 cm x 1.52 cm (L x W x H) - (3.13" x 2.0" x 0.6")
112 grams (3.95 ounces)
Temperature: 5°C (41°F) to 37°C (98.6°F) Humidity: 20% to 90% RH non-condensing
Temperature: -20°C (-4°F) to 60°C (140°F) Humidity: 20% to 90% RH non-condensing
-396 meters to 3,048 meters (-1,300 feet to 10,000 feet)
IPX7: Watertight to a depth of 0.91 meters (3 feet) for up to 30 minutes
3.0 mL or 300 units
0.1 to 1.0 units of insulin
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CHAPTER 33 · Technical Specifications
t:slim X2 Pump Specifications (Continued)
Specification Type
Specification Details
Insulin Concentration Alarm Type
Basal Delivery Accuracy at all Flow Rates (tested per IEC 60601-2-24)
Bolus Delivery Accuracy at all Volumes (tested per IEC 60601-2-24)
Patient Protection from Air Infusion
Maximum Infusion Pressure Generated and Occlusion Alarm Threshold Frequency of Basal Delivery Retention Time of Electronic Memory when Internal System Battery is Fully Discharged (including Alarm Settings and Alarm History) Infusion Set used for Testing
Typical Operating Time when System is Operating at Intermediate Rate
U-100 Visual, audible, and vibratory ±5% The pump is designed to vent automatically when there is a pressure difference between inside the cartridge and the surrounding air. In certain conditions, such as a gradual elevation change of 305 meters (1,000 feet), the pump may not vent immediately and delivery accuracy can vary up to 15% until 3 units have been delivered or elevation changes by more than 305 meters (1,000 feet).
±5%
The pump provides subcutaneous delivery into interstitial tissue and does not deliver intravenous injections. Clear tubing aids in detecting air.
30 PSI
5 minutes for all Basal Rates
Greater than 30 days
Unomedical Comfort Infusion Set During normal use, the intermediate rate is 2 units/hr; battery charge can be reasonably expected to last between 4 and 7 days, depending on your use of CGM features from a fully charged state to a totally discharged state
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CHAPTER 33 · Technical Specifications
t:slim X2 Pump Specifications (Continued)
Specification Type
Specification Details
The method of delivery isolates the insulin chamber from the patient and the software performs frequent monitoring of system status. Multiple software monitors provide redundant protection against unsafe conditions.
Handling of Over-Infusion or Under-Infusion
Over-infusion is mitigated by monitoring glucose, (whether via CGM, BG meter, or both), layering of redundancies and confirmations, and numerous other safeguard alarms. Users are required to review and confirm the details of all bolus deliveries, Basal Rates, and Temp Rates to ensure certainty before initiating a delivery. In addition, once bolus deliveries are confirmed, the user is given 5 seconds to cancel the delivery before it is started. An optional Auto-Off alarm triggers when the user has not interacted with the pump's user interface for a predefined period of time.
Bolus Volume at Release of Occlusion (2 units per hour Basal)
Residual Insulin Remaining in the Cartridge (unusable)
Minimum Audible Alarm Volume
Under-infusion is mitigated by occlusion detection and BG monitoring as BG entries are recorded. Users are prompted to treat high BG conditions with a correction bolus. Less than 3 units with Unomedical Comfort (110cm) Infusion Set
Approximately 15 units 45 dBA at 1 meter
NOTE
Delivery Accuracies: Accuracies stated in this table are valid for all Tandem Diabetes Care, Inc. branded infusion sets including: AutoSoftTM 90, AutoSoftTM XC, AutoSoftTM 30, VariSoftTM, TruSteelTM branded infusion sets.
318
USB Charging/Download Cable Specifications
Specification Type
Specification Detail
Tandem P/N Length Type
004113 2 meters (6 feet) USB A to USB Micro B
Power Supply/Charger, AC, Wall Mount, USB Specifications
Specification Type
Specification Detail
Tandem P/N Input Output Voltage Max Output Power Output Connector
007866 100 to 240 Volts AC, 50/60 Hz 5 Volts DC 5 Watts USB type A
CHAPTER 33 · Technical Specifications
319
CHAPTER 33 · Technical Specifications
Car Power USB Adapter (sold separately), Specifications
Specification Type
Specification Detail
Tandem P/N Input Output Voltage Max Output Power Output Connector
003934 12 Volts DC 5 Volts DC 5 Watts minimum USB type A
Computer, USB Connector, Specifications
Specification Type
Specification Detail
Output Voltage Output Connector Safety Standard Compliance
5 Volts DC USB type A 60950-1 or 60601-1 or equivalent
320
Requirements for Charging from a Computer The t:slim X2 pump is designed to be connected to a host computer for battery charging and data transfer. The following minimum characteristics are required of the host computer: · USB 1.1 port (or later) · Computer compliant with 60950-1
or equivalent safety standard Connecting the pump to a host computer that is attached to other equipment could result in previously unidentified risks to the patient, operator, or a third party. The user should identify, analyze, evaluate, and control these risks. Subsequent changes to the host computer could introduce new risks and require additional analysis. These changes can include but are not limited to changing the configuration of the computer, connecting additional items to the computer, disconnecting items from the computer, and updating or upgrading equipment connected to the computer.
CHAPTER 33 · Technical Specifications
321
CHAPTER 33 · Technical Specifications
33.3 t:slim X2 Pump Options and Settings
t:slim X2 Pump Options and Settings Option/Setting Type Time Maximum Basal Rate Insulin Delivery Profiles (Basal and Bolus) Basal Rate Segments Basal Rate Increment Temp Basal Rate Bolus Setup
Insulin-to-Carb (IC) Ratio BG Target Value Correction Factor Duration of Insulin Action Bolus Increment Quick Bolus Increments Maximum Extended Bolus Time
Option/Setting Detail
May be set to 12-hour or 24-hour clock (default is 12-hour clock)
0.1 15 units/hr
6
16 per delivery profile
0.001 at programed rates equal to or greater than 0.1 units/hr
15 minutes to 72 hours with 1 minute resolution with a range of 0% to 250%
Can deliver based on carb input (grams) or insulin input (units). The range for carbs is 1 to 999 grams, the range for insulin is 0.05 to 25 units
16 time segments per 24-hour period; Ratio: 1 unit of insulin per x grams of carb; 1:1 to 1:300 (can be set by 0.1 below 10)
16 time segments. 3.9 to 13.9 mmol/L in 0.1 mmol/L increments
16 time segments; Ratio: 1 unit of insulin reduces glucose x mmol/L; 1:0.1 to 1:33.3 (0.1 mmol/L increments)
1 time segment; 2 to 8 hours in 1-minute increments (default is 5 hrs)
0.01 at volumes greater than 0.05 units
When set to units of insulin: 0.5, 1, 2, 5 units (default is 0.5 units); or when set to grams of carb: 2, 5, 10, 15 grams (default is 2 g)
8 hours; 2 hours when Control-IQ technology is enabled
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CHAPTER 33 · Technical Specifications
t:slim X2 Pump Options and Settings (Continued)
Option/Setting Type
Option/Setting Detail
Maximum Bolus Size Maximum Automatic Bolus Size Low Cartridge Volume Indicator
Auto-Off Alarm History Storage Language Security PIN Screen Lock Site Reminder Missed Meal Bolus Reminder
After Bolus Reminder
High BG Reminder
Low BG Reminder
25 units
6 units
Status indicator visible on Home screen; Low Insulin Alert is user adjustable from 10 to 40 units (default is 20 units).
On or Off (default is on); user-adjustable (5 to 24 hours; default is 12 hours, which you can change when option is set to on).
At least 90 days of data
Dependent on region of use. May be set to English, Czech, Danish, Dutch, Finnish, French, German, Italian, Norwegian, Spanish, or Swedish (default is English).
Protects from unintentional access, and blocks access to quick bolus when enabled (default is off).
Protects from unintentional screen interactions.
