t:slim User Guide - Tandem Diabetes Care

t:slim User Guide - Tandem Diabetes Care
User Guide
t:slim® Insulin Delivery System User Guide
t:slim® and Tandem Diabetes Care® are registered trademarks of Tandem Diabetes Care, Inc.
touch simplicity™ is a trademark of Tandem Diabetes Care, Inc.
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.
Tandem Diabetes Care, Inc.
San Diego, CA
(858) 366-6900
www.tandemdiabetes.com
© 2012 Tandem Diabetes Care, Inc. All rights reserved.
t:slim Pump User Guide
At Tandem Diabetes Care, Inc. we listen closely to the diabetes community in order to understand your
needs. We recognize and respect the importance of your decision to begin insulin pump therapy as a
member of our family. We also recognize that your pump purchase is only the beginning of your relationship
with Tandem. Our commitment 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 t:slim User Guide is designed to assist you with the features and functions of the t:slim Pump and
cartridge. It provides important warnings and cautions on proper operation to ensure your safety, as well
as technical information. It also provides step-by-step illustrative instructions on how to properly program,
manage and care for your t:slim Pump.
Need help? We are here for you 24 hours a day, 7 days a week at 1-877-801-6901.
CAUTION
We know you can’t wait to use your t:slim Pump! If your training has not been scheduled, call us at 1-877-801-6901.
Do not deliver insulin with your t:slim Pump until you have completed your training.
Changes in equipment, software, or procedures occur periodically; information describing these changes will
be included in future editions of this User Guide. Please contact Tandem Diabetes Care Customer Technical
Support at 1-877-801-6901 to obtain a replacement 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 system, 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. This document is protected by copyright law.
Tandem Diabetes Care, Inc.
11045 Roselle Street
San Diego, CA 92121
USA
Customer Technical Support: 1-877-801-6901
Tandem Diabetes Care, Inc. Patient Bill of Rights
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.
9.
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.
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.
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
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.
Patient Responsibilities
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
the outcomes if they do not follow the product
instructions for use, service and payment plans.
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.
Table of Contents
Section 1 – Welcome
Chapter 1
About this User Guide
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
Chapter 2
Introduction
2.1
2.2
2.3
2.4
2.5
Chapter 3
Purpose of this Guide .......................................................................................................10
Working with your Healthcare Provider.............................................................................10
Important Safety Information ............................................................................................10
Emergency Kit ...................................................................................................................11
Indications for Use and Contraindications........................................................................12
Verification of Proper Functionality ...................................................................................12
Warnings and Precautions ................................................................................................13
Conventions of this Guide.................................................................................................15
Welcome ...........................................................................................................................17
What your t:slim Insulin Delivery System Package Includes ......................................................17
Explanation of Symbols ....................................................................................................18
Explanation of t:slim Colors ..............................................................................................18
Warranty Information.........................................................................................................19
t:slim Pump Overview
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
t:slim Pump Overview .......................................................................................................22
t:slim System Terminology ................................................................................................22
Screen Lock ......................................................................................................................24
Home Screen ....................................................................................................................25
Status Screen....................................................................................................................26
Bolus Screen .....................................................................................................................27
Options Screen .................................................................................................................28
My Pump Screen ..............................................................................................................29
Number Keypad Screen ....................................................................................................30
Letter Keypad Screen .......................................................................................................31
Section 2 – Key Pump Features
Chapter 4
Getting Started
4.1
4.2
4.3
4.4
4.5
Chapter 5
Charging t:slim Pump .......................................................................................................34
Turning On t:slim Pump Screen ........................................................................................35
Unlocking t:slim Pump Screen ..........................................................................................36
Edit Time ...........................................................................................................................37
Edit Date ...........................................................................................................................39
Infusion Site Care and Loading Cartridge
5.1
5.2
5.3
5.4
5.5
5.6
Infusion Site Selection and Care .......................................................................................42
Cartridge Instructions for Use ...........................................................................................43
Loading and Filling a t:slim Cartridge ...............................................................................44
Filling Tubing .....................................................................................................................49
Filling Cannula...................................................................................................................51
Setting Site Reminder .......................................................................................................52
Table of Contents
Chapter 6
Personal Profile
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
Chapter 7
Bolus
7.1
7.2
7.3
7.4
7.5
7.6
Chapter 8
Personal Profile Overview .................................................................................................56
Creating a New Profile ......................................................................................................56
Programming a New Personal Profile ...............................................................................58
Editing an Existing Profile .................................................................................................63
Duplicating an Existing Profile ..........................................................................................65
Activating an Existing Profile.............................................................................................67
Renaming an Existing Profile ............................................................................................68
Deleting an Existing Profile ...............................................................................................69
Bolus Overview .................................................................................................................71
Food Bolus Using Units ....................................................................................................71
Food Bolus Using Grams ..................................................................................................73
Correction Bolus ...............................................................................................................74
Extended Bolus .................................................................................................................76
Canceling or Stopping a Bolus .........................................................................................78
Stop/Resume Insulin
8.1
8.2
Stopping Insulin Delivery ..................................................................................................81
Resuming Insulin Delivery .................................................................................................82
Section 3 – Additional Pump Operations
Chapter 9
Temporary Basal Rate
9.1
9.2
Chapter 10
Quick Bolus
10.1
10.2
Chapter 11
Setting Up Quick Bolus.....................................................................................................88
Delivering Quick Bolus ......................................................................................................91
t:slim Pump Settings
11.1
11.2
Chapter 12
Setting a Temp Rate..........................................................................................................85
Stopping a Temp Rate ......................................................................................................86
t:slim Pump Volume ..........................................................................................................94
Screen Options .................................................................................................................95
t:slim Pump Info and History
12.1
12.2
t:slim Pump Info ................................................................................................................99
t:slim Pump History .........................................................................................................100
Table of Contents
Chapter 13
Reminders
13.1
13.2
13.3
13.4
13.5
Chapter 14
Low BG Reminder ...........................................................................................................102
High BG Reminder ..........................................................................................................104
After Bolus BG Reminder ................................................................................................106
Missed Meal Bolus Reminder .........................................................................................108
Site Reminder .................................................................................................................109
User Settable Alerts and Alarms
14.1
14.2
Low Insulin Alert ..............................................................................................................111
Auto-Off Alarm ................................................................................................................112
Section 4 – Safety Alerts and Alarms
Chapter 15
Alerts
15.1
15.2
15.3
15.4
15.5
15.6
15.7
15.8
15.9
15.10
15.11
15.12
15.13
Chapter 16
Alarms
16.1
16.2
16.3
16.4
16.5
16.6
16.7
16.8
16.9
16.10
Chapter 17
Low Power Alert ..............................................................................................................117
Low Insulin Alert ..............................................................................................................118
Incomplete Bolus Alert ....................................................................................................118
Incomplete Temp Rate Alert............................................................................................118
Incomplete Load Sequence Alerts ..................................................................................119
Incomplete Setting Alert .................................................................................................120
Basal Rate Required Alert ...............................................................................................120
Max Bolus Alert ...............................................................................................................121
Max Hourly Bolus Alert ...................................................................................................122
Max Basal Alert ...............................................................................................................122
Connection Error Alert ....................................................................................................123
Power Source Alert .........................................................................................................123
Data Error Alert ...............................................................................................................124
Resume Pump Alarm ......................................................................................................126
Low Power Alarms ..........................................................................................................127
Empty Cartridge Alarm....................................................................................................128
Cartridge Error Alarm ......................................................................................................128
Cartridge Removal Alarm ................................................................................................129
Occlusion Alarm ..............................................................................................................130
Temperature Alarm ..........................................................................................................130
Screen On/Quick Bolus Button Alarm ............................................................................131
Altitude Alarm..................................................................................................................131
Reset Alarm.....................................................................................................................131
Malfunction
17.1
Malfunction .....................................................................................................................133
Table of Contents
Section 5 – Care and Maintenance
Chapter 18
Taking Care of your t:slim Pump
18.1
Overview .........................................................................................................................136
Section 6 – Technical Specifications
Chapter 19
Technical Specifications
19.1
19.2
19.3
19.4
19.5
19.6
19.7
19.8
19.9
Index
Overview .........................................................................................................................139
t:slim Pump Specifications .............................................................................................139
t:slim Pump Options and Settings ..................................................................................140
Additional t:slim Pump Specifications ............................................................................141
Electromagnetic Compatibility ........................................................................................142
Electromagnetic Emissions .............................................................................................142
Electromagnetic Immunity ..............................................................................................143
Distances Between the t:slim Pump and RF Equipment ................................................144
FCC Notice Concerning Interference ..............................................................................146
Section 1
Welcome
Chapter 1
About this User Guide
1.1
Purpose of this Guide ................................................................. 10
1.2
Working with your Healthcare Provider ...................................... 10
1.3
Important Safety Information ...................................................... 10
1.4
Emergency Kit ............................................................................. 11
1.5
Indications for Use and Contraindications ................................. 12
1.6
Verification of Proper Functionality ............................................. 12
1.7
Warnings and Precautions .......................................................... 13
1.8
Conventions of this Guide .......................................................... 15
Section 1
1.1
Welcome
Chapter 1
|
About this User Guide
Purpose of this Guide
The User Guide is for users of the t:slim Insulin Delivery System (t:slim System). The intended use
of the t:slim System is for the Continuous Subcutaneous Insulin Infusion (CSII), at set and variable
rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years
of age and greater.
WARNING
United States (U.S.) Federal law restricts this device to sale by or on the order of a physician.
If you are unable to use the t:slim System according to the instructions in this User Guide, you
may be putting your health and safety at risk. Be sure to speak with your healthcare provider if you
have questions or concerns about using your pump properly.
CAUTION
Before using your t:slim Pump, ensure that you have been appropriately trained on its use by a certified t:slim
Pump trainer.
Read all of the instructions provided in this User Guide before using your t:slim Pump, and monitor
your blood glucose (BG) with the guidance of your healthcare provider. According to the American
Association of Diabetes Educators’ white paper Insulin Pump Therapy: Guidelines for Successful
Outcomes, patients should routinely check their BG levels at least 4 times daily (optimally 6–8
times daily) in order to detect hyperglycemia and hypoglycemia early. Undetected hyperglycemia
or hypoglycemia can result without proper monitoring.
1.2
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 insulin
infusion therapy. Your healthcare provider can help you establish diabetes management guidelines
that best fit your lifestyle and needs.
Your needs will influence how your healthcare provider helps you enter your initial pump settings.
If you have any questions about diabetes management after you start using your t:slim Pump, do
not hesitate to contact your healthcare provider.
1.3
Important Safety Information
This section covers important safety information, including indications for use and
contraindications, what to keep in an emergency kit, and warnings and precautions.
In case of an emergency, call 911 (U.S. only).
CAUTION
Before using your t:slim Pump, ensure that you have been appropriately trained on its use by a certified
t:slim Pump trainer. Incorrect use of your t:slim Pump or failure to follow the appropriate instructions in this
User Guide can lead to serious injury or even death. If you have questions or need further clarification on
your t:slim Pump use, ask your healthcare provider or call our around-the-clock Customer Technical Support
Department at 1-877-801-6901.
Customer Technical Support: 1-877-801-6901
10
Section 1
Welcome
Chapter 1
|
About this User Guide
Your t:slim Pump is designed only for the Continuous Subcutaneous Insulin Infusion (CSII) of
U-100 insulin; it is not intended for use with any other delivery substance. Consult your healthcare
provider before using your t:slim Pump to determine which programming features are most
appropriate for you. Only your healthcare provider can determine your basal rate, insulin-tocarbohydrate ratios, correction factors, BG target, and duration of insulin action. Additionally:
• Ensure that any small components on your t:slim Pump and its accessories are kept away
from small children who could potentially ingest them.
• Avoid changing your infusion set before bedtime or if you will not be able to test your BG at
least 1–2 hours after a new set is placed.
• Always check that your cartridge has insulin to last through the night.
• Unless otherwise recommended by your healthcare provider, do not use the vibrate feature
during sleep; rather, set the volume to high for all alarms and alerts.
• Since air bubbles can compromise delivery accuracy, always remove all bubbles when
drawing insulin into syringe; always hold the pump with the white insulin fill port pointed
up when filling cartridge; and always ensure that there are no air bubbles in the tubing
when filling.
• Ensure that the t:slim Pump you use for therapy has all your personal settings programmed
with your specific treatment plan.
• If you damage or drop your t:slim Pump, ensure that it is still working properly. If you
are unsure as to potential damage, call Tandem Diabetes Care Customer Technical Support
at 1-877-801-6901.
1.4
Emergency Kit
Make sure that you always have an insulin syringe and a vial of insulin 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 Everyday:
• Blood glucose testing supplies: meter, strips, lancets, meter batteries
• Fast-acting carbohydrate for low blood glucose
• Extra snack for longer coverage than fast-acting carbohydrate
• Glucagon emergency kit (for recurrent, severe hypoglycemia)
• Rapid-acting insulin and syringes
• Infusion sets (a minimum of two)
• Insulin pump cartridges (a minimum of two)
• Infusion site preparation products (antiseptic wipes, skin adhesive)
• Ketone-testing strips
• t:slim Wallet Card (for troubleshooting tips and pump settings)
• Diabetes identification card or jewelry
Customer Technical Support: 1-877-801-6901
11
Section 1
Welcome
Chapter 1
|
About this User Guide
CAUTION
1.5
»
Your t:slim 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. In order to prevent Diabetic Ketoacidosis (DKA) or a very
high BG, you must be prepared to inject insulin if delivery is interrupted for any reason. Only use U-100
insulin, as any lesser or greater concentration can result in serious health consequences.
»
Never fill your tubing while your infusion set is connected to your body. Doing so can result in unintended
delivery of insulin, which can result in serious injury or death.
»
If you have any questions regarding these cautions, call your healthcare provider or Tandem Diabetes
Care Customer Technical Support at 1-877-801-6901.
»
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 compensate for missed basal and/or bolus insulin. Check your blood glucose before
disconnecting from the pump and again when you reconnect.
Indications for Use and Contraindications
Indications for Use
The t:slim Insulin Delivery System is intended for the subcutaneous delivery of insulin, at set and
variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals
12 years of age and greater.
Contraindications
The t:slim Pump is not intended for anyone unable or unwilling to:
•
•
•
•
Test BG levels as recommended by your healthcare provider
Demonstrate adequate carbohydrate-counting skills (preferred, but not required)
Maintain sufficient diabetes self-care skills
See your healthcare provider(s) regularly
You must also have adequate vision and/or hearing in order to recognize your t:slim Pump alerts.
1.6
Verification of Proper Functionality
A power supply (AC adapter with USB micro-connector) is provided as part of the t:slim System.
Before using your t:slim Pump, ensure that the following occur when you connect a power supply
into the USB port of your t:slim Pump:
• You hear an audible alert
• You see the green light (from the edge around the Screen On/Quick Bolus Button) illuminate
• You feel a vibratory alert
• You see a charge symbol (lightning bolt) on the battery level indicator
In addition, before using your t:slim Pump, ensure the following:
• Press the Screen On/Quick Bolus Button to illuminate the screen so that you can easily
read the display
• When the screen is illuminated, the touch screen responds to your finger tap
Customer Technical Support: 1-877-801-6901
12
Section 1
Welcome
Chapter 1
|
About this User Guide
CAUTION
If any of these conditions fail to occur, do NOT use the t:slim Pump, as this may be an indication that
the pump’s alarms, alerts, and other built-in safety features may not be working properly. If the pump is
connected to your body, disconnect the infusion set from your body and contact Tandem Diabetes Care
Customer Technical Support at 1-877-801-6901.
1.7
Warnings and Precautions
When using your t:slim Pump, always take precautions regarding the following:
• Radiology and Medical Procedures
• Extreme Temperatures
• Amusement Park Rides
• Aircraft Without Cabin Pressurization
• Small Parts Potentially Ingestible by Children
• Do Not Use in the Presence of Flammable Anesthetics or Explosive Gases
• Air Travel
• Submersion in Fluid
• Other Precautions
Radiology and Medical Procedures
If you are going to have an X-ray, computerized tomography (CAT) scan, magnetic resonance
imaging (MRI), or other exposure to radiation, take off your t:slim Pump and remove it from the
procedure room. If you have questions, contact Tandem Diabetes Care Customer Technical
Support at 1-877-801-6901. Your t:slim Pump, however, has been designed to withstand
common electromagnetic interference, including airport and department store security systems.
Refer to Electromagnetic Compatibility in section 19.5 for more detailed information.
In addition to radiological procedures, there are a number of other medical procedures which will
require you to remove your t:slim Pump, most notably:
• Pacemaker/Implantable Cardioverter Defibrillator (AICD) – Disconnect your t:slim Pump
and leave it outside the procedure room during the insertion of the pacemaker device and
reprogramming (the infusion set can remain in place).
• Cardiac Catheterization – Disconnect your t:slim Pump and leave it outside the
procedure room.
• Nuclear Stress Test – Disconnect your t:slim Pump and leave it outside the procedure
room during the scan (it can remain connected during the injection of radioisotopes).
There are also other procedures where you should proceed with caution, most notably:
• Laser Surgery – Your t:slim Pump and infusion set can usually be worn during the
procedure. However, some lasers can create interference and cause your t:slim Pump to
set off an alarm.
• General Anesthesia – Depending on the equipment being used, you may or may not need
to remove your t:slim Pump. Be sure to ask your healthcare provider.
There is no need to disconnect for electrocardiograms (EKGs) or colonoscopies.
Customer Technical Support: 1-877-801-6901
13
Section 1
Welcome
Chapter 1
|
About this User Guide
Extreme Temperatures
Avoid exposure of your t:slim Pump to temperatures below 40°F (5°C) or above 99°F (37°C), as
insulin solutions can freeze at low temperatures or degrade at high temperatures. Do not steam,
sterilize, or autoclave your t:slim Pump at any time.
