Tandem Diabetes Care (TNDM) 2019年年度报告「NASDAQ」.pdf

1、2019 ANNUAL REPORTwith Control-IQ TechnologyImportant Safety Information:Caution:Federal(USA)law restricts the t:slim X2 insulin pump and Control-IQ technology to sale by or on the order of a physician.The t:slim X2 pump and Control-IQ technology are intended for single patient use.The t:slim X2 pum

2、p and Control-IQ technology are indicated for use with NovoLog or Humalog U-100 insulin.t:slim X2 insulin pump:The t:slim X2 insulin pump with interoperable technology is an alternate controller enabled(ACE)pump that is intended for the subcutaneous delivery of insulin,at set and variable rates,for

3、the management of diabetes mellitus in people requiring insulin.The pump is able to reliably and securely communicate with compatible,digitally connected devices,?greater.Control-IQ technology:Control-IQ technology is intended for use with a compatible integrated continuous glucose monitor(iCGM,sold

4、 separately)and ACE pump to automatically increase,decrease,and suspend delivery of basal insulin based on iCGM readings and predicted glucose values.It can also deliver correction boluses when the glucose value is predicted?Control-IQ technology is intended for the management of Type 1 diabetes mel

5、litus in persons 14 years of age and greater.Control-IQ technology is not indicated for use in pregnant women,people on dialysis,or critically ill patients.Do not use Control-IQ technology if using hydroxyurea.Users of the t:slim X2 pump and Control-IQ technology must:use the insulin pump,CGM,and al

6、l other system components in accordance with their respective instructions for use;test blood glucose levels as recommended by their healthcare?recognize all functions of the pump,including alerts,alarms,and reminders.The t:slim X2 pump,transmitter,and sensor must be removed before MRI,CT,or diather