Prompts user to change infusion set. Can be set for 1 to 3 days at a time selected by user (default is off).
Prompts user if a bolus has not occurred during the period of time the reminder is set for. 4 reminders available (default is off).
Prompts user to test BG at a selected time period after a bolus has been delivered. Can be set between 1 to 3 hours (default is off).
Prompts user to retest BG after a High BG has been entered. User selects High BG value and time for reminder. (default is off).
Prompts user to retest BG after a Low BG has been entered. User selects Low BG value and time for reminder. (default is off).
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CHAPTER 33 · Technical Specifications
33.4 t:slim X2 Pump Performance Characteristics
The t:slim X2 insulin pump delivers insulin in two ways: basal insulin delivery (continuous) and bolus insulin delivery. The following accuracy data was collected on both types of delivery in laboratory studies performed by Tandem. Basal Delivery To assess basal delivery accuracy, 32 t:slim X2 pumps were tested by delivering at low, medium, and high Basal Rates (0.1, 2.0, and 15 U/hr). Sixteen of the pumps were new, and 16 had been aged to simulate four years of regular use. For both aged and unaged pumps, eight pumps were tested with a new cartridge, and eight with a cartridge which underwent two years of real time aging. Water was used as a substitute for insulin. The water was pumped into a container on a scale and the weight of the liquid at various time points was used to assess pumping accuracy. The following tables report the typical basal performance (median) observed, along with the lowest and highest results observed for low, medium, and high Basal Rate settings for all pumps tested. For the medium and high Basal Rates, accuracy is reported from the time basal delivery started with no warm-up period. For the minimum Basal Rate, accuracy is reported after a 1-hour warm-up period. For each time period, the tables show the volume of insulin requested in the first row and the volume that was delivered as measured by the scale in the second row. Low Basal Rate Delivery Performance (0.1 U/hr)
Basal Duration (Number of Units Delivered with 0.1 U/hr Setting)
Amount Delivered [min, max]
1 hour (0.1 U)
0.12 U [0.09, 0.16]
6 hours (0.6 U)
0.67 U [0.56, 0.76]
12 hours (1.2 U)
1.24 U [1.04, 1.48]
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CHAPTER 33 · Technical Specifications
Medium Basal Rate Delivery Performance (2.0 U/hr)
Basal Duration (Number of Units Delivered with 2 U/hr Setting) Amount Delivered [min, max]
1 hour (2 U)
2.1 U [2.1, 2.2]
6 hours (12 U)
12.4 U [12.0, 12.8]
12 hours (24 U)
24.3 U [22.0, 24.9]
High Basal Rate Delivery Performance (15 U/hr) Basal Duration (Number of Units Delivered with 15 U/hr Setting) Amount Delivered [min, max]
1 hour (15 U)
15.4 U [14.7, 15.7]
6 hours (90 U)
90.4 U [86.6, 93.0]
12 hours (180 U)
181 U [175.0, 187.0]
Bolus Delivery To assess bolus delivery accuracy, 32 t:slim X2 pumps were tested by delivering consecutive low, medium, and high bolus volumes (0.05, 2.5, and 25 units). Sixteen of the pumps were new, and 16 had been aged to simulate four years of regular use. For both aged and unaged pumps, eight pumps were tested with a new cartridge, and eight with a cartridge which underwent two years of real time aging. Water was used as a substitute for insulin for this testing. The water was pumped into a container on a scale, and the weight of the liquid at various time points was used to assess pumping accuracy. Delivered bolus volumes were compared to the requested bolus volume delivery for minimum, intermediate, and maximum bolus volumes. The tables below show average, minimum and maximum bolus sizes observed as well as the number of boluses which were observed to be within the specified range of each target bolus volume.
325
CHAPTER 33 · Technical Specifications
Summary of Bolus Delivery Performance (n=32 pumps)
Individual Bolus Accuracy Performance
Min Bolus Delivery Performance (n=800 boluses)
Intermediate Bolus Delivery Performance (n=800 boluses)
Max Bolus Delivery Performance (n=256 boluses)
Target Bolus Size Mean Bolus Size
[Units]
[Units]
0.050
0.050
2.50
2.46
25.00
25.03
Min Bolus Size [Units] 0.000 0.00 22.43
Max Bolus Size [Units] 0.114 2.70 25.91
Low Bolus Delivery Performance (0.05U) (n=800 boluses)
Units of Insulin Delivered After a 0.05 U Bolus Request
<0.0125 (<25%)
0.0125 0.0375 (2575%)
0.0375 0.045 (7590%)
0.045 0.0475 (9095%)
0.0475 0.0525 (95105%)
0.0525 0.055 (105110%)
0.055 0.0625 (110125%)
0.0625 0.0875 (125175%)
0.0875 0.125 (175250%)
>0.125 (>250%)
Number and Percent of Boluses Within Range
21/800 (2.6%)
79/800 (9.9%)
63/800 (7.9%)
34/800 (4.3%)
272/800 (34.0%)
180/800 (22.5%)
105/800 (13.1%)
29/800 (3.6%)
17/800 (2.1%)
0/800 (0.0%)
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CHAPTER 33 · Technical Specifications
Intermediate Bolus Delivery Performance (2.5U) (n=800 boluses)
Number and Percent of Boluses Within Range
<0.625 (<25%)
9/800 (1.1%)
0.625 1.875 (2575%)
14/800 (1.8%)
Units of Insulin Delivered After a 2.5 U Bolus Request
1.875 2.25 (7590%)
2.25 2.375 (9095%)
2.375 2.625 (95105%)
2.625 2.75 (105110%)
2.75 3.125 (110125%)
3.125 4.375 (125175%)
4.375 6.25 (175250%)
>6.25 (>250%)
11/800 (1.4%)
8/800 (1.0%)
753/800 (94.1%)
5/800 (0.6%)
0/800 (0.0%)
0/800 (0.0%)
0/800 (0.0%)
0/800 (0.0%)
High Bolus Delivery Performance (25U) (n=256 boluses)
Units of Insulin Delivered After a 25 U Bolus Request
Number and Percent of Boluses Within Range
<6.25 (<25%)
0/256 (0.0%)
6.25 18.75 22.5
18.75
22.5
23.75
(2575%) (7590%) (9095%)
0/256 (0.0%)
1/256 (0.4%)
3/256 (1.2%)
23.75 26.25 (95105%)
26.25
27.5
31.25
43.75
27.5
31.25
43.75
62.5
(105110%) (110125%) (125175%) (175250%)
>62.5 (>250%)
252/256 (98.4%)
0/256 (0.0%)
0/256 (0.0%)
0/256 (0.0%)
0/256 (0.0%)
0/256 (0.0%)
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CHAPTER 33 · Technical Specifications
Rate of Delivery
Characteristic 25 Unit Bolus Delivery Speed 2.5 Unit Bolus Delivery Speed 20 Unit Prime
Value 2.97 Units/min Typical 1.43 Units/min Typical 9.88 Units/min Typical
Bolus Duration
Characteristic 25 Unit Bolus Duration 2.5 Unit Bolus Duration
Value 8 minutes 26 seconds Typical 1 minute 45 seconds Typical
Time to Occlusion Alarm*
Operating Rate
Typical
Maximum
Bolus (3 units or Greater) Basal (2 units/hr) Basal (0.1 units/hr)
1 minute 2 seconds 1 Hour 4 Minutes 19 Hours 43 Minutes
3 Minutes 2 Hours 36 Hours
*The time to occlusion alarm is based on insulin volume not delivered. During an occlusion event, boluses of less than 3 units may not trigger an occlusion alarm if no basal insulin is being delivered. The bolus amount will reduce the time to occlusion depending on the Basal Rate.
