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Tandem t-slim X2 User Manual
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Tandem t-slim X2 User Manual

Insulin pump with control-iq+ technology
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Do you have a question about the t-slim X2 and is the answer not in the manual?

Questions and answers

Dianne Lofton
February 25, 2025

How do I use my t-slim X2 insulin pump to push insulin through my pump?

0
1 comments:
Mr. Anderson
February 25, 2025

The Tandem t:slim X2 insulin pump delivers insulin in two ways:
1. Basal Insulin Delivery – Continuous insulin delivery throughout the day.
2. Bolus Insulin Delivery – Insulin delivered at mealtimes or to correct high blood sugar.

To use the pump:
- Fill the disposable cartridge with up to 300 units of U-100 insulin and attach it to the pump.
- Use a compatible infusion set.
- If using a CGM (Dexcom G6, Dexcom G7, or Abbott FreeStyle Libre 2 Plus), glucose readings will be sent to the pump.
- Activate a Personal Profile for insulin delivery settings.
- Start insulin delivery following on-screen instructions.
- Check for air bubbles in the insulin to ensure proper delivery.

If insulin delivery is stopped, the pump will display an All Deliveries Stopped screen.

This answer is automatically generated

0

Related Manuals for Tandem t-slim X2

Summary of Contents for Tandem t-slim X2

  • Page 1 User Guide MG/DL...
  • Page 3 Tandem Diabetes Care. Please contact Customer Technical Support to obtain a replacement copy of the user guide that is the correct version for your pump.

  • Page 4: Table Of Contents

    Tandem Cybersecurity Preventative Measures ........
  • Page 5 Tandem t:slim Mobile App Dashboard ........
  • Page 6 Tandem t:slim Mobile App Notifications Screen ........
  • Page 7 Correction Bolus Using the Tandem t:slim Mobile App ....... . .
  • Page 8 Canceling or Stopping a Bolus Using the Tandem t:slim Mobile App ......
  • Page 9 13.16 Pump Connection Lost Alert – Tandem t:slim Mobile App .......
  • Page 10 Chapter 16 • Taking Care of Your Pump 16.1 Overview ................202 Chapter 17 •...
  • Page 11 20.4 Dexcom G6 Transmitter Overview ............. 229 20.5 Sensor Overview .
  • Page 12 23.13 Start the Abbott FreeStyle Libre 2 Plus Sensor ........... 252 23.14 Abbott FreeStyle Libre 2 Plus Sensor Startup Period .
  • Page 13 26.11 Incomplete Calibration (Dexcom Only) ............281 26.12 Calibration Timeout (Dexcom Only) .
  • Page 14 Section 4: Control-IQ+ Technology Features Chapter 28 • Control-IQ+ Technology Important Safety Information 28.1 Control-IQ+ Warnings ..............308 28.2 Control-IQ+ Precautions .
  • Page 15 Tandem t:slim Mobile App Security ........
  • Page 16 34.10 IEC 60601-1-10: Physiological Closed-Loop Controlled System ........424 34.11 Quality of Wireless Service .

  • Page 17: Section 1: Before You Begin

    Before You Begin CHAPTER 1 Introduction...

  • Page 18: 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 19 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 or the Tandem t:slim mobile app responds to the previous instruction.

  • Page 20: Explanation Of Symbols

    CHAPTER 1 • Introduction 1.2 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.
  • Page 21 CHAPTER 1 • Introduction Explanation of t:slim X2 Insulin Pump Symbols (Continued) Symbol Definition Symbol Definition Date of manufacture Authorized representative in Switzerland Importer (EU MDR) Responsible person in the United Kingdom Direct Current (DC) voltage UK Conformity assessed (UKCA) conformity marking Separate collection for waste electrical and electronic CE mark equipment...

  • Page 22: System Description

    X2 3mL (300 units) The Tandem t:slim X2 insulin pump, the CGM. If a CGM is not used, sensor cartridge.The t:slim X2 pump must be Tandem t:slim mobile app, and a glucose readings will not be sent to the used with a compatible infusion set.

  • Page 23: About This User Guide

    CGM with tandemdiabetes.com/mobilesupport, or tap connected devices, including your pump. Section 4 covers Help on the Tandem t:slim mobile app Settings automated insulin dosing software, to instructions for using Control-IQ+ on screen, then tap App Guide.

  • Page 24: Compatible Insulins

    • Dexcom G6 CGM Bluetooth Technology. For connecting your rapid acting insulin analogs that have Pump to the Tandem t:slim mobile app, see been tested and found to be safe for • Dexcom G7 CGM Section 4.3 Connecting to a Smartphone.

  • Page 25: Important User Information

    Younger children may inadvertently The t:slim X2 insulin pump with Control-IQ+ should not be used in children under the age of press or tap the pump or the Tandem If you are new to using CGM, continue 2 years old.

  • Page 26: Emergency Kit

    CHAPTER 1 • Introduction • Rapid-acting insulin and syringes or tampering with the insulin pump could result in ⚠ WARNING over delivery or under delivery of insulin. This a prefilled insulin pen and pen The pump includes parts (such as the USB cable can cause hypoglycemia (low BG) or needles and infusion set tubing) that could pose a...

  • Page 27: Section 2: T:slim X2 Insulin Pump Features

    t:slim X2 Insulin Pump Features CHAPTER 2 Important Safety Information...

  • Page 28: T:slim X2 Insulin Pump Warnings

    ⚠ WARNING or hyperglycemia (high BG) events. The user must also have adequate vision and/or DO NOT start to use your pump or the Tandem hearing in order to recognize all functions of the t:slim™ mobile app before reading the user pump, including alerts, alarms, and reminders.
  • Page 29 Care. Use of cartridges not manufactured by swelling, irritation or infection. This can affect Diabetic Ketoacidosis (DKA). Tandem Diabetes Care or reuse of cartridges insulin absorption and cause high or low BG. may result in over delivery or under delivery of...
  • Page 30 CHAPTER 2 • Important Safety Information ⚠ WARNING ⚠ WARNING ⚠ WARNING DO NOT deliver a bolus until you have reviewed DO NOT allow small children (either pump users For patients whose insulin administration is the calculated bolus amount. If you deliver an or non-users) to ingest small parts, such as the managed by a caregiver, ALWAYS turn off the insulin amount that is too high or too low, this...

  • Page 31: Magnetic Resonance Imaging Safety

    ⚠ WARNING manufacturer’s instructions before » Cardiac Catheterization using the Tandem t:slim mobile app Some skin care products such as lotions, » Nuclear Stress Test sunscreens, and insect repellents can cause during any of the radiology or medical procedures listed below.

  • Page 32: Tandem T:slim Mobile App Warnings

    ⚠ WARNING help on the bolus feature of the Tandem t:slim you requested it. DO NOT use the pump if you have a condition mobile app could result in delay of therapy.

  • Page 33: T:slim X2 Insulin Pump Precautions

    The pump is a sealed device that should set if you notice leaks around the site. can result in over delivery or under delivery of be opened and repaired only by Tandem Improperly placed sites or leaks around the insulin. Consult with your healthcare provider as Diabetes Care.
  • Page 34 CHAPTER 2 • Important Safety Information discontinue use of the pump and contact the proper insulin amount that your healthcare any signs of fluid entry. If there are signs of fluid Customer Technical Support. provider has prescribed for you. entry, discontinue use of the pump and contact Customer Technical Support.

  • Page 35: Tandem T:slim Mobile App Precautions

    CHECK your BG using a BG meter following a you must complete it on the pump. You cannot gradual elevation change of up to each 1,000 request a bolus from the Tandem t:slim mobile ⚠ PRECAUTION feet (305 meters), such as when snow skiing or app while a bolus request is active on the pump.
  • Page 36 Tandem t:slim mobile app will not display If you close or force stop your Tandem t:slim request, stop, or cancel a bolus from the current insulin pump information and cannot be mobile app, it will not be running in the Tandem t:slim mobile app.

  • Page 37: Tandem Cybersecurity Preventative Measures

    • Do not share your pump’s serial tandemdiabetes.com/mobilesupport, or tap number or Tandem t:slim mobile Help on the Tandem t:slim mobile app Settings • The pump provides an automated app pairing code with any untrusted screen, then tap App Guide.

  • Page 38: Possible Risks From Using Your Pump

    CHAPTER 2 • Important Safety Information • From the Bolus screen, the bolus the likelihood that you will forget to bruising, itching, scarring, or skin calculator feature allows you to check your BG or bolus for meals. discoloration). enter multiple carbohydrate values •...

  • Page 39: Working With Your Healthcare Provider

    You see the green light illuminate Functionality diabetes management guidelines that from the edge around the Screen Before using the Tandem t:slim mobile best fit your lifestyle and needs. On/Quick Bolus button app, when you connect a smartphone Consult your healthcare provider before •...
  • Page 40 CHAPTER 2 • Important Safety Information ⚠ PRECAUTION ALWAYS ensure your pump has established a Bluetooth wireless connection with your smartphone before you use the Tandem t:slim mobile app. Confirm that the information displayed to you matches your signs and symptoms.
  • Page 41 t:slim X2 Insulin Pump Features CHAPTER 3 Getting to Know Your t:slim X2 Insulin Pump...

  • Page 42: What Your T:slim X2 Pump Package Includes

    Basal is a slow continuous delivery of compatible infusion sets with the t:lock Control-IQ+™ Technology User insulin, which keeps glucose levels connector are available from Tandem Guide stable between meals and during sleep. Diabetes Care, Inc. The t:lock It is measured in units per hour connector allows a secure connection 4.
  • Page 43 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump Bolus insulin. Also known as the Insulin Load A bolus is a quick dose of insulin that is Sensitivity Factor (ISF). Load refers to the process of removing, usually delivered to cover food eaten or filling, and replacing a new cartridge Extended Bolus correct high glucose.
  • Page 44 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump rate for a short period of time to accommodate special situations. 100% is the same basal rate as programmed. 120% means 20% more and 80% means 20% less than the programmed basal rate.

  • Page 45: 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: Pump Icon Definitions Symbol Definition Symbol Definition The amount of charge left in the pump battery. The amount of insulin remaining in the cartridge.
  • Page 46 An extended bolus was delivered. The square represents the DELIVER NOW portion of the bolus, and the line Tandem logo. When the pump screen is turned on and represents the DELIVER LATER portion of the bolus. This unlocked, tap to return to the Home screen.

  • Page 47: 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. Green LED •...

  • Page 48: Pump Back Side

    ⚠ PRECAUTION If you choose to use a pump case or other accessories not provided by Tandem, DO NOT cover the six vent holes on the back of the pump. Covering the vent holes could affect insulin delivery.
  • Page 49 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 50: Lock Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 8. Insulin Level: Displays the current 3.6 Lock Screen amount of insulin in the cartridge. The Lock screen appears anytime you turn on the screen. You must tap 1–2–3 in sequential order to unlock the pump.
  • Page 51 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 10:20 100% 14 Nov 2019 235 u INSULIN ON BOARD (IOB) Units 1.1 u Time Remaining 1:09 hrs...

  • Page 52: Home Screen

    8. Insulin Level: Displays the current 3.7 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. connected for charging, the charging icon (lightning bolt) will 10.
  • Page 53 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 54: Current Status Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 7. Correction Factor: Displays current smartphone is actively connected to 3.8 Current Status Screen correction factor used to calculate a the pump. bolus. The Current Status screen can be 15.
  • Page 55 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 56: Bolus Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump • Control-IQ+ is turned on and 3.9 Bolus Screen available • A CGM session is active The Bolus screen will default to use units of insulin in calculating a bolus. •...
  • Page 57 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump Using Units Using Grams...

  • Page 58: Options Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 9. History: Displays historical log of 3.10 Options Screen pump and CGM events. : Returns to the Home screen. 2. Stop Insulin: Stops insulin delivery. If insulin delivery is stopped, RESUME INSULIN will be displayed.
  • Page 59 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 60: My Pump Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 3.11 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+ and enter required values. 4.
  • Page 61 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 62: Device Settings Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 3.12 Device Settings Screen : Returns to the Options screen. 2. Display Settings: Customize the Screen Timeout settings. 3. Bluetooth Settings: Turn on/off Mobile Connection. 4. Time and Date: Edit the time and date that will be displayed on the pump.
  • Page 63 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 64: Number Keypad Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 3.13 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 65 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 66: Letter Keypad Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 3.14 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. 6.
  • Page 67 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...
  • Page 68 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump This Page is Intentionally Left Blank...
  • Page 69 X2 Insulin Pump Features CHAPTER 4 Getting to Know Your Tandem t:slim Mobile App...

  • Page 70: Overview

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App app to request a bolus, stop a ⚠ WARNING 4.1 Overview bolus, and cancel a bolus. ALWAYS rely on your pump to make therapy decisions when using a smartphone that is To download the Tandem t:slim mobile The Tandem t:slim™...

  • Page 71: Install The Tandem T:slim Mobile App

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App Supported mobile devices are request or control a bolus from the Tandem follow your smartphone manufacturer's t:slim mobile app. compliant with appropriate electrical instructions for charging. safety standards (IEC 60950-1, IEC 62368-1, or equivalent).

