Tandem 1004000 User Manual

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Page 1 User Guide...
Page 3 TANDEM MOBI SYSTEM USER GUIDE ® ® Pump Model: 1004000, Software Version: Control-IQ (7.7), Compatible with Apple iPhone iOS only This user guide is designed to assist you or your trusted WARNINGS: caregiver with the features and functions of the Tandem Control-IQ technology should not be used in anyone under Mobi™...
Page 4: Table Of Contents
Radiology and Medical Procedures and Your Tandem Mobi System ....... .
Page 5 Mobile Tandem Device Updater Precautions ........
Page 6 Control-IQ Screen ................86 4.16 Connection Between the Tandem Mobi Mobile App and the Tandem Mobi Insulin Pump ....88 4.17 About Bluetooth Technology .
Page 7 Creating a New Personal Profile ............. . 107 Programming a New Personal Profile .
Page 8 Chapter 9 • Starting, Stopping, or Resuming Insulin Starting Insulin Delivery ..............144 Stopping Insulin Delivery .
Page 9 13.7 Basal Rate Required Alert ..............168 13.8 Basal and Carb Ratio Required Alert .
Page 10 Potential Benefits From Using the Tandem Mobi Insulin Pump with CGM ......
Page 11 Reasons You May Need to Calibrate ............238 Chapter 24 • Viewing CGM Data on Your Tandem Mobi Mobile App 24.1...
Page 12 25.3 12 Hour Calibration Alert – Dexcom G6 Only ........... . . 249 25.4 Incomplete Calibration .
Page 13 26.4 Out of Range/No Antenna Troubleshooting ............275 26.5 Failed Sensor Troubleshooting .
Page 14 Tandem Mobi Insulin Pump Options and Settings ........
Page 15 32.10 Electromagnetic Immunity ..............360 32.11 IEC 60601-1-10: Physiological Closed-Loop Controlled System .
Page 16 This Page is Intentionally Left Blank...
Page 17: Section 1: Before You Begin
Before You Begin CHAPTER 1 Introduction...
Page 18: Conventions Of This Guide
Calls out a reference to a separate user guide location or website link. Terminology Definitions Term Definition The front glass screen of your smartphone, which displays all Tandem Mobi™ mobile app programming, operating, and alarm/alert Touchscreen information. Quickly and lightly touch the screen with your finger.
Page 19 CHAPTER 1 • Introduction Symbol Definitions Symbol Definition ⚑ Calls out an important note regarding the use or operation of the system. ⚠ Calls out safety precautions which, if ignored, could result in minor or moderate injury. ⚠ Calls out critical safety information which, if ignored, could result in serious injury or death. Indicates how the system responds to the previous instruction.
Page 20: 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 Tandem Mobi System Symbols Symbol Definition...
Page 21 CHAPTER 1 • Introduction Explanation of Tandem Mobi System Symbols (Continued) Symbol Definition Symbol Definition Direct Current (DC) voltage Regulatory Compliance Mark Separate collection for waste electrical and electronic Humidity limitation equipment Electric equipment designed primarily for indoor use Temperature limit...
Page 22: System Terminology
CHAPTER 1 • Introduction Correction, an Extended, or a Quick commonly used to cover food that 1.3 System Terminology Bolus. takes longer to digest. When administering an extended bolus, enter Cannula Pump Terminology the DELIVER NOW portion to dose a The cannula is the part of the infusion percentage of insulin immediately and Basal...
Page 23 Calibration is when you enter BG values accommodate special situations. 100% Pairing Code – Dexcom G7 Only from a BG meter into the Tandem Mobi is the same basal rate as programmed. A unique code provided with each mobile app. Calibrations may be...
Page 24: System Description
Dexcom app may Glucose trends let you see the pattern numbers and/or letters that you enter be used in addition to the Tandem Mobi of your glucose levels. The graph into your Tandem Mobi mobile app to mobile app to receive sensor readings.
Page 25 You can also find this diabetes management. Control-IQ arrows. information in the Tandem Mobi mobile app technology utilizes the CGM sensor from the Settings screen. Tap Help, then Pump The sensor measures glucose in the...
Page 26: About This User Guide
Control-IQ technology is not a operation and technical information to The Tandem Mobi insulin pump with substitute for your own active diabetes ensure your safety. interoperable technology (the pump) is management.
Page 27: Compatible Cgms
Tandem Mobi mobile app see Dexcom CGMs currently allow pairing with one Section 4.21 Using the Pump Without medical device at a time (either the Tandem • NovoLog U-100 insulin the Tandem Mobi Mobile App.
Page 28: Important Pediatric User Information
Always in relation to the Tandem Diabetes Care this device and the Tandem Mobi mobile app. use the appropriate length of infusion set tubing products to Tandem Diabetes Care.
Page 29: Emergency Kit
CHAPTER 1 • Introduction • Rapid-acting insulin and syringes or your smartphone is not available and the Quick Bolus feature is not enabled. a prefilled insulin pen and pen needles 1.12 Emergency Kit • Infusion sets (minimum of 2) • Insulin pump cartridges (minimum You should always have an appropriate of 2)
Page 30 CHAPTER 1 • Introduction This Page is Intentionally Left Blank...
Page 31: Section 2: Tandem Mobi System Features
Tandem Mobi System Features CHAPTER 2 Important Safety Information...
Page 32: Insulin Pump Warnings
DO NOT use manual injections or inhaled ⚠ WARNING rate(s), carb ratio(s), correction factor(s), target insulins while using the Tandem Mobi pump. DO NOT start to use your pump before you have BG, and duration of insulin action. In addition,...
Page 33 BG Tandem Mobi mobile app prior to loading a new may cause hypoglycemia (low BG) or 1 to 2 hours after the new infusion set is placed.
Page 34 12 inches (30.5 cm) to any part of the ⚠ WARNING damaged and ALWAYS suspend insulin and Tandem Mobi insulin pump, including cables DO NOT remove or add insulin from a filled disconnect your infusion site before replacing specified by the manufacturer. Otherwise, cartridge after loading it onto the pump.
Page 35: Magnetic Resonance Imaging Safety
Customer Technical manufacturer’s instructions before ⚠ WARNING Support. using the Tandem Mobi mobile app Some skin care products such as lotions, during any of the radiology or medical sunscreens, and insect repellents can cause ⚠ WARNING procedures listed below.
Page 36: Tandem Mobi Mobile App Warnings
⚠ WARNING the above medical procedures. your OS. If you update to an incompatible OS, DO NOT start to use the Tandem Mobi mobile you will lose the ability to adjust insulin and app before you have been appropriately trained program your pump with the Tandem Mobi ⚠...
Page 37: Mobile Tandem Device Updater Warnings
(low BG) events. method in case you encounter any issues while long as your pump and the Tandem Mobi mobile However, if your smartphone is lost or damaged, updating your pump. Failure to have an app are connected.
Page 38: Insulin Pump Precautions
The pump is a sealed device that should set if you notice leaks around the site. can result in over delivery or under delivery of be opened and repaired only by Tandem Improperly placed sites or leaks around the insulin. Consult with your healthcare provider as Diabetes Care.
Page 39 When editing time, always high temperatures. Insulin that has been check that the AM/PM setting is accurate, if ALWAYS look at the Tandem Mobi mobile app exposed to conditions outside of the applicable. AM is to be used from midnight until screen following confirmation of a Quick Bolus manufacturer’s recommended ranges can affect...
Page 40 CHAPTER 2 • Important Safety Information and starting or stopping exercise. Your insulin use if you receive a warranty replacement ⚠ PRECAUTION needs may change in response to lifestyle pump. Failure to enter your insulin delivery AVOID areas where there may be flammable changes.
Page 41: Tandem Mobi Mobile App Precautions
When you force stop or quit your app, it is no established a Bluetooth wireless connection with DO NOT close or force stop the Tandem Mobi longer running in the background on your your pump before you use the Tandem Mobi mobile app during an update.
Page 42: Cybersecurity Preventative Measures
Incorrect use the of the your pump may not function. • Contact Tandem’s Customer Tandem Mobi system or your failure to Technical Support if you suspect follow the instructions, precautions, and your system may have been ⚠ PRECAUTION...
Page 43: Cybersecurity Threat Notification
Tandem Mobi Pump suspect your app may have been • Encryption and Authentication of compromised by any cybersecurity The Tandem Mobi system will provide Wireless Communications: All interference or vulnerability. notification when a cybersecurity threat wireless communications are is detected. If possible, the pump will encrypted and authenticated to 2.11 Potential Benefits From Using...
Page 44: Possible Risks From Using Your System
CHAPTER 2 • Important Safety Information looking at the pump or Tandem mobile app screen, including the while you are wearing it. If you think a Mobi mobile app, and can be time and amount of your last bolus, cannula has broken under your skin,...
Page 45: Working With Your Healthcare Provider
• You see a charge symbol (lightning bolt) on the pump battery level Consult your healthcare provider before indicator on the Tandem Mobi using the system to determine which mobile app features are most appropriate for you. Only your healthcare provider can ⚠...
Page 46 CHAPTER 2 • Important Safety Information This Page is Intentionally Left Blank...
Page 47 Tandem Mobi System Features CHAPTER 3 Getting to Know Your Tandem Mobi System...
Page 48: What Your Package Includes
CHAPTER 3 • Getting to Know Your Tandem Mobi System normally inserted. This cover must be Supply Reordering 3.1 What your Package Includes removed and replaced with a cartridge To order cartridges, infusion sets, prior to initiating insulin delivery. supplies, or accessories, please...
Page 49: Pump Components/Diagram
CHAPTER 3 • Getting to Know Your Tandem Mobi System 3.2 Pump Components/Diagram 1. Pump status lights: Illuminates to indicate pumping status and when charging. 2. Pump button: Turns the pump on/off, programs a Quick Bolus (if enabled), snoozes alerts and alarms (if enabled), activates the pump status lights.
Page 50: Pump Status Light Colors
Either an alarm Check the Tandem Mobi mobile or malfunction app. and all insulin delivery has stopped. ⚠ WARNING Test your BG if you are unable to check your Tandem Mobi mobile app for messaging about any alert, alarm, or malfunction.
Page 51 CHAPTER 3 • Getting to Know Your Tandem Mobi System The patterns in the table below appear when you initiate an insulin delivery, or when you check the pump status by pressing and releasing the Pump button. Solid and Pulsating Pattern Definitions...
Page 52: Check Status
CHAPTER 3 • Getting to Know Your Tandem Mobi System logos are not properly aligned, the The pump status lights will also indicate 3.5 Check Status pump will not charge. When the pump charge amount. When charging, the is initially placed, the charging pad will...
Page 53 CHAPTER 3 • Getting to Know Your Tandem Mobi System These lights will remain lit until fully need to disconnect from the pump 3. Plug the other end of the cable into charged. while charging. the USB-C port on the charging pad.
Page 54: Turning The Pump On
CHAPTER 3 • Getting to Know Your Tandem Mobi System • You are logged in to your conditions that require your attention. If these 3.8 Turning the Pump Off features are not working, discontinue use of the Tandem account on your...
Page 55 CHAPTER 3 • Getting to Know Your Tandem Mobi System 4. If you have not completed any 10. Disconnect the infusion site from Once the cartridge has been reset, applicable training, tap Go to your body. you may resume insulin delivery.
Page 56 CHAPTER 3 • Getting to Know Your Tandem Mobi System This Page is Intentionally Left Blank...
