Tandem Source Personal

Intended Use of the Tandem Source Platform

The Tandem Source platform is intended for use by individuals with diabetes mellitus who use Tandem Diabetes Care™ insulin pumps, their caregivers, and their healthcare providers in home and clinical settings. The Tandem Source platform supports diabetes management through the display and analysis of information uploaded from Tandem insulin pumps.

/!\ Important User Information

Thoroughly review all product instructions for warnings and other important user information before using Tandem Source. Medical devices, like other computer systems, can be vulnerable to cybersecurity risks, potentially impacting the safety and effectiveness of the device. Incorrect use of Tandem Source or your failure to follow the instructions, precautions and warnings in this user guide, may result in an inoperable pump or expose your computer to cybersecurity risks.

Note: Tandem Source does not support the t:flex insulin pump, the t:slim G4 insulin pump, or the t:slim insulin pump as these pumps do not support software updates. The pump software update instructions in this user guide only apply to the t:slim X2 insulin pump.

Always use Tandem Source on a Trusted Computer using a web browser through a secure internet connection. A Trusted Computer is a personal computer or a computer controlled by your healthcare provider’s office that has the latest security patches for a supported operating system, including virtual machines used at healthcare provider’s offices.

For local support in your area, see the contact information on the back cover of this user guide.

You can request a printed copy of this user guide at any time, which we will send to you free of charge within seven days of your request. See the contact information on the back cover of this user guide.

Important User Information Regarding the Tandem t:slim Mobile App and the Tandem Mobi Mobile App

The information on the Tandem t:slim mobile app or Tandem Mobi mobile app display may not be identical to the current status of your pump. Wireless uploads from the Tandem t:slim mobile app or Tandem Mobi mobile app to Tandem Source require a compatible phone and an internet or wireless data connection. Uploads to Tandem Source do not take place in real time and should not be relied upon by healthcare providers or caregivers for remote patient monitoring. Users should always follow the advice of their healthcare professional and seek medical attention when appropriate and remember to consult their healthcare provider before adjusting pump therapy. Standard carrier data rates may apply.

The feature set available within the Tandem t:slim mobile app is dependent on the t:slim X2 pump software version and the compatible smartphone’s model and operating system (OS). See your Tandem pump user guide for available feature sets.

This user guide is applicable above and beyond any recommendations made by the manufacturer of the mobile device on which the Tandem t:slim mobile app or the Tandem Mobi mobile app is installed.

For an up-to-date list of supported smartphones, please visit tandemdiabetes.com/mobilesupport. If you use the Tandem t:slim mobile app or Tandem Mobi mobile app, tap Help on the Settings screen, then tap App Guide.

/!\ Precautions

NEVER update your pump before reading the User Guide. Incorrect use of Tandem Source or failure to follow the instructions and precautions in this user guide during a pump software update may result in an inoperable pump or expose your pump to cybersecurity risks. If you have questions, contact Customer Technical Support.

ALWAYS complete the training appropriate to your device and feature set as instructed in the Tandem t:slim X2 Pump user guide before starting to use updated software.

Have a backup insulin delivery option available as the pump cannot be used for therapy during a pump update.

ALWAYS check your blood glucose (BG) before beginning an update. Check your high or low BG levels as directed by your healthcare provider prior to updating your pump.

ALWAYS suspend all pump insulin delivery prior to using Tandem Source to update your pump software.

NEVER update your pump while your infusion set is connected to your body.

ALWAYS confirm your pump’s personal settings, date, time, and serial number are correct immediately after a pump software update. Closely monitor your insulin delivery and BG following an update.

The Insulin On Board (IOB) has been reset to zero during the pump update process. Since the IOB has been reset to zero, the calculated bolus amount may be more insulin than you need. Consult with your healthcare provider about how long to wait to dose after your IOB has been reset.

NEVER connect your pump to a public computer. Always use a Trusted Computer.

ALWAYS use the USB cable provided by Tandem Diabetes Care to perform a pump software update.