Amusement Park Rides
Very powerful electromagnets are sometimes used on “free-fall” or thrill rides. Remove your t:slim
Pump and do not take it on these types of rides. Also, on high-speed/high-gravity roller coasters,
you should disconnect (NOT stop or suspend) your pump as well.
Aircraft Without Cabin Pressurization
Disconnect (NOT stop or suspend) your t:slim Pump before flying in an aircraft without cabin
pressurization or in planes used for aerobatics or combat simulation (pressurized or not).
Small Parts Potentially Ingestible by Children
Insulin pumps, including the t:slim Pump, include small parts (such as pieces of the infusion set,
rubber USB port cover, and cartridge components) that could be ingested by children. Therefore,
keep your t:slim Pump and accessories out of the reach of children.
Do Not Use in the Presence of Flammable Anesthetics or Explosive Gases
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 Pump in the presence of flammable
anesthetics or explosive gases.
Submersion in Fluid
The t:slim Pump is watertight to a depth of 3 feet for up to 30 minutes (IPX7 rating). If your t:slim
Pump has been submerged, check your pump for any signs of fluid entry. If there are signs of fluid
entry, disconnect the set from your body, and contact Tandem Diabetes Care Customer Technical
Support at 1-877-801-6901.
Air Travel
Follow TSA and airline guidelines whenever traveling with medical equipment. For further
information, contact Tandem Diabetes Care Customer Technical Support at 1-877-801-6901.
Other Precautions
Be sure to heed these other important precautions regarding your t:slim Pump:
• If your t:slim Pump is damaged, disconnect the set from your body, and contact Tandem
Diabetes Care Customer Technical Support at 1-877-801-6901.
• Always follow proper aseptic (clean) technique when handling your pump and cartridge:
» Wash your hands with anti-bacterial soap before handling.
» Use only sterile, unopened products, such as needles, cartridges, and infusion sets.
» Thoroughly clean the insertion site on your body.
• Your t:slim Pump is a sealed device that should be opened and repaired only by the
manufacturer. If your t:slim Pump seal is broken the warranty is voided and your t:slim
Pump is no longer watertight.
Customer Technical Support: 1-877-801-6901
14
Section 1
Welcome
Chapter 1
|
About this User Guide
• Conduct regular checks of your t:slim Pump and infusion set, particularly:
» Check that your luer-lock connection between the cartridge tubing and the infusion set
tubing is tight and secure.
» Check your infusion site for proper placement and leaks. Improperly placed sites or leaks
around the infusion site can result in under-infusion.
» Check your infusion set tubing for any damage, leaks, or kinks while using your t:slim
Pump. Damaged, leaking, or kinked tubing may restrict or stop insulin delivery and
result in under-infusion.
» Check your t:slim Pump’s personal settings to ensure that they are correct.
» Check your t:slim Pump’s audible tones and vibratory alerts to ensure they are easily detectable.
• Use only single-use, disposable t:slim cartridges. The efficacy of your t:slim Pump cannot
be guaranteed if cartridges other than those manufactured by Tandem Diabetes Care, Inc.
are used or if cartridges are filled more than once. Use of cartridges not manufactured by
Tandem Diabetes Care, Inc. or reuse of cartridges may result in over-infusion or underinfusion and may cause serious injury or death.
• Use only FDA cleared infusion sets with a standard luer-lock connection and consult its
instructions for use. Failure to do so may result in over-infusion or under-infusion and may
cause serious injury or death. Change your infusion set every 48–72 hours. Consult your
healthcare provider for more information.
• Do not disconnect the luer-lock connection between the cartridge tubing and the infusion
set tubing. If the connection comes loose, disconnect the infusion set from the site (from
your body) before tightening to avoid unintentional insulin delivery.
• Always dispose of used cartridges and infusion sets following your community’s
regulations. Insulin can be absorbed through the skin, so wash your hands thoroughly after
handling any insulin-holding device.
• Regularly check your t:slim Pump screen for potential failure conditions that may display.
• Everyone who connects additional equipment to the pump configures a medical system,
and is therefore responsible to ensure that the system complies with the requirements of
standard IEC60601-1-1.
1.8
Conventions of this Guide
The following are conventions used in this Guide (such as terms, icons, text formatting, and other
conventions) along with their explanations.
Convention
Explanation
Bolded Text
Text that is in bold and in a different font than the rest of the sentence or step indicates an onscreen or
physical button name.
Touch Screen
The front glass screen of your pump, which displays all programming, operating, and alarm/alert
information.
Tap
Quickly and lightly touch the screen with your finger.
Press
Use your finger to depress a physical button (the Screen On/Quick Bolus Button is the only
physical/hardware button on your t:slim Pump).
Hold
Keep pressing a button or touching an icon or menu until its function is complete.
Menu
A list of options on your touch screen that allow you to perform specific tasks.
Icon
An image on your touch screen that indicates an option or item of information, or a symbol on the back
of your t:slim Pump or its packaging.
Customer Technical Support: 1-877-801-6901
15
Chapter 2
Introduction
2.1
Welcome ..................................................................................... 17
2.2
What your t:slim Insulin Delivery System Package Includes .......... 17
2.3
Explanation of Symbols .............................................................. 18
2.4
Explanation of t:slim Colors ....................................................... 18
2.5
Warranty Information .................................................................. 19
®
®
Section 1
2.1
Welcome
Chapter 2
|
Introduction
Welcome
Congratulations on the purchase of your new t:slim System. Your decision to use insulin pump
therapy is a sign of your commitment to your diabetes care. The t:slim Pump is designed using
the latest technology. The following pages provide step-by-step illustrative instructions on how to
properly program, manage, and care for your pump.
2.2
What your t:slim Insulin Delivery System Package Includes
Your t:slim System should contain the following items:
1.
t:slim Insulin Pump
2.
t:slim Screen Protector (pre-applied)
3.
Protective Case with Rotatable Clip
4.
USB Cable (6 ft.)
5.
Wall Power USB Adapter
6.
Car Power USB Adapter
7.
t:slim Reference Guide
8.
Emergency Wallet Card
9.
USB Memory Card (with User Guide)
If any of these items are missing, contact Tandem Diabetes Care Customer Technical Support
at 1-877-801-6901.
NOTE
Your t:slim Pump is shipped from Tandem Diabetes Care, Inc. with a clear screen protector. Do not remove
the screen protector. Additional screen protectors can be ordered by contacting Tandem Diabetes Care
Customer Technical Support at 1-877-801-6901.
NOTE
Your t:slim Pump is shipped from Tandem Diabetes Care, Inc. 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 therapy.
Customer Technical Support: 1-877-801-6901
17
Section 1
2.3
Welcome
Chapter 2
|
Introduction
Explanation of Symbols
The following are symbols (and their descriptions), which you may find on your t:slim
Pump and/or its packaging:
Caution; Consult Manual for Important
Safety Documentation
Type BF Applied Part
(patient isolation, not defibrillator protected)
Consult Instructions for Use
Manufacturer
Serial Number of Device
For sale by or on the order of a physician
only (U.S.)
Part Number
Direct Current (DC) voltage
Water-tight Equipment (protected against the
effects of temporary immersion in water)
2.4
Explanation of t:slim Colors
Touch Screen Colors
Blue
• The use of blue text may relate to bolus delivery activity.
Orange
• The orange text relates to t:slim’s setup or delivery settings.
Orange Highlight
• The orange highlighted area indicates a recent change
made to a setting.
Customer Technical Support: 1-877-801-6901
18
Section 1
Welcome
Chapter 2
|
Introduction
LED 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 90 seconds indicates the pump is
functioning normally.
• 3 green blinks every 90 seconds indicate the pump
is charging.
2.5
Warranty Information
Warranty
t:slim Insulin Pump
Tandem Diabetes Care, Inc. (“Tandem”) warrants the t:slim insulin pump against defects in materials
and workmanship for the period of 4 years from the original date of shipment of the pump to the
original end use purchaser (the “Warranty Period”). During the Warranty Period, Tandem will replace
any defective t:slim Pump, subject to the conditions and exclusions stated herein.
The warranty is valid only if the t:slim Pump is used in accordance with Tandem’s
instructions and will not apply:
• If damage results from changes or modifications made to the t:slim Pump by the user or
third persons after the date of manufacture;
• If damage results from service or repairs performed to any part of the t:slim Pump by any
person or entity other than Tandem;
• If the t:slim Pump seal is broken;
• If a non-Tandem cartridge is used with the t:slim Pump;
• If damage results from a force majeure or other event beyond the control of Tandem; or
• If damage results from negligence or improper use, including but not limited to improper
storage or physical abuse.
Customer Technical Support: 1-877-801-6901
19
Section 1
Welcome
Chapter 2
|
Introduction
This warranty shall be personal to the original end use purchaser. Any sale, rental or other transfer
or use of the t:slim 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 Pump and does not apply to other products or accessories.
THE REMEDIES PROVIDED FOR IN THIS WARRANTY ARE THE EXCLUSIVE REMEDIES
AVAILABLE FOR ANY WARRANT CLAIMS. NEITHER TANDEM NOR ITS SUPPLIERS OR
DISTRIBUTORS SHALL BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL, OR SPECIAL
DAMAGE OF ANY NATURE OR 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
Infusion Sets and Cartridges
Tandem Diabetes Care, Inc. (“Tandem”) warrants its infusion sets and cartridge against defects in
materials and workmanship for the period 3 days after the individual cartridge/infusion set sterile
packaging has been opened, not to exceed 6 months from date of shipment of the infusion set or
cartridge to the end user (the “Warranty Period”). During the Warranty Period, Tandem will replace
any defective cartridge or infusion set, subject to the conditions and exclusions stated herein.
The warranty is valid only if the infusion sets and cartridges are used in accordance with
Tandem’s instructions and will not apply:
• If the infusion set or cartridge has been used for more than a single-time use by a
single end-user;
• If damage results during the improper opening of the sterile package not in conformance
with the procedures outlined in the associated Instructions for Use;
• If 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;
• If damage results from changes or modifications made to the infusion set or cartridge by
the user or third persons after the date of manufacture;
• If damage results from service or repairs performed to any part of the infusions set or
cartridge by any person or entity other than Tandem;
• If damage is caused by use of the cartridge or infusion set with any non-Tandem
insulin pump;
• If damage results from a force majeure or other event beyond the control of Tandem; or
• If 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.
THE REMEDIES PROVIDED FOR IN THIS WARRANTY ARE THE EXCLUSIVE REMEDIES
AVAILABLE FOR ANY WARRANT CLAIMS. NEITHER TANDEM NOR ITS SUPPLIERS OR
DISTRIBUTORS SHALL BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL, OR SPECIAL
DAMAGE OF ANY NATURE OR 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.
Customer Technical Support: 1-877-801-6901
20
Chapter 3
t:slim® Pump Overview
®
3.1
t:slim Pump Overview ................................................................ 22
3.2
t:slim System Terminology ......................................................... 22
3.3
Screen Lock ................................................................................ 24
3.4
Home Screen .............................................................................. 25
3.5
Status Screen ............................................................................. 26
3.6
Bolus Screen ............................................................................... 27
3.7
Options Screen ........................................................................... 28
3.8
My Pump Screen ........................................................................ 29
3.9
Number Keypad Screen.............................................................. 30
3.10
Letter Keypad Screen ................................................................. 31
®
Section 1
3.1
Welcome
Chapter 3
|
t:slim Pump Overview
t:slim Pump Overview
Your t:slim Pump uses touch screen technology. To activate and interact with your t:slim Pump,
use the pad of your finger to quickly and lightly tap on the screen. Do not use your finger nail or
another object to interact with the screen. It will not activate the screen or its functions.
Your t:slim 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.
NOTE
t:slim has several safety features to prevent unintentional interaction with the touch screen. The screen must
be unlocked by tapping 1–2–3 in sequence. On all screens, if three non-active areas of the touch screen are
tapped before an active area is tapped, the screen will turn off to prevent accidental button presses.
NOTE
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.
3.2
t:slim System Terminology
Basal
Basal is a slow continuous delivery of insulin, which keeps BG 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 mg/dL.
BG Target
BG target is a specific blood glucose goal, an exact number, not a range. When a BG is entered
in the t:slim Pump, the calculated insulin bolus will be adjusted up or down as needed to attain
this target.
Bolus
A bolus is a quick dose of insulin that is usually delivered to cover food eaten or an elevated BG.
With t:slim Pump it can be delivered as a Standard, a Correction, an Extended, or a Quick Bolus.
Cannula
The cannula is part of the infusion set that is inserted under the skin through which insulin
is delivered.
Carb
Carbs or Carbohydrates are 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 one unit of insulin will cover. Also
known as insulin-to-carbohydrate ratio.
Customer Technical Support: 1-877-801-6901
22
Section 1
Welcome
Chapter 3
|
t:slim Pump Overview
Correction Bolus
A correction bolus is given to correct elevated BG.
Correction Factor
A correction factor is the amount of BG that is lowered by one 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 t:slim Pump,
enter the DELIVER NOW portion to dose a percentage of insulin immediately and the remaining
percentage over a period time.
Grams
Grams are a unit of measurement for carbohydrates.
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 BG) in the body after a
bolus has been delivered.
Load
Load refers to the process of removing, replacing and filling 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 Quick Bolus Button) is a way to deliver a bolus by following beep/vibration
commands without navigating through or viewing the t:slim Pump screen.
Temp Rate
Temp rate is an abbreviation for a temporary basal rate. It is used to increase or decrease the
current basal rate for a short period of time to accommodate special situations. 100% is the
same basal rate as programmed. 120% means 20% more and 80% means 20% less than the
programmed basal rate.
Units
Units are the measurement for insulin.
USB Cable
USB is the abbreviation for Universal Serial Bus. The USB cable connects into the t:slim Pump’s
micro USB port.
Customer Technical Support: 1-877-801-6901
23
Section 1
3.3
Welcome
Chapter 3
|
t:slim Pump Overview
Screen Lock
1
5
2
6
3
7
8
4
1.
Time and Date Display: Displays the
current time and date.
5.
Active Bolus Icon: Indicates a bolus
is active.
2.
Alert Icon: Indicates a reminder, alert or
alarm is active behind the lock screen.
6.
Status: Displays current pump settings and
insulin delivery status.
3.
BATTERY Level: Displays the level of
battery power remaining. When connected
for charging, the charging icon (lightning bolt)
will display.
7.
INSULIN Level: Displays the current
amount of insulin in the cartridge.
8.
Tandem Logo: Returns to the Home Screen.
4.
INSULIN ON BOARD (IOB): Amount and
time remaining of any active insulin on board.
Customer Technical Support: 1-877-801-6901
24
Section 1
3.4
Welcome
Chapter 3
|
t:slim Pump Overview
Home Screen
12
6
1
13
7
8
2
9
3
4
10
5
11
1.
2.
3.
BATTERY Level: Displays the level of
battery power remaining. When connected
for charging, the charging icon (lightning bolt)
will display.
7.
Status: Displays current pump 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.
USB Port: Port to charge your t:slim Pump
battery. Close the cover when not in use.
BOLUS: Program and deliver a bolus.
10. Cartridge Tubing: Tubing that is attached
to the cartridge.
4.
5.
6.
OPTIONS: Stop/Resume insulin delivery,
manage Pump Settings, Load cartridge,
program a Temp Rate, and view History.
INSULIN ON BOARD (IOB): Amount and
time remaining of any active insulin on board.
11. Luer-Lock Connection: Connects the
cartridge tubing to the infusion set tubing.
12. Screen On/Quick Bolus Button: Turns
the t:slim Pump screen on/off or programs a
Quick Bolus (if activated).
Time and Date Display: Displays the
current time and date.
13. LED Indicator: Illuminates when connected
to a power supply and indicates proper
functionality.
Customer Technical Support: 1-877-801-6901
25
Section 1
3.5
Welcome
Chapter 3
|
t:slim Pump Overview
Status Screen
1
6
2
7
3
8
4
9
5
1.
Profile: Displays current active
Personal Profile.
6.
Correction Factor: Displays current
correction factor used to calculate bolus.
2.
Basal: Displays current basal rate being
delivered. (Temp Rate: If active this
displayed in units/hr.)
7.
BG Target: Displays current BG target used
to calculate bolus.
8.
3.
Last Bolus: Displays the amount, date and
time of last bolus.
Insulin Duration: Displays current insulin
duration used to calculate insulin on board.
9.
4.
Carb Ratio: Displays current carb ratio used
to calculate bolus.
Carbohydrates: Indicates whether feature
is On or Off.
5.
Up/Down Arrow: Indicates there is
more information.
NOTE
NA represents Not Applicable (does not apply).
NOTE
The status screen is for display only, no changes can be made from this screen.
Customer Technical Support: 1-877-801-6901
26
Section 1
3.6
Welcome
Chapter 3
|
t:slim Pump Overview
Bolus Screen
Using Grams
1
2
3
4
5
Using Units
6
1
2
3
4
5
6
1.
BACK: Returns to the Home Screen.
1.
BACK: Returns to the Home Screen.
2.
CARBS: Enter grams of carb to
be consumed.
2.
INSULIN: Enter units of insulin.
3.
Units: Displays total units calculated.
3.
Units: Displays total units calculated.
4.
4.
View Calculation: Displays how the
insulin dose was calculated using the
current settings.
View Calculation: Displays how the
insulin dose was calculated using the
current settings.
5.
BG: Enter blood glucose level.
5.
BG: Enter blood glucose level.
6.
NEXT: Moves to next step.
6.
NEXT: Moves to next step.