Page 57 Tandem Mobi System Features CHAPTER 4 Getting to Know the Tandem Mobi Mobile App...
Page 58: Explanation Of Icons
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App 4.1 Explanation of Icons The following icons may appear on the Tandem Mobi™ mobile app: Tandem Mobi Mobile App Icon Definitions Symbol Definition Symbol Definition The amount of charge left in the pump battery.
Page 59 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App Tandem Mobi Mobile App Icon Definitions (Continued) Symbol Definition Symbol Definition Displays the date and time the current CGM sensor session Unknown sensor reading. was started. CGM sensor session is active, and the CGM is CGM sensor session is active, but the CGM is not communicating with the pump;...
Page 60 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App Tandem Mobi Mobile App Icon Definitions (Continued) Symbol Definition Symbol Definition Dexcom G7 CGM sensor startup 16–23 minutes remaining. Dexcom G7 CGM sensor startup 24–30 minutes remaining. 23 min 30 min Sleep is on.
Page 61 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App This Page is Intentionally Left Blank...
Page 62: Navigation Bar
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App 4.2 Navigation Bar The Navigation bar appears at the bottom of the Tandem Mobi mobile app. The following provides a summary of what each menu item displays. 1. Dashboard: Pump status bar,...
Page 63 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App...
Page 64: Dashboard Screen
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App time within recommended CGM 4.3 Dashboard Screen thresholds. The Dashboard screen can be 6. Current Status: Displays the time in accessed from the Navigation bar. range information, current basal rate, bolus information, Control-IQ 1.
Page 65 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App Expanded view showing full dashboard screen...
Page 66: Dashboard Screen - Pump Status Bar
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App 5. Active Bolus Icon: Indicates a 4.4 Dashboard Screen – Pump bolus is being delivered. Status Bar 6. Status: Displays current pump 1. Battery Level: Displays the level of settings and insulin delivery status.
Page 67 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App...
Page 68: Dashboard Screen - Glucose & Iob Bar
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App 4.5 Dashboard Screen – Glucose & IOB Bar 1. Most Recent 5-Minute Sensor Glucose Reading. 2. Trend Arrow: Indicates direction and rate of change. 3. Insulin On Board: Amount and time remaining of any active insulin on board.
Page 69 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App...
Page 70: Dashboard Screen - Graph
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App 9. Insulin Suspension Bar: Indicates a 4.6 Dashboard Screen – Graph time period when insulin is being delivered at 0 u/hr. 1. High Glucose Threshold. 10. Time: Displays the current time of 2.
Page 71 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App...
Page 72: Dashboard Screen - Current Status
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App 8. Insulin Duration: Displays current 4.7 Dashboard Screen – Current insulin duration setting used to Status calculate insulin on board. 1. Basal Rate: Displays current basal 9. Last CGM Calibration: Displays rate of insulin delivery in units/hr.
Page 73 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App...
Page 74: Bolus Screen
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App Personal Profile for more 4.8 Bolus Screen information. The Bolus screen can be accessed 5. Add Glucose: Enter BG or sensor from the Navigation bar and will default glucose level. This value is...
Page 75 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App...
Page 76: Actions Screen
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App 6. Load Cartridge: Change Cartridge, 4.9 Actions Screen Fill Tubing, Fill Cannula, and Site Reminder. The Actions screen can be accessed from the Navigation bar and allows you to control aspects of your pump. You...
Page 77 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App...
Page 78: Notifications Screen
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App delete the reminder or informational 4.10 Notifications Screen message. The Notifications screen informs you when information related to your pump or CGM requires attention. The outline color of the notification indicates the importance of the information.
Page 79 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App...
Page 80: Settings Screen
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App additional information about 4.11 Settings Screen Tandem and corporate policies. The Settings screen allows you to 5. Help: View user guide links, read adjust settings related to the pump, the...
Page 81 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App...
Page 82: Pump Screen
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App 4.12 Pump Screen 1. Personal Profiles: Customize settings that define basal and bolus delivery within specific time segments. 2. Control-IQ: Turn on/off Control-IQ technology and enter required values. 3. Quick Bolus Settings: Turn on/off and setup of the Quick Bolus feature.
Page 83 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App...
Page 84: Dexcom G6 Screen
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App 4.13 Dexcom G6 Screen 1. Start G6 Sensor: Starts or stops a CGM sensor session. If a sensor is active, Stop G6 Sensor will be displayed. 2. Transmitter ID: Enter the transmitter ID.
Page 85 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App...
Page 86: Dexcom G7 Screen
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App 4.14 Dexcom G7 Screen 1. Start G7 Sensor: Starts or stops a CGM sensor session. If a sensor is active, Stop G7 Sensor will be displayed. 2. CGM Info: View the CGM information.
Page 87 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App...
Page 88: Control-Iq Screen
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App TDI is 10 u. The maximum value for TDI is 4.15 Control-IQ Screen 100 u. 1. Control-IQ: Turns Control-IQ technology on or off. 2. Weight: Displays your current weight. This value is manually entered using the on-screen keyboard.
Page 89 CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App...
Page 90: Connection Between The Tandem Mobi Mobile App And The Tandem Mobi Insulin Pump
4.16 Connection Between the Tandem Mobi Mobile App and the Tandem Mobi Insulin Pump The Tandem Mobi mobile app allows you to program settings on your Tandem Mobi insulin pump, once your pump and smartphone have been paired. For more information on the pairing process, see Section 5.3 Pairing the Tandem Mobi Mobile App...
Page 91: About Bluetooth Technology
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App If the pump and smartphone become While in a disconnection state, when 4.17 About Bluetooth Technology disconnected during the Loading your smartphone and the pump are not Cartridge or Fill Tubing process, insulin...
Page 92: Reconnect Bluetooth Connection
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App If the connection is not restored ⚠ PRECAUTION within five minutes, reset the DO NOT ignore symptoms of high and low connection between your glucose. If your Tandem Mobi mobile app...
Page 93: Restart The Tandem Mobi Mobile App
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App continue delivering insulin as your smartphone. These notifications are only ⚠ PRECAUTION received when the Tandem Mobi mobile app is programmed when disconnected from DO NOT ignore symptoms of high and low either active or open in the background.
Page 94: Using The Tandem Mobi Mobile App Without The Pump
CHAPTER 4 • Getting to Know the Tandem Mobi Mobile App that your smartphone with the Tandem recognition, fingerprint, or pattern 4.22 Using the Tandem Mobi Mobile Mobi mobile app is out of range from recognition) is configured before using App Without the Pump the pump.
Page 95: Chapter 5 • Getting Started
Tandem Mobi System Features CHAPTER 5 Getting Started...
Page 96: Download The Tandem Mobi Mobile App
⚠ WARNING Smartphone Compatibility from the index. Tandem cloud. When you connect the Tandem DO NOT use the Tandem Mobi mobile app on a Mobi mobile app to your pump, you must Ensure your smartphone security smartphone that has been jailbroken, rooted, or...
Page 97 CHAPTER 5 • Getting Started You should allow all permission 4. Tap the circle at the bottom to requests from the Tandem Mobi mobile accept the Terms of Use and the app so that you receive all notifications Notices of Privacy Practices.
Page 98: Pairing The Tandem Mobi Mobile App With Your Pump
⚑ NOTE perform pairing in a controlled environment, Store, do not uninstall the app. When Always use the Tandem Mobi mobile app to pair such as your home or at your healthcare you download and install an update, your pump with your smartphone. Do not provider’s office.
Page 99 13. Tap Sync pump data. However, if you did not sign in to or create a 5. Pick up your pump and press the Tandem Source account, tap Go to Pump button two times. Make sure Dashboard.
Page 100: Unpairing The Tandem Mobi Mobile App From Your Pump
This allows you and your healthcare confirm that the Tandem Mobi mobile app is You will need to turn off the Bluetooth provider easy access to your data via compatible with the new operating system.
Page 101: Set Mobile Notifications
The Tandem Mobi mobile app displays 2. Tap Notifications. notifications generated by your pump or sent from the Tandem cloud, including 3. Locate and tap on the Tandem pump alerts, alarms, and reminders. Mobi mobile app. To turn on push notifications: 4.
Page 102: Enable And Set Snooze
1. From the Navigation bar, tap the Tandem Mobi Mobile App with Your Pump, Settings. or tap Help on the Tandem Mobi mobile app 5. Using the on-screen time picker, Settings screen, then tap Pump and App Guide. select the time (hour, minutes, and 2.
Page 103 When the Tandem Mobi mobile app time is changed, a vertical purple line will appear on the Dashboard graph. Additionally, at the base of the graph, an icon displays the direction that the pump clock was changed.
Page 104 CHAPTER 5 • Getting Started This Page is Intentionally Left Blank...
Page 105 Tandem Mobi System Features CHAPTER 6 Insulin Delivery Settings...
Page 106: Overview
4. Tap Max Bolus.  A Delivery Limits have been saved 6.1 Overview banner is displayed at the top of the Tandem Mobi™ mobile app. This section describes how to program the pump settings that affect insulin 6.3 Basal Rate Limit delivery.
Page 107: Personal Profiles Overview
Only your healthcare provider can 5. Using the on-screen keyboard, The Tandem Mobi pump uses the determine and help you adjust your basal enter a Basal Rate Limit amount settings in your active Personal Profile...
Page 108 When you are creating a you will receive less insulin than expected provides more flexibility for your body new Personal Profile, the Tandem Mobi in this scenario. and lifestyle. For example, you could mobile app prompts you to set up any have “Weekday”...
Page 109: Creating A New Personal Profile
CHAPTER 6 • Insulin Delivery Settings Below a carb ratio of 1:10, Consult your healthcare provider to for all bolus deliveries as well as for basal increments can be entered in 0.1 adjustments made by Control-IQ accurately set your Insulin Duration. gram.
Page 110: Programming A New Personal Profile
CHAPTER 6 • Insulin Delivery Settings 4. Tap Add New Profile. programmed. Consult your healthcare Time Segments provider to accurately set Personal ⚑ NOTE 5. Tap the Profile Name field, and Profile settings. The first time segment is always set to 12:00 using the on-screen keyboard, •...
Page 111 You may add up to 16 Time Segments  A Time Segment deleted banner is enter your Correction Factor and to any Personal Profile. To set up displayed at the top of the Tandem tap Done. additional Time Segments: Mobi mobile app.
Page 112 Bolus Settings. 6. Tap Save.  A Bolus Settings have been saved banner is displayed at the top of the Tandem Mobi mobile app. 7. Tap Personal Profiles in the upper left corner to return to the previous screen.
Page 113: Editing Or Reviewing An Existing Profile
3. Tap the start time of the Time enter the desired start time. Segment you wish to edit.  A Profile duplicated banner is displayed at the top of the Tandem 4. Tap Basal Rate, Correction Factor, Carb Ratio or Target BG to make Mobi mobile app.
Page 114: Activating An Existing Profile
 A new Personal Profile will be 3. Tap Activate. 5. A Profile renamed banner is created with the same settings as displayed at the top of the Tandem the duplicated Personal Profile. 4. Confirm profile to activate by Mobi mobile app.
Page 115: Starting A Temporary Basal Rate
 The Temp Rate started banner is can be set from a minimum of 0% of displayed at the top of the Tandem current basal rate to a maximum of 1. From the Navigation bar, tap Mobi mobile app.
Page 116: Stopping A Temp Rate
3. At the bottom of the Temp Rate screen, tap Stop. 4. Tap Yes.  The Temp Rate stopped banner is displayed at the top of the Tandem Mobi mobile app.  Tap Dashboard on the Navigation bar to view the Dashboard screen...