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CHAPTER 33 · Technical Specifications
33.5 Electromagnetic Compatibility The information contained in this section is specific to the System. This information provides reasonable assurance of normal operation, but does not guarantee such under all conditions. If the System must be used in close proximity with other electrical equipment, the System should be observed in this environment to verify normal operation. Special precautions for electromagnetic compatibility must be taken when using medical electrical equipment. The System shall be placed into service with adherence to the EMC information provided here. Using cables and accessories not specified in this user guide may adversely impact safety, performance, and electromagnetic compatibility, including increased emissions and/or decreased immunity.
For IEC 60601-1 testing, Essential Performance for the System is defined as follows: · The System will not over deliver a
clinically significant amount of insulin. · The System will not under deliver a clinically significant amount of insulin without notification to the user. · The System will not deliver a clinically significant amount of insulin after occlusion release. · The System will not discontinue reporting CGM data without notification to the user. This section contains the following tables of information: · Wireless Co-existence and Data Security · Electromagnetic Emissions · Electromagnetic Immunity · Distances Between the System and RF Equipment
33.6 Wireless Co-existence and Data Security
The System is designed to work safely and effectively in the presence of wireless devices typically found at home, work, retail stores, and places of leisure where daily activities occur. See Section 33.9 Distances Between the t:slim X2 Pump and RF Equipment for more information. The System is designed to send and accept Bluetooth wireless technology communication. Communication is not established until you enter the appropriate credentials into your pump. The System and system components ensure data security via proprietary means and ensure data integrity using error checking processes, such as cyclic redundancy checks.
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CHAPTER 33 · Technical Specifications
33.7 Electromagnetic Emissions
The System is intended for use in the electromagnetic environment specified below. Always make sure that the System is used in such an environment. Guidance and Manufacturer's Declaration Electromagnetic Emissions
Emissions Test
Compliance
Electromagnetic Environment Guidance
RF Emissions, CISPR 11
Group 1
The System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF Emissions, CISPR 11
Class B
Harmonic Emissions, IEC 61000-3-2 N/A
Voltage Fluctuations/Flicker Emissions, IEC 61000-3-3
N/A
The System is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
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CHAPTER 33 · Technical Specifications
33.8 Electromagnetic Immunity
The System is intended for use in the electromagnetic environment specified below. Always make sure that the System is used in such an environment. Guidance and Manufacturer's Declaration Electromagnetic Immunity
Immunity Test
Electrostatic Discharge (ESD) IEC 61000-4-2
Electrical Fast Transient/burst IEC 61000-4-4
Surge IEC 61000-4-5
IEC 60601 Test Level
± 8 kV contact ± 15 kV air
± 2 kV for power supply lines ± 1 kV for input/ output lines (100 kHz repetition frequency)
± 1 kV differential mode ± 2 kV common mode
Compliance Level
± 8 kV contact ± 15 kV air
± 2 kV for power supply lines ± 1 kV for input/output lines (100 kHz repetition frequency)
± 1 kV differential mode ± 2 kV common mode
Electromagnetic Environment Guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
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Guidance and Manufacturer's Declaration Electromagnetic Immunity (Continued)
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment Guidance
Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3
Proximity Field from Wireless Transmitters
3 Vrms 150 kHz to 80 MHz
10 V/m 80 MHz to 2.7 GHz
385 MHz: 27 V/m @ 18 Hz Pulse modulation 450 MHz: 28 V/m @ FM modulation 710 MHz, 745 MHz, 780 MHz: 9 V/m @ 217 Hz Pulse modulation 810 MHz, 870 MHz, 930 MHz: 28 V/m @ 18 Hz Pulse modulation 1720 MHz, 1845 MHz, 1970 MHz: 28 V/m @ 217 Hz Pulse Modulation 2450 MHz: 28 V/m @ 217 Hz Pulse modulation 5240 MHz, 5500 MHz, 5785 MHz: 9 V/m @ 217 Hz Pulse modulation
10 Vrms
30 V/m
385 MHz: 27 V/m @ 18 Hz Pulse modulation 450 MHz: 28 V/m @ FM modulation 710 MHz, 745 MHz, 780 MHz: 9 V/m @ 217 Hz Pulse modulation 810 MHz, 870 MHz, 930 MHz: 28 V/m @ 18 Hz Pulse modulation 1720 MHz, 1845 MHz, 1970 MHz: 28 V/m @ 217 Hz Pulse Modulation 2450 MHz: 28 V/m @ 217 Hz Pulse modulation 5240 MHz, 5500 MHz, 5785 MHz: 9 V/m @ 217 Hz Pulse modulation
Portable and mobile RF communications equipment should be used no closer to any part of the pump, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: 150 MHz to 80MHz, d = 1.20P 80 MHz to 800 MHz, d = 1.20P 800 MHz to 2.5GHz, d = 2.30P Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey*, should be less than the compliance level in each frequency range**. Interference may occur in the vicinity of equipment marked with the following symbol:
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CHAPTER 33 · Technical Specifications
Guidance and Manufacturer's Declaration Electromagnetic Immunity (Continued)
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment Guidance
Voltage Dips, Short Interruptions, and Voltage Variations on Power Supply Input Lines IEC 61000-4-11
70% UR (30% dip in Ur) for 25 cycles 0% Ur (100% dip in Ur) for 1 cycle at 0 degrees 0% Ur (100% dip in Ur) for 0.5 cycles at 0, 45, 90, 135, 180, 225, 270, and 315 degrees 0% Ur (100% dip in Ur) for 250 cycles
70% UR (30% dip in Ur) for 25 cycles 0% Ur (100% dip in Ur) for 1 cycle at 0 degrees 0% Ur (100% dip in Ur) for 0.5 cycles at 0, 45, 90, 135, 180, 225, 270, and 315 degrees 0% Ur (100% dip in Ur) for 250 cycles
Power Frequency (50/60 Hz) Magnetic Field IEC 61000-4-8
30 A/m
400 A/m (IEC 60601-2-24)
Mains power quality should be that of a typical commercial or hospital environment. If the user of the pump requires continued operation during power mains interruptions, it is recommended that the pump be powered from an uninterruptible power supply or a battery. NOTE: Ur is the a.c. mains voltage prior to application of the test level.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
*Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the pump is used exceeds the applicable RF compliance level above, the pump should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the System.
**Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
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33.9 Distances Between the t:slim X2 Pump and RF Equipment
The System is intended for use in an electromagnetic environment typically found in the home, at work, retail stores, and places of leisure, where daily activities occur. The chart below can be used as a guideline for determining the recommended minimum distance to maintain between a radio frequency (RF) transmitter and the System. For specific concerns about a particular RF transmitter interfering with your System's operation, please contact the CGM transmitter manufacturer for its rated power and frequency. Recommended Distances Between the System and a Radio Frequency Transmitter
Rated Maximum Output Power of Transmitter in Watts
Separation Distance According to Frequency of Transmitter in meters
150 kHz to 80 MHz (d = 1.20P)
80 MHz to 800 MHz (d = 1.20P)
800 MHz to 2.5 GHz (d = 2.30P)
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
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CHAPTER 33 · Technical Specifications
The table below provides a list of typical devices for various levels of transmitter power and frequency, and the recommended separation distances from the transmitter and the System. Recommended Distances Between the System and Devices
Rated Maximum Output Power of Transmitter in Watts
Typical Devices
0.001W
Bluetooth Class 3 (standard 1 meter range). Commonly used as Bluetooth
headset.
0.01W
Internet to music adapter. Commonly used for FM wireless music streaming
Bluetooth Class 1 (100 meter range).
0.1W
Wireless router (WiFi).
Typical cellular/smart phone*
Recommended Separation Distance in Meters (Inches)
0.007 m (0.3 in) 0.013 m (0.5 in) 0.073 m (2.9 in)
1W
Typical microwave oven RF leakage.
0.23 m (9.0 in)
*Caution: Interference with pump electronics by cell phones can occur if worn in close proximity. It is recommended that your pump and cell phone be worn at least 0.163 meters (6.4 inches) apart.
