Tandem t:slim X2 User manual

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mg/dL
190
3
HRS
INSULIN ON BOARD: 1.1 u |1:09 hrs
OPTIONS BOLUS
B
10:20 AM
March 5, 2017
100% 235 u
Dexcom G5®Mobile CGM Enabled

Customer Technical Support: [phone] 3
Congratulations on the purchase of
your new t:slim X2 System. Your deci-
sion to use insulin pump therapy and
continuous glucose monitoring is a sign
of your commitment to your diabetes
care. We recognize and respect the
importance of your decision. We also
recognize that your t:slim X2 System
purchase is only the beginning of your
relationship with Tandem. Our commit-
ment goes much deeper than simply
supplying products to help you in your
diabetes management. We pledge to
be here to support you with training
and education through our network of
Clinical Diabetes Specialists. We also
pledge to be here to support you with
our dedicated Customer Technical
Support.
This User Guide is designed to assist
you with the features and functions
of the t:slim X2 System. 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 System.
Changes in equipment, software, or
procedures occur periodically; informa-
tion describing these changes will be
included in future editions of this User
Guide. Please contact Tandem Diabe-
tes Care Customer Technical Support
at [phone] to obtain a replace-
ment copy of the User Guide that is the
correct version for your pump.
No part of this publication may be
reproduced, stored in a retrieval sys-
tem, nor transmitted in any form or by
any means, electronic or mechanical,
without the prior written permission
of Tandem Diabetes Care, Inc., San
Diego, California, USA.
Tandem Diabetes Care, Inc.
11075 Roselle Street
San Diego, CA 92121 USA
[phone]
www.tandemdiabetes.com
Need help? We are here for you
24 hours a day, 7 days a week
at [phone].
© 2019 Tandem Diabetes Care, Inc. All
rights reserved. Tandem Diabetes Care,
t:connect, touch simplicity, and t:slim
are registered trademarks, and t:slim
X2 is a trademark of Tandem Diabetes
Care, Inc.
Dexcom, Dexcom G5, Dexcom G5
Mobile CGM, and SEVEN are either
registered trademarks or trademarks of
Dexcom, Inc. in the United States and/
or other countries.
Humalog®is a registered trademark of
Eli Lilly and Company.
NovoLog®is a registered trademark of
Novo Nordisk A/S.
Comfort™is a trademark of Unomedical
A/S.
Bluetooth®is a registered trademark of
Bluetooth SIG, Inc.
All other trademarks and copyrights are
the property of their respective owners.
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM User Guide Software Version Pendleton

Table of Contents
Customer Technical Support: (877) 801-69014
Section 1 – Before You Begin
Chapter 1 – Introduction
1.1 System Description .......................................................................................................22
1.2 About this User Guide ...................................................................................................22
1.3 Important User Information ...........................................................................................23
1.4 Important Pediatric User Information ............................................................................23
1.5 Conventions of this Guide.............................................................................................25
Chapter 2 – Important Safety Information
2.1 Indications for Use ........................................................................................................28
2.2 Contraindications ..........................................................................................................28
2.3 System Warnings ..........................................................................................................29
2.4 System Precautions ......................................................................................................34
2.5 Potential Benefits From Using the System....................................................................38
2.6 Possible Risks From Using the System ........................................................................40
2.7 Working with your Healthcare Provider .........................................................................41
2.8 Emergency Kit ...............................................................................................................42
2.9 Verification of Proper Functionality................................................................................43

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Customer Technical Support: [phone] 5
2.10 Wireless Co-existence
and Data Security..........................................................................................................43
Chapter 3 – Getting to Know Your t:slim X2 System
3.1 What your t:slim X2 System Package Includes.............................................................46
3.2 System Terminology ......................................................................................................46
3.3 Explanation of System Symbols....................................................................................50
3.4 Explanation of System Icons.........................................................................................52
3.5 Explanation of System Colors .......................................................................................54
3.6 Screen Lock ..................................................................................................................56
3.7 CGM Screen Lock.........................................................................................................58
3.8 Home Screen.................................................................................................................60
3.9 CGM Home Screen .......................................................................................................62
3.10 Status Screen ................................................................................................................64
3.11 Bolus Screen .................................................................................................................66
3.12 Options Screen..............................................................................................................68
3.13 My Pump Screen...........................................................................................................70
3.14 My CGM Screen............................................................................................................72
3.15 Number Keypad Screen ................................................................................................74

