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

Tandem t:slim X2 User Manual

Insulin pump with control-iq technology
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Summary of Contents for Tandem t:slim X2

  • Page 1 User Guide MMOL/L...
  • Page 3 Software Version: Control-IQ (7.8.1) This user guide is designed to assist you or your trusted WARNINGS: caregiver with the features and functions of the t:slim X2™ Control-IQ technology should not be used in anyone under insulin pump with Control-IQ™ technology. It provides the age of six years old.
  • Page 4 +45 70 27 52 20 (242) 702-9310 info_dk@rubinmedical.dk www.rubinmedical.dk BELGIUM / BELGIË Air Liquide Medical nv EU IMPORTER Erasmuslaan 40 Tandem Diabetes Care Europe B.V. 1804 Zemst Basisweg 10 +32(0)2 255 96 00 1043 AP Amsterdam www.makingdiabeteseasier.com/be-nl The Netherlands KVK #85766364...
  • Page 5 IMPORTER AND DISTRIBUTOR CONTACT INFORMATION FINLAND / SUOMI IRELAND Rubin Medical Oy Air Liquide Healthcare Tiilenlyöjänkatu 9b Unit 23 North Park 01720 Vantaa North Road, Dublin 11 +358 34 22 11 50 Eirecode D11 F791, Ireland info_fi@rubinmedical.fi 1800124912 www.rubinmedical.fi makingdiabeteseasier.com/uk FRANCE ISRAEL Dinno Santé...

  • Page 6: Saudi Arabia

    IMPORTER AND DISTRIBUTOR CONTACT INFORMATION NETHERLANDS / NEDERLAND PORTUGAL VitalAire Nederland BV VitalAire, SA Archimedeslaan 11 Rua Dr. António Loureiro Borges, 8218 ME Lelystad nº4 - 3º - Arquiparque - Miraflores +31 (0) 88 250 3500 1495-131 Algés www.makingdiabeteseasier.com/nl 808788877 ptvitalaire-diabetes@airliquide.com NEW ZEALAND www.vitalaire.pt...
  • Page 7 IMPORTER AND DISTRIBUTOR CONTACT INFORMATION SOUTH AFRICA SWITZERLAND (CH-IMPORTER) Continuous Oxygen Supplies Proprietary Limited T/A VitalAire VitalAire Schweiz AG 4-6 Skeen Boulevard Waldeggstrasse 38, 3097 Bedfordview, 2008 Liebefeld Switzerland South Africa 0800 480 000 086 133 9266 www.vitalaire.ch/diabetes/ za.vitalaire.com UNITED KINGDOM SPAIN / ESPANA Air Liquide Healthcare Air Liquide Heathcare España S.L...

  • Page 8: Table Of Contents

    Radiology and Medical Procedures and Your t:slim X2 Pump ....... .
  • Page 9 What your t:slim X2 Pump Package Includes ........
  • Page 10 Tandem t:slim Mobile App Notifications Screen ........
  • Page 11 Correction Bolus Using the Tandem t:slim Mobile App ....... . .
  • Page 12 Canceling or Stopping a Bolus Using the Tandem t:slim Mobile App ......
  • Page 13 13.16 Pump Connection Lost Alert – Tandem t:slim Mobile App .......
  • Page 14 Potential Benefits From Using the t:slim X2 Insulin Pump with CGM ......
  • Page 15 Chapter 21 • CGM Settings 21.1 About Bluetooth Technology ..............234 21.2 Disconnecting from the Dexcom Receiver .
  • Page 16 Reasons You May Need to Calibrate ............258 Chapter 25 • Viewing CGM Data on Your t:slim X2 Insulin Pump 25.1...
  • Page 17 26.19 Failed Sensor Error ............... . 285 26.20 Incompatible Sensor Alert –...
  • Page 18 Chapter 30 • Introduction to Control-IQ Technology 30.1 Control-IQ Technology Overview ............. . 312 30.2 How Control-IQ Technology Works .
  • Page 19 X2 Pump Performance Characteristics ........
  • Page 20 This Page is Intentionally Left Blank...

  • Page 21: Section 1: Before You Begin

    Before You Begin CHAPTER 1 Introduction...

  • Page 22: 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 23 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 24: Explanation Of Symbols

    The following are symbols (and their descriptions), which you may find on your pump, pump supplies and/or their packaging. These symbols tell you about the proper and safe use of the pump. Some of these symbols may not be relevant in your region, and are listed for informational purposes only. Explanation of t:slim X2 Insulin Pump Symbols Symbol Definition...
  • Page 25 CHAPTER 1 • Introduction Explanation of t:slim X2 Insulin Pump Symbols (Continued) Symbol Definition Symbol Definition Authorized Representative in the European Community Authorized representative in Switzerland Manufacturer Responsible person in the United Kingdom Date of manufacture UK Conformity Assessed (UKCA) conformity marking...

  • Page 26: System Description

    For more information on how Control-IQ™ technology, referred to as your smartphone. This functionality is Control-IQ technology is activated, see the “pump” or the “t:slim X2 pump,” limited to compatible smartphone Chapter 30 Introduction to consists of the t:slim X2 insulin pump,...

  • Page 27: About This User Guide

    The t:slim X2 insulin pump is intended perform some pump functions on the The user guide is organized into for the subcutaneous delivery of insulin, smartphone as well as display pump sections.

  • Page 28: Contraindications

    Dexcom CGMs currently allow pairing with one diseases including cancer and sickle compatible with the system for use up medical device at a time (either the t:slim X2 cell anemia. Your Dexcom CGM to 72 hours (3 days). Humalog and...

  • Page 29: Important User Information

    Bluetooth Technology. For connecting your with this device and the Tandem t:slim pump to the Tandem t:slim mobile app, see Whether or not you are using a Dexcom mobile app. Section 4.3 Connecting to a Smartphone.

  • Page 30: Emergency Kit

    ⚠ WARNING Some examples of what to include in (low BG) or hyperglycemia (high BG) events. See The t:slim X2 insulin pump with Control-IQ your everyday emergency kit are: Section 5.14 Turn Security PIN On or Off technology should not be used in children under details on how to turn the Security PIN function the age of 6 years old.

  • Page 31: Section 2: T:slim X2 Insulin Pump Features

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

  • Page 32: T:slim X2 Insulin Pump Warnings

    ⚠ WARNING The user must also have adequate vision and/or ⚠ WARNING DO NOT start to use your pump or the Tandem hearing in order to recognize all functions of the DO NOT put any other drugs or medications in t:slim™...
  • Page 33 This can cause very high BG, or Care. Use of cartridges not manufactured by hyperglycemia (high BG) events. Diabetic Ketoacidosis (DKA). Tandem Diabetes Care or reuse of cartridges may result in over delivery or under delivery of ⚠ WARNING ⚠ WARNING insulin.
  • Page 34 Otherwise, degradation of the ALWAYS use the USB cable provided with your changes can potentially lead to hypoglycemic or performance of this equipment could result. t:slim X2 insulin pump to minimize the risk of hyperglycemic events. fires or burns. ⚠ WARNING ⚠...

  • Page 35: Magnetic Resonance Imaging Safety

    BG levels as support. DO NOT start to use the bolus feature of the recommended by your healthcare provider. Tandem t:slim mobile app before you have been appropriately trained on its use. Failure to follow...

  • Page 36: T:slim X2 Insulin Pump Precautions

    2.5 t:slim X2 Insulin Pump help on the bolus feature of the Tandem t:slim you requested it. Precautions mobile app could result in delay of therapy. If the information displayed to you in your Tandem ⚠...
  • Page 37 CHAPTER 2 • Important Safety Information tubing when filling. Air in the cartridge and 1–2 hours after the new infusion set is placed. It ⚠ PRECAUTION tubing takes space where insulin should be and is important to confirm that the infusion set is CONFIRM that the screen display turns on, you can affect insulin delivery.
  • Page 38 CHAPTER 2 • Important Safety Information screen will ensure that you are correctly using exposed to conditions outside of the ⚠ PRECAUTION the beep/vibration commands to program the manufacturer’s recommended ranges can affect DISCONNECT your infusion set from your body intended bolus amount.

  • Page 39: Tandem T:slim Mobile App Precautions

    You cannot ⚠ PRECAUTION request a bolus from the Tandem t:slim mobile ⚠ PRECAUTION ALWAYS dispose of used components such as app while a bolus request is active on the pump.
  • Page 40 ⚠ PRECAUTION ⚠ PRECAUTION your smartphone. ALWAYS ensure your pump has established a The Tandem t:slim mobile app is not intended to Bluetooth wireless connection with your replace self-monitoring practices as advised by ⚠ PRECAUTION smartphone before you use the Tandem t:slim a physician.

  • Page 41: Tandem Cybersecurity Preventative Measures

    Incorrect use the of the navigating to different menus. You t:slim X2 insulin pump or your failure to • Do not use any software or can also program a bolus more...

  • Page 42: Possible Risks From Using Your Pump

    CHAPTER 2 • Important Safety Information additional food or correction Other risks associated with infusion 2.9 Possible Risks From Using boluses, the pump will subtract the sets include occlusions and air bubbles Your Pump amount of IOB from the in the tubing or dislodged cannula, recommended bolus if your BG is which can affect insulin delivery.

  • Page 43: Working With Your Healthcare Provider

    Bluetooth wireless connection with your information to help you manage your • Press the Screen On/Quick Bolus smartphone before you use the Tandem t:slim diabetes. button to turn the screen on so that mobile app. Confirm that the information you can see the display displayed to you matches your signs and symptoms.
  • Page 44 CHAPTER 2 • Important Safety Information This Page is Intentionally Left Blank...
  • Page 45 X2 Insulin Pump Features CHAPTER 3 Getting to Know Your t:slim X2 Insulin Pump...

