Tandem T:Slim User Manual

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INSULIN ON BOARD (IOB)
Units 1.1 u 1:09 hrsTime Remaining
B
10:20 AM
March 15, 2015 235 u
OPTIONS
BOLUS
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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 User Guide is designed to assist you with the features and functions of the t:slim System. It provides important warnings and cautions on proper op­eration as well as technical information to ensure your safety. It also provides step-by-step instructions on how to properly program, manage and care for your t:slim System.
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.
Tandem Diabetes Care, Inc. 11045 Roselle Street San Diego, CA 92121 USA (858) 366-6900 www.tandemdiabetes.com
Need help? We are here for you 24 hours a day, 7 days a week at 1-877-801-6901.
© 2015 Tandem Diabetes Care, Inc. All rights reserved. touch simplicity, t:slim, t:connect and Tandem Diabe­tes Care are registered trademarks 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.
All other trademarks and copyrights are the property of their respective owners.
t:slim Insulin Pump User Guide Software Part Number 007234
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1. Patients have the right to good quality service and high professional standards that are continually maintained and reviewed.
2. A patient has the right to have all records pertaining to his or her medical care treated as confidential, except as otherwise provided by law or third party contractual arrangements.
3. A patient has the right to respectful service provided by competent personnel.
4. A patient, or when appropriate, a patient’s representative has the right to be informed of his or her rights at the
earliest possible time.
5. A patient has the right to have their personal preferences be heard.
6. A patient has the right to be free from all forms of abuse or harassment.
7. A patient has the right to receive services in a safe setting. A safe setting includes environmental safety, infection control,
security, protection of emotional health and safety, including respect, dignity, and comfort, as well as physical safety.
8. A patient has the right to medical services including training without discrimination based upon race, color, religion, gender, sexual preference, national origin or source of payment.
9. A patient shall not be denied the right to designate a legally allowed individual or agency, who is authorized, to act on his or her behalf.
10. Tandem Diabetes Care shall provide a patient, or patient designee, upon written request, access to all information contained in their patient information record.
11. Except for medical emergencies, Tandem Diabetes Care must obtain the necessary informed consent prior to the start of collection or sharing of personal medical information as it relates to the purchase of Tandem products and or services.
Tandem Diabetes Care, Inc. Patient Bill of Rights
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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
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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.
Patient Responsibilities
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Table of Contents
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Section 1 – Welcome
Chapter 1 – About this User Guide
1.1 Introduction to this Guide ..............................................................................................18
1.2 Important Safety Information.........................................................................................18
1.3 Working with your Healthcare Provider .........................................................................19
1.4 Emergency Kit ...............................................................................................................19
1.5 Verification of Proper Functionality................................................................................20
1.6 Indications for Use and Contraindications ....................................................................21
1.7 Warnings and Precautions ............................................................................................21
1.8 Conventions of this Guide .............................................................................................26
Chapter 2 – Introduction
2.1 Welcome ........................................................................................................................28
2.2 What your t:slim System Package Includes ..................................................................28
2.3 Explanation of Symbols .................................................................................................29
2.4 Explanation of Icons ......................................................................................................30
2.5 Explanation of System Colors .......................................................................................31
2.6 Warranty Information .....................................................................................................32
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Chapter 3 – t:slim Pump Overview
3.1 t:slim Pump Overview ...................................................................................................36
3.2 System Terminology ......................................................................................................36
3.3 Screen Lock ..................................................................................................................38
3.4 Home Screen .................................................................................................................40
3.5 Status Screen ................................................................................................................42
3.6 Bolus Screen .................................................................................................................44
3.7 Options Screen ..............................................................................................................46
3.8 My Pump Screen ...........................................................................................................48
3.9 Number Keypad Screen ................................................................................................50
3.10 Letter Keypad Screen ....................................................................................................52
Section 2 – Key Pump Features
Chapter 4 – Getting Started
4.1 Charging the t:slim Pump ..............................................................................................56
4.2 Turning on the t:slim Pump Screen ...............................................................................58
4.3 Unlocking the t:slim Pump Screen ................................................................................58
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4.4 Edit Time .......................................................................................................................59
4.5 Edit Date ........................................................................................................................59
Chapter 5 – Infusion Site Care and Loading Cartridge
5.1 Infusion Site Selection and Care ...................................................................................62
5.2 Cartridge Instructions for Use .......................................................................................64
5.3 Filling and Loading a t:slim Cartridge ............................................................................64
5.4 Filling Tubing .................................................................................................................70
5.5 Filling Cannula ...............................................................................................................72
5.6 Setting Site Reminder ...................................................................................................73
Chapter 6 – Personal Profile
6.1 Personal Profile Overview .............................................................................................76
6.2 Creating a New Profile ...................................................................................................76
6.3 Programming a New Personal Profile ...........................................................................78
6.4 Editing or Reviewing an Existing Profile ........................................................................81
6.5 Duplicating an Existing Profile .......................................................................................82
6.6 Activating an Existing Profile .........................................................................................82
6.7 Renaming an Existing Profile .........................................................................................83
6.8 Deleting an Existing Profile ............................................................................................83
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Chapter 7 – Bolus
7.1 Bolus Overview .............................................................................................................86
7.2 Food Bolus Using Units.................................................................................................87
7.3 Food Bolus Using Grams ..............................................................................................87
7.4 Correction Bolus ............................................................................................................88
7.5 Extended Bolus .............................................................................................................89
7.6 Canceling or Stopping a Bolus......................................................................................91
Chapter 8 – Stop/Resume Insulin
8.1 Stopping Insulin Delivery ...............................................................................................94
8.2 Resuming Insulin Delivery .............................................................................................94
Section 3 – Additional Pump Operations
Chapter 9 – Temporary Basal Rate
9.1 Setting a Temp Rate ......................................................................................................98
9.2 Stopping a Temp Rate ...................................................................................................99
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Chapter 10 – Quick Bolus
10.1 Setting Up Quick Bolus ...............................................................................................102
10.2 Delivering Quick Bolus ................................................................................................102
Chapter 11 – t:slim Pump Settings
11.1 t:slim Pump Volume .....................................................................................................106
11.2 Screen Options ............................................................................................................106
Chapter 12 – t:slim Pump Info and History
12.1 t:slim Pump Info ..........................................................................................................110
12.2 t:slim Pump History .....................................................................................................110
Chapter 13 – t:slim Pump Reminders
13.1 Low BG Reminder .......................................................................................................112
13.2 High BG Reminder ......................................................................................................113
13.3 After Bolus BG Reminder ............................................................................................114
13.4 Missed Meal Bolus Reminder......................................................................................114
13.5 Site Reminder ..............................................................................................................115
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Chapter 14 – User Settable Alerts and Alarms
14.1 Low Insulin Alert ..........................................................................................................118
14.2 Auto-Off Alarm ............................................................................................................118
Section 4 – t:slim Pump Safety Alerts and Alarms
Chapter 15 – t:slim Pump Alerts
15.1 Low Insulin Alert ..........................................................................................................123
15.2 Low Power Alerts ........................................................................................................124
15.3 Incomplete Bolus Alert ................................................................................................126
15.4 Incomplete Temp Rate Alert ........................................................................................127
15.5 Incomplete Load Sequence Alerts ..............................................................................128
15.6 Incomplete Setting Alert ..............................................................................................131
15.7 Basal Rate Required Alert ...........................................................................................132
15.8 Max Hourly Bolus Alert ................................................................................................133
15.9 Max Bolus Alerts .........................................................................................................134
15.10 Max Basal Alerts .........................................................................................................136
15.11 Min Basal Alerts ..........................................................................................................138
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15.12 Connection Error Alert .................................................................................................140
15.13 Power Source Alert......................................................................................................141
15.14 Data Error Alert ............................................................................................................142
Chapter 16 – t:slim Pump Alarms
16.1 Resume Pump Alarm ..................................................................................................145
16.2 Low Power Alarms ......................................................................................................146
16.3 Empty Cartridge Alarm ................................................................................................148
16.4 Cartridge Error Alarm ..................................................................................................149
16.5 Cartridge Removal Alarm ............................................................................................150
16.6 Temperature Alarm ......................................................................................................151
16.7 Occlusion Alarms ........................................................................................................152
16.8 Screen On/Quick Bolus Button Alarm .........................................................................154
16.9 Altitude Alarm ..............................................................................................................155
16.10 Reset Alarm .................................................................................................................156
Chapter 17 – t:slim Pump Malfunction
17.1 Malfunction ..................................................................................................................158
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Section 5 – System Care and Maintenance
Chapter 18 – Taking Care of Your t:slim System
18.1 Overview ......................................................................................................................162
Section 6 – System Technical Specifications
Chapter 19 – Technical Specifications
19.1 Overview ......................................................................................................................166
19.2 t:slim Pump Specifications ..........................................................................................166
19.3 t:slim Pump Options and Settings ..............................................................................172
19.4 Electromagnetic Compatibility ....................................................................................174
19.5 Electromagnetic Emissions .........................................................................................175
19.6 Electromagnetic Immunity ...........................................................................................176
19.7 Distances Between the t:slim Pump and RF Equipment ............................................178
19.8 FCC Notice Concerning Interference ..........................................................................181
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THIS PAGE IS
INTENTIONALLY
LEFT BLANK
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Section 1
Welcome
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Chapter 1
About this User Guide
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Chapter 1 – About this User Guide
1.1 Introduction to this Guide
This User Guide is for people who use the t:slim® Insulin Delivery System (t:slim System). The t:slim System is made up of the t:slim Insulin Pump and the t:slim 3 mL (300 units) cartridge.
