Tandem t:slim X2 User Manual
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Tandem t:slim X2 User Manual

With control-iq technology
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07:35
14 Nov 2019
100%
235 u
400
162
350
mg/dL
300
250
200
150
3
100
HRS
50
INSULIN ON BOARD
3.4 u
BOLUS
with Control-IQ
Technology
Control-IQ: 0.80 u
™
User Guide
UNITS OF MEASURE
MG/DL

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Questions and answers

Lilly
May 8, 2025

My tslim pump won't let me turn on allow mobile connection under the pumps bluetooth. the option is there but it is turned off and cannot be turned on. It is updated to the most recent 7.7 software version and i want to connect it to the app

0
1 comments:
Mr. Anderson
May 19, 2025

You may not be able to turn on the mobile connection for the Tandem t:slim X2 pump's Bluetooth because your pump software may be outdated. If the "Bluetooth Settings" or "Mobile Connection" toggle is grayed out or unresponsive, you should log in to your Tandem Source account and update the pump's software. Also, Bluetooth settings may be restricted in certain regions like New Zealand, which could affect availability.

This answer is automatically generated

0
Dennis S
July 3, 2025

Able to document a manual insulin injection on my T slim X2 pump?

0
James Crouch
July 2, 2025

How can I find out the date I started using my takin tandem pump

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Sue Keenoy
June 28, 2025

Pump says cannot operate

0
Jessie Mattox
June 26, 2025

How do I get to the home screen where it will show my glucose numbers? See attached to see my home screen after pressing 1,2,3. Thanks

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Summary of Contents for Tandem t:slim X2

  • Page 1 07:35 14 Nov 2019 100% 235 u mg/dL INSULIN ON BOARD 3.4 u BOLUS with Control-IQ Technology Control-IQ: 0.80 u ™ User Guide UNITS OF MEASURE MG/DL...
  • Page 3 Control-IQ technology to operate safely. your safety. It also provides step-by-step instructions on how to properly program, manage and care for your t:slim X2 insulin pump with Control-IQ technology. Changes in equipment, software, or procedures occur periodically;...

  • Page 4: Table Of Contents

    X2 Insulin Pump Precautions ........
  • Page 5 What your t:slim X2 Pump Package Includes ........
  • Page 6 4.14 Sound Volume ................66 4.15 Turn Security PIN On or Off .
  • Page 7 Disconnecting When Using Automated Insulin Dosing ..........104 Chapter 9 • t:slim X2 Insulin Pump Information and History t:slim X2 Pump Info .
  • Page 8 12.15 Data Error Alert ................136 Chapter 13 • t:slim X2 Insulin Pump Alarms 13.1...
  • Page 9 Potential Benefits From Using the t:slim X2 System ....... . .
  • Page 10 Reasons You May Need to Calibrate ............204 Chapter 24 • Viewing CGM Data on Your t:slim X2 Insulin Pump 24.1...
  • Page 11 Chapter 25 • CGM Alerts and Errors 25.1 Startup Calibration Alert ..............215 25.2 Second Startup Calibration Alert .
  • Page 12 26.6 Sensor Inaccuracies ............... 240 Section 4: Control-IQ Technology Features Chapter 27 •...
  • Page 13 X2 Pump Performance Characteristics ........
  • Page 14 Distances Between the t:slim X2 Pump and RF Equipment ....... .

  • Page 15: Section 1: Before You Begin

    Before You Begin CHAPTER 1 Introduction...

  • Page 16: Conventions Of This Guide

    CHAPTER 1 • Introduction 1.1 Conventions of This Guide The following are conventions used in this user guide (such as terms, icons, text formatting, and other conventions) along with their explanations. Formatting Conventions Convention Explanation Bolded Text Text that is in bold in a sentence or step indicates an on-screen icon or physical button name. Italic Text Text that is in italics indicates the name of a screen or menu on the pump display.
  • Page 17 CHAPTER 1 • Introduction Symbol Definitions Symbol Definition Calls out an important note regarding the use or operation of the system. Calls out safety precautions which, if ignored, could result in minor or moderate injury. Calls out critical safety information which, if ignored, could result in serious injury or death. Indicates how the pump responds to the previous instruction.

  • Page 18: Explanation Of Symbols

    The following are symbols (and their descriptions), which you may find on your pump, pump supplies and/or their packaging. These symbols tell you about the proper and safe use of the pump. Some of these symbols may not be relevant in your region, and are listed for informational purposes only. Explanation of t:slim X2 Insulin Pump Symbols Symbol Definition...
  • Page 19 CHAPTER 1 • Introduction Explanation of t:slim X2 Insulin Pump Symbols (Continued) Symbol Definition Symbol Definition Direct Current (DC) voltage Humidity limitation Separate collection for waste electrical and electronic Temperature limit equipment Electric Equipment Designed Primarily for Indoor Use Keep Dry...

  • Page 20: System Description

    The t:slim X2™ insulin pump is made an automated insulin dosing feature. The pump shows sensor glucose up of the t:slim X2 insulin pump, the The addition of this feature enables the readings, a trend graph, as well as the t:slim™...

  • Page 21: Indications For Use

    1.5 Indications for Use the glucose value is predicted to The user guide is organized into exceed a predefined threshold. The t:slim X2 insulin pump with sections. Section 1 provides important interoperable technology (the Pump) is information you need to know before...

  • Page 22: Compatible Icgms

    BG meter until you are It is the responsibility of the healthcare at a time (either the t:slim X2 pump or the familiar with CGM usage. provider and caregiver to determine if...

  • Page 23: Emergency Kit

    WARNING or changes in the pump settings. These items this kit should include. The t:slim X2 insulin pump with Control-IQ changes can potentially lead to hypoglycemia technology should not be used in children under (low BG) or hyperglycemia (high BG) events. See Supplies to carry every day: the age of six years old.
  • Page 24 CHAPTER 1 • Introduction • Infusion sets (minimum of 2) • Insulin pump cartridges (minimum of 2) • Infusion site preparation products (antiseptic wipes, skin adhesive) • Diabetes identification card or jewelry...

  • Page 25: Section 2: T:slim X2 Insulin Pump Features

    X2 Insulin Pump Features CHAPTER 2 Important Safety Information...

  • Page 26: T:slim X2 Insulin Pump Warnings

    CHAPTER 2 • Important Safety Information The following includes important safety Consult with your healthcare provider for your » Demonstrate adequate information related to your t:slim X2™ individual training needs for the pump. Failure to carbohydratecounting skills pump and its components. The complete the necessary training on your pump »...
  • Page 27 Care. Use of cartridges not manufactured by cartridge. This can cause very high BG, or may cause hypoglycemia (low BG) or Tandem Diabetes Care or reuse of cartridges Diabetic Ketoacidosis (DKA). hyperglycemia (high BG) events. may result in over delivery or under delivery of insulin.
  • Page 28 Radiology and Medical Procedures WARNING strangulation or asphyxiation hazard. ALWAYS and Your t:slim X2 System use the appropriate length of infusion set tubing In addition to the above, DO NOT expose your and arrange cables and tubing to minimize the...

  • Page 29: T:slim X2 Insulin Pump Precautions

    The pump is a sealed device that should CHECK your infusion site daily for proper delivery. be opened and repaired only by Tandem placement and leaks. REPLACE your infusion Diabetes Care. Modification could result in a set if you notice leaks around the site.
  • Page 30 CHAPTER 2 • Important Safety Information bed. If you are sleeping, you could fail to hear discontinue use of the pump and contact USB port and confirming that the display turns the Empty Cartridge Alarm and miss part of your Customer Technical Support.

  • Page 31: Potential Benefits From Using Your Pump

    CHAPTER 2 • Important Safety Information of explosion. Remove your pump if you need to and starting or stopping exercise. Your insulin PRECAUTION enter these areas. needs may change in response to lifestyle ENSURE that your personal insulin delivery changes. Your basal rate(s) and other settings settings are programmed into the pump before PRECAUTION may need adjustment.

  • Page 32: Possible Risks From Using Your Pump

    CHAPTER 2 • Important Safety Information based on up to six customizable • The pump keeps track of the 2.4 Possible Risks From Using Personal Profiles, each with up to amount of active insulin from food Your Pump 16 time-based settings for basal and correction boluses (IOB).

  • Page 33: Working With Your Healthcare Provider

    CHAPTER 2 • Important Safety Information Other risks associated with infusion 2.5 Working with your Healthcare 2.6 Verification of Proper sets include occlusions and air bubbles Provider Functionality in the tubing or dislodged cannula, which can affect insulin delivery. If your Any clinical language presented in this A power supply (AC adapter with BG does not decrease after initiating a...
  • Page 34 CHAPTER 2 • Important Safety Information 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/Quick Bolus button when you connect a power source to the USB port.
  • Page 35 X2 Insulin Pump Features CHAPTER 3 Getting to Know Your t:slim X2 Insulin Pump...

  • Page 36: What Your T:slim X2 Pump Package Includes

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump Your pump comes with a protective Supply Reordering 3.1 What your t:slim X2 Pump cover in the place where the cartridge is To order cartridges, infusion sets, Package Includes normally inserted.
  • Page 37 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump Bolus known as the Insulin Sensitivity Factor Load A bolus is a quick dose of insulin that is (ISF). Load refers to the process of removing, usually delivered to cover food eaten or...
  • Page 38 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump Units Units are the measurement for insulin. USB Cable USB is the abbreviation for Universal Serial Bus. The USB cable connects into the pump’s micro USB port.

  • Page 39: Explanation Of T:slim X2 Insulin Pump Icons

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 3.3 Explanation of t:slim X2 Insulin Pump Icons The following icons may appear on your pump screen: Pump Icon Definitions Symbol Definition Symbol Definition The amount of charge left in the pump battery.
  • Page 40 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump Pump Icon Definitions (Continued) Symbol Definition Symbol Definition OK. Tap to confirm the current instruction or setting on the Space. Tap to enter a space on the character keypad.

  • Page 41: Explanation Of Pump Colors

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 3.4 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.

  • Page 42: Lock Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 8. Insulin Level: Displays the current 3.5 Lock Screen amount of insulin in the cartridge. The Lock screen appears anytime you 9. Tandem Logo: Returns to the turn on the screen. You must tap 1–2–3 Home screen.
  • Page 43 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 44: Home Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 8. Insulin Level: Displays the current 3.6 Home Screen amount of insulin in the cartridge. 1. Battery Level: Displays the level of 9. Tandem Logo: Returns to the battery power remaining. When Home screen.
  • Page 45 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 46: Current Status Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 7. Correction Factor: Displays current The mobile connection may not yet 3.7 Current Status Screen correction factor used to calculate a be available in your region. bolus. The Current Status screen can be accessed from the Lock screen and the 8.
  • Page 47 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 48: Bolus Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump  A CGM trend arrow is available 3.8 Bolus Screen on the CGM Home screen : Returns to the Home screen. NOTE For more information about CGM trend 2. Carbs: Enter grams of arrows and how to use them for treatment carbohydrate.
  • Page 49 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump Using Grams Using Units...

  • Page 50: Options Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 8. Device Settings: Display settings, 3.9 Options Screen Bluetooth settings, Time and Date, Sound Volume, and Security PIN. : Returns to the Home screen. 9. History: Displays historical log of 2.
  • Page 51 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 52: My Pump Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 3.10 My Pump Screen : Returns to the Options screen. 2. Personal Profiles: A group of settings that define basal and bolus delivery. 3. Control-IQ: Turn on/off Control-IQ technology and enter required values.
  • Page 53 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 54: Device Settings Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 3.11 Device Settings Screen : Returns to the Options screen. 2. Display Settings: Customize the Screen Timeout settings. 3. Bluetooth Settings: Turn on/off mobile connection. The mobile connection may not yet be available in your region.
  • Page 55 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 56: Number Keypad Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 3.12 Number Keypad Screen 1. Value Entered. : Returns to previous screen. 3. Keypad Numbers. : Allows numbers to be added on the gram screen. If in units, this displays as a decimal point.
  • Page 57 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 58: Letter Keypad Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 3.13 Letter Keypad Screen 1. Name of Profile. : Returns to previous screen. : Enters a space. 4. 123: Changes keypad mode from letters (ABC) to numbers (123). : Saves entered information.
  • Page 59 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...
  • Page 60 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump This Page is Intentionally Left Blank...
  • Page 61 X2 Insulin Pump Features CHAPTER 4 Getting Started...