  • Page 46: What Your T:slim X2 Pump Package Includes

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump Your pump comes with a protective Supply Reordering 3.1 What your t:slim X2 Pump cover in the place where the cartridge is To order cartridges, infusion sets, Package Includes normally inserted.
  • Page 47 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...
  • Page 48 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 49: 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.
  • Page 50 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump Pump Icon Definitions (Continued) Symbol Definition Symbol Definition Security PIN has been enabled. See Section 5.14 Turn Space. Tap to enter a space on the character keypad. Security PIN On or Off.

  • Page 51: Explanation Of Pump Colors

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 3.4 Explanation of Pump Colors Red LED 1 red blink every 30 seconds indicates a malfunction or alarm condition. Yellow LED 1 yellow blink every 30 seconds indicates an alert or reminder condition.

  • Page 52: Pump Back Side

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 3.5 Pump Back Side 1. t:slim X2 Cartridge: A single-use disposable cartridge can hold up to 300 units (3.0 mL) of insulin. 2. Vent Holes: Ensures that the pump functions correctly.
  • Page 53 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 54: 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 55 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 56: Home Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 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.
  • Page 57 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 58: Current Status Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump 7. Correction Factor: Displays current 15. Time Sensor Remaining 3.8 Current Status Screen correction factor used to calculate a (Dexcom G7 only): Displays time bolus. remaining in the current CGM The Current Status screen can be sensor session.
  • Page 59 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 60: Bolus Screen

    CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump  Control-IQ technology is turned 3.9 Bolus Screen on and available The Bolus screen will default to use  A CGM session is active units of insulin in calculating a bolus.
  • Page 61 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump Using Units Using Grams...

  • Page 62: 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 63 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 64: 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 technology and enter required values.
  • Page 65 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 66: 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 67 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 68: 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 69 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...

  • Page 70: 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.
  • Page 71 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump...
  • Page 72 CHAPTER 3 • Getting to Know Your t:slim X2 Insulin Pump This Page is Intentionally Left Blank...
  • Page 73 X2 Insulin Pump Features CHAPTER 4 Getting to Know Your Tandem t:slim Mobile App...

  • Page 74: Overview

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

  • Page 75: Install The Tandem T:slim Mobile App

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App recognition) before using the Tandem request or control a bolus from the Tandem ⚠ PRECAUTION t:slim mobile app. t:slim mobile app to administer a bolus. Use of mobile devices not complying with either...

  • Page 76: Connecting To A Smartphone

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App 2. Enter your account information, and install an update, your Tandem If you update to an incompatible operating including name, account type, and t:slim mobile app will still be connected system version, you will lose the ability to login information.
  • Page 77 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App Pair the Tandem t:slim mobile app with to confirm. Pair Device is now ⚑ NOTE your pump as follows: displayed. For more information on the setup and configuration of your smartphone to work with 1.
  • Page 78 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App 4. From your pump’s Bluetooth mobile app to proceed with your if available in your region, without Settings screen, tap Pair Device. normal pump use. The Tandem requiring access to your pump or t:slim mobile app will display your connection cables.

  • Page 79: Set Mobile Notifications

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App a. Tap Settings on the Navigation 3. From your smartphone, remove 4.4 Set Mobile Notifications bar. your pump from your smartphone’s Bluetooth device list. b. Tap App. The Tandem t:slim mobile app can...

  • Page 80: Mobile Connection Security

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App The following example shows Check your smartphone settings to secure communications between the possible push notification settings. ensure your Tandem t:slim mobile app pump and smartphone. All can connect to the internet.
  • Page 81 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App pump to administer therapy while Unavailable alert as shown in the displayed to you matches your signs and symptoms. troubleshooting the loss of connection. following example. ⚠ PRECAUTION The Pump Connection Lost notification...

  • Page 82: Restart The Tandem T:slim Mobile App

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App If the connection is not restored within applications to locate it among your 4.7 Restart the Tandem t:slim five minutes, reset the connection apps. Mobile App between your smartphone and your pump: 4.
  • Page 83 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App 5. Repeat the pairing process as shown in Section 4.3 Connecting to Smartphone.

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

    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 Screen past 24-hour period.
  • Page 85 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App...

  • Page 86: Tandem T:slim Mobile App Bolus Screen

    CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App 6. Glucose: Enter BG or sensor 4.9 Tandem t:slim Mobile App glucose level. This value is Bolus Screen populated automatically if each of the following are true: 1. Cancel: Exit the Bolus screen and return to the Dashboard.
  • Page 87 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App...

  • Page 88: 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 89 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App...

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

    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 Screen 5. Dashboard: Displays pump status 1. CGM: View CGM information for bar, current glucose reading, IOB the current sensor session.
  • Page 91 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App...

  • Page 92: 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 93 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App...

  • Page 94: 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 95 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App...
  • Page 96 CHAPTER 4 • Getting to Know Your Tandem t:slim Mobile App This Page is Intentionally Left Blank...

  • Page 97: Getting Started

    X2 Insulin Pump Features CHAPTER 5 Getting Started...

  • Page 98: Charging The T:slim X2 Pump

    ALWAYS use the USB cable provided with your LED around the Screen On/Quick Bolus button t:slim X2™ insulin pump to minimize the risk of To charge the pump from an AC power will blink green until there is enough charge to fires or burns.

  • Page 99: Turning The Pump On

    If these features are not working, outlet. discontinue use of the t:slim X2 pump and 1. Plug the included USB cable into contact your local customer support. your computer. 3. Plug the other end of the cable into the micro USB port on the pump.

  • Page 100: Using The Touchscreen

    Arrow to see additional language ⚑ NOTE 5.3 Using the Touchscreen selections. When using the pump, tap the Tandem logo to return to the Home screen or tap to return To turn on your pump screen, first to the previous screen.

  • Page 101: Turning The Pump Off

    30 seconds. 6. Tap Time. 5.9 Edit Time 7. Using the on-screen keypad, enter 5.8 Unlocking the t:slim X2 Pump Screen the hour and minutes. Verify and After powering up your pump for the first time, set the current time and date.

  • Page 102: Basal Limit

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

  • Page 103: Display Settings

    5 and 6. 5.12 Display Settings The Sound Volume is preset to high. 8. Tap when all changes are The display settings for your t:slim X2 Sound Volume can be personalized for complete. pump includes Screen Timeout. Alarms, Alerts, Reminders, Keypad, Bolus, Quick Bolus, and Fill Tubing.

  • Page 104: Mobile Connection

    13. Tap to turn the Security PIN PIN feature is on. If desired, you may use pump information and perform some this as a valid Security PIN. pump functions on that smartphone using the Tandem t:slim mobile app. 14. Tap...
  • Page 105 ⚑ NOTE Do not turn the Mobile Connection on if you are not using or do not have access to the Tandem t:slim mobile app. Turning the Mobile Connection on may impact pump battery life.
  • Page 106 CHAPTER 5 • Getting Started This Page is Intentionally Left Blank...
  • Page 107 X2 Insulin Pump Features CHAPTER 6 Insulin Delivery Settings...

  • Page 108: Personal Profiles Overview

    Only your healthcare provider can can set any or all of the following Timed determine and help you adjust your Basal Settings: The t:slim X2 pump uses the settings in Rate(s), Carb Ratio(s), Correction Factor(s), your active profile to calculate the •...
  • Page 109 CHAPTER 6 • Insulin Delivery Settings • Basal (range: 0 and 0.1 to 15 units/ when a sensor session ends, or when there pump and the Tandem t:slim™ mobile hour) is a transmitter or sensor error. In order to app.

  • Page 110: Creating A New Profile

    CHAPTER 6 • Insulin Delivery Settings Insulin Duration and Insulin on Board delivered above and below the 5. Using the on-screen keypad, enter (IOB) programmed basal rate, in addition to a profile name (up to 16 characters) all bolus insulin delivered. The insulin and tap Your pump remembers how much duration time is not displayed on the...
  • Page 111 CHAPTER 6 • Insulin Delivery Settings • You must program a Basal Rate in Timed Settings 6. Using the on-screen keypad, enter order to have a Personal Profile that your Carb Ratio and tap you can activate. 7. Tap Target BG. •...
  • Page 112 CHAPTER 6 • Insulin Delivery Settings 11. Tap to set the Bolus Settings, 3. On the Add Segment screen, tap Bolus Settings or tap to create additional time Time of Day to select AM or PM, if 1. Tap the Bolus Settings panel. segments.

  • Page 113: Editing Or Reviewing An Existing Profile

    5. Confirm Settings. 11. Tap the Bolus Settings panel to to navigate to the Personal Profiles list change Insulin Duration or or tap the Tandem logo to return to the  Tap if entered data is Carbohydrates as needed. Use the Home screen.

  • Page 114: Activating An Existing Profile

    CHAPTER 6 • Insulin Delivery Settings 2. Tap the name of the Personal 2. Tap the name of the Personal 2. Tap the name of the Personal Profile to duplicate. Profile to be activated. Profile to be renamed. 3. Tap Duplicate. ...