  • Page 72: Connecting To A Smartphone

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App If you have an existing Tandem t:slim Updating Your Smartphone ⚑ NOTE account, log in using your username We encourage you to discuss these values Before you manually update your and password.
  • Page 73 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App pump functions on that smartphone a. Tap OPTIONS. attempt to use your smartphone's Bluetooth using the Tandem t:slim mobile app. menu. b. Tap the Down Arrow. ⚑ NOTE ⚑ NOTE This Mobile Connection setting is not related to c.
  • Page 74 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App b. Choose the appropriate pump 6. From your smartphone, enter the Your Tandem t:slim mobile app will serial number on the Select your pairing code generated in Step 5 remain synchronized with your pump as pump screen and tap Next.
  • Page 75 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App • If you replace your pump, you must b. Tap Device Settings. been unpaired and returns you to unpair your old pump from your the pairing screen. smartphone before you can pair c.

  • Page 76: Set Mobile Notifications

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App To ensure you receive notifications on and CGM alerts and alarms are set to your 4.4 Set Mobile Notifications the Tandem t:slim mobile app, confirm preference. the smartphone sound mode is not set...

  • Page 77: Lost Pump Connection

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App status until you re-establish the ⚠ PRECAUTION 4.6 Lost Pump Connection Bluetooth connection. DO NOT ignore symptoms of high and low glucose. If your Tandem t:slim mobile app When your smartphone is more than...

  • Page 78: Restart The Tandem T:slim Mobile App

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App Reconnect Bluetooth 5. If your connection is lost again, sign For Android devices: out of your Tandem t:slim account. 1. Open your smartphone’s Settings When you see the Pump Connection menu.
  • Page 79 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App 1. From the Tandem t:slim mobile app, tap Settings. 2. Tap Paired Pump. 3. Tap Unpair Pump. 4. Repeat the pairing process as shown in Section 4.3 Connecting to...

  • Page 80: Tandem T:slim Mobile App Dashboard

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App 6. Delivered Basal: The amount of 11. Dashboard: Displays pump status 4.8 Tandem t:slim Mobile App insulin delivered as basal for the bar, current glucose reading, IOB Dashboard past 24-hour period. This includes...
  • Page 81 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App...

  • Page 82: Tandem T:slim Mobile App Bolus Screen

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App populated automatically if each of 4.9 Tandem t:slim Mobile App the following are true: Bolus Screen • Control-IQ+ is turned on and 1. Cancel: Exit the Bolus screen and available return to the Dashboard.
  • Page 83 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App...

  • Page 84: Tandem T:slim Mobile App Notifications Screen

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App notification (blue outline) with your 4.10 Tandem t:slim Mobile App finger to the left. Tap this icon to Notifications Screen delete the reminder or informational message. ⚠ PRECAUTION Pump notifications cannot be cleared from your 6.
  • Page 85 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App...

  • Page 86: Tandem T:slim Mobile App Settings

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App up your smartphone, and 4.11 Tandem t:slim Mobile App troubleshooting information. Settings 5. Dashboard: Displays pump status 1. CGM: View CGM information for bar, current glucose reading, IOB the current sensor session.
  • Page 87 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App...

  • Page 88: Tandem T:slim Mobile App Settings - App Screen

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App product identifiers, links to 4.12 Tandem t:slim Mobile App important safety information, Settings – App Screen consent statements, and instructions for use. 1. Settings: Return to the Settings screen.
  • Page 89 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App...

  • Page 90: Tandem T:slim Mobile App Settings - Help Screen

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App 7. Bolus: Navigate to the Bolus screen 4.13 Tandem t:slim Mobile App to program and deliver a bolus (only Settings – Help Screen available with compatible devices). 1. Settings: Return to the Settings 8.
  • Page 91 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App...
  • Page 92 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App This Page is Intentionally Left Blank...

  • Page 93: Getting Started

    t:slim X2 Insulin Pump Features CHAPTER 5 Getting Started...

  • Page 94: Charging The T:slim X2 Pump

    MAKE SURE to not move further than the length is less than 5%, it will begin decreasing CGM and the Tandem t:slim™ mobile of the USB cable when you are connected to the 1% at a time (for example, you will see pump and to a charging source.
  • Page 95 AC power adapter. the micro USB port on the pump. time will vary. The pump will display a Align the Tandem logo on the cable Connection Error Alert message if it is 2. Plug the AC power adapter into a with the Tandem logo on the pump.

  • Page 96: Turning The Pump On

    CHAPTER 5 • Getting Started • The screen illuminates ⚑ NOTE 5.3 Using the Touchscreen When using the pump, tap the Tandem logo to • An audible alert return to the Home screen or tap to return To turn on your pump screen, first to the previous screen.

  • Page 97: Turning The Pump Screen Off

    CHAPTER 5 • Getting Started 1. Tap the circle next to the language 1–2–3 in sequential order, the pump will 5.7 Turning the Pump Off you want to display. force you to restart the unlock sequence from the beginning. To turn the pump off completely, plug If the Security PIN feature is enabled, the pump into a power source and hold you will need to enter your PIN after...

  • Page 98: Edit Date

    CHAPTER 5 • Getting Started 3. Tap Device Settings. 3. Using the on-screen keypad enter 0.2 to 15 units per hour. Work with your the current day. Verify and tap healthcare provider to set the proper 4. Tap Time and Date. Basal Limit.

  • Page 99: Display Settings

    CHAPTER 5 • Getting Started 5. Tap Basal Limit. Limit will be set to a value two times the 2. Tap the Down Arrow. highest Basal Rate setting in your pump. 3. Tap Device Settings. ⚑ NOTE 4. Tap Display Settings. When Control-IQ+ technology is turned on, the Basal Limit may be exceeded if Control-IQ+ 5.

  • Page 100: Turn Security Pin On Or Off

    CHAPTER 5 • Getting Started 3. Tap Device Settings. 4. Tap the Down Arrow. It is possible to change your Security PIN or override an old Security PIN if 4. Tap Sound Volume. 5. Tap Security PIN. you forget your Security PIN. 1.

  • Page 101: Mobile Connection

    11. Use the keypad to enter a new Do not turn the mobile connection on if you are Security PIN. not using or do not have access to the Tandem t:slim mobile app. Turning the mobile 12. Tap connection on may impact pump battery life.
  • Page 102 CHAPTER 5 • Getting Started This Page is Intentionally Left Blank...
  • Page 103 t:slim X2 Insulin Pump Features CHAPTER 6 Insulin Delivery Settings...

  • Page 104: Personal Profiles Overview

    CHAPTER 6 • Insulin Delivery Settings • Bolus Settings: Insulin Duration ⚑ NOTE 6.1 Personal Profiles Overview and Carbohydrates setting (on/off). Some of the Personal Profile settings are overridden when Control-IQ+ is turned on. See ⚑ NOTE ⚠ WARNING Chapter 30 Introduction to Control-IQ+ In order to turn on Control-IQ+™...
  • Page 105 Limit after you have set any of your boluses. It does this by relying on the pump and the Tandem t:slim mobile app. ™ Personal Profiles, you cannot set your Basal insulin duration.

  • Page 106: Creating Your First Profile

    CHAPTER 6 • Insulin Delivery Settings consider any active IOB and adjusts the 2. Tap My Pump. Default Settings calculated bolus if necessary. To use the default pump settings to 3. Tap Personal Profiles. The insulin duration time is displayed on create your first profile: the Home screen when Control-IQ+ is 4.

  • Page 107: Creating A New Profile

    Basal Rate, Correction Factor, or Carb Ratio that OPTIONS. first profile: fall outside the pump’s allowable ranges, no profile will be created, and a message will direct 1. Tap Enter My Own Settings. 2. Tap My Pump. you to contact your Tandem trainer or doctor for...

  • Page 108: Programming A New Personal Profile

    CHAPTER 6 • Insulin Delivery Settings 3. Tap Personal Profiles. Timed Settings 6.4 Programming a New Personal Profile 4. Tap to create a new profile. Once the Personal Profile has been 5. Using the on-screen keypad, enter created, the settings must be a profile name (up to 16 characters) programmed.
  • Page 109 CHAPTER 6 • Insulin Delivery Settings 5. Tap Carb Ratio. 11. Tap to set the Bolus Settings, 3. On the Add Segment screen, tap or tap to create additional time Time of Day to select AM or PM, if 6. Using the on-screen keypad, enter segments.

  • Page 110: Editing Or Reviewing An Existing Profile

    CHAPTER 6 • Insulin Delivery Settings Bolus Settings 4. Review entered values and tap to navigate to the Personal Profiles list or tap the Tandem logo to return to the 1. Tap the Bolus Settings panel. Home screen. 5. Confirm Settings.

  • Page 111: Duplicating An Existing Profile

    CHAPTER 6 • Insulin Delivery Settings 10. Tap the Bolus Settings panel to 2. Tap Duplicate. because the profile is already change Insulin Duration activated. You cannot delete a Carbohydrates as needed. Use the 3. Confirm profile to duplicate by profile until you have activated on-screen keypad to enter desired tapping...

  • Page 112: Deleting An Existing Profile

    CHAPTER 6 • Insulin Delivery Settings 3. Using the on-screen keypad, feature can be helpful for situations 1. From the Home screen, tap rename the profile name (up to 16 such as exercise or illness. OPTIONS, then tap Activity, then characters) and tap tap Temp Rate, then tap Temp The default values for the Temp Rate...

  • Page 113: Stopping A Temp Rate

    CHAPTER 6 • Insulin Delivery Settings • A T in a red box means a Temp Rate of 0 u/hr is active. ⚑ NOTE If a Temp Rate is active when you stop insulin, including when you change a cartridge or infusion set, the Temp Rate timer will remain active.
  • Page 114 CHAPTER 6 • Insulin Delivery Settings This Page is Intentionally Left Blank...

  • Page 115: Infusion Site Care And Loading Cartridge

    t:slim X2 Insulin Pump Features CHAPTER 7 Infusion Site Care and Loading Cartridge...

  • Page 116: Infusion Site Selection And Care

    CHAPTER 7 • Infusion Site Care and Loading Cartridge Discuss options with your insulin absorption and cause hypoglycemia (low 7.1 Infusion Site Selection and BG) or hyperglycemia (high BG) events. healthcare provider. Care • The most commonly used sites are ⚠...
  • Page 117 CHAPTER 7 • Infusion Site Care and Loading Cartridge set and thoroughly clean the insertion site on your body to avoid infection. Contact your healthcare provider if you have symptoms of infection at your insulin infusion site. Areas of Body for Infusion Set Insertion •...

  • Page 118: Cartridge Instructions For Use

    Section 1.6 Compatible Insulins ALWAYS use cartridges manufactured by are encouraged. Tandem Diabetes Care. Use of any other • alcohol prep swab cartridge brand may result in over delivery or 7.2 Cartridge Instructions for Use under delivery of insulin.
  • Page 119 CHAPTER 7 • Infusion Site Care and Loading Cartridge The illustration identifies the Drawing Insulin from Vial into Syringe 4. Remove the needle and syringe connector and insulin fill port used in from their packaging. Securely twist ⚠ PRECAUTION the cartridge filling process. needle onto syringe.
  • Page 120 CHAPTER 7 • 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 121 CHAPTER 7 • 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 122: Loading A Cartridge

    Make sure cartridge is lined up to both guide During the load sequence, the tracks. Tandem logo is disabled. Tapping it will not return to the Home screen. 3. Tap Change Cartridge. 4. A screen will display to notify you 10.

  • Page 123: Filling Tubing

    CHAPTER 7 • Infusion Site Care and Loading Cartridge cartridge onto the pump. Tap the To fill the tubing: insulin before the pump detects an empty UNLOCK icon when completed. cartridge. This can cause very high BG, or 1. Confirm the infusion set is not Diabetic Ketoacidosis (DKA).

  • Page 124: Filling Tubing Without Changing The Cartridge

    CHAPTER 7 • Infusion Site Care and Loading Cartridge ⚑ NOTE » If you are finished filling the tubing, tap ⚠ WARNING DONE. The Fill Tubing is complete ALWAYS ensure there is a tight connection The tubing must be filled with a minimum of screen is temporarily displayed.

  • Page 125: Filling Cannula

    CHAPTER 7 • Infusion Site Care and Loading Cartridge 5. Confirm that the tubing is To fill the cannula without filling the on-screen keypad to enter a value disconnected from your body and tubing, from the Home screen, tap between 0.1 to 1.0 unit. to continue.

  • Page 126: Setting Site Reminder

    CHAPTER 7 • Infusion Site Care and Loading Cartridge Site Reminder screen (see the next 1. Tap if settings are correct and ⚑ NOTE section). skip to step 6. Tap Edit Reminder If this is the first time using your pump and to change settings.

  • Page 127: Manual Bolus

    t:slim X2 Insulin Pump Features CHAPTER 8 Manual Bolus...

  • Page 128: Manual Bolus Overview

    You cannot ⚠ WARNING Control-IQ+™ technology. For information request a bolus from the Tandem t:slim mobile DO NOT deliver a bolus until you have reviewed about Automatic Bolus Delivery, see Automatic app while a bolus request is active on the pump.

  • Page 129: Initiating A Bolus

    Tandem t:slim mobile on the Bolus screen. The pump can app will say “requesting bolus” during this time.
  • Page 130 The t:slim X2 insulin pump and the Your glucose value is automatically the current CGM reading is used to Tandem t:slim mobile app can entered into the GLUCOSE field on the calculate the correction bolus. The automatically use CGM readings in their...
  • Page 131 CHAPTER 8 • Manual Bolus To change the glucose value • If your CGM value or trend arrow Calculate and add a correction bolus auto-populated from your CGM you are not available on the Home from the pump as follows: can tap on the GLUCOSE value on the screen, the Bolus screen appears.
  • Page 132 CHAPTER 8 • Manual Bolus correction bolus from any other bolus BG Value Manual Entry 1. From the Home screen tap BOLUS. you request. If your glucose value was not 2. Tap Add BG. auto-populated on the Bolus screen based on the conditions needed for that feature, you will need to manually enter your BG value into the pump before confirming bolus delivery.

