TANDEM T:Slim X2 Insulin Pump Instruction Manual

June 5, 2024
Tandem

TANDEM T: Slim X2 Insulin Pump

TANDEM-T-Slim-X2-Insulin-Pump-Product

Bolus icons displayed on the CGM graph

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  1. Standard/Correction Bolus
  2. Extended Bolus
  3. Control-IQ Technology Automatic Correction Bolus

After a bolus has been delivered, you will see a blue square icon on the bottom of your CGM graph. The icon will move along to the left as time passes, like the CGM graph timeline. There are three types of icons that you might see, depending on the type of bolus delivered.

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Control-IQ technology updates

If your t: slim X2 insulin pump features Basal-IQ technology, updates include those listed above and on the reverse side. If your t: slim X2 pump features Control-IQ technology, updates include those listed above, on the reverse side, as well as:

High Alert Adjustments

This software contains an adjustment to the Control-IQ technology high alert behavior, which will now annunciate a maximum of once every two hours as long as the same high alert state remains

Switching Between Activities

If Exercise Activity is manually turned off during a programmed Sleep Schedule time frame, the Sleep Activity will now start automatically

Additional Bolus Reminder

An additional bolus reminder will appear when Control-IQ technology is turned on and a food bolus size greater than 25 units is calculated. Once the first 25 units has been delivered, the reminder will appear to allow for the additional remaining bolus to be delivered.

Custom alarm to resume insulin

You now have the ability to set up an alarm after you stop insulin manually to help you remember to resume insulin delivery. The default setting is 15 minutes after insulin is stopped, but you may change this to 30 minutes, 45 minutes, or 60 minutes. After the custom amount of time has passed, the pump will present a Resume Pump Alarm to remind you to manually resume insulin. You will have to resume insulin manually after acknowledging the alarm

Updates to fill cannula selectable options

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Responsible Use of Basal-IQ and Control-IQ Technologies

Systems like the t: slim X2 insulin pump with Basal-IQ technology and the t: slim X2 insulin pump with Control-IQ technology are not substitutes for active diabetes management. For example, users still must bolus for meals. Basal-IQ technology is designed to predict and help prevent lows, but it cannot prevent all lows and Basal-IQ technology does not predict high glucose events. Control-IQ technology is designed to predict and help prevent low and high glucose events, but it cannot prevent all highs and lows, and Control-IQ requires that users accurately input information, such as meals and periods of sleep or exercise. The Basal-IQ and Control-IQ features rely on continuous CGM readings and will not be able to predict glucose levels and adjust insulin dosing if your CGM is not working properly or is unable to communicate with your pump. Be sure to always use your pump, cartridges, CGM, and infusion sets as instructed and check them regularly to make sure they are working properly. Always pay attention to your symptoms, actively monitor your glucose levels, and treat according to your healthcare provider’s recommendations.

Important Safety Information

RX ONLY. The t: slim X2 insulin pump, Basal-IQ technology, and Control-IQ technology are intended for single-patient use. The t: slim X2 pump, Basal-IQ technology, 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 the set and variable rates, for the management of diabetes mellitus in people requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in individuals six years of age and greater. Basal- IQ technology: Basal-IQ technology is intended for use with a compatible integrated continuous glucose monitor (AGM, sold separately) and ACE pump to automatically suspend delivery of insulin based on ECG readings and predicted glucose values. The bolus calculator is indicated for the management of diabetes by people with diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. Basal-IQ technology is intended for the management of diabetes mellitus in persons six years of age and greater. Control-IQ technology: Control-IQ technology is intended for use with a compatible iCGM (sold separately) and ACE pump to automatically increase, decrease, and suspend delivery of basal insulin based on ECG readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control- IQ technology is intended for the management of Type 1 diabetes mellitus in persons six years of age and greater.

WARNING: Control-IQ technology should not be used by anyone under the age of six years old. It should also not be used in patients who require less than 10 units of insulin per day or who weigh less than 55 pounds.  Control-IQ technology and Basal-IQ technology are 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, Basal-IQ technology, and Control-IQ technology must: be able and willing 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 a healthcare provider(s) regularly; and have adequate vision and/or hearing to recognize all functions of the pump, including alerts, alarms, and reminders. The t:slim X2 pump, and the CGM transmitter and sensor must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information.
© 2022 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, Basal-IQ, Control-IQ, and t: slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. Dexcom and Dexcom G6 are either trademarks or registered trademarks of Dexcom, Inc. in the United States and/or other countries. All third-party marks are the property of their respective owners. TRG-1010129_A

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