  • Page 115: Starting A Temporary Basal Rate

    CHAPTER 6 • Insulin Delivery Settings Limit set up in the Pump Settings, you You can always tap View Units to 6.9 Starting a Temporary Basal will be notified that the selected rate is see the actual units to be delivered. Rate too high and that it will be reduced so that it does not exceed the maximum...
  • Page 116 CHAPTER 6 • Insulin Delivery Settings 1. From the Home screen, tap OPTIONS. 2. Tap Activity. 3. On the Activity screen, tap the right side of Temp Rate. 4. On the confirmation screen, tap  The TEMP RATE STOPPED screen appears before returning to the Activity screen.

  • Page 117: Infusion Site Care And Loading Cartridge

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

  • Page 118: Infusion Site Selection And Care

    CHAPTER 7 • Infusion Site Care and Loading Cartridge • The abdomen is the most popular set if you notice leaks around the site, or if you 7.1 Infusion Site Selection and suspect your infusion set cannula may have site because of access to fatty Care become dislodged.
  • Page 119 CHAPTER 7 • Infusion Site Care and Loading Cartridge • The infusion set must be replaced and rotated every 48 hours if using Humalog or Admelog insulin; every 72 hours if using NovoRapid or Areas of Body for Infusion Set Insertion Trurapi insulin, or more often if needed.

  • Page 120: Cartridge Instructions For Use

    Control-IQ™ technology will continue to make insulin. This can cause hypoglycemia (low BG) calculations based on CGM values while the 7.3 Filling and Loading a t:slim X2 or hyperglycemia (high BG) events. cartridge is being filled. Since there is no insulin...
  • Page 121 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 122 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 123 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 124: Loading A Cartridge

    Make sure cartridge is lined up to both guide  During the load sequence, the tracks. Tandem logo is disabled. Tapping it 10. Maintain pressure on the plunger will not return to the Home screen. while you remove the needle from the cartridge.

  • Page 125: Filling Tubing

    CHAPTER 7 • Infusion Site Care and Loading Cartridge cartridge onto the pump. Tap the damaged or opened, discard insulin before the pump detects an empty UNLOCK icon when completed. cartridge. This can cause very high BG, or properly and use another tubing Diabetic Ketoacidosis (DKA).

  • Page 126: Filling Tubing Without Changing The Cartridge

    CHAPTER 7 • Infusion Site Care and Loading Cartridge 4. Hold the pump vertically to ensure  STOPPING FILL screen is ⚑ NOTE any air in the cartridge will be displayed. If you do not tap STOP, a notification screen dispelled first.

  • Page 127: Filling Cannula

    CHAPTER 7 • Infusion Site Care and Loading Cartridge 4. A screen will display to notify you This section describes how to fill the set. If the amount needed is not that all insulin deliveries will be infusion set cannula with insulin after listed on the pump screen, tap stopped.

  • Page 128: Setting Site Reminder

    CHAPTER 7 • Infusion Site Care and Loading Cartridge 9. If Site Reminder is turned on, the Reminder then follow the instructions  A reminder to test BG in 1 to 2 pump will automatically display the below. hours will display. Site Reminder screen.

  • Page 129: Manual Bolus

    X2 Insulin Pump Features CHAPTER 8 Manual Bolus...

  • Page 130: Manual Bolus Overview

    You cannot If your smartphone is not connected to the The information in this chapter does NOT apply request a bolus from the Tandem t:slim mobile pump, you can only request a bolus from the to boluses delivered automatically by...

  • Page 131: Initiating A Bolus

    Tandem t:slim mobile your BG to ensure that the treatment be added to any other bolus requested app will say “requesting bolus”...
  • Page 132 CHAPTER 8 • Manual Bolus Glucose Value Auto-Population with bolus, you might wait 60 minutes to see product instructions. You can also see if your readings respond to the bolus. Section 25.3 Rate of Change Arrows. ⚑ NOTE ⚠ PRECAUTION When the CGM reading is automatically Retrospective analysis of the pivotal study PAY ATTENTION to the trend information on the...
  • Page 133 CHAPTER 8 • Manual Bolus following example shows the Bolus • If you have a CGM value and trend and add a correction bolus to any other screen on the pump: arrow, the Correction Bolus bolus you request. confirmation screen appears (if appropriate).
  • Page 134 CHAPTER 8 • Manual Bolus Below Target  The Bolus screen appears whether ⚑ NOTE you tap For more information about CGM trend If your glucose value is below your arrows and how to use them for treatment Target BG, the pump presents you with Within Target decisions, see the CGM manufacturer’s the option for the pump to calculate...

  • Page 135: Bolus Override

    CHAPTER 8 • Manual Bolus history whether or not a bolus  Tap if entered data is 8.5 Food Bolus Using Units delivered. correct. If you are using Control-IQ technology, 4. Follow the steps in the appropriate  Tap to go back to make skip to Section 8.6 Food Bolus Using Target section above depending on...

  • Page 136: Extended Bolus

    CHAPTER 8 • Manual Bolus 4. Check that the grams of carb are  After the bolus delivery is complete, can be helpful for high fat meals such entered in the correct location on an icon displays below the CGM as pizza or if you have gastroparesis the screen.
  • Page 137 CHAPTER 8 • Manual Bolus 5. Tap to confirm the units of 9. Use the on-screen keypad to enter 11. Use the on-screen keypad to adjust insulin to be delivered. the percentage of the bolus to the length of time the bolus is to be DELIVER NOW and tap delivered, then tap You can always tap View...

  • Page 138: Max Bolus

    CHAPTER 8 • Manual Bolus  After the extended bolus delivery is one unit. To adjust the Max Bolus ⚑ NOTE complete, an icon displays below setting: If you set the Max Bolus to 25 units and a the CGM graph. bolus larger than 25 units is calculated 1.
  • Page 139 CHAPTER 8 • Manual Bolus carbohydrate intake to optimize insulin 8. Tap Increment Amount. ⚠ PRECAUTION delivery after eating. ALWAYS look at the screen to confirm correct 9. Select the preferred increment programming of the bolus amount when you Configure Quick Bolus amount.

  • Page 140: Canceling Or Stopping A Bolus Using The Pump

    Alert will be displayed on your pump to confirm the bolus amount. If the and, if applicable, on your Quick Bolus screen does not smartphone via the Tandem t:slim display the correct bolus amount, mobile app. use the touchscreen to enter bolus information.

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

    Max Bolus setting (see Section 8.8 ⚑ NOTE screen. Bolus) If your smartphone is not compatible with the Bolus Delivery feature set of the Tandem t:slim • Quick Bolus (see Section 8.9 Quick 2. Tap to stop delivery. mobile app, you cannot use the Tandem t:slim Bolus) mobile app to request, cancel, or stop a bolus.

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

    Bolus screen. The Tandem t:slim mobile app Calculate and add a correction bolus can receive your glucose value from from the Tandem t:slim mobile app as manual entry into the Tandem t:slim follows: mobile app or auto-populate from the CGM.
  • Page 143 • To accept the correction bolus, tap and the Tandem t:slim mobile app will display the Correction Bolus toggle to the off Yes on the Correction Bolus the Low BG alert in its place.

  • Page 144: Bolus Override Using The Tandem T:slim Mobile App

    Mobile App BG value in your pump history and close the number keypad. To deliver a food bolus using the If you use the Tandem t:slim mobile app Tandem t:slim mobile app: to set the override bolus value, the ⚑ NOTE Bolus Override alert will appear as an 1.

  • Page 145: Canceling Or Stopping A Bolus Using The Tandem T:slim Mobile App

    Both the visit the Bolus screen to cancel a bolus. go back to make changes or pump and the Tandem t:slim mobile app will say view calculations. “requesting bolus” during this time as long as your pump and the Tandem t:slim mobile app 7.

  • Page 146: Pump Connection Lost

    CHAPTER 8 • Manual Bolus 2. Tap Yes in the confirmation prompt 3. Tap OK on the Tandem t:slim Connection Lost During Bolus to cancel the bolus. mobile app informational message. Delivery If your smartphone becomes 8.16 Pump Connection Lost...
  • Page 147 Bluetooth information, see Section 21.1 About Bluetooth Technology. Even if the Tandem t:slim mobile app has established a connection with the pump, you cannot use the Tandem t:slim mobile app to request a bolus until it has received your bolus settings from the pump.
  • Page 148 CHAPTER 8 • Manual Bolus This Page is Intentionally Left Blank...
  • Page 149 X2 Insulin Pump Features CHAPTER 9 Starting, Stopping, or Resuming Insulin...

  • Page 150: Starting, Insulin Delivery

    2. Tap STOP INSULIN. corresponds with the time you If pump screen is not on, press Screen would like the Resume Pump Alarm On/Quick Bolus button once to turn on  A confirmation screen displays. to display. your t:slim X2 pump screen.

  • Page 151: Disconnecting When Using Control-Iq Technology

    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 152 CHAPTER 9 • Starting, Stopping, or Resuming Insulin This Page is Intentionally Left Blank...
  • Page 153 X2 Insulin Pump Features CHAPTER 10 t:slim X2 Insulin Pump Information and History...

  • Page 154: T:slim X2 Pump Information

    CHAPTER 10 • t:slim X2 Insulin Pump Information and History recent events. The following can be Bolus history shows the bolus request, 10.1 t:slim X2 Pump Info viewed in Pump History: the bolus start time, and the bolus completion time.

  • Page 155: Tandem T:slim Mobile App Info

    CHAPTER 10 • t:slim X2 Insulin Pump Information and History ⚑ NOTE You must access these logs on the pump; the Tandem t:slim™ mobile app does not display the pump history logs. 10.3 Tandem t:slim Mobile App Info The Tandem t:slim mobile app allows access to information about the Tandem t:slim mobile app.
  • Page 156 CHAPTER 10 • t:slim X2 Insulin Pump Information and History This Page is Intentionally Left Blank...
  • Page 157 X2 Insulin Pump Features CHAPTER 11 t:slim X2 Insulin Pump Reminders...

