Tandem t:slim G4 User manual

400
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mg/dL
190
3
HRS
INSULIN ON BOARD: 1.1 u |1:09 hrs
OPTIONS BOLUS
B
10:20 AM
July 22, 2015
100% 235 u
Dexcom G4®PLATINUM CGM Enabled

Customer Technical Support: 1-877-801-6901 3
Congratulations on the purchase of
your new t:slim G4 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 G4 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 G4 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 G4 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 1-877-801-6901 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.
11045 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 1-877-801-6901.
©2015 Tandem Diabetes Care, Inc.
All rights reserved. t:slim, touch sim-
plicity and Tandem Diabetes Care are
registered trademarks, and t:slim G4
is a trademark of Tandem Diabetes
Care, Inc.
Dexcom, Dexcom G4, Dexcom G4
PLATINUM, 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 G4 Insulin Pump with Dexcom G4 PLATINUM CGM User Guide Software Part Number 007249

Customer Technical Support: 1-877-801-69014
1. Patients have the right to good quality service and high professional standards that are continually maintained
and reviewed.
2. A patient has the right to have all records pertaining to his or her medical care treated as confidential, except as
otherwise provided by law or third party contractual arrangements.
3. A patient has the right to respectful service provided by competent personnel.
4. A patient, or when appropriate, a patient’s representative has the right to be informed of his or her rights at the
earliest possible time.
5. A patient has the right to have their personal preferences be heard.
6. A patient has the right to be free from all forms of abuse or harassment.
7. A patient has the right to receive services in a safe setting. A safe setting includes environmental safety, infection control,
security, protection of emotional health and safety, including respect, dignity, and comfort, as well as physical safety.
8. A patient has the right to medical services including training without discrimination based upon race, color, religion,
gender, sexual preference, national origin or source of payment.
9. A patient shall not be denied the right to designate a legally allowed individual or agency, who is authorized, to act
on his or her behalf.
10. Tandem Diabetes Care shall provide a patient, or patient designee, upon written request, access to all information
contained in their patient information record.
11. Except for medical emergencies, Tandem Diabetes Care must obtain the necessary informed consent prior to the start of
collection or sharing of personal medical information as it relates to the purchase of Tandem products and or services.
Tandem Diabetes Care, Inc. Patient Bill of Rights

Customer Technical Support: 1-877-801-6901 5
12. Tandem Diabetes Care is committed to ensuring the safety of its customers. Tandem has implemented policies covering
situations when a Tandem employee believes that a customer is suffering from a medical emergency, including contacting
the applicable emergency medical care.
13. A patient has a right to full information and counseling on the availability of known financial resources for his or her health
care received by Tandem Diabetes Care for the purpose of beneficiary coverage of Tandem Product and Services.
14. A patient has the right to examine and receive a detailed explanation of his or her financial bill.
15. A patient has the right to be advised when they are being considered for a medical care research program. In this
occurrence, Tandem Diabetes Care will send an informed consent agreement to a patient, requesting their participation
in a clinical investigation.
16. A patient has the right to decide whether their personal health information could be used for any fundraising efforts.
17. A patient, and when appropriate, a patient’s representative has the right to have any concerns, complaints and grievances
addressed. Sharing concerns, complaints and grievances will not compromise a patient’s care, treatment or services.
18. If a patient has a concern, complaint, or grievance, he or she may contact Tandem Diabetes Care Customer Support by:
»Calling Customer Support
1-877-801-6901
»Writing a letter to Tandem Diabetes Care
ATTN: Customer Support
and sending it to
11045 Roselle Street
San Diego, CA 92121

Customer Technical Support: 1-877-801-69016
1. Patients and their families when appropriate are responsible for providing correct and complete information when
requesting assistance with insurance verification and other services provided by Tandem Diabetes Care.
2. Patients and their families are responsible for reporting unexpected changes with their medical, financial, or
insurance condition.
3. Patients and their families are responsible for asking questions when they do not understand the service being provided
or the reason for the information being requested.
4. Patients and their families are responsible for following the product training, instructions for use and service that have
been developed by Tandem Diabetes Care and agreed to by a patient.
5. Patients and their families are responsible for following the treatment plan prescribed by their healthcare provider, or
contact their healthcare provider if unable to do so. If the treatment plan is not followed, patients and their families should
accept shared responsibility for the outcomes of care, treatment, and services.
6. Patients and their families are responsible for being considerate of Tandem Diabetes Care’s staff and property,
as well as other patients and their property.
7. Patients and their families are responsible to promptly meet any financial obligation agreed to with Tandem Diabetes Care.
8. Patient and their family agree to hold harmless Tandem Diabetes Care from any expenses they may incur as a result of
Tandem contacting the applicable emergency medical care on their behalf.
Patient Responsibilities