Page 117 Tandem Mobi System 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 most commonly used sites are set if you notice leaks around the site, or if you 7.1 Infusion Site Selection and suspect your infusion set cannula may have the abdomen, upper buttocks, hips, Care become dislodged.
Page 119 CHAPTER 7 • Infusion Site Care and Loading Cartridge symptoms of infection at your insulin infusion site. • The infusion set must be replaced Areas of Body for Infusion Set Insertion and rotated every 48 to 72 hours, or more often if needed. •...
Page 120: Cartridge Instructions For Use
This section describes how to fill the the Tandem Mobi mobile app. Failure to do so cartridge with insulin and load the may result in damage to the pump or possible ⚠...
Page 121 ⚑ NOTE cartridge. Air in the system takes space where The insulin amount displayed on the Tandem insulin should be and can affect insulin delivery. Mobi mobile app is the amount of insulin...
Page 122 CHAPTER 7 • Infusion Site Care and Loading Cartridge Prepare the Cartridge 2. Pull the fill rod down completely and 2. Push the fill rod down to force air then push it back up to force the air from the cartridge into the vial and 1.
Page 123 CHAPTER 7 • Infusion Site Care and Loading Cartridge 4. Slowly pull back the fill rod to the 5. Pull the vial out from the vial 2. Hold the cartridge set completely desired insulin volume. adapter. upright and tap so that any air bubbles rise to the top.
Page 124 New Cartridge counterclockwise to remove it from the cartridge. 1. Open the Tandem Mobi mobile app on your smartphone. 4. Dispose of used needles, cartridges, set components, and 2. Press the release tab and pull the...
Page 125: Filling Tubing
Always ensure that the  After completing the cartridge infusion set is disconnected from your body change, the Tandem Mobi mobile before changing the cartridge or filling the app will automatically prompt you to tubing. Failure to disconnect your infusion set fill the tubing.
Page 126 • Tap New if you loaded a new If the pump and smartphone become cartridge. disconnected, or if the Tandem Mobi mobile app is restarted during the Fill ⚠ PRECAUTION Tubing process, the following prompt CHECK your infusion set tubing daily for any will display.
Page 127 Release the Pump button. end of your tubing. b. Tap OK. b. Tap No if you do not see drops. 6. Tap Continue on the Tandem Mobi  The Filling Stopped screen is mobile app. c. Press and hold the Pump displayed.
Page 128: Filling Cannula
CHAPTER 7 • Infusion Site Care and Loading Cartridge  The Tandem Mobi mobile app The amount of insulin remaining amount. Filling stops at this returns to the Load Cartridge displayed on the Dashboard screen will amount. screen and the pump status lights...
Page 129: Setting Site Reminder
CHAPTER 7 • Infusion Site Care and Loading Cartridge  The Tandem Mobi mobile app will the number of days (1 to 3). Tap return to the Load Cartridge screen Done. if the Site Reminder is turned off.  The default for the Site Reminder is 5.
Page 130 CHAPTER 7 • Infusion Site Care and Loading Cartridge This Page is Intentionally Left Blank...
Page 131 Tandem Mobi System Features CHAPTER 8 Manual Bolus...
Page 132: Manual Bolus Overview
Control-IQ™ technology. For information on DO NOT deliver a bolus until you have reviewed bolus. automatic bolus delivery, see the Automatic the calculated bolus amount on the Tandem Correction Bolus Delivery section in Section If your smartphone becomes Mobi™ mobile app display. If you deliver an 28.2 How Control-IQ Technology...
Page 133: Initiating A Bolus
Dashboard screen, as well as your symptoms, food bolus and the correction bolus long as your pump and the Tandem Mobi mobile before using CGM values to calculate and will be added together. If IOB is app are connected.
Page 134 CHAPTER 8 • Manual Bolus bolus calculator when Control-IQ Bolus screen when each of the change the glucose value used to technology is on and there is a valid following conditions are true: calculate your correction dose, you can reading and trend arrow available from manually override the glucose value •...
Page 135 CHAPTER 8 • Manual Bolus displays information in the Delivery • To decline the correction bolus, tap bolus will automatically be added to any Calculation portion of the Bolus screen. the toggle above Delivery other bolus you request. A correction bolus will be added to any Calculation off.
Page 136: Bolus Override
BG value into the Tandem Mobi mobile insulin (or grams of carb) and the app manually. The Tandem Mobi 2.
Page 137: Food Bolus Using Units
CHAPTER 8 • Manual Bolus 2. Tap 0 units on the left side of the 8.7 Deliver a Bolus screen. Once you have entered in your glucose 3. Using the on-screen keyboard enter or BG value for a correction bolus, units of insulin to be delivered, then entered in your grams of carbohydrate tap Done.
Page 138: Extended Bolus
CHAPTER 8 • Manual Bolus 4. Use your smartphone security When extending a bolus, any correction 6. Tap the toggle next to Extend Food feature to authorize the bolus bolus amount will always be given in the Bolus. delivery. DELIVER NOW portion. Talk with your healthcare provider to determine if this 7.
Page 139 CHAPTER 8 • Manual Bolus The default for the Extended would like the entire bolus to be in 12. Confirm request. Duration field is 2 hours. the Deliver Later portion. Any amount entered between 0.00–0.05 • Tap Confirm in the upper units will automatically be rounded right-hand corner if entered data up to 0.05 units.
Page 140: Quick Bolus
1. From the Navigation bar, tap beep/vibration commands without Save. Settings. navigating through or viewing the Tandem Mobi mobile app screen. Your  A Quick Bolus Settings have been 2. Tap Pump. smartphone security feature is required saved banner is displayed at the top to change Quick Bolus settings.
Page 141: Canceling Or Stopping A Bolus
Tandem Mobi mobile app by pressing the Pump button on your pump to You cannot exceed the Max Bolus  The BOLUS IN PROGRESS deliver your bolus.
Page 142  Bolus will remain inactive while the Dashboard displays the “Requesting bolus is being canceled. Bolus” message. Your pump and the Tandem Mobi mobile app need to be  Once canceled, Bolus will become connected in order to cancel the bolus. active again.
Page 143 ⚠ WARNING If your smartphone disconnects from your pump when attempting to cancel or stop a bolus, a Bolus Not Stopped alert appears on the Tandem Mobi mobile app. Disconnect your infusion set from your body to immediately stop bolus delivery into your body.
Page 144 CHAPTER 8 • Manual Bolus This Page is Intentionally Left Blank...
Page 145 Tandem Mobi System Features CHAPTER 9 Starting, Stopping, or Resuming Insulin...
Page 146: Starting, Insulin Delivery
⚑ NOTE insulin delivery can take place while pump from your body, stop insulin A paired smartphone with the Tandem Mobi your pump is stopped. Your delivery. Stopping insulin delivery tells mobile app is required to start or stop insulin...
Page 147 Tandem Mobi System Features CHAPTER 10 Pump Information and History...
Page 148: Pump Information
Customer You must be logged into your Tandem account The Control-IQ history shows the on your Tandem Mobi mobile app and have the Technical Support contact information, historical log of the Control-IQ™ website, and software/hardware...
Page 149 Tandem Mobi System Features CHAPTER 11 Reminders...
Page 150: Low Bg Reminders
CHAPTER 11 • Reminders Your pump and Tandem Mobi™ mobile They repeat every 10 minutes until 5. Tap the toggle next to Low BG app let you know important information acknowledged. Reminders do not Reminder. about the system with reminders, escalate.
Page 151: High Bg Reminder
 A High BG Reminder saved banner hours. 3. Tap Pump Reminders. is displayed at the top of the Tandem Mobi mobile app. 1. From the Navigation bar, tap 4. Tap After Bolus BG. Settings. To Respond to the High BG Reminder 5.
Page 152: Missed Meal Bolus Reminder
 A Missed Meal Bolus Reminder 1 complete. (or 2, 3,4) saved banner is displayed 4. Tap Missed Meal Bolus. at the top of the Tandem Mobi  An After Bolus BG Reminder saved mobile app. banner is displayed at the top of the 5.
Page 153: Site Reminder
CHAPTER 11 • Reminders 5. Tap Save. If you do not hear or feel the confirmation, the bolus may be incomplete. The Tandem Mobi mobile app will display a notification. See Section 13.3 Incomplete Bolus Alert more information. 11.6 Site Reminder The Site Reminder prompts you to change your infusion set.
Page 154 CHAPTER 11 • Reminders This Page is Intentionally Left Blank...
Page 155 Tandem Mobi System Features CHAPTER 12 User Settable Alerts and Alarms...
Page 156: Low Insulin Alerts
The default for this alert is preset to  A Pump Alerts saved banner is and the pump will stop all insulin 20 units. You can set this alert setting displayed at the top of the Tandem deliveries. anywhere between 15 and 40 units. Mobi mobile app.
Page 157 Five minutes before the specified time you set up for the Auto-Off Alarm, a push notification will appear on the lock screen of your smartphone.You will only receive this notification if the Tandem Mobi mobile app is running on your...
Page 158: Max Basal Alert
Unlock your smartphone and open or  The Dashboard screen appears, To Respond to Max Basal Alert navigate to the Tandem Mobi mobile indicating a status of All Deliveries From the Notifications screen, swipe app. The Auto-Off Alarm timer will reset Stopped.
Page 159 Tandem Mobi System Features CHAPTER 13 Alerts...
Page 160 CHAPTER 13 • Alerts Your Tandem Mobi™ pump lets you If you are in the Tandem Mobi mobile Snooze, see Section 5.7 Enable and know important information about its app, you will see a red circle with the Snooze. performance with reminders, alerts, and number of notifications waiting for your ⚑...
Page 161: Low Insulin Alerts
CHAPTER 13 • Alerts 13.1 Low Insulin Alert Screen Explanation What will I see on the Tandem Mobi What does it mean? 10 units or less of insulin remain in the cartridge. mobile app screen? What sound setting will I hear or...
Page 162: Low Power Alerts
CHAPTER 13 • Alerts 13.2 Low Power Alerts Low Power Alert 1 Screen Explanation What will I see on the Tandem Mobi What does it mean? Less than 20% of battery power remains. mobile app screen? What sound setting will I hear or...
Page 163 CHAPTER 13 • Alerts Low Power Alert 2 Screen Explanation What will I see on the Tandem Mobi Less than 5% of battery power remains. Insulin delivery will mobile app screen? What does it mean? continue for 30 minutes and then the pump will power off and insulin delivery will stop.
Page 164: Incomplete Bolus Alert
What does it mean? mobile app screen? 90 seconds. What sound setting will I hear or Displays on the Tandem Mobi mobile app screen only, the pump will feel? not beep or vibrate. Will the Tandem Mobi mobile app The Tandem Mobi mobile app will re-notify you every 5 minutes until and pump re-notify me? the action is completed or cancelled.
Page 165: Incomplete Temp Rate Alert
What does it mean? mobile app screen? within 90 seconds. What sound setting will I hear or Displays on the Tandem Mobi mobile app screen only, the pump will feel? not beep or vibrate. Will the Tandem Mobi mobile app...
Page 166: Incomplete Load Sequence Alerts
3 minutes. What sound setting will I hear or Displays on the Tandem Mobi mobile app screen only, the pump will feel? not beep or vibrate. Will the Tandem Mobi mobile app...