  • Page 158: 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.

  • Page 159: 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 160: 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 161: User Settable Alerts And Alarms

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

  • Page 162: Low Insulin Alerts

    CGM or 12.1 Low Insulin Alert use Control-IQ™ technology. The default for this alarm is off. If you Your t:slim X2™ pump keeps track of 7. Tap when all changes are turn this feature on, the default time is how much insulin remains in the complete.

  • Page 163: Max Basal Alert

    12.3 Max Basal Alert 9. Tap the Tandem logo to return to Your pump allows you to set a limit to the Home screen. the basal rate that the pump will not allow you to exceed during a Temp Rate.
  • Page 164 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 165 X2 Insulin Pump Features CHAPTER 13 t:slim X2 Insulin Pump Alerts...
  • Page 166 CHAPTER 13 • t:slim X2 Insulin Pump Alerts Your pump lets you know important until acknowledged. Alerts do not ⚑ NOTE information about its performance with escalate. There is an additional list of alerts related to reminders, alerts, and alarms.

  • Page 167: 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 168: 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 169 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 170: 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 171 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 172: 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 173: 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 174 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.
  • Page 175 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.

  • Page 176: 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 What does it mean? technology setting but did not save or complete the programming within 5 minutes.

  • Page 177: 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 178: 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.

  • Page 179: 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 180 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?

  • Page 181: 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 182: 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 183 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.

  • Page 184: Connection Error Alert

    You connected pump to a computer with the USB cable to charge it What does it mean? or upload data to the Tandem Source platform, if available in your region, and a connection could not be made. 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 185: 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 186: 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.

  • Page 187: 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 188: 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 189 X2 Insulin Pump Features CHAPTER 14 t:slim X2 Insulin Pump Alarms...
  • Page 190 CHAPTER 14 • t:slim X2 Insulin Pump Alarms Information in this section will help you ⚑ NOTE ⚠ PRECAUTION learn how to respond to alarms. CHECK your pump regularly for potential alarm There is a list of alerts and errors related to CGM conditions that may display.

  • Page 191: 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.

  • Page 192: 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.

  • Page 193: 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 194: 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...

  • Page 195: 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 196: 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 2ºC (35ºF) or What does it mean? above 45ºC (113ºF) or a battery temperature below 2ºC (35ºF) or above 52ºC (125ºF) and all deliveries have stopped.

  • Page 197: 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...
  • Page 198 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.

  • Page 199: 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 stuck What does it mean? or not functioning properly and all deliveries have stopped.

  • Page 200: 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 -396 meters to 3,048 meters (-1,300 feet to 10,000 feet) and all deliveries have stopped.

  • Page 201: 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 202 CHAPTER 14 • t:slim X2 Insulin Pump Alarms This Page is Intentionally Left Blank...

  • Page 203: Chapter 15 • T:slim X2 Insulin Pump Malfunction

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

  • Page 204: 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 your local customer support. Malfunctions notify you with 3 sequences of 3 notes at highest volume and 3 vibrations.
  • Page 205 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 back up insulin method, or contact your healthcare provider for an alternate insulin delivery plan.
  • Page 206 CHAPTER 15 • t:slim X2 Insulin Pump Malfunction This Page is Intentionally Left Blank...

  • Page 207: Chapter 16 • Taking Care Of Your Pump

    X2 Insulin Pump Features CHAPTER 16 Taking Care of Your Pump...

  • Page 208: Overview

    CHAPTER 16 • Taking Care of Your Pump going into storage mode. Disconnect a hard surface. Check that the pump is working 16.1 Overview properly by plugging a power source into the the pump from the power source. USB port and confirming that the display turns Keep the pump protected when not in This section provides information on on, you hear audible beeps, feel the pump...

  • Page 209: Chapter 17 • Lifestyle Issues And Travel

    X2 Insulin Pump Features CHAPTER 17 Lifestyle Issues and Travel...

  • Page 210: Overview

    If you choose to use a pump case or other your local customer 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 211 CHAPTER 17 • Lifestyle Issues and Travel Other Activities Which Require enough supplies with you while you’re Your pump has been designed to Removing Your Pump away from home. In addition to pump withstand common electromagnetic supplies, you should also always bring interference including airport metal ⚠...
  • Page 212 Bluetooth. ⚠ WARNING ALWAYS use your t:slim X2™ insulin pump for therapy decisions if your Bluetooth connection between your smartphone and pump is disabled. ⚑ NOTE...

  • Page 213: Section 3: Cgm Features

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

  • Page 214: Cgm Warnings

    CHAPTER 18 • Important Safety Information When Using the t:slim X2 Insulin Pump with a Compatible CGM The following includes important safety In order to receive CGM alerts, a sensor session communication, it is suggested that you face information related to your CGM and its...

  • Page 215: 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 information can be useful for you and • There are a number of risks as a management, such as giving a higher dose of...
  • Page 216 CHAPTER 18 • Important Safety Information When Using the t:slim X2 Insulin Pump with a Compatible CGM This Page is Intentionally Left Blank...

  • Page 217: Chapter 19 • Getting To Know Your Cgm System

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

  • Page 218: Cgm Terminology

    Dexcom G6 to be used insertion needle inside. The entire individual CGM sensor, used to pair the without the need for fingersticks or applicator is disposed of once the t:slim X2™ pump with that sensor. calibrations. sensor is inserted. Receiver Sensor Glucose Data Gaps...
  • Page 219 CHAPTER 19 • Getting to Know Your CGM System Startup Period Once a new sensor session is started on the pump, the startup period is an interval during which the new sensor is establishing a connection with the pump. Sensor glucose readings are not available during this time.

  • Page 220: Explanation Of Cgm Pump Icons

    CHAPTER 19 • Getting to Know Your CGM System 19.2 Explanation of CGM Pump Icons The following CGM icons may appear on your pump screen: CGM Icon Definitions Symbol Meaning Symbol Meaning Unknown sensor reading. Transmitter error (Dexcom G6 only). mmol/L CGM sensor session is active, but the transmitter and pump CGM sensor session is active, and the transmitter is...
  • Page 221 CHAPTER 19 • Getting to Know Your CGM System This Page is Intentionally Left Blank...

  • Page 222: Cgm Lock Screen

    CHAPTER 19 • Getting to Know Your CGM System 9. Active Bolus Icon: Indicates a 19.3 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 223 CHAPTER 19 • Getting to Know Your CGM System...

  • Page 224: Cgm Home Screen

    CHAPTER 19 • Getting to Know Your CGM System one bolus delivery even if the icon is Tap the “minimize” icon to return to the 19.4 CGM Home Screen temporarily obstructed by the hash CGM Home screen. marks on the bolus bar as the 1.
  • Page 225 CHAPTER 19 • Getting to Know Your CGM System...

  • Page 226: Dexcom G6 Screen

    CHAPTER 19 • Getting to Know Your CGM System 19.5 Dexcom G6 Screen The Dexcom G6 screen can be accessed from the My CGM screen by tapping Change Sensor Type. See Section 23.1 Choosing Your Sensor Type. 1. START G6 SENSOR: Starts a CGM session.
  • Page 227 CHAPTER 19 • Getting to Know Your CGM System...

  • Page 228: Dexcom G7 Screen

    CHAPTER 19 • Getting to Know Your CGM System 19.6 Dexcom G7 Screen The Dexcom G7 screen can be accessed from the My CGM screen by tapping Change Sensor Type. See Section 23.1 Choosing Your Sensor Type. 1. START G7 SENSOR: Starts a CGM session.
  • Page 229 CHAPTER 19 • Getting to Know Your CGM System...
  • Page 230 CHAPTER 19 • Getting to Know Your CGM System This Page is Intentionally Left Blank...

  • Page 231: Chapter 20 • Cgm Overview

    CGM Features CHAPTER 20 CGM Overview...

  • Page 232: Cgm System Overview

    (either above or below a given level, or are allows readings from your sensor to be the t:slim X2 pump or the Dexcom rising or falling quickly. If CGM readings displayed on your pump screen. To receiver), but you can still use the become 3.1 mmol/L or lower, the CGM...

  • Page 233: Receiver (T:slim X2 Insulin Pump) Overview

    CHAPTER 20 • CGM Overview well through water. To ensure communication, it 20.3 Receiver (t:slim X2 Insulin is suggested that you face your pump screen Pump) Overview out and away from the body, and wear the pump on the same side of the body that you wear your To review the icons and controls CGM.
  • Page 234 CHAPTER 20 • CGM Overview This Page is Intentionally Left Blank...

  • Page 235: Cgm Settings

    CGM Features CHAPTER 21 CGM Settings...

  • Page 236: About Bluetooth Technology

    CHAPTER 21 • CGM Settings Soft pump. The receiver power must be completely 21.1 About Bluetooth Technology off in order to avoid connection problems. When you want your alert to be less noticeable. This sets all alerts and Bluetooth Low Energy technology is a You may still use a smartphone with the alarms to lower volume beeps.
  • Page 237 CHAPTER 21 • CGM Settings • If the alert is not confirmed in 5 To Select Your CGM Volume: minutes, the pump vibrates and 1. From the Home screen, tap beeps. OPTIONS. • If the alert is not confirmed in 5 more minutes, the pump vibrates 2.
  • Page 238 CHAPTER 21 • CGM Settings Sound Option Descriptions CGM Volume Vibrate Soft Normal HypoRepeat 2 long vibrates + 2 long vibrates + 2 long vibrates + High Alert 2 long vibrates 2 low beeps 2 medium beeps 2 medium beeps 3 short vibrates + 3 short vibrates + 3 short vibrates +...