  • Page 133: Bolus Override

    CHAPTER 8 • Manual Bolus 2. Tap 0 units on the left side of the 8.4 Bolus Override 8.6 Food Bolus Using Grams screen. You can override the calculated bolus To deliver a food bolus using the pump: 3. Using the on-screen keypad enter by tapping on the calculated units value units of insulin to be delivered, then 1.

  • Page 134: Extended Bolus

    CHAPTER 8 • Manual Bolus 6. Confirm Request. 3. Use the on-screen keypad to enter graph settings; these hash marks may temporarily obstruct a bolus icon as the grams of carb (or units of insulin). • Tap if entered data is graph changes over time.

  • Page 135: Max Bolus

    CHAPTER 8 • Manual Bolus The percentage value for DELIVER 11. Use the on-screen keypad to adjust  After the bolus delivery is complete, LATER is automatically calculated the length of time the bolus is to be an icon displays below the CGM by the pump.

  • Page 136: Quick Bolus

    CHAPTER 8 • Manual Bolus 1. From the Home screen, tap units of insulin or grams of screen will appear. The option of delivering OPTIONS. the remaining amount of the bolus up to an carbohydrate. The increment options additional 25 units will be given (see are 0.5, 1.0, 2.0, and 5.0 units;...
  • Page 137 The will sound to notify you (if Quick pump will beep/vibrate for each Bolus is set to vibrate, the pump will 12. Tap the Tandem logo to return to button press. stop vibrating in response to the Home screen.

  • Page 138: Canceling Or Stopping A Bolus Using The Pump

    If your smartphone is not compatible with the 2. Tap to stop delivery. delivery during a Quick Bolus, the remaining Bolus Delivery feature set of the Tandem t:slim Quick Bolus insulin will be delivered. mobile app, you cannot use the Tandem t:slim 3. Tap mobile app to request, cancel, or stop a bolus.

  • Page 139: Correction Bolus Using The Tandem T:slim Mobile App

    Section 8.14 Food Bolus Using can tap on the GLUCOSE value on the the Tandem t:slim Mobile App) Bolus screen. The following example shows the Bolus screen in the Tandem You must use your pump for the t:slim mobile app. following features: •...
  • Page 140 Calculate and add a correction bolus option to subtract a correction bolus from the Tandem t:slim mobile app as from any other bolus you request; any follows: values the Tandem t:slim mobile app...

  • Page 141: Bolus Override Using The Tandem T:slim Mobile App

    CHAPTER 8 • Manual Bolus • To accept the correction bolus, tap 3. Use the on-screen number keypad the Tandem t:slim mobile app will display the Yes on the Correction Bolus Low BG Alert in its place. to enter your BG value.

  • Page 142: Food Bolus Using The Tandem T:slim Mobile App

    Tandem t:slim mobile app: to completely avoid insulin delivery. Both the entered data is correct. pump and the Tandem t:slim mobile app will say 1. Tap the Bolus icon on the • Tap Back (iOS) or X (Android) to “requesting bolus” during this time as long as Navigation bar.

  • Page 143: Pump Connection Lost

    2. Tap Yes in the confirmation prompt 8.16 Pump Connection Lost the Tandem t:slim mobile app as long to cancel the bolus. as the Tandem t:slim mobile app has a Connection Lost During Bolus Bluetooth connection to the pump, Request...
  • Page 144 CHAPTER 8 • Manual Bolus pump is delivering a bolus, the Tandem ⚑ NOTE t:slim mobile app generates a Pump This Mobile Connection setting is not related to Connection Lost Alert. When you your CGM Bluetooth connection. For CGM receive this notification, the Tandem Bluetooth information, see Section 21.1 About...
  • Page 145 t:slim X2 Insulin Pump Features CHAPTER 9 Starting, Stopping, or Resuming Insulin...

  • Page 146: Starting, Insulin Delivery

    CHAPTER 9 • Starting, Stopping, or Resuming Insulin 3. To change the Resume Pump  The pump returns to the 9.1 Starting Insulin Delivery Alarm setting, skip to Step 4. confirmation screen. Otherwise, tap to accept the Insulin delivery starts once you have a default setting.

  • Page 147: Disconnecting When Using Control-Iq

    CHAPTER 9 • Starting, Stopping, or Resuming Insulin 1. Tap 1–2–3. 2. Tap  The RESUMING INSULIN screen is temporarily displayed. – OR – 1. From the Home screen, tap OPTIONS. 2. Tap RESUME INSULIN. 3. Tap The RESUMING INSULIN screen is temporarily displayed.
  • Page 148 CHAPTER 9 • Starting, Stopping, or Resuming Insulin This Page is Intentionally Left Blank...
  • Page 149 t:slim X2 Insulin Pump Features CHAPTER 10 t:slim X2 Insulin Pump Information and History...

  • Page 150: T:slim X2 Pump Information

    It can be requested, canceled, or stopped via software/hardware versions. viewed by the selected time period of: the Tandem t:slim mobile app. Today, 7 Day, 14 Day and 30 Day 1. From the Home screen, tap The Control-IQ+™ technology history Average.

  • Page 151: Tandem T:slim Mobile App Info

    CHAPTER 10 • t:slim X2 Insulin Pump Information and History 6. Tap the Tandem logo to return to the Home screen. ⚑ NOTE You must access these logs on the pump; the Tandem t:slim™ mobile app does not display the pump history logs.
  • Page 152 CHAPTER 10 • t:slim X2 Insulin Pump Information and History This Page is Intentionally Left Blank...
  • Page 153 t:slim X2 Insulin Pump Features CHAPTER 11 t:slim X2 Insulin Pump Reminders...

  • Page 154: Low Bg Reminders

    CHAPTER 11 • t:slim X2 Insulin Pump Reminders Your pump lets you know important until acknowledged. Reminders do not 6. Low BG is set to on; to turn off, tap Low BG. information about the pump with escalate. Reminders, Alerts, and Alarms. Reminders are displayed to notify you a.

  • Page 155: After Bolus Bg Reminder

    CHAPTER 11 • t:slim X2 Insulin Pump Reminders reminder, as well as how much time b. Tap Remind Me After and using 4. Tap Pump Reminders. should pass before the reminder the on-screen keypad, enter the occurs. time (from 1 to 3 hours), then 5.

  • Page 156: Site Reminder

    CHAPTER 11 • t:slim X2 Insulin Pump Reminders 1. From the Home screen, tap e. Tap Time of Day to select AM For detailed information on the Site OPTIONS. or PM, if applicable, then tap Reminder feature, see Section 7.8 Setting Site Reminder.

  • Page 157: User Settable Alerts And Alarms

    t:slim X2 Insulin Pump Features CHAPTER 12 User Settable Alerts and Alarms...

  • Page 158: Low Insulin Alerts

    1-2-3 to unlock the pump. 3. Tap Alerts & Reminders. • Performed certain actions within the Tandem t:slim mobile app. 4. Tap Pump Alerts. 12.2 Auto-Off Alarm Enable and configure the Auto-Off 5. Tap Low Insulin.

  • Page 159: Max Basal Alert

    12.3 Max Basal Alert 9. Tap the Tandem logo to return to the Home screen. Your pump allows you to set a limit to the Basal Rate that the pump will not allow you to exceed during a Temp Rate.
  • Page 160 CHAPTER 12 • User Settable Alerts and Alarms Once the Basal Limit in the Pump Settings has been set up (see Section 5.11 Basal Limit), you will receive an alert if the following scenarios occur. 1. A Temp Rate was requested that exceeds the Basal Limit.
  • Page 161 t:slim X2 Insulin Pump Features CHAPTER 13 t:slim X2 Insulin Pump Alerts...
  • Page 162 Notifications must be enabled on empty). Pay special attention to Alarms. your smartphone, and the Tandem t:slim mobile app must be open in the background for pump If multiple Reminders, Alerts, and notifications to be received on your smartphone.

  • Page 163: Low Insulin Alerts

    CHAPTER 13 • t:slim X2 Insulin Pump Alerts 13.1 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. 1 sequence of 3 notes or 1 vibration depending on the How will the pump notify me? volume/vibrate setting selected in Sound Volume.

  • Page 164: Low Power Alerts

    CHAPTER 13 • t:slim X2 Insulin Pump Alerts 13.2 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. 1 sequence of 3 notes or 1 vibration depending on the How will the pump notify me? volume/vibrate setting selected in Sound Volume.
  • Page 165 CHAPTER 13 • 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 166: Incomplete Bolus Alert

    CHAPTER 13 • t:slim X2 Insulin Pump Alerts 13.3 Incomplete Bolus Alert Incomplete Bolus Alert – Pump Screen 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.
  • Page 167 The Bolus screen will appear. Continue with your bolus request. ⚑ NOTE The Incomplete Bolus Alert is the only alert in this chapter that appears differently on the pump. All other pump alerts are identical in the Tandem t:slim mobile app.

  • Page 168: Incomplete Temp Rate Alert

    CHAPTER 13 • t:slim X2 Insulin Pump Alerts 13.4 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 169: Incomplete Load Sequence Alerts

    CHAPTER 13 • t:slim X2 Insulin Pump Alerts 13.5 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 170 CHAPTER 13 • 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. 2 sequences of 3 notes or 2 vibrations depending on the How will the pump notify me? volume/vibrate setting selected in Sound Volume.
  • Page 171 CHAPTER 13 • 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. 2 sequences of 3 notes or 2 vibrations depending on the How will the pump notify me? volume/vibrate setting selected in Sound Volume.

  • Page 172: Incomplete Setting Alert

    CHAPTER 13 • t:slim X2 Insulin Pump Alerts 13.6 Incomplete Setting Alert Screen Explanation What will I see on the screen? You started to set up a new Personal Profile or Control-IQ+ setting What does it mean? but did not save or complete the programming within 5 minutes. 2 sequences of 3 notes or 2 vibrations depending on the How will the pump notify me? volume/vibrate setting selected in Sound Volume.

  • Page 173: Basal Rate Required Alert

    CHAPTER 13 • t:slim X2 Insulin Pump Alerts 13.7 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 What does it mean? Profiles. A Basal Rate must be entered in each time segment (rate can be 0 u/hr).

  • Page 174: Max Hourly Bolus Alert

    CHAPTER 13 • t:slim X2 Insulin Pump Alerts 13.8 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. How will the pump notify me? Display only, the pump will not beep or vibrate.

  • Page 175: Max Bolus Alerts

    CHAPTER 13 • t:slim X2 Insulin Pump Alerts 13.9 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 176 CHAPTER 13 • 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? Your Max Bolus is set to 25 units and you requested a bolus larger What does it mean? than 25 units.

  • Page 177: Max Basal Alert

    CHAPTER 13 • t:slim X2 Insulin Pump Alerts 13.10 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 178: Min Basal Alerts

    CHAPTER 13 • t:slim X2 Insulin Pump Alerts 13.11 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 What does it mean? requested a Basal Rate less than half of the lowest basal rate defined in your Personal Profile.
  • Page 179 CHAPTER 13 • 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. 1 sequence of 3 notes or 1 vibration depending on the How will the pump notify me? volume/vibrate setting selected in Sound Volume.

  • Page 180: Connection Error Alert

    What will I see on the screen? You connected your pump to a computer with the USB cable to charge it, upload data to the Tandem t:slim web application, or What does it mean? upload data to the Tandem Source platform, and a connection could not be made.

  • Page 181: Pairing Code Timeout

    CHAPTER 13 • t:slim X2 Insulin Pump Alerts 13.13 Pairing Code Timeout Screen Explanation What will I see on the screen? You attempted to connect a smartphone to the pump, but the What does it mean? pairing process took too long (more than 5 minutes) and was unsuccessful.

  • Page 182: Power Source Alert

    CHAPTER 13 • t:slim X2 Insulin Pump Alerts 13.14 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. 1 sequence of 3 notes or 1 vibration depending on the How will the pump notify me? volume/vibrate setting selected in Sound Volume.

  • Page 183: Data Error Alert

    CHAPTER 13 • t:slim X2 Insulin Pump Alerts 13.15 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 How will the pump notify me? volume/vibrate setting selected in Sound Volume.

  • Page 184: Pump Connection Lost Alert - Tandem T:slim Mobile App

    • You cannot use the Tandem t:slim mobile app to request another bolus until you have restored your smartphone’s connection to the pump. ⚑ NOTE The Pump Connection Lost Alert is the only alert in this chapter that appears in the Tandem t:slim mobile app but not on the pump.
  • Page 185 t:slim X2 Insulin Pump Features CHAPTER 14 t:slim X2 Insulin Pump Alarms...
  • Page 186 Notifications must be enabled on If multiple Reminders, Alerts, and your smartphone, and the Tandem t:slim mobile Alarms happen at the same time, app must be open in the background for pump Alarms will be displayed first, Alerts will notifications to be received on your smartphone.

  • Page 187: Resume Pump Alarms

    CHAPTER 14 • t:slim X2 Insulin Pump Alarms 14.1 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. 3 sequences of 3 notes or 3 vibrations depending on the How will the pump notify me? volume/vibrate setting selected in Sound Volume.