Page 167 What does it mean? mobile app screen? complete the process within 3 minutes. What sound setting will I hear or Displays on the Tandem Mobi mobile app screen only, the pump will feel? not beep or vibrate. Will the Tandem Mobi mobile app...
Page 168 3 minutes. What sound setting will I hear or Displays on the Tandem Mobi mobile app screen only, the pump will feel? not beep or vibrate. Will the Tandem Mobi mobile app...
Page 169: Incomplete Setting Alert
5 minutes. What sound setting will I hear or Displays on the Tandem Mobi mobile app screen only, the pump will feel? not beep or vibrate. Will the Tandem Mobi mobile app...
Page 170: Basal Rate Required Alert
A basal rate must be entered in each time segment (rate can be 0 u/hr). What sound setting will I hear or Displays on the Tandem Mobi mobile app screen only, the pump will feel? not beep or vibrate. Will the Tandem Mobi mobile app No, a basal rate must be entered to save the time segment.
Page 171: Basal And Carb Ratio Required Alert
(rate can be 0 u/hr). What sound setting will I hear or Displays on the Tandem Mobi mobile app screen only, the pump will feel? not beep or vibrate.
Page 172: Max Hourly Bolus Alert
1.5 times your Max Bolus setting. What sound setting will I hear or Displays on the Tandem Mobi mobile app screen only, the pump will feel? not beep or vibrate. Will the Tandem Mobi mobile app No, you must tap No or Yes to deliver the bolus.
Page 173: Max Bolus Alert
What does it mean? mobile app screen? active Personal Profile. What sound setting will I hear or Displays on the Tandem Mobi mobile app screen only, the pump will feel? not beep or vibrate. Will the Tandem Mobi mobile app No, you must tap Cancel or Continue to deliver the bolus.
Page 174: Max Basal Alert
CHAPTER 13 • Alerts 13.11 Max Basal Alert Screen Explanation What will I see on the Tandem Mobi An active Temp Rate exceeds your Basal Rate Limit setting due to a mobile app screen? What does it mean? new timed segment activation within Personal Profiles. This alert will only display once your timed segment changes.
Page 175: Min Basal Alert
CHAPTER 13 • Alerts 13.12 Min Basal Alert Screen Explanation What will I see on the Tandem Mobi An active temp rate dropped below half of your lowest basal setting What does it mean? mobile app screen? defined in your Personal Profile.
Page 176: Pump Button Alert
CHAPTER 13 • Alerts 13.13 Pump Button Alert Screen Explanation What will I see on the Tandem Mobi The Pump button on your pump has been pressed too many times What does it mean? mobile app screen? during a Quick Bolus request.
Page 177: Quick Bolus Alert
CHAPTER 13 • Alerts 13.14 Quick Bolus Alert Screen Explanation What will I see on the Tandem Mobi A Quick Bolus has been requested three times, but has not been What does it mean? mobile app screen? delivered successfully. What sound setting will I hear or...
Page 178: Data Error Alert
CHAPTER 13 • Alerts 13.15 Data Error Alert Screen Explanation What will I see on the Tandem Mobi Your pump encountered a condition that could potentially result in a What does it mean? mobile app screen? loss of data. What sound setting will I hear or...
Page 179: Temperature Alert
CHAPTER 13 • Alerts 13.16 Temperature Alert Screen Explanation What will I see on the Tandem Mobi What does it mean? The internal temperature of your pump is too high or too low. mobile app screen? What sound setting will I hear or...
Page 180 CHAPTER 13 • Alerts This Page is Intentionally Left Blank...
Page 181: Chapter 14 • Alarms
Tandem Mobi System Features CHAPTER 14 Alarms...
Page 182 Your Tandem Mobi pump lets you a set period of time in the event that know important information about its If you are in the Tandem Mobi mobile you are unable to look at your Tandem performance with reminders, alerts, and app, you will see a red circle with the Mobi mobile app.
Page 183: Resume Insulin Alarms
14.1 Resume Insulin Alarms Resume Insulin Alarm 1 Screen Explanation What will I see on the Tandem Mobi You selected Stop Insulin from the Actions screen and insulin What does it mean? mobile app screen? delivery has been stopped for more than 15 minutes.
Page 184 CHAPTER 14 • Alarms Resume Insulin Alarm 2 Screen Explanation What will I see on the Tandem Mobi What does it mean? Insulin has been stopped by a separate alarm event. mobile app screen? What sound setting will I hear or...
Page 185: Low Power Alarm
CHAPTER 14 • Alarms 14.2 Low Power Alarm Screen Explanation What will I see on the Tandem Mobi Your pump detected a power level of 1% or less remaining and all What does it mean? mobile app screen? deliveries have stopped.
Page 186: Empty Cartridge Alarm
CHAPTER 14 • Alarms 14.3 Empty Cartridge Alarm Screen Explanation What will I see on the Tandem Mobi Your pump detected that the cartridge is empty and all deliveries What does it mean? mobile app screen? have stopped. What sound setting will I hear or...
Page 187: Cartridge Error Alarm
14.4 Cartridge Error Alarm Screen Explanation What will I see on the Tandem Mobi Your pump detected that the cartridge could not be used and all mobile app screen? deliveries have stopped. This can be caused by cartridge defect or What does it mean? not following the proper procedure to load the cartridge.
Page 188: Temperature Alarm - Pump
CHAPTER 14 • Alarms 14.5 Temperature Alarm – Pump Screen Explanation What will I see on the Tandem Mobi Your pump detected an internal temperature below -31ºF (-35ºC) or What does it mean? mobile app screen? above 176ºF (80ºC) and all deliveries have stopped.
Page 189: Occlusion Alarms
CHAPTER 14 • Alarms 14.6 Occlusion Alarms Occlusion Alarm 1 Screen Explanation What will I see on the Tandem Mobi Your pump detected that insulin delivery is blocked and all deliveries mobile app screen? have stopped. See Section 32.5 Pump Performance Characteristics...
Page 190 CHAPTER 14 • Alarms Occlusion Alarm 2 Screen Explanation What will I see on the Tandem Mobi Your pump detected a second occlusion alarm shortly after the first What does it mean? mobile app screen? occlusion alarm and all deliveries have stopped.
Page 191: Pump Button Alarm
CHAPTER 14 • Alarms 14.7 Pump Button Alarm Screen Explanation What will I see on the Tandem Mobi The Pump button on your pump is stuck or not functioning properly What does it mean? mobile app screen? and all deliveries have stopped.
Page 192: Pump & Iob Reset Alarm
You may have IOB that is not displayed if you recently delivered a What does it mean? bolus. DO NOT rely on the IOB displayed on your Tandem Mobi mobile app after a restart. Additionally, DO NOT rely on the Max Hourly Bolus Alert for 60 minutes following a pump restart.
Page 193 Tandem Mobi System Features CHAPTER 15 Malfunction...
Page 194: Malfunction
BG levels as recommended by your If your pump detects a critical error, the healthcare provider. Pump Malfunction screen appears on the Tandem Mobi™ mobile app and all deliveries are stopped. Contact Customer Technical Support. Malfunctions notify you with 3...
Page 195: Pump Malfunction
CHAPTER 15 • Malfunction 15.2 Pump Malfunction Screen Explanation What will I see on the Tandem Mobi Your pump detected a critical error and all deliveries have been mobile app screen? What does it mean? stopped. Use your backup insulin delivery method, or contact your healthcare provider for an alternate insulin delivery plan.
Page 196 CHAPTER 15 • Malfunction This Page is Intentionally Left Blank...
Page 197: Chapter 16 • Taking Care Of Your Pump
Tandem Mobi System Features CHAPTER 16 Taking Care of Your Pump...
Page 198: Taking Care Of Your Pump
CHAPTER 16 • Taking Care of Your Pump Inspecting Your Pump for Damage on the charging pad and then press 16.1 Taking Care of Your Pump and hold down the Pump button for 20 ⚠ PRECAUTION seconds. The pump will beep 3 times Cleaning Your Pump DO NOT use your pump if you think it might be before going into storage mode.
Page 199 CHAPTER 16 • Taking Care of Your Pump maintained in storage mode regardless of the pump battery charge state. Disposing of System Components Consult your healthcare provider and local regulations for instructions for disposal of devices containing electronic waste such as your pump, and for instructions for disposal of potentially biohazardous materials such as used cartridges, needles, syringes,...
Page 200 CHAPTER 16 • Taking Care of Your Pump This Page is Intentionally Left Blank...
Page 201 Tandem Mobi System Features CHAPTER 17 Lifestyles Issues and Travel...
Page 202: Lifestyles Issues And Travel For Your Pump
During exercise, the pump can be worn tubing from your infusion site, the pump pump for an extended period of time. in the provided case, the Tandem Mobi should continue to receive data from Your pump should not be worn in hot...
Page 203 CHAPTER 17 • Lifestyles Issues and Travel Extreme Altitudes There are other activities, such as provider in case you need to take bathing and intimacy, when it may be insulin by injection. ⚠ PRECAUTION more convenient for you to remove your •...
Page 204 Bluetooth technology. ⚑ NOTE The Tandem Mobi mobile app requires an active Bluetooth connection to connect with your pump. If you turn on Airplane mode, make sure...
Page 205 CGM Features CHAPTER 18 Important CGM Safety Information...
Page 206: Cgm Warnings
18.1 CGM Warnings Using a Dexcom CGM with Your that you wear your CGM. Types of obstruction Tandem Mobi Insulin Pump differ and have not been tested. If your CGM and Using a Dexcom CGM with Your pump are farther than 20 feet (6 meters) apart Tandem Mobi™...
Page 207: Potential Benefits From Using The Tandem Mobi Insulin Pump With Cgm
ID is entered into the Tandem Mobi or feel the vibration. help you to spot potential low or high mobile app. If the pump and transmitter are not BG sooner than you would using only a •...
Page 208 CHAPTER 18 • Important CGM Safety Information how it is measured in interstitial fluid, and glucose is absorbed into the interstitial fluid slower than it is absorbed into the blood, which can cause CGM readings to lag behind readings from a BG meter.
Page 209 CGM Features CHAPTER 19 CGM Overview...
Page 210: Cgm System Overview
Dexcom G7 mobile apps and instructions for using a CGM with your Dexcom CGM sensor, connecting and Tandem Mobi mobile app at the same Tandem Mobi™ system. Use of a CGM pairing to a CGM, and Dexcom product time. The Dexcom G6 and Dexcom G7 is optional, but in order to use specifications, visit the manufacturer’s...
Page 211: Dexcom G6 Transmitter Overview
19.4 Dexcom G6 Transmitter Dexcom G7 Sensor Overview If you are using the Dexcom G7 sensor, the Tandem Mobi mobile app will alert For information about the Dexcom G6 you at the following times: transmitter, visit the manufacturer’s 19.5 Sensor Overview website for applicable product •...
Page 212 CHAPTER 19 • CGM Overview This Page is Intentionally Left Blank...
Page 213 CGM Features CHAPTER 20 CGM Settings...
Page 214: About Bluetooth Technology
To transfer an existing sensor session type of wireless communication used in from a Dexcom receiver: cell phones and many other devices. 3. Pair your CGM to the Tandem Mobi Your Tandem Mobi™ system uses pump. 1. Turn off the Dexcom receiver.
Page 215 CHAPTER 20 • CGM Settings Beep • If the alert is not acknowledged in 5 The default profile when you receive more minutes, the pump vibrates your pump. This sets all alerts and and beeps again. This continues alarms to beep. every 5 minutes until acknowledged.