  • Page 239: Cgm Info

    CHAPTER 21 • CGM Settings 21.4 CGM Info CGM Info contains important information about your device. The following an be found in CGM Info: • Firmware Revision • Hardware Revision • BLE Hardware ID • Software Number You can view this information at any time.
  • Page 240 CHAPTER 21 • CGM Settings This Page is Intentionally Left Blank...

  • Page 241: Setting Cgm Alerts

    CGM Features CHAPTER 22 Setting CGM Alerts...

  • Page 242: 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 243: 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 244: Rate Alerts

    CHAPTER 22 • Setting CGM Alerts beeps according to your CGM volume 22.3 Rate Alerts 22.4 Setting Your Rise Alert selection. Rate alerts tell you when your glucose 1. From the Home screen, tap levels are rising (Rise Alert) or falling (Fall OPTIONS.

  • Page 245: Setting Your Fall Alert

    CHAPTER 22 • Setting CGM Alerts value is on and will alert after 20 22.5 Setting Your Fall Alert 22.6 Setting Your Out of Range minutes. Alert The Out Of Range symbol appears on 1. From the Home screen, tap the pump CGM Home screen and on The range from the CGM to the pump OPTIONS.
  • Page 246 CHAPTER 22 • Setting CGM Alerts The default is set to on and the time is set to 20 minutes. 6. To change the time, tap Alert After. 7. Using the on-screen keypad, enter the time after which you want to be alerted (between 20 minutes and 3 hours and 20 minutes) then tap 8.
  • Page 247 CGM Features CHAPTER 23 Starting or Stopping a CGM Sensor Session...

  • Page 248: 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 249: Start The Dexcom G6 Sensor

    If you don't enter a code into either not match you will be prompted to sensor code, or to skip this step. If the t:slim X2 pump you will need to start the process again. you choose to enter the sensor...

  • Page 250: Dexcom G6 Sensor Startup Period

    CHAPTER 23 • Starting or Stopping a CGM Sensor Session  Your pump will return to the CGM • If the correct transmitter ID is Sensor Startup Period Timeline Home screen with the 3 hour trend entered and the pump and CGM graph and the sensor startup are still not communicating, contact countdown symbol displayed.
  • Page 251 CHAPTER 23 • Starting or Stopping a CGM Sensor Session If you started your sensor session 90 Follow the instructions in the next ⚠ WARNING minutes ago, you would see this chapter to calibrate your sensor. Skip Continue to use a BG meter and test strips in countdown symbol on the CGM Home the calibration instructions if you order to make treatment decisions during the...

  • Page 252: Dexcom G6 Automatic Sensor Shut-Off

    4. Tap STOP G6 SENSOR. readings normally show. 5. Tap to confirm. Your t:slim X2™ pump tells you how New sensor glucose readings do not much time you have left until your show on your pump or Tandem t:slim  The SENSOR STOPPED screen is sensor session is complete.

  • Page 253: Removing The Dexcom G6 Sensor And Transmitter

    CHAPTER 23 • Starting or Stopping a CGM Sensor Session ends. You must remove your sensor, 1. From the CGM Home screen, tap Check your pump CGM Home screen insert a new sensor, and start a new OPTIONS. 10 minutes after starting your sensor sensor session.

  • Page 254: Dexcom G7 Automatic Sensor Shut-Off

    3 units/hour during 16-23 Minutes sensor startup, turn Control-IQ technology off. Your t:slim X2 pump tells you how much time you have left until your sensor session is complete. The Sensor Expiring Soon screen shows at 24 hours remaining and 2 hours remaining.

  • Page 255: Ending A Dexcom G7 Sensor Session Before Automatic Shut-Off

    New sensor glucose readings do not  The CGM Home screen will appear when there are 30 minutes remaining. show on your pump or Tandem t:slim with the Replace Sensor icon in the mobile app after your sensor session place where sensor glucose When you see the Sensor Expiring ends.
  • Page 256 CHAPTER 23 • Starting or Stopping a CGM Sensor Session manufacturer’s website for applicable product instructions.
  • Page 257 CGM Features CHAPTER 24 Calibrating Your Dexcom CGM System...

  • Page 258: Calibration Overview

    CHAPTER 24 • Calibrating Your Dexcom CGM System Calibration is required for the Dexcom On the first day of your sensor session, that 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 259: 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 260: Calibration Bg Value And Correction Bolus

    If you enter your Target BG as a Correction Bolus calibration value, the pump will return to the CGM Home screen. Your t:slim X2™ pump uses the BG value entered for calibration to 24.4 Reasons You May Need to determine if a correction bolus is...
  • Page 261 CGM Features CHAPTER 25 Viewing CGM Data on Your t:slim X2 Insulin Pump...

  • Page 262: Overview

    CHAPTER 25 • Viewing CGM Data on Your t:slim X2 Insulin Pump Your BG meter measures glucose in • The current time and date are 25.1 Overview your blood. Your sensor measures shown at the top of the screen in glucose from interstitial fluid (the fluid the middle.

  • Page 263: Cgm Trend Graphs

    CHAPTER 25 • Viewing CGM Data on Your t:slim X2 Insulin Pump • If the Low Alert is not set and your reading along with the last 3 hours of with the last 12 hours of sensor glucose sensor glucose reading is 3.1 sensor glucose readings.

  • Page 264: Rate Of Change Arrows

    CHAPTER 25 • Viewing CGM Data on Your t:slim X2 Insulin Pump with the last 1 hour of sensor glucose HIGH shows when your most recent The trend arrows show below your sensor glucose reading is greater than readings. current sensor glucose reading.
  • Page 265 CHAPTER 25 • Viewing CGM Data on Your t:slim X2 Insulin Pump The table below shows the different trend arrows your receiver or pump displays: Trend Arrow Definitions Constant: Your sensor glucose is steady (not Slowly falling: Your sensor glucose is falling 0.06–0.11 increasing/decreasing more than 0.06 mmol/L each...

  • Page 266: 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 267: Cgm Alerts And Errors

    CGM Features CHAPTER 26 CGM Alerts and Errors...
  • Page 268 You must customize the CGM alert settings on smartphone. Notifications must be enabled on your t:slim X2 pump and the Dexcom CGM apps your smartphone, and the Tandem t:slim mobile separately. The alert settings apply to the phone app must be open in the background for pump and pump separately.

  • Page 269: Startup Calibration Alerts - Dexcom G6 Only

    CHAPTER 26 • CGM Alerts and Errors 26.1 Startup Calibration Alert – Dexcom G6 Only Screen Explanation What will I see on the screen? 2-hour CGM startup period is complete. This will only appear if you What does it mean? did not enter a sensor code.

  • Page 270: Second Startup Calibration Alert - Dexcom G6 Only

    CHAPTER 26 • CGM Alerts and Errors 26.2 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 271: Hour Calibration Alert - Dexcom G6 Only

    CHAPTER 26 • CGM Alerts and Errors 26.3 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 272: Incomplete Calibration

    CHAPTER 26 • CGM Alerts and Errors 26.4 Incomplete Calibration Screen Explanation What will I see on the screen? If you start to enter a calibration value using the keypad and do not What does it mean? complete the entry within 90 seconds, this screen appears. How will the pump notify me? 2 beeps or vibrations depending on Sound Volume selected.

  • Page 273: Calibration Timeout

    CHAPTER 26 • CGM Alerts and Errors 26.5 Calibration Timeout Screen Explanation What will I see on the screen? If you start to enter a calibration value using the keypad and do not What does it mean? complete the entry within 5 minutes, this screen appears. How will the pump notify me? 2 beeps or vibrations depending on Sound Volume selected.

  • Page 274: Calibration Error Alert

    CHAPTER 26 • CGM Alerts and Errors 26.6 Calibration Error Alert 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 275: Calibration Required Alert - Dexcom G6 Only

    CHAPTER 26 • CGM Alerts and Errors 26.7 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 276: Cgm High Alert

    CHAPTER 26 • CGM Alerts and Errors 26.8 CGM High Alert Screen Explanation What will I see on the screen? Your most recent sensor glucose reading is at or above the High What does it mean? Alert setting. 2 vibrations, then 2 vibrations/beeps every 5 minutes until How will the pump notify me? confirmed or your sensor glucose value drops below the alert level.

  • Page 277: Cgm Low Alert

    CHAPTER 26 • CGM Alerts and Errors 26.9 CGM Low Alert Screen Explanation What will I see on the screen? Your most recent sensor glucose reading is at or below the Low What does it mean? Alert setting. 3 vibrations, then 3 vibrations/beeps every 5 minutes until How will the pump notify me? confirmed or your sensor glucose value goes above the alert level.

  • Page 278: Cgm Fixed Low Alert

    CHAPTER 26 • CGM Alerts and Errors 26.10 CGM Fixed Low Alert Screen Explanation What will I see on the screen? What does it mean? Your most recent sensor glucose reading is at or below 3.1 mmol/L. 4 Vibrations, then 4 vibrations/beeps every 5 minutes until How will the pump notify me? confirmed or your sensor glucose value goes above 3.1 mmol/L.

  • Page 279: Cgm Rise Alert

    CHAPTER 26 • CGM Alerts and Errors 26.11 CGM Rise Alert Screen Explanation What will I see on the screen? Your sensor glucose levels are rising at 0.11 mmol/L per minute or What does it mean? faster (at least 1.7 mmol/L in 15 minutes). 2 vibrations, then 2 vibrations/beeps every 5 minutes or until How will the pump notify me? confirmed.

