TANDEM Diabetes Care tslim X2 Insulin Pump User Guide

TANDEM Diabetes Care slim X2 Insulin Pump

Product Information

T: SLIM X2 INSULIN PUMP

The t: slim X2 insulin pump is a device that helps individuals manage their insulin therapy. It has various features, including the Sleep Activity function, which allows users to program the pump to automatically switch into sleep mode. The pump also utilizes Control-IQ technology, which uses continuous glucose monitoring (CGM) values to predict glucose levels and adjust insulin delivery accordingly.

Product Usage Instructions

1. From the Home screen, tap OPTIONS and then Activity.
2. Tap Sleep.
3. Tap Sleep Schedules and then tap a Sleep Schedule.
   • Note: If the user does not program Sleep Schedules, the Sleep Activity must be manually turned on and off.
4. Tap Selected Days and then tap each day of the week the user wants Sleep scheduled.
5. Tap Start Time and then tap Time. Use the keypad to enter the desired time. Tap to continue and then tap again.
6. Repeat the same process to configure the End Time.
   • Note: These times should reflect the time the user generally goes to sleep and wakes up. If applicable, also confirm the time of day is accurate.
7. Tap to save the settings. The SETTING SAVED screen will appear to confirm.
8. To manually turn on the Sleep Activity, go to Activity > Sleep > START.
   • Note: To disable the Sleep Activity, tap anywhere on the Sleep button from the Activity screen.

Pump Tip: Control-IQ technology must be on and a continuous glucose monitoring (CGM) session must be active on the pump to start the Sleep Activity.

• Users can program their t: slim X2 insulin pump to automatically switch into the Sleep Activity. Two Sleep Schedules can be used.

From the Home screen, tap OPTIONS and then Activity.

Note: These instructions are provided as a reference tool for pump users and caregivers who are already familiar with the use of an insulin pump and with insulin therapy in general. Not all screens are shown.For more detailed information on the operation of the t: slim X2 pump, please refer to its user guide.

Tap Sleep.

Tap Sleep Schedules and then tap a Sleep Schedule.

• ⚑ Note: If the user does not program Sleep Schedules, the Sleep Activity must be manually turned on and off
• Pump Tip: Control-IQ technology must be on and continuous glucose monitoring (CGM)* session must be active on the pump to start the Sleep Activity.
• Tap Selected Days and then tap each day of the week the user wants Sleep scheduled. Tap to continue
• Tap Start Time and then tap Time. Use the keypad to enter the desired time. Tap to continue and then tap again.
• Repeat the same process to configure the End Time.
• ⚑ Note: These times should reflect the time the user generally goes to sleep and wakes up. If applicable, also confirm the time of day is accurate
• Tap to save the settings.
• The SETTING SAVED screen will appear to confirm.
• In addition to creating Sleep Schedules, the Sleep Activity can also be manually turned on and off from the t: slim X2 insulin pump. Flip to the back to learn how the Sleep Activity adjusts insulin delivery when enabled.

From the Home screen, tap OPTIONS and then Activity. Tap Sleep.

• Tap START to manually turn on the Sleep Activity.
  ⚑ Note: To disable the Sleep Activity, tap anywhere on the Sleep button from the Activity screen.

• Sleep is now enabled.

Configuration Settings

• To ensure that both Sleep Schedules can be saved and enabled at the same time, the two schedules cannot overlap. One or both Sleep Schedules may be disabled at any time.
• If you manually start the Sleep Activity before a Sleep Schedule begins, it does not impact the scheduled wake-time
• Automatic correction boluses will not be delivered while theSleep Activity is enabled
• Pump Tip: On the Sleep Schedule screen, the default for Selected Days is always the current day of the week according to the insulin pump.

Responsible Use of Control-IQ Technology Control-IQ technology does not prevent all high and low blood glucose events and is not a substitute for meal boluses and active self-management of your diabetes. Control-IQ technology will not be able to predict sensor glucose values and adjust insulin dosing if your CGM is not working properly or is unable to communicate with your pump. Always pay attention to your symptoms and blood glucose levels and treat them accordingly. Please visit tandemdiabetes.com/ tslimX2-use for more information.

Need additional help? Scan this code to visit our support center.

How it Works

The t:slim X2 insulin pump with Control-IQ technology uses CGM values to predict glucose levels 30 minutes ahead and automatically adjust insulin every 5 minutes. When the Sleep Activity is enabled, the algorithm narrows and lowers the range of treatment values to 112.5-120 mg/dL when determining whether to decrease, stop, or increase basal insulin delivery.

CGM is sold separately.