Customer Technical Support: 1-877-801-6901
27
Section 1
3.7
Welcome
Chapter 3
|
t:slim Pump Overview
Options Screen
1
2
3
4
5
6
7
1.
BACK: Returns to the Home Screen.
5.
Temp Rate: Programs a temporary
basal rate.
2.
STOP INSULIN: Stops insulin delivery. If
insulin delivery is stopped, RESUME INSULIN
will be displayed.
6.
Menu Arrows: Indicates additional menu
options are available.
7.
History: Displays historical log of
pump events.
3.
My Pump: Personal Profiles, Alert Settings,
Pump Settings, and Pump Info.
4.
Load: Change Cartridge, Fill Tubing, Fill
Cannula, and Site Reminder.
Customer Technical Support: 1-877-801-6901
28
Section 1
3.8
Welcome
Chapter 3
|
t:slim Pump Overview
My Pump Screen
1
2
3
4
1.
Personal Profiles: A group of settings that
defines basal and bolus delivery.
2.
Alert Settings: Customize Reminders
and Alerts.
Customer Technical Support: 1-877-801-6901
3.
Pump Settings: Customize Quick
Bolus, Pump Volume, Screen Options,
and Time and Date.
4.
Pump Info: Displays t:slim Pump serial
number, Customer Technical Support phone
number and website.
29
Section 1
3.9
Welcome
Chapter 3
|
t:slim Pump Overview
Number Keypad Screen
1
5
2
6
3
7
4
1.
Value Entered.
2.
BACK: Returns to previous screen.
3.
5.
DONE: Completes task and saves
information entered.
6.
Units/Grams: Value of what is entered.
Keypad Numbers.
7.
4.
: Deletes last number entered.
+/=: Allows numbers to be added on
gram screen. If in units, this displays as
a decimal point.
NOTE
If changing an existing number, begin by tapping the numbers on the keypad to override the current value.
Customer Technical Support: 1-877-801-6901
30
Section 1
Welcome
Chapter 3
|
t:slim Pump Overview
3.10 Letter Keypad Screen
1
5
2
6
3
7
4
1.
Name of Profile.
5.
SAVE: Saves entered information.
2.
BACK: Returns to previous screen.
6.
Letters: Tap once for first letter displayed,
two quick taps for middle letter, and three
quick taps for third letter.
3.
Space: Enters a space.
7.
: Deletes last letter or number entered.
4.
123: Changes keypad mode from letters
(ABC) to numbers (123).
NOTE
If changing an existing name, begin by tapping the letters on the keypad to enter new text. The maximum number of
characters is 16.
Customer Technical Support: 1-877-801-6901
31
Section 2
Key Pump Features
Chapter 4
Getting Started
®
4.1
Charging t:slim Pump ................................................................ 34
4.2
Turning On t:slim Pump Screen ................................................. 35
4.3
Unlocking t:slim Pump Screen .................................................. 36
4.4
Edit Time ..................................................................................... 37
4.5
Edit Date ..................................................................................... 39
®
®
Section 2
Key Pump Features
Chapter 4
|
Getting Started
WARNING
Before you can safely and effectively use your t:slim Pump, it is very important that you carefully follow the
procedures in these sections.
The t:slim Pump continues to operate normally while charging and full pump functionality is
available, therefore, insulin therapy does not need to be interrupted.
If you choose to disconnect 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 compensate for missed basal and/or bolus insulin. Check your blood glucose before
disconnecting from the pump and again when you reconnect.
4.1
Charging t:slim Pump
Your t:slim Pump is shipped in a factory set state for minimal battery usage. The pump can only be
switched from the original state to an operational state by charging the pump.
The t:slim Pump is powered by an internal lithium polymer rechargeable battery. Included with
the pump are accessories for charging from wall or automobile outlets, and a PC USB port. Upon
receipt of the pump, you should charge it using the AC charger for at least 2.5 hours to ensure
a full charge.
WARNING
In order to maintain compliance with the IEC 60601-1 safety standard, the pump must be charged with a
power supply that conforms to either IEC 60601-1 or IEC 60950-1, or an equivalent safety standard, when
connected to an alternating current (AC) mains power source.
To Charge the Pump
1.
Plug the 2-prong end of the AC charger into a grounded AC electrical outlet.
2.
Plug the USB cable into the AC charger and the other end into the micro USB port of
your t:slim Pump. The screen illuminates.
You may also charge the t:slim Pump by connecting the supplied charge adapter to an
auxiliary power outlet and the USB cable to the pump, or connect the pump to a USB port
on a PC that complies with IEC 60950 (or equivalent) safety standard.
WARNING
When using the DC vehicle adapter charger, the charger must be connected to an isolated, batterypowered 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.
CAUTION
When you are connected to the pump and to a charging source, take caution when moving further
than the length of the USB cable. Failure to do so may result in the cannula becoming dislodged at the
infusion site. For this reason it is recommended not to charge the pump while sleeping.
Customer Technical Support: 1-877-801-6901
34
Section 2
Key Pump Features
Chapter 4
|
Getting Started
When you charge the t:slim Pump, the following should occur:
• The screen illuminates
• An audible alert
• The LED (edge around the Screen On/Quick Bolus Button) illuminates green
• A vibrating alert
• A charge symbol (lightning bolt) on the battery level indicator appears
CAUTION
If any of these conditions fail to occur, do NOT use the t:slim Pump, as this may be an indication that
the pump’s alarms, alerts, and other built-in safety features may not be working properly. If the t:slim
Pump is connected to your body, disconnect the set from your body and contact Tandem Diabetes
Care Customer Technical Support at 1-877-801-6901.
NOTE
Before using a Mac or PC to charge the t:slim Pump, it is recommended that a driver be installed on
the computer. This can be done by downloading the application from the USB Memory Card that is
included in the t:slim System. Depending on your computer, charging time will vary. The pump will
display a CONNECTION ERROR ALERT message if it is not charging properly (refer to section 15.10).
Charging Tips
Tandem Diabetes Care, Inc. recommends periodically checking the battery level indicator,
charging the pump for a short period of time every day (10–15 minutes), and also avoiding
frequent full discharges.
NOTE
If the battery is fully discharged, the Home Screen will not power on immediately when connected
to a charging source. The LED around the Screen On/Quick Bolus Button will blink green every 2
seconds until there is enough charge to power on the touch screen.
4.2
Turning On t:slim Pump Screen
1.
To turn on your t:slim Pump screen, press the Screen
On/Quick Bolus Button, located on the top of the
pump, once.
Z The Screen Lock screen will be displayed.
NOTE
The pump continues to function normally when the screen is
not illuminated.
NOTE
Upon completion of programming a feature, tap the Tandem
Logo to return to the Home Screen or tap BACK to return to the
previous screen.
Customer Technical Support: 1-877-801-6901
35
Section 2
4.3
Key Pump Features
Chapter 4
|
Getting Started
Unlocking t:slim Pump Screen
1.
Press Screen On/Quick Bolus Button.
2.
Tap 1.
3.
Tap 2.
4.
Tap 3.
Z The pump screen is now unlocked. The last screen that was
viewed will be displayed.
NOTE
You must tap 1–2–3 in sequential order to unlock the pump. If
you do not press 1–2–3 in sequential order, the pump will force
you to restart the unlock sequence from the beginning.
NOTE
The pump will return to the Screen Lock position after all bolus
and temp basal are requested.
NOTE
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 to prevent unintentional interactions with the
touchscreen. Always position the pump screen away from the
skin when worn under clothing.
Customer Technical Support: 1-877-801-6901
36
Section 2
4.4
Key Pump Features
Chapter 4
|
Getting Started
Edit Time
After powering up your t:slim 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.
CAUTION
It is very important to set the current time and date accurately to ensure precise settings, and thus, facilitate
safe insulin delivery. When editing time, always ensure that the AM/PM setting is accurate. 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 My Pump.
3.
Tap Pump Settings.
4.
Tap Time and Date.
Customer Technical Support: 1-877-801-6901
37
Section 2
Key Pump Features
5.
Tap Edit Time.
6.
Tap Time.
7.
Using the onscreen keypad, enter the hour and
minutes. Verify and tap DONE.
8.
Tap Time of Day to set AM or PM.
9.
Verify the correct time is set and tap SAVE.
Chapter 4
|
Getting Started
NOTE
Any edits to Time or Date will not be saved until you tap SAVE.
Customer Technical Support: 1-877-801-6901
38
Section 2
4.5
Key Pump Features
Chapter 4
|
Getting Started
Edit Date
1.
From the Time and Date screen tap Edit Date.
2.
Tap Month.
3.
Find and tap current month displayed on the right.
Use Up/Down Arrow to view months not displayed.
4.
Tap Day. Using the onscreen keypad enter the current
day. Verify and tap DONE.
5.
Tap Year.
6.
Using the onscreen keypad enter the current year.
Verify and tap DONE.
Customer Technical Support: 1-877-801-6901
39
Section 2
Key Pump Features
7.
Verify the correct date is set and tap SAVE.
8.
Tap Tandem Logo to return to the Home Screen.
Customer Technical Support: 1-877-801-6901
Chapter 4
|
Getting Started
40
Chapter 5
Infusion Site Care and Loading Cartridge
5.1
Infusion Site Selection and Care................................................. 42
5.2
Cartridge Instructions for Use..................................................... 43
5.3
Loading and Filling a t:slim Cartridge ......................................... 44
5.4
Filling Tubing ............................................................................... 49
5.5
Filling Cannula ............................................................................ 51
5.6
Setting Site Reminder ................................................................. 52
Section 2
5.1
Key Pump Features
Chapter 5
|
Infusion Site Care and Loading Cartridge
Infusion Site Selection and Care
WARNING
»
Use only FDA cleared insulin infusion sets with a standard luer-lock connection and consult its instructions
for use. Failure to do so may result in over-infusion or under-infusion and may cause serious injury or death.
Change your infusion set every 48–72 hours. Consult your healthcare provider for more information.
»
Use only single-use disposable cartridges. Failure to do so may result in over-infusion or under-infusion
and may cause serious injury or death.
»
Use only Humalog® or NovoLog® U-100 insulin. Failure to do so may result in serious
health consequences.
General Guidelines
Site Selection
• Your infusion set can be worn anywhere on your body that you would normally inject
insulin. Absorption varies from site to site. Discuss options with your healthcare provider.
• The most commonly used sites are the abdomen, upper buttocks, hips, upper arms, and
upper legs.
• The abdomen is the most popular site because of access to fatty tissue. If using the
abdominal area, AVOID:
» Areas that would constrict the site such as the belt line, waistline, or where you would
normally bend.
» Areas 2 inches around your bellybutton.
» Any scars, moles, stretch marks, or tattoos.
Site Rotation
• The infusion set must be replaced and rotated every two to three days, 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.
Customer Technical Support: 1-877-801-6901
42
Section 2
Key Pump Features
Chapter 5
|
Infusion Site Care and Loading Cartridge
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 area
clean to avoid contamination.
• Site preparation products that have both an antiseptic and an adhesive are encouraged.
5.2
Cartridge Instructions for Use
Symbols
Use By Date ( MM/DD/YYYY)
Model Number
Do Not Re-Use
No Latex
See Instructions for Use
Non Pyrogenic
Method of Sterilization: Gamma
Temperature Limits
-4°F (-20°C) to 140°F (+60°C)
t:slim 3mL cartridge (300 units)
REF: 003380 (10 pack) / REF: 003379
Indications for Use
The cartridge is indicated as a reservoir for the delivery of rapid-acting insulin with the t:slim Pump.
Humalog® and NovoLog® have been tested by Tandem Diabetes Care, Inc. and found to be safe
for use in the t:slim Pump. Humalog® was tested for up to 48 hours as labeled, NovoLog® was
tested for up to 72 hours.
WARNING
United States (U.S.) Federal law restricts this device to sale by or on the order of a physician.
Contraindications
The cartridge is contraindicated for use with products other than Humalog® and NovoLog®.
WARNING
»
The cartridge is sterile, non-pyrogenic, and for single-use only.
»
Do not use if package has been opened or damaged.
»
Dispose of filling syringe and needle safely in a sharps container.
»
Failure to remove air from filling syringe and tubing may result in inaccurate delivery of medication.
»
Always disconnect infusion set from body when filling cartridge with insulin or while priming tubing.
»
Refer to the insulin manufacturer’s package insert for proper handling.
Customer Technical Support: 1-877-801-6901
43
Section 2
Key Pump Features
Chapter 5
|
Infusion Site Care and Loading Cartridge
CAUTION
5.3
»
Insulin should be at room temperature before filling cartridge.
»
Do not store filled cartridges.
»
Check for leaks regularly after changing cartridge and infusion set.
»
The first set-up should be done in the presence of your healthcare provider.
»
Attach only FDA cleared insulin infusion sets compatible with luer connectors to the cartridge.
»
Minimize contact with insulin. Wash hands thoroughly after handling any device that contains insulin.
Loading and Filling a t:slim Cartridge
This section describes how to load the cartridge into your t:slim Pump and fill the cartridge with
insulin. The single-use, disposable cartridge can hold up to 300 units (3.0 mL) of insulin.
CAUTION
Inspect the cartridge to ensure that there is no damage. Never use a cartridge that is damaged (cracks,
dislodged tip connectors, etc). If there is damage, call Tandem Diabetes Care Customer Technical Support at
1-877-801-6901 to request a replacement cartridge.
CAUTION
Before you begin, verify that the infusion set is NOT connected to your body.
Before you begin, make sure you have the following items:
• 1 unopened, disposable, sterile, single-use cartridge
• Vial of Humalog® or NovoLog® insulin
• 3.0 mL syringe and fill needle
• Alcohol prep swab
• 1 new infusion set
NOTE
Do NOT remove the cartridge during the Load process until prompted on the t:slim Pump screen.
The illustration below identifies the luer-lock and insulin fill port
used in the cartridge filling process
Luer-Lock Tail
of the Cartridge
Insulin
Fill Port
Customer Technical Support: 1-877-801-6901
44
Section 2
Key Pump Features
Chapter 5
1.
From the Home Screen, tap OPTIONS.
2.
Tap Load.
|
Infusion Site Care and Loading Cartridge
NOTE
During the load sequence, the Tandem Logo is disabled.
Tapping it will not return to the Home Screen.
3.
Tap Change Cartridge.
4.
Screen will display that all insulin deliveries will be
stopped. Tap YES.
NOTE
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
NEXT to continue.
Z Preparing for Cartridge screen is displayed.
Customer Technical Support: 1-877-801-6901
45
Section 2
Key Pump Features
6.
Chapter 5
|
Infusion Site Care and Loading Cartridge
Remove the cartridge and install an unused cartridge.
Tap UNLOCK when completed.
CAUTION
»
If this is the very first time you are loading the cartridge,
remove the shipping canister (which is not for human use,
as indicated on its label) from the back of the pump.
»
Do not fill the cartridge until prompted by instructions on the
pump screen.
NOTE
If needed, place the edge of a coin in the slot at the bottom of
the cartridge and twist to aid in the removal of the cartridge.
Instructions on How to Install a Cartridge
1. Inspect cartridge package for any indication of damage. Discard any damaged product.
2. Open package and remove cartridge.
3. Place bottom of the cartridge at the
end of the pump. Make sure cartridge
is lined up to both guide tracks.
7.
4. Push on the circular fill port next
to the cartridge tubing to slide the
cartridge onto the pump.
Tap NEXT.
Z Detecting Cartridge and Removing Air from Cartridge
screens are displayed.
Customer Technical Support: 1-877-801-6901
46
Section 2
Key Pump Features
Chapter 5
|
Infusion Site Care and Loading Cartridge
Instructions for Drawing Insulin from Vial into Syringe
CAUTION
Use only the syringe and needle provided by Tandem Diabetes Care, Inc. to fill the cartridge.
After filling the cartridge and before connecting and filling the tubing, reduce the possibility of
trapped air in the cartridge by holding your t:slim Pump vertically with the cartridge insulin fill
port on top.
1. Wash your hands and remove the needle and syringe from their
package. Securely twist needle onto syringe.
2. Safely remove protective cap from needle by pulling outward.
3. Draw air into syringe up to the amount of insulin desired. The
cartridge requires a minimum fill of 50 units after tubing has been
filled.The amount of insulin required to fill tubing should be added
to the total amount drawn from the insulin vial. For approximate
tubing fill amounts, see section 5.4. The maximum fill is 300 units.
4. Wipe the rubber septum of the insulin vial with an alcohol swab.
5. With insulin vial upright, insert needle into vial. Inject air from
syringe into vial. Maintain pressure on syringe plunger.
6. With needle still inserted into vial, turn vial and syringe upside
down. Release syringe plunger. Pressure will push plunger and
let the insulin flow from vial into syringe.
7. Release the pressure on the plunger and slowly withdraw the
desired amount of insulin (equal to the amount of air you filled
previously) from the vial into the syringe.
8. While the filling needle is still in the vial and upside down, tap
the syringe and slowly push its plunger upwards, forcing any air
bubbles back into the vial.
9. Check the syringe for air bubbles and do one of the following:
» If there are air bubbles present, repeat step 8.
» If no air bubbles are present, remove the filling needle from the vial.
Customer Technical Support: 1-877-801-6901
47
Section 2
Key Pump Features
Chapter 5
|
Infusion Site Care and Loading Cartridge
Instructions on How to Fill a Cartridge
1. When prompted on the pump screen, fill the cartridge by gently
inserting the syringe needle into the white insulin fill port on
the t:slim Cartridge. The screen will automatically lock during
this sequence.
2. Hold the pump upright (as shown to the right).
Slowly depress the syringe plunger to inject
insulin into the cartridge (you may feel some
back pressure as you fill the cartridge).