  • Page 280: Cgm Rapid Rise Alert

    CHAPTER 26 • CGM Alerts and Errors 26.12 CGM Rapid Rise Alert Screen Explanation What will I see on the screen? Your sensor glucose levels are rising at 0.17 mmol/L per minute or What does it mean? faster (at least 2.5 mmol/L in 15 minutes). 2 vibrations, then 2 vibrations/beeps every 5 minutes or until How will the pump notify me? confirmed.

  • Page 281: Cgm Fall Alert

    CHAPTER 26 • CGM Alerts and Errors 26.13 CGM Fall Alert Screen Explanation What will I see on the screen? Your sensor glucose levels are falling at 0.11 mmol/L per minute or What does it mean? faster (at least 1.7 mmol/L in 15 minutes). 3 vibrations, then 3 vibrations/beeps every 5 minutes or until How will the pump notify me? confirmed.

  • Page 282: Cgm Rapid Fall Alert

    CHAPTER 26 • CGM Alerts and Errors 26.14 CGM Rapid Fall Alert Screen Explanation What will I see on the screen? Your sensor glucose levels are falling at 0.17 mmol/L per minute or What does it mean? faster (at least 2.5 mmol/L in 15 minutes). 3 vibrations, then 3 vibrations/beeps every 5 minutes or until How will the pump notify me? confirmed.

  • Page 283: Unknown Sensor Glucose Reading

    CHAPTER 26 • CGM Alerts and Errors 26.15 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 284: Out Of Range Alert

    CHAPTER 26 • CGM Alerts and Errors 26.16 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 technology is not able to predict sensor glucose levels or adjust...

  • Page 285: Low Transmitter Battery Alert - Dexcom G6 Only

    CHAPTER 26 • CGM Alerts and Errors 26.17 Low Transmitter Battery Alert – Dexcom G6 Only Screen Explanation What will I see on the screen? What does it mean? The Dexcom G6 transmitter battery is low. How will the pump notify me? 1 vibration, then vibration/beep every 5 minutes until confirmed.

  • Page 286: Transmitter Error - Dexcom G6 Only

    CHAPTER 26 • CGM Alerts and Errors 26.18 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 287: Failed Sensor Error

    CHAPTER 26 • CGM Alerts and Errors 26.19 Failed Sensor Error Screen Explanation What will I see on the screen? The sensor is not working properly and the CGM session has What does it mean? stopped. How will the pump notify me? 1 vibration, then vibration/beep every 5 minutes.

  • Page 288: Incompatible Sensor Alert - Dexcom G7 Only

    CHAPTER 26 • CGM Alerts and Errors 26.20 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.

  • Page 289: Cgm Unavailable

    CHAPTER 26 • CGM Alerts and Errors 26.21 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 290: Cgm Error - Dexcom G7 Only

    CHAPTER 26 • CGM Alerts and Errors 26.22 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 291: Unable To Pair - Dexcom G7 Only

    CHAPTER 26 • CGM Alerts and Errors 26.23 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.

  • Page 292: Cgm System Error

    CHAPTER 26 • CGM Alerts and Errors 26.24 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 293: Cgm Troubleshooting

    CGM Features CHAPTER 27 CGM Troubleshooting...

  • Page 294: Cgm Pairing Troubleshooting

    The pump will not use a BG Difficulty pairing your Dexcom CGM sensor glucose readings are normally value for calibration when this symbol is with your t:slim X2™ insulin pump. shown on the screen. on your screen. Troubleshooting tip: Do not calibrate if you see “- - -”...

  • Page 295: Out Of Range/No Antenna Troubleshooting

    Troubleshooting sensor glucose readings, contact your sensor glucose reading normally local customer support. shows, then your t:slim X2 pump is not ⚠ WARNING communicating with your CGM and Control-IQ™ technology can only adjust insulin sensor glucose readings will not show delivery when your CGM is in range.

  • Page 296: Failed Sensor Troubleshooting

    Failed Sensor screen greater than 20% for sensor readings sensor only and not to your CGM or shows on your t:slim X2 pump. If you >4.4 mmol/L or greater than 1.1 pump. Your sensor glucose readings see this screen, it means your CGM mmol/L for sensor readings <4.4...
  • Page 297 CHAPTER 27 • CGM Troubleshooting value. Use a BG value only from your fingers for calibration. • Use only BG values between 1.1– 33.3 mmol/L for calibration. If one or more of your values is outside of this range, the receiver will not calibrate.
  • Page 298 CHAPTER 27 • CGM Troubleshooting This Page is Intentionally Left Blank...

  • Page 299: Section 4: Control-Iq Technology Features

    Control-IQ Technology Features CHAPTER 28 Control-IQ Technology Important Safety Information...

  • Page 300: Control-Iq Technology Warnings

    25 kilograms (55 pounds), ⚠ WARNING which are the minimum inputs required to The t:slim X2 insulin pump with Control-IQ initiate Control-IQ technology and for it to 28.1 Control-IQ Technology technology should not be used in children under Warnings operate safely.

  • Page 301: Control-Iq Technology Precautions

    CHAPTER 28 • Control-IQ Technology Important Safety Information sensor session must be started and transmitting also result in errors when reviewing, analyzing technology requires to make predictions to sensor values to the pump. and interpreting historical patterns for assessing automate insulin dosing. glucose control.
  • Page 302 CHAPTER 28 • Control-IQ Technology Important Safety Information This Page is Intentionally Left Blank...
  • Page 303 Control-IQ Technology Features CHAPTER 29 Getting to Know Control-IQ Technology...

  • Page 304: 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...

  • Page 305: 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 technology, you may see the following additional icons on your pump screen: Control-IQ Technology Icon Definitions Symbol Meaning Symbol...

  • Page 306: 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 technology enabled. The Control-IQ Lock screen is the same as the CGM Lock screen, with the following additions.
  • Page 307 CHAPTER 29 • Getting to Know Control-IQ Technology...

  • Page 308: Control-Iq Home Screen

    CHAPTER 29 • Getting to Know Control-IQ Technology 29.4 Control-IQ Home Screen The Home screen with Control-IQ technology enabled is identical to the CGM Home screen, with the following additions. See Section 19.4 CGM Home Screen. 1. Control-IQ Technology Status: Indicates the status of Control-IQ technology.
  • Page 309 CHAPTER 29 • Getting to Know Control-IQ Technology...

  • Page 310: Control-Iq Screen

    CHAPTER 29 • Getting to Know Control-IQ Technology 29.5 Control-IQ Screen 1. Control-IQ Technology on/off: Turns on, or off, Control-IQ technology. 2. Weight: Displays your current weight. This value is manually entered in on the numerical keypad. ⚑ NOTE Your weight should be representative of what you weigh when you start Control-IQ technology.
  • Page 311 CHAPTER 29 • Getting to Know Control-IQ Technology...
  • Page 312 CHAPTER 29 • Getting to Know Control-IQ Technology This Page is Intentionally Left Blank...
  • Page 313 Control-IQ Technology Features CHAPTER 30 Introduction to Control-IQ Technology...

  • Page 314: Control-Iq Technology Overview

    CHAPTER 30 • Introduction to Control-IQ Technology ⚑ NOTE level, and treat according to the 30.1 Control-IQ Technology recommendations of your healthcare provider. The Insulin On Board (IOB) Time Remaining, Overview which indicates how long the total units of ⚠ WARNING insulin from food and correction boluses will be Control-IQ™...
  • Page 315 CHAPTER 30 • Introduction to Control-IQ Technology predicts CGM values 30 minutes in the different insulin delivery actions are below a preset treatment value (6.25 future. Insulin delivery is automatically described below. Each of the insulin mmol/L) 30 minutes in the future, the adjusted based on the predicted CGM delivery adjustments occurs in different rate of insulin delivery will start...
  • Page 316 CHAPTER 30 • Introduction to Control-IQ Technology Current 30-minute Reading Prediction 6.25 6.25 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 317 CHAPTER 30 • Introduction to Control-IQ Technology Insulin Decreased or Delivering 0 Units per Hour Control-IQ technology can reduce the basal delivery to a percent of the Basal Rate in addition to completely suspending. When Control-IQ technology predicts that your sensor glucose value will be lower than a preset treatment value (3.9 mmol/L) 30 minutes in the future, insulin delivery will...
  • Page 318 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 319 CHAPTER 30 • Introduction to Control-IQ Technology Increasing Insulin Delivery When Control-IQ technology predicts that your sensor glucose value will be at or above a preset treatment value (8.9 mmol/L) 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 320 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 321 Stopping a Bolus Using the Pump Section Control-IQ technology is either 8.15 Canceling or Stopping a Bolus Using the Increasing Insulin Delivery or delivering Tandem t:slim Mobile App. Maximum Insulin Delivery, the pump will automatically deliver correction boluses ⚑ NOTE to attempt to achieve the target range.
  • Page 322 CHAPTER 30 • Introduction to Control-IQ Technology Current 30-minute Reading Prediction 10.0 10.0 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 323: Control-Iq Technology And Activity

    CHAPTER 30 • Introduction to Control-IQ Technology Suspended Insulin With No Activity setting the hours you plan to sleep and 30.3 Control-IQ Technology and Enabled Section 31.7 Manually Start or Stop Activity Insulin is set to 0 units/hour when Sleep for starting the Sleep Activity Control-IQ technology predicts a CGM manually in that chapter.
  • Page 324 CHAPTER 30 • Introduction to Control-IQ Technology Increasing Insulin During Sleep accommodate the likely natural drop in automatic correction boluses as Activity glucose following exercise. described in the Automatic Correction Insulin is increased when Control-IQ Bolus Delivery section of this chapter. If the Exercise Activity is on when a technology predicts a CGM reading of Sleep Schedule is due to begin, the...
  • Page 325 CHAPTER 30 • Introduction to Control-IQ Technology Control-IQ Sleep Activity Exercise Activity Delivers an automatic correction bolus if sensor Delivers 10.0 –– 10.0 glucose is predicted to be above mmol/L Increases basal insulin delivery if sensor glucose is Increases predicted to be above mmol/L Maintains active Personal Profile settings* when sensor Maintains...
  • Page 326 CHAPTER 30 • Introduction to Control-IQ Technology This Page is Intentionally Left Blank...
  • Page 327 Control-IQ Technology Features CHAPTER 31 Configuring and Using Control-IQ Technology...