Only the t:slim 3 mL cartridge will connect to and work with the t:slim System. The System is not compatible with any other cartridge.
In this Guide, the t:slim Pump may be referred to as “your pump” or “your t:slim Pump.” The t:slim cartridge may be referred to as “your cartridge.” Together, the t:slim Insulin Pump and the t:slim cartridge may be referred to as “your system”.
1.2 Important Safety Information
This User Guide covers important infor­mation on how to operate your t:slim Pump. It provides step-by-step instruc­tions to help you properly program, manage and care for the System. It also provides important warnings and cautions on proper operation and tech­nical information to ensure your safety.
Review all instructions in this User Guide before using the System.
If you are not able to use the System according to the instructions in this User Guide, you may be putting your health and safety at risk.
Pay special attention to Warnings and Precautions in this User Guide. Warnings and Precautions are identified with .
If you still have questions after read­ing this User Guide, contact Tandem Diabetes Care Customer Technical Support at 1-877-801-6901. We are here for you 24 hours a day, 7 days a week.
The User Guide is organized in sec­tions that allow you to learn to use your t:slim System. Pump screens used in this guide to demonstrate how to use features are examples only. They should not be considered suggestions for your individual needs.
WARNING
United States (U.S.) Federal law restricts this device to sale by or on the order of a physician.
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1.3 Working with your Healthcare Provider
Any clinical language presented in this User Guide is based on the assumption that you have been educated by your healthcare provider on certain terms and how they apply to you in your diabetes management. Your healthcare provider can help you establish diabe­tes management guidelines that best fit your lifestyle and needs.
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 (high blood glucose) and hypoglycemia (low blood glucose) early. Undetected hy­perglycemia or hypoglycemia can result without proper monitoring.
Consult your healthcare provider before using the System to determine which features are most appropriate for you. Only your healthcare provider can de-
termine and help you adjust your basal rate(s), insulin-to-carbohydrate ratio(s), correction factor(s), blood glucose (BG) target, and duration of insulin action.
1.4 Emergency Kit
Make sure that you always have an in­sulin syringe and 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 every day:
•
Blood glucose testing supplies: meter, strips, control solution, lancets, meter batteries
•
Fast-acting carbohydrate to treat low blood glucose
•
Extra snack for longer coverage than fast-acting carbohydrate
•
Glucagon emergency kit
•
Rapid-acting insulin and syringes
•
Infusion sets (minimum of 2)
•
Insulin pump cartridges (minimum of 2)
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Chapter 1 – About this User Guide
•
Infusion site preparation products (antiseptic wipes, skin adhesive)
•
Diabetes identification card or jewelry
1.5 Verification of Proper Functionality
A power supply (AC adapter with micro-USB connector) is provided as part of the System. Before using your System, 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
•
Your see the green light illuminate from the edge around the Screen On/Quick Bolus Button
•
You feel a vibratory alert
•
You see a charge symbol (lightning bolt) on the battery level indicator
In addition, before using the System, ensure the following:
•
Press the Screen On/Quick Bolus Button to turn the screen on so that you can see the display
•
When the display screen is on, the touch screen responds to your finger tap
PRECAUTION
If any of these conditions fail to occur, do NOT use the t:slim System, 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.
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1.6 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 System is not intended for anyone unable or unwilling to:
•
Test blood glucose (BG) levels as recommended by your healthcare provider
•
Demonstrate adequate carbohydrate-counting skills (preferred, 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 System alerts.
1.7 Warnings and Precautions
Warnings
Before using your System, consult with your healthcare provider for your individ­ual training needs and ensure that you have been appropriately trained on its use by a certified t:slim Pump trainer.
Incorrect use of your System 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 System use, ask your healthcare provider or call our around­the-clock Customer Technical Support Department at 1-877-801-6901.
Your t:slim System 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 Humalog® or NovoLog® U-100 insulin, as any lesser or greater concentration can result in serious
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health consequences. Only Humalog® and NovoLog® have been tested by Tandem Diabetes Care, Inc., and found to be compatible for use in the t:slim System. It is not intended for use with any other delivery substance.
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.
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.
Do not deliver a bolus until you have reviewed the calculated bolus amount on the pump display. If you dose an in­sulin amount that is too high or too low, this could lead to a very low or very high BG level. You can always adjust the insulin units up or down before you decide to deliver your bolus.
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 from Tandem Diabetes Care. The efficacy of your t:slim System 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 under-infusion and may cause serious injury or death.
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.
Do not modify this equipment. Modifi­cation could result in a safety hazard.
Radiology and Medical
Procedures
Always notify the provider/technician about your diabetes and your insulin pump.
You must take off your t:slim System and leave it outside the procedure room if you are going to have any of the following procedures. Follow your healthcare provider’s instructions to replace missed insulin when you reconnect to the pump. Check your blood glucose before disconnecting from the pump and again when you reconnect and treat high blood glu­cose levels as recommended by your healthcare provider:
•
X-ray
•
Computed Tomography (CT) scan
•
Magnetic Resonance Imaging (MRI)
•
Positron Emission Tomography (PET) scan
•
Other exposure to radiation
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In addition to the above, you must take off your t:slim System and leave it outside the procedure room if you are going to have any of the following medical procedures:
•
Pacemaker/Automatic Implantable Cardioverter Defibrillator (AICD) placement or reprogramming
•
Cardiac Catheterization
•
Nuclear Stress Test
There are other procedures where you should proceed with caution:
•
Laser Surgery – Your System can usually be worn during the procedure. However, some lasers can create interference and cause the System to alarm.