Page 216 CHAPTER 20 • CGM Settings Sound Option Descriptions CGM Volume Vibrate Beep HypoRepeat 2 long vibrates + 2 long vibrates + High Alert 2 long vibrates 2 beeps 2 beeps 3 short vibrates + 3 short vibrates + Low Alert 3 short vibrates 3 beeps 3 beeps...
Page 217: Cgm Info
5. Tap Beep, Vibrate, or HypoRepeat to select, and tap Done. 6. Tap Save.  Once a value is selected, the Tandem Mobi mobile app will return to the previous screen. 20.4 CGM Info CGM Info contains important information about your device. The following an be found in CGM Info: •...
Page 218 CHAPTER 20 • CGM Settings This Page is Intentionally Left Blank...
Page 219 CGM Features CHAPTER 21 Setting CGM Alerts...
Page 220: High And Low Glucose Alerts
This safety feature tells you a time for the High Alert to sound your sensor glucose level may be 1. From the Dashboard screen, tap again and display on your Tandem Settings. dangerously low. Mobi™ mobile app as long as your...
Page 221: Setting Your Low Glucose Alert And Repeat Feature
The repeat feature allows you to set a time for the Low Alert to sound 21.4 Rate Alerts again and display on your Tandem 21.3 Setting Your Low Glucose Alert and Repeat Feature Mobi mobile app as long as your...
Page 222: Setting Your Rise Alert
Done, then tap Save or beeps according to your CGM alert sound selection.  Once a value is saved, the Tandem  Once a value is saved, the Tandem Mobi mobile app will return to the Mobi mobile app will return to the previous screen.
Page 223: Setting Your Out Of Range Alert
CHAPTER 21 • Setting CGM Alerts The Out Of Range symbol appears on 6. Select the time after which you 21.7 Setting Your Out of Range the Dashboard screen (if turned on) want to be alerted. You may select Alert when the CGM and pump are not a value between 20 minutes and 3 communicating.
Page 224 CHAPTER 21 • Setting CGM Alerts This Page is Intentionally Left Blank...
Page 225 CGM Features CHAPTER 22 Starting or Stopping a CGM Sensor Session...
Page 226: Choosing Your Sensor Type
To switch from a Dexcom G7: to enter the unique transmitter ID into time. your Tandem Mobi™ mobile app. Once 1. From the Dashboard screen, tap To switch from a Dexcom G6 CGM: the transmitter ID has been entered, the Settings.
Page 227: Start The Dexcom G6 Sensor
ID was entered and after you re-pair your replacement prompted to enter a valid ID. 1. From the Dashboard screen, tap pump to the Tandem Mobi mobile app. Settings. 1. Remove the transmitter from its 7. Using the on-screen keyboard, packaging.
Page 228 ID is  The Sensor session started banner entered. is displayed at the top of the Tandem Mobi mobile app to let you c. If the correct transmitter ID is know your sensor startup has entered and the pump and begun.
Page 229: Dexcom G6 Sensor Startup Period
CHAPTER 22 • Starting or Stopping a CGM Sensor Session Sensor Startup Period Timeline ⚠ WARNING 22.4 Dexcom G6 Sensor Startup Continue to use a BG meter and test strips in Period order to make treatment decisions during the 2-hour startup period. Start The Dexcom G6 sensor needs a 2-hour startup period to adjust to being under...
Page 230: Dexcom G6 Automatic Sensor Shut-Off
New sensor glucose readings do not calibration into the pump at any time, New sensor glucose readings do not show on your Tandem Mobi mobile app even if you have already entered sensor show on your Tandem Mobi mobile app after your sensor session ends.
Page 231: Removing The Dexcom G6 Sensor And Transmitter
 The Sensor Session Stopped 22.8 Start the Dexcom G7 Sensor banner is displayed at the top of the Tandem Mobi mobile app. The following information is specific to the Dexcom G7 sensor. For information  The Replace Sensor icon will...
Page 232: Dexcom G7 Sensor Startup Period
CHAPTER 22 • Starting or Stopping a CGM Sensor Session 5. Tap the Verify Pairing Code field to b. If the pump and CGM are still enter the 4-digit pairing code again. not communicating, contact Customer Technical Support. 6. Tap Done. ...
Page 233: Dexcom G7 Automatic Sensor Shut-Off
CGM reading. 15 min 8–15 Minutes 22.10 Dexcom G7 Automatic Sensor Shut-Off Your Tandem Mobi mobile app tells you 7 min 0–7 Minutes how much time you have left until your sensor session is complete. The CGM...
Page 234: Ending A Dexcom G7 Sensor Session Before Automatic Shut-Off
Control-IQ technology, it each reminder. During the grace period, place where sensor glucose becomes inactive when a CGM sensor the Tandem Mobi mobile app tells you readings normally show. session is ended. You must remove when there are 2 hours remaining, and...
Page 235: Removing The Dexcom G7 Sensor
CHAPTER 22 • Starting or Stopping a CGM Sensor Session place where sensor glucose readings normally show. 22.12 Removing the Dexcom G7 Sensor ⚠ WARNING DO NOT ignore broken or detached sensor wires. A sensor wire could remain under your skin.
Page 236 CHAPTER 22 • Starting or Stopping a CGM Sensor Session This Page is Intentionally Left Blank...
Page 237 CGM Features CHAPTER 23 Calibrating Your Dexcom CGM System...
Page 238: Calibration Overview
The pump and G7 CGM and can be performed if you reading shows in the upper left Tandem Mobi mobile app will remind have symptoms that do not align with portion of the Dashboard screen you when these calibrations are your posted CGM values.
Page 239: Startup Calibration
 A banner is displayed at the top of meter. Blood from other places may be less The instructions in this section do not apply if the Tandem Mobi mobile app to accurate and not as timely. you entered the sensor code when you started confirm the calibration entry.
Page 240: Calibration Bg Value And Correction Bolus
If you enter your Target BG as a calibration value, the Tandem Mobi mobile app will return to the Your Tandem Mobi pump uses the BG Dexcom G6 or Dexcom G7 screen. value entered into the Tandem Mobi mobile app for calibration to determine if a correction bolus is needed, or to 23.4 Reasons You May Need to...
Page 241 CGM Features CHAPTER 24 Viewing CGM Data on Your Tandem Mobi Mobile App...
Page 242: Overview
CHAPTER 24 • Viewing CGM Data on Your Tandem Mobi Mobile App Your BG meter measures glucose in If your sensor glucose reading is above 24.1 Overview your blood. Your sensor measures your High glucose threshold setting, it is glucose from interstitial fluid (the fluid shown in orange.
Page 243: Rate Of Change Arrows
CHAPTER 24 • Viewing CGM Data on Your Tandem Mobi Mobile App HIGH shows when your most recent during the last 15 to 20 minutes due to sensor glucose reading is greater than being out of range or due to an error 400 mg/dL.
Page 244 CHAPTER 24 • Viewing CGM Data on Your Tandem Mobi Mobile App The table below shows the different trend arrows your Tandem Mobi mobile app displays: Trend Arrow Definitions Constant: Your sensor glucose is steady (not Slowly falling: Your sensor glucose is falling 1–2 mg/dL increasing/decreasing more than 1 mg/dL each minute).
Page 245: Cgm History
CHAPTER 24 • Viewing CGM Data on Your Tandem Mobi Mobile App the time it was declared. The letter “C” attempt to backfill missing data points 24.4 CGM History (C: Alert) indicates the time it was in the Tandem Mobi mobile app up to 3 cleared.
Page 246 CHAPTER 24 • Viewing CGM Data on Your Tandem Mobi Mobile App This Page is Intentionally Left Blank...
Page 247 CGM Features CHAPTER 25 CGM Alerts and Errors...
Page 248 Notifications area of the Navigation bar. You must customize the CGM alert settings on and errors. It applies only to the CGM the Tandem Mobi mobile app and the Dexcom Enabling the Snooze function allows portion of your system. CGM alerts and G6 CGM app separately.
Page 249: Startup Calibration Alerts - Dexcom G6 Only
CHAPTER 25 • CGM Alerts and Errors 25.1 Startup Calibration Alert – Dexcom G6 Only Screen Explanation What will I see on the Tandem Mobi 2-hour CGM startup period is complete. This will only appear if you What does it mean? mobile app screen? did not enter a sensor code.
Page 250: Second Startup Calibration Alert - Dexcom G6 Only
CHAPTER 25 • CGM Alerts and Errors 25.2 Second Startup Calibration Alert – Dexcom G6 Only Screen Explanation What will I see on the Tandem Mobi The CGM needs an additional BG value to complete startup What does it mean? mobile app screen? calibration.
Page 251: Hour Calibration Alert - Dexcom G6 Only
25.3 12 Hour Calibration Alert – Dexcom G6 Only Screen Explanation What will I see on the Tandem Mobi The CGM needs a BG value to calibrate. This will only appear if you What does it mean? mobile app screen? did not enter a sensor code.
Page 252: Incomplete Calibration
90 seconds, this screen appears. What sound setting will I hear or Displays on the Tandem Mobi mobile app screen only, the pump will feel? not beep or vibrate. Will the Tandem Mobi mobile app...
Page 253: Calibration Timeout
5 minutes, this screen appears. What sound setting will I hear or Displays on the Tandem Mobi mobile app screen only, the pump will feel? not beep or vibrate. Will the Tandem Mobi mobile app...
Page 254: Calibration Error Alert - Dexcom G6 Only
CHAPTER 25 • CGM Alerts and Errors 25.6 Calibration Error Alert – Dexcom G6 Only Screen Explanation What will I see on the Tandem Mobi The CGM cannot calibrate using the last BG meter value you What does it mean? mobile app screen? entered.
Page 255: Calibration Required Alert - Dexcom G6 Only
CHAPTER 25 • CGM Alerts and Errors 25.7 Calibration Required Alert – Dexcom G6 Only Screen Explanation What will I see on the Tandem Mobi The CGM needs a BG value to calibrate. Sensor glucose readings What does it mean? mobile app screen? will not be displayed at this time.
Page 256: Cgm High Alert
CHAPTER 25 • CGM Alerts and Errors 25.8 CGM High Alert Screen Explanation What will I see on the Tandem Mobi Your most recent sensor glucose reading is at or above the High What does it mean? mobile app screen? Alert setting.
Page 257: Cgm Low Alert
CHAPTER 25 • CGM Alerts and Errors 25.9 CGM Low Alert Screen Explanation What will I see on the Tandem Mobi Your most recent sensor glucose reading is at or below the Low What does it mean? mobile app screen? Alert setting.
Page 258: Cgm Fixed Low Alert
CHAPTER 25 • CGM Alerts and Errors 25.10 CGM Fixed Low Alert Screen Explanation What will I see on the Tandem Mobi What does it mean? Your most recent sensor glucose reading is at or below 55 mg/dL. mobile app screen? What sound setting will I hear or 4 long vibrations.
Page 259: Cgm Rise Alert
CHAPTER 25 • CGM Alerts and Errors 25.11 CGM Rise Alert Screen Explanation What will I see on the Tandem Mobi Your sensor glucose levels are rising at 2 mg/dL per minute or faster What does it mean? mobile app screen? (at least 30 mg/dL in 15 minutes).
Page 260: Cgm Rapid Rise Alert
CHAPTER 25 • CGM Alerts and Errors 25.12 CGM Rapid Rise Alert Screen Explanation What will I see on the Tandem Mobi Your sensor glucose levels are rising at 3 mg/dL per minute or faster What does it mean? mobile app screen? (at least 45 mg/dL in 15 minutes).