Use of security features on your Trusted Computer is important. These security features include:

  • The use of a password or PIN to unlock the Trusted Computer.
  • Making sure that your Trusted Computer has current security software.
  • Keeping your software updated when prompted by your Trusted Computer.
  • Some web pages can be unsafe and can affect your Trusted Computer just by visiting them. You should minimize visits to unknown websites and look for 'https' in the browser address or for the padlock symbol next to the URL when visiting websites.
  • You can check system requirements at tandemdiabetes.com/tandem-source-system-requirements. You can verify the tandemdiabetes.com certificate in the browser by clicking on the padlock symbol next to the URL.

Exercise caution whenever you connect your pump to a Trusted Computer and remain in the presence of the pump at all times while your pump is connected to a Trusted Computer.

Connecting the pump to a Trusted Computer that is attached to other equipment could result in previously unidentified risks to the patient, operator, or a third-party. The user should identify, analyze, evaluate, and control these risks.

Subsequent changes to a Trusted Computer could introduce new risks and require additional analysis. These changes can include but are not limited to changing the configuration of the Trusted Computer, connecting additional items to the Trusted Computer, disconnecting items from the Trusted Computer, and updating or upgrading equipment connected to the Trusted Computer.

NEVER shut down your computer or allow it to go into “hibernate”, “sleep” or “standby” mode during a pump software update. If you are using a laptop, do not close the laptop. Doing so could interrupt the update, and your pump may not function.

NEVER disconnect from the Internet during a pump software update. Doing so could interrupt the update, and your pump may not function.

NEVER disconnect your pump from your Trusted Computer during an update unless instructed to do so. Doing so could interrupt the update, and your pump may not function.

If you had an active CGM sensor session when you started the pump software update process, you will need to resume your current session as described in your Tandem pump user guide once the update is complete. The CGM sensor session continues to be active, but you will not see your CGM trend graph until you start your CGM sensor session again from your pump.

NEVER rely on the Max Hourly Bolus Alert for 60 minutes following an update. Your Max Hourly Bolus will be reset to zero during the update process.

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Tandem Source Professional

Intended Use of the Tandem Source Platform

The Tandem Source platform is intended for use by individuals with diabetes mellitus who use Tandem Diabetes Care insulin pumps, their caregivers, and their healthcare providers in home and clinical settings. The Tandem Source platform supports diabetes management through the display and analysis of information uploaded from Tandem insulin pumps.

/!\ Important User Information

Thoroughly review all product instructions for warnings and other important user information before using Tandem Source. Medical devices, like other computer systems, can be vulnerable to cybersecurity risks, potentially impacting the safety and effectiveness of the device. Incorrect use of Tandem Source or your failure to follow the instructions, precautions and warnings in this user guide, may expose your computer to cybersecurity risks.

Always use Tandem Source on a Trusted Computer using a web browser through a secure connection. A Trusted Computer is a computer controlled by your office that has the latest security patches for a supported operating system, including virtual machines used at healthcare provider’s offices.

For local support in your area, see the contact information on the back cover of this user guide.

You can request a printed copy of this user guide at any time, which we will send to you free of charge within seven days of your request. See the contact information on the back cover of this user guide.

/!\ Precautions

Use of security features on your Trusted Computer is important. These security features include:

  • The use of a password or PIN to unlock the Trusted Computer.
  • Making sure that your Trusted Computer has current security software.
  • Keeping your software updated when prompted by your Trusted Computer.
  • Some web pages can be unsafe and can affect your Trusted Computer just by visiting them. You should minimize visits to unknown websites and look for 'https' in the browser address or for the padlock symbol next to the URL when visiting websites.
  • You can check system requirements at tandemdiabetes.com/tandem-source-system-requirements. You can verify the tandemdiabetes.com certificate in the browser by clicking on the padlock symbol next to the URL.

Exercise caution whenever you connect a Tandem pump to a Trusted Computer and remain in the presence of the pump at all times while the pump is connected to a Trusted Computer.

Connecting the pump to a Trusted Computer that is attached to other equipment could result in previously unidentified risks to the patient, operator, or a third-party. The user should identify, analyze, evaluate, and control these risks.

Subsequent changes to a Trusted Computer could introduce new risks and require additional analysis. These changes can include but are not limited to changing the configuration of the Trusted Computer, connecting additional items to the Trusted Computer, disconnecting items from the Trusted Computer, and updating or upgrading equipment connected to the Trusted Computer.