•
General Anesthesia – Depending on the equipment being used, you may or may not need to remove your System. Be sure to ask your healthcare provider.
There is no need to disconnect for
electrocardiograms (EKGs) or colonos­copies.
If you have questions, contact Tandem Diabetes Care Customer Technical Support at 1-877-801-6901
Extreme Temperatures
Avoid exposure of your t:slim to tem­peratures below 40°F (5°C) or above 99°F (37°C), as insulin can freeze at low temperatures or degrade at high temperatures. Do not steam, sterilize, or autoclave your System at any time.
Amusement Park Rides
Very powerful electromagnets are sometimes used on “free-fall” or thrill rides. Remove your t:slim System and do not take it on these types of rides. Also, you should disconnect the infusion set from your body while on high-speed/high-gravity roller coasters.
Aircraft Without Cabin
Pressurization
Disconnect the infusion set from your body before flying in an aircraft without cabin pressurization or in planes used for aerobatics or combat simulation (pressurized or not).
Small Parts Potentially Ingestible
by Children
The System includes small parts (such as pieces of the infusion set, rubber USB port cover, and cartridge com­ponents) that could pose a choking hazard for small children. Ensure that any small parts are kept away from small children.
Strangulation or Asphyxiation
The System includes parts (such as the USB cable and the infusion set tubing) that could pose a strangulation or as­phyxiation hazard. Arrange cables and tubing to minimize the risk of strangula­tion or asphyxiation. Ensure that these parts are stored in a secure place when not in use.
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 System in the presence of flammable anesthetics or explosive gases. If you have questions, contact
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Tandem Diabetes Care Customer Technical Support at 1-877-801-6901.
Submersion in Fluid
The t:slim System is watertight to a depth of 3 feet for up to 30 minutes (IPX7 rating). If your t:slim System 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
Your System should not be exposed to X-ray screening used for carry-on and checked luggage. Newer full body scanners used in airport security screening are also a form of X-ray and your System should not be exposed to them. Notify the Transportation Security Administration (TSA) Agent that your System cannot be exposed to X-ray screening and request alternate means of screening other than X-ray.
Your System has been designed to withstand common electromagnetic interference including airport metal detectors.
For further information, contact Tandem Diabetes Care Customer Technical Support at 1-877-801-6901.
Additional Precautions
Your System is a sealed device that should be opened and repaired only by the manufacturer. If your t:slim System seal is broken, the warranty is voided and the System is no longer watertight.
Replace the cartridge every 48 hours if using Humalog®; every 72 hours if using NovoLog®.
Always follow proper aseptic (clean) technique when handling your pump, filling syringe/needle, cartridge, and infusion set.
•
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.
Always remove all air bubbles when
drawing insulin into the filling syringe. Always hold the pump with the white fill port pointed up when filling the car­tridge. Always ensure that there are no air bubbles in the tubing when filling.
Avoid changing your infusion set before bedtime or if you will not be able to test your blood glucose 1-2 hours after the new infusion set is placed.
Before bedtime, always check that your cartridge has enough insulin to last through the night.
Unless otherwise directed by your healthcare provider, do not use the vibrate feature during sleep. Having the volume for alerts and alarms set to high will help ensure that you don’t miss an alert or alarm.
Conduct regular checks of your t:slim System 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
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placement and leaks. Improperly placed sites or leaks around the infusion site can result in under­infusion.
•
Check your infusion set tubing for any damage, leaks, or kinks while using your t:slim System. Damaged, leaking, or kinked tubing may restrict or stop insulin delivery and result in under-infusion.
•
Check your t:slim System’s personal settings to ensure they are correct.
•
Check your t:slim System’s audible tones and vibration to ensure they are easily detectable.
Regularly check your t:slim Pump screen for potential failure conditions that may display.
If you damage or drop your t:slim Sys­tem, ensure that it is still working prop­erly. If you are unsure about potential damage, disconnect the infusion set from your body and contact Tandem Diabetes Care Customer Technical Support at 1-877-801-6901.
It is very important to set the current time and date accurately to ensure safe insulin delivery. When editing time, always check 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.
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.
Your insulin needs may change in response to lifestyle changes such weight gain or loss, and starting or stopping exercise. Consult your health­care provider for help with adjusting your basal rate(s) and other settings.
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.
Interference with your System’s electronics by cell phones can occur if worn in close proximity. It is recom­mended that your pump and cell phone be worn at least 6.4 inches apart.
Always check with your healthcare provider for specific guidelines if you want or need to disconnect from the pump for any reason. Depending on the length of time and reason you are disconnecting, you may need to replace missed basal and/or bolus insulin. Check your blood glucose before disconnecting from the pump and again when you reconnect, and treat high blood glucose (BG) levels as recom­mended by your healthcare provider.
If you receive a warranty replacement System from Tandem Diabetes Care, ensure that your personal settings are programmed before using the pump.
Always dispose of used cartridges, syringes, needles, and infusion sets following your community’s regulations. Wash your hands thoroughly after han­dling any insulin-holding device.
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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.
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Chapter 2
Introduction
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Chapter 2 – Introduction
2.1 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 System delivers insulin in two ways: continuous, or basal insulin delivery, and bolus insulin delivery to cover carbohydrates eaten and to lower high blood glucose. The following pages provide step-by-step instructions on how to properly program, manage, and care for your System.
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.
Supply Reordering
To order cartridges, infusion sets, supplies, and accessories, please contact Tandem Diabetes Care, Inc. at 1-877-801-6901 or your usual supplier of diabetes products.
2.2 What your t:slim System Package Includes
Your t:slim System should include the following items:
1. t:slim Insulin Pump
2. Pump Case
3. t:slim User Guide
4. t:connect® Getting Started Guide
5. USB Cable
6. Wall Power USB Adapter
7. Car Power USB Adapter
8. Cartridge Removal Tool
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2.3 Explanation of Symbols
The following are symbols (and their descriptions), which you may find on your t:slim System and/or its packaging.
Symbol Meaning Symbol Meaning
Caution; Consult Manual for Important Safety Documentation
Use By Date
See Instructions for Use Do Not Re-Use
Serial Number of Device Method of Sterilization: Gamma
Part Number Non Pyrogenic
Watertight Equipment (protected against the effects of temporary immersion in water)
Temperature Limits
Type BF Applied Part (patient isolation, not defibrillator protected)
Lot Number
Manufacturer Non-ionizing Radiation
For sale by or on the order of a physician only (U.S.) Date of Manufacture
Direct Current (DC) voltage
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Chapter 2 – Introduction
2.4 Explanation of Icons
The following icons may appear in the status area (to the left or right of the time and date) on your t:slim Pump Home Screen. Tap the icon to access the status screen for more information.
Icon Meaning
A system reminder, alert, error, or alarm is active.
Basal insulin is programed and being delivered.
A temporary basal rate is active.
A basal rate of 0 u/hr is active.
A temporary basal rate of 0 u/hr is active.
A bolus is being delivered.
All insulin deliveries are stopped.
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2.5 Explanation of System Colors
Red LED
» 1 red blink every 30 seconds indicates a malfunction
or alarm condition.
