The Tandem Device Updater is intended for use by individuals with diabetes mellitus who use t:slim X2 insulin pumps, their care givers, and their healthcare professionals in home and clinical settings. The Device Update remotely updates software for the t:slim X2 insulin pump using a computer with internet access.
Federal (U.S.) law restricts t:slim X2 insulin pumps to sale by or on the order of a physician.
Thoroughly review all product instructions for warnings and other important user information before using the Tandem Device Updater. Medical devices, like other computer systems, can be vulnerable to cybersecurity risks, potentially impacting the safety and effectiveness of the device. Incorrect use of the Tandem Device Updater or your failure to follow instructions, precautions and warnings in this user guide, may result in an inoperable pump or expose your t:slim X2 pump to cybersecurity risks.
The Tandem Device Updater should always connect to a Trusted Computer. 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.
DO NOT update your pump before reading the User Guide. Incorrect use of the Tandem Device Updater or your failure to follow the instructions, precautions and warnings in this user guide, may lead to an inoperable pump or expose your t:slim X2 pump to cybersecurity risks. If you have questions or need further clarification on the Tandem Device Updater or pump use, contact Customer Technical Support.
DO complete the training appropriate to your device and feature set before starting to use the updated software. Failure to complete necessary training could result in serious injury or death.
DO 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 blood glucose (BG) or Diabetic Ketoacidosis (DKA.
DO check your BG prior to suspending delivery and be sure to treat high or low BG levels as directed by your healthcare professional prior to update.
DO suspend all pump insulin delivery prior to using the Tandem Device Updater.
DO NOT update your pump while your infusion set is connected to your body.
DO confirm your pump’s personal settings, date, time, and serial number are correct after the 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.
DO NOT 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.
ONLY use the Tandem Device Updater to update your pump.
ONLY download the Tandem Device Updater following the instructions provided in the Update Instructions section of the user guide.
ENSURE you are always using the latest version of the Tandem Device Updater.
NEVER connect your pump to a public computer. Always use a Trusted Computer.
Use of security features on your Trusted Computer is important. These security features include:
ONLY use the USB cable provided by Tandem Diabetes Care to perform a software update.
Exercise caution whenever you connect your pump to a Trusted Computer and remain in the presence of the pump at all times while updating your pump.
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.
DO NOT shut down your computer or allow it to go into “hibernate”, “sleep” or “standby” mode during an update. If you are using a laptop, do not close the laptop. Doing so could interrupt the update, and your pump may not function.
DO NOT disconnect from the Internet during an update. Doing so could interrupt the update, and your pump may not function.
DO NOT 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 update process, you will need to resume your current session by tapping START SENSOR on the My CGM screen of your pump once the update is complete. The CGM sensor session continues to be active, but you will not see your CGM trend graph until your start your CGM sensor session again from your pump.
DO NOT 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.
Subsequent changes to a Trusted Computer could introduce new risks and require additional analysis. These changes can include by 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.
DO NOT 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.