Table of Contents
Customer Technical Support: 1-877-801-6901 7
Section 1 – Before You Begin
Chapter 1 – Introduction
1.1 System Description .......................................................................................................24
1.2 About this User Guide ...................................................................................................24
1.3 Important User Information ...........................................................................................25
1.4 Conventions of this Guide.............................................................................................26
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
2.10 Wireless Co-existence, Quality of Service (QoS), and Data Security............................43

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Customer Technical Support: 1-877-801-69018
Chapter 3 – Getting to Know Your t:slim G4 System
3.1 What your t:slim G4 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
3.16 Letter Keypad Screen....................................................................................................76

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Customer Technical Support: 1-877-801-6901 9
Section 2 – Key Pump Features
Chapter 4 – Getting Started
4.1 Charging the t:slim G4 Pump ........................................................................................80
4.2 Using the Touch Screen ...............................................................................................82
4.3 Turning on the t:slim G4 Pump Screen .........................................................................82
4.4 Unlocking the t:slim G4 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
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

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Customer Technical Support: 1-877-801-690110
Chapter 6 – Personal Profile
6.1 Personal Profile 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
7.2 Food Bolus Using Units...............................................................................................111
7.3 Food Bolus Using Grams ............................................................................................111
7.4 Correction Bolus..........................................................................................................112
7.5 Extended Bolus ...........................................................................................................113
7.6 Canceling or Stopping a Bolus....................................................................................115

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Customer Technical Support: 1-877-801-6901 11
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
10.2 Delivering Quick Bolus ................................................................................................126

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Customer Technical Support: 1-877-801-690112
Chapter 11 – t:slim G4 Pump Settings
11.1 t:slim G4 Pump Volume...............................................................................................130
11.2 Screen Options............................................................................................................130
Chapter 12 – t:slim G4 Pump Info and History
12.1 t:slim G4 Pump Info.....................................................................................................134
12.2 t:slim G4 Pump History ...............................................................................................134
Chapter 13 – t:slim G4 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
Chapter 14 – User Settable Alerts and Alarms
14.1 Low Insulin Alert ..........................................................................................................142
14.2 Auto-Off Alarm ............................................................................................................142

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Customer Technical Support: 1-877-801-6901 13
Section 4 – t:slim G4 Pump Safety Alerts and Alarms
Chapter 15 – t:slim G4 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
15.11 Min Basal Alerts ..........................................................................................................162
15.12 Connection Error Alert.................................................................................................164
15.13 Power Source Alert......................................................................................................165
15.14 Data Error Alert............................................................................................................166

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Customer Technical Support: 1-877-801-690114
Chapter 16 – t:slim G4 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
Chapter 17 – t:slim G4 Pump Malfunction
17.1 Malfunction..................................................................................................................182

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Customer Technical Support: 1-877-801-6901 15
Section 5 – Getting Started with Your CGM System
Chapter 18 – Dexcom G4 PLATINUM CGM Overview
18.1 CGM System Overview ...............................................................................................186
18.2 Sensor Overview .........................................................................................................187
18.3 Transmitter Overview...................................................................................................188
18.4 Receiver (t:slim G4 Pump) Overview...........................................................................190
Chapter 19 – CGM Settings
19.1 Entering Your Transmitter ID........................................................................................194
19.2 Setting CGM Volume...................................................................................................195
19.3 CGM Info .....................................................................................................................197

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Customer Technical Support: 1-877-801-690116
Chapter 20 – Setting CGM Alerts
20.1 Setting Your High Glucose Alert and Repeat Feature .................................................200
20.2 Setting Your Low Glucose Alert and Repeat Feature..................................................201
20.3 Rate Alerts...................................................................................................................202
20.4 Setting Your Rise Alert.................................................................................................203
20.5 Setting Your Fall Alert ..................................................................................................203
20.6 Setting Your Out of Range Alert ..................................................................................204
Chapter 21 – Inserting the Sensor and Placing the Transmitter
21.1 Before You Start ..........................................................................................................206
21.2 Removing the Sensor From its Packaging..................................................................208
21.3 Choosing an Insertion Site ..........................................................................................208
21.4 Placing the CGM Sensor.............................................................................................209
21.5 Inserting the CGM Sensor...........................................................................................210
21.6 Attaching the CGM Transmitter...................................................................................212
Chapter 22 – Starting a CGM Sensor Session
22.1 Starting Sensor............................................................................................................216
22.2 Sensor Startup Period.................................................................................................217