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Customer Technical Support: (877) 801-69016
3.16 Letter Keypad Screen....................................................................................................76
Section 2 – Key Pump Features
Chapter 4 – Getting Started
4.1 Charging the t:slim X2 Pump.........................................................................................80
4.2 Using the Touch Screen ................................................................................................82
4.3 Turning on the t:slim X2 Pump Screen..........................................................................82
4.4 Unlocking the t:slim X2 Pump Screen...........................................................................82
4.5 Edit Time .......................................................................................................................83
4.6 Edit Date........................................................................................................................83
Chapter 5 – Infusion Site Care and
Loading Cartridge
5.1 Infusion Site Selection and Care ...................................................................................86
5.2 Cartridge Instructions for Use .......................................................................................88

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Customer Technical Support: [phone] 7
5.3 Filling and Loading a t:slim Cartridge............................................................................88
5.4 Filling Tubing .................................................................................................................94
5.5 Filling Cannula ...............................................................................................................96
5.6 Setting Site Reminder ...................................................................................................97
Chapter 6 – Personal Profiles
6.1 Personal Profiles Overview..........................................................................................100
6.2 Creating a New Profile.................................................................................................100
6.3 Programming a New Personal Profile .........................................................................102
6.4 Editing or Reviewing an Existing Profile......................................................................105
6.5 Duplicating an Existing Profile.....................................................................................106
6.6 Activating an Existing Profile.......................................................................................106
6.7 Renaming an Existing Profile.......................................................................................107
6.8 Deleting an Existing Profile..........................................................................................107
Chapter 7 – Bolus
7.1 Bolus Overview ...........................................................................................................110

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Customer Technical Support: (877) 801-69018
7.2 Food Bolus Using Units...............................................................................................110
7.3 Food Bolus Using Grams ............................................................................................111
7.4 Correction Bolus..........................................................................................................112
7.5 Extended Bolus ...........................................................................................................113
7.6 Canceling or Stopping a Bolus....................................................................................114
Chapter 8 – Stop/Resume Insulin
8.1 Stopping Insulin Delivery.............................................................................................118
8.2 Resuming Insulin Delivery ...........................................................................................118
Section 3 – Additional Pump Operations
Chapter 9 – Temporary Basal Rate
9.1 Setting a Temp Rate....................................................................................................122
9.2 Stopping a Temp Rate.................................................................................................123
Chapter 10 – Quick Bolus
10.1 Setting Up Quick Bolus ...............................................................................................126

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Customer Technical Support: [phone] 9
10.2 Delivering Quick Bolus ................................................................................................126
Chapter 11 – t:slim X2 Pump Settings
11.1 t:slim X2 Pump Volume ...............................................................................................130
11.2 Screen Options............................................................................................................130
Chapter 12 – t:slim X2 Pump Info and History
12.1 t:slim X2 Pump Info .....................................................................................................134
12.2 t:slim X2 Pump History................................................................................................134
Chapter 13 – t:slim X2 Pump Reminders
13.1 Low BG Reminder .......................................................................................................136
13.2 High BG Reminder ......................................................................................................137
13.3 After Bolus BG Reminder ............................................................................................138
13.4 Missed Meal Bolus Reminder......................................................................................138
13.5 Site Reminder..............................................................................................................139