  • Page 188: Low Power Alarm

    CHAPTER 14 • t:slim X2 Insulin Pump Alarms 14.2 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. 3 sequences of 3 notes or 3 vibrations depending on the How will the pump notify me? volume/vibrate setting selected in Sound Volume.

  • Page 189: Empty Cartridge Alarm

    CHAPTER 14 • t:slim X2 Insulin Pump Alarms 14.3 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 How will the pump notify me? volume/vibrate setting selected in Sound Volume.

  • Page 190: Cartridge Error Alarm

    CHAPTER 14 • t:slim X2 Insulin Pump Alarms 14.4 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 What does it mean? following the proper procedure to load the cartridge, or over filling the cartridge (with more than 300 units of insulin).

  • Page 191: Cartridge Removal Alarm

    CHAPTER 14 • t:slim X2 Insulin Pump Alarms 14.5 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 How will the pump notify me? volume/vibrate setting selected in Sound Volume.

  • Page 192: Temperature Alarm

    CHAPTER 14 • t:slim X2 Insulin Pump Alarms 14.6 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 193: Occlusion Alarms

    CHAPTER 14 • t:slim X2 Insulin Pump Alarms 14.7 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 34.4 t:slim X2 Pump Performance What does it mean? Characteristics for more information on how long it can take the...
  • Page 194 CHAPTER 14 • 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. 3 sequences of 3 notes or 3 vibrations depending on the How will the pump notify me? volume/vibrate setting selected in Sound Volume.

  • Page 195: Screen On/Quick Bolus Button Alarm

    CHAPTER 14 • t:slim X2 Insulin Pump Alarms 14.8 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. 3 sequences of 3 notes or 3 vibrations depending on the How will the pump notify me? volume/vibrate setting selected in Sound Volume.

  • Page 196: Altitude Alarm

    CHAPTER 14 • t:slim X2 Insulin Pump Alarms 14.9 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 197: Reset Alarm

    CHAPTER 14 • t:slim X2 Insulin Pump Alarms 14.10 Reset Alarm Screen Explanation What will I see on the screen? Your pump experienced a reset and all deliveries have been What does it mean? stopped. 3 sequences of 3 notes or 3 vibrations depending on the How will the pump notify me? volume/vibrate setting selected in Sound Volume.
  • Page 198 CHAPTER 14 • t:slim X2 Insulin Pump Alarms This Page is Intentionally Left Blank...

  • Page 199: Chapter 15 • T:slim X2 Insulin Pump Malfunction

    t:slim X2 Insulin Pump Features CHAPTER 15 t:slim X2 Insulin Pump Malfunction...

  • Page 200: Malfunction

    CHAPTER 15 • t:slim X2 Insulin Pump Malfunction 15.1 Malfunction If your pump detects a critical 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 201 CHAPTER 15 • t:slim X2 Insulin Pump Malfunction Screen Explanation What will I see on the screen? Your pump detected a critical error and all deliveries have been What does it mean? stopped. Use your backup insulin method, or contact your healthcare provider for an alternate insulin delivery plan.
  • Page 202 CHAPTER 15 • t:slim X2 Insulin Pump Malfunction This Page is Intentionally Left Blank...

  • Page 203: Chapter 16 • Taking Care Of Your Pump

    t:slim X2 Insulin Pump Features CHAPTER 16 Taking Care of Your Pump...

  • Page 204: Overview

    CHAPTER 16 • Taking Care of Your Pump Inspecting Your Pump for Damage pump in storage mode. To place the 16.1 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 caring for and maintaining your pump.

  • Page 205: Chapter 17 • Lifestyle Issues And Travel

    t:slim X2 Insulin Pump Features CHAPTER 17 Lifestyle Issues and Travel...

  • Page 206: Overview

    If you choose to use a pump case or other Customer Technical Support. accessories not provided by Tandem, DO NOT While the convenience and flexibility of cover the six vent holes on the back of the...
  • Page 207 Newer travel loaner pump in case your pump Travel full body scanners used in airport security malfunctions outside of Tandem’s screening are also a form of X-ray and your replacement area. The flexibility afforded by an insulin pump should not be exposed to them.
  • Page 208 ⚑ NOTE The Tandem t:slim mobile app requires an active Bluetooth connection to connect with your pump. If you turn on Airplane mode, make sure you keep Bluetooth enabled to connect to your...

  • Page 209: Section 3: Cgm Features

    CGM Features CHAPTER 18 Important Safety Information When Using the t:slim X2 Insulin Pump with a Compatible CGM...

  • Page 210: Cgm Warnings

    In order to receive CGM alerts on your pump ⚠ PRECAUTION information related to your CGM and its and/or your Tandem t:slim mobile app, a sensor AVOID separating the CGM and pump by more components. The information session must be started and transmitting sensor than 20 feet (6 meters).

  • Page 211: Potential Benefits From Using The T:slim X2 Insulin Pump With Cgm

    CHAPTER 18 • Important Safety Information When Using the t:slim X2 Insulin Pump with a Compatible CGM Using an Abbott FreeStyle Libre 2 as a trend graph on the CGM Home affect sensor accuracy and could result in you Plus Sensor with Your t:slim X2 Insulin missing severe hypoglycemia (low BG) or screen.
  • Page 212 CHAPTER 18 • Important Safety Information When Using the t:slim X2 Insulin Pump with a Compatible CGM Other risks associated with CGM use include the following: • You will not get sensor glucose alerts when the alert function is turned off, your CGM and pump are out of range, or when your pump is not showing sensor glucose readings.

  • Page 213: Chapter 19 • Getting To Know Your Cgm System

    CGM Features CHAPTER 19 Getting to Know Your CGM System...

  • Page 214: Cgm Terminology

    CHAPTER 19 • Getting to Know Your CGM System CGM Reading with the Dexcom app may be used in 19.1 CGM Terminology A CGM reading is a sensor glucose addition to the pump to receive sensor reading shown on your pump. This readings.
  • Page 215 CHAPTER 19 • Getting to Know Your CGM System Sensor Glucose Trends Trend (Rate of Change) Arrows Glucose trends let you see the pattern Trend arrows show how fast your of your glucose levels. The trend graph glucose levels are changing. Different shows where your glucose levels have arrows show when your glucose been during the time shown on the...

  • Page 216: Explanation Of Dexcom Cgm Pump Icons

    CHAPTER 19 • Getting to Know Your CGM System 19.2 Explanation of Dexcom CGM Pump Icons When wearing a Dexcom CGM, the following CGM icons may appear on your pump screen: CGM Icon Definitions — Dexcom Symbol Meaning Symbol Meaning Unknown sensor reading.

  • Page 217: Explanation Of Abbott Freestyle Libre 2 Plus Sensor Cgm Pump Icons

    CHAPTER 19 • Getting to Know Your CGM System 19.3 Explanation of Abbott FreeStyle Libre 2 Plus Sensor CGM Pump Icons When wearing the Abbott FreeStyle Libre 2 Plus Sensor CGM, the following CGM icons may appear on your pump screen: CGM Icon Definitions —...

  • Page 218: Cgm Lock Screen

    CHAPTER 19 • Getting to Know Your CGM System 9. Active Bolus Icon: Indicates a 19.4 CGM Lock Screen bolus is being delivered. The CGM Lock screen appears anytime 10. Status: Displays current pump you turn on the screen and you are settings and insulin delivery status.
  • Page 219 CHAPTER 19 • Getting to Know Your CGM System...

  • Page 220: Cgm Home Screen

    CHAPTER 19 • Getting to Know Your CGM System 10. Bolus: Program and deliver a bolus. To view CGM information on the full 19.5 CGM Home Screen screen: 11. Status: Displays current pump From the CGM Home screen tap 1. Time and Date Display: Displays settings and insulin delivery status.
  • Page 221 CHAPTER 19 • Getting to Know Your CGM System...

  • Page 222: Dexcom G6 Screen

    CHAPTER 19 • Getting to Know Your CGM System 7. Change Sensor Type: Return to 19.6 Dexcom G6 Screen the Select Sensor screen to start a new sensor session with a different The Dexcom G6 screen can be sensor type. accessed from the My CGM screen by tapping Change Sensor Type.
  • Page 223 CHAPTER 19 • Getting to Know Your CGM System...

  • Page 224: Dexcom G7 Screen

    CHAPTER 19 • Getting to Know Your CGM System 19.7 Dexcom G7 Screen The Dexcom G7 screen can be accessed from the My CGM screen tapping Change Sensor Type. See Section 23.1 Choosing Your Sensor Type. : Returns to the Options screen.
  • Page 225 CHAPTER 19 • Getting to Know Your CGM System...

  • Page 226: Abbott Freestyle Libre 2 Plus Sensor Cgm Screen

    19.8 Abbott FreeStyle Libre 2 Plus You must start an Abbott FreeStyle Libre 2 Sensor CGM Screen Plus Sensor session from your Tandem t:slim mobile app. If you tap FreeStyle Libre The FreeStyle Libre 2 Plus screen can 2 Plus on the Select Sensor screen, a...
  • Page 227 CHAPTER 19 • Getting to Know Your CGM System...
  • Page 228 CHAPTER 19 • Getting to Know Your CGM System This Page is Intentionally Left Blank...

  • Page 229: Chapter 20 • Cgm Overview

    CGM Features CHAPTER 20 CGM Overview...

  • Page 230: Cgm System Overview

    CHAPTER 20 • CGM Overview from interstitial fluid (the fluid under your ⚠ PRECAUTION 20.1 CGM System Overview skin). The CGM uses Bluetooth wireless AVOID separating the CGM and pump by more technology communication. than 20 feet (6 meters). The transmission range This section of the user guide covers from the CGM to the pump is up to 20 feet (6 •...

  • Page 231: Receiver (T:slim X2 Insulin Pump) Overview

    Once you and Dexcom G7 mobile apps and the see the Low Transmitter Battery Alert, Tandem t:slim mobile app at the same 20.4 Dexcom G6 Transmitter replace the transmitter as soon as time. The Dexcom G6 and Dexcom G7 Overview possible.

  • Page 232: Sensor Overview

    CHAPTER 20 • CGM Overview 20.5 Sensor Overview For information about your CGM sensor, visit the manufacturer’s website for applicable product instructions.

  • Page 233: Cgm Settings

    CGM Features CHAPTER 21 CGM Settings...

  • Page 234: About Bluetooth Technology

    The default profile when you receive as a CGM or smartphone running the your pump. This sets all alerts and Tandem t:slim™ mobile app. This alarms to higher volume beeps. 21.3 Setting CGM Volume allows the pump to wirelessly...
  • Page 235 CHAPTER 21 • CGM Settings The Soft, Normal, and HypoRepeat 5. Tap the Down Arrow. options have the following sequence: 6. Tap CGM Alerts. • The first alert is vibrate only. 7. Tap Vibrate, Soft, Normal or • If the alert is not confirmed in 5 HypoRepeat to select.
  • Page 236 CHAPTER 21 • CGM Settings Sound Option Descriptions (Dexcom only) 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 237 CHAPTER 21 • CGM Settings Sound Option Descriptions (Abbott only) CGM Volume Vibrate Soft Normal HypoRepeat 2 short vibrates + 2 short vibrates + 2 short vibrates + High Alert 2 short vibrates 2 low beeps 2 medium beeps 2 medium beeps 3 short vibrates + 3 short vibrates + 3 short vibrates +...

  • Page 238: Cgm Info

    CHAPTER 21 • CGM Settings 1. From the Home screen, tap 21.4 CGM Info OPTIONS. CGM Info contains important 2. Tap the Down Arrow. information about your device. 3. Tap My CGM. If you use a Dexcom CGM, the following can be found in CGM Info: 4.

  • Page 239: Setting Cgm Alerts

    CGM Features CHAPTER 22 Setting CGM Alerts...

  • Page 240: Setting Your High Glucose Alerts And Repeat Feature

    CHAPTER 22 • Setting CGM Alerts Setting Your CGM Alerts CGM and the pump are too far apart, 5. Tap High and Low. you will not get sensor glucose You can create personal settings for readings or alerts. 6. To Set the High Alert, tap High how and when you want the pump to Alert.

  • Page 241: Setting Your Low Glucose Alert And Repeat Feature

    CHAPTER 22 • Setting CGM Alerts hour, 2 hours, 3 hours, 4 hours, or 2. Tap the Down Arrow. remains below the Low Alert value. 5 hours when your sensor glucose The default value is: Never (the alert reading remains above the High 3.

  • Page 242: Rate Alerts

    CHAPTER 22 • Setting CGM Alerts beeps according to your CGM volume sensor session, the CGM Rise Alert 22.3 Rate Alerts selection. shows one arrow pointing up. Rate alerts tell you when your glucose levels are rising (Rise Alert) or falling (Fall Alert) and by how much.

  • Page 243: Setting Your Fall Alert

    CHAPTER 22 • Setting CGM Alerts To change your selection, tap Rate. To change your selection, tap Rate. Your CGM is providing the data that Control-IQ+™ technology requires to make predictions to automate insulin dosing. ⚑ NOTE ⚑ NOTE To turn off the Rise Alert, tap the on/off To turn off the Fall Alert, tap the on/off Keep the CGM and the pump within 20 toggle.
  • Page 244 CHAPTER 22 • Setting CGM Alerts present for 20 minutes, Control-IQ+ will stop operation until the two devices are within range. To Set Your Out of Range Alert: 1. From the Home screen, tap OPTIONS. 2. Tap the Down Arrow. 3.
  • Page 245 CGM Features CHAPTER 23 Starting or Stopping a CGM Sensor Session...