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CHAPTER 33 · Technical Specifications
33.10 Quality of Wireless Service
The manufacturer defines the quality of service of the System as the percent of readings successfully received by the pump, where the CGM transmitter and pump attempt to communicate every 5 minutes. One of the System's essential performance requirements states that the System will not discontinue reporting data and/or information from the Dexcom G6 transmitter to the user without notification. The System notifies the user of a missed reading, or when the transmitter and pump are out of range of one another in several ways. The first is when a dot is missed on the CGM Trend Graph which will occur within five minutes of the previous reading.The second indication occurs after 10 minutes when the Out of Range Icon is displayed on the CGM Home screen. The third is a user settable alert that will notify the user when the transmitter and pump are out of range of one another. Setting this alert is defined in Section 21.6 Setting Your Out of Range Alert.
The System performance requirements state that 90% of readings will be successfully transferred to the pump display while the transmitter and pump are within 6 meters (20 feet) of each other, and no more than 12 consecutive readings (1 hour) will be missed. To improve quality of service when other devices operating in the 2.4 GHz band are around, the t:slim X2 insulin pump uses the built-in coexistence features provided by Bluetooth wireless technology.
33.11 FCC Notice Concerning Interference
The transmitter covered by this user guide has been certified under FCC ID: PH29433. Although the transmitter has been approved by the United States Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from the transmitter will be free from interference.
Compliance Statement (Part 15.19) This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful
interference, and
2. This device must accept any interference received, including interference that may cause undesired operation.
Warning (Part 15.21) Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. FCC Interference Statement (Part 15.105 (b)) This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference
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CHAPTER 33 · Technical Specifications
in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of the following measures: · Reorient or relocate the receiving
antenna. · Increase the separation between
the equipment and receiver. · Connect the equipment into an
outlet on a circuit different from that to which the receiver is connected. · Consult the dealer or an experienced radio/TV technician for help.
This portable transmitter with its antenna complies with FCC/IC RF exposure limits for general population/uncontrolled exposure. 33.12 Warranty Information Warranty t:slim X2 Insulin Pump This warranty is valid only in Canada. Tandem Diabetes Care Canada, Inc., 675 Cochran Drive, East Tower, 6th Floor, Markham, ON, L3R 0B8 ("Tandem") warrants the t:slim X2 insulin pump against defects in materials and workmanship, under normal use, for the period of four years from the earlier of the original date of delivery or shipment of the pump by Tandem or its authorized distributor to the original end-use purchaser (the "Warranty Period"). For any defective t:slim X2 pump covered by the foregoing warranty, Tandem will, at its discretion, repair the pump or replace it with a new or refurbished t:slim X2 pump, subject to the conditions and exclusions stated herein. Repair or replacement of a t:slim X2 pump will not extend the original four-year warranty,
which will continue to apply. If your t:slim X2 pump is replaced, then you must return your original pump in accordance with Tandem's instructions. In the event the defective t:slim X2 pump is not returned, then this warranty shall be void, and you will not be entitled to future pump replacement or repairs. Notwithstanding the foregoing, in the event the t:slim X2 insulin pump has been discontinued or is otherwise unavailable as a replacement, in its sole discretion, Tandem may replace the warranted product with a product that has similar or greater functionality. The warranty is valid only if the t:slim X2 pump is used in accordance with Tandem's instructions for use and this user guide and will not apply if: · damage results from changes or
modifications made to the t:slim X2 insulin pump by the user or third persons after the date of manufacture;
· damage results from service or repairs performed to any part of the
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t:slim X2 pump by any person or entity other than Tandem; · the t:slim X2 pump seal is broken; · a non-Tandem cartridge is used with the t:slim X2 pump; · a non-Tandem infusion set is used with the t:slim X2 pump (HOWEVER, this sentence shall not apply to Quebec consumers in respect of non-Tandem infusion sets with a standard Luer connector when used according to instructions for use and user guide with a Tandem cartridge with a standard Luer connector); · damage consists of scratches and wear to surfaces and other externally exposed parts due to wear and tear; · damage results from an event or accident beyond the control of Tandem; or · damage results from negligence or improper use, including but not
limited to improper storage or physical abuse. From time-to-time Tandem may, but shall not be obligated to, offer software updates for your t:slim X2 pump to help to ensure the up-to-date functionality of your pump or software that are intended to add new features to your t:slim X2 pump. Tandem reserves the right to offer those updates, if any, in its sole discretion either at no charge or for an additional fee to be determined at a future date. To the extent that an update is offered at no charge, it is considered to be included in the original cost of your pump. Any future software updates will be subject to your acceptance of other terms and conditions that may be applicable at that time, including additional terms that may modify or limit the terms of this Warranty. This warranty shall be personal to the original end-use purchaser. Any sale, rental or other transfer or use of the t:slim X2 pump covered by this warranty to or by a user other than the original end-use purchaser shall cause this warranty to immediately terminate.
This warranty only applies to the t:slim X2 pump and does not apply to other products or accessories. (FOLLOWING PARAGRAPHS NOT APPLICABLE TO QUEBEC CONSUMERS) No employee of Tandem or any other party, including without limitation any authorized distributor, is authorized to make any warranty in addition to those made in this warranty. The remedies provided for in this warranty are the exclusive remedies available for any warranty claims. Neither Tandem nor its suppliers or distributors shall be liable for losses, liabilities, claims or damages of any kind or nature whatsoever, including, without limitation, any indirect, incidental, consequential, or special damages of any kind caused by or arising out of a defect in the product. All other warranties, express or implied, are excluded, including the warranties of merchantability and fitness for a particular purpose.
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Warranty t:slim X2TM 3 mLCartridges This warranty is valid only in Canada. Tandem Diabetes Care, Inc., 675 Cochran Drive, East Tower, 6th Floor, Markham, ON, L3R 0B8 ("Tandem") warrants its cartridge against defects in materials and workmanship for one use during the period of three days after the individual cartridge sterile packaging has been opened, not to exceed six months from date of shipment of the cartridge to the end user (the "Warranty Period"). During the Warranty Period, Tandem will replace any defective cartridge, subject to the conditions and exclusions stated herein. The warranty is valid only if the cartridges are used in accordance with the accompanying instructions for use and user guide and will not apply if: · the cartridge has been used for
more than a single-time use by a single end-user;
· the sterile package is compromised while in the control of the user by any means other than purposeful
opening by the user at the time of intended product use; · damage results during the improper opening of the sterile package not in conformance with the procedures outlined in the associated instructions for use; · damage results from changes or modifications made to the cartridge by the user or third persons after the date of manufacture; · damage results from service or repairs performed to any part of the cartridge by any person or entity other than Tandem; · damage is caused by use of the cartridge with any non-Tandem insulin pump; · damage results from an event or accident beyond the control of Tandem; or · damage results from negligence or improper use, including but not limited to improper storage or
physical abuse such as dropping or otherwise.