  • Page 62: Charging The T:slim X2 Pump

    CHAPTER 4 • Getting Started (for example, you will see 100%, 95%, time you are disconnected, you may 4.1 Charging the t:slim X2 Pump 90%, 85%). When the charge amount need to replace missed basal and/or is less than 5%, it will begin decreasing bolus insulin.

  • Page 63: Turning The Pump On

    If these features are not working, press the Screen On/Quick Bolus tandemdiabetes.com. This will also allow discontinue use of the t:slim X2™ pump and button, then use the pad of your finger communication between the pump, the contact Customer Technical Support.

  • Page 64: Turning The T:slim X2 Pump Screen On

    4. Tap 3. under clothing. Touchscreen Tips: When using the pump, tap  The pump screen is now unlocked. the Tandem logo to return to the Home screen The pump continues to function The last screen that was viewed will or tap to return to the previous screen.

  • Page 65: Edit Time

    PRECAUTION ALWAYS make sure that the correct time and Any edits to Time or Date will not be Tap the Tandem logo to return to the date are set on your pump. Not having the saved until you tap Home screen.

  • Page 66: Display Settings

    Basal Limit. You can set your Basal Limit from 0.2 to 15 units per hour. The display settings for your t:slim X2 pump includes Screen Timeout. Work with your healthcare provider to set the proper Basal Limit.

  • Page 67: Mobile Connection

    CHAPTER 4 • Getting Started 7. Tap the Tandem logo to return to 3. Tap Device Settings. minutes have passed, repeat step the Home screen. 4. Tap Bluetooth Settings. 9. Tap to close the PAIRING 4.12 Mobile Connection 5. Tap the on/off toggle next to Mobile CODE screen.

  • Page 68: Sound Volume

    Bolus, Quick Bolus, and Fill Tubing. 8. Using the keypad, enter a number Options for Sound Volume include high, 9. Tap the Tandem logo to return to between four and six digits. A PIN medium, low, and vibrate. the Home screen.
  • Page 69 CHAPTER 4 • Getting Started 1. From the Home screen, tap 11. Use the keypad to enter a new OPTIONS. Security PIN. 2. Tap the Down Arrow. 12. Tap 3. Tap Device Settings. 13. Tap to verify your new Security PIN.
  • Page 70 CHAPTER 4 • Getting Started This Page is Intentionally Left Blank...
  • Page 71 X2 Insulin Pump Features CHAPTER 5 Insulin Delivery Settings...

  • Page 72: Personal Profiles Overview

    Technology. determine and help you adjust your basal rate(s), carb ratio(s), correction factor(s), target The t:slim X2 pump uses the settings in BG, and duration of insulin action. In addition, 5.2 Creating a New Profile your active profile to calculate the...
  • Page 73 CHAPTER 5 • Insulin Delivery Settings • Target BG (your ideal BG level, • Target BG (range: 70 mg/dL to 250 rate to a maximum of 3 units/hour. measured in mg/dL) Examples of CGM readings not being mg/dL) received include when pump and CGM and Although you do not need to define In addition, you can set any or all of the pump are out of range, during the sensor...

  • Page 74: Programming A New Personal Profile

    CHAPTER 5 • Insulin Delivery Settings The insulin duration time is displayed on To use the letter keypad, tap once NOTE the Home screen when the automated for first letter displayed, two quick Carbs Default Setting: If you received a insulin dosing feature is not enabled.
  • Page 75 CHAPTER 5 • Insulin Delivery Settings • You must have Carbs turned on, Timed Settings that 1 unit of insulin will lower BG) and you must set a basal rate, and tap correction factor, carb ratio, and target BG in order to turn the 5.
  • Page 76 CHAPTER 5 • Insulin Delivery Settings  Tap if entered data is 2. Using the on-screen keypad, enter Bolus Settings correct. the time (hour and minutes) that you 1. Tap the Bolus Settings panel. want the segment to begin, and tap ...

  • Page 77: Editing Or Reviewing An Existing Profile

    You can tap segments. steps for Timed Settings and Bolus to navigate to the Personal Profiles list Settings. or tap the Tandem logo to return to the 13. Tap the Bolus Settings panel to Home screen. change Insulin Duration NOTE Carbohydrates as needed.

  • Page 78: Duplicating An Existing Profile

    6. Confirm profile to duplicate by  The Activate and Delete options tapping are disabled for the active profile 15. Tap the Tandem logo to return to because the profile is already the Home screen. 7. Using the on-screen keypad, enter activated.

  • Page 79: Renaming An Existing Profile

     Profile Deleted screen is displayed. minimum allowable rate for delivery. Rename. If you program a Temp Rate more than 7. Tap the Tandem logo to return to 6. Using the on-screen keypad, the maximum allowable basal rate of 15 the Home screen.

  • Page 80: Stopping A Temp Rate

    CHAPTER 5 • Insulin Delivery Settings 2. Tap Activity.  An T in an orange box means a  The TEMP RATE STOPPED screen Temp Rate is active. appears before returning to the 3. Tap Temp Rate. Activity screen.  A T in a red box means a Temp 4.
  • Page 81 X2 Insulin Pump Features CHAPTER 6 Infusion Site Care and Loading Cartridge...

  • Page 82: Infusion Site Selection And Care

    CHAPTER 6 • Infusion Site Care and Loading Cartridge • The abdomen is the most popular set if you notice leaks around the site, or if you 6.1 Infusion Site Selection and suspect your infusion set cannula may have site because of access to fatty Care become dislodged.
  • Page 83 CHAPTER 6 • Infusion Site Care and Loading Cartridge • The infusion set must be replaced and rotated every 48–72 hours, or more often if needed. Areas of Body for Infusion Set Insertion • With experience, you will find areas that not only provide better absorption, but are more comfortable.

  • Page 84: Cartridge Instructions For Use

    • 1 unopened cartridge cartridge into your t:slim X2 pump. The adjustments until the cartridge is filled and single-use disposable cartridge can loaded back onto the pump. Control-IQ •...
  • Page 85 CHAPTER 6 • Infusion Site Care and Loading Cartridge The illustration identifies the Instructions for Drawing Insulin from 1. Inspect the needle and syringe connector and insulin fill port used in Vial into Syringe package for any signs of damage. the cartridge filling process.
  • Page 86 CHAPTER 6 • Infusion Site Care and Loading Cartridge syringe into vial. Maintain pressure 8. Slowly pull back the plunger to the 10. Check the syringe for air bubbles on syringe plunger. desired amount of insulin. and do one of the following: ...
  • Page 87 CHAPTER 6 • Infusion Site Care and Loading Cartridge 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. 4.
  • Page 88 Make sure cartridge is lined up to both guide During the load sequence, the tracks. Tandem logo is disabled. Tapping it 10. Maintain pressure on the plunger will not return to the Home screen. while you remove the needle from the cartridge.

  • Page 89: Filling Tubing

    CHAPTER 6 • Infusion Site Care and Loading Cartridge cartridge onto the pump. Tap the OPTIONS, tap Load, tap Fill Tubing cartridge. This can cause very high BG, or UNLOCK icon when completed. Diabetic Ketoacidosis (DKA). and then follow the instructions. •...
  • Page 90 CHAPTER 6 • Infusion Site Care and Loading Cartridge 4. Attach the infusion set tubing to the while the tubing is being filled, 6. Tap STOP after 3 drops of insulin tubing connector on the cartridge depending on your Sound Volume are seen at the end of the infusion tubing.

  • Page 91: Filling Cannula

    CHAPTER 6 • Infusion Site Care and Loading Cartridge go back to the Fill Tubing 2. Insert a new infusion set and The amount of insulin remaining displayed screen. on the Home screen will decrease 5 units at connect filled tubing to site, then a time (for example, you will see 140, 135, ...

  • Page 92: Setting Site Reminder

    CHAPTER 6 • Infusion Site Care and Loading Cartridge 2. Tap Remind Me In and select the profile must be activated to resume insulin. NOTE number of days (1–3). Tap CLOSE. Stopping Fill: You can tap STOP at any time during the fill process if you want to ...
  • Page 93 X2 Insulin Pump Features CHAPTER 7 Manual Bolus...

  • Page 94: Manual Bolus Overview

    Consult insulin to deliver the bolus. your healthcare provider as needed. WARNING Your t:slim X2 pump offers you the If you do not see a reduction in BG after initiating ability to deliver different boluses to 7.2 Correction Bolus Calculation...
  • Page 95 CHAPTER 7 • Manual Bolus When your glucose value is: Glucose Value Auto-Population with bolus, you might wait 60 minutes to see if your readings respond to the bolus. • Above Target BG: the insulin for the food bolus and the correction bolus PRECAUTION NOTE will be added together.
  • Page 96 CHAPTER 7 • Manual Bolus manually override the glucose value screens to change the sensor glucose decisions, see the CGM manufacturer’s user guide. You can also see Section 24.3 auto-populated from your CGM. value auto-populated from your CGM. Rate of Change Arrows.
  • Page 97 CHAPTER 7 • Manual Bolus pump to calculate and add a correction correction bolus from any other bolus BG Value Manual Entry bolus to any other bolus you request. you request. If your sensor glucose value was not auto-populated on the Bolus screen based on the conditions needed for that feature, you will need to enter your BG value into the pump manually...

  • Page 98: Bolus Override

    CHAPTER 7 • Manual Bolus 1. From the Home screen tap BOLUS. want delivered. The bolus override is WARNING always an available option. ALWAYS confirm that the decimal point 2. Tap Add BG. 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.

  • Page 99: Extended Bolus

    CHAPTER 7 • Manual Bolus 3. Using the on-screen keypad enter 7. Tap 1. From the Home screen, tap grams of carb and tap BOLUS.  The BOLUS INITIATED screen is  To add multiple carb values enter temporarily displayed. 2.

  • Page 100: Max Bolus

    CHAPTER 7 • Manual Bolus 8. Tap 50% under DELIVER NOW to The default maximum duration for 16. Only one extended bolus can be adjust the percentage of the food extended bolus delivery is 8 hours. active at any given time. However, if bolus that is to be delivered The default maximum duration for the DELIVER LATER portion of an...

  • Page 101: Quick Bolus

    CHAPTER 7 • Manual Bolus 5. Tap Max Bolus. NOTE 7.8 Quick Bolus Automated Insulin Dosing and Carbs: It is recommended to use grams of carbohydrate in The Quick Bolus function enables you a bolus delivery whenever eating and using the to deliver a bolus by simply pressing a automated insulin dosing feature.
  • Page 102 X2 pump screen. notify you). Look at the screen to confirm Simply use the Screen On/Quick Bolus 4. After the pump beeps/vibrates, the bolus amount.

  • Page 103: Canceling Or Stopping A Bolus

    CHAPTER 7 • Manual Bolus 2. Tap to cancel the bolus.  The BOLUS STOPPED screen is amount. If the Quick Bolus screen does not display the correct bolus amount, use the displayed and the units delivered touchscreen to enter bolus information. are calculated.
  • Page 104 CHAPTER 7 • Manual Bolus This Page is Intentionally Left Blank...
  • Page 105 X2 Insulin Pump Features CHAPTER 8 Start, Stop, or Resume Insulin...

  • Page 106: Starting Insulin Delivery

    On/Quick Bolus button once to turn on rate are immediately stopped. No insulin delivery adjustments. your t:slim X2 pump screen. insulin delivery can take place while your pump is stopped. 1. Tap 1–2–3.
  • Page 107 X2 Insulin Pump Features CHAPTER 9 t:slim X2 Insulin Pump Information and History...