Page 261: Cgm Fall Alert
CHAPTER 25 • CGM Alerts and Errors 25.13 CGM Fall Alert Screen Explanation What will I see on the Tandem Mobi Your sensor glucose levels are falling at 2 mg/dL per minute or What does it mean? mobile app screen? faster (at least 30 mg/dL in 15 minutes).
Page 262: Cgm Rapid Fall Alert
CHAPTER 25 • CGM Alerts and Errors 25.14 CGM Rapid Fall Alert Screen Explanation What will I see on the Tandem Mobi Your sensor glucose levels are falling at 3 mg/dL per minute or What does it mean? mobile app screen? faster (at least 45 mg/dL in 15 minutes).
Page 263: Unknown Sensor Glucose Reading
The sensor is sending sensor glucose readings that the system does mobile app screen? What does it mean? not understand, or the pump and the Tandem Mobi mobile app are disconnected. You will not receive sensor glucose readings. What sound setting will I hear or...
Page 264: Out Of Range Alert
What will I see on the Tandem Mobi The CGM and pump are not communicating. The pump will not mobile app screen? receive sensor glucose readings, the Tandem Mobi mobile app will What does it mean? not display the sensor glucose readings, and Control-IQ technology is not able to predict sensor glucose levels or adjust insulin delivery.
Page 265: Low Transmitter Battery Alert - Dexcom G6 Only
CHAPTER 25 • CGM Alerts and Errors 25.17 Low Transmitter Battery Alert – Dexcom G6 Only Screen Explanation What will I see on the Tandem Mobi What does it mean? Transmitter battery is low. mobile app screen? What sound setting will I hear or 1 long vibration.
Page 266: Transmitter Expired Alert - Dexcom G6 Only
CHAPTER 25 • CGM Alerts and Errors 25.18 Transmitter Expired Alert – Dexcom G6 Only Screen Explanation What will I see on the Tandem Mobi What does it mean? Transmitter battery has expired. mobile app screen? What sound setting will I hear or 1 long vibration.
Page 267: Transmitter Error - Dexcom G6 Only
CHAPTER 25 • CGM Alerts and Errors 25.19 Transmitter Error – Dexcom G6 Only Screen Explanation What will I see on the Tandem Mobi What does it mean? The transmitter has failed and the CGM session has stopped. mobile app screen? What sound setting will I hear or 1 sequence of 1 long vibration.
Page 268: Failed Sensor Error
CHAPTER 25 • CGM Alerts and Errors 25.20 Failed Sensor Error Screen Explanation What will I see on the Tandem Mobi The sensor is not working properly and the CGM session has What does it mean? mobile app screen? stopped.
Page 269: Failed/Incompatible Sensor Alert - Dexcom G7 Only
CHAPTER 25 • CGM Alerts and Errors 25.21 Failed/Incompatible Sensor Alert – Dexcom G7 Only Screen Explanation What will I see on the Tandem Mobi The Dexcom G7 CGM you are attempting to pair is not compatible What does it mean? mobile app screen? with your pump.
Page 270: Invalid Pairing Code - Dexcom G7 Only
CHAPTER 25 • CGM Alerts and Errors 25.22 Invalid Pairing Code – Dexcom G7 Only Screen Explanation What will I see on the Tandem Mobi Your Dexcom G7 CGM is unable to pair with the Mobi pump for one mobile app screen? of the following reasons: »...
Page 271: Unable To Pair - Dexcom G7 Only
CHAPTER 25 • CGM Alerts and Errors 25.23 Unable to Pair – Dexcom G7 Only Screen Explanation What will I see on the Tandem Mobi Your Dexcom G7 CGM has attempted to pair too many times while What does it mean? mobile app screen? in an area with too many Dexcom G7 sensors.
Page 272: Cgm Error - Dexcom G7 Only
CHAPTER 25 • CGM Alerts and Errors 25.24 CGM Error – Dexcom G7 Only Screen Explanation What will I see on the Tandem Mobi Your Dexcom G7 CGM sensor is not working properly. The CGM What does it mean? mobile app screen? session has stopped and the CGM can no longer be used.
Page 273: Cgm Unavailable
CHAPTER 25 • CGM Alerts and Errors 25.25 CGM Unavailable Screen Explanation What will I see on the Tandem Mobi Your CGM session is still active, but the pump is receiving invalid What does it mean? mobile app screen? CGM readings.
Page 274: Cgm Error
CHAPTER 25 • CGM Alerts and Errors 25.26 CGM Error Screen Explanation What will I see on the Tandem Mobi What does it mean? The pump Bluetooth hardware mobile app screen? What sound setting will I hear or 1 vibration, then vibration/beep every 5 minutes.
Page 275 CGM Features CHAPTER 26 CGM Troubleshooting...
Page 276: Cgm Pairing Troubleshooting
Difficulty pairing your Dexcom CGM Range symbol in the place where your use a BG value for calibration when this with your Tandem Mobi™ insulin pump. sensor glucose readings are normally symbol is on your Dashboard screen. shown on the Dashboard screen.
Page 277: Out Of Range/No Antenna Troubleshooting
CGM is in range. If you go show on your Dashboard. Each time out of range during insulin adjustment, your you start a new sensor session, wait 10 basal insulin delivery will revert to the basal rate minutes for your Tandem Mobi pump to...
Page 278: Failed Sensor Troubleshooting
Failed Sensor Inaccuracies are usually related to your for sensor readings <80 mg/dL, alert displays on your Tandem Mobi sensor only and not to your CGM or recalibrate your sensor using the mobile app. If you see this alert, it pump.
Page 279 CHAPTER 26 • CGM Troubleshooting • Use only BG values between 20 to 600 mg/dL for calibration. If one or more of your values is outside of this range, the pump will not calibrate. • Use the same BG meter you routinely use to measure your BG to calibrate.
Page 280 CHAPTER 26 • CGM Troubleshooting This Page is Intentionally Left Blank...
Page 281: Section 4: Control-Iq Technology Features
Control-IQ Technology Features CHAPTER 27 Important Control-IQ Technology Safety Information...
Page 282: Responsible Use Of Control-Iq Technology
⚠ WARNING Systems like the Tandem Mobi™ insulin ⚠ WARNING The Tandem Mobi insulin pump with Control-IQ pump with Control-IQ technology are Control-IQ technology has not been evaluated in not substitutes for the active technology should not be used in children under pregnant women or persons on dialysis.
Page 283: Control-Iq Technology Precautions
CHAPTER 27 • Important Control-IQ Technology Safety Information sensor readings that are higher than actual technology requires to make predictions to ⚠ WARNING glucose levels, it could result in missed automate insulin delivery. If a sensor session is ended, either automatically hypoglycemia alerts and errors in diabetes or manually, Control-IQ technology is management, such as delivery of excess basal...
Page 284 CHAPTER 27 • Important Control-IQ Technology Safety Information This Page is Intentionally Left Blank...
Page 285 Control-IQ Technology Features CHAPTER 28 Introduction to Control-IQ Technology...
Page 286: Control-Iq Technology Overview
Control-IQ™ technology is a feature of active in the body, is not displayed when Do not use Control-IQ technology unless the Tandem Mobi™ pump that Control-IQ technology is on due to the variability recommended by your healthcare provider. automatically adjusts insulin dosing in of insulin delivery when automatically response to readings from a CGM.
Page 287 CHAPTER 28 • Introduction to Control-IQ Technology predicts CGM values 30 minutes in the Personal Profile settings. These or below a preset treatment value future. Insulin delivery is automatically different insulin delivery actions are (112.5 mg/dL) 30 minutes in the future, adjusted based on the predicted CGM described below.
Page 288 CHAPTER 28 • Introduction to Control-IQ Technology Current 30-minute Reading Prediction 112.5 112.5 CGM SENSOR READINGS CGM SENSOR READINGS INSULIN DELIVERY INSULIN DELIVERY 5-minute Interval CGM Prediction Personal Profile Basal Rate Control-IQ Decreased Basal Rate ⚑ NOTE Diagrams are for illustrative purposes only and are not intended to reflect actual results.
Page 289 CHAPTER 28 • 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 (70 mg/dL) 30 minutes in the future, insulin delivery will...
Page 290 CHAPTER 28 • 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 291 CHAPTER 28 • 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 (160 mg/dL) 30 minutes in the future, the rate of insulin delivery will start increasing to attempt to keep the actual CGM values within the target CGM range.
Page 292 CHAPTER 28 • 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 293 CGM value will be at or above delivery in the same way that a manual bolus delivery has started. The following Tandem Mobi a preset treatment value (180 mg/dL) can be stopped. See Section 8.10 Canceling or...
Page 294 CHAPTER 28 • Introduction to Control-IQ Technology Current 30-minute Reading Prediction 5-minute Interval CGM Prediction Personal Profile Basal Rate CGM SENSOR READINGS Control-IQ Increased Basal Rate Control-IQ Max Basal Rate Automatic Correction Bolus INSULIN DELIVERY ⚑ NOTE Diagrams are for illustrative purposes only and are not intended to reflect actual results.
Page 295: Control-Iq Technology Actions
CHAPTER 28 • Introduction to Control-IQ Technology Suspended Insulin Without Sleep or Manually Start Sleep section for 28.3 Control-IQ Technology Actions Exercise starting Sleep manually in that chapter. Insulin is set to 0 units/hour when The CGM range targeted by Control-IQ When Control-IQ technology is turned Control-IQ technology predicts a CGM technology during Sleep is 112.5...
Page 296 CHAPTER 28 • Introduction to Control-IQ Technology Automatic Correction Bolus During Suspended Insulin During Exercise Sleep Insulin is set to 0 units/hour when Automatic correction boluses will not Control-IQ technology predicts a CGM be delivered while Sleep is on. reading ≤80 mg/dL 30 minutes in the future.
Page 297 CHAPTER 28 • Introduction to Control-IQ Technology &RQWURO 4 6OHHS ([HUFLVH 'HOLYHUV DQ DXWRPDWLF FRUUHFWLRQ EROXV LI 'HOLYHUV JOXFRVH LV SUHGLFWHG WR EH DERYH PJG/ QFUHDVHV EDVDO LQVXOLQ GHOLYHU\ LI JOXFRVH QFUHDVHV LV SUHGLFWHG WR EH DERYH PJG/ 0DLQWDLQV ZKHQ JOXFRVH LV EHWZHHQ...
Page 298 CHAPTER 28 • Introduction to Control-IQ Technology This Page is Intentionally Left Blank...
Page 299 Control-IQ Technology Features CHAPTER 29 Configuring and Using Control-IQ Technology...
Page 300: Required Settings
CHAPTER 29 • Configuring and Using Control-IQ Technology Recommended Control-IQ 4. To turn Control-IQ technology on, 29.1 Required Settings Technology Pump Settings tap the toggle next to Control-IQ. Although Sleep can be started and Required Personal Profile Settings stopped manually, it is recommended In order to use Control-IQ™...
Page 301: Turn Control-Iq Technology Off
55 pounds to a maximum of 308  A Control-IQ saved banner is Total Daily Insulin value is used by pounds. displayed at the top of the Tandem Control-IQ technology to calculate the Mobi™ mobile app. maximum insulin delivery rate and to 4.