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Customer Technical Support: (877) 801-690110
Chapter 14 – User Settable Alerts and Alarms
14.1 Low Insulin Alert ..........................................................................................................142
14.2 Auto-Off Alarm ............................................................................................................142
Section 4 – t:slim X2 Pump Safety Alerts and Alarms
Chapter 15 – t:slim X2 Pump Alerts
15.1 Low Insulin Alert ..........................................................................................................147
15.2 Low Power Alerts ........................................................................................................148
15.3 Incomplete Bolus Alert ................................................................................................150
15.4 Incomplete Temp Rate Alert........................................................................................151
15.5 Incomplete Load Sequence Alerts ..............................................................................152
15.6 Incomplete Setting Alert..............................................................................................155
15.7 Basal Rate Required Alert ...........................................................................................156
15.8 Max Hourly Bolus Alert................................................................................................157
15.9 Max Bolus Alerts .........................................................................................................158
15.10 Max Basal Alerts .........................................................................................................160

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Customer Technical Support: [phone] 11
15.11 Min Basal Alerts ..........................................................................................................162
15.12 Connection Error Alert.................................................................................................164
15.13 Power Source Alert......................................................................................................165
15.14 Data Error Alert............................................................................................................166
Chapter 16 – t:slim X2 Pump Alarms
16.1 Resume Pump Alarm ..................................................................................................169
16.2 Low Power Alarms ......................................................................................................170
16.3 Empty Cartridge Alarm................................................................................................172
16.4 Cartridge Error Alarm ..................................................................................................173
16.5 Cartridge Removal Alarm ............................................................................................174
16.6 Temperature Alarm ......................................................................................................175
16.7 Occlusion Alarms ........................................................................................................176
16.8 Screen On/Quick Bolus Button Alarm.........................................................................178
16.9 Altitude Alarm ..............................................................................................................179
16.10 Reset Alarm .................................................................................................................180

Table of Contents
Customer Technical Support: (877) 801-690112
Chapter 17 – t:slim X2 Pump Malfunction
17.1 Malfunction..................................................................................................................182
Section 5 – Getting Started with Your CGM System
Chapter 18 – Dexcom G5 Mobile CGM Overview
18.1 CGM System Overview ...............................................................................................186
18.2 Sensor Overview .........................................................................................................186
18.3 Receiver (t:slim X2 Pump) Overview ...........................................................................188
18.4 Transmitter Overview...................................................................................................190
Chapter 19 – CGM Settings
19.1 Entering Your Transmitter ID........................................................................................192
19.2 Setting CGM Volume...................................................................................................193
19.3 CGM Info .....................................................................................................................195
Chapter 20 – Setting CGM Alerts
20.1 Setting Your High Glucose Alert and Repeat Feature .................................................198

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Customer Technical Support: [phone] 13
20.2 Setting Your Low Glucose Alert and Repeat Feature..................................................199
20.3 Rate Alerts...................................................................................................................200
20.4 Setting Your Rise Alert.................................................................................................201
20.5 Setting Your Fall Alert..................................................................................................201
20.6 Setting Your Out of Range Alert ..................................................................................202
Chapter 21 – Inserting the Sensor and Placing the Transmitter
21.1 Before You Start ..........................................................................................................204
21.2 Removing the Sensor From its Packaging..................................................................205
21.3 Choosing an Insertion Site ..........................................................................................206
21.4 Placing the CGM Sensor.............................................................................................206
21.5 Inserting the CGM Sensor...........................................................................................207
21.6 Attaching the CGM Transmitter...................................................................................209
Chapter 22 – Starting a CGM Sensor Session
22.1 Starting Sensor............................................................................................................212
22.2 Sensor Startup Period.................................................................................................213

Table of Contents
Customer Technical Support: (877) 801-690114
Chapter 23 – Calibrating Your CGM System
23.1 Calibration Overview ...................................................................................................216
23.2 Startup Calibration ......................................................................................................217
23.3 Calibration Blood Glucose Value and
Correction Bolus..........................................................................................................219
23.4 12 Hour Calibration Update ........................................................................................219
23.5 Other Reasons You May Need to Calibrate ................................................................220
Chapter 24 – Viewing CGM Data on Your t:slim X2 Pump
24.1 Overview......................................................................................................................222
24.2 CGM Trend Graphs .....................................................................................................223
24.3 Rate of Change Arrows ...............................................................................................225
24.4 Additional CGM Status Symbols.................................................................................226
24.5 CGM History................................................................................................................229
Chapter 25 – Ending Your CGM Sensor Session