3. While maintaining pressure on the plunger, remove the syringe
needle from the cartridge. Check the area around the white
insulin fill port for leaks. If you detect insulin is leaking from the
white insulin fill port, discard the cartridge and repeat entire
process with a new cartridge. If you need a replacement
cartridge, call Tandem Diabetes Care Customer Technical
Support at 1-877-801-6901.
4. Dispose of used needles in a labeled sharps container in
accordance with local requirements.
CAUTION
The maximum cartridge fill amount is 300 units. Do not overfill or ‘top off’ when filling the
cartridge as the additional amount cannot be delivered. This can lead to a cartridge error,
which will require a new cartridge.
NOTE
If a cartridge is filled with between 240 and 300 units, the insulin level will display +240 on the
Home Screen. The insulin level will decline in increments of 5 units between 240 and 40 and in
one (1) unit increments below 40.
WARNING
Do not remove or add insulin from a filled cartridge. This will result in an inaccurate display of
the insulin level on the Home Screen.
Customer Technical Support: 1-877-801-6901
48
Section 2
Key Pump Features
8.
Fill the cartridge and tap Unlock.
9.
Tap NEXT.
Chapter 5
|
Infusion Site Care and Loading Cartridge
Z Cartridge Changed screen is displayed.
NOTE
After completing the cartridge change, the pump will
automatically prompt you to fill tubing.
5.4
Filling Tubing
Filling the Infusion Set Tubing with Insulin
This section describes how to fill the infusion set tubing with insulin.
WARNING
Never fill the infusion set tubing while the tubing is connected to your body. Filling the tubing while it is
connected to your body can result in the unintended delivery of insulin.
NOTE
If starting from the Home Screen, tap OPTIONS, tap Load, tap Fill Tubing and then follow the instructions.
Insulin delivery will be stopped and must be resumed upon completion.
1.
Verify that the infusion set is disconnected from
your body.
2.
Connect the infusion set tubing to the luer-lock tail of
the cartridge:
a) 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.
b) Remove the infusion set tubing cap from the luer
connector. Be careful to keep the luer connector away
from unsanitary areas.
c) Insert the infusion set tubing to the luer connector
on the cartridge tubing (“tail”) and twist clockwise
to secure it.
Tap NEXT.
Customer Technical Support: 1-877-801-6901
49
Section 2
Key Pump Features
3.
Chapter 5
|
Infusion Site Care and Loading Cartridge
Hold the pump vertically (as illustrated to the right) to
ensure any air in the cartridge will be dispelled first.
Tap Start.
Z Starting Fill screen is displayed.
NOTE
The following are approximate amounts of insulin to
fill different tubing lengths:
4.
»
15–20 units
for
23 inch tubing
»
20–25 units
for
32 inch tubing
»
25–30 units
for
42 inch tubing
Tap STOP once 3 drops of insulin are seen at the end
of the tubing.
Z Stopping Fill screen is displayed.
NOTE
During tubing fill, your pump will stop the fill process and notify
you if the tubing has been filled with 30 units. You then have the
option to continue filling more than this system max fill amount.
5.
Verify that drops are seen and tap DONE.
•
If you do not see drops, tap FILL. The Fill Tubing
screen appears, repeat steps 3–5 until you see 3 drops
of insulin at the end of the tubing.
•
If you did not tap STOP, the “Max fill amount reached!”
screen will appear. Do one of the following:
a) If you are finished filling the tubing, tap DONE.
b) If you want to fill the tubing with more than 30 units,
tap FILL to go back to the Fill Tubing screen.
6.
Fill Tubing is complete.
Customer Technical Support: 1-877-801-6901
50
Section 2
5.5
Key Pump Features
Chapter 5
|
Infusion Site Care and Loading Cartridge
Filling Cannula
Filling the Infusion Set Cannula with Insulin
This section describes how to fill the infusion set cannula with insulin.
For the correct cannula fill amount, as well as procedures on needle/cannula insertion and
attaching the tubing to your body, refer to the instructions for use included with the infusion set.
To Fill the Cannula
NOTE
»
If starting from the Home Screen, tap OPTIONS, tap Load, tap Fill Cannula and then follow the
instructions. Insulin delivery will be stopped and must be resumed upon completion.
»
If using a steel needle infusion set, there is no cannula. Skip this section.
1.
Tap Fill Cannula.
2.
Insert a new infusion set and connect tubing to site,
then tap NEXT.
3.
Tap Edit Fill Amount.
NOTE
The cannula fill amount displayed is based on your last cannula
fill amount. Delivery stops at this amount (unless you tap STOP
before this amount is reached).
4.
Select amount needed for cannula fill.
NOTE
If the amount needed is not listed, tap Other Amount and use
the onscreen keypad to enter a value between 0.1 to 1.0 unit.
WARNING
Refer to your infusion set instructions for proper insertion and
cannula fill amount.
Customer Technical Support: 1-877-801-6901
51
Section 2
Key Pump Features
5.
Chapter 5
|
Infusion Site Care and Loading Cartridge
Tap START.
Z Starting Fill screen is displayed.
Z After fill is complete, Stopping Fill screen is displayed.
NOTE
You can tap STOP at any time during the fill process if you want
to stop filling the cannula.
NOTE
The screen will return to the Load menu if the Site Reminder
is turned OFF. Tap DONE 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
(refer to next section).
5.6
Setting Site Reminder
NOTE
If starting from the Home Screen, tap OPTIONS, tap Load, tap Site Reminder then follow the
instructions below.
CAUTION
Avoid changing an infusion set before going to bed or if you will not be able to test your BG 1–2 hours after a
new set is placed.
1.
Tap SAVE if correct. Tap Edit Reminder if settings
need to be changed.
Customer Technical Support: 1-877-801-6901
52
Section 2
Key Pump Features
2.
Chapter 5
|
Infusion Site Care and Loading Cartridge
Tap Remind Me In and select the number of days.
NOTE
Default reminder is set for 3 days.
3.
Tap Remind Me At. Use the onscreen keypad to enter
time and tap DONE.
4.
Tap Time of Day to change AM or PM. Tap BACK.
5.
Verify Site Reminder is set correctly and tap SAVE.
Z Site Reminder Set screen is displayed.
6.
Load screen is displayed. Tap DONE.
Z A reminder to test BG in 1–2 hours will display.
Customer Technical Support: 1-877-801-6901
53
Section 2
Key Pump Features
7.
Chapter 5
|
Infusion Site Care and Loading Cartridge
Tap RESUME.
NOTE
If this is the first time using your t:slim 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.
8.
RESUMING INSULIN splash screen is displayed.
Customer Technical Support: 1-877-801-6901
54
Chapter 6
Personal Profile
6.1
Personal Profile Overview ........................................................... 56
6.2
Creating a New Profile ................................................................ 56
6.3
Programming a New Personal Profile ......................................... 58
6.4
Editing an Existing Profile ........................................................... 63
6.5
Duplicating an Existing Profile .................................................... 65
6.6
Activating an Existing Profile ...................................................... 67
6.7
Renaming an Existing Profile ...................................................... 68
6.8
Deleting an Existing Profile ......................................................... 69
Section 2
6.1
Key Pump Features
Chapter 6
|
Personal Profile
Personal Profile Overview
A Personal Profile is a group of settings that define the basal and bolus delivery within specific time
segments throughout a 24 hour period. Each profile can be personalized with a name. Within a
Personal Profile the following can be set:
• Timed Settings: Basal Rate, Correction Factor, Carb Ratio and Target BG.
• Bolus Settings: Insulin Duration, Max Bolus and Carbohydrates setting (ON/OFF).
The t:slim Pump uses the settings in your currently active profile to calculate the delivery of basal
insulin, food boluses and correction boluses based on your Target BG.
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 variables such as schedule, food intake, activity, and
exercise, etc.
NOTE
Up to 6 different Personal Profiles can be created and up to 16 different time segments can be set in each
Personal Profile. For example, within your “Weekday” profile you might have time segments set up for 12:00
AM, 5:30 AM and 3:00 PM based on your healthcare provider’s recommendation.
NOTE
Once defined, a Personal Profile can be viewed by selecting EDIT from the profile menu.
6.2
Creating a New Profile
Creating Personal Profiles
You can create up to 6 Personal Profiles, however; only one can be active at a time. In the
Personal Profiles screen, the currently active profile is positioned at the top of the list and is
indicated as ON. When you create a Personal Profile, you can define any or all of the following
Timed Settings:
•
•
•
•
Basal (your basal rate in units of insulin per hour)
Correction Factor (amount BG is lowered by 1 unit of insulin)
Carb Ratio (number of carbs covered by 1 unit of insulin)
Target BG (your ideal BG level)
NOTE
An initial maximum basal rate of 2 units/hr is set for each Personal Profile. If you enter a basal rate greater
than 2 units/hr you will be prompted to confirm whether you want to continue with this basal amount. Once
basal rates are set in a Personal Profile the maximum basal rate becomes two times the highest basal rate in
that Personal Profile. The absolute maximum basal rate is 15 units/hr.
Customer Technical Support: 1-877-801-6901
56
Section 2
Key Pump Features
Chapter 6
|
Personal Profile
The ranges for Timed Settings (initially inactive) are:
• Basal (range: 0 and 0.1 – 15 units/hr)
• Correction Factor (range: 1 unit:1 mg/dL – 1 unit:600 mg/dL)
• Carb Ratio (range: 1 unit:1 g – 1 unit:300 g)
• Target BG (range: 70 mg/dL – 250 mg/dL)
NOTE
Below a carb ratio of 1:10, increments can be entered in 0.1 g.
For example a carb ratio of 1:8.2 can be programmed.
In addition, you can define any or all of the following Bolus Settings:
• Carbs (ON indicates entering grams of Carb; OFF indicates entering units of insulin)
• Insulin Duration (how long a bolus lowers your BG)
• Max Bolus (the maximum amount for a single bolus)
The default settings and ranges for Bolus Settings are as follows:
• Carbs (default: OFF if no Carb Ratio is defined)
• Insulin Duration (default: 5 hrs; range: 2–8 hrs)
• Max Bolus (default: 10 units; range: 1–25 units)
Insulin Duration and Insulin on Board (IOB)
Your t:slim 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.
Insulin Duration in your t:slim Pump is set from the factory at 5 hours but can be changed from 2
to 8 hours. Please consult your healthcare provider to accurately set your Insulin Duration.
While the Insulin Duration setting reflects how long insulin from previous boluses lowers your BG,
the IOB feature reflects how much insulin is remaining in your body from previous boluses. IOB is
always displayed on the Home Screen and is used in bolus delivery calculations when applicable.
When a BG is entered during bolus programming, your t:slim Pump will consider any active IOB
and calculate an adjusted bolus if necessary.
NOTE
Although you do not need to define every setting, some pump features require certain settings to be
defined and activated. During profile setup, your pump prompts you to set up any required settings
before you can continue.
1.
From the Home Screen, tap OPTIONS.
2.
Tap My Pump.
Customer Technical Support: 1-877-801-6901
57
Section 2
Key Pump Features
3.
Tap Personal Profiles.
4.
Tap NEW to create a new profile.
5.
Using the onscreen keypad, enter a profile name (up to
16 characters) and tap SAVE.
Chapter 6
|
Personal Profile
NOTE
Refer to section 3.10 for instructions on using the
onscreen keypads.
6.
6.3
Tap Press to Setup to begin setting insulin
delivery settings.
Programming a New Personal Profile
NOTE
»
Once the Personal Profile has been created, the settings must be programmed. The first time segment will
start at 12:00 AM (midnight).
»
You must program a basal rate in order to have a valid Personal Profile that you can activate.
»
Be sure to tap SAVE after entering or changing a value.
Customer Technical Support: 1-877-801-6901
58
Section 2
Key Pump Features
Chapter 6
|
Personal Profile
CAUTION
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 deliver correction boluses or trigger BG alerts.
1.
Once the new profile has been created, Tap Basal.
2.
Using the onscreen keypad, enter the desired basal
rate and tap DONE.
CAUTION
Always confirm that the decimal point placement is correct.
3.
Tap Correction Factor.
4.
Using the onscreen keypad, enter the desired
correction factor and tap DONE.
NOTE
Enter the mg/dL that 1 unit of insulin will lower BG.
5.
Tap Carb Ratio.
6.
Using the onscreen keypad, enter the desired insulinto-carbohydrate ratio and tap DONE.
NOTE
Enter the grams of carb to be covered by 1 unit of insulin.
Customer Technical Support: 1-877-801-6901
59
Section 2
Key Pump Features
7.
Tap Target BG.
8.
Using the onscreen keypad, enter the desired BG
target and tap DONE.
9.
Review entered values and tap SAVE.
Chapter 6
|
Personal Profile
10. Confirm Settings.
Tap YES if entered data is correct.
Tap NO to make changes.
11. Tap BACK to set the Bolus Settings.
Tap ADD to create additional time settings.
Customer Technical Support: 1-877-801-6901
60
Section 2
Key Pump Features
Chapter 6
|
Personal Profile
Adding More Time Segments
NOTE
Any settings that you defined 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 define them all over again.
1. On the Add Segment screen, tap Start Time.
2. Using the onscreen keypad, enter the time (hour and minutes) that you want the segment to
begin, and tap DONE.
3. On the Add Segment screen, tap Time of Day to select AM or PM.
4. Tap NEXT.
5. Repeat steps 1–10 from the above Programming a New Personal Profile for each segment
you want to set up (up to 16).
NOTE
Once a time segment is set beyond 12:00 PM, the default will change to PM.
NOTE
To find time segments in the list that are not displayed on the first screen, tap the scroll arrows.
12. Tap the Bolus Settings Panel.
13. Tap Insulin Duration.
14. Using the onscreen keypad, enter the desired time for
the duration of insulin action and tap DONE.
15. Tap Max Bolus.
16. Using the onscreen keypad, enter the desired amount
for maximum bolus (1–25 units) and tap DONE.
Customer Technical Support: 1-877-801-6901
61
Section 2
Key Pump Features
Chapter 6
|
Personal Profile
17. Tap Carbohydrates to activate and use the carb ratio
when calculating boluses.
NOTE
If not using a carb ratio, do not turn the Carbohydrates setting
to ON.
18. Review entered values and tap SAVE.
19. Confirm Settings.
Tap YES if entered data is correct.
Tap NO to make changes.
20. Tap Tandem Logo to return to the Home Screen.
NOTE
Editing, duplicating and renaming an inactive profile will not automatically activate that profile. Refer to
section 6.6 for instructions on activating profiles.
Adding More Personal Profiles
NOTE
If starting from the Home Screen, tap OPTIONS, tap My Pump, tap Personal Profiles, tap NEW.
Name the new profile and repeat steps 1–10 in section 6.3.
NOTE
If the first profile is programmed using a carb ratio, any new profile will also have the
Carbohydrates option turned ON, but a ratio will still need to be defined.
Customer Technical Support: 1-877-801-6901
62
Section 2
6.4
Key Pump Features
Chapter 6
|
Personal Profile
Editing 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.
6.
Tap Timed Settings Panel.
Customer Technical Support: 1-877-801-6901
63
Section 2
Key Pump Features
7.
Tap the desired time segment to be edited.
8.
Tap Basal, Correction Factor, Carb Ratio or Target
BG to make changes as needed and use the onscreen
keypad to enter desired changes. Tap DONE.
9.
View recent changes and tap SAVE.
Chapter 6
|
Personal Profile
10. Confirm Settings.
Tap YES if entered data is correct.
Tap NO to make changes.
11. Tap BACK after editing all of the time segments.
NOTE
Edit other time segments within the Timed Settings by tapping
on them and using the same method described above.
NOTE
To Add a time segment:
1. Tap ADD.
2. Enter desired start time.
To Delete a time segment:
1. Tap on the X to the left of the time segment.
2. Tap YES to confirm.
Customer Technical Support: 1-877-801-6901
64
Section 2
Key Pump Features
Chapter 6
|
Personal Profile
12. Tap the Bolus Settings Panel to change DURATION,
MAX BOLUS or CARBS as needed. Use the onscreen
keypad to enter desired changes. Tap SAVE.
13. Confirm Settings.
Tap YES if entered data is correct.
Tap NO and make changes.
14. Tap Tandem logo to return to the Home Screen.
6.5
Duplicating an Existing Profile
1.
From the Home Screen, tap OPTIONS.
2.
Tap My Pump.
3.
Tap Personal Profiles.
Customer Technical Support: 1-877-801-6901
65
Section 2
Key Pump Features
4.
Tap the name of the Personal Profile to duplicate.
5.
Tap Duplicate.
6.
Confirm profile to duplicate by tapping YES.
7.
Using the onscreen keypad, enter the name (up to 16
characters) for the new profile and tap SAVE.
Chapter 6
|
Personal Profile
Z Profile Duplicated screen is displayed.
Z 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.
Customer Technical Support: 1-877-801-6901
66
Section 2
6.6
Key Pump Features
Chapter 6
|
Personal Profile
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.
NOTE
5.
»
The Activate and Delete options are disabled for the
currently 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).
Tap Activate.
Z A screen to confirm the activation of the profile is displayed.
6.
Tap YES.
Z Profile Activated screen is displayed.
Customer Technical Support: 1-877-801-6901
67
Section 2
6.7
Key Pump Features
Chapter 6
|
Personal Profile
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.
6.
Using the onscreen keypad, rename the profile name
(up to 16 characters) and tap SAVE.
7.
Tap Tandem logo to return to the Home Screen.
Customer Technical Support: 1-877-801-6901
68
Section 2
6.8
Key Pump Features
Chapter 6
|
Personal Profile
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
The active Personal Profile cannot be deleted.
5.
Tap Delete.
6.
Tap YES.
Z Profile Deleted screen is displayed.
7.
Tap Tandem logo to return to the Home Screen.