This warranty shall be personal to the original end use purchaser. Any sale, rental or other transfer or use of the product covered by this warranty to or by a user other than the original end use purchaser shall cause this warranty to immediately terminate. This warranty does not apply to insulin pumps and other accessories. (FOLLOWING PARAGRAPHS NOT APPLICABLE TO QUEBEC CONSUMERS) No employee of Tandem or any other party, including without limitation any authorized distributor, is authorized to make any warranty in addition to those made in this warranty. The remedies provided for in this warranty are the exclusive remedies available for any warranty claims. Neither Tandem nor its suppliers or distributors shall be liable for losses, liabilities, claims or damages of any kind or nature whatsoever, including, without limitation, any indirect, incidental, consequential, or special
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CHAPTER 33 · Technical Specifications
damages of any kind caused by or arising out of a defect in the product. All other warranties, express or implied, are excluded, including the warranties of merchantability and fitness for a particular purpose. Warranty t:lockTM Infusion Sets Luer Infusion Sets This warranty is valid only in Canada. Tandem Diabetes Care, Inc., 675 Cochran Drive, East Tower, 6th Floor, Markham, ON, L3R 0B8 ("Tandem") warrants its infusion sets against defects in materials and workmanship for one use during the period of three days after the individual infusion set sterile packaging has been opened, not to exceed six months from date of shipment of the infusion set to the end user (the "Warranty Period"). During the Warranty Period, Tandem will replace any defective infusion set, subject to the conditions and exclusions stated herein. The warranty is valid only if the infusion sets are used in accordance with the accompanying instructions
for use and user guide provided with your insulin pump and will not apply if: · the infusion set has been used for
more than a single-time use by a single end-user; · the sterile package is compromised while in the control of the user by any means other than purposeful opening by the user at the time of intended product use; · damage results during the improper opening of the sterile package not in conformance with the procedures outlined in the accompanying instructions for use; · damage results from changes or modifications made to the infusion set by the user or third persons after the date of manufacture; · damage results from service or repairs performed to any part of the infusion set by any person or entity other than Tandem; · damage is caused by use of the t:lock infusion set with any non-Tandem insulin pump;
· damage results from an event or accident beyond the control of Tandem; or
· damage results from negligence or improper use, including but not limited to improper storage or physical abuse such as dropping or otherwise.
This warranty shall be personal to the original end-use purchaser. Any sale, rental or other transfer or use of the product covered by this warranty to or by a user other than the original end-use purchaser shall cause this warranty to immediately terminate. This warranty does not apply to insulin pumps and other accessories. (FOLLOWING PARAGRAPHS NOT APPLICABLE TO QUEBEC CONSUMERS) No employee of Tandem or any other party, including without limitation any authorized distributor, is authorized to make any warranty in addition to those made in this warranty. The remedies provided for in this warranty are the exclusive remedies
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CHAPTER 33 · Technical Specifications
available for any warranty claims. Neither Tandem nor its suppliers or distributors shall be liable for losses, liabilities, claims or damages of any kind or nature whatsoever, including, without limitation, any indirect, incidental, consequential, or special damages of any kind caused by or arising out of a defect in the product. All other warranties, express or implied, are excluded, including the warranties of merchantability and fitness for a particular purpose. CGM Warranty Tandem Diabetes Care does not sell CGM sensors or transmitters and therefore provides no warranty for CGM sensors or transmitters used with the t:slim X2 insulin pump. For more information about CGM warranty information, visit the manufacturer's website. 33.13 Returned Goods Policy Any insulin pump product ("Pump") that was originally purchased from Tandem Diabetes Care Canada, Inc. ("Tandem") or one of its authorized Canadian distributors may be returned to Tandem
only for the following reasons: (1) during the applicable Warranty Period, if the customer experiences an issue with the Pump that is covered by the Warranty set forth at tandemdiabetes.com/warranty, then Tandem will, in its sole discretion, repair or replace the Pump as provided under the applicable warranty above, (2) during the applicable Return Period (defined below), if the customer discovers that the Pump is not suited for the customer based on a valid, good faith medical reason which has been confirmed by the customer's healthcare professional, then Tandem will refund the applicable Pump purchase price to the original source(s) of payment. The Return Period shall be calculated from the date of pump shipment and shall means 90 days for Provincial-funded Pumps, and 30 days for all other Pumps. Tandem will not accept or be obligated to accept for return any Pump that is not based on one of the two reasons outlined above. The customer must first obtain a returned materials authorization (RMA) number from Tandem's Customer Service Department. Tandem will provide a label which will include the RMA
number on it, this label should be attached to the outer box. All return pre-authorized by Tandem should be sent to: Tandem Diabetes Care, Inc. c/o Apple Express Customer Returns 5300 Satellite Drive, Mississauga, ON L4W 5J2 Returns made without the RMA number will be returned to the customer, freight collect. This policy is subject to applicable law.
33.14 t:slim X2 Insulin Pump Event Data (Black Box)
Your t:slim X2 pump's event data is monitored and logged on the pump. The information stored on the pump may be obtained and used by Customer Technical Support for troubleshooting purposes when a pump is uploaded to a data management application that supports use of the t:slim X2 pump, or if the pump is returned for any reason. Others who may assert a legal right to know, or who obtain your consent to
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know such information may also have access to read and use this data.
33.15 Product List
For a complete product list, please contact your Customer Technical Support. Insulin Delivery · t:slim X2 insulin pump with
Control-IQTM technology · t:case (pump cover with clip) · t:slim X2 user guide · USB cable · USB charger with power plugs · cartridge removal tool Consumables · cartridge
· t:slim X2 cartridge (t:lockTM connector)
· infusion set (all with t:lock connector)
Infusion sets are available in different cannula sizes, tubing lengths, insertion angles, and may come with or without an insertion device. Some infusion sets have a soft cannula and others and have a steel needle.
Contact your local customer support service for available sizes and lengths of the following infusion sets with t:lock connectors:
· AutoSoft 90 infusion set · AutoSoft 30 infusion set · VariSoft infusion set · TruSteel infusion set Optional Accessories/Replacement Parts · t:case pump cover (black, blue,
pink, purple, turquoise, olive) · t:slim USB charging cable · t:slim USB charger · power plug for t:slim USB charger
· car adapter for t:slim USB charging cable
· cartridge removal tool · t:slim screen protector · USB rubber door
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This Page is Intentionally Left Blank
343
INDEX
A
AC power adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Active Bolus Icon . . . . . . . . . . . . . . . . . . . . . . . . . . 40, 170 After Bolus BG Reminder . . . . . . . . . . . . . . . . . . . . . . . 107 Air Bubbles
Check Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Removing Before Delivery . . . . . . . . . . . . . . . . . . . . . 81 Airport Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135 Altitude Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146 Cartridge Error Alarm . . . . . . . . . . . . . . . . . . . . . . . . 140 Cartridge Removal Alarm . . . . . . . . . . . . . . . . . . . . . 141 Empty Cartridge Alarm . . . . . . . . . . . . . . . . . . . . . . . 139 Low Power Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . 138 Occlusion Alarms . . . . . . . . . . . . . . . . . . . . . . . 143, 144 Reset Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147 Resume Pump Alarm . . . . . . . . . . . . . . . . . . . . . . . . 137 Screen On/Quick Bolus Button Alarm . . . . . . . . . . . 145 Temperature Alarm . . . . . . . . . . . . . . . . . . . . . . . . . 142 Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113 Alert Icon, Where to Find . . . . . . . . . . . . . . . . . . . . . . 40
344
Alerts & Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Basal Rate Required Alert . . . . . . . . . . . . . . . . . . . . 124 CGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187, 211 CGM Rise and Fall . . . . . . . . . . . . . . . . . . . . . . . . . 190 CGM, 12 Hour Calibration Alert . . . . . . . . . . . . . . . 215 CGM, Calibrate CGM Alert . . . . . . . . . . . . . . . . . . . 219 CGM, Calibration Error Alert . . . . . . . . . . . . . . . . . . 218 CGM, Calibration Timeout Alert . . . . . . . . . . . . . . . 217 CGM, Failed Sensor . . . . . . . . . . . . . . . . . . . . . . . . 231 CGM, Fall Alert . . . . . . . . . . . . . . . . . . . . . . . . 225, 226 CGM, High Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . 220 CGM, Incomplete Calibration Alert . . . . . . . . . . . . . 216 CGM, Low Alert . . . . . . . . . . . . . . . . . . . . . . . 221, 222 CGM, Low Transmitter Battery Alert . . . . . . . . . . . . 229 CGM, Out of Range Alert . . . . . . . . . . . . 228, 279, 280 CGM, Rise Alert . . . . . . . . . . . . . . . . . . . . . . . 223, 224 CGM, Second Startup Calibration Alert . . . . . . . . . 214 CGM, Startup Calibration Alert . . . . . . . . . . . . . . . . 213 CGM, System Error . . . . . . . . . . . . . . . . . . . . . . . . 233 CGM, Transmitter Error . . . . . . . . . . . . . . . . . . . . . 230 CGM, Unavailable . . . . . . . . . . . . . . . . . . . . . . . . . . 232 Connection Error Alert . . . . . . . . . . . . . . . . . . . . . . 131 Control-IQ Technology . . . . . . . . . . . . . . . . . . . . . . 277 Control-IQ Technology, High Alert . . . . . . . . . . . . . 282 Control-IQ Technology, Low Alert . . . . . . . . . . . . . . 281 Control-IQ Technology, Max Insulin Alert . . . . . . . . 283