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Customer Technical Support: [phone] 15
25.1 Automatic Sensor Shut-Off .........................................................................................232
25.2 Ending a Sensor Session Before Automatic Shut-Off.................................................233
25.3 Removing the Sensor and Transmitter ........................................................................233
Section 6 – CGM Alerts, Errors and Troubleshooting
Chapter 26 – CGM Alerts and Errors
26.1 Startup Calibration Alert..............................................................................................238
26.2 Second Startup Calibration Alert.................................................................................239
26.3 12 Hour Calibration Alert.............................................................................................240
26.4 Incomplete Calibration ................................................................................................241
26.5 Calibration Timeout .....................................................................................................242
26.6 Wait 15 Minute Calibration Error Alert.........................................................................243
26.7 Calibration Required Alert ...........................................................................................244
26.8 CGM High Alert ...........................................................................................................245
26.9 CGM Low Alert............................................................................................................246
26.10 CGM Fixed Low Alert ..................................................................................................247
26.11 CGM Rise Alert............................................................................................................248
26.12 CGM Rapid Rise Alert .................................................................................................249

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Customer Technical Support: (877) 801-690116
26.13 CGM Fall Alert .............................................................................................................250
26.14 CGM Rapid Fall Alert...................................................................................................251
26.15 Unknown Sensor Reading...........................................................................................252
26.16 Out of Range Alert.......................................................................................................253
26.17 Low Transmitter Battery Alert......................................................................................254
26.18 Transmitter Error..........................................................................................................255
26.19 Failed Sensor Error......................................................................................................256
26.20 CGM Error ...................................................................................................................257
26.21 CGM System Error ......................................................................................................258
Chapter 27 – CGM Troubleshooting
27.1 Sensor Insertion Troubleshooting................................................................................260
27.2 Calibration Troubleshooting ........................................................................................261
27.3 Unknown Sensor Reading Troubleshooting................................................................262
27.4 Out of Range/No Antenna Troubleshooting ................................................................263
27.5 Failed Sensor Troubleshooting....................................................................................263
27.6 Sensor Inaccuracies....................................................................................................264

Table of Contents
Customer Technical Support: [phone] 17
Section 7 – Living With and Caring for Your System
Chapter 28 – Lifestyle Issues and Travel
28.1 Overview......................................................................................................................268
Chapter 29 – Taking Care of Your t:slim X2 System
29.1 Overview......................................................................................................................272
Section 8 – Technical Specifications and Warranty
Chapter 30 – Technical Specifications
30.1 Overview......................................................................................................................276
30.2 t:slim X2 System Specifications ..................................................................................276
30.3 t:slim X2 Pump Options and Settings .........................................................................284
30.4 t:slim X2 Pump Performance Characteristics .............................................................286
30.5 Dexcom G5 Mobile CGM Transmitter Performance Characteristics ..........................291
30.6 Dexcom G5 Mobile CGM Sensor Performance Characteristics .................................292
30.7 Electromagnetic Compatibility ....................................................................................334

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Customer Technical Support: (877) 801-690118
30.8 Electromagnetic Emissions .........................................................................................335
30.9 Electromagnetic Immunity...........................................................................................336
30.10 Distances Between the t:slim X2 Pump and RF Equipment .......................................338
30.11 Quality of Wireless Service .........................................................................................341
30.12 FCC Notice Concerning Interference ..........................................................................341
30.13 Warranty Information...................................................................................................342
30.14 Returned Goods Policy ...............................................................................................345
Index

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Customer Technical Support: [phone] 19
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Section 1
Before You Begin