Customer Technical Support: 1-877-801-6901
69
Chapter 7
Bolus
7.1
Bolus Overview ........................................................................... 71
7.2
Food Bolus Using Units .............................................................. 71
7.3
Food Bolus Using Grams............................................................ 73
7.4
Correction Bolus ......................................................................... 74
7.5
Extended Bolus........................................................................... 76
7.6
Canceling or Stopping a Bolus ................................................... 78
Section 2
7.1
Key Pump Features
Chapter 7
|
Bolus
Bolus Overview
A bolus is a quick dose of insulin that is usually delivered to cover food eaten or an elevated BG.
Your t:slim 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.
CAUTION
»
Before delivering insulin, always check your pump and infusion set for damage, leaks, or kinks in the
tubing, as these problems could restrict or stop insulin delivery and possibly result in under-infusion.
»
If Carbohydrates is turned On in the Bolus Settings of your active Personal Profile, you can deliver
boluses only in grams of carbs, not in units of insulin. To deliver in units of insulin, you need to turn off
the Carbohydrates setting. Note that the quick bolus delivery setting (grams of carbohydrates or units of
insulin) is independent of the active Personal Profile bolus settings.
»
When a standard bolus is being delivered, you cannot initiate another bolus. However, if the DELIVER
LATER portion of an extended bolus is being delivered, you can initiate another standard bolus.
»
Only one extended bolus can be running at any given time.
»
When attempting to deliver a bolus that exceeds either your Personal Profile’s Max Bolus setting or
the pump’s maximum bolus amount allowed, a Max Bolus Alert will occur and you will need to make a
decision on whether to continue with bolus delivery, adjust the amount, or accept the pump’s maximum
allowable amount. Refer to Max Bolus Alert in section 15.7.
NOTE
If the max bolus is set at 25 units and the requested bolus is greater than 25 units, after the bolus is delivered
a reminder screen will appear. The option of delivering the remaining amount of the bolus of up to an
additional 25 units will be given. Refer to Max Bolus Alert in section 15.7.
NOTE
When attempting to deliver a bolus that exceeds the amount of insulin remaining in the cartridge, a message
screen appears indicating there is not enough insulin to deliver the requested bolus. You are required to enter
a new amount.
7.2
Food Bolus Using Units
NOTE
If bolusing using a carb ratio skip to the next section Food Bolus Using Grams.
1.
From the Home Screen, tap BOLUS.
2.
Tap 0 units.
Customer Technical Support: 1-877-801-6901
71
Section 2
Key Pump Features
3.
Chapter 7
|
Bolus
Using the onscreen keypad enter desired units of
insulin, tap DONE.
CAUTION
Always confirm that the decimal point placement is correct.
4.
Tap NEXT to confirm the units of insulin to be delivered.
5.
Confirm Request.
Tap YES if entered data is correct.
Tap NO to go back to make changes
or view calculations.
6.
Tap DELIVER.
7.
The bolus splash is displayed.
Customer Technical Support: 1-877-801-6901
72
Section 2
7.3
Key Pump Features
Chapter 7
|
Bolus
Food Bolus Using Grams
1.
From the Home Screen, tap BOLUS.
2.
Tap 0 grams.
3.
Using the onscreen keypad enter grams of carb
and tap DONE.
NOTE
4.
»
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.
Tap NEXT to confirm the units of insulin to be delivered.
NOTE
Tap View Calculation to display the Delivery
Calculation screen.
NOTE
Tap the displayed units calculated to override the amount.
5.
Confirm Request.
Tap YES if entered data is correct.
Tap NO to go back to make changes
or view calculations.
6.
Tap DELIVER.
Customer Technical Support: 1-877-801-6901
73
Section 2
Key Pump Features
7.
7.4
Chapter 7
|
Bolus
The bolus splash screen is displayed.
Correction Bolus
1.
From the Home Screen, tap BOLUS.
2.
Tap Add BG.
3.
Using the onscreen keypad, enter BG value
and tap DONE.
NOTE
Once DONE is tapped, the BG value is saved in pump History
whether or not a bolus is delivered.
NOTE
»
If BG is above the Target BG, a message screen will indicate
BG is above Target. To add a correction bolus tap YES.
»
If BG is below Target BG, a message screen advises to eat
carbs and retest. Tap Close.
»
If BG is at Target BG, it will return to the Bolus Screen with
no recommended bolus amount for correction.
NOTE
»
Tap the View Calculation to display the Delivery
Calculation screen.
»
If there is IOB, the amount will be subtracted from the
correction portion of the bolus.
»
Tap the displayed units calculated to override the amount.
Customer Technical Support: 1-877-801-6901
74
Section 2
Key Pump Features
Chapter 7
|
Bolus
NOTE
When your blood glucose is:
»
Above Target BG: the insulin for the food bolus and the
correction bolus will be added together. If IOB is present, it
will only be used in the calculation of the correction portion
of the bolus.
»
Between 70 mg/dL and Target BG: No correction bolus is
calculated. No adjustment will be made to the food bolus
even if IOB is present.
»
Below 70 mg/dL: The food bolus will be reduced to correct
for the low blood glucose. In addition, if IOB is present, it will
also be used in the calculation of the food bolus to return
your BG to target.
4.
Tap NEXT to confirm the units of insulin to be delivered.
5.
Confirm Request.
Tap YES if entered data is correct.
Tap NO to go back to make changes
or view calculations.
6.
Tap DELIVER.
7.
The bolus splash screen is displayed.
Customer Technical Support: 1-877-801-6901
75
Section 2
7.5
Key Pump Features
Chapter 7
|
Bolus
Extended Bolus
1.
From the Home Screen, tap BOLUS.
2.
Tap 0 grams (or 0 units).
3.
Using the onscreen keypad enter grams of carb
(or units of insulin). Tap DONE.
4.
If desired, tap Add BG and using the onscreen keypad
enter BG value. Tap DONE.
5.
Tap NEXT to confirm the units of insulin to be delivered.
NOTE
Tap View Calculation to display the Delivery
Calculation screen.
6.
Confirm Request.
Tap YES if entered data is correct.
Tap NO to go back to make changes
or view calculations.
7.
Tap EXTENDED to turn ON the extended feature,
then tap NEXT.
8.
Tap 50% under DELIVER NOW to adjust the
percentage of the food bolus that is to be
delivered immediately.
NOTE
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.
Customer Technical Support: 1-877-801-6901
76
Section 2
Key Pump Features
Chapter 7
|
Bolus
NOTE
A correction bolus will always be given in the
DELIVER NOW portion.
9.
Use the onscreen keypad to enter the percentage of
the bolus to DELIVERED NOW and tap DONE.
NOTE
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.
10. Tap 2 hrs under DURATION.
NOTE
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 will be notified and the
duration of the DELIVER LATER portion will be adjusted.
11. Use the onscreen keypad to adjust the length of time
the bolus is to be delivered, then tap DONE.
12. Tap NEXT.
NOTE
Tap View Units to display the breakdown of units to be delivered
NOW versus LATER.
13. Confirm Request.
Tap YES if entered data is correct.
Tap NO to go back to make changes
or view calculations.
Customer Technical Support: 1-877-801-6901
77
Section 2
Key Pump Features
Chapter 7
|
Bolus
14. Verify settings and tap DELIVER.
15. The bolus splash screen is displayed.
7.6
Canceling or Stopping a Bolus
Canceling a Bolus
If delivery Has Not Started but has been initiated:
1.
Tap red X to cancel the bolus.
The bolus button will remain inactive while the bolus
is being cancelled.
Once cancelled, the bolus button will become active
again on the Home Screen.
Customer Technical Support: 1-877-801-6901
78
Section 2
Key Pump Features
Chapter 7
|
Bolus
Stopping a Bolus
If delivery of the bolus Has Started:
1.
Tap red X to stop delivery.
2.
Tap YES.
Z The BOLUS STOPPED screen is displayed and the units
delivered are calculated.
3.
Units requested and delivered are shown. Tap CLOSE.
Customer Technical Support: 1-877-801-6901
79
Chapter 8
Stop/Resume Insulin
8.1
Stopping Insulin Delivery ............................................................ 81
8.2
Resuming Insulin Delivery ........................................................... 82
Section 2
8.1
Key Pump Features
Chapter 8
|
Stop/Resume Insulin
Stopping Insulin Delivery
At any time, even after delivery has started, you can stop all insulin deliveries at once, including
basal and any active bolus or temp rate deliveries.
1.
From the Home Screen, tap OPTIONS.
2.
Tap STOP INSULIN.
3.
Tap STOP.
Z The All Deliveries Stopped screen appears before
returning to the Home Screen showing the status
“ALL DELIVERIES STOPPED”.
NOTE
»
When you tap STOP on the confirmation screen, any active
bolus and any active temp rate are immediately suspended.
If you tap BACK on the confirmation screen, bolus delivery
continues.
»
No insulin delivery can take place while your pump
is stopped.
Customer Technical Support: 1-877-801-6901
81
Section 2
8.2
Key Pump Features
Chapter 8
|
Stop/Resume Insulin
Resuming Insulin Delivery
1.
If pump screen is not on, press Screen On/Quick Bolus Button once to turn on your
t:slim Pump screen.
2.
Tap RESUME.
3.
The RESUMING INSULIN splash screen
is displayed.
– OR –
1.
From the Home Screen, tap OPTIONS.
2.
Tap RESUME INSULIN.
3.
Tap RESUME.
4.
The RESUMING INSULIN splash screen is displayed.
Customer Technical Support: 1-877-801-6901
82
Section 3
Additional Pump Operations
Chapter 9
Temporary Basal Rate
9.1
Setting a Temp Rate ................................................................... 85
9.2
Stopping a Temp Rate ................................................................ 86
Section 3
9.1
Additional Pump Operations
Chapter 9
|
Temporary Basal Rate
Setting a Temp Rate
A Temp Rate is used to increase or decrease (by percentage) the current basal rate for a period
of time to accommodate special situations. 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%. If 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
minimal allowable rate for delivery. If you program a Temp Rate more than the maximum allowable
basal rate of 15 units/hr, you will be notified that the selected rate is too high and that it will be set
to the maximum allowable rate for delivery. Duration can be set from a minimum of 15 minutes to a
maximum of 72 hours in increments of 1 minute.
1.
From the Home Screen, tap OPTIONS.
2.
Tap Temp Rate.
3.
Tap Temp Rate.
4.
Using the onscreen keypad enter desired percentage.
Tap DONE.
NOTE
Current rate is 100%. An increase is greater than 100%
and decrease is less than 100%.
5.
Tap Duration. Using the onscreen keypad enter
desired length of time for temp rate. Tap DONE.
NOTE
To see the actual units to be delivered tap View Units.
Customer Technical Support: 1-877-801-6901
85
Section 3
Additional Pump Operations
6.
Verify settings and tap START.
7.
The TEMP RATE STARTED splash screen
is displayed.
Chapter 9
|
Temporary Basal Rate
NOTE
If a Temp Rate is currently active, the status of insulin delivery
displays an orange “T”. If a Temp Rate of 0% is currently active,
the status of insulin delivery displays a red “T”.
8.
9.2
The Screen Lock screen will be displayed with the icon
indicating a Temp Rate is active.
Stopping a Temp Rate
You can stop a temp rate that is currently being delivered.
1.
On the Home Screen, tap OPTIONS.
2.
On the Options screen, tap X (stop icon)
on the right side of Temp Rate.
3.
On the confirmation screen, tap STOP. The TEMP
RATE STOPPED screen appears before returning to
the Options screen.
Customer Technical Support: 1-877-801-6901
86
Chapter 10
Quick Bolus
10.1
Setting Up Quick Bolus .............................................................. 88
10.2
Delivering Quick Bolus ................................................................ 91
Section 3
Additional Pump Operations
Chapter 10
|
Quick Bolus
10.1 Setting Up Quick Bolus
Setting up 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.
The default of 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 carbs.
1.
From the Home Screen, tap OPTIONS.
2.
Tap My Pump.
3.
Tap Pump Settings.
4.
Tap Quick Bolus.
5.
Tap Quick Bolus to turn On.
Customer Technical Support: 1-877-801-6901
88
Section 3
Additional Pump Operations
6.
Tap Increment Type.
7.
Tap units of insulin or grams of carbohydrate.
8.
Tap Increment Amount.
Chapter 10
|
Quick Bolus
Quick Bolus using units
Quick Bolus using grams
Customer Technical Support: 1-877-801-6901
89
Section 3
Additional Pump Operations
9.
Chapter 10
|
Quick Bolus
Select the preferred increment amount.
NOTE
The increment amount is added with each press of the Quick
Bolus Button when delivering a quick bolus.
10. Review entered values and tap SAVE.
Quick Bolus using units
Quick Bolus using units
Quick Bolus using grams
Quick Bolus using grams
11. Confirm Settings.
Tap YES if entered data is correct.
Tap NO to go back to make changes.
12. Tap Tandem Logo to return to the Home Screen.
Customer Technical Support: 1-877-801-6901
90
Section 3
Additional Pump Operations
Chapter 10
|
Quick Bolus
10.2 Delivering Quick Bolus
If the Quick Bolus function is turned On, you can deliver a bolus without having to look at the
t:slim Pump’s screen. Simply use the Quick Bolus Button to deliver your bolus. Quick boluses are
delivered as standard boluses (there is no BG entry nor extended delivery capabilities).
CAUTION
When you first use the Quick Bolus feature, you should always look at the screen to confirm correct
programming until you are comfortable with this feature.
1.
Press and hold Quick Bolus Button. The Quick Bolus
screen will appear. Listen for 2 beeps (if Pump Volume
is set to beep) or feel for vibrations (if Pump Volume is
set to vibrate).
NOTE
t:slim will beep and vibrate during a Quick Bolus if a beep
volume is set. It will only vibrate if the vibrate option is selected.
2.
Press Quick Bolus Button for each increment until
desired amount is reached. The pump will beep/vibrate
for each button press.
Quick Bolus using units
Quick Bolus using grams
Customer Technical Support: 1-877-801-6901
91
Section 3
Additional Pump Operations
3.
Please wait a few seconds for the pump to beep/
vibrate back for each increment pressed to confirm
desired amount.
4.
After the pump beeps/vibrates, press and hold Quick
Bolus button to deliver the bolus.
Chapter 10
|
Quick Bolus
NOTE
»
If more than 5 seconds have passed with no input, the bolus
is cancelled and never delivered.
»
If you want to cancel the bolus and return to the Home
Screen, tap CANCEL on the QUICK BOLUS screen.
»
If the amount you indicated by your button presses exceeds
the Max Bolus amount defined in your active Personal
Profile, the Quick Bolus Button does not respond to any
more button presses.
Quick Bolus using units
Quick Bolus using grams of carbs
5.
The bolus splash screen is displayed.
Customer Technical Support: 1-877-801-6901
92
Chapter 11
t:slim® Pump Settings
11.1
t:slim Pump Volume .................................................................... 94
11.2
Screen Options ........................................................................... 95
Section 3
Additional Pump Operations
Chapter 11
|
t:slim Pump Settings
11.1 t:slim Pump Volume
Your t:slim Pump is delivered from Tandem Diabetes Care, Inc. with the volume pre-set at High.
A change to the Pump Volume can be made in Pump Settings.
Pump Volume can be personalized for the Buttons, Quick Bolus, Bolus, Reminders, Alerts, and
Alarms. Options for Pump Volume include high, medium, low and vibrate.
1.
From the Home Screen, tap OPTIONS.
2.
Tap My Pump.
3.
Tap Pump Settings.
4.
Tap Pump Volume.
5.
Tap desired option.
Customer Technical Support: 1-877-801-6901
94
Section 3
Additional Pump Operations
6.
Select preferred volume.
7.
Continue to make changes for all Pump Volume
options by repeating steps 5 and 6.
8.
Tap Tandem Logo to return to the Home Screen.
Chapter 11
|
t:slim Pump Settings
11.2 Screen Options
The Screen Options for your t:slim Pump include Screen Timeout and Feature Lock.
The Screen Timeout can be personalized to the duration the screen stays on without any touch
screen interaction. The default for the Screen Timeout is 30 seconds. The increment options are
15, 30, 60, and 120 seconds.
Your t:slim Pump is delivered from Tandem Diabetes Care, Inc. with the Feature Lock turned OFF.
With the Feature Lock turned ON, you cannot deliver a bolus, change any pump settings or
access any Personal Profiles.
NOTE
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 to prevent unintentional interactions with the touchscreen. Always position the pump screen
away from the skin when worn under clothing.
Customer Technical Support: 1-877-801-6901
95
Section 3
Additional Pump Operations
1.
From the Home Screen, tap OPTIONS.
2.
Tap My Pump.
3.
Tap Pump Settings.
4.
Tap Screen Options.
5.
Tap desired option.
Chapter 11
|
t:slim Pump Settings
For Screen Timeout
1.
Tap Screen Timeout.
2.
Select preferred time.
3.
Tap Tandem logo to return to the Home Screen.
Customer Technical Support: 1-877-801-6901
96
Section 3
Additional Pump Operations
Chapter 11
|
t:slim Pump Settings
For Feature Lock
1.
Tap Feature Lock to turn ON or OFF.
Z A screen to verify that you want to activate the Feature Lock
will be displayed.
2.
Tap Tandem logo to return to the Home Screen.
NOTE
If Feature Lock is turned on, all screen taps will be on a high
volume until the Feature Lock is turned off.
To Turn the Feature Lock Off
1.
From the Home Screen, tap OPTIONS.
2.
Tap My Pump.
3.
Tap Pump Settings.
4.
Tap Screen Options.
5.
Tap Feature Lock.
6.
Tap YES.