Page 302 CHAPTER 29 • Configuring and Using Control-IQ Technology turned on and off manually. This section 1. From the Navigation bar, tap 5. Tap Start Time. covers how to set Sleep to turn on and Actions. off automatically. For detailed 6. Using the on-screen time picker, information about how to use 2.
Page 303: Start Or Stop A Sleep Schedule
Section 29.4 Schedule Sleep.)  A Sleep Schedule saved banner is displayed at the top of the Tandem 4. Tap the toggle next to the Sleep Mobi mobile app. Schedule title. 13. When you are done setting up the 5.
Page 304: Manually Start Or Stop Sleep
CGM session must be active to start Sleep. Manually Start Sleep 1. From the Navigation bar, tap Actions.  A Sleep started banner is displayed at the top of the Tandem Mobi mobile app. The Sleep icon is displayed on the Dashboard...
Page 305: Manually Stop Or Start Exercise
Dashboard screen. This icon uses different colors to  An Exercise started banner is communicate information about how displayed at the top of the Tandem Control-IQ technology is operating. Mobi mobile app. The Exercise icon Each different color and its meaning...
Page 306 CHAPTER 29 • Configuring and Using Control-IQ Technology Exercise and Sleep Icons meaning can be found in Section 4.1 Explanation of Icons. When Exercise or Sleep is turned on, The following image highlights where an icon is displayed near the top of the the basal status icons display at the top Dashboard screen, directly under the of and under the CGM reading on the...
Page 307 CHAPTER 29 • Configuring and Using Control-IQ Technology The Current Status area of the Dashboard also indicates that there is an automatic correction bolus delivered by Control-IQ technology. The text Bolus in Progress, with Control-IQ listed below is displayed. The amount of the bolus is also displayed.
Page 308 CHAPTER 29 • Configuring and Using Control-IQ Technology This Page is Intentionally Left Blank...
Page 309 Control-IQ Technology Features CHAPTER 30 Control-IQ Technology Alerts...
Page 310 It applies a set period of time in the event that only to the Control-IQ technology within you are unable to look at your Tandem your pump. The Control-IQ technology Mobi mobile app. To enable and set up...
Page 311: Out Of Range Alerts - Control-Iq Technology Off
What will I see on the Tandem Mobi The CGM and pump are not communicating. The pump will not mobile app screen? receive sensor glucose readings, the Tandem Mobi mobile app will What does it mean? not display the sensor glucose readings, and Control-IQ technology is not able to predict sensor glucose levels or adjust insulin delivery.
Page 312: Out Of Range Alert - Control-Iq Technology On
Control-IQ technology is turned on, but the CGM and pump are not mobile app screen? communicating. The pump will not receive sensor glucose readings, and the Tandem Mobi mobile app will not display the sensor glucose readings. Control-IQ technology will continue to adjust basal rates What does it mean? and deliver automatic correction boluses for the first 20 minutes that the CGM and pump are out of range.
Page 313 CHAPTER 30 • Control-IQ Technology Alerts ⚠ WARNING Control-IQ technology can only adjust insulin delivery when your CGM is in range. If you go out of range during insulin adjustment, your basal insulin delivery will revert to the basal rate settings in your active Personal Profile, limited to 3 units/hr. In order to receive more than 3 units/hour while the sensor is not communicating with the pump, turn Control-IQ technology off.
Page 314: Control-Iq Technology Low Alert
CHAPTER 30 • Control-IQ Technology Alerts 30.3 Control-IQ Technology Low Alert Screen Explanation What will I see on the Tandem Mobi Control-IQ Low Alert has predicted that your sensor glucose reading mobile app screen? What does it mean? will drop below 70 mg/dL, or below 80 mg/dL if Exercise is on, in the next 15 minutes.
Page 315: Control-Iq High Alert
CHAPTER 30 • Control-IQ Technology Alerts 30.4 Control-IQ High Alert Screen Explanation What will I see on the Tandem Mobi Control-IQ technology has three hours of CGM data and has mobile app screen? increased insulin delivery, but detects a sensor glucose reading...
Page 316: Max Insulin Alert
CHAPTER 30 • Control-IQ Technology Alerts 30.5 Max Insulin Alert Screen Explanation What will I see on the Tandem Mobi The pump has delivered the maximum allowable 2 hour insulin mobile app screen? amount based on your Total Daily Insulin setting. You see this alert...
Page 317: Chapter 31 • Control-Iq Technology Clinical Study Overview
Control-IQ Technology Features CHAPTER 31 Control-IQ Technology Clinical Study Overview...
Page 318: Clinical Study Overview
CHAPTER 31 • Control-IQ Technology Clinical Study Overview protocols were very similar. In the of type 1 diabetes, but they were 31.1 Introduction DCLP3, participants (N=168) were younger; 6 to 13 years of age. They randomly assigned to use Control-IQ or were treated with insulin via an insulin The following data represents the SAP for the study in a 2:1 ratio.
Page 319 CHAPTER 31 • Control-IQ Technology Clinical Study Overview • Any skin condition in the area of randomized into the study. Eighty-three insertion that prevents safe sensor (83) participants in the DCLP3 and 68 or pump placement (e.g. bad participants in the DCLP5 declined the sunburn, pre-existing dermatitis, training, while 85 participants in the intertrigo, psoriasis, extensive...
Page 320: Demographics
CHAPTER 31 • Control-IQ Technology Clinical Study Overview 31.3 Demographics Baseline characteristics including demographics of the study participants are provided in the table below. Results of all subgroup analyses indicate that the Control-IQ technology treatment effect is similar across the distribution of age, race and income. There is no evidence to suggest that baseline demographics are associated with more or less benefit or risk from the use of the t:slim X2 insulin pump with Control-IQ technology.
Page 321 CHAPTER 31 • Control-IQ Technology Clinical Study Overview DCLP3: Baseline Characteristics including Demographics at Enrollment (N=168) (Continued) Characteristic Control-IQ (n=112) SAP (n=56) † Income <$50,000 10 (11%) 2 (4%) $50,000 – <$100,000 24 (27%) 18 (36%) ≥$100,000 55 (62%) 30 (60%) ‡...
Page 322 CHAPTER 31 • Control-IQ Technology Clinical Study Overview DCLP5: Baseline Characteristics including Demographics at Enrollment (N=101) Characteristic Control-IQ (n=78*) SAP (n=23*) Age (years) 6 – 9 21 (27%) 8 (35%) 10 – 13 57 (73%) 15 (65%) Median (IQR) 11 (9, 12) 10 (8, 13) Range 6 to 13...
Page 323 CHAPTER 31 • Control-IQ Technology Clinical Study Overview DCLP5: Baseline Characteristics including Demographics at Enrollment (N=101) (Continued) Characteristic Control-IQ (n=78*) SAP (n=23*) $75,000 – <$100,000 13 (18%) 4 (19%) $100,000 – <$200,000 27 (36%) 8 (38%) ≥$200,000 26 (35%) 7 (33%) Parent Education ≤High School Diploma 2 (3%)
Page 324: Adverse Effects
CHAPTER 31 • Control-IQ Technology Clinical Study Overview 31.4 Adverse Effects The following tables provide a full list of adverse events that occurred during the main part of the study for both DCLP3 and DCLP5 study groups. DCLP3: Types of Adverse Events by Treatment Group (N=168) Number of Events Control-IQ (n=112) SAP (n=56)
Page 325 CHAPTER 31 • Control-IQ Technology Clinical Study Overview DCLP5: Types of Adverse Events by Treatment Group (N=101) Number of Events Control-IQ (n=78) SAP (n=23) Total Number of Adverse Events Adverse Events Related to Study Device Ketosis (Infusion Site Failure) Abscess at Sensor Site (CGM Sensor) Hyperglycemia (Defective Cartridge) Adverse Effects Not Related to a Study Device Hypoglycemia (User Error)
Page 326 CHAPTER 31 • Control-IQ Technology Clinical Study Overview The following tables provide a list of only hyperglycemia or ketosis events during the study for both DCLP3 and DCLP5 study groups. These tables also include the cause of these events. DCLP3: Hyperglycemia/Ketosis Events by Treatment Group (N=168) Number of Events Control-IQ (n=112) SAP (n=56)
Page 327 CHAPTER 31 • Control-IQ Technology Clinical Study Overview DCLP5: Hyperglycemia/Ketosis Events by Treatment Group (N=101) Number of Events Control-IQ (n=78) SAP (n=23) Ketosis (Infusion Site Failure) Hyperglycemia (Defective Cartridge) Ketosis (User Error)* Ketosis (Gastroenteritis) † Hyperglycemia (User Error) *Improper cartridge fill †...
Page 328: Intervention Compliance
CHAPTER 31 • Control-IQ Technology Clinical Study Overview 31.5 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, BG meters, and infusion sets were used during the studies, respectively. The analysis for Control-IQ technology use is specific to the Control-IQ technology group, while the analysis for CGM and BG meter use represents both the Control-IQ technology group and the SAP group.
Page 329 CHAPTER 31 • Control-IQ Technology Clinical Study Overview 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% Overall 92.8% *Control-IQ Available is calculated as the percent of time when Control-IQ technology was available and operating normally during the 4-month study period.
Page 330 CHAPTER 31 • Control-IQ Technology Clinical Study Overview 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 331 CHAPTER 31 • Control-IQ Technology Clinical Study Overview The duration of infusion set used in both the DCLP3 and the DCLP5 was estimated by reviewing the number of times a t:slim X2 study pump was used to prime tubing. In the DCLP3 study, the average duration of infusion set use was 2.8 days in the SAP group and 3.1 days in the Control-IQ technology group.
Page 332: Primary Analysis
CHAPTER 31 • Control-IQ Technology Clinical Study Overview 31.6 Primary Analysis The primary outcome of both the DCLP3 and DCLP5 studies was to compare the CGM sensor values in range between 70–180 mg/dL between the Control-IQ technology group and the SAP group. The data represents the overall system performance 24-hours per day.
Page 333 CHAPTER 31 • Control-IQ Technology Clinical Study Overview 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 162 mg/dL 179 mg/dL -17 mg/dL (std dev) (18 mg/dL) (26 mg/dL) Average % 70–180 mg/dL +11%...
Page 334 CHAPTER 31 • Control-IQ Technology Clinical Study Overview The tables below describes the average time participants in both the Control-IQ technology group and the SAP group spent with sensor glucose levels between 70–180 mg/dL by month at baseline and during the study period. DCLP3: Percentage of Time in Range per Study Arm by Month (N=168) Study Arm Control Arm...
Page 335: Secondary Analysis
CHAPTER 31 • Control-IQ Technology Clinical Study Overview 31.7 Secondary Analysis The following tables compare the percent of time that participants spent at the indicated sensor glucose levels during the daytime (6 AM up to and including midnight/6:00 up to and including 24:00) and nighttime (midnight up to and including 6 AM/24:00 up to and including 6:00).
Page 336 CHAPTER 31 • Control-IQ Technology Clinical Study Overview The following table compares the percent of time spent between 70–180 mg/dL across the different baseline HbA1c values observed in the Control-IQ group and the SAP group. Percentage of Time in Range per Study Arm by Baseline HbA1c (N=168) Time in Range Baseline HbA1c Control-IQ...
Page 337 CHAPTER 31 • Control-IQ Technology Clinical Study Overview The following tables compare the change in HbA1c values for both DCLP3 and DCLP5 participants over the course of their respective studies. DCLP3: Change in HbA1c Values from Randomization to 26 Weeks (N=168) Number of Subjects (% of Subjects) with Change in HbA1c Decrease Decrease...
