t:slim X2 Insulin Pump

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Important Safety Information

The t:slim X2 insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices. The pump is indicated for use in individuals 6 years of age and greater. The pump is intended for single user, home use and requires a prescription in certain countries. The pump is indicated for use with NovoRapid, Admelog, Trurapi, or Humalog U-100 insulin. The System is not indicated for use in pregnant women, people on dialysis, or critically ill users. Users of the pump and the System must: be willing and able to use the insulin pump, CGM, and all other system components in accordance with their respective instructions for use; test blood glucose levels as recommended by their healthcare provider; demonstrate adequate carb-counting skills; maintain sufficient diabetes self-care skills; see healthcare provider(s) regularly; and have adequate vision and/or hearing to recognize all functions of the pump, including alerts. If your CGM readings do not match your symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions. The t:slim X2 pump must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information.

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.