Customer Technical Support: 1-877-801-6901
97
Chapter 12
t:slim® Pump Info and History
12.1
t:slim Pump Info .......................................................................... 99
12.2
t:slim Pump History................................................................... 100
Section 3
Additional Pump Operations
Chapter 12
|
t:slim Pump Info and History
12.1 t:slim Pump Info
Your t:slim Pump allows access to information regarding your pump. In the Pump Info screen you
have access to items such as your pump Serial Number, Customer Technical Support telephone
number, 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 Tandem logo to return to the Home Screen.
Customer Technical Support: 1-877-801-6901
99
Section 3
Additional Pump Operations
Chapter 12
|
t:slim Pump Info and History
12.2 t:slim Pump History
The History displays the historical log of pump events. The following history reports can be viewed:
Delivery Summary, Bolus, Basal, Load, BG, Alerts and Alarms, and Complete.
The 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.
The Bolus, Basal, Load, BG Alerts and Alarms and Complete are categorized by date. The event
details in each report are listed by time.
Bolus History shows the bolus start time and the bolus completion time.
1.
From the Home Screen, tap OPTIONS.
2.
Tap the Down Arrow.
3.
Tap History.
4.
Tap desired option.
5.
Tap Tandem logo to return to the Home Screen.
Customer Technical Support: 1-877-801-6901
100
Chapter 13
Reminders
13.1
Low BG Reminder..................................................................... 102
13.2
High BG Reminder .................................................................... 104
13.3
After Bolus BG Reminder.......................................................... 106
13.4
Missed Meal Bolus Reminder ................................................... 108
13.5
Site Reminder ........................................................................... 109
Section 3
Additional Pump Operations
Features
Chapter 13
|
Reminders
Your t:slim Pump has customizable reminders, including:
• Low BG Reminder
• High BG Reminder
• After Bolus BG Reminder
• Missed Meal Bolus Reminder
• Site Reminder
Reminders sound with a single note at the volume/vibe selected in Pump Settings. They repeat at
regular intervals until acknowledged. Reminders do not escalate.
13.1 Low BG Reminder
The Low BG Reminder prompts you to re-test your BG after a low BG value is entered. When
turning this reminder setting On, you need to specify a low BG value that triggers the reminder, as
well as how much time should pass before the reminder occurs. The default values are pre-set to
Off, or if On; Remind Me Below 70 mg/dL, and Remind Me After 15 min, but you can set these
values from 70–120 mg/dL and 10–20 min.
NOTE
Reminders sound with a single note at the volume selected in Pump Settings. They repeat at regular intervals until
acknowledged. Reminders do not escalate.
1.
From the Home Screen, tap OPTIONS.
2.
Tap My Pump.
3.
Tap Alert Settings.
4.
Tap Reminders.
Customer Technical Support: 1-877-801-6901
102
Section 3
Additional Pump Operations
Features
5.
Chapter 13
|
Reminders
Tap Low BG.
NOTE
If not first-time setup, previous values appear instead of
“Press to Turn On.”
6.
Tap Low BG to turn ON or OFF:
a) Tap Remind Me Below and using the onscreen
keypad, enter a Low BG value (from 70–120 mg/dL)
that you want to trigger the reminder, then tap SAVE.
b) Tap Remind Me After and using the onscreen
keypad, enter the time duration (from 10–20 min), then
tap SAVE.
7.
Tap BACK on the Low BG Reminder screen to verify
your Low BG Reminder setting.
8.
Tap Tandem logo to return to the Home Screen.
To Respond to the Low BG Reminder
To clear the reminder and return to whatever activity was in
progress when the reminder occurred, tap CLOSE.
Customer Technical Support: 1-877-801-6901
103
Section 3
Additional Pump Operations
Features
Chapter 13
|
Reminders
13.2 High BG Reminder
The High BG Reminder prompts you to re-test your BG after a high BG value is entered. When
you turn this reminder setting on, you need to specify a high BG value that triggers the reminder,
as well as how much time should pass before the reminder occurs. The default values are pre-set
to Off, or if On, Remind Me Above 200 mg/dL, and Remind Me After 120 min, but you can set
these values from 150–300 mg/dL and 1–3 hrs.
1.
From the Home Screen, tap OPTIONS.
2.
Tap My Pump.
3.
Tap Alert Settings.
4.
Tap Reminders.
5.
Tap High BG.
NOTE
If not first-time setup, previous values appear instead of
“Press to Turn On”.
Customer Technical Support: 1-877-801-6901
104
Section 3
Additional Pump Operations
Features
6.
Chapter 13
|
Reminders
Tap High BG to turn ON or OFF.
a) Tap Remind Me Above and using the onscreen
keypad, enter a High BG value (from 150–300
mg/dL) that you want to trigger the reminder,
then tap SAVE.
b) Tap Remind Me After and using the onscreen
keypad, enter the time duration (from 1–3 hours),
then tap SAVE.
7.
Tap BACK on the High BG Reminder screen to verify
your High BG Reminder setting.
8.
Tap Tandem logo to return to the Home Screen.
To Respond to the High BG Reminder
To clear the reminder and return to whatever activity was in
progress when the reminder occurred, tap CLOSE.
Customer Technical Support: 1-877-801-6901
105
Section 3
Additional Pump Operations
Features
Chapter 13
|
Reminders
13.3 After Bolus BG Reminder
The After Bolus BG Reminder prompts you to test your BG a selected time period after a bolus
has been delivered. When turning this reminder on, you need to specify how much time should
pass before the reminder occurs. The options include: 1 hour, 1:30 hrs, 2 hrs and 3 hrs.
1.
From the Home Screen, tap OPTIONS.
2.
Tap My Pump.
3.
Tap Alert Settings.
4.
Tap Reminders.
5.
Tap After Bolus BG.
NOTE
If not first-time setup, previous values appear instead of
“Press to Turn On”.
Customer Technical Support: 1-877-801-6901
106
Section 3
Additional Pump Operations
Features
6.
Tap After Bolus BG to turn ON of OFF.
7.
Tap Remind Me After.
8.
Tap the preferred time duration.
9.
Tap BACK on the After Bolus BG screen to verify your
After BG Reminder setting.
Chapter 13
|
Reminders
10. Tap Tandem logo to return to the Home Screen.
To Respond to the After Bolus BG Reminder
To clear the reminder and return to whatever activity was in
progress when the reminder occurred, tap CLOSE.
Customer Technical Support: 1-877-801-6901
107
Section 3
Additional Pump Operations
Features
Chapter 13
|
Reminders
13.4 Missed Meal Bolus Reminder
The Missed Meal Bolus Reminder is a personalized reminder that notifies you that 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 Alert Settings.
4.
Tap Reminders.
5.
Tap Missed Meal Bolus.
NOTE
If not first-time setup, previous values appear instead of
“Press to Set Up”.
Customer Technical Support: 1-877-801-6901
108
Section 3
Additional Pump Operations
Features
6.
Chapter 13
|
Reminders
On the Missed Meal Bolus screen, tap which reminder
you want to set (Reminder 1–4) and do the following:
a) Tap Reminder 1 (or 2, 3, 4).
b) Tap Reminder 1 (or 2, 3, 4) to set the reminder ON.
c) Tap Selected Days and tap the desired day(s) you
want the reminder to be on, tap BACK.
d) Tap Start Time, tap Time and using the onscreen
keypad enter the start time, tap DONE.
e) Tap Time of Day to select AM or PM, tap SAVE.
f) Tap End Time, tap Time and using the onscreen
keypad enter the end time, tap DONE.
g) Tap Time of Day to select AM or PM, tap SAVE
h) Tap BACK to return to the Missed Meal Bolus menu
to review.
7.
Tap Tandem Logo to return to the Home Screen.
To Respond to the Missed Meal Bolus Reminder
To clear the reminder and return to whatever activity was in
progress when the reminder occurred, tap CLOSE.
13.5 Site Reminder
The Site Reminder prompts you to change your infusion set. If enabled (default is off), 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, refer to section 5.6.
To Respond to the Site Reminder
To clear the reminder and return to whatever activity was in
progress when the reminder occurred, tap CLOSE.
Customer Technical Support: 1-877-801-6901
109
Chapter 14
User Settable Alerts and Alarms
14.1
Low Insulin Alert........................................................................ 111
14.2
Auto-Off Alarm .......................................................................... 112
Section 3
Additional Pump Operations
Chapter 14
|
User Settable Alerts and Alarms
14.1 Low Insulin Alert
Your t:slim Pump continually tracks how much insulin is remaining in the cartridge and alerts you
when it is low. You can adjust the Low Insulin Alert setting (the default value is pre-set to 20 units,
but it can be set anywhere from 10 to 40 units). When the insulin amount reaches the set value,
the Low Insulin Alert beeps/vibrates and appears on the screen.
1.
From the Home Screen, tap OPTIONS.
2.
Tap My Pump.
3.
Tap Alert Settings.
4.
Tap Alerts.
5.
Tap Low Insulin.
Customer Technical Support: 1-877-801-6901
111
Section 3
Additional Pump Operations
Chapter 14
6.
Using the onscreen keypad, enter the number of
units (from 10–40 units) that you want the Low Insulin
Alert value to be set, and tap SAVE.
7.
Tap Tandem logo to return to the Home Screen.
|
User Settable Alerts and Alarms
To Respond to the Low Insulin Alert
To clear the reminder and return to whatever activity was in
progress when the reminder occurred, tap CLOSE.
NOTE
Once the LOW INSULIN ALERT occurs, the low insulin indicator (a
single red bar on the insulin level) appears in the upper right corner of
the Home Screen.
14.2 Auto-Off Alarm
Your t:slim 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. You can adjust the Auto-Off Alarm
setting (the default value is pre-set to 12 hrs, but it can be set anywhere from 5 hrs to 24 hrs,
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 30 seconds.
When the number of hours since you have tapped on the screen or pressed the Screen On/Quick
Bolus Button 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.
Customer Technical Support: 1-877-801-6901
112
Section 3
Additional Pump Operations
Chapter 14
3.
Tap Alert Settings.
4.
Tap Alerts.
5.
Tap Auto-Off.
6.
Verify Auto-Off is set to ON,
then tap Time.
7.
Using the onscreen keypad, enter the number of
hours (from 5–24 hrs) that you want the Auto-Off
Alarm to be triggered, and tap SAVE.
Customer Technical Support: 1-877-801-6901
|
User Settable Alerts and Alarms
113
Section 3
Additional Pump Operations
Chapter 14
8.
Tap BACK on the Auto-Off screen to verify your AutoOff Alarm setting.
9.
When changing this feature from on to off or from off
to on, a confirmation screen will appear. Tap YES to
change the setting.
|
User Settable Alerts and Alarms
10. Tap Tandem logo to return to the Home Screen.
To Respond to Auto-Off Warning
1.
Tap DO NOT SHUT DOWN.
The alarm clears and the pump returns to normal
operation and whatever activity was in progress when
the alert occurred.
If you do not clear the alarm within the 30-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
1.
Tap CLOSE.
The Home Screen then appears, indicating a status
of “All Deliveries Stopped.” Resuming insulin delivery
must be performed manually (refer to section 8.2).
Customer Technical Support: 1-877-801-6901
114
Section 4
Safety Alerts and Alarms
Chapter 15
Alerts
15.1
Low Power Alert........................................................................ 117
15.2
Low Insulin Alert........................................................................ 118
15.3
Incomplete Bolus Alert.............................................................. 118
15.4
Incomplete Temp Rate Alert ..................................................... 118
15.5
Incomplete Load Sequence Alerts............................................ 119
15.6
Incomplete Setting Alert ........................................................... 120
15.7
Basal Rate Required Alert ......................................................... 120
15.8
Max Bolus Alert......................................................................... 121
15.9
Max Hourly Bolus Alert ............................................................. 122
15.10
Max Basal Alert ......................................................................... 122
15.11
Connection Error Alert .............................................................. 123
15.12
Power Source Alert ................................................................... 123
15.13
Data Error Alert ......................................................................... 124
Section 4
Safety Alerts and Alarms
Chapter 15
|
Alerts
Your t:slim Pump has Alerts that are sounded for an incomplete activity, an impending alarm, or if a
max bolus has been reached.
Alerts sound with two notes at the volume/vibe selected in Pump Settings. They repeat at regular
intervals until acknowledged. Alerts do not escalate.
15.1 Low Power Alert
If the t:slim Pump detects a power level of 25% or less remaining, the LOW POWER ALERT
occurs. This alert screen displays the level of remaining power. When the pump reaches a 5%
battery level the pump has 30 minutes of remaining battery life.
To Respond to the Low Power Alert
To clear the Alert and return to whatever activity was in
progress when the alert occurred, tap CLOSE.
NOTE
Once the LOW POWER ALERT occurs, the low-power indicator
(a single red bar on the battery level) appears on the Home Screen.
NOTE
The battery level will decline in increments of 5%. At 5% it will decline
in 1% increments.
NOTE
Alerts sound with two notes at the volume selected in Pump Settings.
They repeat at regular intervals until acknowledged. Alerts do not escalate.
If your t:slim Pump detects a battery level of 5% or less power remaining, a second LOW POWER
ALERT occurs, requesting that you recharge your t:slim Pump. The alert will continue until the
condition has been corrected. Insulin delivery will continue until the LOW POWER ALARM is
triggered and insulin delivery stops.
To Respond to the second Low Power Alert
To temporarily clear the alert and return to whatever activity
was in progress when the alert occurred, tap CLOSE.
NOTE
Once the second LOW POWER ALERT occurs the low power
indicator (a red 5% on the battery level indicator) appears in the upper
left corner of the Home Screen.
Customer Technical Support: 1-877-801-6901
117
Section 4
Safety Alerts and Alarms
Chapter 15
|
Alerts
15.2 Low Insulin Alert
If your t:slim Pump detects an insulin level of 5 units or less, the LOW INSULIN ALERT occurs,
requesting you to change the cartridge. The alert will continue until the condition has been
corrected. Insulin delivery will continue until the EMPTY CARTRIDGE ALARM is triggered and
insulin delivery stops.
To Respond to the Low Insulin Alert
To temporarily clear the alert and return to whatever activity
was in progress when the alarm occurred, tap CLOSE.
15.3 Incomplete Bolus Alert
If you start to program a bolus but do not complete the request within 90 seconds, the INCOMPLETE
BOLUS ALERT occurs. You are prompted to return to the Bolus screen to complete the request.
To Respond to the Incomplete Bolus Alert
Tap CLOSE to return to the Bolus screen so that you can
complete the bolus request.
15.4 Incomplete Temp Rate Alert
If you start to set up a temp rate but do not complete the setup within 90 seconds, the INCOMPLETE
TEMP RATE ALERT occurs. You are prompted to return to the Temp Rate screen to complete
the setup.
To Respond to the Incomplete Temp Rate Alert
Tap CLOSE to return to the Temp Rate screen so that you can
complete the temp rate setup.
Customer Technical Support: 1-877-801-6901
118
Section 4
Safety Alerts and Alarms
Chapter 15
|
Alerts
15.5 Incomplete Load Sequence Alerts
Incomplete Cartridge Change Alert
If you begin to change a cartridge but do not complete the process within 3 minutes, the CHANGE
CARTRIDGE ALERT occurs.
To Respond to the Incomplete Cartridge Change Alert
Tap CLOSE to return to the screen you were on prior to the
alert, and complete the cartridge changing process.
Incomplete Fill Tubing Alert
If you select Fill Tubing from the Load menu but do not complete the process within 3 minutes, the
FILL TUBING ALERT occurs.
To Respond to the Incomplete Fill Tubing Alert
Tap CLOSE to return to the screen you were on prior to the
alert, and complete the tube filling process.
Incomplete Fill Cannula Alert
If you select Fill Cannula from the Load menu but do not complete the process within 3 minutes,
the FILL CANNULA ALERT occurs.
To Respond to the Incomplete Fill Cannula Alert
Tap CLOSE to return to the screen you were on prior to the
alert, and complete the cannula filling process.
Customer Technical Support: 1-877-801-6901
119
Section 4
Safety Alerts and Alarms
Chapter 15
|
Alerts
15.6 Incomplete Setting Alert
During the setup of a new Personal Profile if you do not save or complete the programming within
5 minutes, the INCOMPLETE SETTING ALERT occurs.
To Respond to the Incomplete Setting Alert
Tap CLOSE to clear the alert and return to the previous screen
to finish programming a Personal Profile.
15.7 Basal Rate Required Alert
During the setup of a new time segment in a Personal Profile you must enter a basal rate to have
an active profile. If you do not enter a basal rate a BASAL RATE REQUIRED ALERT occurs.
To Respond to the Basal Rate Required Alert
Tap CLOSE to clear the alert and to return to the time
segment to finish programming a basal rate.
Customer Technical Support: 1-877-801-6901
120
Section 4
Safety Alerts and Alarms
Chapter 15
|
Alerts
15.8 Max Bolus Alert
If you request a bolus amount that exceeds the Max Bolus setting in the currently active Personal
Profile, a MAX BOLUS ALERT occurs. You are prompted to confirm whether you want to deliver the
max bolus amount.
To Respond to the Max Bolus Alert
Do one of the following:
•
To return to the Bolus screen and adjust the bolus
delivery amount, tap BACK.
•
To deliver the requested bolus tap CONTINUE.
If your Max Bolus amount is defined to be 25 units and you request a bolus that exceeds 25 units,
the MAX BOLUS ALERT occurs. If you continue with this max bolus delivery of 25 units, upon
completion of this bolus delivery, you will receive a prompt to request the remaining amount of the
requested bolus if desired (up to an additional 25 units)
To Respond to Remaining Bolus Request:
Do one of the following:
•
Tap NO.
Z This returns to the previous screen.
•
Tap YES to confirm delivery, tap DELIVER.
