Contents

Intended Use

The Tandem Device Updater is intended for use by individuals with diabetes mellitus who use Tandem Diabetes Care insulin pumps, their care givers, and their healthcare professionals in home and clinical settings. The Device Updater provides Tandem insulin pump users the ability to update their device software remotely using a computer with internet access.

/!\ CAUTION

Federal (USA) law restricts this device to sale by or on the order of a physician.

/!\ IMPORTANT USER INFORMATION

Thoroughly review all product instructions for warnings and other important user information before using the Tandem Device Updater. Incorrect use may result in an inoperable pump.

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System Warnings

DO NOT update your Tandem insulin pump before reading the User Guide. Incorrect use of the Tandem Device Updater or failure to follow the appropriate instructions can lead to an inoperable pump. If you have questions or need further clarification on the Tandem Device Updater or pump use, call Customer Technical Support at (877) 801-6901.

DO NOT update your pump while your infusion set is connected to your body. Always ensure that the infusion set is disconnected from your body before updating your pump software.

DO suspend all pump insulin delivery prior to using the Tandem Device Updater.

DO 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 update.

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 or Diabetic Ketoacidosis (DKA).

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 NOT rely on the Insulin On Board (IOB) displayed on your pump for a period of time after an update. 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.

DO confirm your pump’s personal settings, date, and time 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.

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System Precautions

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 computer during an update unless instructed to do so. Doing so could interrupt the update, and your pump may not function.

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.