  • Page 108: T:slim X2 Pump Information

    CHAPTER 9 • t:slim X2 Insulin Pump Information and History the oldest events are removed from the declared. The letter “C” (C: Alert) 9.1 t:slim X2 Pump Info history log and replaced with the most indicates the time it was cleared.
  • Page 109 X2 Insulin Pump Features CHAPTER 10 t:slim X2 Insulin Pump Reminders...

  • Page 110: Low Bg Reminders

    CHAPTER 10 • t:slim X2 Insulin Pump Reminders Your pump lets you know important acknowledged. Reminders do not 6. Low BG is set to on; to turn off, tap information about the System with escalate. Low BG. Reminders, Alerts, and Alarms.

  • Page 111: After Bolus Bg Reminder

    CHAPTER 10 • t:slim X2 Insulin Pump Reminders value is read. When you turn this to 300 mg/dL) that you want to 1. From the Home screen, tap reminder on, you need to set a high trigger the reminder, then tap OPTIONS.

  • Page 112: Missed Meal Bolus Reminder

    CHAPTER 10 • t:slim X2 Insulin Pump Reminders c. Tap Selected Days and tap the To Respond to the Missed Meal Bolus 10.4 Missed Meal Bolus Reminder day(s) you want the reminder to Reminder be on, then tap To clear the reminder tap The Missed Meal Bolus Reminder lets deliver a bolus if necessary.
  • Page 113 X2 Insulin Pump Features CHAPTER 11 User Settable Alerts and Alarms...

  • Page 114: Low Insulin Alerts

    11.1 Low Insulin Alert specified number of hours and the pump will shut down after 60 seconds. Your t:slim X2 pump keeps track of 7. Tap when all changes are When the number of hours since you how much insulin remains in the complete.

  • Page 115: Max Basal Alert

    4.10 Basal Limit), you will receive an alert if the following scenarios occur. 10. Tap the Tandem logo to return to the Home screen. 1. A Temp Rate was requested that exceeds the Basal Limit. To Respond to Auto-Off Warning 2.
  • Page 116 CHAPTER 11 • User Settable Alerts and Alarms the same Basal Limit value that was set up in Personal Profiles.
  • Page 117 X2 Insulin Pump Features CHAPTER 12 t:slim X2 Insulin Pump Alerts...
  • Page 118 CHAPTER 12 • t:slim X2 Insulin Pump Alerts Your pump lets you know important until acknowledged. Alerts do not information about the System with escalate. Reminders, Alerts, and Alarms. NOTE Reminders are displayed to notify you CGM Alerts: There is an additional list of alerts...

  • Page 119: Low Insulin Alerts

    CHAPTER 12 • t:slim X2 Insulin Pump Alerts 12.1 Low Insulin Alert Screen Explanation What will I see on the screen? What does it mean? 5 units or less of insulin remain in the cartridge. 2 sequences of 3 notes or 2 vibrations depending on the volume/ How will the System notify me? vibrate setting selected in Sound Volume.

  • Page 120: Low Power Alerts

    CHAPTER 12 • t:slim X2 Insulin Pump Alerts 12.2 Low Power Alerts Low Power Alert 1 Screen Explanation What will I see on the screen? What does it mean? Less than 25% of battery power remains. 2 sequences of 3 notes or 2 vibrations depending on the volume/ How will the System notify me? vibrate setting selected in Sound Volume.
  • Page 121 CHAPTER 12 • t:slim X2 Insulin Pump Alerts Low Power Alert 2 Screen Explanation What will I see on the screen? Less than 5% of battery power remains. Insulin delivery will What does it mean? continue for 30 minutes and then the pump will power off and insulin delivery will stop.

  • Page 122: Incomplete Bolus Alert

    CHAPTER 12 • t:slim X2 Insulin Pump Alerts 12.3 Incomplete Bolus Alert Screen Explanation What will I see on the screen? You started a bolus request but did not complete the request within What does it mean? 90 seconds. 2 sequences of 3 notes or 2 vibrations depending on the volume/ How will the System notify me? vibrate setting selected in Sound Volume.

  • Page 123: Incomplete Temp Rate Alert

    CHAPTER 12 • t:slim X2 Insulin Pump Alerts 12.4 Incomplete Temp Rate Alert Screen Explanation What will I see on the screen? You started to set up a temp rate but did not complete the request What does it mean? within 90 seconds.

  • Page 124: Incomplete Load Sequence Alerts

    CHAPTER 12 • t:slim X2 Insulin Pump Alerts 12.5 Incomplete Load Sequence Alerts Incomplete Cartridge Change Alert Screen Explanation What will I see on the screen? You selected Change Cartridge from the Load menu but did not What does it mean? complete the process within 3 minutes.
  • Page 125 CHAPTER 12 • t:slim X2 Insulin Pump Alerts Incomplete Fill Tubing Alert Screen Explanation What will I see on the Screen? You selected Fill Tubing from the Load menu but did not complete What does it mean? the process within 3 minutes.
  • Page 126 CHAPTER 12 • t:slim X2 Insulin Pump Alerts Incomplete Fill Cannula Alert Screen Explanation What will I see on the Screen? You selected Fill Cannula from the Load menu but did not complete What does it mean? the process within 3 minutes.

  • Page 127: Incomplete Setting Alert

    CHAPTER 12 • t:slim X2 Insulin Pump Alerts 12.6 Incomplete Setting Alert Screen Explanation What will I see on the screen? You started to set up a new Personal Profile or automated insulin What does it mean? dosing setting but did not save or complete the programming within 5 minutes.

  • Page 128: Basal Rate Required Alert

    CHAPTER 12 • t:slim X2 Insulin Pump Alerts 12.7 Basal Rate Required Alert Screen Explanation What will I see on the screen? You did not enter a basal rate in a time segment in Personal Profiles. What does it mean? A basal rate must be entered in each time segment (rate can be 0 u/ hr).

  • Page 129: Max Hourly Bolus Alert

    CHAPTER 12 • t:slim X2 Insulin Pump Alerts 12.8 Max Hourly Bolus Alert Screen Explanation What will I see on the screen? In the previous 60 minutes, you requested total bolus delivery that is What does it mean? more than 1.5 times your Max Bolus setting.

  • Page 130: Max Bolus Alerts

    CHAPTER 12 • t:slim X2 Insulin Pump Alerts 12.9 Max Bolus Alerts Max Bolus Alert 1 Screen Explanation What will I see on the screen? You requested a bolus larger than the Max Bolus setting in your What does it mean? active Personal Profile.
  • Page 131 CHAPTER 12 • t:slim X2 Insulin Pump Alerts Max Bolus Alert 2 The following applies only if you have Carbs turned on in your active Personal Profile and your Max Bolus amount is set to 25 units. Screen Explanation What will I see on the screen?

  • Page 132: Max Basal Alert

    CHAPTER 12 • t:slim X2 Insulin Pump Alerts 12.10 Max Basal Alert Screen Explanation What will I see on the screen? An active Temp Rate exceeds your Basal Limit setting due to a new What does it mean? timed segment activation within Personal Profiles. This alert will only display once your timed segment changes.

  • Page 133: Min Basal Alerts

    CHAPTER 12 • t:slim X2 Insulin Pump Alerts 12.11 Min Basal Alerts Min Basal Alert 1 Screen Explanation What will I see on the screen? When entering a basal rate or requesting a temp rate, you requested What does it mean? a basal rate less than half of the lowest basal rate defined in your Personal Profile.
  • Page 134 CHAPTER 12 • t:slim X2 Insulin Pump Alerts Min Basal Alert 2 Screen Explanation What will I see on the screen? An active temp rate dropped below half of your lowest basal setting What does it mean? defined in your Personal Profile.

  • Page 135: Connection Error Alert

    CHAPTER 12 • t:slim X2 Insulin Pump Alerts 12.12 Connection Error Alert Screen Explanation What will I see on the screen? You connected pump to a computer with the USB cable to charge it What does it mean? or upload data to the t:connect™ web application and a connection could not be made.

  • Page 136: Pairing Code Timeout

    CHAPTER 12 • t:slim X2 Insulin Pump Alerts 12.13 Pairing Code Timeout Screen Explanation What will I see on the screen? You attempted to connect a mobile device to the pump, but the What does it mean? pairing process took too long (more than 5 minutes) and was unsuccessful.

  • Page 137: Power Source Alert

    CHAPTER 12 • t:slim X2 Insulin Pump Alerts 12.14 Power Source Alert Screen Explanation What will I see on the screen? You connected your pump to a power source that does not have What does it mean? enough power to charge the pump.

  • Page 138: Data Error Alert

    CHAPTER 12 • t:slim X2 Insulin Pump Alerts 12.15 Data Error Alert Screen Explanation What will I see on the screen? Your pump encountered a condition that could potentially result in a What does it mean? loss of data. 2 sequences of 3 notes or 2 vibrations depending on the volume/ How will the System notify me? vibrate setting selected in Sound Volume.
  • Page 139 X2 Insulin Pump Features CHAPTER 13 t:slim X2 Insulin Pump Alarms...
  • Page 140 CHAPTER 13 • t:slim X2 Insulin Pump Alarms Information in this section will help you PRECAUTION learn how to respond to Alarms. CHECK your pump regularly for potential alarm conditions that may display. It is important to be Alarms notify you with 3 sequences of 3...

  • Page 141: Resume Pump Alarms

    CHAPTER 13 • t:slim X2 Insulin Pump Alarms 13.1 Resume Pump Alarm Screen Explanation What will I see on the screen? You selected STOP INSULIN in the Options menu and insulin What does it mean? delivery has been stopped for more than 15 minutes.

  • Page 142: Low Power Alarm

    CHAPTER 13 • t:slim X2 Insulin Pump Alarms 13.2 Low Power Alarm Screen Explanation What will I see on the screen? Your pump detected a power level of 1% or less remaining and all What does it mean? deliveries have stopped.

  • Page 143: Empty Cartridge Alarm

    CHAPTER 13 • t:slim X2 Insulin Pump Alarms 13.3 Empty Cartridge Alarm Screen Explanation What will I see on the screen? Your pump detected that the cartridge is empty and all deliveries What does it mean? have stopped. 3 sequences of 3 notes or 3 vibrations depending on the volume/ How will the System notify me? vibrate setting selected in Sound Volume.

  • Page 144: Cartridge Error Alarm

    CHAPTER 13 • t:slim X2 Insulin Pump Alarms 13.4 Cartridge Error Alarm Screen Explanation What will I see on the screen? Your pump detected that the cartridge could not be used and all deliveries have stopped. This can be caused by cartridge defect, not...

  • Page 145: Cartridge Removal Alarm

    CHAPTER 13 • t:slim X2 Insulin Pump Alarms 13.5 Cartridge Removal Alarm Screen Explanation What will I see on the screen? Your pump detected that the cartridge has been removed and all What does it mean? deliveries have stopped. 3 sequences of 3 notes or 3 vibrations depending on the volume/ How will the System notify me? vibrate setting selected in Sound Volume.

  • Page 146: Temperature Alarm

    CHAPTER 13 • t:slim X2 Insulin Pump Alarms 13.6 Temperature Alarm Screen Explanation What will I see on the screen? Your pump detected an internal temperature below 35ºF (2ºC) or What does it mean? above 113ºF (45ºC) or a battery temperature below 35ºF (2ºC) or above 125ºF (52ºC) and all deliveries have stopped.

  • Page 147: Occlusion Alarms

    CHAPTER 13 • t:slim X2 Insulin Pump Alarms 13.7 Occlusion Alarms Occlusion Alarm 1 Screen Explanation What will I see on the screen? Your pump detected that insulin delivery is blocked and all deliveries have stopped. See Section 33.4 t:slim X2 Pump Performance...
  • Page 148 CHAPTER 13 • t:slim X2 Insulin Pump Alarms Occlusion Alarm 2 Screen Explanation What will I see on the screen? Your pump detected a second occlusion alarm shortly after the first What does it mean? occlusion alarm and all deliveries have stopped.