Customer Technical Support: 1-877-801-6901
121
Section 4
Safety Alerts and Alarms
Chapter 15
|
Alerts
15.9 Max Hourly Bolus Alert
If, within a 60-minute period of time, you request a bolus delivery that is more than 1.5 times your
Max Bolus setting, the MAX HOURLY BOLUS ALERT occurs, and you are prompted to confirm
whether you want to deliver this bolus amount.
To Respond to the Max Hourly Bolus Alert
Do one of the following:
•
To return to the Bolus screen and adjust your bolus
amount, tap BACK.
•
To deliver the bolus, tap CONTINUE.
15.10 Max Basal Alert
In either of the following scenarios, if you exceed 2 times the highest basal rate defined in your
Personal Profile, the MAX BASAL ALERT occurs:
• When defining a basal rate and tapping SAVE.
• When requesting a temp rate and tapping START.
You are cautioned that you will exceed 2 times your highest basal setting and prompted to confirm
whether you want to continue with this basal amount.
To Respond to the Max Basal Alert Before Starting a
Temp Rate or Saving a Basal Rate
Do one of the following:
•
To return to the previous screen and adjust the amount,
tap BACK.
•
To continue regardless of the excess amount,
tap CONTINUE.
Customer Technical Support: 1-877-801-6901
122
Section 4
Safety Alerts and Alarms
Chapter 15
|
Alerts
If you have already started a temp rate and, while the temp
rate is running, you activate a new profile that exceeds 2 times
your highest basal setting, the MAX BASAL ALERT occurs.
You are prompted to review your current temp rate.
To Respond to the Max Basal Alert After
the Temp Rate Has Started
1.
Tap CLOSE.
Z The Options screen appears, showing the
current Temp Rate value.
15.11 Connection Error Alert
If you connect your t:slim Pump to a computer via a USB cable in order to sync data and a
connection cannot be made, the CONNECTION ERROR ALERT occurs. You are prompted to
disconnect and reconnect the USB cable.
To Respond to the Connection Error Alert
1.
To clear the alert, tap CLOSE.
Z This returns to the previous screen prior to the alarm.
2.
Disconnect and reconnect the USB cable to try again
15.12 Power Source Alert
If you attempt to charge your t:slim Pump by connecting to a power source that has insufficient
power to charge the t:slim Pump, the POWER SOURCE ALERT occurs. You are prompted to try a
different power source.
To Respond to the Power Source Alert
1.
To clear the alert, tap CLOSE.
Z This returns to the previous screen prior to the alarm.
2.
Disconnect and reconnect to a different power source.
Customer Technical Support: 1-877-801-6901
123
Section 4
Safety Alerts and Alarms
Chapter 15
|
Alerts
15.13 Data Error Alert
If your t:slim Pump encounters a condition that causes a potential loss of data, the DATA ERROR
ALERT occurs. You are prompted to check your active Personal Profile and pump settings.
To Respond to the Data Error Alert
1.
To clear the alert, tap CLOSE.
Z This returns to the previous screen prior to the alarm.
2.
Check your Personal Profiles and pump settings to
verify they are accurate (refer to section 6.4).
Customer Technical Support: 1-877-801-6901
124
Chapter 16
Alarms
16.1
Resume Pump Alarm ................................................................ 126
16.2
Low Power Alarms .................................................................... 127
16.3
Empty Cartridge Alarm ............................................................. 128
16.4
Cartridge Error Alarm ................................................................ 128
16.5
Cartridge Removal Alarm .......................................................... 129
16.6
Occlusion Alarm ........................................................................ 130
16.7
Temperature Alarm .................................................................... 130
16.8
Screen On/Quick Bolus Button Alarm ...................................... 131
16.9
Altitude Alarm ........................................................................... 131
16.10
Reset Alarm .............................................................................. 131
Section 4
Safety Alerts and Alarms
Chapter 16
|
Alarms
Your t:slim Pump has Alarms that sound for potential interruption of insulin delivery.
CAUTION
Monitor your blood glucose (BG) levels frequently with the guidance of your healthcare provider anytime
there is an interruption of insulin delivery. Treat elevated blood glucose(BG) levels as recommended by
healthcare provider.
Alarms sound with three notes at the volume/vibe selected in Pump Settings. If not acknowledged,
alarms escalate to highest volume and vibe. Alarms repeat at regular intervals until the condition
that caused the alarm is resolved.
16.1 Resume Pump Alarm
If insulin delivery has stopped for more than 15 minutes, the RESUME PUMP ALARM occurs.
To Respond to the Resume Pump Alarm
1.
Tap CLOSE to clear the alarm.
2.
From the Home Screen, tap OPTIONS.
3.
Tap Resume Insulin, and tap Resume.
Customer Technical Support: 1-877-801-6901
126
Section 4
Safety Alerts and Alarms
Chapter 16
|
Alarms
16.2 Low Power Alarms
If your t:slim Pump detects a power level of 1% or less power remaining, the LOW POWER ALARM
occurs and all insulin deliveries are stopped. You must recharge your t:slim Pump to resume insulin
delivery. The alarm will continue until the condition has been corrected or the pump shuts down.
To Respond to the Low Power Alarm
1.
To temporarily clear the alarm, tap CLOSE.
NOTE
Once the LOW POWER ALARM occurs the low power indicator
(a red X and 1% on the battery level indicator) appears in the
upper left corner of the Home Screen.
Your t:slim Pump monitors power level in several different ways. If, at any time, your t:slim Pump
detects a voltage level too low to ensure normal performance, the LOW POWER ALARM occurs and
all insulin deliveries are stopped. You must recharge your t:slim Pump to resume insulin delivery.
To Respond the Low Power Alarm
1.
To silence the alarm, tap SILENCE ALARM.
Customer Technical Support: 1-877-801-6901
127
Section 4
Safety Alerts and Alarms
Chapter 16
|
Alarms
16.3 Empty Cartridge Alarm
If your t:slim Pump detects an insulin level in the cartridge of 1 unit or less, the EMPTY
CARTRIDGE ALARM occurs and all insulin deliveries are stopped. You must change the cartridge
and fill the new cartridge with insulin before you can resume delivery. The alarm will continue until
the condition has been corrected.
To Respond to the Empty Cartridge Alarm
1.
Tap CLOSE.
Z This returns to the previous screen prior to the alarm.
2.
Under OPTIONS, tap Load to follow the proper
procedure for a cartridge change (refer to section 5.3).
NOTE
Once the EMPTY CARTRIDGE ALARM occurs, the empty
cartridge indicator (a red X on the insulin level) appears in the
upper right corner of the Home Screen.
16.4 Cartridge Error Alarm
If any of the following cartridge error scenarios are detected, a CARTRIDGE ALARM occurs and all
insulin deliveries stop:
• The pump determines that the loaded cartridge cannot be used (eg, it is defective, etc.).
• The pump detects that you tried to fill the cartridge with insulin without following the proper
procedure in the Load menu.
• The pump detects that you have filled the cartridge with more than the maximum amount
(300 units) of insulin and therefore the cartridge cannot be used.
To Respond to the Cartridge Alarm
1.
To temporarily clear the alarm, tap CLOSE.
Z This returns to the previous screen prior to the alarm.
Customer Technical Support: 1-877-801-6901
128
Section 4
Safety Alerts and Alarms
2.
Chapter 16
|
Alarms
Use the Load menu to follow the proper procedure for a
cartridge change (refer to section 5.3).
16.5 Cartridge Removal Alarm
If your t:slim Pump detects that the cartridge has been removed, the Cartridge Removal Alarm
occurs and all insulin deliveries are stopped.
To Respond to the Cartridge Removal Alarm
1.
Tap CONNECT to reattach the current cartridge.
2.
Tap INSTALL to install a new cartridge.
Customer Technical Support: 1-877-801-6901
129
Section 4
Safety Alerts and Alarms
Chapter 16
|
Alarms
16.6 Occlusion Alarm
If your t:slim Pump detects insulin delivery is blocked, the OCCLUSION ALARM occurs and all insulin
deliveries are stopped. Check the cartridge, tubing and cannula to help determine the cause.
To Respond to the Occlusion Alarm
1.
To temporarily clear the alarm, tap CLOSE.
Z This returns to the previous screen prior to the alarm.
2.
Check the cartridge, tubing, and cannula and correct
the condition.
3.
Resume insulin delivery (refer to section 8.2)
16.7 Temperature Alarm
If your t:slim Pump detects a temperature outside of the normal operating range, the
TEMPERATURE ALARM occurs and all insulin deliveries are stopped.
To Respond to the Temperature Alarm
1.
To temporarily clear the alarm, tap CLOSE.
Z This returns to the previous screen prior to the alarm.
2.
Remove the pump from the extreme temperature.
3.
Resume insulin delivery (refer to section 8.2).
Customer Technical Support: 1-877-801-6901
130
Section 4
Safety Alerts and Alarms
Chapter 16
|
Alarms
16.8 Screen On/Quick Bolus Button Alarm
If the Screen On/Quick Bolus Button (on the top of your t:slim Pump) is stuck or not functioning
properly, the BUTTON ALARM occurs and all insulin deliveries are stopped. Contact Tandem
Diabetes Care Customer Technical Support at 1-877-801-6901.
To Respond to the Button Alarm
1.
To temporarily clear the alarm, tap CLOSE.
Z This returns to the previous screen prior to the alarm.
2.
Contact Customer Technical Support
at 1-877-801-6901.
16.9 Altitude Alarm
If your t:slim Pump detects a pressure change outside of the operating range, the ALTITUDE
ALARM occurs and all insulin deliveries are stopped.
To Respond to the Altitude Alarm
1.
To temporarily clear the alarm, tap CLOSE.
Z This returns to the previous screen prior to the alarm.
2.
Remove cartridge from the pump and reconnect
the cartridge.
3.
Resume insulin delivery (refer to section 8.2).
16.10 Reset Alarm
If your t:slim Pump detects that one of its micro-processors has experienced a reset, the PUMP
RESET screen appears and all insulin deliveries are stopped.
To Respond to the Reset Alarm
1.
To temporarily clear the alarm, tap CLOSE.
2.
Contact Customer Service at 1-877-801-6901.
3.
Do not resume insulin before speaking with a
Customer Service representative.
Customer Technical Support: 1-877-801-6901
131
Chapter 17
Malfunction
17.1
Malfunction ............................................................................... 133
Section 4
Safety Alerts and Alarms
Chapter 17
|
Malfunction
17.1 Malfunction
If your t:slim Pump detects a system error, the MALFUNCTION ALARM occurs and all insulin
deliveries are stopped. Malfunctions sound with three notes at the highest volume and vibe.
They repeat at regular intervals until acknowledged. Malfunctions cannot be resolved.
CAUTION
Monitor your blood glucose (BG) levels frequently with the guidance of your healthcare provider anytime
there is an interruption of insulin delivery. If pump therapy can not be resumed start backup plan per your
healthcare provider.
To Respond to the Malfunction Alarm
1.
Write down the Malfunction Code number that appears
on the screen.
2.
Tap SILENCE ALARM. The alarm is silenced and the
screen times out. Press the Screen On/Quick Bolus
Button to see the screen again. The MALFUNCTION
screen appears but the alarm is silenced.
3.
Contact Tandem Diabetes Care Customer Technical
Support at 1-877-801-6901 and provide the
Malfunction Code number you wrote down.
Customer Technical Support: 1-877-801-6901
133
Section 5
Care and Maintenance
Chapter 18
Taking Care of your t:slim® Pump
18.1
Overview ................................................................................... 136
Section 5
Care and Maintenance
Chapter 18
|
Taking Care of your t:slim Pump
18.1 Overview
This section provides information on caring for and maintaining your t:slim Pump.
Cleaning Your t:slim 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.
Inspecting Your t:slim Pump for Damage
If you drop your t:slim Pump or it has been hit against something hard, ensure that it is still working
properly. Check that the touch screen is working and clear, and that the cartridge and infusion set
are properly in place. Check for leaks around the cartridge and at the luer connector to the infusion
set. Immediately contact Tandem Diabetes Care Customer Technical Support at 1-877-801-6901
if you notice any cracks, chips, or other damage.
Disposing of t:slim Pump Accessories
Regulations require controlled disposal of devices such as insulin infusion pumps and related
disposables, so ask your Tandem Diabetes Care, Inc. representative or healthcare provider about
local regulations regarding disposal of cartridges, infusion sets, and other disposable accessories.
Customer Technical Support: 1-877-801-6901
136
Section 6
Technical Specifications
Chapter 19
Technical Specifications
19.1
Overview ................................................................................... 139
19.2
t:slim Pump Specifications ...................................................... 139
19.3
t:slim Pump Options and Settings ........................................... 140
19.4
Additional t:slim Pump Specifications ..................................... 141
19.5
Electromagnetic Compatibility .................................................. 142
19.6
Electromagnetic Emissions ....................................................... 142
19.7
Electromagnetic Immunity ........................................................ 143
19.8
Distances Between the t:slim Pump and RF Equipment ......... 144
19.9
FCC Notice Concerning Interference........................................ 146
®
®
®
®
Section 6
Technical Specifications
Chapter 19
|
Technical Specifications
19.1 Overview
This appendix provides tables of technical specifications, options, settings, and electromagnetic
compliance information for the t:slim Pump. The specifications in this appendix meet the
international standards set forth in IEC 60601-1 and IEC 60601-2-24.
19.2 t:slim Pump Specifications
The following table lists the t:slim Pump specifications and their related details.
Specification Type
Specification Details
Classification
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 Pump in the presence
of flammable anesthetics or explosive gases.
Size
3.13˝ x 2.0˝ x 0.6˝ (L x W x H)
(7.95 cm x 5.08 cm x 1.52 cm)
Weight (with full disposable)
3.95 ounces (112 grams)
Operating Temperature Range
41°F and 98.6°F, 5°C and 37°C at maximum relative humidity of 90% non-condensing
Storage Temperature Range
-4°F and 140°F -20°C to 60°C at maximum relative humidity of 90% non-condensing
Atmospheric Pressure
700 hPa to 1060 hPa (equivalent from sea level up to 10,000 ft.)
Reservoir Volume
3.0 mL or 300 units
Cannula Fill Amount
0.1 to 1.0 units of insulin
Insulin Concentration
U-100
Alarm Type
Visual, audible, and vibratory
Basal Delivery Accuracy
at all Flow Rates
(tested per IEC 60601-2-24)
±5% *
Bolus Delivery Accuracy
at all Volumes
(tested per IEC 60601-2-24)
±5% *
* In extreme pressure environments, delivery accuracy may vary up to ±15%. Extreme pressure environments include any rapid elevation change
of 1,000 ft.
Time to Occlusion Alarm
Operating Rate
Typical
Maximum
Bolus (3 units or Greater)
21 Seconds
23 Seconds
Basal (2 units/hr)
1 Hour 4 Minutes
1 Hour 10 Minutes
Basal (1 units/hr)
1 Hour 57 Minutes
2 Hours 7 Minutes
Basal (0.1 units/hr)
19 Hours 43 Minutes
25 Hours 30 Minutes
Customer Technical Support: 1-877-801-6901
139
Section 6
Technical Specifications
Chapter 19
|
Technical Specifications
19.3 t:slim Pump Options and Settings
The following table lists the t:slim Pump options and settings, and their related details.
Option/Setting Type
Option/Setting Details
Time
12-hour clock
Maximum Basal Rate
15 units/hr
Insulin Delivery Profiles
(Basal and Bolus)
6
Basal Rate Segments
16 per delivery profile
Basal Rate Increment
0.001 at programed rates equal to or greater than 0.1 units/hr
Temp Basal Rate
15 minutes to 72 hours with 1 minute resolution Range: 0%–250%
Bolus Setup
Can deliver based on carb input (grams) or insulin input (units). Default is units. (The range for
carbs is 1–999 grams; the range for insulin is 0.05–25 units)
Insulin-to-Carb (IC) Ratio
16 time segments per 24-hour period; Ratio: 1 unit of insulin per x grams of carbs; 1:1 to 1:300
(resolution is 1 above 10 and 0.1 below 10)
BG Correction Target Value
16 time segments. 70 to 250 mg/dL in 1 mg/dL increments
Insulin Sensitivity Factor (ISF)
16 time segments; Ratio: 1 unit of insulin reduces glucose x mg/dL; 1:1 to 1:600
(1 mg/dL increments)
Duration of Insulin Action
1 time segment; 2–8 hours in 1-minute increments (default is 5 hrs)
Bolus Increment
0.01 at volumes greater than 0.05 units
Quick Bolus Increments
When set to units: 0.5, 1, 2, 5 units (default is 0.5 units); or when set to grams/carbs: 2, 5,
10, 15 grams (default is 2 g)
Maximum Extended Bolus Time
8 hours
Maximum Bolus Size
25 units
Low Reservoir Volume Indicator
Status indicator (visible on home screen); Low Insulin Alert (user adjustable: 10–40 units)
Auto-Off Alarm
On or Off (default is On); user-adjustable (5–24 hours; default is 12 hours, which you can
change when option is set to On)
History Storage
Up to 90 days of data (11,000 events)
Language
English
Feature Lock
Blocks access to insulin delivery screens and pump setting screens(default is Off)
Screen Lock
Protects from unintentional taps
Site Reminder
Prompts user to change infusion set. Can be set for 1–3 days at a time selected by user
(default is Off).
Missed Meal Bolus Reminder
Prompts user if a bolus has not occurred during the period of time the reminder is set for.
4 reminders available.
After Bolus Reminder
Prompts user to test BG at a selected time period after a Bolus has been delivered. Increment
options of 1 hr, 1:30 hrs, 2 hrs and 3 hrs.