Yellow LED
» 1 yellow blink every 30 seconds indicates an alert
or reminder condition.
Green LED
» 1 green blink every 30 seconds indicates the pump
is functioning normally.
» 3 green blinks every 30 seconds indicate the pump
is charging.
Orange Highlight
» When editing settings, changes are highlighted in
orange for review before saving.
12:00 AM
SAVEBACK
Basal
0.75 u/hr
Correction Factor Press to Set Up
Carb Ratio Press to Set Up
Target BG Press to Set Up
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Chapter 2 – Introduction
2.6 Warranty Information
Warranty
t:slim Insulin Pump
The expected life of the t:slim Pump is a maximum of 4 years. 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 Insulin 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.
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.
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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 of 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 single­time 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 infusion 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.
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Chapter 3
t:slim Pump Overview
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Chapter 3 – t:slim Pump Overview
3.1 t:slim Pump Overview
To turn on your t:slim Pump screen, first press the Screen On/Quick Bolus Button, then use the pad of your finger to quickly and lightly tap on the screen. Do not use your 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-to­day diabetes management – whether basic or advanced.
NOTE
The t:slim Pump 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 System Terminology
Pump 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 a high BG. With the t:slim Pump it can be delivered as a Standard, a Correc­tion, an Extended, or a Quick Bolus.
Cannula
The cannula is the part of the infusion set that is inserted under the skin through which insulin is delivered.
Carb
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 1 unit of insulin will cover. Also known as insulin-to-carbo­hydrate ratio.
Correction Bolus
A correction bolus is given to correct high BG.
Correction Factor
A correction factor is the amount of BG that is lowered by 1 unit of insulin. Also known as the Insulin Sensitivity Factor (ISF).
Extended Bolus
An extended bolus is a bolus that is delivered over a period of time. It is commonly used to cover food that
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Chapter 3 – t:slim Pump Overview
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, filling, and replacing a new cartridge and infusion set.
mg/dL
Milligrams per deciliter. The standard unit of measure for blood glucose readings in the United States.
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.
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3.3 Screen Lock
1. Time and Date Display: Displays the current time and date.
2. Alert Icon: Indicates a reminder, alert or alarm is active behind the lock screen.
3. Battery Level: Displays the level of battery power remaining. When connected for charging, the charging icon (lightning bolt) will display.
4. 1-2-3: Unlocks pump screen.
5. Insulin On Board (IOB): Amount
and time remaining of any active insulin on board.
6. Active Bolus Icon: Indicates a bolus is active.
7. Status: Displays current system settings and insulin delivery status.
8. Insulin Level: Displays the current amount of insulin in the cartridge.
9. Tandem Logo: Returns to the Home Screen.
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INSULIN ON BOARD (IOB)
Units 1.1 u 1:09 hrsTime Remaining
B
10:20 AM
March 15, 2015 235 u
231
!
8
6
7
9
5
3
4
1
2
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Chapter 3 – t:slim Pump Overview
3.4 Home Screen
1. Battery Level: Displays the level of battery power remaining. When connected for charging, the charging icon (lightning bolt) will display.
2. USB Port: Port to charge your t:slim Pump battery. Close the cover when not in use.
3. Bolus: Program and deliver a bolus.
4. Options: Stop/Resume insulin delivery, manage Pump Settings, Load cartridge, program a Temp Rate, and view History.
5. Insulin On Board (IOB): Amount and time remaining of any active insulin on board.
6. Time and Date Display: Displays the current time and date.
7. Status: Displays current system settings and insulin delivery status.
8. Insulin Level: Displays the current amount of insulin in the cartridge.
9. Tandem Logo: Returns to the Home Screen.
10. Cartridge Tubing: Tubing that is attached to the cartridge.
11. 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).
13. LED Indicator: Illuminates when connected to a power supply and indicates proper functionality.
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Chapter 3 – t:slim Pump Overview
INSULIN ON BOARD (IOB)
Units 1.1 u 1:09 hrsTime Remaining
B
10:20 AM
March 15, 2015 235 u
100%
OPTIONS
BOLUS
10
11
8
7
9
6
2
1
3
4
5
13
12
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Chapter 3 – t:slim Pump Overview
3.5 Status Screen
1. Profile: Displays current active Personal Profile.
2. Basal Rate: Displays current basal rate being delivered. (Temp Rate: If active, displays in units/hr.)
3. Last Bolus: Displays the amount, date and time of last bolus.
4. Carbohydrates: Indicates whether feature is on or off.
5. Up/Down Arrow: Indicates there is more information.
6. Correction Factor: Displays current correction factor used to calculate a bolus.
7. Carb Ratio: Displays current carb ratio used to calculate a bolus.
8. Target BG: Displays current BG target used to calculate a bolus.
9. Insulin Duration: Displays current insulin duration setting used to calculate insulin on board.
NOTE
NA represents Not Applicable (does not apply).
NOTE
The status screen can be accessed from the lock screen and the Home Screen. It is for display only, no changes can be made from this screen.
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BACK
Current Status
Weekly
P
Basal Rate 0.2 u/hr
B
Carbohydrates
ON
Last Bolus
3 u
12/23 - 10:45 PM
BACK
Current Status
Insulin Duration
5 hours
Target BG
120 mg/dL
Carb Ratio
1u: 10g
Correction Factor
1u: 50 mg/dL
1
2
3
4
5
6
7
8
9
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Chapter 3 – t:slim Pump Overview
3.6 Bolus Screen
1. Back: Returns to the Home Screen.
2. Carbs: Enter grams of carb.
3. Units: Displays total units
calculated. Tap to enter a bolus request or change (override) a calculated bolus.
4. View Calculation: Displays how the insulin dose was calculated using the current settings.
5. Add BG: Enter blood glucose level.
6. Next: Moves to next step.
7. Back: Returns to the Home
Screen.
8. Insulin: Enter units of insulin.
9. Units: Displays total units
calculated. Tap to enter a bolus request or change (override) a calculated bolus.
10. View Calculation: Displays how the insulin dose was calculated using the current settings.
11. Add BG: Enter blood glucose level.
12. Next: Moves to next step.
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Using Grams Using Units
units
NEXT
BACK
0
BG
View Calculation
Add BG
CARBS
grams
0
units
NEXT
BACK
0
BG
View Calculation
Add BG
INSULIN
units
0
1 2 4 5
6
3 7 8 10 11
12
9
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Chapter 3 – t:slim Pump Overview
3.7 Options Screen
1. Back: Returns to the Home Screen.
2. Stop Insulin: Stops insulin delivery. If insulin delivery is stopped, RESUME INSULIN will be displayed.
3. My Pump: Personal Profiles, Alert Settings, Pump Settings, and Pump Info.
4. Load: Change Cartridge, Fill Tubing, Fill Cannula, and Site Reminder.
5. Temp Rate: Programs a temporary basal rate.
6. Menu Arrows: Indicates additional menu options are available.
7. Up/Down Arrow: Indicates there is more information.
8. History: Displays historical log of pump events.
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BACK
Options
Load
My Pump
STOP INSULIN
Temp Rate
BACK
Options
History
2
1
3
4
5
76
8
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3.8 My Pump Screen
1. Personal Profiles: A group of settings that defines basal and bolus delivery.
2. Alert Settings: Customize Pump Reminders and Alerts.
3. Pump Settings: Customize Quick Bolus, Pump Volume, Screen Options, and Time and Date.
4. Pump Info: Displays t:slim Pump serial number, Tandem Diabetes Care Customer Technical Support phone number, website, and other technical information.