  • Page 149: Screen On/Quick Bolus Button Alarm

    CHAPTER 13 • t:slim X2 Insulin Pump Alarms 13.8 Screen On/Quick Bolus Button Alarm Screen Explanation What will I see on the screen? The Screen On/Quick Bolus button (on the top of your pump) is What does it mean? stuck or not functioning properly and all deliveries have stopped.

  • Page 150: Altitude Alarm

    CHAPTER 13 • t:slim X2 Insulin Pump Alarms 13.9 Altitude Alarm Screen Explanation What will I see on the screen? Your pump detected a pressure difference between inside the cartridge and the surrounding air within the validated operating What does it mean? range of -1,300 feet to 10,000 feet (-396 meters to 3,048 meters) and all deliveries have stopped.

  • Page 151: Reset Alarm

    CHAPTER 13 • t:slim X2 Insulin Pump Alarms 13.10 Reset Alarm Screen Explanation What will I see on the screen? Your pump detected that one if its micro-processors experienced a What does it mean? reset and all deliveries have been stopped.
  • Page 152 CHAPTER 13 • t:slim X2 Insulin Pump Alarms This Page is Intentionally Left Blank...

  • Page 153: Chapter 14 • T:slim X2 Insulin Pump Malfunction

    X2 Insulin Pump Features CHAPTER 14 t:slim X2 Insulin Pump Malfunction...

  • Page 154: Malfunction

    CHAPTER 14 • t:slim X2 Insulin Pump Malfunction 14.1 Malfunction If your pump detects a system error, the MALFUNCTION screen appears and all deliveries are stopped. Contact Customer Technical Support. Malfunctions notify you with 3 sequences of 3 notes at highest volume and 3 vibrations.
  • Page 155 CHAPTER 14 • t:slim X2 Insulin Pump Malfunction Screen Explanation What will I see on the screen? Your pump detected a system error and all deliveries have been What does it mean? stopped. How will the System notify me? 3 sequences of 3 notes at highest volume and 3 vibrations.
  • Page 156 CHAPTER 14 • t:slim X2 Insulin Pump Malfunction This Page is Intentionally Left Blank...
  • Page 157 X2 Insulin Pump Features CHAPTER 15 Taking Care of Your Pump...

  • Page 158: Overview

    CHAPTER 15 • Taking Care of Your Pump Inspecting Your Pump for Damage pump in storage mode. To place the 15.1 Overview pump in storage mode, connect the PRECAUTION pump to a power source and then This section provides information on DO NOT use your pump if you think it might be press and hold down the Screen On/ caring for and maintaining your pump.
  • Page 159 X2 Insulin Pump Features CHAPTER 16 Lifestyles Issues and Travel...

  • Page 160: Overview

    CHAPTER 16 • Lifestyles Issues and Travel periods of time. If planning to period of time. Your pump should not 16.1 Overview disconnect from your pump, discuss a be worn in hot tubs or Jacuzzis. plan with your healthcare provider to Extreme Altitudes While the convenience and flexibility of compensate for any basal insulin...
  • Page 161 BG to rise. used for carry-on and checked luggage. Newer travel loaner pump in case your pump full body scanners used in airport security malfunctions outside of Tandem’s Travel screening are also a form of X-ray and your replacement area.
  • Page 162 CHAPTER 16 • Lifestyles Issues and Travel This Page is Intentionally Left Blank...

  • Page 163: Section 3: Cgm Features

    CGM Features CHAPTER 17 Important CGM Safety Information...

  • Page 164: Cgm Warnings

    CHAPTER 17 • Important CGM Safety Information The following includes important safety broken sensor wire, please report this to sensor glucose readings to be inaccurate and information related to your CGM and its Customer Technical Support. could result in you missing severe hypoglycemia components.

  • Page 165: Cgm Precautions

    Using Dexcom G6 CGM with Your areas of skin with scarring, tattoos, or irritation enter the exact BG value that your BG meter t:slim X2 Insulin Pump as these are not ideal sites to measure sensor displays within 5 minutes of a carefully glucose.
  • Page 166 CHAPTER 17 • Important CGM Safety Information hypoglycemia (low BG) or hyperglycemia (high PRECAUTION PRECAUTION BG) events. DO NOT use alternative BG site testing (blood The Dexcom G6 sensor is not compatible with from your palm or forearm, etc.) for calibration. older versions of transmitters or receivers.

  • Page 167: Potential Benefits From Using The T:slim X2 System

    The Diabetes Control and 17.3 Potential Benefits From Using (lowered A1C values, reduced Complications Research Group. The the t:slim X2 System glycemic variability and time spent effect of intensive treatment of diabetes in low and high BG ranges) on the development and progression of 1, 2, 3 •...

  • Page 168: Possible Risks From Using The T:slim X2 System

    CHAPTER 17 • Important CGM Safety Information G6 CGM takes readings from fluid 17.4 Possible Risks From Using the below the skin (interstitial fluid) t:slim X2 System instead of blood. There are differences in how glucose is Inserting the sensor and wearing the...
  • Page 169 CGM Features CHAPTER 18 Getting to Know Your CGM System...

  • Page 170: Cgm Terminology

    CHAPTER 18 • Getting to Know Your CGM System every 5 seconds until your sensor Sensor 18.1 CGM Terminology glucose value rises above 55 mg/dL or The sensor is the part that of the CGM you confirm it. This alert can be helpful if includes an applicator and wire.
  • Page 171 CHAPTER 18 • Getting to Know Your CGM System System Reading A System reading is a sensor glucose reading shown on your pump. This reading is in mg/dL units and is updated every 5 minutes. Transmitter The transmitter is the part of the CGM that snaps into the sensor pod and wirelessly sends sensor glucose information to your pump.

  • Page 172: Explanation Of Cgm Pump Icons

    CHAPTER 18 • Getting to Know Your CGM System 18.2 Explanation of CGM Pump Icons The following CGM icons may appear on your pump screen: CGM Icon Definitions Symbol Meaning Symbol Meaning Unknown sensor reading. Transmitter error. CGM sensor session is active, but the transmitter and pump CGM sensor session is active, and the transmitter is are out of range.
  • Page 173 CHAPTER 18 • Getting to Know Your CGM System This Page is Intentionally Left Blank...

  • Page 174: Cgm Lock Screen

    CHAPTER 18 • Getting to Know Your CGM System 9. Active Bolus Icon: Indicates a 18.3 CGM Lock Screen bolus is being delivered. The CGM Lock screen appears anytime 10. Status: Displays current system you turn on the screen and you are settings and insulin delivery status.
  • Page 175 CHAPTER 18 • Getting to Know Your CGM System...

  • Page 176: Cgm Home Screen

    CHAPTER 18 • Getting to Know Your CGM System 10. Status: Displays current system To view CGM information on the full 18.4 CGM Home Screen settings and insulin delivery status. screen: From the CGM Home screen tap 1. Time and Date Display: Displays 11.
  • Page 177 CHAPTER 18 • Getting to Know Your CGM System...

  • Page 178: My Cgm Screen

    CHAPTER 18 • Getting to Know Your CGM System 18.5 My CGM Screen 1. Start Sensor: Starts a CGM session. If sensor is active, STOP SENSOR will be displayed. 2. Calibrate CGM: Enter a calibration BG value. Only active when sensor session is active.
  • Page 179 CHAPTER 18 • Getting to Know Your CGM System...
  • Page 180 CHAPTER 18 • Getting to Know Your CGM System This Page is Intentionally Left Blank...
  • Page 181 CGM Features CHAPTER 19 CGM Overview...

  • Page 182: Cgm System Overview

    CGM with your wireless technology communication to spot potential low or high sensor t:slim X2 pump. Use of a CGM is and sends readings to the pump glucose sooner than you would using a optional, but in order to use an display every 5 minutes.
  • Page 183 CHAPTER 19 • CGM Overview glucose information to your pump. If • Can transmit data to your pump for the same side of the body that you wear your you have a new transmitter, only open up to 20 feet (6 meters). Range is CGM.

  • Page 184: Sensor Overview

    CHAPTER 19 • CGM Overview 19.4 Sensor Overview This section provides information about CGM devices that have a separate sensor. The information contained in this section is specific to the Dexcom G6 CGM and is provided as an example. For information about the Dexcom G6 sensor, visit the manufacturer’s website for applicable user guides.
  • Page 185 CGM Features CHAPTER 20 CGM Settings...

  • Page 186: About Bluetooth

    Your t:slim X2 pump and a CGM 3. Tap the Down Arrow. transmitter wirelessly pair together with You may still use a smartphone with the other devices using Bluetooth wireless 4.

  • Page 187: Setting Cgm Volume

    CHAPTER 20 • CGM Settings 9. Repeat step 6 above, then tap at 55 mg/dL, which alerts you as a The Soft, Normal, and HypoRepeat vibration first, followed by beeps 5 options have the following sequence: If the transmitter IDs you entered do minutes later if not confirmed.
  • Page 188 CHAPTER 20 • CGM Settings Sound Option Descriptions CGM Volume Vibrate Soft Normal HypoRepeat 2 long vibrates + 2 long vibrates + 2 long vibrates + High Alert 2 long vibrates 2 low beeps 2 medium beeps 2 medium beeps 3 short vibrates + 3 short vibrates + 3 short vibrates +...

  • Page 189: Cgm Info

    CHAPTER 20 • CGM Settings • Hardware Revision To Select Your CGM Volume: 1. From the Home screen, tap • BLE Hardware ID OPTIONS. • Software Number 2. Tap the Down Arrow. You can view this information at any time. 3.
  • Page 190 CHAPTER 20 • CGM Settings This Page is Intentionally Left Blank...
  • Page 191 CGM Features CHAPTER 21 Setting CGM Alerts...

  • Page 192: Setting Your High Glucose Alerts And Repeat Feature

    CHAPTER 21 • Setting CGM Alerts Setting Your CGM Alerts and the pump within 20 feet (6 meters) 4. Tap CGM Alerts. of each other without obstruction. You can create personal settings for When the transmitter and the pump are 5.

  • Page 193: Setting Your Low Glucose Alert And Repeat Feature

    CHAPTER 21 • Setting CGM Alerts the repeat feature to sound again 9. Tap 21.2 Setting Your Low Glucose Alert every 15 minutes, 30 minutes, 1 and Repeat Feature hour, 2 hours, 3 hours, 4 hours, or The repeat feature allows you to set 5 hours when your sensor glucose a time for the Low Alert to sound 1.

  • Page 194: Rate Alerts

    CHAPTER 21 • Setting CGM Alerts  Once a value is selected, the pump beeps according to your CGM volume 21.4 Setting Your Rise Alert will return to the previous screen. selection. 1. From the Home screen, tap 12. Tap OPTIONS.

  • Page 195: Setting Your Fall Alert

    CHAPTER 21 • Setting CGM Alerts alerts. The default value is on and will 21.5 Setting Your Fall Alert 21.6 Setting Your Out of Range alert after 20 minutes. Alert The Out Of Range symbol appears on 1. From the Home screen, tap the pump Home screen and on the Out The range from the transmitter to the OPTIONS.
  • Page 196 CHAPTER 21 • Setting CGM Alerts 4. Tap CGM Alerts. 5. Tap Out of Range. The default is set to on and the time is set to 20 minutes. 6. To change the time, tap Alert After. 7. Using the on-screen keypad, enter the time after which you want to be alerted (between 20 minutes and 3 hours and 20 minutes) then tap...
  • Page 197 CGM Features CHAPTER 22 Start or Stop a CGM Sensor Session...

  • Page 198: Start The Sensor

    If you don't enter a code into either the antenna symbol is grayed out, sensor code, or to skip this step. If the t:slim X2 pump or the Dexcom follow these troubleshooting tips: you choose to enter the sensor G6 CGM app you will need to...