Important Safety Information

RX ONLY. The t: slim X2 pump and Control-IQ technology are intended for single-patient use. The t: slim X2 pump and Control-IQ technology are indicated for use with U-100 insulin only. 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 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 t: slim X2 pump is indicated for use in individuals six years of age and greater. Control-IQ technology: Control-IQ technology is intended for use with a compatible integrated continuous glucose monitor (iCGM, sold 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 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 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 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, 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.

© 2023 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, the Tandem logo, 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. ML-1011573_A

• Users can program their t: slim X2 insulin pump to automatically switch off the Exercise Activity by setting a custom duration with the Exercise timer.
• From the Home screen, tap OPTIONS and then Activity.
• Note: These instructions are provided as a reference tool for pump users and caregivers who are already familiar with the use of an insulin pump and with insulin therapy in general. Not all screens are shown. For more detailed information on the operation of the t: slim X2 pump, please refer to its user guide
• Tap Exercise.
• ⚑ Note: Activities may not be enabled at the same time. If programmed, Sleep Schedule(s) will automatically start once Exercise is disabled.
• Tap Set a Timer.
• ⚑ Note: If the user does not program a timer, the Exercise Activity must be manually turned off.
• Pump Tip: The default value for the Exercise timer duration is 30 minutes, or the pump will display the value from the last time the Duration was set by the user.
• Tap Duration to edit the timer duration. Otherwise, skip to step 6 to continue
• Use the keypad to enter the desired time. Tap to continue.
• Note: The timer duration can be set from 30 minutes to 8 hours.
• Tap START to turn on the Exercise Activity.
• The EXERCISE STARTED screen will appear.
• Exercise is now enabled and displayed on the Home screen.
• ⚑ Note: The Exercise Activity will automatically be disabled once the set timer duration ends
• In addition to setting an Exercise Timer, the Exercise Activity can also be manually turned on and off from the t: slim X2 insulin pump. Flip to the back to learn how the Exercise Activity adjusts insulin delivery when enabled.
• From the Home screen, tap OPTIONS and then Activity. Tap Exercise.
• Tap START to manually turn on the Exercise Activity
• Exercise is now enabled.
• ⚑ Note: To disable the Exercise Activity, tap anywhere on the Exercise button from the Activity screen.

The t: slim X2 insulin pump with Control-IQ technology uses continuous glucose monitoring (CGM)* values to predict glucose levels 30 minutes ahead and automatically adjust insulin every 5 minutes. When the Exercise Activity is enabled, a tighter range of treatment values from 140-160 mg/dL is used when determining whether to decrease or increase basal insulin delivery and a predicted value of 80 mg/dL is used when determining whether to stop basal insulin delivery.

CGM is sold separately.
Important Safety Information: RX ONLY. The t: slim X2 pump and Control-IQ technology are intended for single-patient use. The t: slim X2 pump and Control-IQ technology are indicated for use with U-100 insulin only. 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 ofinsulin, at 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 t: slim X2 pump is indicated for use in individuals six years of age and greater. Control-IQ technology: Control-IQ technology is intended for use with a compatible integrated continuous glucose monitor (iCGM, sold 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 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 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 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, alarms, andreminders. 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.

© 2023 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, the Tandem logo, 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. ML-1011570_A

• Control-IQ technology must be on and the CGM session must be active on the t:slim X2 insulin pump to start the Exercise Activity
• Exercise will automatically be disabled if the Sleep Activity is enabled manually. Any enabled Sleep Schedules will not start until the Exercise Activity ends.
• Automatic correction boluses ( ) will be delivered up to once per hour while the Exercise Activity is enabled
• If glucose values are predicted to be above 180 mg/dL, Control-IQ technology calculates a correction bolus using the Personal Profile settings and a target of 110 mg/dL and delivers 60% of that value. An Automatic Correction Bolus will not occur within 60 minutes of a bolus that has been delivered or canceled.

Responsible Use of Control-IQ Technology
Control-IQ technology does not prevent all high and low blood glucose events and is not a substitute for meal boluses and active self-management of your diabetes. Control-IQ technology will not be able to predict sensor glucose values and adjust insulin dosing if your CGM is not working properly or is unable to communicate with your pump. Always pay attention to your symptoms and blood glucose levels and treat them accordingly. Please visit tandemdiabetes.com/ tslimX2-use for more information.

• Need additional help? Scan this code to visit our support center

References

• Diabetes Management | Insulin Pumps | Tandem Diabetes Care
• Diabetes Management | Insulin Pumps | Tandem Diabetes Care
• Important Safety Information - Tandem Insulin Pumps

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