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BACK
My Pump
Pump Settings
Alert Settings
Personal Profiles
Pump Info
1
2
3
4
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3.9 Number Keypad Screen
1. Value Entered.
2. Back: Returns to previous screen.
3. Keypad Numbers.
4. +/=: Allows numbers to be added
on gram screen. If in units, this displays as a decimal point.
5. Done: Completes task and saves information entered.
6. Units/Grams: Value of what is entered.
7. : Deletes last number entered.
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grams
21 3
0
87 9
54 6
DONEBACK
20
+ / =
3
4
1
2
5
6
7
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3.10 Letter Keypad Screen
1. Name of Profile.
2. Back: Returns to previous screen.
3. Space: Enters a space.
4. 123: Changes keypad mode from
letters (ABC) to numbers (123).
5. Save: Saves entered information.
6. Letters: Tap once for first letter
displayed, 2 quick taps for middle letter, and 3 quick taps for third letter.
7. : Deletes last letter or number entered.
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.
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name
defabc ghi
space
vwxstu yz
mnojkl pqr
SAVEBACK
Weekday
123
1
3
6
2
4 7
5
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Section 2
Key Pump Features
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Chapter 4
Getting Started
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Chapter 4 – Getting Started
WARNING
Before you can safely and effectively use your t:slim System, it is very important that you carefully follow the instructions in these sections.
4.1 Charging the t:slim Pump
The t:slim Pump is powered by an internal lithium polymer rechargeable battery. A full charge will last up to 7 days with normal use. Accessories for charging from wall and automobile outlets, as well as from a PC USB port are included with the pump. Use only the accessories provided with the Sys­tem to charge your t:slim Pump. If you lose any of the accessories, or need a replacement, contact Tandem Diabetes Care Customer Technical Support at 1-877-801-6901.
The battery level indicator is displayed in the upper left portion of the Home Screen. The charge amount will increase or decrease by 5% at a time (for example, you will see 100%, 95%, 90%, 85%). When the charge amount is less than 5%, it will begin decreasing
insulin. Check your blood glucose be­fore disconnecting from the pump and again when you reconnect.
To charge the pump from an AC Power Outlet:
1. Plug the included USB cable into the AC power adapter.
2. Plug the AC power adapter into a grounded AC power outlet.
3. Plug the other end of the cable into the micro USB port on the pump.
To charge the pump using the includ­ed Car Power USB Adapter:
1. Plug the USB cable into the included Car Power USB Adapter.
2. Plug the Car Power USB Adapter into a grounded auxiliary power outlet.
3. Plug the other end of the cable into the micro USB port on the pump.
1% at a time (for example, you will see 4%, 3%, 2%, 1%).
When you first receive your t:slim Pump, you will need to connect it to a charging source before it can be used. Charge the pump until the battery level indicator on the upper left portion of the Home Screen reads 100% (initial charge can take up to 2.5 hours).
The t:slim Pump continues to operate normally while charging. You do not need to disconnect from the pump while charging.
PRECAUTION
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.
If you choose to disconnect from the pump while charging, check with your healthcare provider for specific guide­lines. Depending on the length of time you are disconnected, you may need to replace missed basal and/or bolus
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Chapter 4 – Getting Started
WARNING
When using the Car Power USB Adapter, the charger must be connected to an isolated, battery powered 12 Volt system, such as an automobile. Connecting the DC vehicle adapter charger to 12 Volt DC that is generated by a power supply connected to alternating current (AC) mains is prohibited.
To charge the pump using a USB port on a Personal Computer (PC):
Ensure that the PC complies with the IEC 60950-1 (or equivalent) safety standard.
1. Plug the included USB cable into your computer.
2. Plug the other end of the cable into the micro USB port on the pump.
NOTE
Before using a Mac or PC to charge the t:slim Pump, it is recommended that a driver be installed on the computer by downloading the t:connect Uploader Software from our website at www.tandemdiabetes.com. This will also allow communication between the pump, the PC, and the t:connect Application. Depending
on your computer, charging time will vary. The pump will display a CONNECTION ERROR ALERT message if it is not charging properly.
When you charge the t:slim Pump, you will notice the following:
•
The screen illuminates
•
An audible alert
•
The LED (edge around the Screen On/Quick Bolus Button) blinks green
•
A vibrating alert
•
A charge symbol (lightning bolt) on the battery level indicator appears
PRECAUTION
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 are not 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.
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 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.
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4.2 Turning on the 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.
The Screen Lock screen will be displayed.
NOTE
The pump continues to function normally when the screen is not on.
NOTE
When using the t:slim Pump, tap the Tandem Logo to return to the Home Screen or tap BACK to return to the previous screen.
4.3 Unlocking the t:slim Pump Screen
1. Press Screen On/Quick Bolus Button.
2. Tap 1.
3. Tap 2.
4. Tap 3.
The pump screen is now unlocked. The last screen that was viewed will be displayed.
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 a bolus or temp basal is 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.
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Chapter 4 – Getting Started
4.4 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.
PRECAUTION
It is very important to set the current time and date accurately to ensure 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.
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.
NOTE
Any edits to Time or Date will not be saved until you tap SAVE.
4.5 Edit Date
1. From the Time and Date screen tap Edit Date.
2. Tap Month.
3. Find and tap the 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.
7. Verify the correct date is set and tap SAVE.
8. Tap Tandem Logo to return to the Home Screen.
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Chapter 5
Infusion Site Care and
Loading Cartridge
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Chapter 5 – Infusion Site Care and Loading Cartridge
5.1 Infusion Site Selection and Care
WARNINGS
» 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
from Tandem Diabetes Care. 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 under-infusion and may cause serious injury or death.
» Only use Humalog® or NovoLog® U-100
insulin, as any lesser or greater concentration can result in serious health consequences. Only Humalog® and NovoLog® have been tested by Tandem Diabetes Care, Inc., and found to be safe for use in the t:slim Pump.
Site Rotation:
•
The infusion set must be replaced and rotated every 48–72 hours, or more often if needed.
•
With experience, you will find areas that not only provide better absorption, but are more comfortable. Keep in mind, using the same areas may cause scarring or lumps which can affect insulin absorption.
•
Consult your healthcare provider to establish a rotation schedule that best fits your needs.
Keep it clean:
•
When changing your infusion set, use clean techniques to avoid an infection.
•
Wash your hands, use antiseptic wipes or infusion site preparation products, and keep the area clean.
•
Site preparation products that have both an antiseptic and an adhesive are encouraged.
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
belly button.
» Any scars, moles, stretch marks,
or tattoos.
» Areas within 3 inches of your
sensor site, if using Continuous Glucose Monitoring.
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Areas of Body for Infusion Set Insertion
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5.2 Cartridge Instructions for Use
For complete cartridge labeling, consult the Cartridge Instructions for Use included in the t:slim Cartridge box.
5.3 Filling and Loading a t:slim Cartridge
This section describes how to fill the cartridge with insulin and load the cartridge into your t:slim Pump. The single-use disposable cartridge can hold up to 300 units (3.0 mL) of insulin.
PRECAUTION
Replace the cartridge every 48 hours if using Humalog®; every 72 hours if using Novolog®.
PRECAUTION
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 1-877-801­6901 to request a replacement cartridge.
PRECAUTION
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 cartridge
•
3.0 mL syringe and fill needle
•
Vial of Humalog® or NovoLog® insulin
•
Alcohol prep swab
•
1 new infusion set
•
Infusion set Instructions for Use
NOTE
Do NOT remove the used cartridge from the pump during the load process until prompted on the t:slim Pump screen.
The illustration identifies the luer-lock and insulin fill port used in the cartridge filling process.
Luer-Lock Tail of the Cartridge
Insulin Fill Port
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Instructions for Drawing Insulin from Vial into Syringe
PRECAUTION
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.
NOTE
The fill estimate displayed on the pump is the amount of insulin available for delivery. It does not include insulin needed to fill the tubing (up to 30 units) and a small amount of insulin that is not available for delivery. When filling the syringe, add approximately 45 units to the amount of insulin you want available for delivery.
For example, the pump requires a minimum of 50 units available for delivery after fill tubing has been completed. Fill the syringe with approximately 95 units to have enough to fill your tubing and still have 50 units available for delivery.
1. Inspect the needle and syringe package for any signs of damage. Discard any damaged product.
2. Wash your hands thoroughly.
3. Wipe the rubber septum of the insulin vial with an alcohol swab.
4. Remove the needle and syringe from their packaging. Securely twist needle
onto syringe. Safely remove protective cap from needle by pulling outward.
5. Draw air into syringe up to the amount of insulin desired (see image A).
6. With insulin vial upright, insert needle into vial. Inject air from syringe into vial.
Maintain pressure on syringe plunger (see image B).
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7. With needle still inserted into vial, turn vial and syringe upside down. Release syringe plunger. Insulin will begin to flow from the vial into the syringe.
8. Slowly pull back the plunger to the desired amount of insulin (see image C).
9. While the filling needle is still in the vial and upside down, tap the syringe
so that any air bubbles rise to the top (see image D). Then slowly push the plunger upwards, forcing any air bubbles back into the vial.
10. Check the syringe for air bubbles and do one of the following:
» If there are air bubbles present, repeat step 9.
» If no air bubbles are present, remove the filling needle from the vial.
PRECAUTION
Always remove all air bubbles when drawing insulin into the filling syringe.
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Instructions for Filling the Cartridge
1. Inspect the cartridge package for any signs of damage. Discard any damaged product.
2. Open the package and remove the cartridge.
3. Hold the cartridge upright and gently insert the needle into the white
insulin fill port on the cartridge (see image E). The needle is not intended to go all the way in, so do not force it.
4. Keeping the syringe vertically aligned with the cartridge, and the needle inside the fill port, pull back on the plunger until it is fully retracted (see image F). This will remove any residual air from the cartridge. Bubbles will rise toward the plunger.
5. Make sure the needle is still in the fill port and release the plunger. Pressure will pull the plunger to its neutral position but it will NOT push any air back inside the cartridge (see image G).
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6. Withdraw the needle from the fill port.
7. Turn the syringe upright and pull down on the plunger (see image H).
Flick the barrel to make sure that any air bubbles rise to the top.
8. Gently press on the plunger to remove air bubbles until insulin fills the needle hub and you see a drop of insulin at the tip of the needle (see image I).
9. Re-insert the needle in the fill port and slowly fill the cartridge with insulin (see image J). It is normal to feel some back pressure as you slowly press on the plunger.
10. Maintain pressure on the plunger while you remove the needle from the cartridge. Check the cartridge for leaks. If you detect insulin leaking, discard the cartridge and repeat entire process with a new cartridge.
11. Always dispose of used needles, syringes, cartridges, and infusion sets following your community’s regulations.
PRECAUTION
Do not fill the cartridge with more than 300 units. This can cause a cartridge error.
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Instructions on How to Install a Cartridge
PRECAUTION
If this is the very first time you are loading the cartridge, remove the shipping canister (which is not for human use), from the back of the pump.
1. From the Home Screen, tap OPTIONS.
2. Tap Load.
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 to continue.
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.
“Preparing for Cartridge” screen is displayed.
6. Remove the used cartridge and install a filled cartridge. Tap UNLOCK icon when completed.
NOTE
If needed, place the cartridge removal tool or the edge of a coin in the slot at the bottom of the cartridge and twist to aid in the removal of the cartridge.
Place bottom of the cartridge at the end of the pump. Make sure cartridge is lined up to both guide tracks.
Push on the circular fill port next to the cartridge tubing to slide the cartridge onto the pump.
7. Tap NEXT to continue.
“Detecting Cartridge” screen is displayed.
NOTE
After completing the cartridge change, the pump will automatically prompt you to fill tubing.
WARNING
Do not remove or add insulin from a filled cartridge after it is installed on the pump. This will result in an inaccurate display of the insulin level on the Home Screen.
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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 unintended delivery of insulin.
WARNING
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.
PRECAUTION
Always ensure that there are no air bubbles in the tubing when filling.
NOTE
If starting from the Home Screen, tap OPTIONS, tap Load, tap Fill Tubing and then follow the instructions. Tap NEW if you installed a new cartridge. Tap FILL if you did not install a new
cartridge and want to continue with filling the tubing.
1. Verify that the infusion set is disconnected from your body.
2. Connect the infusion set tubing to the luer-lock on 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 unclean areas.
c. Attach the infusion set tubing
to the luer connector on the cartridge tubing. Twist clockwise until finger tight and then twist another quarter of a turn to en­sure a secure connection.
Tap NEXT.
PRECAUTION
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 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.
3. Hold the pump vertically to ensure any air in the cartridge will be dispelled first. Tap START. The pump will beep and vibrate regularly while the tubing is being filled.
“Starting Fill” screen is displayed.
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NOTE
The following are approximate amounts of insulin to fill different tubing lengths:
» 15–20 units for 23 inch tubing » 20–25 units for 32 inch tubing » 25–30 units for 42 inch tubing
4. Tap STOP after 3 drops of insulin are seen at the end of the infusion set tubing.
“Stopping Fill” screen is displayed.
“Detecting Insulin” screen is displayed.
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 tub-
ing, 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.
NOTE
After tubing fill is complete, when the pump returns to the Home Screen, an estimate of how much insulin is in the cartridge is displayed in the upper right portion of the screen. You will see one of the following on the screen:
» + 40 u More than 40 units
detected in the cartridge
» + 60 u More than 60 units
detected in the cartridge
» + 120 u More than 120 units
detected in the cartridge
» + 180 u More than 180 units
detected in the cartridge
» + 240 u More than 240 units
detected in the cartridge
After 10 units are delivered, an actual number of units remaining in the cartridge will be displayed on the Home Screen
The amount of insulin remaining displayed on the Home Screen will decrease 5 units
at a time (for example, you will see 140, 135, 130, 125). When less than 40 units remain, it will begin decreasing 1 unit at a time (for example, you will see 40, 39, 38,
37) until there is 1 unit remaining.
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5.5 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 proper insertion technique, 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 filled 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. Filling 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.
5. Tap START.
“Starting Fill” screen is displayed.
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).
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5.6 Setting Site Reminder
NOTE
If starting from the Home Screen, tap OPTIONS, tap Load, tap Site Reminder then follow the instructions below.
PRECAUTION
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.
2. Tap Remind Me In and select the number of days (1-3).
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 DONE.
5. Verify Site Reminder is set correctly and tap SAVE.
“Setting Saved” screen is displayed.
6. Load screen is displayed. Tap DONE.
A reminder to test BG in 1–2 hours will display.
7. 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.
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Chapter 6
Personal Profile
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Chapter 6 – Personal Profile
6.1 Personal Profile Overview
A Personal Profile is a group of settings that define basal and bolus delivery within specific time segments through­out a 24-hour period. Each profile can be personalized with a name. Within a Personal Profile the following can be set:
•
Timed Settings: Basal Rate, Correction Factor, Carb Ratio and Target BG.
•
Bolus Settings: Insulin Duration, Max Bolus and Carbohydrates setting (on/off).
The t:slim Pump uses the settings in your active profile to calculate the delivery of basal insulin, food boluses and correction boluses based on your Target BG.
Having several Personal Profiles pro­vides more flexibility for your body and lifestyle. For example, you could have “Weekday” and “Weekend” profiles if you have different insulin delivery needs on weekdays and weekends, based on schedule, food intake, activity, and exercise, etc.
6.2 Creating a New Profile
Creating Personal Profiles
You can create up to 6 Personal Pro­files, however, only 1 can be active at a time. In the Personal Profiles screen, the active profile is positioned at the top of the list and is marked as ON. When you create a Personal Profile, you can set any or all of the following Timed Settings:
•
Basal Rate (your basal rate in units/hr)
•
Correction Factor (amount 1 unit of insulin lowers BG)
•
Carb Ratio (grams of carbs covered by 1 unit of insulin)
•
Target BG (your ideal BG level, measured in mg/dL)
The ranges you can set for Timed Settings are:
•
Basal (range: 0 and 0.1 – 15 units/hr)
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.
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•
Correction Factor (range: 1 unit:1 mg/dL – 1 unit:600 mg/dL)
•
Carb Ratio (range: 1 unit:1 gram – 1 unit:300 grams)
•
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 set any or all of the following Bolus Settings:
•
Carbs (on indicates entering grams of Carb; off indicates entering units of insulin)
•
Insulin Duration (how long a bolus lowers your BG)
•
Max Bolus (the maximum amount for a single bolus)
The default settings and ranges for Bolus Settings are as follows:
•
Carbs (default: off if no Carb Ratio is defined)
•
Insulin Duration (default: 5 hrs; range: 2–8 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.
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.
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NOTE
Tap once for first letter displayed, 2 quick taps for middle letter; and 3 quick taps for the third letter.
6. Tap Press to Setup to begin setting insulin delivery settings.
BACK
Weekday
Timed Settings
Press to Set Up
Bolus Settings
5 hrs
DURATION
10 u
MAX BOLUS
OFF
CARBS
6.3 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 Personal Profile that you can activate.
» Be sure to tap SAVE after entering or
changing a value.
PRECAUTION
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.
Timed Settings
1. Once the new profile has been created, Tap Basal.
2. Using the onscreen keypad, enter your basal rate and tap DONE.
PRECAUTION
Always confirm that the decimal point placement is correct.
3. Tap Correction Factor.
4. Using the onscreen keypad, enter
your correction factor and tap DONE.
NOTE
Enter the mg/dL that 1 unit of insulin will lower BG.
12:00 AM
SAVE
BACK
Basal Press to Set Up
Correction Factor Press to Set Up
Carb Ratio Press to Set Up
Target BG Press to Set Up
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5. Tap Carb Ratio.
6. Using the onscreen keypad, enter
your insulin-to-carbohydrate ratio and tap DONE.
NOTE
Enter the grams of carb to be covered by 1 unit of insulin.
7. Tap Target BG.
8. Using the onscreen keypad, enter
your target BG and tap DONE.
9. Review entered values and tap SAVE.
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 segments.
Adding More Time Segments
NOTE
Any settings that you entered in the previous time segment are copied and appear in the new segment. This allows you to simply adjust only the specific settings you want, rather than have to enter them all over again.
1. On the “Add Segment” screen, tap Start Time.
2. Using the onscreen keypad, enter the time (hour and minutes) that
BACK
Timed Settings
ADD
12:00 AM
0.75
BASAL
1:50
CORRECT
1:10
CARB TARGET BG
120
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
“Programming a New Personal Profile” section above 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.
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Bolus Settings
1. Tap the Bolus Settings Panel.
2. Tap Insulin Duration.
3. Using the onscreen keypad, enter
the desired time for the duration of insulin action (2-8 hrs) and tap DONE.
BACK
Weekday
Bolus Settings
5 hrs
DURATION
10 u
MAX BOLUS
OFF
CARBS
Timed Settings 12:00a - 12:00a
0.75
BASAL
1:50
CORRECT
120
TARGET BG
1:10
CARB
SAVE
BACK
Insulin Duration
5 hrs
Max Bolus
10 u
Bolus Settings
Carbohydrates
ON
OFF
4. Tap Max Bolus.
5. Using the onscreen keypad, enter
the desired amount for maximum bolus (1–25 units) and tap DONE.
6. Tap Carbohydrates to turn on and use the carb ratio when calculating boluses.
NOTE
If not using a carb ratio, do not turn the Carbohydrates setting to ON.
7. Review entered values and tap SAVE.
8. Confirm Settings.
Tap YES if entered data is correct.
Tap NO to make changes.
9. 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 Chapter 6.6 for instructions on activating profiles.
Adding More Personal Profiles
1. From the Home Screen, tap OPTIONS.
2. Tap My Pump.
3. Tap Personal Profiles.
4. Tap NEW.
5. Name the new profile and repeat
steps for Timed Settings and Bolus Settings.
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.
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6.4 Editing or Reviewing an Existing Profile
1. From the Home Screen, tap OPTIONS.
2. Tap My Pump.
3. Tap Personal Profiles.
4. Tap the name of the Personal
Profile to edit or review.
5. Tap Edit.
6. Tap Timed Settings Panel.
7. Tap the desired time segment
to edit.
8. Tap Basal, Correction Factor, Carb Ratio or Target BG to make
changes as needed and use the onscreen keypad to enter changes. Tap DONE.
9. View recent changes and tap SAVE.
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 steps described above.
NOTE
To Add a time segment:
» Ta p ADD. » Enter desired start time.
To Delete a time segment:
» Tap on the X to the left of the time
segment.
» Ta p YES to confirm.
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.
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6.5 Duplicating an Existing Profile
1. From the Home Screen, tap OPTIONS.
2. Tap My Pump.
3. Tap Personal Profiles.
4. Tap the name of the Personal
Profile to duplicate.
5. Tap Duplicate.
6. Confirm profile to duplicate by
tapping YES.
7. Using the onscreen keypad, enter the name (up to 16 characters) for the new profile and tap SAVE.
“Profile Duplicated” screen is displayed.
A new Personal Profile will be cre­ated with the same settings as the profile copied.
8. Tap the Timed Settings or Bolus Settings Panel to make changes
to the new profile.
6.6 Activating an Existing Profile
1. From the Home Screen, tap OPTIONS.
2. Tap My Pump.
3. Tap Personal Profiles.
4. Tap the name of the Personal
Profile to be activated.
NOTE
» The Activate and Delete options are
disabled for the active profile because the profile is already activated. You cannot delete a profile until you have activated another profile.
» If you have only 1 profile defined, you
do not need to activate it (that profile is automatically activated).
5. Tap Activate.
A screen to confirm the activation request is displayed.
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6. Tap YES.
“Profile Activated” screen is displayed.
6.7 Renaming an Existing Profile
1. From the Home Screen, tap OPTIONS.
2. Tap My Pump.
3. Tap Personal Profiles.
4. Tap the name of the Personal
Profile to be renamed.
5. Tap Down Arrow, and then Rename.
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.
6.8 Deleting an Existing Profile
1. From the Home Screen, tap OPTIONS.
2. Tap My Pump.
3. Tap Personal Profiles.
4. Tap the name of the Personal
Profile to be deleted.
NOTE
The active Personal Profile cannot be deleted.
5. Tap Delete.
6. Tap YES.
“Profile Deleted” screen is displayed.
7. Tap Tandem Logo to return to the Home Screen.
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Chapter 7
Bolus
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Chapter 7 – Bolus
7.1 Bolus Overview
A bolus is a quick dose of insulin that is usually delivered to cover food eaten or to correct a high 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 programed together.
If Carbohydrates is turned on in your active personal profile, you will enter grams of carbohydrate and the bolus will be calculated using your Carb Ratio.
You can always override the calculated bolus by tapping the area above “units” located at the top of the bolus screen between BACK and NEXT. The override function is always active.
If Carbohydrates is turned off in your active personal profile, you will enter units of insulin to request the bolus.
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.
WARNING
Do not deliver a bolus until you have reviewed the calculated bolus amount on the pump display. If you dose an insulin amount that is too high or too low, this could lead to a very low or very high BG level. You can always adjust the insulin units up or down before you decide to deliver your bolus.
PRECAUTION
» 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.
» Before delivering insulin, check your t:slim
Pump’s personal settings to ensure they are correct.
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 Chapter 15.9.
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Chapter 7 – Bolus
7.2 Food Bolus Using Units
NOTE
If bolusing using a carb ratio skip to the next chapter, Food Bolus Using Grams.
1. From the Home Screen, tap BOLUS.
2. Tap 0 units.
3. Using the onscreen keypad enter
units of insulin to be delivered, then tap DONE.
PRECAUTION
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 screen
is displayed.
7.3 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
» To add multiple carb values enter first
value, then tap +/=, enter second value, tap +/=. Continue until done.
» To clear the value entered and start over,
tap the back arrow.
4. Check that the grams of carb are entered in the correct location on the screen.
5. Tap 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.
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Chapter 7 – Bolus
6. Confirm Request.
Tap YES if entered data is correct.
Tap NO to go back to make changes or view calculations.
7. Tap DELIVER.
8. The bolus splash screen
is displayed.
7.4 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
» Tap the view calculation screen to
display the Delivery Calculation Screen.
» Tap the displayed units calculated to
override the amount.
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 will indicate BG is below Target.
To reduce bolus calculation tap YES.
NO
YES
Your BG is Above Target
Add Correction Bolus?
Current IOB
0 u
Current BG
280 mg/dL
NO
YES
Your BG is Below Target
Reduce Bolus Calculation?
Current IOB
0 u
Current BG
85 mg/dL
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Key Pump Features2
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: You
will be given an option to reduce the food bolus to correct for the low blood glucose. In addition, if IOB is present, it will also be used to reduce the bolus calculation.
» Below 70 mg/dL: The food bolus will be
reduced to automatically correct for the low blood glucose. In addition, if IOB is present, it will also be used to reduce the bolus calculation.
Always treat hypoglycemia (low blood glucose) with fast-acting carbohydrates according to the instructions of your healthcare provider and then re-test your blood glucose to ensure that the treatment was successful.
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.
7.5 Extended Bolus
The Extended Bolus feature allows you to deliver part of the bolus now and part of the bolus slowly over a period of up to 8 hours. This can be helpful for high fat meals such as pizza or if you have gastroparesis (delayed stomach emptying). Talk with our healthcare provider to determine if this feature is appropriate for you as well as for recommendations on the split between now and later and the duration for the later portion.
Only 1 extended bolus can be active at any given time. However, if the DELIVER LATER portion of an extend­ed bolus is active, you can request another standard bolus.
1. From the Home Screen, tap BOLUS.
2. Tap 0 grams (or 0 units).
3. Using the onscreen keypad enter
grams of carb (or units of insulin). Tap DONE.
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Chapter 7 – Bolus
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.
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 DELIVER 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.
14. Tap DELIVER.
15. The bolus splash screen
is displayed.
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Chapter 7 – Bolus
7.6 Canceling or Stopping a Bolus
Canceling a Bolus If delivery
Has Not Started
1. Tap 1-2-3 to access the Home Screen.
2. Tap X (stop icon) to cancel the bolus.
The bolus button will remain inactive while the bolus is being canceled.
Once canceled, the bolus button will become active again on the Home Screen.
INSULIN ON BOARD (IOB)
Units 1.1 u 1:09 hrsTime Remaining
B
10:20 AM
March 15, 2015 235 u
OPTIONS
Requesting 10 u Bolus ...
BOLUS
Stopping a Bolus if delivery of the bolus Has Started:
1. Tap 1-2-3 to access the Home Screen.
2. Tap X (stop icon) to stop delivery.
3. Tap YES.
The BOLUS STOPPED screen is displayed and the units delivered are calculated.
4. Units requested and delivered are shown. Tap CLOSE.
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Chapter 7 – Bolus
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Chapter 8
Stop/Resume Insulin
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Chapter 8 – Stop/Resume Insulin
8.1 Stopping Insulin Delivery
You can stop all insulin deliveries, including basal, and any active bolus or temp rate at any time.
1. From the Home Screen, tap OPTIONS.
2. Tap STOP INSULIN.
3. Tap STOP.
The “All Deliveries Stopped” screen appears before returning to the Home Screen showing the status “ALL DELIVERIES STOPPED”. A red exclamation mark icon also appears to the right of the time and date.
NOTE
When you tap STOP on the confirmation screen, any active bolus and any active temp rate are immediately stopped. If you tap BACK on the confirmation screen, bolus delivery continues.
» No insulin delivery can take place while
your pump is stopped.
8.2 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 1-2-3 to access the Home Screen.
3. Tap RESUME.
4. 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.
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Section 3
Additional Pump
Operations
Page 97
Chapter 9
Temporary Basal Rate
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Chapter 9 – Temporary Basal Rate
9.1 Setting a Temp Rate
A Temp Rate is used to increase or decrease (by percentage) the current basal rate for a period of time. This fea­ture can be helpful for situations such as exercise or illness.
When you enter the Temp Rate screen, the default values are 100% (current basal rate) and a Duration of 0:15 min. The Temp Rate can be set from a minimum of 0% of current basal rate to a maximum of 250% of current basal rate in increments of 1%.
Duration can be set from a minimum of 15 minutes to a maximum of 72 hours in increments of 1 minute.
If you program a Temp Rate greater than 0% but less than the minimum allowable basal rate of 0.1 units/hr, you will be notified that the selected rate is too low and that it will be set to the minimum allowable rate for delivery.
If you program a Temp Rate more than the maximum allowable basal rate of 15 units/hr, you will be notified that the selected rate is too high and that it will
NOTE
If a Temp Rate is active, the status of insulin delivery displays an orange “T”. If a Temp Rate of 0% is active, the status of insulin delivery displays a red “T”.
8. The Screen Lock screen will be displayed with the icon indicating a Temp Rate is active.
be set to the maximum allowable rate for delivery.
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.
6. Verify settings and tap START.
7. The “TEMP RATE STARTED”
splash screen is displayed.
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Chapter 9 – Temporary Basal Rate
9.2 Stopping a Temp Rate
To stop an active temp rate:
1. From 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.
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