  • Page 246: Choosing Your Sensor Type

    CHAPTER 23 • Starting or Stopping a CGM Sensor Session 5. Select your sensor type. paired, allowing your sensor glucose 23.1 Choosing Your Sensor Type readings to be displayed on your pump. If you need to replace your transmitter, If this is the first time you have used you will need to enter the new your pump, or if you have updated your transmitter ID into your pump.

  • Page 247: Start The Dexcom G6 Sensor

    CHAPTER 23 • Starting or Stopping a CGM Sensor Session The transmitter ID can be found on codes, visit the manufacturer’s 23.3 Start the Dexcom G6 Sensor the back of your transmitter or on website for applicable user guides. the transmitter box. To start a CGM session, follow the steps below.

  • Page 248: Dexcom G6 Sensor Startup Period

    CHAPTER 23 • Starting or Stopping a CGM Sensor Session  Your pump will return to the CGM Sensor Startup Period Timeline 23.4 Dexcom G6 Sensor Startup Home screen with the 3 hour trend Period graph and the sensor startup countdown symbol displayed.
  • Page 249 CHAPTER 23 • Starting or Stopping a CGM Sensor Session If you started your sensor session 90 Follow the instructions in the next ⚠ PRECAUTION 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...

  • Page 250: Dexcom G6 Automatic Sensor Shut-Off

    New sensor glucose readings do not place where sensor glucose Your t:slim X2 pump tells you how show on your pump or Tandem t:slim readings normally show. much time you have left until your mobile app after your sensor session sensor session is complete.

  • Page 251: Start The Dexcom G7 Sensor

    CHAPTER 23 • Starting or Stopping a CGM Sensor Session 5. Enter your pairing code. Tap • Make sure your pump and CGM are professional medical help if you have symptoms of infection or inflammation (redness, swelling, confirm. within 20 feet (6 meters) of each or pain) at the insertion site.
  • Page 252 CHAPTER 23 • Starting or Stopping a CGM Sensor Session countdown symbol fills in over time to Sensor Startup Period Timeline ⚠ PRECAUTION show that you are getting closer to the Continue to use a BG meter and test strips in active sensor session.

  • Page 253: Dexcom G7 Automatic Sensor Shut-Off

    Soon screen: with the Replace Sensor icon in the New sensor glucose readings do not place where sensor glucose show on your pump or Tandem t:slim 1. Tap to return to the previous readings normally show. mobile app after your sensor session screen.

  • Page 254: Removing The Dexcom G7 Sensor

    You will need to start an Abbott For iOS smartphones, see step 4; FreeStyle Libre 2 Plus Sensor CGM for Android smartphones, see  Your Tandem t:slim mobile app will session using the Tandem t:slim mobile step 5. return to the CGM screen.

  • Page 255: Abbott Freestyle Libre 2 Plus Sensor Startup Period

    The • Make sure your pump and CGM Tandem t:slim mobile app will also sensor are within 20 feet (6 meters) display the time remaining in the startup of each other without obstruction.

  • Page 256: Abbott Freestyle Libre 2 Plus Automatic Sensor Shut-Off

    Check BG icon is displayed, check your BG to confirm your sensor values before making any treatment decisions. The following is an example of the Check BG icon on the Tandem t:slim ⚠ PRECAUTION mobile app Dashboard screen. 23.15 Abbott FreeStyle Libre 2 Plus...

  • Page 257: Ending An Abbott Freestyle Libre 2 Plus Sensor Session Before Automatic Shut-Off

    When you see the Sensor Expiring New sensor glucose readings do not 23.16 Ending an Abbott FreeStyle Soon screen: show on your pump or Tandem t:slim Libre 2 Plus Sensor Session mobile app after your sensor session Before Automatic Shut-Off 1.
  • Page 258 CHAPTER 23 • Starting or Stopping a CGM Sensor Session This Page is Intentionally Left Blank...
  • Page 259 CGM Features CHAPTER 24 Calibrating Your Dexcom CGM System...

  • Page 260: Calibration Overview

    CHAPTER 24 • Calibrating Your Dexcom CGM System Calibration is required for the Dexcom On the first day of your sensor session, you treat your BG value before G6 CGM if you did not enter a sensor you must enter four BG values into your calibrating.

  • Page 261: Startup Calibration

    CHAPTER 24 • Calibrating Your Dexcom CGM System blood drops will stay on the screen ⚠ PRECAUTION 24.2 Startup Calibration until you enter two separate BG To calibrate the CGM, DO enter the exact values to calibrate. BG value displayed on your BG meter within If you did not enter a sensor code when 5 minutes of a carefully performed BG starting the Dexcom G6 CGM, the...

  • Page 262: Calibration Bg Value And Correction Bolus

    CHAPTER 24 • Calibrating Your Dexcom CGM System  The on-screen keypad will appear. » If Control-IQ+ technology is BG value to calibrate in either 15 disabled, the Above Target minutes or 1 hour, depending on the 12. Wash and dry your hands, make Correction Bolus confirmation error.
  • Page 263 CGM Features CHAPTER 25 Viewing CGM Data on Your t:slim X2 Insulin Pump...

  • Page 264: Overview

    CHAPTER 25 • Viewing CGM Data on Your t:slim X2 Insulin Pump every 5 minutes regardless of which Home screen with the 3 hour trend 25.1 Overview CGM sensor you are wearing. graph displayed. The trend graph provides additional ⚠ WARNING information that your BG meter does DO NOT ignore symptoms of high and low not.

  • Page 265: Cgm Trend Graphs

    CHAPTER 25 • Viewing CGM Data on Your t:slim X2 Insulin Pump • Sensor glucose readings are shown Your trend graph shows a flat line or with the last 6 hours of sensor glucose in milligrams per deciliter (mg/dL). dots at 50 or 400 mg/dL when your readings.

  • Page 266: Rate Of Change Arrows

    CHAPTER 25 • Viewing CGM Data on Your t:slim X2 Insulin Pump with the last 24 hours of sensor glucose LOW shows when your most recent 25.3 Rate of Change Arrows readings. sensor glucose reading is less than 40 mg/dL. Your rate of change arrows add detail about the direction and speed of sensor glucose change over the last 15–20...
  • Page 267 CHAPTER 25 • 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 using your BG meter.
  • Page 268 CHAPTER 25 • Viewing CGM Data on Your t:slim X2 Insulin Pump The table below shows the different trend arrows you may see during a Dexcom CGM sensor session: Dexcom CGM Trend Arrow Definitions Constant: Your sensor glucose is steady (not Slowly falling: Your sensor glucose is falling 1–2 mg/dL increasing/decreasing more than 1 mg/dL each minute).
  • Page 269 CHAPTER 25 • Viewing CGM Data on Your t:slim X2 Insulin Pump The table below shows the different trend arrows you may see during an Abbott FreeStyle Libre 2 Plus CGM sensor session: Abbott FreeStyle Libre 2 Plus CGM Trend Arrow Definitions Changing Slowly: Your sensor glucose is steady Falling: Your sensor glucose is falling between 1 and (increasing/decreasing 1 mg/dL or less each minute).

  • Page 270: Cgm History

    CHAPTER 25 • 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. 25.4 CGM History (C: Alert) indicates the time it was The pump will automatically attempt to cleared.

  • Page 271: Cgm Alerts And Errors

    CGM Features CHAPTER 26 CGM Alerts and Errors...
  • Page 272 Chapter 15 t:slim X2 smartphone. Notifications must be enabled on Insulin Pump Malfunction. your smartphone, and the Tandem t:slim mobile app must be open in the background for pump For information on Control-IQ+™ notifications to be received on your smartphone.

  • Page 273: Cgm High Alerts

    CHAPTER 26 • CGM Alerts and Errors 26.1 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 pump notify me? confirmed or your sensor glucose value drops below the Alert level.

  • Page 274: Cgm Low Alert

    CHAPTER 26 • CGM Alerts and Errors 26.2 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 pump notify me? confirmed or your sensor glucose value goes above the Alert level.

  • Page 275: Cgm Fixed Low Alert

    CHAPTER 26 • CGM Alerts and Errors 26.3 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 pump notify me? confirmed or your sensor glucose value goes above 55 mg/dL.

  • Page 276: Cgm Rise Alert

    CHAPTER 26 • CGM Alerts and Errors 26.4 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 pump notify me? confirmed.

  • Page 277: Cgm Fall Alert

    CHAPTER 26 • CGM Alerts and Errors 26.5 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 pump notify me? confirmed.

  • Page 278: Unknown Sensor Glucose Reading

    CHAPTER 26 • CGM Alerts and Errors 26.6 Unknown Sensor Glucose Reading Screen Explanation What will I see on the screen? The sensor is sending sensor glucose readings that the pump does What does it mean? not understand. You will not receive sensor glucose readings. How will the pump notify me? On screen only with no vibration or beep.

  • Page 279: Out Of Range Alert

    CHAPTER 26 • CGM Alerts and Errors 26.7 Out of Range Alert Screen Explanation What will I see on the screen? The CGM and pump are not communicating. You may see slightly different error screens depending on which CGM you are using. The What does it mean? pump will not receive sensor glucose readings, and Control-IQ+ is not able to predict sensor glucose levels or adjust insulin delivery.

  • Page 280: Failed Sensor Error

    CHAPTER 26 • CGM Alerts and Errors 26.8 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 pump notify me? 1 vibration, then vibration/beep every 5 minutes.

  • Page 281: Cgm Unavailable

    CHAPTER 26 • CGM Alerts and Errors 26.9 CGM Unavailable Screen Explanation 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 pump notify me? confirmed.

  • Page 282: Cgm System Error

    CHAPTER 26 • CGM Alerts and Errors 26.10 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 pump notify me? 1 vibration, then vibration/beep every 5 minutes.

  • Page 283: Incomplete Calibration (Dexcom Only)

    CHAPTER 26 • CGM Alerts and Errors 26.11 Incomplete Calibration (Dexcom Only) 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 pump notify me? 2 beeps or vibrations depending on Sound Volume selected.

  • Page 284: Calibration Timeout (Dexcom Only)

    CHAPTER 26 • CGM Alerts and Errors 26.12 Calibration Timeout (Dexcom Only) 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 pump notify me? 2 beeps or vibrations depending on Sound Volume selected.

  • Page 285: Calibration Error Alert (Dexcom Only)

    CHAPTER 26 • CGM Alerts and Errors 26.13 Calibration Error Alert (Dexcom Only) Screen Explanation What will I see on the screen? The CGM cannot calibrate using the last BG meter value you What does it mean? entered. How will the pump notify me? 1 vibration, then vibration/beep every 5 minutes until confirmed.

  • Page 286: Cgm Rapid Rise Alert (Dexcom Only)

    CHAPTER 26 • CGM Alerts and Errors 26.14 CGM Rapid Rise Alert (Dexcom Only) 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).

  • Page 287: Cgm Rapid Fall Alert (Dexcom Only)

    CHAPTER 26 • CGM Alerts and Errors 26.15 CGM Rapid Fall Alert (Dexcom Only) 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 pump notify me? confirmed.

  • Page 288: Startup Calibration Alert (Dexcom G6 Only)

    CHAPTER 26 • CGM Alerts and Errors 26.16 Startup Calibration Alert (Dexcom G6 Only) Screen Explanation What will I see on the screen? The startup period is complete. This will only appear if you did not What does it mean? enter a sensor code.

  • Page 289: Second Startup Calibration Alert (Dexcom G6 Only)

    CHAPTER 26 • CGM Alerts and Errors 26.17 Second Startup Calibration Alert (Dexcom G6 Only) Screen Explanation What will I see on the screen? The CGM 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 pump notify me? 1 vibration, then vibration/beep every 5 minutes until confirmed.

  • Page 290: Hour Calibration Alert (Dexcom G6 Only)

    CHAPTER 26 • CGM Alerts and Errors 26.18 12 Hour Calibration Alert (Dexcom G6 Only) Screen Explanation What will I see on the screen? The CGM needs a BG value to calibrate. This will only appear if you What does it mean? did not enter a sensor code.

  • Page 291: Calibration Required Alert (Dexcom G6 Only)

    CHAPTER 26 • CGM Alerts and Errors 26.19 Calibration Required Alert (Dexcom G6 Only) Screen Explanation What will I see on the screen? The CGM needs a BG value to calibrate. Sensor glucose readings What does it mean? will not be displayed at this time. How will the pump notify me? 1 vibration, then vibration/beep every 5 minutes until confirmed.

  • Page 292: Low Transmitter Battery Alert (Dexcom G6 Only)

    CHAPTER 26 • CGM Alerts and Errors 26.20 Low Transmitter Battery Alert (Dexcom G6 Only) Screen Explanation What will I see on the screen? What does it mean? Dexcom G6 transmitter battery is low. How will the pump notify me? 1 vibration, then vibration/beep every 5 minutes until confirmed.

  • Page 293: Transmitter Error (Dexcom G6 Only)

    CHAPTER 26 • CGM Alerts and Errors 26.21 Transmitter Error (Dexcom G6 Only) Screen Explanation What will I see on the screen? The Dexcom G6 transmitter has failed and the CGM session has What does it mean? stopped. How will the pump notify me? 1 vibration, then vibration/beep every 5 minutes.