Data Error Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134 High Glucose Alert, Set . . . . . . . . . . . . . . . . . . . . . . 188 Incomplete Bolus Alert . . . . . . . . . . . . . . . . . . . . . . . 118 Incomplete Cartridge Change Alert . . . . . . . . . . . . . 120 Incomplete Fill Cannula Alert . . . . . . . . . . . . . . . . . . 122 Incomplete Fill Tubing Alert . . . . . . . . . . . . . . . . . . . 121 Incomplete Load Sequence Alerts . . . . . . . . . . . . . . 120 Incomplete Personal Profile Alert . . . . . . . . . . . . . . . 123 Incomplete Setting Alert . . . . . . . . . . . . . . . . . . . . . . 123 Incomplete Temp Rate Alert . . . . . . . . . . . . . . . . . . 119 Low Glucose Alert, Set . . . . . . . . . . . . . . . . . . . . . . 189 Low Insulin Alert . . . . . . . . . . . . . . . . . . . . . . . 110, 115 Low Power Alerts . . . . . . . . . . . . . . . . . . . . . . 116, 117 Max Bolus Alerts . . . . . . . . . . . . . . . . . . . . . . . 126, 127 Max Hourly Bolus Alert . . . . . . . . . . . . . . . . . . . . . . 125 Min Basal Alerts . . . . . . . . . . . . . . . . . . . . . . . . 129, 130 Out of Range Alert, Set . . . . . . . . . . . . . . . . . . . . . . 191 Power Source Alert . . . . . . . . . . . . . . . . . . . . . . . . . 133 Alternate Site BG Testing . . . . . . . . . . . . . . . . . . . . . . . 166
Altitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Altitude Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Aquatic Activities, Pump . . . . . . . . . . . . . . . . . . . . . . . 156
Arrows
CGM Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208 Up/Down Arrows . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
B
Basal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34 Basal Rate Required Alert . . . . . . . . . . . . . . . . . . . .124 Current Basal Rate . . . . . . . . . . . . . . . . . . . . . . . . . . .44 Delivery Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . .317 Frequency of Delivery . . . . . . . . . . . . . . . . . . . . . . . .317 in Personal Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . .71 Set a Temp Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . .75 Stop a Temp Rate . . . . . . . . . . . . . . . . . . . . . . . . . . .76 Temp Basal Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . .35 Timed Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
Basal Rate Required Alert . . . . . . . . . . . . . . . . . . . . . .124 Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
Battery Level . . . . . . . . . . . . . . . . . . . . . . . . . . . .40, 42 Battery, Charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61 BG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
High BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . .106 Low BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . .106 Target BG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34, 69 Target BG in Personal Profiles . . . . . . . . . . . . . . . . . .71 BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107 Bluetooth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .182 Bluetooth, Recommended Distance Between Devices 335 Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35, 89
345
Active Bolus Icon . . . . . . . . . . . . . . . . . . . . . . . . 40, 170 After Bolus BG Reminder . . . . . . . . . . . . . . . . . . . . . 107 Bolus Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 Bolus Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Cancel a Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Correction Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Delivery Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . 317 Extended Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . 35, 95 Food Bolus Using Grams . . . . . . . . . . . . . . . . . . . . . . 94 Food Bolus Using Units . . . . . . . . . . . . . . . . . . . . . . . 94 in Personal Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 Quick Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Stop a Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Timed Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
C
Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Calibrate CGM Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . 219 Calibration Alert, 12 Hour . . . . . . . . . . . . . . . . . . . . . . . 215 Calibration Error Alert . . . . . . . . . . . . . . . . . . . . . . . . . . 218 Calibration Timeout Alert . . . . . . . . . . . . . . . . . . . . . . . 217 Cancel a Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Cannula, Fill Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Carb Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Current Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 in Personal Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Timed Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Carbohydrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Carbohydrates
Carbs, in Personal Profiles . . . . . . . . . . . . . . . . . . . . 69 Food Bolus Using Grams . . . . . . . . . . . . . . . . . . . . . 94 Food Bolus, on Bolus Screen . . . . . . . . . . . . . . . . . . 46 Carbs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Carbs, on Bolus Screen . . . . . . . . . . . . . . . . . . . . . . . . 46 Caring for Your Pump . . . . . . . . . . . . . . . . . . . . . . . . . 153 Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 Cartridge Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Change Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 Fill Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Load Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . 80, 84 Load the Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Cartridge Error Alarm . . . . . . . . . . . . . . . . . . . . . . . . . 140 Cartridge Removal Alarm . . . . . . . . . . . . . . . . . . . . . . 141 Cartridge, Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . 339 CGM 12 Hour Calibration Alert . . . . . . . . . . . . . . . . . . . . 215 Alerts and Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . 211 Automatic Sensor Shut-Off . . . . . . . . . . . . . . . . . . . 197
346
Calibrate Blood Glucose Value . . . . . . . . . . . . . . . . 202 Calibrate CGM Alert . . . . . . . . . . . . . . . . . . . . . . . . . 219 Calibrating Your CGM . . . . . . . . . . . . . . . . . . . . . . . 199 Calibration Error Alert . . . . . . . . . . . . . . . . . . . . . . . 218 Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . 200 Calibration Prompts . . . . . . . . . . . . . . . . . . . . . . . . . 168 Calibration Timeout Alert . . . . . . . . . . . . . . . . . . . . . 217 CGM Fall Alert . . . . . . . . . . . . . . . . . . . . . . . . . 225, 226 CGM High Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220 CGM Info . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185 CGM Low Alert . . . . . . . . . . . . . . . . . . . . . . . . 221, 222 CGM Rise Alert . . . . . . . . . . . . . . . . . . . . . . . . 223, 224 CGM Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182 CGM System Error . . . . . . . . . . . . . . . . . . . . . . . . . 233 CGM Unavailable . . . . . . . . . . . . . . . . . . . . . . . . . . . 232 Clinical Studies, Sensor . . . . . . . . . . . . . . . . . . . . . . 287 Default Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183 Distance to Pump and other devices . . . . . . . . . . . . 334 End a Sensor Session . . . . . . . . . . . . . . . . . . . . . . . 197 Enter Transmitter ID . . . . . . . . . . . . . . . . . . . . . . . . . 182 Failed Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231 Failed Sensor, Troubleshooting . . . . . . . . . . . . . . . . 238 Glucose Trend Arrows . . . . . . . . . . . . . . . . . . . . . . . 206 Glucose Trend Graphs . . . . . . . . . . . . . . . . . . . . . . 205 High BG Alert Default . . . . . . . . . . . . . . . . . . . . . . . 188 High BG Alert Repeat . . . . . . . . . . . . . . . . . . . . . . . 188
High Glucose Alert, Set . . . . . . . . . . . . . . . . . . . . . .188 History, View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .209 Incomplete Calibration Alert . . . . . . . . . . . . . . . . . . .216 Low BG Alert Default . . . . . . . . . . . . . . . . . . . . . . . .189 Low BG Alert Repeat . . . . . . . . . . . . . . . . . . . . . . . .189 Low Glucose Alert, Set . . . . . . . . . . . . . . . . . . . . . . .189 Low Transmitter Battery Alert . . . . . . . . . . . . . . . . . .229 My CGM Screen . . . . . . . . . . . . . . . . . . . . . . . . . . .174 Out of Range Alert . . . . . . . . . . . . . . . . . .228, 279, 280 Out of Range Alert, Set . . . . . . . . . . . . . . . . . . . . . .191 Out of Range/No Antenna, Troubleshooting . . . . . . .237 Pair Your CGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . .182 Rate of Change Arrows . . . . . . . . . . . . . . . . . . . . . .206 Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .178 Rise and Fall Alerts . . . . . . . . . . . . . . . . . . . . . . . . . .190 Second Startup Calibration Alert . . . . . . . . . . . . . . .214 Sensor Inaccuracies, Troubleshooting . . . . . . . . . . .238 Sensor Startup Period . . . . . . . . . . . . . . . . . . . . . . .195 Set Correction Bolus . . . . . . . . . . . . . . . . . . . . . . . .202 Set Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183 Start Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . .200 Start or Stop a CGM Sensor . . . . . . . . . . . . . . . . . .193 Startup Calibration Alert . . . . . . . . . . . . . . . . . . . . . .213 Status Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . .168 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . .178 Transmitter Error . . . . . . . . . . . . . . . . . . . . . . . . . . .230