  • Page 328: Required Settings

    CHAPTER 31 • Configuring and Using Control-IQ Technology Recommended Control-IQ 31.1 Required Settings Technology Pump Settings Although Sleep can be started and Required Personal Profile Settings stopped manually, it is recommended In order to use Control-IQ™ that you schedule sleep. This chapter technology, the following Personal explains how to do both.

  • Page 329: Set Total Daily Insulin

    8. When you are done setting up • Tap to leave Control-IQ on. (basal and bolus) delivered in a 24-hour Control-IQ, tap the Tandem logo to period. Consult your healthcare return to the CGM Home screen. provider if you need assistance...

  • Page 330: Schedule Sleep

    CHAPTER 31 • Configuring and Using Control-IQ Technology ⚑ NOTE 31.5 Schedule Sleep Exercise and Sleep may not be enabled at the same time. If Exercise is active at the time a Control-IQ technology operates Sleep Schedule is set to begin, the Sleep differently during Sleep than with no Schedule does not start until the Exercise timer Activity enabled.

  • Page 331: Enable Or Disable A Sleep Schedule

    . You are returned to the sleep, tap to return to the Start Time screen. Activity screen or tap the Tandem logo to return to the Home screen. 13. Tap AM or PM to set the Time of Day, if applicable.

  • Page 332: Manually Start Or Stop Sleep

    CHAPTER 31 • Configuring and Using Control-IQ Technology 5. Tap the schedule summary next to Tap the schedule summary next to Manually Start Sleep the name of the Sleep Schedule the Sleep Schedule you want to 1. From the Home screen, tap you want to enable.

  • Page 333: Enable Or Disable Exercise

    CHAPTER 31 • Configuring and Using Control-IQ Technology Manually Stop Sleep duration. For detailed information about 6. Tap Duration. The number keypad how to use Control-IQ technology, see is displayed. You may enter an 1. From the Home screen, tap Chapter 30 Introduction to Exercise duration between 30 OPTIONS.

  • Page 334: Control-Iq Technology Information On Your Screen

    CHAPTER 31 • Configuring and Using Control-IQ Technology 3. Tap 4. Tap START. 3. Tap  An EXERCISE STOPPED message  An EXERCISE STARTED message  An EXERCISE STOPPED message is temporarily displayed. The is temporarily displayed. The is temporarily displayed. The Exercise icon is removed from the Exercise icon is removed from the Exercise icon is removed from the...
  • Page 335 Section 3.3 Explanation operating. Each different color and its the respective icon displays in the same of t:slim X2 Insulin Pump Icons for the meaning can be found in Section 29.2 place on the screen, since they can manual bolus icon image.) The following...
  • Page 336 CHAPTER 31 • Configuring and Using Control-IQ Technology appearing below BOLUS indicates that there is an automatic correction bolus delivered by Control-IQ technology. The amount of the bolus is also displayed. CGM Trend Graph Insulin Delivery Suspended Portions of the CGM Trend Graph that display a red band in the background indicate the times when Control-IQ technology was delivering 0 units/hour.
  • Page 337 Control-IQ Technology Features CHAPTER 32 Control-IQ Technology Alerts...
  • Page 338 Chapter 26 CGM Alerts and The Tandem t:slim™ mobile app also Errors. can provide messages, alerts, and alarms from your t:slim X2™ pump as push notifications on your smartphone. These push notifications will be identical to your pump’s display unless otherwise noted in this chapter.

  • Page 339: Out Of Range Alerts - Control-Iq Technology Disabled

    CHAPTER 32 • Control-IQ Technology Alerts 32.1 Out of Range Alert – Control-IQ Technology Disabled Screen Explanation What will I see on the screen? The CGM and pump are not communicating. The pump will not What does it mean? receive sensor glucose readings, and Control-IQ technology is not able to predict sensor glucose levels or adjust insulin delivery.

  • Page 340: Out Of Range Alert - Control-Iq Technology Enabled

    CHAPTER 32 • Control-IQ Technology Alerts 32.2 Out of Range Alert – Control-IQ Technology Enabled Screen Explanation What will I see on the screen? Control-IQ technology is turned on, but the CGM and pump are not communicating. The pump will not receive sensor glucose readings. Control-IQ technology will continue to adjust basal rates and deliver What does it mean? automatic correction boluses for the first 20 minutes that the CGM...

  • Page 341: Control-Iq Technology Low Alert

    CHAPTER 32 • Control-IQ Technology Alerts 32.3 Control-IQ Technology Low Alert Screen Explanation What will I see on the screen? Control-IQ Low Alert has predicted that your sensor glucose reading What does it mean? will drop below 3.9 mmol/L, or below 4.4 mmol/L if Exercise is enabled, in the next 15 minutes.

  • Page 342: Control-Iq High Alert

    CHAPTER 32 • Control-IQ Technology Alerts 32.4 Control-IQ High Alert Screen Explanation What will I see on the screen? Control-IQ technology has three hours of CGM data and has increased insulin delivery, but detects a sensor glucose reading What does it mean? above 11.1 mmol/L and does not predict that the sensor glucose reading will decrease in the next 30 minutes.

  • Page 343: Max Insulin Alert

    CHAPTER 32 • Control-IQ Technology Alerts 32.5 Max Insulin Alert Screen Explanation What will I see on the screen? The pump has delivered the maximum allowable 2 hour insulin amount based on your Total Daily Insulin setting. You see this alert when Control-IQ technology has delivered 50% of your Total Daily Insulin (through basal and/or bolus deliveries) over the previous What does it mean?
  • Page 344 CHAPTER 32 • Control-IQ Technology Alerts This Page is Intentionally Left Blank...
  • Page 345 Control-IQ Technology Features CHAPTER 33 Overview of Control-IQ Technology Clinical Studies...

  • Page 346: Introduction

    ≥6 years to 13 years old. In to 71 years of age, treated with insulin diabetes-related emergencies and both studies, the t:slim X2 insulin pump via an insulin pump or injections for at willing to participate in all training with Control-IQ technology was least one year.
  • Page 347 CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies site failure, in the DCLP3 Control-IQ arm. There were no episodes of DKA in the DCLP5. There were no severe hypoglycemic events in either study. No other adverse events related to the device were reported.

  • Page 348: Demographics

    CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies 33.3 Demographics Baseline characteristics including demographics of the study participants are provided in the table below. DCLP3: Baseline Characteristics Including Demographics at Enrollment (N=168) Average Age Average HbA Median Diabetes Duration Gender MDI Users CGM Users...

  • Page 349: Intervention Compliance

    33.4 Intervention Compliance The following tables provide an overview of the how often the t:slim X2 insulin pump with Control-IQ technology, Dexcom G6 CGM, and BG meters were used during the studies, respectively. The analysis for Control-IQ technology use is specific to the Control-IQ arm, while the analysis for CGM and BG meter use represents both the Control-IQ arm and the SAP arm.
  • Page 350 CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies DCLP5: Percentage of t:slim X2 Insulin Pump with Control-IQ Technology Use Over the 4-Month Period (n=78) Average Time Control-IQ Available* Weeks 1–4 93.4% Weeks 5–8 93.8% Weeks 9–12 94.1% Weeks 13–End 94.4%...
  • Page 351 CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies DCLP5: Percentage of CGM Use Over the 4-Month Period (N=101) Control-IQ* SAP* Weeks 1–4 Weeks 5–8 Weeks 9–12 Weeks 13–End Overall *The denominator is the total possible time within the 4-month study period. CGM use includes warm-up time. DCLP3: Daily BG Meter Use Over the 6-Month Period (N=168) Control-IQ BG Meter Use Per Day...

  • Page 352: Primary Analysis

    CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies 33.5 Primary Analysis The primary outcome of both the DCLP3 and DCLP5 studies was to compare the CGM sensor values in range between 3.9–10 mmol/L between the Control-IQ arms 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 353 CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies DCLP5: Comparison of CGM Values Between Control-IQ and SAP Users (N=101) Difference Between Study Arm Characteristic Control-IQ and Control Arm Average Sensor Glucose 9.0 mmol/L 9.9 mmol/L -0.9 mmol/L (std dev) (1.0 mmol/L) (1.4 mmol/L) Average % 3.9–10 mmol/L...
  • Page 354 CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies The tables below describes the average time participants in both the Control-IQ arm and the SAP arm spent with sensor glucose levels between 3.9–10 mmol/L 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 355: Secondary Analysis

    CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies 33.6 Secondary Analysis The following tables compares the percent of time that participants spent at the indicated sensor glucose levels during the daytime and nighttime. The definitions of daytime and nighttime differ slightly between the two studies and are defined in the tables. DCLP3: Secondary Analysis by Time of Day (N=168) Daytime Nighttime...
  • Page 356 CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies The following table compares the percent of time spent between 3.9–10 mmol/L 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 357: Insulin Delivery Differences

    CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies 33.7 Insulin Delivery Differences The following table compares the insulin delivery statistics between the Control-IQ arm and the SAP arm in the DCLP3 study. DCLP3: Insulin Delivery Comparison (N=168) Characteristic Timepoint Control-IQ After 2-weeks Average (std dev)
  • Page 358 CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies The following table compares the insulin delivery statistics between the Control-IQ arm and the SAP arm in the DCLP5 study. Total daily insulin is reported as Units of insulin per body weight of participant, in kilograms (kg), per day. DCLP5: Insulin Delivery Comparison (N=101) Characteristic Timepoint...