  • Page 199: Sensor Startup Period

    CHAPTER 22 • Start or Stop a CGM Sensor Session b. If the pump and transmitter are Sensor Startup Period Timeline 22.2 Sensor Startup Period still not communicating, check the My CGM screen to make As an example, the Dexcom G6 sensor sure the correct transmitter ID is Start needs a 2-hour startup period to adjust...
  • Page 200 CHAPTER 22 • Start or Stop a CGM Sensor Session If you started your sensor session 90 Follow the instructions in the next WARNING minutes ago, you would see this chapter to calibrate your sensor. Skip Continue to use a BG meter and test strips in countdown symbol on the CGM Home the calibration instructions if you order to make treatment decisions during the 2-...

  • Page 201: Automatic Sensor Shut-Off

    22.3 Automatic Sensor Shut-Off New sensor glucose readings do not New sensor glucose readings do not Your t:slim X2 pump tells you how show on your pump after your sensor show on your pump after your sensor much time you have left until your session ends.
  • Page 202 CHAPTER 22 • Start or Stop a CGM Sensor Session This Page is Intentionally Left Blank...
  • Page 203 CGM Features CHAPTER 23 Calibrating Your CGM System...

  • Page 204: Calibration Overview

    CHAPTER 23 • Calibrating Your CGM System • Make sure the antenna symbol is PRECAUTION 23.1 Calibration Overview visible to the right of the battery DO NOT calibrate when your trend arrow is up, indicator on the CGM Home screen double-up, down, or double-down because your If you did not enter a CGM sensor code and is active (white, not greyed out)
  • Page 205 CHAPTER 23 • Calibrating Your CGM System sample to the test strip following NOTE hypoglycemia (low BG) or hyperglycemia your BG meter manufacturer’s (high BG) events. Sensor Code: The instructions in this section do instructions. not apply if you entered the sensor code when 9.

  • Page 206: Calibration Bg Value And Correction Bolus

    23.3 Calibration BG Value and Calibrate Correction Bolus You may need to calibrate if your Your t:slim X2 pump uses the BG value symptoms do not match the sensor entered for calibration to determine if a glucose values provided by your CGM.
  • Page 207 CGM Features CHAPTER 24 Viewing CGM Data on Your t:slim X2 Insulin Pump...

  • Page 208: Overview

    CHAPTER 24 • Viewing CGM Data on Your t:slim X2 Insulin Pump Your BG meter measures glucose in • The current time and date are 24.1 Overview your blood. Your sensor measures shown at the top of the screen in glucose from interstitial fluid (the fluid the middle.

  • Page 209: Cgm Trend Graphs

    CHAPTER 24 • Viewing CGM Data on Your t:slim X2 Insulin Pump • If your sensor glucose reading is 55 To view different Trend Graph times, with the last 6 hours of sensor glucose mg/dL or lower, it is shown in red, tap on the Trend Graph Time (HRS) to readings.

  • Page 210: Rate Of Change Arrows

    CHAPTER 24 • Viewing CGM Data on Your t:slim X2 Insulin Pump with the last 24 hours of sensor glucose LOW shows when your most recent 24.3 Rate of Change Arrows readings. sensor glucose reading is less than 40 mg/dL.
  • Page 211 CHAPTER 24 • Viewing CGM Data on Your t:slim X2 Insulin Pump condition, an arrow may not display. If the trend arrow is missing, and you are concerned that your BG level may be rising or falling, take a BG measurement...
  • Page 212 CHAPTER 24 • Viewing CGM Data on Your t:slim X2 Insulin Pump The table below shows the different trend arrows your receiver or pump displays: Trend Arrow Definitions Constant: Your sensor glucose is steady (not increasing/ Slowly falling: Your sensor glucose is falling 1–2 mg/dL decreasing more than 1 mg/dL each minute).

  • Page 213: Cgm History

    CHAPTER 24 • Viewing CGM Data on Your t:slim X2 Insulin Pump the time it was declared. The letter “C” screen and on the CGM Lock screen. 24.4 CGM History (C: Alert) indicates the time it was The system will automatically attempt cleared.
  • Page 214 CHAPTER 24 • Viewing CGM Data on Your t:slim X2 Insulin Pump This Page is Intentionally Left Blank...
  • Page 215 CGM Features CHAPTER 25 CGM Alerts and Errors...
  • Page 216 Control-IQ technology to be enabled, a sensor session must be started and transmitting sensor values to the pump based on a sensor code or sensor calibration. PRECAUTION You must customize the CGM alert settings on your t:slim X2 pump and the Dexcom G6 CGM...

  • Page 217: Startup Calibration Alerts

    CHAPTER 25 • CGM Alerts and Errors 25.1 Startup Calibration Alert Screen Explanation What will I see on the screen? 2-hour CGM startup period is complete. This will only appear if you What does it mean? did not enter a sensor code. How will the System notify me? 1 vibration, then vibration/beep every 5 minutes until confirmed.

  • Page 218: Second Startup Calibration Alert

    CHAPTER 25 • CGM Alerts and Errors 25.2 Second Startup Calibration Alert Screen Explanation What will I see on the screen? The System needs an additional BG value to complete startup What does it mean? calibration. This will only appear if you did not enter a sensor code. How will the System notify me? 1 vibration, then vibration/beep every 5 minutes until confirmed.

  • Page 219: Hour Calibration Alert

    CHAPTER 25 • CGM Alerts and Errors 25.3 12 Hour Calibration Alert Screen Explanation What will I see on the screen? The System needs a BG value to calibrate. This will only appear if What does it mean? you did not enter a sensor code. How will the System notify me? On screen only with no vibration or beep.

  • Page 220: Incomplete Calibration

    CHAPTER 25 • CGM Alerts and Errors 25.4 Incomplete Calibration Screen Explanation What will I see on the screen? If you start to enter a calibration value using the keypad and do not What does it mean? complete the entry within 90 seconds, this screen appears. How will the System notify me? 2 beeps or vibrations depending on Sound Volume selected.

  • Page 221: Calibration Timeout

    CHAPTER 25 • CGM Alerts and Errors 25.5 Calibration Timeout Screen Explanation What will I see on the screen? If you start to enter a calibration value using the keypad and do not What does it mean? complete the entry within 5 minutes, this screen appears. How will the System notify me? 2 beeps or vibrations depending on Sound Volume selected.

  • Page 222: Wait 15 Minute Calibration Error Alert

    CHAPTER 25 • CGM Alerts and Errors 25.6 Wait 15 Minute Calibration Error Alert Screen Explanation What will I see on the screen? What does it mean? The sensor cannot calibrate. How will the System notify me? 1 vibration, then vibration/beep every 5 minutes until confirmed. Will the System re-notify me? to confirm.

  • Page 223: Calibration Required Alert

    CHAPTER 25 • CGM Alerts and Errors 25.7 Calibration Required Alert Screen Explanation What will I see on the screen? The System needs a BG value to calibrate. Sensor glucose readings What does it mean? will not be displayed at this time. How will the System notify me? 1 vibration, then vibration/beep every 5 minutes until confirmed.

  • Page 224: Cgm High Alert

    CHAPTER 25 • CGM Alerts and Errors 25.8 CGM High Alert Screen Explanation What will I see on the screen? Your most recent sensor glucose reading is at or above the High What does it mean? Alert setting. 2 vibrations, then 2 vibrations/beeps every 5 minutes until How will the System notify me? confirmed or your sensor glucose value drops below the Alert level.

  • Page 225: Cgm Low Alert

    CHAPTER 25 • CGM Alerts and Errors 25.9 CGM Low Alert Screen Explanation What will I see on the screen? Your most recent sensor glucose reading is at or below the Low What does it mean? Alert setting. 3 vibrations, then 3 vibrations/beeps every 5 minutes until How will the System notify me? confirmed or your sensor glucose value goes above the Alert level.

  • Page 226: Cgm Fixed Low Alert

    CHAPTER 25 • CGM Alerts and Errors 25.10 CGM Fixed Low Alert Screen Explanation What will I see on the screen? What does it mean? Your most recent sensor glucose reading is at or below 55 mg/dL. 4 Vibrations, then 4 vibrations/beeps every 5 minutes until How will the System notify me? confirmed or your sensor glucose value goes above 55 mg/dL.

  • Page 227: Cgm Rise Alert

    CHAPTER 25 • CGM Alerts and Errors 25.11 CGM Rise Alert Screen Explanation What will I see on the screen? Your sensor glucose levels are rising at 2 mg/dL per minute or faster What does it mean? (at least 30 mg/dL in 15 minutes). 2 vibrations, then 2 vibrations/beeps every 5 minutes or until How will the System notify me? confirmed.

  • Page 228: Cgm Rapid Rise Alert

    CHAPTER 25 • CGM Alerts and Errors 25.12 CGM Rapid Rise Alert Screen Explanation What will I see on the screen? Your sensor glucose levels are rising at 3 mg/dL per minute or faster What does it mean? (at least 45 mg/dL in 15 minutes). 2 vibrations, then 2 vibrations/beeps every 5 minutes or until How will the System notify me? confirmed.

  • Page 229: Cgm Fall Alert

    CHAPTER 25 • CGM Alerts and Errors 25.13 CGM Fall Alert Screen Explanation What will I see on the screen? Your sensor glucose levels are falling at 2 mg/dL per minute or What does it mean? faster (at least 30 mg/dL in 15 minutes). 3 vibrations, then 3 vibrations/beeps every 5 minutes or until How will the System notify me? confirmed.

  • Page 230: Cgm Rapid Fall Alert

    CHAPTER 25 • CGM Alerts and Errors 25.14 CGM Rapid Fall Alert Screen Explanation What will I see on the screen? Your sensor glucose levels are falling at 3 mg/dL per minute or What does it mean? faster (at least 45 mg/dL in 15 minutes). 3 vibrations, then 3 vibrations/beeps every 5 minutes or until How will the System notify me? confirmed.

  • Page 231: Unknown Sensor Glucose Reading

    CHAPTER 25 • CGM Alerts and Errors 25.15 Unknown Sensor Glucose Reading Screen Explanation What will I see on the screen? The sensor is sending sensor glucose readings that the System What does it mean? does not understand. You will not receive sensor glucose readings. How will the System notify me? On screen only with no vibration or beep.

  • Page 232: Out Of Range Alert

    CHAPTER 25 • CGM Alerts and Errors 25.16 Out of Range Alert Screen Explanation What will I see on the screen? The transmitter and pump are not communicating. The pump will not receive sensor glucose readings, and the automated insulin What does it mean? dosing feature is not able to predict sensor glucose levels or adjust insulin delivery.

  • Page 233: Low Transmitter Battery Alert

    CHAPTER 25 • CGM Alerts and Errors 25.17 Low Transmitter Battery Alert Screen Explanation What will I see on the screen? What does it mean? Transmitter battery is low. How will the System notify me? 1 vibration, then vibration/beep every 5 minutes until confirmed. Yes, the alarm will notify you when there are 21, 14, and 7 days of Will the System re-notify me? transmitter battery life remaining.

  • Page 234: Transmitter Error

    CHAPTER 25 • CGM Alerts and Errors 25.18 Transmitter Error Screen Explanation What will I see on the screen? What does it mean? The transmitter has failed and the CGM session has stopped. How will the System notify me? 1 vibration, then vibration/beep every 5 minutes. Will the System re-notify me? Tap MORE INFO.

  • Page 235: Failed Sensor Error

    CHAPTER 25 • CGM Alerts and Errors 25.19 Failed Sensor Error Screen Explanation What will I see on the screen? The sensor is not working properly and the CGM session has What does it mean? stopped. How will the System notify me? 1 vibration, then vibration/beep every 5 minutes.

  • Page 236: Cgm Unavailable

    CHAPTER 25 • CGM Alerts and Errors 25.20 CGM Unavailable What will I see on the screen? Your CGM session has been stopped for more than 20 minutes and What does it mean? the CGM can no longer be used. 2 vibrations, then 2 vibrations/beeps every 5 minutes or until How will the System notify me? confirmed.