347
Transmitter ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235 Unknown Sensor Reading . . . . . . . . . . . . . . . . . . . . 227 Unknown Sensor Reading, Troubleshooting . . . . . . 236 View Data on Pump, Overview . . . . . . . . . . . . . . . . . 204 CGM Fall Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225, 226 CGM High Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220 CGM ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182 CGM Low Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . 221, 222 CGM Rise Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . 223, 224 CGM Safety Information . . . . . . . . . . . . . . . . . . . . . . . . 160 CGM System Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233 CGM Unavailable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232 Charge AC Power Outlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Car Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Charge the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Cleaning Your System . . . . . . . . . . . . . . . . . . . . . . . . . 154 Colors Explanation of Pump Colors . . . . . . . . . . . . . . . . . . . . 39 Computer Charging Specifications . . . . . . . . . . . . . . . 321 Connection Error Alert . . . . . . . . . . . . . . . . . . . . . . . . . 131 Contents, of Pump Package . . . . . . . . . . . . . . . . . . . . . 34 Control-IQ Technology
348
Automatic Correction Bolus Delivery . . . . . . . . . . . . 263 Calculate Total Daily Insulin . . . . . . . . . . . . . . . . . . . 269 During Exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . 266 During Sleep . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 265 High Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282 Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250 How it Works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256 Increasing Insulin Delivery . . . . . . . . . . . . . . . . . . . . 261 Information on Your Screen . . . . . . . . . . . . . . . . . . 273 Insulin Decreased . . . . . . . . . . . . . . . . . . . . . . . . . . 257 Insulin Suspended . . . . . . . . . . . . . . . . . . . . . . . . . 259 Low Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281 Manually Start or Stop Sleep . . . . . . . . . . . . . . . . . 272 Max Insulin Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . 283 Maximum Insulin Delivery . . . . . . . . . . . . . . . . . . . . 261 No Activity Enabled . . . . . . . . . . . . . . . . . . . . . . . . 265 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256 Personal Profile Basal Rate Delivery . . . . . . . . . . . . 257 Required Settings . . . . . . . . . . . . . . . . . . . . . . . . . . 268 Responsible Use . . . . . . . . . . . . . . . . . . . . . . . . . . 246 Schedule Sleep . . . . . . . . . . . . . . . . . . . . . . . . . . . 270 Set Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268 Start or Stop Exercise . . . . . . . . . . . . . . . . . . . . . . . 273 Total Daily Insulin . . . . . . . . . . . . . . . . . . . . . . . . . . 252 Turn On or Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269 Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252
Control-IQ Technology Safety Information . . . . . . . . . 242 Correction Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Correction Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . 35, 69
in Personal Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Timed Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Current Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 44
D
Data Error Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134 Data, View CGM Overview . . . . . . . . . . . . . . . . . . . . . . 204 Date
Date and Time Display . . . . . . . . . . . . . . . . . . . . . . . . 40 Edit Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Default Auto-Off Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 Basal Temp Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 CGM Default Volume . . . . . . . . . . . . . . . . . . . . . . . . 183 CGM Fall Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190 CGM Out of Range Alert . . . . . . . . . . . . . . . . . . . . . 191 CGM Rise Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190 Extended Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 High BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . 107 High Glucose Alert . . . . . . . . . . . . . . . . . . . . . . . . . . 188 Low BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Low Glucose Alert . . . . . . . . . . . . . . . . . . . . . . . . . .189 Low Insulin Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . .110 Quick Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97 Screen Timeout . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64 Site Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . .108 Delete Personal Profile . . . . . . . . . . . . . . . . . . . . . . . . . .75 Delivery Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104 Device Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52, 64 Disconnect When Filling . . . . . . . . . . . . . . . . . . . . . . . . .85 Display Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64 Disposing of System Components . . . . . . . . . . . . . . . .154
E
Edit Edit Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63 Edit Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63 Site Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . .329 Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . .330 Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . .331 Empty Cartridge Alarm . . . . . . . . . . . . . . . . . . . . . . . . .139 End CGM Sensor Session . . . . . . . . . . . . . . . . . . . . . .197 Extended Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35, 95
Default . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
349
F
Failed Sensor Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231 Fall Alert, Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191 Fill
Fill Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Fill Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Fill Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81, 82 Fill Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
G
Glucose Rate of Change Arrows . . . . . . . . . . . . . . . . . 206 Glucose Trend Graphs . . . . . . . . . . . . . . . . . . . . . . . . . 205 Grams
Food Bolus, on Bolus Screen . . . . . . . . . . . . . . . . . . . 46 Food Bolus, using . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
H
Healthcare Provider . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 High Alert
Control-IQ Technology . . . . . . . . . . . . . . . . . . . . . . . 282 High BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
History CGM History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209 Control-IQ Technology History . . . . . . . . . . . . . . . . 104 Pump History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Home Screen, CGM . . . . . . . . . . . . . . . . . . . . . . . . . . . 172 Home Screen, Control-IQ Technology . . . . . . . . . . . . 250
I
Icons Explanation of Icons . . . . . . . . . . . . . . . . . 37, 168, 247
Incomplete Bolus Alert . . . . . . . . . . . . . . . . . . . . . . . . 118 Incomplete Calibration Alert . . . . . . . . . . . . . . . . . . . . 216 Incomplete Cartridge Change Alert . . . . . . . . . . . . . . 120 Incomplete Fill Cannula Alert . . . . . . . . . . . . . . . . . . . 122 Incomplete Fill Tubing Alert . . . . . . . . . . . . . . . . . . . . 121 Incomplete Load Sequence Alerts . . . . . . . . . . . . . . . 120 Incomplete Setting Alert . . . . . . . . . . . . . . . . . . . . . . . 123 Incomplete Temp Rate Alert . . . . . . . . . . . . . . . . . . . . 119 Infusion Set Risks . . . . . . . . . . . . . . . . . . . . . . . . . . 30, 78 Infusion Site Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Infusion Site Care, Pediatric . . . . . . . . . . . . . . . . . . . . . 20 Insulin
350
Insulin Duration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Insulin Level Display . . . . . . . . . . . . . . . . . . . . . . . 40, 87 Insulin On Board (IOB) . . . . . . . . . . . . . . . . . . . . . 35, 40 Insulin On Board (IOB) Display . . . . . . . . . . . . . . . . . . 40 Resume Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . 102 Stop Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . 102 Insulin Duration, in Personal Profiles . . . . . . . . . . . . . . . 69 Insulin on Board (IOB), in Personal Profiles . . . . . . . . . 70 Interference, FCC Notice . . . . . . . . . . . . . . . . . . . . . . . 336
K
Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54, 56 Letter Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Number Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
L
Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 LED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 LED, location on Home Screen . . . . . . . . . . . . . . . . . . . 42 Lifestyle Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155 Load Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80, 84 Low BG Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Low Insulin Alert . . . . . . . . . . . . . . . . . . . . . . . . . .110, 115 Low Power Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . .138 Low Power Alerts . . . . . . . . . . . . . . . . . . . . . . . . .116, 117 Low Transmitter Battery Alert . . . . . . . . . . . . . . . . . . . .229
M
Maintaining Your Pump . . . . . . . . . . . . . . . . . . . . . . . .153 Malfunction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150 Manual Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90 Max Basal Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111 Max Basal Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .129 Max Bolus Alerts . . . . . . . . . . . . . . . . . . . . . . . . . .126, 127 Max Hourly Bolus Alert . . . . . . . . . . . . . . . . . . . . . . . . .125 Max Insulin Alert
Control-IQ Technology . . . . . . . . . . . . . . . . . . . . . . .283 Min Basal Alerts . . . . . . . . . . . . . . . . . . . . . . . . . .129, 130 Missed Meal Bolus Reminder . . . . . . . . . . . . . . . . . . . .108 My Pump Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