  • Page 294: Incompatible Sensor Alert (Dexcom G7 Only)

    CHAPTER 26 • CGM Alerts and Errors 26.22 Incompatible Sensor Alert (Dexcom G7 Only) Screen Explanation What will I see on the screen? The Dexcom G7 CGM you are attempting to pair is not compatible What does it mean? with your pump. 1 beep/vibration, then beep/vibration every 5 minutes until How will the pump notify me? confirmed.

  • Page 295: Cgm Error (Dexcom G7 Only)

    CHAPTER 26 • CGM Alerts and Errors 26.23 CGM Error (Dexcom G7 Only) Screen Explanation What will I see on the screen? Your Dexcom G7 CGM sensor is not working properly; the CGM What does it mean? session has stopped and the CGM can no longer be used. How will the pump notify me? 1 vibration, then vibration/beep every 5 minutes.

  • Page 296: Unable To Pair (Dexcom G7 Only)

    CHAPTER 26 • CGM Alerts and Errors 26.24 Unable to Pair (Dexcom G7 Only) Screen Explanation What will I see on the screen? Your Dexcom G7 CGM has attempted to pair too many times while What does it mean? in an area with too many Dexcom G7 sensors. How will the pump notify me? 1 vibration, then vibration/beep every 5 minutes.

  • Page 297: Cgm Check Sensor Alert (Abbott Freestyle Libre 2 Plus Sensor Only)

    CHAPTER 26 • CGM Alerts and Errors 26.25 CGM Check Sensor Alert (Abbott FreeStyle Libre 2 Plus Sensor Only) Insertion Error Screen Explanation What will I see on the screen? The CGM sensor is unable to connect to the pump upon initial What does it mean? sensor insertion.
  • Page 298 CHAPTER 26 • CGM Alerts and Errors Pairing Error Screen Explanation What will I see on the screen? The CGM sensor is unable to connect to the pump and establish a What does it mean? Bluetooth connection. 1 vibrate, then vibration/beep every 5 minutes until the CGM and How will the pump notify me? pump are back in range or you begin a new CGM sensor session.

  • Page 299: Cgm Unavailable Alert (Abbott Freestyle Libre 2 Plus Sensor Only)

    CHAPTER 26 • CGM Alerts and Errors 26.26 CGM Unavailable Alert (Abbott FreeStyle Libre 2 Plus Sensor Only) Screen Explanation What will I see on the screen? The sensor is sending sensor glucose readings that the pump does What does it mean? not understand.

  • Page 300: Sensor Temperature Alert (Abbott Freestyle Libre 2 Plus Sensor Only)

    CHAPTER 26 • CGM Alerts and Errors 26.27 Sensor Temperature Alert (Abbott FreeStyle Libre 2 Plus Sensor Only) Screen Explanation What will I see on the screen? What does it mean? The CGM sensor is outside of its operating temperature range. How will the pump notify me? On-screen only with no vibration or beep.

  • Page 301: Cgm System Error (Abbott Freestyle Libre 2 Plus Sensor Only)

    CHAPTER 26 • CGM Alerts and Errors 26.28 CGM System Error (Abbott FreeStyle Libre 2 Plus Sensor Only) 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.
  • Page 302 CHAPTER 26 • CGM Alerts and Errors This Page is Intentionally Left Blank...

  • Page 303: Cgm Troubleshooting

    CGM Features CHAPTER 27 CGM Troubleshooting...

  • Page 304: Cgm Pairing Troubleshooting

    CHAPTER 27 • CGM Troubleshooting This chapter provides helpful tips and your pump. See Section 21.2 Do not calibrate if you see the Out of instructions to help you fix issues you Disconnecting from the Dexcom Range symbol in the place where your may have while using the CGM portion Receiver.

  • Page 305: Out Of Range/No Antenna Troubleshooting

    CHAPTER 27 • CGM Troubleshooting If you are using a Dexcom CGM, do not • Dexcom G6 only: Wipe the bottom result in you missing severe hypoglycemia (low enter any BG values for calibration of the transmitter with an isopropyl BG) or hyperglycemia (high BG) events.

  • Page 306: Failed Sensor Troubleshooting

    CHAPTER 27 • CGM Troubleshooting • Make sure you have removed your • Make sure your sensor pod is not values for calibration. Entering incorrect BG sensor and stopped your sensor dislodged or peeling up. values, BG values obtained more than 5 minutes session before changing your before entry, or sensor glucose readings might •...

  • Page 307: Sensor Inaccuracies - Abbott Freestyle Libre 2 Plus Only

    CHAPTER 27 • CGM Troubleshooting • Make sure you do not calibrate required). Carefully apply the blood when “- - -” or the Out of Range sample to the test strip following the icon are on the screen. instructions provided with your BG meter or test strips.
  • Page 308 CHAPTER 27 • CGM Troubleshooting This Page is Intentionally Left Blank...
  • Page 309 Control-IQ+ Technology Features CHAPTER 28 Control-IQ+ Technology Important Safety Information...

  • Page 310: Control-Iq+ Warnings

    CHAPTER 28 • Control-IQ+ Technology Important Safety Information The following includes important safety hypoglycemia (low BG) or hyperglycemia (high ⚠ WARNING information related to Control-IQ+™ BG) events. Do not use Control-IQ+ unless recommended by technology. The information presented your healthcare provider. in this chapter does not represent all ⚠...

  • Page 311: Control-Iq+ Precautions

    CHAPTER 28 • Control-IQ+ Technology Important Safety Information BG meter and consult with your healthcare ⚠ WARNING ⚠ PRECAUTION provider about alternative glucose monitoring DO NOT use manual injections or inhaled We recommend that you enable the High approaches. insulins while using Control-IQ+. Using insulin Glucose Alert and the Low Glucose Alert when not provided by the pump while using closed using Control-IQ+ so that you will be notified if...
  • Page 312 CHAPTER 28 • Control-IQ+ Technology Important Safety Information This Page is Intentionally Left Blank...
  • Page 313 Control-IQ+ Technology Features CHAPTER 29 Getting to Know Control-IQ+ Technology...

  • Page 314: Responsible Use Of Control-Iq+ Technology

    CHAPTER 29 • Getting to Know Control-IQ+ Technology 29.1 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 315: Explanation Of Control-Iq+ Technology Icons

    CHAPTER 29 • Getting to Know Control-IQ+ Technology 29.2 Explanation of Control-IQ+ Technology Icons If you have a CGM session active and are using Control-IQ+, you may see the following additional icons on your pump screen: Control-IQ+ Icon Definitions Symbol Meaning Symbol Meaning...

  • Page 316: Control-Iq+ Lock Screen

    CHAPTER 29 • Getting to Know Control-IQ+ Technology 29.3 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+ enabled. The Control-IQ+ Lock screen is the same as the CGM Lock screen, with the following additions.
  • Page 317 CHAPTER 29 • Getting to Know Control-IQ+ Technology CHAPTER 29 • Getting to Know Control-IQ+ Technology...

  • Page 318: Control-Iq+ Home Screen

    CHAPTER 29 • Getting to Know Control-IQ+ Technology 29.4 Control-IQ+ Home Screen The Home screen with Control-IQ+ enabled is identical to the CGM Home screen, with the following additions. Section 19.5 CGM Home Screen. 1. Control-IQ+ Status: Indicates the status of Control-IQ technology. 2.
  • Page 319 CHAPTER 29 • Getting to Know Control-IQ+ Technology CHAPTER 29 • Getting to Know Control-IQ+ Technology...

  • Page 320: Control-Iq+ Screen

    CHAPTER 29 • Getting to Know Control-IQ+ Technology 29.5 Control-IQ+ Screen 1. Control-IQ on/off: Turns on, or off, Control-IQ+. 2. Weight: Displays your current weight. This value is manually entered in on the numerical keypad. ⚑ NOTE Your weight should be representative of what you weigh when you start Control-IQ+.
  • Page 321 CHAPTER 29 • Getting to Know Control-IQ+ Technology CHAPTER 29 • Getting to Know Control-IQ+ Technology...
  • Page 322 CHAPTER 29 • Getting to Know Control-IQ+ Technology This Page is Intentionally Left Blank...
  • Page 323 Control-IQ+ Technology Features CHAPTER 30 Introduction to Control-IQ+ Technology...

  • Page 324: Control-Iq+ Technology Overview

    CHAPTER 30 • Introduction to Control-IQ+ Technology to CGM values. The IOB units will always be ⚠ WARNING 30.1 Control-IQ+ Technology displayed on the Home and Lock screens. Do not use Control-IQ+ until you have received Overview training. 30.2 How Control-IQ+ Works Control-IQ+™...
  • Page 325 CHAPTER 30 • Introduction to Control-IQ+ Technology Sections Control-IQ+ With No Activity ⚑ NOTE Rate. The diagram on the left depicts Enabled, Control-IQ+ During Sleep, and the prediction, the diagram on the right Control-IQ+ activity types are not automatically Control-IQ+ During Exercise Activity depicts how the insulin and CGM enabled, and must be set up as a scheduled this chapter.
  • Page 326 CHAPTER 30 • 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 for illustrative purposes only and are not intended to reflect actual results.
  • Page 327 CHAPTER 30 • Introduction to Control-IQ+ Technology Insulin Decreased or Delivering 0 Units per Hour Control-IQ+ can reduce the basal delivery to a percent of the Basal Rate in addition to completely suspending. When Control-IQ+ predicts that your sensor glucose value will be lower than a preset treatment value (70 mg/dL) 30 minutes in the future, insulin delivery will decrease and may set the Basal Rate at...
  • Page 328 CHAPTER 30 • 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 for illustrative purposes only and are not intended to reflect actual results.
  • Page 329 CHAPTER 30 • Introduction to Control-IQ+ Technology Increasing Insulin Delivery When Control-IQ+ predicts that your sensor glucose value will be at or above a preset treatment value (160 mg/dL) 30 minutes in the future, the rate of insulin delivery will start increasing to attempt to keep the actual CGM values within the target CGM range.
  • Page 330 CHAPTER 30 • 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 ⚑...
  • Page 331 Stopping a Bolus Using the Pump Section Control-IQ+ is either Increasing Insulin 8.15 Canceling or Stopping a Bolus Using the Delivery or delivering Maximum Insulin Tandem t:slim Mobile App. Delivery, the pump will automatically deliver correction boluses to attempt to ⚑ NOTE achieve the target range.
  • Page 332 CHAPTER 30 • 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 for illustrative purposes only and are not intended to reflect actual results.

  • Page 333: Control-Iq+ And Activity

    CHAPTER 30 • Introduction to Control-IQ+ Technology Suspended Insulin With No Activity the Sleep Activity manually in that 30.3 Control-IQ+ and Activity Enabled chapter. Insulin is set to 0 units/hour when The CGM range targeted by When Control-IQ+ is turned on you can Control-IQ+ predicts a CGM reading Control-IQ+ during the Sleep Activity is choose to activate Sleep or Exercise to...
  • Page 334 CHAPTER 30 • Introduction to Control-IQ+ Technology Automatic Correction Bolus During Decreasing Insulin During Exercise Activity, see the diagram on the next Sleep Activity Activity page. Automatic correction boluses will not Insulin is decreased when Control-IQ+ be delivered while Sleep is enabled. predicts a CGM reading of ≤140 mg/dL 30 minutes in the future.
  • Page 335 CHAPTER 30 • Introduction to Control-IQ+ Technology Control-IQ Sleep Activity Exercise Activity Delivers an automatic correction bolus if sensor Delivers –– glucose is predicted to be above mg/dL Increases basal insulin delivery if sensor glucose is Increases predicted to be above mg/dL Maintains active Personal Profile settings when sensor Maintains...
  • Page 336 CHAPTER 30 • Introduction to Control-IQ+ Technology This Page is Intentionally Left Blank...
  • Page 337 Control-IQ+ Technology Features CHAPTER 31 Configuring and Using Control-IQ+ Technology...

  • Page 338: Required Settings

    CHAPTER 31 • Configuring and Using Control-IQ+ Technology Recommended Control-IQ+ Pump 31.1 Required Settings 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 339: Set Total Daily Insulin

    8. When you are done setting up off automatically, or it can be turned on (basal and bolus) delivered in a 24-hour Control-IQ+, tap the Tandem logo and off manually. This section covers period. Consult your healthcare to return to the CGM Home screen.
  • Page 340 CHAPTER 31 • Configuring and Using Control-IQ+ Technology Chapter 30 Introduction to Control-IQ+ 4. Tap Sleep Schedules. 7. On the Select Days screen, tap the Technology. checkmark to the right of each day 5. Select which Sleep Schedule to of the week that you want included You can configure two different Sleep configure.

  • Page 341: Enable Or Disable A Sleep Schedule

    Section 31.5 Schedule Sleep.) sleep, tap to return to the 13. Tap AM or PM to set the Time of Activity screen or tap the Tandem 6. Tap Day, if applicable. logo to return to the Home screen. Disable a Sleep Schedule 14.

  • Page 342: Manually Start Or Stop Sleep

    CHAPTER 31 • Configuring and Using Control-IQ+ Technology Tap the schedule summary next to Manually Start Sleep Manually Stop Sleep the Sleep Schedule you want to 1. From the Home screen, tap 1. From the Home screen, tap disable. OPTIONS. OPTIONS.
  • Page 343 CHAPTER 31 • Configuring and Using Control-IQ+ Technology duration. For detailed information about 6. Tap Duration. The number keypad 3. Tap how to use Control-IQ+, see Chapter is displayed. You may enter an 30 Introduction to Control-IQ+ Exercise duration between 30 Technology.