Page 338 CHAPTER 31 • Control-IQ Technology Clinical Study Overview DCLP3: Change in HbA1c Values from Randomization to 26 Weeks (N=168) (Continued) Number of Subjects (% of Subjects) with Change in HbA1c Treatment 100% HbA1c ≥ 10% Control Treatment <1% Overall Control DCLP5: Change in HbA1c Values from Randomization to 16 Weeks (N=101) Number of Subjects (% of Subjects) with Change in HbA1c Decrease...
Page 339 CHAPTER 31 • Control-IQ Technology Clinical Study Overview DCLP5: Change in HbA1c Values from Randomization to 16 Weeks (N=101) (Continued) Number of Subjects (% of Subjects) with Change in HbA1c Treatment 8% ≤ HbA1c < 9% Control Treatment 9% ≤ HbA1c < 10% Control 100% Treatment...
Page 340: Insulin Delivery Differences
CHAPTER 31 • Control-IQ Technology Clinical Study Overview 31.8 Insulin Delivery Differences The following table compares the insulin delivery statistics between the Control-IQ technology group and the SAP group in the DCLP3 study. DCLP3: Insulin Delivery Comparison (N=168) Characteristic Unit of Measure Control-IQ After 2-weeks Average (std dev)
Page 341 CHAPTER 31 • Control-IQ Technology Clinical Study Overview The following table compares the insulin delivery statistics between the Control-IQ technology group and the SAP group in the DCLP5 study. Total daily insulin is reported as Units of insulin per body weight of participant, in kilograms (kg), per day. DCLP5: Insulin Delivery Comparison (N=101) Characteristic Timepoint...
Page 342: Control-Iq Technology High And Low Alert Accuracy
CHAPTER 31 • Control-IQ Technology Clinical Study Overview 31.9 Control-IQ Technology High and Low Alert Accuracy The following data table characterizes the accuracy of the Control-IQ technology high and low alerts, respectively. This analysis depicts the percent of alerts that were triggered relative to the resulting sensor glucose value achieving the level the alert predicted. The Control-IQ technology Low Alert notifies the user when Control-IQ technology predicts that the sensor glucose value will be below 70 mg/dL 15 minutes in the future, or 80 mg/dL when the Exercise is on.
Page 343 CHAPTER 31 • Control-IQ Technology Clinical Study Overview 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 344: Additional Analysis Of Sensor Glucose Value Auto-Population With Cgm
CHAPTER 31 • Control-IQ Technology Clinical Study Overview 31.10 Additional Analysis of Sensor Glucose Value Auto-Population with CGM Upon completion of the Pivotal Study, an evaluation of the auto-population of CGM readings into the bolus calculator was performed. The results of the analysis indicate, when a sensor glucose value was >250 mg/dL, there was an increased incidence of CGM values <70 mg/dL five hours after a bolus was delivered using auto-populated CGM readings compared to the five hours the bolus was delivered using manually entered sensor glucose values.
Page 345 CHAPTER 31 • Control-IQ Technology Clinical Study Overview DCLP3: Post-Correction Bolus CGM Readings (5 hours): Based on Starting Sensor Glucose Values One or More CGM Three Consecutive CGM Five or More CGM CGM Reading Entry Type Reading <54 mg/dL Readings <70 mg/dL Readings <70 mg/dL (95% CI) (95% CI)
Page 346 CHAPTER 31 • Control-IQ Technology Clinical Study Overview DCLP5: Post-Correction Bolus CGM Readings (5 hours): Based on Starting Sensor Glucose Readings One or More CGM Three Consecutive CGM Five or More CGM CGM Reading Entry Type Reading <54 mg/dL Readings <70 mg/dL Readings <70 mg/dL (95% CI) (95% CI)
Page 347: Section 5: Technical Specifications And Warranty
Technical Specifications and Warranty CHAPTER 32 Technical Specifications...
Page 348: Overview
32.1 Overview This section provides tables of technical specifications, performance characteristics, options, settings, and electromagnetic compliance information for the Tandem Mobi™ pump. The specifications in this section meet the international standards set forth in IEC 60601-1 and IEC 60601-2-24. 32.2 Tandem Mobi Insulin Pump Specifications...
Page 349 During normal use, the intermediate rate is 2 units/hr; battery charge can be reasonably expected to last Typical Operating Time when Pump is between 3 and 5 days, depending on your use of CGM and Tandem Mobi mobile app features from a fully Operating at Intermediate Rate...
Page 350 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 351: Accessory Specifications
CHAPTER 32 • Technical Specifications 32.3 Accessory Specifications USB Charging Pad Cable Specifications Specification Type Specification Detail Length 5 feet (1.5 meters) Type USB A to USB C Power Supply/Charger, AC, Wall Mount, USB Specifications Specification Type Specification Detail Part Number 1005742 Input 100 to 240 Volts AC, 50/60 Hz...
Page 352: Tandem Mobi Insulin Pump Options And Settings
CHAPTER 32 • Technical Specifications 32.4 Tandem Mobi Insulin Pump Options and Settings Options and Settings Option/Setting Type Option/Setting Detail Time User defined with a 12-hour clock Basal Rate Setting Range 0.1 – 15 units/hr Insulin Delivery Profiles (Basal and Bolus)
Page 353 CHAPTER 32 • Technical Specifications Options and Settings (Continued) Option/Setting Type Option/Setting Detail Maximum Extended Bolus Time 8 hours; 2 hours when Control-IQ™ technology is on Maximum Bolus Size 25 units Maximum Automatic Bolus Size 6 units Status indicator visible on Dashboard screen; Low Insulin Alert is user adjustable from 15 to 40 units (default Low Cartridge Volume Indicator is 20 units).
Page 354: Pump Performance Characteristics
Basal Delivery To assess basal delivery accuracy, 32 Tandem Mobi 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 aging.
Page 355 Bolus Delivery To assess bolus delivery accuracy, 32 Tandem Mobi 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 aging.
Page 356 CHAPTER 32 • 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 0.051 0.031 0.058 (n=800 boluses) Intermediate Bolus Delivery Performance 2.50...
Page 357 CHAPTER 32 • Technical Specifications Intermediate Bolus Delivery Performance (2.5 U) (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%)
Page 358 CHAPTER 32 • Technical Specifications Rate of Delivery Characteristic Value 25 Unit Bolus Delivery Speed 4.93 units/min Typical 2.5 Unit Bolus Delivery Speed 1.72 units/min Typical Bolus Duration Characteristic Value 25 Unit Bolus Duration 5 minutes 4 seconds Typical 2.5 Unit Bolus Duration 1 minute 27 seconds Typical Time to Occlusion Alarm* Operating Rate...
Page 359: Electromagnetic Compatibility
12 inches (30.5 cm) to any part of the • The pump will not discontinue observed in this environment to verify Tandem Mobi pump, including cables specified reporting CGM data without normal operation. Special precautions by the manufacturer. Otherwise, degradation of notification to the user.
Page 360: Tandem Mobi Mobile App Security
Data may become smartphone or OS, no further security smartphone. You must pair each device with vulnerable if you install the Tandem Mobi mobile updates will be provided. your pump. The pump wireless communications app on a smartphone that has been jailbroken or ⚑...
Page 361: Electromagnetic Emissions
CHAPTER 32 • Technical Specifications 32.9 Electromagnetic Emissions The system is intended for use in the electromagnetic environment specified below. Always make sure that the system is used in such an environment. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment –...
Page 362: Electromagnetic Immunity
CHAPTER 32 • Technical Specifications 32.10 Electromagnetic Immunity The system is intended for use in home healthcare electromagnetic environments. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level ± 8 kV contact ± 8 kV contact Electrostatic Discharge (ESD) IEC 61000-4-2 ±...
Page 363 CHAPTER 32 • 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 364: Iec 60601-1-10: Physiological Closed-Loop Controlled System
CHAPTER 32 • Technical Specifications 32.11 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 365: Quality Of Wireless Service
32.12 Quality of Wireless Service capable of successfully receiving at uploading of data to the Tandem cloud. least 90% of CGM readings while the Wi-Fi or cellular services are required to The quality of wireless service between...
Page 366: Wireless Technology
CHAPTER 32 • Technical Specifications 32.13 Wireless Technology The system utilizes wireless technology with the following characteristics: Wireless Technology Specifications Specification Type Specification Detail Wireless Technology Bluetooth Low Energy (BLE) version 5.0 Tx/Rx Frequency Range 2.360 to 2.500 GHz Bandwidth (per channel) 2 MHz Radiated Output Power (maximum) +8 dBm...
Page 367: Fcc Notice Concerning Interference
Tandem Mobi pump by any person discretion, repair the pump or replace it or entity other than Tandem; This device complies with part 15 of the with a new or refurbished Tandem Mobi FCC Rules. pump, subject to the conditions and •...
Page 368 CHAPTER 32 • Technical Specifications Mobi pump to help to ensure the States. No employee of Tandem or any months from date of shipment of the up-to-date functionality of your pump or other party is authorized to make any cartridge to the end user (the “Warranty...
Page 369 United States. No employee exceed 6 months from date of the date of manufacture; of Tandem or any other party is shipment of the infusion set to the end authorized to make any warranty in user (the “Warranty Period”). During the •...
Page 370: Returned Goods Policy
Pump that is covered by repairs performed to any part of the The remedies provided for in this the Warranty, then Tandem will repair or infusion set by any person or entity warranty are the exclusive remedies replace the Pump as provided under other than Tandem;...
Page 371: System Event Data
(all with t:lock ground service with a tracking number. returned. Others who may assert a legal connector) Tandem is not responsible for lost or right to know, or who obtain your Infusion sets are available in damaged packages.
Page 372: Index
INDEX CGM, 12 Hour Calibration Alert ....249 CGM, Calibrate CGM Alert ....253 CGM, Calibration Error Alert .
Page 373 Dexcom G6, Sensor Expiring Alert ....209 CGM Trends ......242 Dexcom G7, Sensor Expiring Alert .
Page 374 Target BG in Personal Profiles ....109 Calibration Timeout Alert ..... . 251 BG Reminder .
Page 375 Calibrating Your CGM ..... . . 235 Glucose Trend Arrows ..... . .241 Calibration Error Alert .
Page 376 Startup Calibration Alert ..... . 247 Control-IQ Technology System Overview ......208 Automatic Correction Bolus Delivery .
Page 377 Correction Factor ......20, 106 Low BG Reminder ......148 Low Glucose Alert .
Page 378 End Dexcom G6 CGM Sensor Session ... . 228 Graph ........68 End Dexcom G7 CGM Sensor Session .
Page 379 Missed Meal Bolus Reminder ....150 Mobile Tandem Device Updater ....52 LED Status Indicator .
Page 380 Rename a Profile ......112 Power Adapter, AC ......51 Pump Occlusion Alarms .
Page 381 Receiver, CGM ....... 208 Navigation ....... . .60 Notifications .
Page 382 Connected to Pump ......88 in Personal Profiles ..... 106, 109 Disconnected from Pump .
Page 383 Unable to Pair ....... . 269 Units ........21 Food Bolus, on Bolus Screen .
Page 384 ® mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Tandem Diabetes Care, Inc. is under license. App Store is a service mark of Apple Inc. iPhone is a trademark of Apple Inc.

Tandem 1004000 User Manual

Chapter 5 • Getting Started

Chapter 14 • Alarms

Chapter 16 • Taking Care of Your Pump

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