O
Occlusion Alarms . . . . . . . . . . . . . . . . . . . . . . . . .143, 144 Options Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
351
Out of Range Alert . . . . . . . . . . . . . . . . . . . . 228, 279, 280 Overview
CGM Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
P
Pediatric Infusion Site Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Security PIN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Personal Profiles Activate a Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74 Add Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Copy an Existing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74 Create a New Profile . . . . . . . . . . . . . . . . . . . . . . . . . 68 Delete a Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Edit or View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Personal Profiles Overview . . . . . . . . . . . . . . . . . . . . . 68 Program a Personal Profile . . . . . . . . . . . . . . . . . . . . . 70 Rename a Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Power Adapter, AC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Power Source Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133 Pump History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Pump History, Delivery Summary . . . . . . . . . . . . . . . . 104 Pump Info . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Pump Info, Serial Number . . . . . . . . . . . . . . . . . . . . . . 104
Pump Package Contents . . . . . . . . . . . . . . . . . . . . . . . 34 Pump Performance, Specifications . . . . . . . . . . . . . . 324 Pump Settings, Specifications . . . . . . . . . . . . . . . . . . 322 Pump Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 316
Q
Quick Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35, 97 Pediatric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
R
Receiver, CGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178 Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
After Bolus BG . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 Alerts & Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . 50 High BG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 Low BG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 Missed Meal Bolus . . . . . . . . . . . . . . . . . . . . . . . . . 108 Site Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . 88, 108 Reset Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147 Resume Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . 102 Resume Pump Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . 137 Returned Goods Policy . . . . . . . . . . . . . . . . . . . . . . . . 341
352
Rise Alert, Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190 Risks from Using the Pump . . . . . . . . . . . . . . . . . . . . . . 30 Risks from Using the System . . . . . . . . . . . . . . . . . . . . 164
S
Safety Information CGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159 Control-IQ Technology . . . . . . . . . . . . . . . . . . . . . . 241 Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Screen On/Quick Bolus Button Alarm . . . . . . . . . . . . . 145 Screen Protector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Screen Timeout, set . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Screens
Bolus Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 CGM Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . 172 CGM Lock Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 170 Control-IQ Technology . . . . . . . . . . . . . . . . . . . . . . 252 Control-IQ Technology Home Screen . . . . . . . . . . . 250 Control-IQ Technology Lock Screen . . . . . . . . . . . . 248 Current Status Screen . . . . . . . . . . . . . . . . . . . . . . . . 44 Device Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Letter Keypad Screen . . . . . . . . . . . . . . . . . . . . . . . . 56 Lock Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
My CGM Screen . . . . . . . . . . . . . . . . . . . . . . . . . . .174 My Pump Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . .50 Number Keypad Screen . . . . . . . . . . . . . . . . . . . . . . .54 Options Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48 Unlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62 Second Startup Calibration Alert, CGM . . . . . . . . . . . .214 Security PIN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65 Pediatric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 Select Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
Sensor Applicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .166 Automatic Shut-Off . . . . . . . . . . . . . . . . . . . . . . . . .197 CGM Clinical Studies . . . . . . . . . . . . . . . . . . . . . . . .287 Failed Sensor, Troubleshooting . . . . . . . . . . . . . . . .238 Out of Range Alert . . . . . . . . . . . . . . . . . .228, 279, 280 Out of Range/No Antenna, Troubleshooting . . . . . . .237 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . .235 Troubleshooting Sensor Reading . . . . . . . . . . . . . . .236 Unknown Reading . . . . . . . . . . . . . . . . . . . . . . . . . .227
Sensor Startup Period . . . . . . . . . . . . . . . . . . . . . . . . . .195 Sensor, Start a Session . . . . . . . . . . . . . . . . . . . . . . . . .194 Sensor, Start Calibration . . . . . . . . . . . . . . . . . . . . . . . .200 Serial Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16, 104 Set CGM Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183 Settings, Pump Setting Specifications . . . . . . . . . . . . .322
353
Site Reminder Set Site Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Site Reminder, Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 Sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Specifications
Computer Charging . . . . . . . . . . . . . . . . . . . . . . . . . 321 Distance Between CGM, Pump, other devices . . . . . 334 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . 329 Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . 330 Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . 331 Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 316 Pump Performance . . . . . . . . . . . . . . . . . . . . . . . . . 324 Water Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . 316 Startup Calibration Alert . . . . . . . . . . . . . . . . . . . . . . . . 213 Stop a Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 Stop a Temp Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 Stop CGM Sensor Session . . . . . . . . . . . . . . . . . . . . . . 197 Stop Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 Storing Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . 154 Supply Reordering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
T
Tandem Logo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42, 62 Target BG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
in Personal Profiles . . . . . . . . . . . . . . . . . . . . . . . 69, 71 Timed Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . 315 Temp Rate Stop a Temp Rate . . . . . . . . . . . . . . . . . . . . . . . . . . 76 Temp Rate, Set a Temp Basal Rate . . . . . . . . . . . . . . . 75 Temperature Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . 142 Temperature, Extreme . . . . . . . . . . . . . . . . . . . . . . . . . 156 Time Date and Time Display . . . . . . . . . . . . . . . . . . . . . . . 40 Edit Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Time Segments . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 Time Segments, in Personal Profiles . . . . . . . . . . . . . 70 Time Segments add to Personal Profile . . . . . . . . . . . . . . . . . . . . . . . 72 Timed Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 in Personal Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Transmitter Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230 Transmitter ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182 Travel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157 Traveling, by Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157 Trend Graphs, Glucose Trends, Arrows . . . . . . . . . . . 205 Troubleshooting CGM . . . . . . . . . . . . . . . . . . . . . . . . . 235 Tubing Cartridge Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
354
Fill Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Tubing Connector . . . . . . . . . . . . . . . . . . . . . 42, 81, 86
U
Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Food Bolus, on Bolus Screen . . . . . . . . . . . . . . . . . . 46 Food Bolus, Using Units . . . . . . . . . . . . . . . . . . . . . . 94
Units, on Bolus Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Unknown Sensor Reading . . . . . . . . . . . . . . . . . . . . . . 227 Unlock the Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 USB
USB Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 USB Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34, 61 USB Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42, 60
V
View Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
W
Warranty
Cartridges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .339 Pump Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . .337 Water Resistance, Pump . . . . . . . . . . . . . . . . . . . . . . .156 Watertight, Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . .156
355
COPYRIGHTS, PATENTS, AND TRADEMARKS © 2021 Tandem Diabetes Care, Inc. All rights reserved. Covered by one or more patents. For a list of patents, see tandemdiabetes.com/legal/patents. t:slim is a trademark of Tandem Diabetes Care, Inc., registered in the U.S. and other countries. Tandem Diabetes Care, the Tandem Diabetes Care logo, t:connect, t:lock, t:slim X2, Control-IQ, AutoSoft, TruSteel, and VariSoft are trademarks of Tandem Diabetes Care, Inc. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Tandem Diabetes Care, Inc. is under license. All other third party marks are the property of their respective owners.
Medical Device Safety Service GmbH Schiffgraben 41 30175 Hannover Germany
356
CANADA:
(833) 509-3598 tandemdiabetes.ca
UNITED STATES:
(877) 801-6901 tandemdiabetes.com
OTHER COUNTRIES:
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1005581_D
AW-1005580_D 2021-JAN-13
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