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.
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.
NEVER update your pump before reading the User Guide. Incorrect use of Tandem Source or your failure to follow the instructions, precautions and warnings 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 or need further clarification on Tandem Source or pump use during a pump software update, contact Customer Technical Support.
ALWAYS complete the training appropriate to your device and feature set before starting to use updated software. Failure to complete necessary training could result in serious injury or death.
ALWAYS be prepared to inject insulin with an alternative method in case you encounter any issues while updating your pump. Failure to have an alternative method of insulin delivery can lead to very high BG or Diabetic Ketoacidosis (DKA).
ALWAYS check your blood glucose (BG) prior to suspending delivery and be sure to treat high or low BG levels as directed by your healthcare professional 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. Incorrect settings can result in over delivery or under delivery of insulin. Consult with your healthcare professional as needed to establish appropriate settings. Closely monitor your insulin delivery and BG following an update. Ensure your symptoms match your therapy data.
NEVER rely on the Insulin On Board (IOB) displayed on your pump after an update until your prior IOB has been depleted. Your IOB will be reset to zero during the update process. Since the calculated bolus amount relies on IOB, it could prompt you to deliver more insulin than needed and result in hypoglycemia. Consult with your healthcare professional for how long you need to wait after an update before you can rely on the IOB calculation.
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:
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.