  • Page 344: Control-Iq+ Information On Your Screen

    CHAPTER 31 • Configuring and Using Control-IQ+ Technology 4. Tap Start. 3. Tap Explanation of Control-IQ+ Technology Icons. When Control-IQ+ is on but not active (i.e. insulin is being delivered normally), the diamond icon is gray as depicted below. Regardless of the color, the icon always appears in the same place.
  • Page 345 CHAPTER 31 • Configuring and Using Control-IQ+ Technology active on the CGM Trend Graph The following image highlights where an automatic correction bolus delivered by screen. the basal status icons display. Control-IQ+. The amount of the bolus is also displayed. When Exercise is on, the Exercise icon Automatic Correction Bolus Status is displayed in the same location.
  • Page 346 CHAPTER 31 • Configuring and Using Control-IQ+ Technology on the CGM graph represents a five-minute increment.
  • Page 347 Control-IQ+ Technology Features CHAPTER 32 Control-IQ+ Technology Alerts...
  • Page 348 ALWAYS turn on notifications to receive your pump alerts, alarms, and notifications on your smartphone. Notifications must be enabled on your smartphone, and the Tandem t:slim mobile app must be open in the background for pump notifications to be received on your smartphone.

  • Page 349: Control-Iq Low Alerts

    CHAPTER 32 • Control-IQ+ Technology Alerts 32.1 Control-IQ Low Alert Screen Explanation What will I see on the screen? Control-IQ+ Low Alert has predicted that your sensor glucose What does it mean? reading will drop below 70 mg/dL, or below 80 mg/dL if Exercise is enabled, in the next 15 minutes.

  • Page 350: Control-Iq High Alert

    CHAPTER 32 • Control-IQ+ Technology Alerts 32.2 Control-IQ High Alert Screen Explanation What will I see on the screen? Control-IQ+ has three hours of CGM data available and has increased insulin delivery, but detects a sensor glucose reading What does it mean? above 200 mg/dL and does not predict that the sensor glucose reading will decrease in the next 30 minutes.

  • Page 351: Max Insulin Alert

    CHAPTER 32 • Control-IQ+ Technology Alerts 32.3 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+ has delivered 50% of your Total Daily Insulin (through basal and/or bolus deliveries) over the previous rolling 2 What does it mean?

  • Page 352: Out Of Range Alert - Control-Iq+ Disabled

    CHAPTER 32 • Control-IQ+ Technology Alerts 32.4 Out of Range Alert – Control-IQ+ Disabled Screen Explanation What will I see on the screen? The CGM and pump are not communicating. You may see slightly different error screens depending on which CGM you are using. The What does it mean? pump will not receive sensor glucose readings, and Control-IQ+ is not able to predict sensor glucose levels or adjust insulin delivery.

  • Page 353: Out Of Range Alert - Control-Iq+ Enabled

    CHAPTER 32 • Control-IQ+ Technology Alerts 32.5 Out of Range Alert – Control-IQ+ Enabled Screen Explanation What will I see on the screen? Control-IQ+ is turned on, but the CGM and pump are not communicating. You may see slightly different error codes depending on which CGM you are using.
  • Page 354 CHAPTER 32 • Control-IQ+ Technology Alerts This Page is Intentionally Left Blank...
  • Page 355 Control-IQ+ Technology Features CHAPTER 33 Overview of Control-IQ and Control-IQ+ Technology Clinical Studies...

  • Page 356: Introduction

    CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Control-IQ has not been evaluated in 33.1 Introduction children under 2 years of age. The safety and/or effectiveness of The following data represents the Control-IQ in children under 2 years of clinical performance of the t:slim X2™...

  • Page 357: Software Version History

    CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies 33.2 Software Version History Control-IQ+ (v1.5) introduced changes to allow for a wider range of weight and TDI input. Other changes were implemented and are outlined in the table below. Parameter Control-IQ 1.0 Control-IQ+ (v1.5)

  • Page 358: The Dclp 3 Trial

    CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies The summary statistics presented for site failure in the Control-IQ arm. There 33.3 The DCLP 3 Trial the DCLP3 describe the primary were no severe hypoglycemic events in outcome measure of the sensor the DCLP3 with Control-IQ use.
  • Page 359 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Baseline Characteristics DCLP3: Baseline Characteristics including Demographics at Enrollment (N=168) Characteristic Control-IQ (n=112) SAP (n=56) Age (years) Mean ± SD 33 ± 16 33 ± 17 Range 14 to 71 14 to 63 <18 years 31 (28%)
  • Page 360 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies DCLP3: Baseline Characteristics including Demographics at Enrollment (N=168) (Continued) <$50,000 10 (11%) 2 (4%) $50,000 – <$100,000 24 (27%) 18 (36%) ≥$100,000 55 (62%) 30 (60%) ‡ Education ≤High School Diploma 3 (3%) 6 (11%) Associates Degree or Some College...
  • Page 361 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Adverse Effects The following tables provide a full list of adverse events that occurred during the main part of the DCLP3 study: DCLP3: Types of Adverse Events by Treatment Arm (N=168) Number of Events Control-IQ (n=112) SAP (n=56)
  • Page 362 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Adverse Effects The following table provides a list of only hyperglycemia or ketosis events during the DCLP3 study: DCLP3: Hyperglycemia/Ketosis Events by Treatment Arm (N=168) Number of Events Control-IQ (n=112) SAP (n=56) Ketosis (Infusion Site Failure) Hyperglycemia (Infusion Site Failure)
  • Page 363 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Intervention Compliance The following table provides an overview of how often the t:slimX2 insulin pump with Control-IQ was used in the Control-IQ arm: DCLP3: Percentage of t:slim X2 Insulin Pump with Control-IQ Technology Use Over the 6-Month Period (n=112) Average Pump Use* Average Time Control-IQ Available** Weeks 1–4...
  • Page 364 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Primary Analysis The primary outcome of the DCLP3 was to compare the CGM sensor values in range between 70–180 mg/dL between the Control-IQ technology and the SAP arms. The data represent 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 Characteristic...
  • Page 365 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies The following table describes the average time participants in both the Control-IQ technology arm and the SAP arm 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) Month Control-IQ...
  • Page 366 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Secondary Analysis The following table shows secondary analysis comparing the percent of time that participants spent at the indicated sensor glucose levels during the daytime and nighttime for the DCLP3: DCLP3: Secondary Analysis by Time of Day (N=168) Daytime Nighttime...
  • Page 367 CHAPTER 33 • Overview of Control-IQ and 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 arms: Percentage of Time in Range per Study Arm by Baseline HbA1c (N=168) Time in Range Baseline HbA1c Control-IQ...
  • Page 368 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies The following table compares the change in HbA1c values for participants over the course of the DCLP3: DCLP3: Change in HbA1c Values from Randomization to 26 Weeks (N=168) Number of Subjects (% of Subjects) with Change in HbA1c Decrease Decrease Increase...
  • Page 369 CHAPTER 33 • Overview of Control-IQ and 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 <1% Overall Control...

  • Page 370: The Dclp5 Trial

    CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies guardian knowledgeable about investigator would affect the completion 33.4 The DCLP5 Trial diabetes and managing of the protocol. diabetes-related emergencies and The summary statistics presented for The goal of this study was to assess the willing to participate in all training the DCLP5 describe the primary safety and efficacy of Control-IQ when...
  • Page 371 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Baseline Characteristics 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)
  • Page 372 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies DCLP5: Baseline Characteristics including Demographics at Enrollment (N=101) (Continued) Characteristic Control-IQ (n=78*) SAP (n=23*) $50,000 – <$75,000 5 (7%) 0 (0%) $75,000 – <$100,000 13 (18%) 4 (19%) $100,000 – <$200,000 27 (36%) 8 (38%) ≥$200,000...
  • Page 373 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Adverse Effects The following tables provide a full list of adverse events that occurred during the main part of the DCLP5 study: DCLP5: Types of Adverse Events by Treatment Arm (N=101) Number of Events Control-IQ (n=78) SAP (n=23)
  • Page 374 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies The following table provides a list of only hyperglycemia or ketosis events during the DCLP5 study: DCLP5: Hyperglycemia/Ketosis Events by Treatment Arm (N=101) Number of Events Control-IQ (n=78) SAP (n=23) Ketosis (Infusion Site Failure) Hyperglycemia (Defected Cartridge) Ketosis (User Error)*...
  • Page 375 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Intervention Compliance The following table provides an overview of how often the t:slim X2 insulin pump with Control-IQ was used in the Control-IQ arm: 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%...
  • Page 376 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Primary Analysis The primary outcome of the DCLP5 was to compare the CGM sensor values in range between 70–180 mg/dL between the Control-IQ arm and the SAP arm. The data represent the overall system performance 24 hours per day. DCLP5: Comparison of CGM Values Between Control-IQ and SAP Users (N=101) Difference Between Study Arm Characteristic...
  • Page 377 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies The following table describes the average time participants in both the Control-IQ arm and the SAP arm spent with sensor glucose levels between 70–180 mg/dL by month at baseline and during the study period. DCLP5: Percentage of Time in Range per Study Arm by Month (N=101) Month Control-IQ...
  • Page 378 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Secondary Analysis Secondary analysis comparing the percent of time that participants spent at the indicated sensor glucose levels during the daytime and nighttime for the DCLP5 are shown below: DCLP5: Secondary Analysis by Time of Day (N=101) Daytime Nighttime...
  • Page 379 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies The following table compares the change in HbA1c values for participants over the course of the DCLP5: DCLP5: Change in HbA1c Values from Randomization to 16 Weeks (N=101) Number of Subjects (% of Subjects) with Change in HbA1c Decrease Decrease Increase...
  • Page 380 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Treatment 100% HbA1c ≥ 10% Control 100% Treatment Overall Control...

  • Page 381: The Pedap Trial

    CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies managing diabetes-related Results of all subgroup analyses 33.5 The PEDAP Trial emergencies and willing to participate indicate that the Control-IQ treatment in all training sessions. No participants effect is similar across the distribution of The goal of this study was to assess the had a history of adrenal insufficiency, age, race, and income.
  • Page 382 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Baseline Characteristics PEDAP: Baseline Characteristics Including Demographics at Enrollment (N=102) Characteristic Overall (n=102) Control-IQ (n=68) SC (n=34) Age (years) Mean ± SD 3.94 ± 1.24 3.84 (1.23) 4.06 (1.25) Range 2.00 to 5.98 2.00 to 5.98...
  • Page 383 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies PEDAP: Baseline Characteristics Including Demographics at Enrollment (N=102) (Continued) Characteristic Overall (n=102) Control-IQ (n=68) SC (n=34) White non-Hispanic 75 (74%) 50 (74%) 25 (74%) Black / African American 6 (6%) 4 (6%) 2 (6%) Asian...
  • Page 384 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies PEDAP: Baseline Characteristics Including Demographics at Enrollment (N=102) (Continued) Characteristic Overall (n=102) Control-IQ (n=68) SC (n=34) ‡ Private 78 (77%) 52 (76%) 26 (79%) † CHP or another government / Medicaid 22 (24%) 15 (22%) 7 (21%)
  • Page 385 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Adverse Effects The following table provides a full list of adverse events that occurred during the main art of the PEDAP study. PEDAP: Types of Adverse Events by Treatment Arm (N=102) Number of Events Control-IQ (n=68) SC (n=34)
  • Page 386 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies PEDAP: Types of Adverse Events by Treatment Arm (N=102) (Continued) Number of Events Control-IQ (n=68) SC (n=34) COVID-19 Fall Fractured Finger Gastroenteritis Hematuria Medical Device Site Bleeding Skin Infection Streptococcal Sore Throat Upper Respiratory Infection Vomiting...
  • Page 387 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Intervention Compliance The following table provides an overview of how often the t:slim X2 insulin pump with Control-IQ was used during the PEDAP trial in the intervention arm. PEDAP Percentage of t:slim X2 Insulin Pump with Control-IQ Technology Use Over 13-week Period (n=68) Average Time Control-IQ In Use* Weeks 1–4 Weeks 5–8...
  • Page 388 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Primary Analysis The primary outcome of PEDAP was to compare the CGM sensor values in range between 70–180 mg/dL between the Control-IQ arm and the SC arm. The data represent the overall system performance 24 hours per day. PEDAP: Percent Time in Range: Primary Endpoint Tested for Superiority (N=101) Time and Change Control-IQ (n=67)
  • Page 389 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Secondary Analysis Change in HbA1c values by baseline HbA1c subgroups is shown as follows: PEDAP: Change in HbA1c Values by Baseline HbA1c Subgroups (Treatment n=59, Control n=31) Change from Baseline Baseline mean (SD) Mean (SD) Baseline HbA1c...