  • Page 359: Control-Iq Technology High And Low Alert Accuracy

    CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies 33.8 Control-IQ Technology High and Low Alert Accuracy The following data table characterizes the accuracy of the Control-IQ technology high and low alerts, respectively. This analysis depicts the percent of alerts that were triggered relative to the resulting sensor glucose value achieving the level the alert predicted. The Control-IQ technology Low Alert notifies the user when Control-IQ technology predicts that the sensor glucose value will be below 3.9 mmol/L 15 minutes in the future, or 4.4 mmol/L when the exercise activity is enabled.
  • Page 360 CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies The table below depicts the performance of the Control-IQ technology high and low alerts when evaluating the resulting sensor glucose value after 15-minutes and 30-minutes. DCLP3: Percentage of Accurate Control-IQ Technology Alerts (n=112) Performance Predictive Alert 15-minutes...

  • Page 361: Additional Analysis Of Sensor Glucose Value Auto-Population With Cgm

    CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies 33.9 Additional Analysis of Sensor Glucose Value Auto-Population with CGM Upon completion of the Pivotal Study, an evaluation of the auto-population of CGM readings into the bolus calculator was performed. The results of the analysis indicate, when a sensor glucose value was >13.9 mmol/L, there was an increased incidence of CGM values <3.9 mmol/L five hours after a bolus was delivered using auto-populated CGM readings compared to the five hours after the bolus was delivered using manually entered sensor glucose values.
  • Page 362 CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies DCLP3: Post-Correction Bolus CGM Readings (5 hours): Based on Starting Sensor Glucose Readings One or More CGM Three Consecutive CGM Five or More CGM CGM Reading Entry Type Reading <3.0 mmol/L Readings <3.9 mmol/L Readings <3.9 mmol/L (95% CI)
  • Page 363 CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies DCLP5: Post-Correction Bolus CGM Readings (5 hours): Based on Starting Sensor Glucose Readings One or More CGM Three Consecutive CGM Five or More CGM CGM Reading Entry Type Reading <3.0 mmol/L Readings <3.9 mmol/L Readings <3.9 mmol/L (95% CI)
  • Page 364 CHAPTER 33 • Overview of Control-IQ Technology Clinical Studies This Page is Intentionally Left Blank...

  • Page 365: Section 5: Technical Specifications And Warranty

    Technical Specifications and Warranty CHAPTER 34 Technical Specifications...

  • Page 366: 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 367 CHAPTER 34 • Technical Specifications t:slim X2 Pump Specifications (Continued) Specification Type Specification Details Insulin Concentration U-100 The service life of the pump is four years. Contact your local customer support for instructions on safe disposal Service Life Conditions of the pump.
  • Page 368 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 369 CHAPTER 34 • Technical Specifications USB Charging/Download Cable Specifications Specification Type Specification Detail Tandem P/N 004113 Length 2 meters (6 feet) Type USB A to USB Micro B Power Supply/Charger, AC, Wall Mount, USB Specifications Specification Type Specification Detail Tandem P/N...
  • Page 370 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 371: 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...
  • Page 372 CHAPTER 34 • Technical Specifications t:slim X2 Pump Options and Settings (Continued) Option/Setting Type Option/Setting Detail Maximum Extended Bolus Time 8 hours (2 hours when Control-IQ™ technology is enabled) Maximum Bolus Size 25 units Maximum Automatic Bolus Size 6 units Status indicator visible on Home screen;...

  • Page 373: T:slim X2 Pump Performance Characteristics

    Basal Delivery To assess basal delivery accuracy, 32 t:slim X2 pumps were tested by delivering at low, medium, and high Basal Rates (0.1, 2.0, and 15 U/hr). Sixteen of the pumps were new, and 16 had been aged to simulate four years of regular use. For both aged and unaged pumps, eight pumps were tested with a new cartridge, and eight with a cartridge which underwent two years of real time aging.
  • Page 374 Bolus Delivery To assess bolus delivery accuracy, 32 t:slim X2 pumps were tested by delivering consecutive low, medium, and high bolus volumes (0.05, 2.5, and 25 units). Sixteen of the pumps were new, and 16 had been aged to simulate four years of regular use. For both aged and unaged pumps, eight pumps were tested with a new cartridge, and eight with a cartridge which underwent two years of real time aging.
  • Page 375 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 376 CHAPTER 34 • Technical Specifications Intermediate Bolus Delivery Performance (2.5U) (n=800 boluses) Units of Insulin Delivered After a 2.5 U Bolus Request 0.625– 1.875– 2.25– 2.375– 2.625– 2.75– 3.125– 4.375– <0.625 >6.25 1.875 2.25 2.375 2.625 2.75 3.125 4.375 6.25 (<25%) (>250%) (25–75%)
  • Page 377 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 378: Electromagnetic Compatibility

    • Wireless Technology ⚠ WARNING 34.5 Electromagnetic Compatibility ALWAYS use the USB cable provided with your t:slim X2 insulin pump to minimize the risk of 34.6 Wireless Co-existence and The information contained in this Data Security fires or burns. section is specific to the pump and CGM.

  • Page 379: Tandem T:slim Mobile App Security

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

  • Page 380: Electromagnetic Emissions

    CHAPTER 34 • Technical Specifications 34.8 Electromagnetic Emissions The pump and CGM are intended for use in the electromagnetic environment specified below. Always make sure that the pump and CGM are used in such an environment. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment –...

  • Page 381: Electromagnetic Immunity

    CHAPTER 34 • Technical Specifications 34.9 Electromagnetic Immunity The pump and CGM are 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 ±...
  • Page 382 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, 745 745 MHz, 780 MHz: MHz, 780 MHz:...

  • Page 383: 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 384: Quality Of Wireless Service

    CGM is defined as the readings (1 hour) will be missed. percent of CGM readings successfully For proper use of the Tandem t:slim received by the pump. One of the mobile app, the pump and smartphone essential performance requirements...

  • Page 385: Wireless Technology

    CHAPTER 34 • Technical Specifications 34.12 Wireless Technology The pump and CGM utilize 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)

  • Page 386: Fcc Notice Concerning Interference

    • cartridge removal tool management application that supports interference that may cause use of the t:slim X2 pump, or if the Consumables undesired operation. pump is returned. Others who may • t:slim X2 cartridge (t:lock connector) assert a legal right to know, or who •...
  • Page 387 CHAPTER 34 • Technical Specifications Contact your local customer support service for available sizes and lengths of the following infusion sets with t:lock connectors: • AutoSoft 90 infusion set • AutoSoft 30 infusion set • AutoSoft XC infusion set • VariSoft infusion set •...

  • Page 388: Index

    INDEX Alert Icon, Where to Find ..... 52 Alerts & Reminders ......62 Basal Rate Required Alert .
  • Page 389 Incomplete Fill Cannula Alert ....173 Incomplete Fill Tubing Alert ....172 Incomplete Load Sequence Alerts .
  • Page 390 Active Bolus Icon ......52, 220 in Personal Profiles ......109 After Bolus BG Reminder .
  • Page 391 Calibration Prompts ......218 Low Glucose Alert, Set ..... . .241 CGM Fall Alert .
  • Page 392 Troubleshooting ......291 Automatic Correction Bolus Delivery ... . 319 Unknown Sensor Reading .
  • Page 393 Control-IQ Technology Safety Information ..298 Low Glucose Alert ......241 Low Insulin Alert .
  • Page 394 High BG Reminder ......156 History CGM History ......264 Failed Sensor Error .
  • Page 395 Install Mobile App ......73 Load Cartridge ......118, 122 Insulin Low BG Reminder .
  • Page 396 Force Stop ....... . . 80 Pediatric Install ........73 Infusion Site Care .
  • Page 397 Quick Bolus ........45 Safety Information Pediatric .
  • Page 398 Pediatric ........27 Set Site Reminder ......158 Select Language .
  • Page 399 Fill Tubing ....... . .123 Tandem Logo ......54, 98 Tubing Connector .
  • Page 400 Warranty Pump Warranty ......384 Water Resistance, Pump ..... . . 208 Watertight, Pump .
  • Page 401 This Page is Intentionally Left Blank...

  • Page 402: Patents And Trademarks

    Manchester mark and logos are registered trademarks owned by Bluetooth M14 5TP SIG, Inc. and any use of such marks by Tandem Diabetes England, United Kingdom Care, Inc. is under license. All other third party marks are the property of their respective owners.
  • Page 404 CONTACT INFORMATION: tandemdiabetes.com/contact UNITED STATES: (877) 801-6901 tandemdiabetes.com CANADA: (833) 509-3598 tandemdiabetes.ca 1013649_A AW-1013650_A 2024-JUL-22 © 2024 Tandem Diabetes Care, Inc. All rights reserved.
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