  • Page 237: Cgm System Error

    CHAPTER 25 • CGM Alerts and Errors 25.21 CGM System Error Screen Explanation What will I see on the screen? Your CGM System is not working properly; the CGM session has What does it mean? stopped and the CGM can no longer be used. How will the System notify me? 1 vibration, then vibration/beep every 5 minutes.
  • Page 238 CHAPTER 25 • CGM Alerts and Errors This Page is Intentionally Left Blank...
  • Page 239 CGM Features CHAPTER 26 CGM Troubleshooting...

  • Page 240: Cgm Pairing Troubleshooting

    CHAPTER 26 • CGM Troubleshooting This chapter provides helpful tips and G6 CGM app and your t:slim X2 insulin Do not calibrate if your BG value is instructions to help you fix issues you pump simultaneously with the same below 40 mg/dL or above 400 mg/dL.

  • Page 241: Out Of Range/No Antenna Troubleshooting

    10 settings in your active Personal Profile, limited to minutes for your t:slim X2 pump to start • Make sure your sensor pod is not communicating with your transmitter.

  • Page 242: Failed Sensor Troubleshooting

    CHAPTER 26 • CGM Troubleshooting another BG measurement. If the 26.5 Failed Sensor Troubleshooting 26.6 Sensor Inaccuracies difference between this second BG measurement and the sensor is still The System may detect issues with Inaccuracies are usually related to your greater than 20% for sensor readings your sensor where it cannot determine sensor only and not to your transmitter...
  • Page 243 CHAPTER 26 • CGM Troubleshooting more of your values is outside of this range, the receiver will not calibrate. • Use the same BG meter you routinely use to measure your BG to calibrate. Do not switch your BG meter in the middle of a sensor session.
  • Page 244 CHAPTER 26 • CGM Troubleshooting This Page is Intentionally Left Blank...

  • Page 245: Section 4: Control-Iq Technology Features

    Control-IQ Technology Features CHAPTER 27 Control-IQ Technology Important Safety Information...

  • Page 246: Control-Iq Warnings

    If you remove your pump for a period of time, up which can lead to severe hypoglycemia (low BG) The t:slim X2 insulin pump with Control-IQ to 30 minutes or longer, it is recommended that or hyperglycemia (high BG) events.
  • Page 247 CHAPTER 27 • Control-IQ Technology Important Safety Information PRECAUTION We recommend that you keep the CGM Out of Range Alert turned on to notify you if your CGM is disconnected from your pump whenever you are not actively monitoring your pump status. Your CGM is providing the data that Control-IQ technology requires to make predictions to automate insulin dosing.
  • Page 248 CHAPTER 27 • Control-IQ Technology Important Safety Information This Page is Intentionally Left Blank...
  • Page 249 Control-IQ Technology Features CHAPTER 28 Getting to Know Control-IQ Technology...

  • Page 250: Responsible Use Of Control-Iq Technology

    CHAPTER 28 • Getting to Know Control-IQ Technology 28.1 Responsible Use of Control-IQ Technology Systems like the t:slim X2 insulin pump with Control-IQ™ technology are not substitutes for the active management of diabetes, including manually bolusing for meals. There are common scenarios in which automated systems cannot prevent a hypoglycemic event.

  • Page 251: Explanation Of Control-Iq Technology Icons

    CHAPTER 28 • Getting to Know Control-IQ Technology 28.2 Explanation of Control-IQ Technology Icons If you have a CGM session active and are using Control-IQ technology, you may see the following additional icons on your pump screen: Control-IQ Technology Icon Definitions Symbol Meaning Symbol...

  • Page 252: Control-Iq Lock Screen

    CHAPTER 28 • Getting to Know Control-IQ Technology 28.3 Control-IQ Lock Screen The Control-IQ Lock screen appears any time you turn on the screen and you are using your pump with a CGM and Control-IQ technology enabled. The Control-IQ Lock screen is the same as the CGM Lock screen, with the following additions.
  • Page 253 CHAPTER 28 • Getting to Know Control-IQ Technology...

  • Page 254: Control-Iq Home Screen

    CHAPTER 28 • Getting to Know Control-IQ Technology 28.4 Control-IQ Home Screen The Home screen with Control-IQ technology enabled is identical to the CGM Home screen, with the following additions. See Section 18.4 CGM Home Screen. 1. Control-IQ Technology Status: Indicates the status of Control-IQ technology.
  • Page 255 CHAPTER 28 • Getting to Know Control-IQ Technology...

  • Page 256: Control-Iq Screen

    CHAPTER 28 • Getting to Know Control-IQ Technology 28.5 Control-IQ Screen 1. Control-IQ Technology on/off: Turns on, or off, Control-IQ technology. 2. Weight: Displays your current weight. This value is manually entered in on the numerical keypad. NOTE Control-IQ Weight: Your weight should be representative of what you weigh when you start the system.
  • Page 257 CHAPTER 28 • Getting to Know Control-IQ Technology...
  • Page 258 CHAPTER 28 • Getting to Know Control-IQ Technology This Page is Intentionally Left Blank...
  • Page 259 Control-IQ Technology Features CHAPTER 29 Introduction to Control-IQ Technology...

  • Page 260: Control-Iq Technology Overview

    Control-IQ™ technology is a feature of food and correction boluses will be active in the Do not use Control-IQ technology unless the t:slim X2™ pump that automatically body, is not displayed when Control-IQ recommended by your healthcare provider. adjusts insulin delivery rates and...
  • Page 261 CHAPTER 29 • Introduction to Control-IQ Technology predicts CGM values 30 minutes in the whether you are sleeping, exercising, or 30 minute predictions to gradually future. Insulin delivery is automatically neither. For more detail on how insulin decrease insulin delivery compared to adjusted based on the predicted CGM adjustments are made for different the personal profile basal rate.
  • Page 262 CHAPTER 29 • Introduction to Control-IQ Technology Current 30 minute Reading Prediction 112.5 112.5 CGM SENSOR READINGS CGM SENSOR READINGS INSULIN DELIVERY INSULIN DELIVERY 5-minute Interval CGM Prediction Personal Profile Basal Rate Control-IQ Decreased Basal Rate NOTE Diagrams are Illustrative: Diagrams are for illustrative purposes only and are not intended to reflect actual results.
  • Page 263 CHAPTER 29 • Introduction to Control-IQ Technology Insulin Decreased or Delivering 0 Units per Hour Control-IQ technology can reduce the basal delivery to a percent of the basal rate in addition to completely suspending. When Control-IQ technology predicts that your sensor glucose value will be lower than the target range 30 minutes in the future, insulin delivery will decrease and may...
  • Page 264 CHAPTER 29 • Introduction to Control-IQ Technology Current 30 minute Delivery Delivery 30 minute Reading Prediction at 0 u/hr Resumed Prediction CGM SENSOR READINGS CGM SENSOR READINGS INSULIN DELIVERY INSULIN DELIVERY 5-minute Interval CGM Prediction Control-IQ Decreased Basal Rate NOTE Diagrams are Illustrative: Diagrams are for illustrative purposes only and are not intended to reflect actual results.
  • Page 265 CHAPTER 29 • Introduction to Control-IQ Technology Increasing Insulin Delivery When Control-IQ technology predicts that your sensor glucose value will be above the upper limit of the targeted range 30 minutes in the future, the rate of insulin delivered will begin to increase to attempt to keep the actual CGM values within the target CGM range.
  • Page 266 CHAPTER 29 • Introduction to Control-IQ Technology Current 30 minute Current 30 minute Reading Prediction Reading Prediction CGM SENSOR READINGS CGM SENSOR READINGS INSULIN DELIVERY INSULIN DELIVERY 5-minute Interval CGM Prediction Personal Profile Basal Rate Control-IQ Increased Basal Rate Control-IQ Max Basal Rate NOTE Diagrams are Illustrative: Diagrams are for illustrative purposes only and are not intended to reflect actual results.
  • Page 267 CHAPTER 29 • Introduction to Control-IQ Technology Automatic Correction Bolus Delivery NOTE icon and message indicate that an automatic correction bolus is being delivered. Automatic Correction Bolus Delivery: Each When Control-IQ technology predicts automatic correction bolus delivery can be that your CGM value will be at or above manually canceled or stopped during the 180 mg/dL 30 minutes in the future, delivery in the same way that a Manual Bolus...
  • Page 268 CHAPTER 29 • Introduction to Control-IQ Technology Current 30 minute Reading Prediction 5-minute Interval CGM Prediction Personal Profile Basal Rate CGM SENSOR READINGS Control-IQ Increased Basal Rate Control-IQ Max Basal Rate Automatic Correction Bolus INSULIN DELIVERY NOTE Diagrams are Illustrative: Diagrams are for illustrative purposes only and are not intended to reflect actual results.

  • Page 269: Control-Iq Technology And Activity

    CHAPTER 29 • Introduction to Control-IQ Technology Suspended Insulin With No Activity Section Manually Start Sleep 29.3 Control-IQ Technology and Enabled starting Sleep manually in that chapter. Activity Insulin is set to 0 units/hour when The CGM range targeted by Control-IQ Control-IQ technology predicts a CGM technology during Sleep is 112.5 mg/ When Control-IQ technology is turned...
  • Page 270 CHAPTER 29 • Introduction to Control-IQ Technology Automatic Correction Bolus During enabled CGM range occurs slowly and reading ≤80 mg/dL 30 minutes in the Sleep Activity can take 30-60 minutes. This helps future. Automatic correction boluses will not ensure that actual CGM values Increasing Insulin During Exercise be delivered while Sleep is enabled.
  • Page 271 Control-IQ Technology Features CHAPTER 30 Configure and Use Control-IQ Technology...

  • Page 272: Required Settings

    CHAPTER 30 • Configure and Use Control-IQ Technology Recommended Control-IQ 30.1 Required Settings Technology Pump Settings Although Sleep can be started and Required Personal Profile Settings stopped manually, it is recommended In order to use Control-IQ™ that you schedule sleep. This chapter technology, the following Personal explains how to do both.

  • Page 273: Set Total Daily Insulin

    8. When you are done setting up An estimate of Total Daily Insulin should Control-IQ off. Control-IQ, tap the Tandem logo to be entered. Include all types of insulin return to the CGM Home screen. (basal and bolus) delivered in a 24-hour ...

  • Page 274: Schedule Sleep

    CHAPTER 30 • Configure and Use Control-IQ Technology  If you are editing an existing NOTE 30.5 Schedule Sleep schedule, tap the schedule Scheduled Sleep and Exercise: If Exercise is summary that displays to the active at the time sleep is scheduled to start, Control-IQ technology operates right of the sleep schedule you Sleep will not begin.

  • Page 275: Activate Or Deactivate A Sleep Schedule

    . You are returned to the sleep, press to return to the Start Time screen. Activity screen or tap the Tandem logo to return to the Home screen. 12. Tap AM or PM to set the Time of Day, if applicable.

  • Page 276: Manually Start Or Stop Sleep

    CHAPTER 30 • Configure and Use Control-IQ Technology 3. Tap Sleep Schedules. Tap the schedule summary next to Manually Start Sleep the Sleep Schedule you want to 1. From the Home screen, tap 4. Tap the schedule summary next to deactivate.

  • Page 277: Manually Start Or Stop Exercise

    CHAPTER 30 • Configure and Use Control-IQ Technology 3. Tap the STOP text next to Sleep.  An EXERCISE STARTED message color and its meaning can be found in is temporarily displayed. The Section 28.2 Explanation of Control-IQ Exercise icon is displayed on the Technology Icons.
  • Page 278 Control-IQ technology is screen; see the Section 3.3 Explanation indicate the times when Control-IQ operating. Each different color and its of t:slim X2 Insulin Pump Icons for the technology was delivering 0 units/hour. meaning can be found in Section 28.2 manual bolus icon image.) The following...
  • Page 279 CHAPTER 30 • Configure and Use Control-IQ Technology Each dot on the CGM graph represents a five-minute increment.
  • Page 280 CHAPTER 30 • Configure and Use Control-IQ Technology This Page is Intentionally Left Blank...
  • Page 281 Control-IQ Technology Features CHAPTER 31 Control-IQ Technology Alerts...
  • Page 282 Sound Volume selection. For information on insulin delivery reminders, alerts, and alarms see Chapters 12 t:slim X2 Insulin Pump Alerts, 13 t:slim X2 Insulin Pump Alarms, and 14 t:slim X2 Insulin Pump Malfunction.

  • Page 283: Out Of Range Alerts - Control-Iq Technology Off

    CHAPTER 31 • Control-IQ Technology Alerts 31.1 Out of Range Alert – Control-IQ Technology Off Screen Explanation What will I see on the screen? The transmitter and pump are not communicating. The pump will What does it mean? not receive sensor glucose readings, and Control-IQ technology is not able to predict sensor glucose levels or adjust insulin delivery.

  • Page 284: Out Of Range Alert - Control-Iq Technology On

    CHAPTER 31 • Control-IQ Technology Alerts 31.2 Out of Range Alert – Control-IQ Technology On Screen Explanation What will I see on the screen? Control-IQ technology is turned on, but the transmitter and pump are not communicating. The pump will not receive sensor glucose readings.

  • Page 285: Control-Iq Technology Low Alert

    CHAPTER 31 • Control-IQ Technology Alerts 31.3 Control-IQ Technology Low Alert Screen Explanation What will I see on the screen? Control-IQ Low Alert has predicted that your sensor glucose reading What does it mean? will drop below 70 mg/dL, or below 80 mg/dL if Exercise is enabled, in the next 15 minutes.

  • Page 286: Control-Iq High Alert

    CHAPTER 31 • Control-IQ Technology Alerts 31.4 Control-IQ High Alert Screen Explanation What will I see on the screen? Control-IQ technology has increased insulin delivery, but detects a What does it mean? sensor glucose reading above 200 mg/dL and does not predict that the sensor glucose reading will decrease in the next 30 minutes.

  • Page 287: Max Insulin Alert

    CHAPTER 31 • Control-IQ Technology Alerts 31.5 Max Insulin Alert Screen Explanation What will I see on the screen? The pump has delivered the maximum allowable 2 hour insulin amount based on your Total Daily Insulin setting. You see this alert when Control-IQ technology has delivered 50% of your Total Daily Insulin (through basal and/or bolus deliveries) over the previous What does it mean?
  • Page 288 CHAPTER 31 • Control-IQ Technology Alerts This Page is Intentionally Left Blank...
  • Page 289 Control-IQ Technology Features CHAPTER 32 Overview of Control-IQ Technology Clinical Studies...

  • Page 290: Introduction

    ≥6 years to 13 years old. In diabetes, 14 to 71 years of age, treated knowledgeable about diabetes and both studies, the t:slim X2 insulin pump with insulin via an insulin pump or managing diabetes-related with Control-IQ technology was injections for at least one year.
  • Page 291 The safety and/or effectiveness of Control-IQ technology in pediatric users with the conditions above is unknown. During both clinical studies, subjects were given an opportunity to complete a training period to become comfortable with the t:slim X2 insulin pump and CGM prior to being...

  • Page 292: Demographics

    Control-IQ technology treatment effect is similar across the distribution of age, race and income. There is no evidence to suggest that baseline demographics are associated with more or less benefit or risk from the use of the t:slim X2 insulin pump with Control-IQ technology.
  • Page 293 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies DCLP3: Baseline Characteristics including Demographics at Enrollment (N=168) (Continued) Characteristic Control-IQ (n=112) SAP (n=56) † Income <$50,000 10 (11%) 2 (4%) $50,000 – <$100,000 24 (27%) 18 (36%) ≥$100,000 55 (62%) 30 (60%) ‡...
  • Page 294 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies DCLP5: Baseline Characteristics including Demographics at Enrollment (N=101) Characteristic Control-IQ (n=78*) SAP (n=23*) Age (years) 6 – 9 21 (27%) 8 (35%) 10 – 13 57 (73%) 15 (65%) Median (IQR) 11 (9, 12) 10 (8, 13) Range...
  • Page 295 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies DCLP5: Baseline Characteristics including Demographics at Enrollment (N=101) (Continued) Characteristic Control-IQ (n=78*) SAP (n=23*) $75,000 – <$100,000 13 (18%) 4 (19%) $100,000 – <$200,000 27 (36%) 8 (38%) ≥$200,000 26 (35%) 7 (33%) Parent Education ≤High School Diploma...

  • Page 296: Adverse Effects

    CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies 32.4 Adverse Effects The following tables provide a full list of adverse events that occurred during the main part of the study for both DCLP3 and DCLP5 study groups. DCLP3: Types of Adverse Events by Treatment Group (N=168) Number of Events Control-IQ (n=112) SAP (n=56)

  • Page 297: Total Number Of Adverse Events

    CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies DCLP5: Types of Adverse Events by Treatment Group (N=101) Number of Events Control-IQ (n=78) SAP (n=23) Total Number of Adverse Events Adverse Events Related to Study Device Ketosis (Infusion Site Failure) Abscess at Sensor Site (CGM Sensor) Hyperglycemia (Defected Cartridge) Adverse Effects Not Related to a Study Device...

  • Page 298: Ketosis (Infusion Site Failure)

    CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies The following tables provide a list of only hyperglycemia or ketosis events during the study for both DCLP3 and DCLP5 study groups. These tables also include the cause of these events. DCLP3: Hyperglycemia/Ketosis Events by Treatment Group (N=168) Number of Events Control-IQ (n=112)
  • Page 299 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies DCLP5: Hyperglycemia/Ketosis Events by Treatment Group (N=101) Number of Events Control-IQ (n=78) SAP (n=23) Ketosis (Infusion Site Failure) Hyperglycemia (Defected Cartridge) Ketosis (User Error)* Ketosis (Gastroenteritis) † Hyperglycemia (User Error) *Improper cartridge fill †...

  • Page 300: Intervention Compliance

    32.5 Intervention Compliance The following three tables provide an overview of the how often the t:slim X2 insulin pump with Control-IQ technology, Dexcom G6 CGM, BG meters, and infusion sets were used during the study period, respectively. The analysis for Control-IQ technology use is specific to the Control-IQ technology group, while the analysis for CGM and BG meter use represents both the Control-IQ technology group and the SAP group.
  • Page 301 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies DCLP5: Percentage of t:slim X2 Insulin Pump with Control-IQ Technology Use Over the 4-Month Period (n=78) Average Time Control-IQ Available* Weeks 1–4 93.4% Weeks 5–8 93.8% Weeks 9–12 94.1% Weeks 13–End 94.4%...
  • Page 302 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies DCLP3: Percentage of CGM Use Over the 6-Month Period (N=168) Control-IQ* SAP* Weeks 1–4 Weeks 5–8 Weeks 9–12 Weeks 12–16 Weeks 17–20 Weeks 21–End Overall *The denominator is the total possible time within the 6-month study period. CGM use includes warm-up time. DCLP5: Percentage of CGM Use Over the 4-Month Period (N=101) Control-IQ* SAP*...
  • Page 303 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies DCLP3: Daily BG Meter Use Over the 6-Month Period (N=168) Control-IQ BG Meter Use Per Day 0.67 0.73 (average) DCLP5: Daily BG Meter Use Over the 4-Month Period (N=101) Control-IQ BG Meter Use Per Day 0.37 0.36 (average)
  • Page 304 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies The duration of infusion set used in both the DCLP3 and the DCLP5 was estimated by reviewing the number of times a t:slim X2 study pump was used to prime tubing. In the DCLP3 study, the average duration of infusion set use was 2.8 days in the SAP group and 3.1 days in the Control-IQ technology group.

  • Page 305: Primary Analysis

    CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies 32.6 Primary Analysis The primary analysis of this study was to compare the CGM sensor values in range between 70–180 mg/dL between the Control-IQ technology group and the SAP group. The data represents the overall system performance 24-hours per day. DCLP3: Comparison of CGM Values Between Control-IQ and SAP Users (N=168) Difference Between Study Arm and Characteristic...
  • Page 306 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies DCLP5: Comparison of CGM Values Between Control-IQ and SAP Users (N=101) Difference Between Study Arm and Characteristic Control-IQ Control Arm Average Sensor Glucose 162 mg/dL 179 mg/dL -17 mg/dL (std dev) (18 mg/dL) (26 mg/dL) Average % 70–180 mg/dL...
  • Page 307 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies The table below describes the average time participants in both the Control-IQ technology group and the SAP group spent with sensor glucose levels between 70–180 mg/dL by month at baseline and during the study period. DCLP3: Percentage of Time in Range per Study Arm by Month (N=168) Study Arm Control Arm...

  • Page 308: Secondary Analysis

    CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies 32.7 Secondary Analysis The following table compares the percent of time that participants spent at the indicated sensor glucose levels during the daytime and nighttime. The definitions of daytime and nighttime differ slightly between the two studies and are defined in the tables. DCLP3: Secondary Analysis by Time of Day (N=168) Daytime Nighttime...
  • Page 309 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies The following table compares the percent of time spent between 70–180 mg/dL across the different baseline HbA1c values observed in the DCLP3 study in both treatment groups. Percentage of Time in Range per Study Arm by Baseline HbA1c (N=168) Time in Range Baseline HbA1c Control-IQ...
  • Page 310 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies The following tables compare the change in HbA1c values for both DCLP3 and DCLP5 participants over the course of their respective studies. DCLP3: Change in HbA1c Values from Randomization to 26 Weeks (N=168) Number of Subjects (% of Subjects) with Change in HbA1c Decrease Decrease...
  • Page 311 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies DCLP3: Change in HbA1c Values from Randomization to 26 Weeks (N=168) (Continued) Number of Subjects (% of Subjects) with Change in HbA1c Treatment 100% HbA1c ≥ 10% Control Treatment <1% Overall Control DCLP5: Change in HbA1c Values from Randomization to 16 Weeks (N=101) Number of Subjects (% of Subjects) with Change in HbA1c...
  • Page 312 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies DCLP5: Change in HbA1c Values from Randomization to 16 Weeks (N=101) (Continued) Number of Subjects (% of Subjects) with Change in HbA1c Treatment 8% ≤ HbA1c < 9% Control Treatment 9% ≤ HbA1c < 10% Control 100% Treatment...

  • Page 313: Insulin Delivery Differences

    CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies 32.8 Insulin Delivery Differences The following table compares the insulin delivery statistics between the Control-IQ technology group and the SAP group in the DCLP3 study. DCLP3: Insulin Delivery Comparison Characteristic Unit of Measure Control-IQ After 2-weeks Average (std dev)
  • Page 314 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies The following table compares the insulin delivery statistics between the Control-IQ technology group and the SAP group in the DCLP5 study. Total daily insulin is reported as Units of insulin per body weight of participant, in kilograms (kg), per day. DCLP5: Insulin Delivery Comparison (N=101) Characteristic Timepoint...

  • Page 315: Control-Iq Technology High And Low Alert Accuracy

    CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies 32.9 Control-IQ Technology High and Low Alert Accuracy The following data table characterizes the accuracy of the Control-IQ technology high and low alerts, respectively. This analysis depicts the percent of alerts that were triggered relative to the resulting sensor glucose value achieving the level the alert predicted. The Control-IQ technology Low Alert notifies the user when Control-IQ technology predicts that the sensor glucose value will be below 70 mg/dL 15 minutes in the future, or 80 mg/dL when the exercise activity is enabled.
  • Page 316 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies The table below depicts the performance of the Control-IQ technology high and low alerts when evaluating the resulting sensor glucose value after 15-minutes and 30-minutes. DCLP3: Percentage of Accurate Control-IQ Technology Alerts (N=112) Performance Predictive Alert 15-minutes...

  • Page 317: Additional Analysis Of Sensor Glucose Value Auto-Population With Cgm

    CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies 32.10 Additional Analysis of Sensor Glucose Value Auto-Population with CGM Upon completion of the Pivotal Study, an evaluation of the auto-population of CGM readings into the bolus calculator was performed. The results of the analysis indicate, when a sensor glucose value was >250 mg/dL, there was an increased incidence of CGM values <70 mg/dL five hours after a bolus was delivered using auto-populated CGM readings compared to the five hours after the bolus was delivered using manually entered sensor glucose values.
  • Page 318 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies DCLP3: Post-Correction Bolus CGM Readings (5 hours): Based on Starting Sensor Glucose Readings One or More CGM Three Consecutive CGM Five or More CGM CGM Reading Entry Type Reading <54 mg/dL Readings <70 mg/dL Readings <70 mg/dL (95% CI)
  • Page 319 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies DCLP5: Post-Correction Bolus CGM Readings (5 hours): Based on Starting Sensor Glucose Readings One or More CGM Three Consecutive CGM Five or More CGM CGM Reading Entry Type Reading <54 mg/dL Readings <70 mg/dL Readings <70 mg/dL (95% CI)
  • Page 320 CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies This Page is Intentionally Left Blank...

  • Page 321: Section 5: Technical Specifications And Warranty

    Technical Specifications and Warranty CHAPTER 33 Technical Specifications...

  • Page 322: Overview

    33.1 Overview This section provides tables of technical specifications, performance characteristics, options, settings, and electromagnetic compliance information for the t:slim X2™ pump. The specifications in this section meet the international standards set forth in IEC 60601-1 and IEC 60601-2-24. 33.2 t:slim X2 Pump Specifications...
  • Page 323 CHAPTER 33 • Technical Specifications t:slim X2 Pump Specifications (Continued) Specification Type Specification Details Insulin Concentration U-100 Alarm Type Visual, audible, and vibratory ±5% The pump is designed to vent automatically when there is a pressure difference between inside the cartridge Basal Delivery Accuracy at all Flow and the surrounding air.
  • Page 324 Minimum Audible Alarm Volume 45 dBA at 1 meter NOTE Delivery Accuracies: Accuracies stated in this table are valid for all Tandem Diabetes Care, Inc. branded infusion sets including: AutoSoft™ 90, AutoSoft™ XC, AutoSoft™ 30, VariSoft™, and TruSteel™ branded infusion sets.
  • Page 325 CHAPTER 33 • Technical Specifications USB Charging/Download Cable Specifications Specification Type Specification Detail Tandem P/N 004113 Length 6 feet (2 meters) Type USB A to USB Micro B Power Supply/Charger, AC, Wall Mount, USB Specifications Specification Type Specification Detail Tandem P/N...
  • Page 326 CHAPTER 33 • Technical Specifications Car Power USB Adapter (sold separately), Specifications Specification Type Specification Detail Tandem P/N 003934 Input 12 Volts DC Output Voltage 5 Volts DC Max Output Power 5 Watts minimum Output Connector USB type A Computer, USB Connector, Specifications...
  • Page 327 CHAPTER 33 • Technical Specifications Requirements for Charging from a Computer The t:slim X2 pump is designed to be connected to a host computer for battery charging and data transfer. The following minimum characteristics are required of the host computer: •...

  • Page 328: T:slim X2 Pump Options And Settings

    CHAPTER 33 • Technical Specifications 33.3 t:slim X2 Pump Options and Settings t:slim X2 Pump Options and Settings Option/Setting Type Option/Setting Detail Time May be set to 12-hour or 24-hour clock (default is 12-hour clock) Maximum Basal Rate 0.1 – 15 units/hr...
  • Page 329 CHAPTER 33 • Technical Specifications t:slim X2 Pump Options and Settings (Continued) Option/Setting Type Option/Setting Detail Maximum Extended Bolus Time 8 hours (2 hours when Control-IQ technology is enabled) Maximum Bolus Size 25 units Maximum Automatic Bolus Size 6 units Status indicator visible on Home screen;...

  • Page 330: T:slim X2 Pump Performance Characteristics

    Basal Delivery To assess basal delivery accuracy, 32 t:slim X2 pumps were tested by delivering at low, medium, and high basal rates (0.1, 2.0, and 15 U/hr). Sixteen of the pumps were new, and 16 had been aged to simulate four years of regular use. For both aged and unaged pumps, eight pumps were tested with a new cartridge, and eight with a cartridge which underwent two years of real time aging.
  • Page 331 Bolus Delivery To assess bolus delivery accuracy, 32 t:slim X2 pumps were tested by delivering consecutive low, medium, and high bolus volumes (0.05, 2.5, and 25 units). Sixteen of the pumps were new, and 16 had been aged to simulate four years of regular use. For both aged and unaged pumps, eight pumps were tested with a new cartridge, and eight with a cartridge which underwent two years of real time aging.
  • Page 332 CHAPTER 33 • Technical Specifications Summary of Bolus Delivery Performance (n=32 pumps) Target Bolus Size Mean Bolus Size Min Bolus Size Max Bolus Size Individual Bolus Accuracy Performance [Units] [Units] [Units] [Units] Min Bolus Delivery Performance 0.050 0.050 0.000 0.114 (n=800 boluses) Intermediate Bolus Delivery Performance 2.50...
  • Page 333 CHAPTER 33 • Technical Specifications Intermediate Bolus Delivery Performance (2.5U) (n=800 boluses) Units of Insulin Delivered After a 2.5 U Bolus Request 0.625– 1.875– 2.25– 2.375– 2.625– 2.75– 3.125– 4.375– <0.625 >6.25 1.875 2.25 2.375 2.625 2.75 3.125 4.375 6.25 (<25%) (>250%) (25–75%)
  • Page 334 CHAPTER 33 • Technical Specifications Rate of Delivery Characteristic Value 25 Unit Bolus Delivery Speed 2.97 Units/min Typical 2.5 Unit Bolus Delivery Speed 1.43 Units/min Typical 20 Unit Prime 9.88 Units/min Typical Bolus Duration Characteristic Value 25 Unit Bolus Duration 8 minutes 26 seconds Typical 2.5 Unit Bolus Duration 1 minute 45 seconds Typical...

  • Page 335: Electromagnetic Compatibility

    Section 33.9 Distances Between the in close proximity with other electrical insulin without notification to the t:slim X2 Pump and RF Equipment equipment, the System should be user. more information. observed in this environment to verify normal operation.

  • Page 336: Electromagnetic Emissions

    CHAPTER 33 • Technical Specifications 33.7 Electromagnetic Emissions The System is intended for use in the electromagnetic environment specified below. Always make sure that the System is used in such an environment. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment –...

  • Page 337: Electromagnetic Immunity

    CHAPTER 33 • Technical Specifications 33.8 Electromagnetic Immunity The System is intended for use in the electromagnetic environment specified below. Always make sure that the System is used in such an environment. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Electromagnetic Environment – Immunity Test IEC 60601 Test Level Compliance Level...
  • Page 338 CHAPTER 33 • Technical Specifications Guidance and Manufacturer’s Declaration – Electromagnetic Immunity (Continued) Electromagnetic Environment – Immunity Test IEC 60601 Test Level Compliance Level Guidance Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 10 Vrms Portable and mobile RF communications equipment should be used no closer to 10 V/m Radiated RF IEC 61000-4-3...
  • Page 339 CHAPTER 33 • Technical Specifications Guidance and Manufacturer’s Declaration – Electromagnetic Immunity (Continued) Electromagnetic Environment – Immunity Test IEC 60601 Test Level Compliance Level Guidance Mains power quality should be that of a 70% UR (30% dip in Ur) for 25 70% UR (30% dip in Ur) for 25 cycles typical commercial or hospital cycles...

  • Page 340: Distances Between The T:slim X2 Pump And Rf Equipment

    CHAPTER 33 • Technical Specifications 33.9 Distances Between the t:slim X2 Pump and RF Equipment The System is intended for use in an electromagnetic environment typically found in the home, at work, retail stores, and places of leisure, where daily activities occur. The chart below can be used as a guideline for determining the recommended minimum distance to maintain between a radio frequency (RF) transmitter and the System.
  • Page 341 CHAPTER 33 • Technical Specifications The table below provides a list of typical devices for various levels of transmitter power and frequency, and the recommended separation distances from the transmitter and the System. Recommended Distances Between the System and Devices Rated Maximum Output Power Recommended Separation Distance Typical Devices...

  • Page 342: Quality Of Wireless Service

    2.4 GHz the System will not discontinue 2. This device must accept any band are around, the t:slim X2 insulin reporting data and/or information from interference received, including pump uses the built-in coexistence...

  • Page 343: Warranty Information

    In the event the defective radiate radio frequency energy and, if exposure limits for general population/ t:slim X2 pump is not returned, then this not installed and used in accordance uncontrolled exposure. warranty shall be void and you will not...
  • Page 344 This warranty is valid only in the United • damage results from an event or t:slim X2 pump covered by this States. accident beyond the control of warranty to or by a user other than the Tandem Diabetes Care, Inc.
  • Page 345 United States. No employee packaging has been opened, not to of Tandem or any other party is exceed 6 months from date of • damage results from service or...

  • Page 346: Returned Goods Policy

    X2 insulin pump. For more outlined in the accompanying to immediately terminate. This warranty information about CGM warranty instructions for use;...

  • Page 347: T:slim X2 Insulin Pump Event Data (Black Box)

    If • t:slim X2 cartridge (t:lock™ supports use of the t:slim X2 pump, or if Tandem provides a label, the label must connector) with filling syringe and the pump is returned for any reason.
  • Page 348 CHAPTER 33 • Technical Specifications device. Some infusion sets have a • t:slim screen protector soft cannula and others and have a • USB rubber door steel needle. Contact your local customer support service for available sizes and lengths of the following infusion sets with t:lock connectors: •...
  • Page 349 CHAPTER 33 • Technical Specifications This Page is Intentionally Left Blank...

  • Page 350: Index

    INDEX Alerts & Reminders ......50 Basal Rate Required Alert ....126 CGM .
  • Page 351 Data Error Alert ......136 High Glucose Alert, Set ..... . 190 Incomplete Bolus Alert .
  • Page 352 Bolus ........35, 91 Cannula, Fill Cannula .
  • Page 353 Automatic Sensor Shut-Off ....199 History, View ......211 Calibrate Blood Glucose Value .
  • Page 354 Transmitter Error ......232 Contents, of Pump Package ..... 34 Transmitter ID .
  • Page 355 Turn On or Off ......271 High Glucose Alert ......190 Weight .
  • Page 356 Extended Bolus ......35, 97 High BG Reminder ......108 Default .
  • Page 357 Low Insulin Alert ......112, 117 Insulin Insulin Duration ......71 Low Power Alarm .
  • Page 358 Out of Range Alert ....230, 281, 282 Pump Package Contents ..... . . 34 Overview Pump Performance, Specifications .
  • Page 359 Rise Alert, Set ....... . 192 My CGM Screen ......176 My Pump Screen .
  • Page 360 Trend Graphs, Sensor Glucose Trends, Arrows ..207 Tandem Logo ......42, 62...
  • Page 361 Troubleshooting CGM ......237 Tubing Cartridge Tubing ......42 Warranty Fill Tubing .
  • Page 362 COPYRIGHTS, PATENTS, AND TRADEMARKS © 2020 Tandem Diabetes Care, Inc. All rights reserved. Covered by one or more patents. For a list of patents, see tandemdiabetes.com/legal/patents. Tandem Diabetes Care, the Tandem Diabetes Care logo, t:connect, t:lock, t:slim X2, Control-IQ, AutoSoft, TruSteel, and VariSoft are trademarks of Tandem Diabetes Care, Inc.
  • Page 364 UNITED STATES: CANADA: (877) 801-6901 (833) 509-3598 tandemdiabetes.com tandemdiabetes.ca OTHER COUNTRIES: © 2020 Tandem Diabetes Care, Inc. tandemdiabetes.com/contact All rights reserved. AW-1005628_B 1005627_B 2020-JUN-18...

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