  • Page 390: The Pedap Extension Phase

    CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies then switched to Control-IQ for the There were two cases of severe 33.6 The PEDAP Extension Phase extension, N=33). hypoglycemia in the 63 participants in the CLC-CLC group (3%) unrelated to The summary statistics presented for The goal of this study was to assess the the study device, and no cases among...
  • Page 391 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Baseline Characteristics PEDAP Extension Phase: Baseline Characteristics Including Demographics at Enrollment (N=96) Characteristic Overall (N=96) CLC-CLC (n=62) SC-CLC (n=33) Age at Beginning of Extension Phase (years) Mean (SD) 4.17 (1.23) 4.10 (1.23) 4.32 (1.23) Range...
  • Page 392 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies PEDAP Extension Phase: Baseline Characteristics Including Demographics at Enrollment (N=96) (Continued) Characteristic Overall (N=96) CLC-CLC (n=62) SC-CLC (n=33) White non-Hispanic 81 (84%) 53 (85%) 28 (85%) Black / African American 5 (5%) 3 (5%) 2 (6%)
  • Page 393 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies PEDAP Extension Phase: Baseline Characteristics Including Demographics at Enrollment (N=96) (Continued) Characteristic Overall (N=96) CLC-CLC (n=62) SC-CLC (n=33) ‡ Private 74 (78%) 49 (78%) 25 (78%) † Medicare / Medicaid 13 (14%) 9 (14%) 4 (12%)
  • Page 394 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Adverse Effects The following table provides a full list of adverse events that occurred during the PEDAP extension phase. There were no DKA events: Summary of Adverse Events During PEDAP Extension Phase (N=96) Number of Events CLC-CLC (n=63) SC-CLC (n=33)
  • Page 395 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Summary of Adverse Events During PEDAP Extension Phase (N=96) (Continued) Number of Events CLC-CLC (n=63) SC-CLC (n=33) Cellulitis COVID-19 Fever Gastroenteritis Head Injury Influenza Laceration Pneumonia Skin Infection Upper Respiratory Infection Viral Syndrome Vomiting *A severe hypoglycemic event is defined as a hypoglycemic event that a) required assistance of another person due to altered consciousness, and b) required another...
  • Page 396 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Intervention Compliance The following table provides an overview of how often the t:slim X2 insulin pump with Control-IQ was used during the PEDAP extension phase. All participants in the CLC-CLC arm used the original Control-IQ algorithm (Control-IQ 1.0), modified to allow a lower weight and total daily insulin dose entry in weeks 1 - 13.
  • Page 397 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Key CGM Outcomes Time in range 70–180 mg/dL for all phases of the trial is shown below. All participants in the CLC-CLC arm used the original Control-IQ algorithm (Control-IQ 1.0), modified to allow a lower weight and total daily insulin dose entry in weeks 1 - 13. In weeks 14 - 26, all participants in the extension phase in both the CLC-CLC arm and the SC-CLC arm used the updated Control-IQ algorithm (Control-IQ+ v1.5).
  • Page 398 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Secondary Analysis The following table shows secondary analysis of HbA1c outcomes. All participants in the CLC-CLC arm used the original Control-IQ algorithm (Control-IQ 1.0), modified to allow a lower weight and total daily insulin dose entry in weeks 1 - 13. In weeks 14 - 26, all participants in the extension phase in both the CLC-CLC arm and the SC-CLC arm used the updated Control-IQ algorithm (Control-IQ+ v1.5): PEDAP Extension Phase: HbA1c Outcomes*...

  • Page 399: The Higher-Iq Trial

    CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies hemophilia or any other bleeding HbA1c decreased from 7.69% at 33.7 The Higher-IQ Trial disorder, history of adrenal baseline to 6.87% after 13 weeks of insufficiency, untreated thyroid disease, Control-IQ use, a decrease of 0.82%.
  • Page 400 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Baseline Characteristics Higher-IQ Baseline Characteristics Including Demographics at Enrollment (N=34) Characteristic All Participants Used Control-IQ (N=34) Age (years) Mean (SD) 39.9 (11.9) Range 20 to 66 Sex – Female n (%) (14) 41.2% Weight (kg) Mean (SD)
  • Page 401 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Higher-IQ Baseline Characteristics Including Demographics at Enrollment (N=34) (Continued) Characteristic All Participants Used Control-IQ (N=34) Less than high school 1 (2.9%) High School graduate/diploma/GED 4 (11.8%) Some college but no degree 8 (23.5%) Associate Degree 3 (8.8%)
  • Page 402 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Higher-IQ – All Adverse Events (N=34) (Continued) Number of Events All Participants Used Control-IQ Hyperglycemia with or without Ketosis Related to Study Device Hyperglycemia with or without Ketosis Not Related to Study Device Bronchitis Chronic Kidney Disease Cough...
  • Page 403 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Higher-IQ – All Adverse Events (N=34) (Continued) Number of Events All Participants Used Control-IQ Pharyngitis Streptococcal Skin Abrasion Sleep Apnea Syndrome Stiff Person Syndrome Tooth Abscess Tooth Fracture Tympanic Membrane Perforation Upper Respiratory Tract Infection 10/7 *A severe hypoglycemic event is defined as a hypoglycemic event that a) required assistance of another person due to altered consciousness, and b) required...
  • Page 404 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Intervention Compliance The following table provides and overview of how often the t:slim X2 insulin pump with Control-IQ was used during the Higher-IQ trial: Higher-IQ Intervention Adherence over the 13-week Study Period (N=34) Sensor Use (%) Closed-Loop System Use (%) Mean (SD)
  • Page 405 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies Secondary Analysis Higher-IQ: Change in Central Lab HbA1c at 13 Weeks (N=34) Baseline 13 Weeks Change from Baseline P Value HbA1c (%) Mean (SD) 7.69 (1.08) 6.87 (0.57) -0.82 (0.73) p<0.001...
  • Page 406 CHAPTER 33 • Overview of Control-IQ and Control-IQ+ Technology Clinical Studies This Page is Intentionally Left Blank...

  • Page 407: Section 5: Technical Specifications And Warranty

    Technical Specifications and Warranty CHAPTER 34 Technical Specifications...

  • Page 408: Overview

    CHAPTER 34 • Technical Specifications 34.1 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, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-24.
  • Page 409 During normal use, the intermediate rate is 2 units/hr; battery charge can be reasonably expected to last Typical Operating Time when Pump is between 4 and 7 days, depending on your use of CGM and the Tandem t:slim™ mobile app features from a fully Operating at Intermediate Rate...
  • Page 410 Minimum Audible Alarm Volume 45 dBA at 1 meter ⚑ NOTE 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 411 CHAPTER 34 • 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 412 CHAPTER 34 • Technical Specifications Requirements for Charging from a ⚠ WARNING Computer ALWAYS use the USB cable provided with your t:slim X2 insulin pump to minimize the risk of The t:slim X2 pump is designed to be fires or burns. connected to a host computer for battery charging and data transfer.

  • Page 413: T:slim X2 Pump Options And Settings

    CHAPTER 34 • Technical Specifications 34.3 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) Basal Rate Setting Range 0.1 – 15 units/hr Insulin Delivery Profiles (Basal and Bolus) Basal Rate Segments...
  • Page 414 CHAPTER 34 • Technical Specifications t:slim X2 Pump Options and Settings (Continued) Option/Setting Type Option/Setting Detail Maximum Extended Bolus Time 8 hours Maximum Bolus Size 25 units Maximum Automatic Bolus Size 6 units Status indicator visible on Home screen; Low Insulin Alert is user adjustable from 10 to 40 units (default is 20 Low Cartridge Volume Indicator units).
  • Page 415 CHAPTER 34 • Technical Specifications t:slim X2 Pump Options and Settings (Continued) Option/Setting Type Option/Setting Detail Prompts user to retest BG after a Low BG has been entered. User selects Low BG value and time for reminder Low BG Reminder (default is off).

  • Page 416: T:slim X2 Pump Performance Characteristics

    34.4 t:slim X2 Pump Performance Characteristics The t:slim X2 insulin pump delivers insulin in two ways: basal insulin delivery (continuous) and bolus insulin delivery. The following accuracy data was collected on both types of delivery in laboratory studies performed by Tandem. 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,...
  • Page 417 CHAPTER 34 • Technical Specifications Medium Basal Rate Delivery Performance (2.0 U/hr) Basal Duration 1 hour 6 hours 12 hours (Number of Units Delivered with 2 Units/hr (2 units) (12 units) (24 units) Setting) Amount Delivered 2.1 units 12.4 units 24.3 units [min, max] [2.1, 2.2]...
  • Page 418 CHAPTER 34 • 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 419 CHAPTER 34 • Technical Specifications Intermediate Bolus Delivery Performance (2.5Units) (n=800 boluses) Units of Insulin Delivered After a 2.5 Unit 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 420 CHAPTER 34 • 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 421: Electromagnetic Compatibility

    CHAPTER 34 • Technical Specifications For IEC 60601-1-2 testing, Essential 34.5 Electromagnetic Compatibility 34.6 Wireless Co-existence and Performance for the Pump is defined Data Security as follows: The information contained in this The system are designed to work safely • The pump will not over deliver a section is specific to the system.

  • Page 422: Tandem T:slim Mobile App Security

    DO NOT use a smartphone that has been Help on the Tandem t:slim mobile app Settings jailbroken or rooted, or with Android developer screen, then tap App Guide. mode on. Data may become vulnerable if you...

  • Page 423: Electromagnetic Emissions

    CHAPTER 34 • Technical Specifications 34.8 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 424: Electromagnetic Immunity

    CHAPTER 34 • Technical Specifications 34.9 Electromagnetic Immunity The system is intended for use in home healthcare electromagnetic environments. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level ± 8 kV contact ± 8 kV contact Electrostatic Discharge (ESD) IEC 61000-4-2 ±...
  • Page 425 CHAPTER 34 • Technical Specifications Guidance and Manufacturer’s Declaration – Electromagnetic Immunity (Continued) Immunity Test IEC 60601 Test Level Compliance Level 385 MHz: 27 V/m @ 18 Hz Pulse modulation 385 MHz: 27 V/m @ 18 Hz Pulse modulation 450 MHz: 28 V/m @ FM modulation 710 MHz, 450 MHz: 28 V/m @ FM modulation 710 MHz, 745 MHz, 780 MHz: 745 MHz, 780 MHz:...

  • Page 426: Iec 60601-1-10: Physiological Closed-Loop Controlled System

    CHAPTER 34 • Technical Specifications 34.10 IEC 60601-1-10: Physiological Closed-Loop Controlled System Control-IQ+ manages insulin therapy using a closed-loop control algorithm which modulates basal delivery and initiates periodic automatic correction boluses based on predicted glucose, insulin delivery history, and user input variables. The control algorithm uses continual feedback of Estimated Glucose Values (EGVs) from a Continuous Glucose Monitor (CGM), user-reported carbohydrate entries, insulin delivery history, and user weight to predict estimated blood glucose 30 minutes in the future.

  • Page 427: Quality Of Wireless Service

    FreeStyle Libre 2 Plus CGM wirelessly will be missed. sends readings to the pump every minute. One of the essential For proper use of the Tandem t:slim performance requirements states that mobile app, the pump and smartphone the pump will not discontinue reporting...

  • Page 428: Wireless Technology

    CHAPTER 34 • Technical Specifications 34.12 Wireless Technology The system utilizes wireless technology with the following characteristics: Wireless Technology Specifications Specification Type Specification Detail Wireless Technology Bluetooth Low Energy (BLE) version 5.0 Tx/Rx Frequency Range 2.360 to 2.500 GHz Bandwidth (per channel) 2 MHz Radiated Output Power (maximum) +8 dBm...

  • Page 429: Fcc Notice Concerning Interference

    2. This device must accept any Customer Technical Support and other • USB cable interference received, including internal Tandem personnel in • USB charger with power plugs interference that may cause accordance with our Privacy Notice for undesired operation.
  • Page 430 CHAPTER 34 • Technical Specifications angles, and may come with or without • t:slim screen protector an insertion device. Some infusion sets • USB rubber door have a soft cannula and others and have a steel needle. Contact Customer Technical Support service for available sizes and lengths of the following infusion sets with t:lock connectors:...
  • Page 431 CHAPTER 34 • Technical Specifications...

  • Page 432: Index

    INDEX Alerts ........159 Alert Icon, Where to Find .
  • Page 433 CGM, System Error ......280 Min Basal Alerts ......176, 177 CGM, System Error, Abbott .
  • Page 434 Battery ........92 Battery Level .
  • Page 435 Load Cartridge ......116, 120 CGM Settings ......232 Load the Cartridge .
  • Page 436 Out of Range Alert, Set ..... . 241 Troubleshooting ......301 Out of Range/No Antenna, Troubleshooting .
  • Page 437 Cleaning Your System ......202 Responsible Use ......312 Schedule Sleep .
  • Page 438 CGM Fall Alert ......240 Electromagnetic Compatibility ....419 CGM Out of Range Alert .
  • Page 439 Grams Incomplete Calibration Alert, Dexcom ... . .281 Food Bolus, on Bolus Screen ....54 Incomplete Cartridge Change Alert .
  • Page 440 Max Bolus ........133 Max Bolus Alerts ......173, 174 Max Hourly Bolus Alert .
  • Page 441 Overview Pump Info ........148 CGM Overview ......228 Pump Info, Serial Number .
  • Page 442 Resume Pump Alarm ......185 Letter Keypad Screen ......64 Lock Screen .
  • Page 443 Sound ........97 Tandem Logo ......50, 94 Specifications Target BG .
  • Page 444 Time Segments, in Personal Profiles ... . 106 Unlock the Screen ......95 Time Segments add to Personal Profile .

  • Page 446: Patents And Trademarks

    Play logo are trademarks of Google LLC. The Bluetooth ® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Tandem Diabetes Care, Inc. is under license. All other third party marks are the property of their respective owners.
  • Page 448 UNITED STATES: (877) 801-6901 tandemdiabetes.com CANADA: (833) 509-3598 tandemdiabetes.ca OTHER COUNTRIES: tandemdiabetes.com/contact 1014563_B AW-1014562_B 2024-NOV-12 © 2024 Tandem Diabetes Care, Inc. All rights reserved.
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