High BG Reminder
Prompts user to retest BG after a High BG has been entered. User selects High BG value and
time for reminder. Default is Off.
Low BG Reminder
Prompts user to retest BG after a Low BG has been entered. User selects Low BG value and
time for reminder. Default is Off.
Customer Technical Support: 1-877-801-6901
140
Section 6
Technical Specifications
Chapter 19
|
Technical Specifications
19.4 Additional t:slim Pump Specifications
The following table lists additional the t:slim Pump specifications and their related details.
Specification Type
Specification Details
Patient Protection from Air Infusion
The pump provides subcutaneous delivery into interstitial tissue and does not deliver
intravenous injections, clear tubing aids in detecting air.
Maximum Infusion Pressure Generated
and Occlusion Alarm Threshold.
30 PSI
Rate of delivery during Bolus
Bolus > 3 units
Bolus ≤ 3 units
Rate of delivery during Prime
Approximately 7 units/min
Bolus Duration
Bolus > 3 units duration
Bolus ≤ 3 units duration
Frequency of Basal Delivery
5 minutes for all Basal Rates
Retention Time of Electronic Memory
when Internal System Battery is
Fully Discharged
Greater than 30 days
Infusion Set used for Testing
Unomedical Comfort™ Infusion Set
Statement of Meaning of the Claimed
Ingress Protection (IP) Classification
IPX7: watertight to a depth of 3 feet for up to 30 minutes
Internal System Battery
Rechargeable Lithium Polymer
Internal System Battery Life
4 years minimum under normal use conditions
Typical Operating Time when System
is Operating at Intermediate Rate
During normal use, the intermediate rate is 2 units/hr; battery charge can be
reasonably expected to last up to 7 days (depending on the pump settings) from a
fully charged state to a totally discharged state
Handling of Over-Infusion or
Under-Infusion
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.
Approximately 2 units/min
Approximately 1.6 units/min
Approximately 30 seconds/unit
Approximately 37 seconds/unit
Over-infusion is mitigated by continuous self-tests, 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 pre-defined period of time.
Under-infusion is mitigated by occlusion detection and blood glucose monitoring as
blood glucose entries are recorded. Users are prompted to treat high blood glucose
conditions with a correction bolus.
Bolus Volume at Release of Occlusion
Customer Technical Support: 1-877-801-6901
0.4–0.6 units at 2 units per hour with Unomedical Comfort™ (60cm) Infusion Set
141
Section 6
Technical Specifications
Chapter 19
|
Technical Specifications
19.5 Electromagnetic Compatibility
The information contained in this section is specific to the t:slim Pump. This information provides
reasonable assurance of normal operation, but does not guarantee such under all conditions. If the
t:slim Pump must be used in close proximity with other electrical equipment, the pump 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.
This section contains the following tables of information:
• Electromagnetic Emissions
• Electromagnetic Immunity
• Distances Between the t:slim pump and RF Equipment
19.6 Electromagnetic Emissions
The t:slim Pump is intended for use in the electromagnetic environment specified below. Always
make sure that the pump 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 pump 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 pump 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.
Customer Technical Support: 1-877-801-6901
142
Section 6
Technical Specifications
Chapter 19
|
Technical Specifications
19.7 Electromagnetic Immunity
The t:slim Pump is intended for use in the electromagnetic environment specified below. Always
make sure that the pump is used in such an environment.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Electromagnetic
Environment – Guidance
Immunity Test
IEC 60601 Test Level
Compliance Level
Electrostatic Discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical Fast Transient/burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/ output lines
± 2 kV for power supply lines
± 1 kV for input/output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV differential mode
± 2 kV common mode
± 1 kV differential mode
± 2 kV common mode
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage Dips, Short
Interruptions, and Voltage
Variations on Power Supply
Input Lines IEC 61000-4-11
<5% Ur (>95% dip in Ur) for 0,5 cycle
40% Ur (60% dip in Ur) for 5 cycles
70% Ur (30% dip in Ur) for 25 cycles
<5% Ur (>95% dip in Ur) for 5 sec
<5% Ur (>95% dip in Ur) for 0,5 cycle
40% Ur (60% dip in Ur) for 5 cycles
70% Ur (30% dip in Ur) for 25 cycles
<5% Ur (>95% dip in Ur) for 5 sec
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 (50/60
Hz) Magnetic Field IEC
61000-4-8
3 A/m
400 A/m (IEC 60601-2-24)
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
10 V
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5 GHz
30 V/m
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:
d = 0.35√P
80 MHz to 800 MHz, d = 0.12√P
800 MHz to 2.5GHz, d = 0.23√P
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 metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey a,
should be less than the compliance level in each
frequency range b.
Interference may occur in the vicinity of
equipment marked with the following symbol:
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.
a
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 pump.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Customer Technical Support: 1-877-801-6901
143
Section 6
Technical Specifications
Chapter 19
|
Technical Specifications
19.8 Distances Between the t:slim Pump and RF Equipment
The t:slim Pump 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 t:slim Pump. For specific concerns about a particular RF
transmitter interfering with your Pump’s operation, please contact the transmitter manufacturer for
its rated power and frequency.
Recommended Separation Distances Between Portable and Mobile
RF Communications Equipment and the t:slim Pump
The t:slim Pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the t:slim Pump can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the pump as recommended below, according to
the maximum output power of the communications equipment.
Rated Maximum
Output Power of
Transmitter in Watts
Separation Distance According to Frequency of Transmitter
inches or feet (m)
150 kHz to 80 MHz
(d in meters =
0.35√P)
80 MHz to 800 MHz
(d in meters =
0.12√P)
800 MHz to 2.5 GHz
(d in meters =
0.23√P)
0.01
1.6 in
(0.04)
0.12 in (0.012)
0.9 in
(0.023)
0.1
4.3 in
(0.11)
1.5 in
(0.038)
2.9 in
(0.073)
1
1.1 ft
(0.35)
4.7 in
(0.120)
9.0 in
(0.23)
10
3.6 ft
(1.11)
14.9 in (0.379)
2.39 ft
(0.727)
100
11.5 ft
(3.50)
3.94 ft
7.54 ft
(2.3)
(1.20)
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.
Customer Technical Support: 1-877-801-6901
144
Section 6
Technical Specifications
Chapter 19
|
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 pump.
Rated Maximum
Output Power of
Typical Devices
Transmitter in Watts
Recommended
Separation Distance
Inch (Meters)
0.001W
Bluetooth Class 3 (standard 1 meter range)
Commonly used as bluetooth headset
0.3 in (0.007 m)
0.01W
Internet to music adaptor
Commonly used for FM wireless music streaming
0.5 in (0.013 m)
0.1W
Bluetooth Class 1 (100 meter range)
Wireless router (WiFi)
2.9 in (0.073 m)
0.5W
Typical cellular/smart phone *
6.4 in (0.163 m)
1W
Typical microwave oven RF leakage
9 in
(0.23 m)
* 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 6.4 inches apart.
Customer Technical Support: 1-877-801-6901
145
Section 6
Technical Specifications
Chapter 19
|
Technical Specifications
19.9 FCC Notice Concerning Interference
The t:slim Pump complies with FCC/IC RF exposure limits for general population/uncontrolled
exposure.
t:slim Pumps equipped with a Bluetooth® RF option transmit at a maximum effective radiated
power of 3.4 mW in the 2.4 GHz ISM band, which covers the frequency range from 2.40 GHz to
2.50 GHz.
The t:slim Pump complies with Part 15 of the FCC rules. Operation is subject to the
following two conditions:
1.
2.
This device may not cause harmful interference, and;
This device must accept any interference received, including interference that my cause
undesired operation
Compliance with these guidelines provides reasonable protection against harmful interference in a
normal residential environment. The t:slim Pump generates, uses, and can radiate radio frequency
energy, and may cause harmful interference to radio communications. There is no guarantee
that interference will not occur in a particular installation. If the t:slim Pump does cause harmful
interference to radio or television reception, the interference may be corrected by one of the
following measures:
• Move or relocate the t:slim Pump
• Increase the distance between the t:slim Pump and the other device that is emitting or
receiving interference
Changes or modifications not expressly approved by Tandem Diabetes Care, Inc. could void the
user’s authority to operate the equipment.
Customer Technical Support: 1-877-801-6901
146
INDEX
Index
A
Accessories 34, 136
AC Charger 34
Active Bolus 81
Additional Pump Operations 83
After Bolus Reminder 106, 140
Air Bubbles 11, 47
Alarms 94, 100, 110, 125
Altitude Alarm 131
Auto-Off Alarm 112, 140
Cartridge Error 48, 128
Cartridge Removal Alarm 129
Empty Cartridge Alarm 128
Low Power Alarm 127
Occlusion Alarm 130, 139, 141
Reset Alarm 131
Resume Pump Alarm 126
Screen On/Quick Bolus Button Alarm 131
Temperature Alarm 130
Alerts 29, 94, 100, 110, 116
Alert Icon 24
Basal Rate Required Alert 120
Connection Error Alert 35, 123
Data Error Alert 124
Incomplete Bolus Alert 118
Incomplete Cartridge Change Alert 119
Incomplete Fill Cannula Alert 119
Incomplete Fill Tubing Alert 119
Incomplete Load Sequence Alert 119
Incomplete Setting Alert 120
Incomplete Temp Rate Alert 118
Low Insulin Alert 111, 140
Low Power Alert 117
Max Basal Alert 122
Max Bolus Alert 121
Max Hourly Bolus Alert 122
Power Source Alert 123
Altitude Alarm 131
Arrows
Menu Arrows 28
Up/Down Arrow 26
Auto-Off Alarm 112, 140
Battery 24, 25, 34, 141
Battery Level 24, 25, 117, 127
Charging 19, 24, 25, 34, 35
Lithium Polymer Battery 34, 141
BG 22, 27, 100
High BG 12, 104, 140
Low BG 102, 140
Target BG 22, 26, 56, 57, 74, 75, 140
Bluetooth 145, 146
Bolus 18, 22, 25, 70, 100, 140, 141
Active Bolus 81
Active Bolus Icon 24
Bolus Delivery 18, 29, 71, 139, 140, 141
Bolus Overview 71
Bolus Screen 27
Bolus Settings 56, 57
Correction Bolus 23, 74, 75, 77
Extended Bolus 23, 71, 76, 140
Food Bolus 71, 73, 75
Max Bolus 56, 57, 71, 121
Quick Bolus 23, 25, 29, 87, 94, 140
Rate of Delivery 141
C
Cancel 78
Cannula 22
Fill Cannula 28, 51, 139
Carbohydrates 22, 23, 26, 56, 57, 71
Carb Ratio 22, 26, 56, 57
Carbs 27, 56, 65, 71, 88
Cartridge 11, 20, 23, 24, 25, 28, 41, 43, 48
Cartridge Error Alarm 48, 128
Cartridge Fill 44
Cartridge Removal Alarm 129
Cartridge Tubing 25
Change Cartridge 28, 44, 119
Load Cartridge 23, 25, 28, 44, 100
Charging 19, 24, 25, 34, 35
Cleaning 136
Connection Error Alert 35, 123
Correction Bolus 23, 74, 75, 77
Correction Factor 23, 26, 56, 57
Customer Technical Support 10, 29
B
Basal 22, 26, 29, 56, 57, 100, 140
Basal Delivery 22, 26, 56, 139, 141
Basal Rate 22, 26, 56, 140
Basal Rate Required Alert 120
Current Basal Rate 26
Temporary Basal Rate 23, 28, 84
Customer Technical Support: 1-877-801-6901
D
Data Error Alert 124
Date 24, 25, 29
Edit Date 39
Default 53, 57, 76, 85, 88, 95, 102, 104, 109, 111, 112,
140
Delivery Summary 100
Disconnect 12, 13, 14, 15, 43, 49
Duration of Insulin Action 140
147
INDEX
E
Edit
Edit Date 39
Editing an Existing Profile 63
Edit Reminder 52
Edit Time 37
Electromagnetic 142, 143
Emergency Kit 11
Empty Cartridge Alarm 128
Extended Bolus 23, 71, 76, 140
Insulin
Insulin Delivery 12, 24, 25, 28, 81, 112
Insulin Duration 23, 26, 56, 57
Insulin Level 24, 25, 48, 112, 118, 128
Insulin on Board 23, 24, 25, 26, 57
Insulin-to-Carbohydrate Ratio 22
Rapid-Acting Insulin 11, 12, 43
Resume Insulin 25, 28, 82
Stopping Insulin Delivery 112
U-100 Insulin 11, 12, 42
F
K
Feature Lock 95, 97, 140
Fill
Cartridge Fill 44
Fill Cannula 28, 51, 119, 139
Fill Port 44, 46, 47, 48
Fill Tubing 28, 49, 119
Food Bolus 71, 73, 75
Extended Bolus 23, 71, 76, 140
Food Bolus Using Grams 27, 73
Food Bolus Using Units 27, 71
Keypad 30, 31
Key Pump Features 32
G
Grams 23, 27, 30, 71, 88
H
Healthcare Provider 10, 11, 12, 13, 15, 42, 44, 57
High BG Reminder 104, 140
History 25, 28, 100, 140
Home Screen 24, 25, 27, 28
Humalog 42, 43, 44
I
Incomplete
Incomplete Bolus Alert 118
Incomplete Cartridge Change Alert 119
Incomplete Fill Cannula Alert 119
Incomplete Fill Tubing Alert 119
Incomplete Load Sequence Alert 119
Incomplete Setting Alert 120
Incomplete Temp Rate Alert 118
Increment 57, 85, 88, 91, 95, 140
Infusion Set 11, 14, 20, 25, 42
Fill Cannula 28, 51, 139
Fill Tubing 28, 49
Infusion Site 15, 34, 42
Infusion Site Care 42
Preparation Products 11, 43
Customer Technical Support: 1-877-801-6901
L
LED 19, 25, 35
Lithium Polymer Battery 34, 141
Load Cartridge 23, 25, 28, 44, 100
Low BG Reminder 102, 140
Low Insulin Alert 111, 118, 140
Low Power Alarm 127
Low Power Alert 117
Luer-Lock 15, 25, 42, 44, 49
M
Malfunction 19, 133
Max Basal Alert 122
Max Bolus 56, 57, 71, 121
Max Bolus Alert 121
Max Hourly Bolus Alert 122
Missed Meal Bolus Reminder 108, 140
My Pump 28
My Pump Screen 29
N
Needle 44, 47, 48
New Personal Profile 56, 58
NovoLog 42, 43, 44
O
Occlusion Alarm 130, 139, 141
Options 25, 140
Options Screen 28
Screen Options 29, 95
Overview 22, 136, 139
Bolus Overview 71
Personal Profile Overview 56
t:slim Pump Overview 22
148
INDEX
P
Personal Profile 23, 26, 28, 29, 54, 55
Activating an Existing Profile 67
Adding More Personal Profiles 62
Creating a New Profile 56
Deleting an Existing Profile 69
Duplicating an Existing Profile 65
Editing an Existing Profile 63
Personal Profile Overview 56
Programming a New Personal Profile 58
Renaming an Existing Profile 68
Power Source Alert 123
Pump Info 28, 29, 99
Pump Settings 10, 24, 25, 28, 29, 93, 140
Pump Volume 29, 94
Q
Quick Bolus 23, 25, 29, 87, 94, 140
Quick Bolus Button 23, 25, 91
R
Rapid-Acting Insulin 11, 12, 43
Reminders 29, 94, 101
After Bolus Reminder 106, 140
High BG Reminder 104, 140
Low BG Reminder 102, 140
Missed Meal Bolus Reminder 108, 140
Site Reminder 28, 52, 109, 140
Reset Alarm 131
Resume Insulin 25, 28, 82
Resume Pump Alarm 126
S
Safety 3, 10, 115
Screen Lock 24, 35, 36, 140
Screen On/Quick Bolus Button 25, 35
Screen On/Quick Bolus Button Alarm 131
Screen Options 29, 95
Screen Protector 17
Screens
Bolus Screen 27
Home Screen 24, 25, 27, 28
Keypad Screen 30, 31
My Pump Screen 29
Options Screen 28
Status Screen 26
Screen Timeout 95, 96
Serial Number 18, 29, 99
Site Reminder 28, 52, 109, 140
Customer Technical Support: 1-877-801-6901
Status 24, 25
Status Screen 26
Stop
Stopping a Bolus 78
Stopping a Temp Rate 86
Stopping Insulin Delivery 81
Syringe 11, 44, 47, 48
T
Tandem Logo 24, 25, 35
Tap 12, 15, 22
Target BG 22, 26, 56, 57, 74, 75, 140
Temperature Alarm 130
Temp Rate 23, 25, 26, 28, 123
Incomplete Temp Rate Alert 118
Setting a Temp Rate 85
Stopping a Temp Rate 86
Time
Edit Time 37
Time and Date Display 24, 25
Time Segment 56, 58, 61, 64, 140
Timed Settings 56, 57
Tubing
Cartridge Tubing 25
Fill Tubing 28, 49
U
U-100 Insulin 11, 12, 42
Units 23, 27, 30
Unlock 36, 46
USB
Adapter 12, 17
USB Cable 17, 23, 34, 123
USB Port 12, 25, 34
V
Vibrate 11, 94
View Calculation 27, 72, 73, 74, 76
Volume 29, 94
W
Wallet Card 11, 17
Warranty 14, 19, 20
149
11045 Roselle Street
•
San Diego, California 92121
Phone: 1-877-801-6901
www.tandemdiabetes.com
t:slim® and Tandem Diabetes Care® are registered trademarks of Tandem Diabetes Care, Inc.
touch simplicity™ is a trademark of Tandem Diabetes Care, Inc.
© 2012 Tandem Diabetes Care, Inc. All rights reserved.
004898 Rev. C
(09/12)
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertisement