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Tandem t:slim X2, tslim User Manual

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October 16, 2016 235 u
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t:slim X2 Insulin Pump User Guide Software Version: Trestles
Congratulations on the purchase of your new t:slim X2 Pump. Your deci­sion to use insulin pump therapy is a sign of your commitment to your diabe­tes care. We recognize and respect the importance of your decision. We also recognize that your t:slim X2 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 X2 Pump. It provides import­ant warnings and cautions on proper operation as well as technical infor­mation to ensure your safety. It also provides step-by-step instructions on how to properly program, manage and care for your t:slim X2 Pump.
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 (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 (877) 801-6901.
©2016 Tandem Diabetes Care, Inc. All rights reserved. t:slim, touch sim­plicity and Tandem Diabetes Care are registered trademarks, and t:slim X2 is a trademark of Tandem Diabetes Care, Inc.
Humalog® is a registered trademark of Eli Lilly and Company.
NovoLog® is a registered trademark of Novo Nordisk A/S.
Comfort™ is a trademark of Unomedical A/S.
Bluetooth® is a registered trademark of Bluetooth SIG, Inc.
All other trademarks and copyrights are the property of their respective owners.
Customer Technical Support: (877) 801-6901 3
Table of Contents
Section 1 – Before You Begin
Chapter 1 – Introduction
1.1 System Description .......................................................................................................16
1.2 About this User Guide ...................................................................................................16
1.3 Important User Information ...........................................................................................17
1.4 Important Pediatric User Information ............................................................................17
1.5 Conventions of this Guide .............................................................................................18
Chapter 2 – Important Safety Information
2.1 Indications for Use ........................................................................................................20
2.2 Contraindications ..........................................................................................................20
2.3 Pump Warnings .............................................................................................................20
2.4 System Precautions ......................................................................................................24
2.5 Potential Benefits From Using the Pump ......................................................................27
2.6 Possible Risks From Using the Pump ...........................................................................28
2.7 Working with your Healthcare Provider .........................................................................28
2.8 Emergency Kit ...............................................................................................................29
2.9 Verification of Proper Functionality................................................................................30
Customer Technical Support: (877) 801-69014
Table of Contents
Chapter 3 – Getting to Know Your t:slim X2 Pump
3.1 What your t:slim X2 System Package Includes .............................................................32
3.2 Pump Terminology .........................................................................................................32
3.3 Explanation of Pump Symbols ......................................................................................34
3.4 Explanation of Pump Icons ...........................................................................................35
3.5 Explanation of Pump Colors..........................................................................................36
3.6 Screen Lock ..................................................................................................................38
3.7 Home Screen .................................................................................................................40
3.8 Status Screen ................................................................................................................42
3.9 Bolus Screen .................................................................................................................44
3.10 Options Screen ..............................................................................................................46
3.11 My Pump Screen ...........................................................................................................48
3.12 Number Keypad Screen ................................................................................................50
3.13 Letter Keypad Screen ....................................................................................................52
Customer Technical Support: (877) 801-6901 5
Table of Contents
Section 2 – Key Pump Features
Chapter 4 – Getting Started
4.1 Charging the t:slim X2 Pump .........................................................................................56
4.2 Using the Touch Screen ................................................................................................58
4.3 Turning on the t:slim X2 Pump Screen ..........................................................................58
4.4 Unlocking the t:slim X2 Pump Screen ...........................................................................58
4.5 Edit Time .......................................................................................................................59
4.6 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
Customer Technical Support: (877) 801-69016
Table of Contents
Chapter 6 – Personal Profiles
6.1 Personal Profiles 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
Chapter 7 – Bolus
7.1 Bolus Overview .............................................................................................................86
7.2 Food Bolus Using Units.................................................................................................86
7.3 Food Bolus Using Grams ..............................................................................................87
7.4 Correction Bolus ............................................................................................................88
7.5 Extended Bolus .............................................................................................................89
7.6 Canceling or Stopping a Bolus......................................................................................90
Customer Technical Support: (877) 801-6901 7
Table of Contents
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
Chapter 10 – Quick Bolus
10.1 Setting Up Quick Bolus ...............................................................................................102
10.2 Delivering Quick Bolus ................................................................................................102
Chapter 11 – t:slim X2 Pump Settings
11.1 t:slim X2 Pump Volume ...............................................................................................106
11.2 Screen Options ............................................................................................................106
Customer Technical Support: (877) 801-69018
Table of Contents
Chapter 12 – t:slim X2 Pump Info and History
12.1 t:slim X2 Pump Info .....................................................................................................110
12.2 t:slim X2 Pump History ................................................................................................110
Chapter 13 – t:slim X2 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
Chapter 14 – User Settable Alerts and Alarms
14.1 Low Insulin Alert ..........................................................................................................118
14.2 Auto-Off Alarm ............................................................................................................118
Customer Technical Support: (877) 801-6901 9
Table of Contents
Section 4 – t:slim X2 Pump Safety Alerts and Alarms
Chapter 15 – t:slim X2 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
15.12 Connection Error Alert .................................................................................................140
15.13 Power Source Alert......................................................................................................141
15.14 Data Error Alert ............................................................................................................142
Customer Technical Support: (877) 801-690110
Table of Contents
Chapter 16 – t:slim X2 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 X2 Pump Malfunction
17.1 Malfunction ..................................................................................................................158
Customer Technical Support: (877) 801-6901 11
Table of Contents
Section 5 – Living With and Caring for Your t:slim X2 Pump
Chapter 18 – Lifestyle Issues and Travel
18.1 Overview ......................................................................................................................162
Chapter 19 – Taking Care of Your t:slim X2 Pump
19.1 Overview ......................................................................................................................166
Customer Technical Support: (877) 801-690112
Table of Contents
Section 6 – Technical Specifications and Warranty
Chapter 20 – Technical Specifications
20.1 Overview ......................................................................................................................170
20.2 t:slim X2 Pump Specifications .....................................................................................171
20.3 t:slim X2 Pump Options and Settings .........................................................................176
20.4 t:slim X2 Pump Performance Characteristics .............................................................178
20.5 Electromagnetic Compatibility ....................................................................................180
20.6 Electromagnetic Emissions .........................................................................................181
20.7 Electromagnetic Immunity ...........................................................................................182
20.8 Distances Between the t:slim X2 Pump and RF Equipment .......................................184
20.9 FCC Notice Concerning Interference ..........................................................................187
20.10 Warranty Information ...................................................................................................188
20.11 Returned Goods Policy ...............................................................................................190
Index
Customer Technical Support: (877) 801-6901 13
Section 1
Before You Begin
Chapter 1
Introduction
Chapter 1 – Introduction
1.1 System Description
The t:slim X2 System is made up of the t:slim X2™ Insulin Pump and the t:slim® 3mL (300 units) cartridge. The t:slim X2 Insulin Pump delivers insulin in two ways: continuous, or basal insulin delivery, and bolus insulin delivery to cover carbohydrates eaten (food bolus) and to lower high blood glucose (cor­rection bolus). The disposable cartridge is filled with up to 300 units of U-100 insulin and attached to the pump. The cartridge is replaced every few days.
CAUTION
Federal (USA) law restricts this device to sale by or on the order of a physician.
1.2 About this User Guide
This User Guide covers important infor­mation on how to operate your t:slim X2 Pump. It provides step-by-step instructions to help you properly pro­gram, manage and care for the pump. It also provides important warnings and cautions on proper operation and tech­nical information to ensure your safety.
In this Guide, the t:slim X2 Pump may be referred to as “your pump” or “your t:slim X2 Pump”. The t:slim cartridge may be referred to as “your cartridge.” Together, the t:slim X2 Insulin Pump and the t:slim cartridge may be referred to as “your system”.
The User Guide is organized into sec­tions that allow you to learn to use your t:slim X2 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.
Product information, including electron­ic versions of the User Guide, a Guide to Successful Pumping, t:connect Getting Started and User Guides are available at www.tandemdiabetes.com.
Customer Technical Support: (877) 801-690116
Chapter 1 – Introduction
1.3 Important User Information
Review all instructions in this User Guide before using the pump.
If you are not able to use the pump 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 (877) 801-6901. We are here for you 24 hours a day, 7 days a week.
1.4 Important Pediatric User Information
The following recommendations are meant to help younger users and their caregivers program, manage and care for the pump.
Younger children may inadvertently press or tap the pump, leading to unin­tentional delivery of insulin.
It is the responsibility of the healthcare provider and caregiver to determine if the user is appropriate for treatment with this device.
We recommend reviewing the Quick Bolus and Feature Lock capabilities of the Tandem pump and determining how they best fit with your care plan. These features are detailed in Chapters 10 and 11 of this User Guide.
Inadvertent dislodgement of the infu­sion site may occur more frequently with children so consider securing the infusion site and tubing.
WARNING
DO NOT allow small children (either
pump users or non-users) to ingest small parts, such as the rubber USB port cover and cartridge components. Small parts could pose a choking hazard. If ingested or swallowed, these small component pieces may cause internal injury or infection.
WARNING
The Pump includes parts (such as the USB cable and infusion set tubing) that could pose a strangulation or asphyxi­ation hazard. Always use the appropri­ate length of infusion set and arrange cables and tubing to minimize the risk of strangulation. ENSURE that these parts are stored in a secure place when not in use.
WARNING
For patients who do not self-manage their disease, the Feature Lock function should ALWAYS be ON when the pump is not being used by a caregiver. The Feature Lock function is intended to prevent inadvertent button presses that may lead to insulin delivery or changes in the pump settings. These
Before You Begin1
Customer Technical Support: (877) 801-6901 17
Chapter 1 – Introduction
changes can potentially lead to hypo­glycemic or hyperglycemic events.
WARNING
For patients whose insulin adminis­tration is managed by a caregiver, DO turn off the Quick Bolus feature to avoid inadvertent bolus delivery. With the Feature Lock turned on, the Quick Bolus feature is disabled. Inadvertent button presses or tampering with the insulin pump could result in over delivery or under delivery of insulin. This can cause very low of very high blood glucose which could result in serious injury or death.
1.5 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
Touch Screen
Tap
Press
Hold
Menu
Icon
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.
The front glass screen of your pump, which displays all programming, operating, and alarm/alert information.
Quickly and lightly touch the screen with your finger.
Use your finger to depress a physical button (the Screen On/Quick Bolus Button is the only physical/hardware button on your t:slim X2 Pump).
Keep pressing a button or touching an icon or menu until its function is complete.
A list of options on your touch screen that allow you to perform specific tasks.
An image on your touch screen that indicates an option or item of information, or a symbol on the back of your t:slim X2 Pump or its packaging.
Customer Technical Support: (877) 801-690118
Chapter 2
Important Safety Information
Chapter 2 – Important Safety Information
2.1 Indications for Use
Indications for Use
The t:slim X2 Pump 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 6 years of age and greater. The device is indicated for use with NovoLog or Humalog U-100 insulin.
2.2 Contraindications
Contraindications
The t:slim X2 Pump 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 self­care skills
•
See your healthcare provider(s) regularly
You must also have adequate vision and/or hearing in order to recognize your pump alerts.
2.3 Pump Warnings
WARNINGS
DO NOT start to use your t:slim X2
Pump before reading the User Guide. Failure to follow the instructions in the User Guide can result in over delivery or under delivery of insulin. This can cause very low or very high blood glu­cose which could result in serious injury or death. If you have questions or need further clarification on your pump use, ask your healthcare provider or call our around-the-clock Customer Technical Support at (877) 801-6901.
DO NOT start to use your t:slim X2 Pump before you have been appropri­ately trained on its use by a certified Tandem Pump Trainer. Consult with your healthcare provider for your indi­vidual training needs for the t:slim X2 Pump. Failure to complete the neces­sary training on the pump could result in serious injury or death.
Customer Technical Support: (877) 801-690120
Chapter 2 – Important Safety Information
DO NOT use any other insulin with your pump other than U-100 Humalog® or NovoLog®. Only Huma­log® and NovoLog® have been tested and found to be compatible for use in the pump. Use of insulin with lesser or greater concentration can result in un­der delivery or over delivery of insulin. This can cause very high or a very low blood glucose.
DO NOT put any other drugs or medications inside your cartridge. The Pump is designed only for Continuous Subcutaneous Insulin Infusion (CSII) using Humalog® or NovoLog® insulin. Use of other drugs or medications can damage the pump and result in injury if infused.
DO NOT start to use your pump before consulting with your healthcare provider to determine which features are most appropriate for you. Only your healthcare provider can determine and help you adjust your Basal Rate(s), Carb Ratio(s), Correction Factor(s), Tar­get BG, and duration of insulin action. Incorrect settings can result in over delivery or under delivery of insulin. This
can cause very low or very high blood glucose.
DO be prepared to inject insulin with an alternative method if delivery is interrupted for any reason. Your t:slim X2 Pump is designed to deliver insulin reliably, but because it uses only rapid-acting insulin, you will not have long-acting insulin in your body. Failure to have an alternative method of insulin delivery can lead to very high blood glucose or Diabetic Ketoacidosis (DKA).
DO use only FDA cleared insulin infusion sets with a standard Luer-lock connection and follow their instructions for use. Failure to do so may result in over delivery or under delivery of insulin and may cause very low or very high blood glucose.
DO NOT place your infusion set on any scars, lumps, moles, stretch marks or tattoos. Placing your infusion set in these areas can cause swelling, irritation or infection. This can affect insulin absorption and cause high or low blood glucose.
DO NOT ignore infusion set cannula fractures. Infusion set cannulas may fracture on rare occasions. If an infu­sion set cannula breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken infusion set cannula, please report this to Tandem Customer Technical Support at (877) 801-6901.
NEVER fill your tubing while your infusion set is connected to your body. Always ensure that the infusion set is disconnected from your body before filling the tubing. Failure to disconnect your infusion set from your body before filling the tubing can result in over de­livery of insulin. This can cause serious injury or death from very low blood glucose.
DO NOT reuse cartridges or use cartridges other than those manufac­tured by Tandem Diabetes Care, Inc. Use of cartridges not manufactured by Tandem Diabetes Care, Inc. or reuse of cartridges may result in over delivery or
Before You Begin1
Customer Technical Support: (877) 801-6901 21
Chapter 2 – Important Safety Information
under delivery of insulin. This can cause very low or very high blood glucose.
ALWAYS twist the Luer-lock con­nection between the cartridge tubing and the infusion set tubing an extra quarter of a turn to ensure a secure connection. A loose connection can cause insulin to leak, resulting in under delivery of insulin. This can cause high blood glucose.
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 your body before tightening. Failure to disconnect before tightening can result in over delivery of insulin. This can cause low blood glucose.
DO NOT remove or add insulin from a filled cartridge after loading onto the pump. This will result in an inaccurate display of the insulin level on the Home Screen and you could run out of insulin before the pump detects an empty cartridge. This can cause very high blood glucose, or Diabetic Ketoacido­sis (DKA).
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 cause very high or very low blood glucose. You can always adjust the insulin units up or down before you decide to deliver your bolus.
DO NOT allow small children (either pump users or non-users) to ingest small parts, such as the rubber USB port cover and cartridge components. Small parts could pose a choking hazard. If ingested or swallowed, these small component pieces may cause internal injury or infection.
The system includes parts (such as the USB cable and infusion set tubing) that could pose a strangulation or asphyxi­ation hazard. Always use the appropri­ate length of infusion set and arrange cables and tubing to minimize the risk of strangulation. ENSURE that these parts are stored in a secure place when not in use.
For patients who do not self-manage their disease, the Feature Lock function should ALWAYS be ON when the
pump is not being used by a caregiver. The Feature Lock function is intended to prevent inadvertent button presses that may lead to insulin delivery or changes in the pump settings. These changes can potentially lead to hypo­glycemic or hyperglycemic events.
For patients whose insulin adminis­tration is managed by a caregiver, DO turn off the Quick Bolus feature to avoid inadvertent bolus delivery. With the Feature Lock turned on, the Quick Bolus feature is disabled. Inadvertent button presses or tampering with the insulin pump could result in over delivery or under delivery of insulin. This can cause very low or very high blood glucose which could result in serious injury or death.
Customer Technical Support: (877) 801-690122
Chapter 2 – Important Safety Information
WARNING – Radiology
and Medical Procedures and your t:slim X2 Pump
ALWAYS notify the provider/technician about your diabetes and your t:slim X2 Insulin Pump. If you need to discontin­ue use of the pump for medical proce­dures, follow your healthcare provider’s instructions to replace missed insulin when you reconnect to the pump. Check your blood glucose before dis­connecting from the pump and again when you reconnect and treat high blood glucose levels as recommended by your healthcare provider.
The t:slim X2 Insulin Pump is magnet­ic resonance (MR) Unsafe. You must take off your t:slim X2 Pump and leave it outside the procedure room if you are going to have any of the following procedures:
•
X-ray
•
Computed Tomography (CT) scan
•
Positron Emission Tomography (PET) scan
•
Other exposure to radiation
In addition to the above, you must take off your t:slim X2 Pump and leave it outside the procedure room if you are going to have any of the following 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 Pump can usually be worn during the procedure. However, some lasers can create interference and cause the pump to alarm.
your pump. 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 (877) 801-6901.
Before You Begin1
•
Magnetic Resonance Imaging (MRI)
•
General Anesthesia – Depending on the equipment being used, you may or may not need to remove
Customer Technical Support: (877) 801-6901 23
Chapter 2 – Important Safety Information
2.4 System Precautions
PRECAUTIONS
DO NOT open or attempt to repair your
pump. The Pump is a sealed device that should be opened and repaired only by Tandem Diabetes Care, Inc. Modification could result in a safety hazard. If your pump seal is broken, the pump is no longer watertight and the warranty is voided.
CHANGE your infusion set every 48 to 72 hours as recommended by your healthcare provider. Wash your hands with anti-bacterial soap before handling the infusion set and thoroughly clean the insertion site on your body to avoid infection. Contact your healthcare pro­vider if you have symptoms of infection at your insulin infusion site.
ALWAYS remove all air bubbles before beginning insulin delivery. Ensure there are no air bubbles when drawing insulin into the filling syringe, hold the pump with the white fill port pointed up when filling the tubing, and ensure that there are no air bubbles in the tubing when
filling. Air in the pump takes space where insulin should be and can affect insulin delivery.
CHECK your infusion site daily for proper placement and leaks. RE- PLACE your infusion set if you notice leaks around the site. Improperly placed sites or leaks around the infu­sion site can result in under delivery of insulin.
CHECK your infusion set tubing daily for any leaks, air bubbles, or kinks. Air in the tubing, leaks in the tubing, or kinked tubing may restrict or stop insu­lin delivery and result in under delivery of insulin.
CHECK the Luer-lock connection between your cartridge tubing and infusion set tubing daily to ensure it is tight and secure. Leaks around the Lu­er-lock connection can result in under delivery of insulin.
DO NOT change 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. It is important to confirm that the infusion
set is inserted correctly and delivering insulin. It is also important to respond quickly to any problems with the inser­tion to ensure continued insulin delivery.
ALWAYS check that your cartridge has enough insulin to last through the night before going to bed. If you are sleep­ing, you could fail to hear the Empty Cartridge Alarm and miss part of your basal insulin delivery.
CHECK your pump’s personal settings regularly to ensure they are correct. Incorrect settings can result in over delivery or under delivery of insulin. Consult with your healthcare provider as needed.
ALWAYS make sure that the correct time and date are set on your pump. 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. Not having the correct time and date setting may affect safe insulin delivery.
Customer Technical Support: (877) 801-690124
Chapter 2 – Important Safety Information
CONFIRM that the screen display turns on, you can hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On Button when you connect a power source to the USB port. These features are used to notify you about alerts, alarms, and other conditions that require your atten­tion. If these features are not working, discontinue use of the pump and con­tact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.
CHECK your pump regularly for poten­tial alarm conditions that may display. It is important to be aware of condi­tions that may affect insulin delivery and require your attention so you can respond as soon as possible.
DO NOT use the vibrate feature for alerts and alarms during sleep unless otherwise directed by your healthcare provider. Having the volume for alerts and alarms set to high will help ensure that you don’t miss an alert or alarm.
ALWAYS look at the screen to confirm correct programming of the bolus amount when you first use the Quick
Bolus feature. Looking at the screen will ensure that you are correctly using the beep/vibration commands to pro­gram the intended bolus amount.
DO NOT use your pump if you think it might be damaged due to dropping it or hitting it against a hard surface. Check that the pump is working properly by plugging a power source into the USB port and confirming that the display turns on, you hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On Button. If you are unsure about potential damage, discontinue use of the pump and con­tact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.
AVOID exposure of your pump to temperatures below 40°F (5°C) or above 99°F (37°C). Insulin can freeze at low temperatures or degrade at high temperatures. Insulin that has been exposed to conditions outside of the manufacturer’s recommended ranges can affect the safety and performance of the pump.
AVOID submersing your pump in fluid
beyond a depth of 3 feet or for more than 30 minutes (IPX7 rating). If your pump has been exposed to fluid be­yond these limits, check for any signs of fluid ingress. If there are signs of fluid entry, discontinue use of the pump and contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.
AVOID areas where there may be flammable anesthetics or explosive gases. The Pump is not suitable for use in these areas and there is a risk of explosion. Remove your pump if you need to enter these areas.
MAKE SURE to not move further than the length of the USB cable when you are connected to the pump and to a charging source. Moving further than the length of the USB cable may cause the cannula to be pulled out of the infusion site. For this reason it is recommended not to charge the pump while sleeping.
DISCONNECT your infusion set from your body while on high-speed/high gravity amusement park thrill rides.
Before You Begin1
Customer Technical Support: (877) 801-6901 25
Chapter 2 – Important Safety Information
Rapid changes in altitude or gravity can affect insulin delivery and cause injury.
DISCONNECT your infusion set from your body before flying in an aircraft without cabin pressurization or in planes used for aerobatics or combat simulation (pressurized or not). Rapid changes in altitude or gravity can affect insulin delivery and cause injury.
CONSULT your healthcare provider about lifestyle changes such as weight gain or loss, and starting or stopping exercise. Your insulin needs may change in response to lifestyle chang­es. Your basal rate(s) and other settings may need adjustment.
CHECK your blood glucose using a blood glucose meter following a gradu­al elevation change of up to 1,000 feet, such as when snow skiing or driving on a mountain road. Delivery accuracy can vary up to 15% until 3 units of total insulin have been delivered or elevation has changed by more than 1,000 feet. Changes in delivery accuracy can affect insulin delivery and cause injury.
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.
ENSURE that your personal insulin de­livery settings are programmed into the pump before you use if you receive a warranty replacement. Failure to enter your insulin delivery settings could re­sult in over delivery or under delivery of insulin. This can cause very low or very high blood glucose which could result in serious injury or death. Consult your healthcare provider as needed.
Interference with your pump’s electron­ics by cell phones can occur if worn in close proximity. It is recommended that your pump and cell phone be worn at least 6.4 inches apart.
ALWAYS dispose of used components such as cartridges, syringes, needles, and infusion sets following the instruc­tions from your healthcare provider. Wash your hands thoroughly after handling used Pump components.
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Chapter 2 – Important Safety Information
2.5 Potential Benefits From Using the Pump
•
The t:slim X2 Pump provides an automated way to deliver basal and bolus insulin. Delivery can be fine-tuned based on up to 6 customizable Personal Profiles, each with up to 16 time-based settings for Basal Rate, Carb Ratio, Correction Factor, and Target BG. In addition, the Temp Rate feature allows you to program a temporary basal rate change for up to 72 hours.
•
The t:slim X2 Pump gives you the option of delivering a bolus all at once, or delivering a percentage over an extended period of time without navigating to different menus. You can also program a bolus more discreetly using the Quick Bolus feature, which can be used without looking at the pump, and can be programmed in increments of either units of insulin or grams of carbohydrate.
•
From the bolus screen, the “calculator within a calculator”
feature allows you to enter multiple carbohydrate values and add them together. The Pump’s bolus calculator will recommend a bolus based on the entire amount of carbohydrates entered, which can help eliminate guesswork.
•
The Pump keeps track of the amount of active insulin from food and correction boluses (IOB). When programming additional food or correction boluses, the pump will subtract the amount of IOB from the recommended bolus if your BG is below the target set in your active Personal Profile. This can help prevent insulin stacking, which can lead to hypoglycemia.
•
You can program a number of reminders that will prompt you to retest your BG after a low or high BG is entered, as well as a “Missed Meal Bolus Reminder” which will alert you if a bolus isn’t entered during a specified period of time. If activated, these can help reduce the likelihood that you will forget to check your blood glucose or bolus for meals.
•
You have the ability to view a variety of data right on your screen, including the time and amount of your last bolus, your total insulin delivery by day, as well as broken into basal, food bolus, and correction bolus.
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Chapter 2 – Important Safety Information
2.6 Possible Risks From Using the Pump
As with any medical device, there are risks associated with using the t:slim X2 Pump. Many of the risks are com­mon to insulin therapy in general, but there are additional risks associated with continuous insulin infusion. Read­ing your User Guide and following the Instructions for Use are critical for the safe operation of your pump. Consult your health care provider about how these risks may impact you.
Inserting and wearing an infusion set might cause infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring or skin discol­oration).
There is a remote chance that an infu­sion set cannula fragment could remain under your skin if the cannula breaks while you are wearing it. If you think a cannula has broken under your skin, contact your healthcare provider and call Tandem Diabetes Care Customer Technical Support at (877) 801-6901.
Other risks associated with infusion sets include occlusions and air bubbles in the tubing, which can affect insulin delivery.
Risks that could result from pump failure include the following:
•
possible hypoglycemia (low blood glucose) from over-delivery of insulin due to a hardware defect
•
hyperglycemia (high blood glucose) and ketosis possibly leading to Diabetic Ketoacidosis (DKA) due to pump failure resulting in cessation of insulin delivery due to either a hardware defect or software anomaly.
2.7 Working with your Healthcare Provider
Any clinical language presented in this User Guide is based on the assumption that you have been educated by your healthcare provider on certain terms and how they apply to you in your diabetes management. Your healthcare provider can help you establish diabe­tes management guidelines that best fit your lifestyle and needs.
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 to 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 pump to determine which features are most appropriate for you. Only your healthcare provider can de-
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Chapter 2 – Important Safety Information
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.
2.8 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)
•
Infusion site preparation products (antiseptic wipes, skin adhesive)
•
Diabetes identification card or jewelry
Before You Begin1
•
Insulin pump cartridges (minimum of 2)
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Chapter 2 – Important Safety Information
2.9 Verification of Proper Functionality
A power supply (AC adapter with mi­cro-USB connector) is provided as part of the system. Before using your pump, ensure that the following occur when you connect a power supply into the USB port of your t:slim X2 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 pump, ensure the following:
•
Press the Screen On/Quick Bolus Button to turn the screen on so that you can see the display
PRECAUTION
CONFIRM that the screen display turns on, you can hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On Button when you connect a power source to the USB port. These features are used to notify you about alerts, alarms, and other conditions that require your attention. If these features are not working, discontinue use of the pump and contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.
•
When the display screen is on, the touch screen responds to your finger tap
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Chapter 3
Getting to Know Your
t:slim X2 Pump
Chapter 3 – Getting to Know Your t:slim X2 Pump
3.1 What your t:slim X2 System Package Includes
Your t:slim X2 System should include the following items:
1. t:slim X2 Insulin Pump
2. Pump Case
3. t:slim X2 Pump User Guide
4. t:connect Getting Started Guide
5. USB Cable
6. Wall Power USB Adapter
7. Cartridge Removal Tool
If any of these items are missing, con­tact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.
Your t:slim X2 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 (877) 801-6901.
Your t:slim X2 Pump comes 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 delivery.
Supply Reordering
To order cartridges, infusion sets, sup­plies and accessories, please contact Tandem Diabetes Care, Inc. at (877) 801-6901 or your usual supplier of diabetes products.
3.2 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 X2 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 X2 Pump it can be delivered as a Standard, a Correction, an Extended, or a Quick Bolus.
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Chapter 3 – Getting to Know Your t:slim X2 Pump
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
takes longer to digest. When admin­istering an extended bolus with your t:slim X2 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.
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 X2 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 X2 Pump’s micro USB port.
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Chapter 3 – Getting to Know Your t:slim X2 Pump
3.3 Explanation of Pump Symbols
The following are symbols (and their descriptions), which you may find on your t:slim X2 Pump and/or its packaging. These sym­bols tell you about the proper and safe use of the pump.
Symbol Meaning Symbol Meaning
Caution; Consult Manual for Important Safety Documentation
See Instructions for Use Do Not Re-Use
Serial Number of Device Sterile by Radiation
Part Number Non Pyrogenic
Watertight Equipment (protected against the effects of temporary immersion in water)
Type BF Applied Part (patient isolation, not defibrillator protected)
Manufacturer Non-ionizing Radiation
For sale by or on the order of a prescriber only (U.S.) Date of Manufacture
Direct Current (DC) voltage Two-Sided Humidity Limits
Magnetic Resonance Unsafe
Use By Date
Two-sided Temperature Limits
Lot Number
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Chapter 3 – Getting to Know Your t:slim X2 Pump
3.4 Explanation of Pump Icons
The following icons may appear in the status area (to the left or right of the time and date) on your t:slim X2 Pump Home Screen:
Icon Meaning
A Pump reminder, alert, error, or alarm is active.
Basal insulin is programmed 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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Chapter 3 – Getting to Know Your t:slim X2 Pump
3.5 Explanation of Pump Colors
Red LED
» 1 red blink every 30 seconds indicates a malfunction
or alarm condition.
Yellow LED
» 1 yellow blink every 30 seconds indicates an alert
or reminder condition.
Green LED
» 1 green blink every 30 seconds indicates the pump
is functioning normally.
» 3 green blinks every 30 seconds indicate the pump
is charging.
12:00 AM
Basal
Correction Factor Press to Set Up
Carb Ratio Press to Set Up
Target BG Press to Set Up
SAVEBACK
0.75 u/hr
Orange Highlight
» When editing settings, changes are highlighted in
orange for review before saving.
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Chapter 3 – Getting to Know Your t:slim X2 Pump
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Chapter 3 – Getting to Know Your t:slim X2 Pump
3.6 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 Pump settings and insulin delivery status.
8. Insulin Level: Displays the current amount of insulin in the cartridge.
9. Tandem Logo: Returns to the Home Screen.
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Chapter 3 – Getting to Know Your t:slim X2 Pump
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INSULIN ON BOARD (IOB)
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Chapter 3 – Getting to Know Your t:slim X2 Pump
3.7 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 X2 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, program a Temp Rate, Load cartridge, and view History.
5. Insulin On Board (IOB): Amount and time remaining of any active insulin on board.
6. Time and Date Display: Displays the current time and date.
7. Status: Displays current Pump settings and insulin delivery status.
8. Insulin Level: Displays the current amount of insulin in the cartridge.
9. Tandem Logo: Returns to the Home Screen.
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 X2 Pump screen on/off or programs a Quick Bolus (if activated).
13. LED Indicator: Illuminates when connected to a power supply and indicates proper functionality.
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Chapter 3 – Getting to Know Your t:slim X2 Pump
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BOLUS
OPTIONS
INSULIN ON BOARD (IOB)
Units 1.1 u 1:09 hrsTime Remaining
10
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Chapter 3 – Getting to Know Your t:slim X2 Pump
3.8 Status Screen
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.
1. Profile: Displays current active Personal Profile.
2. Basal Rate: Displays current basal rate being delivered. (If a Temp Rate is active, it is displayed 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.
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Chapter 3 – Getting to Know Your t:slim X2 Pump
B
Before You Begin1
BACK
1
P
2
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Current Status
Weekly
Basal Rate 0.2 u/hr
Last Bolus
Carbohydrates
12/23 - 10:45 PM
3 u
ON
BACK
6
7
8
9
Current Status
Correction Factor
Carb Ratio
Target BG
Insulin Duration
1u: 50 mg/dL
1u: 10 g
120 mg/dL
5 hours
5
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Chapter 3 – Getting to Know Your t:slim X2 Pump
3.9 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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Chapter 3 – Getting to Know Your t:slim X2 Pump
NEXT
BG
View Calculation
Add BG
CARBS
grams
0
NEXT
BG
View Calculation
Add BG
INSULIN
units
0
Using Grams Using Units
Before You Begin1
BACK
1 2 4 5
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0
units
3 7 8 10 11
6
BACK
0
units
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Chapter 3 – Getting to Know Your t:slim X2 Pump
3.10 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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Chapter 3 – Getting to Know Your t:slim X2 Pump
Before You Begin1
1
2
3
4
5
BACK
STOP INSULIN
My Pump
Load
Temp Rate
Options
BACK
8
History
Options
76
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Chapter 3 – Getting to Know Your t:slim X2 Pump
3.11 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 X2 Pump serial number, Tandem Diabetes Care Customer Technical Support phone number, website, and other technical information.
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Chapter 3 – Getting to Know Your t:slim X2 Pump
Before You Begin1
BACK
1
2
3
4
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Personal Profiles
Alert Settings
Pump Settings
Pump Info
My Pump
Chapter 3 – Getting to Know Your t:slim X2 Pump
3.12 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.
Customer Technical Support: (877) 801-690150
Chapter 3 – Getting to Know Your t:slim X2 Pump
Before You Begin1
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DONEBACK
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Chapter 3 – Getting to Know Your t:slim X2 Pump
3.13 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.
Customer Technical Support: (877) 801-690152
Chapter 3 – Getting to Know Your t:slim X2 Pump
Before You Begin1
1
2
3
Weekday
name
defabc ghi
SAVEBACK
5
6
mnojkl pqr
vwxstu yz
4 7
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123
space
Section 2
Key Pump Features
Chapter 4
Getting Started
Chapter 4 – Getting Started
4.1 Charging the t:slim
X2 Pump
The t:slim X2 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 outlets and from PC USB ports are included with the pump. A car power adapter is not included with the pump and may be purchased separately. Reference Chapter 20 Tech­nical Specifications for acceptable car adapter specifications.
If you lose any of the included accesso­ries, or need to purchase an accessory, contact Tandem Diabetes Care, Inc. at (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 1% at a time (for example, you will see 4%, 3%, 2%, 1%).
When you first receive your t:slim X2
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 X2 Pump continues to op­erate normally while charging. You do not need to disconnect from the pump while charging.
PRECAUTION
MAKE SURE to not move further than the length of the USB cable when you are connected to the pump and to a charging source. Moving further than the length of the USB cable may cause the cannula to be pulled out of the infusion site. For this reason it is recommended not to charge the pump while sleeping.
If you choose to disconnect from the pump while charging, check with your healthcare provider for specific guide­lines. Depending on the length of time you are disconnected, you may need to replace missed basal and/or bolus insulin. Check your 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 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.
Before using a Mac or PC to charge the t:slim X2 Pump, it is recommended that a driver be installed on the com­puter by downloading the t:connect Uploader Software from our website
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Chapter 4 – Getting Started
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.
To charge the pump using a standard auxiliary-to-USB car adapter (not included):
1. Plug the USB cable into the auxiliary-to-USB car adapter.
2. Plug the car adapter into a grounded auxiliary power outlet.
3. Plug the other end of the cable into the micro USB port on the pump.
WARNING
When using an auxilary-to-USB adapter, the charger must be connected to an isolated, battery powered 12 Volt system, such as in a car. Connecting the DC car adapter to 12 Volt DC that is generated by a power supply connected to an alternating current (AC) source is prohibited.
When you charge the t:slim X2 Pump, you will notice the following:
•
The screen illuminates
•
An audible alert
•
The LED (edge around the Screen On/Quick Bolus Button) blinks green
•
A vibrating alert
•
A charge symbol (lightning bolt) on the battery level indicator appears
PRECAUTION
CONFIRM that the screen display turns on, you can hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On Button when you connect a power source to the USB port. These
features are used to notify you about alerts, alarms, and other conditions that require your attention. If these features are not working, discontinue use of the pump and contact Tandem Diabetes Care Customer Technical Support at (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 to 15 minutes), and also avoiding frequent full discharges.
NOTE: Fully Discharged Battery
If the battery is fully discharged, the screen may not power on immediately when connected to a charging source. The LED around the Screen On/Quick Bolus Button will blink green until there is enough charge to power on the touch screen.
Key Pump Features2
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Chapter 4 – Getting Started
4.2 Using the Touch Screen
To turn on your t:slim X2 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 other object to interact with the screen. It will not activate the screen or its functions.
Your t:slim X2 Pump is designed to give you quick and easy access to the functions that you will use in your day­to-day diabetes management - wheth­er basic or advanced.
The t:slim X2 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: Touch Screen Tips
When using the t:slim X2 Pump, tap the Tandem Logo to return to the Home Screen or tap BACK to return to the previous screen.
4.3 Turning on the t:slim X2 Pump Screen
1. To turn on your t:slim X2 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: Turning off the Pump
Screen
Turn off the pump screen by pressing the Screen On/Quick Bolus button before placing the pump back in its case or any pocket/ clothing. Always position the pump screen away from the skin when worn under clothing.
The pump continues to function nor­mally when the screen is not on.
4.4 Unlocking the t:slim X2 Pump Screen
The screen lock screen appears any­time you turn on the screen, and after a bolus or temp rate is requested. To unlock the screen:
1. Press Screen On/Quick Bolus Button.
2. Tap 1.
3. Tap 2.
4. Tap 3.
The pump screen is now unlocked. The last screen that was viewed will be displayed.
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.
Customer Technical Support: (877) 801-690158
Chapter 4 – Getting Started
4.5 Edit Time
After powering up your t:slim X2 Pump for the first time, set the current time and date. Refer back to this section if you need to edit the time for either traveling in a different time zone or adjusting for Daylight Savings Time.
PRECAUTION
ALWAYS make sure that the correct time and date are set on your pump. 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. Not having the correct time and date setting may affect safe insulin delivery.
1. From the Home Screen, tap OPTIONS.
2. Tap My Pump.
3. Tap Pump Settings.
4. Tap Time and Date.
5. Tap Edit 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.
Any edits to Time or Date will not be saved until you tap SAVE.
4.6 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.
Key Pump Features2
6. Tap Time.
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Chapter 4 – Getting Started
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Chapter 5
Infusion Site Care and
Loading Cartridge
Chapter 5 – Infusion Site Care and Loading Cartridge
5.1 Infusion Site Selection and Care
WARNING
DO use only FDA cleared insulin infusion sets with a standard Luer-lock connection and follow their instructions for use. Failure to do so may result in over delivery or under delivery of insulin and may cause very low or very high blood glucose.
WARNING
DO NOT ignore infusion set cannula fractures. Infusion set cannulas may fracture on rare occasions. If an infusion set cannula breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken infusion set cannula, please report this to Tandem Customer Technical Support at (877) 801-6901.
PRECAUTION
CHECK your infusion site daily for proper placement and leaks. REPLACE your infusion set if you notice leaks around the site. Improperly placed sites or leaks around the infusion site can result in under delivery of insulin.
General Guidelines
WARNING
DO NOT place your infusion set on any scars, lumps, moles, stretch marks or tattoos. Placing your infusion set in these areas can cause swelling, irritation or infection. This can affect insulin absorption and cause high or low blood glucose.
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
CGM sensor site.
Site Rotation:
PRECAUTION
CHANGE your infusion set every 48–72 hours as recommended by your healthcare provider. Wash your hands with anti-bacterial soap before handling the infusion set and thoroughly clean the insertion site on your body to avoid infection. Contact your healthcare provider if you have symptoms of infection at your insulin infusion site.
•
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.
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•
When changing your infusion set, use clean techniques to avoid an infection.
•
Wash your hands, use antiseptic wipes or infusion site preparation products, and keep the area clean.
•
Site preparation products that have both an antiseptic and an adhesive are encouraged.
Chapter 5 – Infusion Site Care and Loading Cartridge
Areas of Body for Infusion Set InsertionKeep it clean:
Key Pump Features2
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Chapter 5 – Infusion Site Care and Loading Cartridge
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 X2 Pump. The single-use disposable cartridge can hold up to 300 units (3.0 mL) of insulin.
WARNING
DO NOT use any other insulin with your pump other than U-100 Humalog® or NovoLog®. Only Humalog® and NovoLog® have been tested and found to be compatible for use with this Pump. Use of insulin with lesser or greater concentration can result in under delivery or over delivery of insulin. This can cause very high or a very low blood glucose.
Diabetes Care, Inc. Use of cartridges not manufactured by Tandem Diabetes Care, Inc. or reuse of cartridges may result in over delivery or under delivery of insulin. This can cause very low or very high blood glucose.
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: Removing the Cartridge
Do NOT remove the used cartridge from the pump during the load process until prompted on the t:slim X2 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
WARNING
DO NOT reuse cartridges or use cartridges other than those manufactured by Tandem
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Chapter 5 – Infusion Site Care and Loading Cartridge
Instructions for Drawing Insulin from Vial into Syringe
PRECAUTION
ALWAYS remove all air bubbles before beginning insulin delivery. Ensure there are no air bubbles when drawing insulin into the filling syringe, hold the pump with the white fill port pointed up when filling the tubing, and ensure that there are no air bubbles in the tubing when filling. Air in the system takes space where insulin should be and can affect insulin delivery.
The fill estimate displayed on the pump is the amount of insulin available for deliv­ery. It does not include insulin needed to fill the tubing (up to 30 units) and a small amount of insulin that is not available for delivery. When filling the syringe, add ap­proximately 45 units to the amount of insulin you want available for delivery.
For example, the pump requires a minimum of 50 units available for delivery after fill tubing has been completed. Fill the syringe with approximately 95 units to have enough to fill your tubing and still have 50 units available for delivery.
1. Inspect the needle and syringe package for any signs of damage. Discard any damaged product.
2. Wash your hands thoroughly.
3. Wipe the rubber septum of the insulin vial with an alcohol swab.
Key Pump Features2
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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Chapter 5 – Infusion Site Care and Loading Cartridge
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.
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Chapter 5 – Infusion Site Care and Loading Cartridge
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).
Key Pump Features2
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Chapter 5 – Infusion Site Care and Loading Cartridge
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 the instructions from your healthcare provider.
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Chapter 5 – Infusion Site Care and Loading Cartridge
Instructions on How to Install a Cartridge
If this is the very first time you are load­ing the cartridge, remove the shipping canister (which is not for human use), from the back of the pump.
1. From the Home Screen, tap OPTIONS.
2. Tap Load.
During the load sequence, the Tan­dem Logo is disabled. Tapping it will not return to the Home Screen.
3. Tap Change Cartridge.
4. Screen will display that all insulin
deliveries will be stopped. Tap
YES to continue.
NOTE: First Time Use
This screen will not be displayed if this is the first time loading a new cartridge and you have not started actively pumping.
5. Disconnect the infusion set from your body and tap NEXT to continue.
“Preparing for Cartridge” screen is displayed.
6. Remove the used cartridge.
If needed, place the cartridge removal tool or the edge of a coin in the slot at the bottom of the cartridge and twist to aid in the removal of the cartridge.
7. Install filled 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.
Tap UNLOCK icon when completed.
8. Tap NEXT to continue.
“Detecting Cartridge” screen is displayed.
WARNING
DO NOT remove or add insulin from a filled cartridge after loading onto the pump. This will result in an inaccurate display of the insulin level on the Home Screen and you could run out of insulin before the pump detects an empty cartridge. This can cause very high blood glucose, or Diabetic Ketoacidosis (DKA).
Key Pump Features2
After completing the cartridge change, the pump will automatically prompt you
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to fill tubing.
Chapter 5 – Infusion Site Care and Loading Cartridge
5.4 Filling Tubing
Filling the Infusion Set Tubing with Insulin
This section describes how to fill the infusion set tubing with insulin after you change the cartridge.
To fill the tubing without changing the cartridge, from the Home Screen tap OPTIONS, tap Load, tap Fill Tubing and then follow the instructions. Tap NEW if you installed a new cartridge. Tap FILL if you did not install a new cartridge and want to continue with filling the tubing.
WARNING
NEVER fill your tubing while your infusion set is connected to your body. Always ensure that the infusion set is disconnected from your body before filling the tubing. Failure to disconnect your infusion set from your body before filling the tubing can result in over delivery of insulin. This can cause serious injury or death from very low blood glucose.
PRECAUTION
ALWAYS remove all air bubbles before beginning insulin delivery. Ensure there are no
air bubbles when drawing insulin into the filling syringe, hold the pump with the white fill port pointed up when filling the tubing, and ensure that there are no air bubbles in the tubing when filling. Air in the system takes space where insulin should be and can affect insulin delivery.
PRECAUTION
CHECK your infusion set tubing daily for any leaks, air bubbles, or kinks. Air in the tubing, leaks in the tubing, or kinked tubing may restrict or stop insulin delivery and result in under delivery of insulin.
1. Verify that the infusion set is disconnected from your body.
2. 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.
WARNING
ALWAYS twist the Luer-lock connection between the cartridge tubing and the infusion set tubing an extra quarter of a turn to ensure a secure connection. A loose connection can cause insulin to leak, resulting in under delivery of insulin. This can cause high blood glucose.
Tap NEXT.
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Chapter 5 – Infusion Site Care and Loading Cartridge
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.
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 to 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: Initial Display of
Insulin Level
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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Chapter 5 – Infusion Site Care and Loading Cartridge
5.5 Filling Cannula
Filling the Infusion Set Cannula with Insulin
This section describes how to fill the infusion set cannula with insulin after you fill the tubing.
To fill the cannula without filling the tubing, from the Home Screen, tap OP­TIONS, tap Load, tap Fill Cannula and then follow the instructions below.
If you are using a steel needle infu­sion set, there is no cannula. Skip this section.
To Fill the Cannula
1. Tap Fill Cannula.
2. Insert a new infusion set and
connect filled tubing to site, then tap NEXT.
3. Tap Edit Fill Amount.
fill amount. Filling stops at this amount.
4. Select amount needed for cannula fill.
Refer to your infusion set instruc­tions for use for proper cannula fill amount.
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.
5. Tap START.
“Starting Fill” screen is displayed.
After fill is complete, “Stopping Fill” screen is displayed.
NOTE: Stopping Fill
You can tap STOP at any time during the fill process if you want to stop filling the cannula.
The screen will return to the Load menu if the Site Reminder is turned off. 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).
The cannula fill amount displayed is based on your last cannula
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Chapter 5 – Infusion Site Care and Loading Cartridge
5.6 Setting Site Reminder
This section describes how to set the Site Reminder after you fill the cannula.
To set the Site Reminder without filling the cannula, from the Home Screen, tap OPTIONS, tap Load, tap Site Reminder then follow the instructions below.
PRECAUTION
DO NOT change 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. It is important to confirm that the infusion set is inserted correctly and delivering insulin. It is also important to respond quickly to any problems with the insertion to ensure continued insulin delivery.
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).
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 to 2 hours will display.
7. Tap RESUME.
NOTE: First Time Use
If this is the first time using your t:slim X2 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.
Key Pump Features2
The default for the Site Reminder is set for 3 days
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8. RESUMING INSULIN screen is temporarily displayed.
Chapter 5 – Infusion Site Care and Loading Cartridge
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Chapter 6
Personal Profiles
Chapter 6 – Personal Profiles
6.1 Personal Profiles Overview
WARNING
DO NOT start to use your pump before consulting with your healthcare provider to determine which features are most appropriate for you. Only your healthcare provider can determine and help you adjust your Basal Rate(s), Carb Ratio(s), Correction Factor(s), Target BG, and duration of insulin action. Incorrect settings can result in over delivery or under delivery of insulin. This can cause very low or very high blood glucose.
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 X2 Pump uses the settings in your active profile to calculate the delivery of basal insulin, food boluses and correction boluses based on your Target BG. If you only define a basal rate in Timed Settings, your pump will only be able to deliver basal insulin and standard and extended boluses. Your pump will not calculate correction boluses.
Up to 6 different Personal Profiles can be created and up to 16 different time segments can be set in each Personal Profile. Having several Personal Profiles provides more flexibility for your body and lifestyle. For example, you could have “Weekday” and “Weekend” pro­files if you have different insulin delivery needs on weekdays and weekends, based on schedule, food intake, activi­ty, 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)
Although you do not need to define every setting, some pump features require certain settings to be defined and activated. When you are creating a new profile, your pump prompts you to
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Chapter 6 – Personal Profiles
set up any required settings before you can continue.
The ranges you can set for Timed Settings are:
•
Basal (range: 0 and 0.1 to 15 units/ hr)
•
Correction Factor (range: 1 unit:1 mg/dL to 1 unit:600 mg/dL)
•
Carb Ratio (range: 1 unit:1 gram to 1 unit:300 grams)
Below a carb ratio of 1:10, incre­ments can be entered in 0.1 g. For example a carb ratio of 1:8.2 can be programmed.
•
Target BG (range: 70 mg/dL to 250 mg/dL)
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 to 8 hrs)
•
Max Bolus (default: 10 units; range: 1 to 25 units)
Insulin Duration and Insulin on Board (IOB)
Your t:slim X2 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.
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 X2 Pump will consider any active IOB and calculate an adjusted bolus if necessary.
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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Chapter 6 – Personal Profiles
Timed Settings
Bolus Settings
SAVE
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
5 hrs
DURATION
Weekday
Press to Set Up
10 u
MAX BOLUS
OFF
CARBS
6.3 Programming a New Personal Profile
Once the Personal Profile has been created, the settings must be pro­grammed. The first time segment will start at 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
ALWAYS confirm that the decimal point placement is correct when entering your Personal Profile information. Incorrect decimal point placement can prevent you from getting the proper insulin amount that your healthcare provider has prescibed for you.
Timed Settings
BACK
Basal Press to Set Up
Correction Factor Press to Set Up
Carb Ratio Press to Set Up
Target BG Press to Set Up
12:00 AM
1. Once the new profile has been created, Tap Basal.
2. Using the onscreen keypad, enter your basal rate and tap DONE.
3. Tap Correction Factor.
4. Using the onscreen keypad, enter
your correction factor (the mg/dL that 1 unit of insulin will lower BG) and tap DONE.
5. Tap Carb Ratio.
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Chapter 6 – Personal Profiles
6. Using the onscreen keypad, enter your insulin-to-carbohydrate ratio (the grams of carb to be covered by 1 unit of insulin) and tap DONE.
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.
BACK
Timed Settings
12:00 AM
0.75
1:50
BASAL
CORRECT
1:10
120
CARB TARGET BG
ADD
Adding More Time Segments
When adding more time segments, any settings that you entered in the previous time segment are copied and appear in the new segment. This allows you to simply adjust only the specific settings you want, rather than have to enter them all over again.
1. On the “Add Segment” screen, tap Start Time.
the time (hour and minutes) that you want the segment to begin, and tap DONE.
Key Pump Features2
3. On the “Add Segment” screen, tap
Time of Day to select AM or PM.
Once a time segment is set beyond 12:00 PM, the default will change to PM.
4. Tap NEXT.
5. Repeat steps 1 to 10 from the
“Programming a New Personal Profile” section above for each segment you want to set up (up to 16).
To find time segments in the list that are not displayed on the first screen, tap the Down Arrow.
2. Using the onscreen keypad, enter
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Chapter 6 – Personal Profiles
Bolus Settings
Timed Settings 12:00a - 12:00a
SAVE
Bolus Settings
1. Tap the Bolus Settings Panel.
1:50
CORRECT
Weekday
1:10
CARB
10 u
MAX BOLUS
120
TARGET BG
OFF
CARBS
BACK
0.75
BASAL
5 hrs
DURATION
2. Tap Insulin Duration.
BACK
Insulin Duration
Max Bolus
Carbohydrates
Bolus Settings
OFF
5 hrs
10 u
ON
3. Using the onscreen keypad, enter the desired time for the duration of insulin action (2–8 hrs) and tap DONE.
4. Tap Max Bolus.
5. Using the onscreen keypad, enter
the desired amount for maximum bolus (1–25 units) and tap DONE.
NOTE: 25 Unit Max Bolus
If you set the max bolus to 25 units and a bolus larger than 25 units is calculated using your Carb Ratio or Correction Factor, after the bolus is delivered a reminder screen will appear. The option of delivering the remaining amount of the bolus up to an additional 25 units will be given (refer to Max Bolus Alert in chapter 15.9).
6. Tap Carbohydrates to turn on and use the carb ratio when calculating boluses.
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.
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.
If the first profile you created 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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Chapter 6 – Personal Profiles
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. Edit other time segments within the Timed Settings by tapping on them and using the same steps described above.
12. Tap BACK after editing all of the time segments.
13. Tap the Bolus Settings Panel to change DURATION, MAX BOLUS or CARBS as needed. Use the onscreen keypad to enter desired changes. Tap SAVE.
14. Confirm Settings.
Tap YES if entered data is correct.
Tap NO and make changes.
15. Tap Tandem Logo to return to the Home Screen.
NOTE: Adding or Deleting
Time Segments
To Add a time segment:
» Tap ADD. » Enter desired start time.
To Delete a time segment:
» Tap on the X to the left of the time
segment.
» Tap YES to confirm.
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Chapter 6 – Personal Profiles
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.
» 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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Chapter 6 – Personal Profiles
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.
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.
Key Pump Features2
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Chapter 6 – Personal Profiles
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Chapter 7
Bolus
Chapter 7 – Bolus
7.1 Bolus Overview
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 cause very high or very low blood glucose. You can always adjust the insulin units up or down before you decide to deliver your bolus.
A bolus is a quick dose of insulin that is usually delivered to cover food eaten or to correct a high BG.
The minimum bolus size is 0.05 units. The maximum bolus size is 25 units. If you attempt to deliver a bolus that is larger than the amount of insulin in the cartridge, a message screen appears indicating that there is not enough insulin to deliver the bolus.
Your t:slim X2 Pump offers you the ability to deliver different boluses to cover carbohydrate intake (food bolus) and bring your BG back to target (correction bolus). Food and correc­tion boluses can also be programmed together.
If 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.
PRECAUTION
CHECK your pump’s personal settings regularly to ensure they are correct. Incorrect settings can result in over delivery or under delivery of insulin. Consult your healthcare provider as needed.
7.2 Food Bolus Using Units
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 when entering bolus information. Incorrect decimal point placement can prevent you from getting the proper amount of insulin that your healthcare provider has prescribed for you.
4. Tap 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.
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Chapter 7 – Bolus
6. Tap DELIVER.
7. The bolus initiated screen is
temporarily 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.
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.
You can always tap View Cal- culation 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 DELIVER.
8. The bolus initiated screen is
temporarily displayed.
Key Pump Features2
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Chapter 7 – Bolus
NO
YES
Current IOB
0 u
Current BG
280 mg/dL
NO
YES
Current IOB
0 u
Current BG
85 mg/dL
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.
Once DONE is tapped, the BG value is saved in pump History whether or not a bolus is deliv­ered.
If BG is above the Target BG, a message screen will indicate BG is above Target.
Your BG is Above Target
Add Correction Bolus?
To add a correction bolus tap YES.
If BG is below Target BG, a message screen will indicate BG is below Target.
Your BG is Below Target
Reduce Bolus Calculation?
To reduce bolus calculation tap YES.
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.
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Chapter 7 – Bolus
4. Tap NEXT to confirm the units of insulin to be delivered.
You can always tap View Cal- culation to display the Delivery Calculation screen.
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 initiated screen is
temporarily 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). When using extended bolus, any correction bolus amount will always be given in the DELIVER NOW portion. 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.
4. If desired, tap Add BG and using the onscreen keypad enter BG value. Tap DONE.
Key Pump Features2
5. Tap NEXT to confirm the units of insulin to be delivered.
You can always tap View Cal- culation 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.
The percentage value for DELIVER LATER is automatically calculated by the pump. The default is 50% NOW and 50% LATER. The de­fault for DURATION is 2 hours.
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Chapter 7 – Bolus
B
Requesting 10 u Bolus ...
9. Use the onscreen keypad to enter the percentage of the bolus to DELIVER NOW and tap DONE.
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.
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.
You can always 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 initiated screen is
temporarily displayed.
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.
12:31 PM
INSULIN ON BOARD (IOB)
Units 1.1 u 1:09 hrsTime Remaining
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.
October 16, 2016 235 u
BOLUS
OPTIONS
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Stopping a Bolus if delivery of the bolus Has Started:
Chapter 7 – Bolus
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.
Key Pump Features2
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Chapter 7 – Bolus
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Chapter 8
Stop/Resume Insulin
Chapter 8 – Stop/Resume Insulin
8.1 Stopping Insulin Delivery
You can stop all insulin delivery at any time. When you stop all insulin delivery, any active bolus and any active temp rate are immediately stopped. No in­sulin delivery can take place while your pump is stopped.
1. From the Home Screen, tap OPTIONS.
2. Tap STOP INSULIN.
3. Tap 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.
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 X2 Pump screen.
2. Tap 1–2–3 to access the Home Screen.
3. Tap RESUME.
4. The RESUMING INSULIN screen
is temporarily displayed.
– OR –
1. From the Home Screen, tap OPTIONS.
2. Tap RESUME INSULIN.
3. Tap RESUME.
4. The RESUMING INSULIN screen
is temporarily displayed.
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Chapter 8 – Stop/Resume Insulin
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Section 3
Additional Pump
Operations
Chapter 9
Temporary Basal Rate
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
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. The current rate is 100%. An increase is greater than 100% and decrease is less than 100%. Tap DONE.
5. Tap Duration. Using the onscreen keypad enter desired length of time for Temp Rate. Tap DONE.
You can always tap View Units to see the actual units to be deliv­ered.
6. Verify settings and tap START.
7. The “TEMP RATE STARTED”
screen is temporarily displayed.
8. The Screen Lock screen will be displayed with the icon indicating a Temp Rate is active.
An orange “T” means a Temp Rate is active. A red “T” means a Temp Rate of 0 is active.
Customer Technical Support: (877) 801-690198
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.
Chapter 9 – Temporary Basal Rate
Additional Pump Operations3
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Chapter 9 – Temporary Basal Rate
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