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Customer Technical Support: 1-877-801-6901 17
Chapter 23 – Calibrating Your CGM System
23.1 Calibration Overview ...................................................................................................220
23.2 Startup Calibration ......................................................................................................221
23.3 Calibration Blood Glucose Value and Correction Bolus..............................................223
23.4 12 Hour Calibration Update ........................................................................................223
23.5 Other Reasons You May Need to Calibrate ................................................................224
Chapter 24 – Viewing CGM Data on Your t:slim G4 Pump
24.1 Overview......................................................................................................................226
24.2 CGM Trend Graphs .....................................................................................................228
24.3 Rate of Change Arrows ...............................................................................................230
24.4 Additional CGM Status Symbols.................................................................................232
24.5 CGM History................................................................................................................235
Chapter 25 – Ending Your CGM Sensor Session
25.1 Automatic Sensor Shut-Off .........................................................................................238
25.2 Ending a Sensor Session Before Automatic Shut-Off.................................................239
25.3 Removing the Sensor and Transmitter ........................................................................239

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Customer Technical Support: 1-877-801-690118
Section 6 – CGM Alerts, Errors and Troubleshooting
Chapter 26 – CGM Alerts and Errors
26.1 Startup Calibration Alert..............................................................................................245
26.2 Second Startup Calibration Alert.................................................................................246
26.3 12 Hour Calibration Alert.............................................................................................247
26.4 Incomplete Calibration ................................................................................................248
26.5 Calibration Timeout .....................................................................................................249
26.6 Wait 15 Minute Calibration Error Alert.........................................................................250
26.7 Wait 1 Hour Calibration Error Alert ..............................................................................251
26.8 Calibration Required Alert ...........................................................................................252
26.9 CGM High Alert ...........................................................................................................253
26.10 CGM Low Alert............................................................................................................254
26.11 CGM Fixed Low Alert ..................................................................................................255
26.12 CGM Rise Alert............................................................................................................256
26.13 CGM Rapid Rise Alert .................................................................................................257
26.14 CGM Fall Alert .............................................................................................................258
26.15 CGM Rapid Fall Alert...................................................................................................259
26.16 Unknown Sensor Reading...........................................................................................260

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Customer Technical Support: 1-877-801-6901 19
26.17 Out of Range Alert.......................................................................................................261
26.18 Low Transmitter Battery Alert......................................................................................262
26.19 Transmitter Error..........................................................................................................263
26.20 Failed Sensor Error......................................................................................................264
26.21 CGM Error ...................................................................................................................265
26.22 CGM System Error ......................................................................................................266
Chapter 27 – CGM Troubleshooting
27.1 Sensor Insertion Troubleshooting................................................................................268
27.2 Calibration Troubleshooting ........................................................................................269
27.3 Unknown Sensor Reading Troubleshooting................................................................270
27.4 Out of Range/No Antenna Troubleshooting ................................................................271
27.5 Failed Sensor Troubleshooting....................................................................................271
27.6 Sensor Inaccuracies....................................................................................................272

Table of Contents
Customer Technical Support: 1-877-801-690120
Section 7 – Living With and Caring for Your System
Chapter 28 – Lifestyle Issues and Travel
28.1 Overview......................................................................................................................276
Chapter 29 – Taking Care of Your t:slim G4 System
29.1 Overview......................................................................................................................280
Section 8 – Technical Specifications and Warranty
Chapter 30 – Technical Specifications
30.1 Overview......................................................................................................................284
30.2 t:slim G4 System Specifications..................................................................................284
30.3 t:slim G4 Pump Options and Settings.........................................................................292
30.4 t:slim G4 Pump Performance Characteristics.............................................................294
30.5 Dexcom G4 PLATINUM Transmitter Performance Characteristics .............................295
30.6 Dexcom G4 PLATINUM Sensor Performance Characteristics....................................297
30.7 Electromagnetic Compatibility ....................................................................................330