TANDEM Diabetes T:Slim X2 Insulin Pump with Dexcom G7 Cgm User Manual

TANDEM Diabetes T:Slim X2 Insulin Pump with Dexcom G7 Cgm

T:SLIM X2 INSULIN PUMP WITH DEXCOM G7 CGM

Specifications:

• Continuous Glucose Monitoring (CGM) system
• Compatible with Dexcom G7 sensors
• Requires pairing code verification
• Sensor startup period: 30 minutes

Product Usage Instructions

Start Sensor Session

• These instructions are specific to Dexcom G7 continuous glucose monitoring (CGM). For information on starting a Dexcom G6 sensor session, please refer to the user guide.
• 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.

Options

1. From the Home screen, tap OPTIONS.

2. Tap the down arrow and then tap My CGM.

3. Select Sensor If this is the first time using a Dexcom G7 sensor, tap Select Sensor and then tap Dexcom G7. Otherwise, skip to Step 4.

4. Dexcom G7 Tap START G7 SENSOR.
   Note: If the user utilizes the Dexcom G7 mobile app, the user must start a sensor session and enter the pairing code on both the Dexcom G7 mobile app and t:slim X2 insulin pump.

5. Enter Code
   Enter the code found on the side of the sensor applicator and tap to continue.
   Note: If using the Dexcom G7 mobile app, the pairing code can be found under Connections.

6. Verify Pairing Code Tap ENTER CODE AGAIN to verify the pairing code and then tap to continue.
   Note: If valid, a CODE CONFIRMED screen will appear to confirm. If invalid, the pump will prompt you to enter the code again.
   Pump Tip
   The Dexcom G7 sensor needs a 30-minute startup period, which begins immediately after insertion, before trend information displays on the pump screen.

7. Start Sensor Tap to start the sensor session startup period.
   The SENSOR STARTED screen will appear to confirm.

Note: If continuing an active sensor session, the startup period will take five to 10 minutes. For a new session, it may take up to 30 minutes.

FAQ:

• Q: How long does the sensor startup period take?
  A: The sensor startup period takes 30 minutes for a new session. If continuing an active sensor session, it takes five to 10 minutes.

• Q: Can I use predictive technology during the startup period?
  A: No, during the startup period, the pump will not display sensor data or allow the use of predictive technology. Users should continue to use a blood glucose (BG) meter and test strips for treatment decisions.

T:SLIM X2 INSULIN PUMP WITH DEXCOM G7 CGM

Start Sensor Session

• These instructions are specific to Dexcom G7 continuous glucose monitoring (CGM).* For information on starting a Dexcom G6 sensor session, please refer to the user guide.
• 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.

1. From the Home screen, tap OPTIONS. Tap the down arrow and then tap My CGM.

2. If this is the first time using a Dexcom G7 sensor, tap Select Sensor and then tap Dexcom G7. Otherwise, skip to Step 3.

3. Tap START G7 SENSOR.
   Note: If the user utilizes the Dexcom G7 mobile app, the user must start a sensor session and enter the pairing code on both the Dexcom G7 mobile app and t:slim X2 insulin pump.

4. If the user is continuing with an active sensor session and is not using the Dexcom G7 mobile app, tap and then skip to Step 6. Otherwise, go to Step 4 to continue.

5. Enter the code found on the side of the sensor applicator and tap to continue.
   Note: If using the Dexcom G7 mobile app, the pairing code can be found under Connections.

6. Tap ENTER CODE AGAIN to verify the pairing code and then tap to continue.
   Note: If valid, a CODE CONFIRMED screen will appear to confirm. If invalid, the pump will prompt you to enter the code again. Pump Tip: The Dexcom G7 sensor needs a 30-minute startup period, which begins immediately after insertion, before trend information displays on the pump screen.

7. Tap  to start the sensor session startup period.
   The SENSOR STARTED screen will appear to confirm.

8. The pump will return to the Home screen with a CGM trend graph and sensor startup countdown symbol.
   Note: If continuing an active sensor session, the startup period will take five to 10 minutes. For a new session, it may take up to 30 minutes .

9. The symbol fills in over time to show how much time is left.
   Note: During this startup period, the pump will not display sensor data or allow use of predictive technology. Users should continue to use a blood glucose (BG) meter and test strips in order to make treatment decisions.

10. Once completed, the new sensor session will begin.
    Note: If you see a Sensor Not Started alert, contact Dexcom support. If glucose alerts and readings do not match symptoms or expectations, use a BG meter to make diabetes treatment decisions.

Connection Tips

If the Out of Range icon is on the insulin pump screen (pictured on the right), then the sensor is not communicating with the pump. When a sensor glucose reading cannot be provided, “- – -” shows in the place where the sensor glucose value is normally shown.

• For ideal connectivity, it is suggested that the user faces the pump screen out and away from their body and wear the pump on the same side of the body that they wear the sensor
•  Make sure that nothing is rubbing or obstructing the sensor
• Please note that wireless communication does not work well through water so the transmission range is much less

Need additional help? See who to contact when the user experiences CGM issue(s).

* CGM sold separately.

Important Safety Information

• RX ONLY. 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 pump is indicated for use in individuals six years of age and greater. The pump is intended for single patient, home use and requires a prescription. The pump is indicated for use with U-100 insulin only. Users of the pump must: be willing and able to use the insulin pump 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. 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, and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. Dexcom, Dexcom G6, Dexcom G7, and any related logos and design marks are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries. ML-1012194_B

T:SLIM X2 INSULIN PUMP WITH DEXCOM G7 CGM

Stop Sensor Session

• These instructions will show pump users how they can manually stop a Dexcom G7 sensor session.* See inside to learn how the pump can also automatically stop a sensor session.
• 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.

1. From the Home screen, tap OPTIONS. Tap the down arrow and then tap My CGM.

2. Tap STOP G7 SENSOR.
   Note: If the sensor session ends early, the user cannot start the session again with that same sensor. A new sensor must be used. Pump Tip: Once the sensor session has ended, sensor glucose alerts and alarms will no longer be received and any Control-IQ technology will become inactive.

3. Tap  to confirm that the user wants to stop their current sensor session.

4. Tap to acknowledge the session cannot be restarted.
   The SENSOR STOPPED screen will appear to confirm.

5. The Home screen will appear with the Replace Sensor icon in the place where the sensor glucose value is shown.

The user must remove the sensor and insert a new sensor. New sensor glucose readings will not show on the Home screen until a new sensor session starts.

Automatic Sensor Shut-Off

• The Dexcom G7 continuous glucose monitoring (CGM) sensor is indicated to be worn for up to 10 days, plus an additional 12-hour grace period.
• The Sensor Expiring Soon screen will appear on the pump to let the user know how much time is left until their sensor session is complete. The user has the option to manually stop the sensor session before it expires or let the sensor automatically shut off.
• After the sensor has expired, a 12-hour grace period will be-gin with additional reminders.
• Note: During this grace period, the pump will continue to receive sensor glucose readings and allow use of predictive technologies.
• Once the 12-hour grace period is over, the Replace Sensor screen will appear.

Sensor Time Remaining

Any time during the sensor session, users can find out when the sensor session was started and how much time is remaining. Tap the insulin level symbol on the Home screen and then tap the down arrow twice.

Need technical help? See who to contact when the user experiences CGM issue(s).

*CGM 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. Dexcom, Dexcom G7, and any related logos and design marks are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries. ML-1011747_A

tandemdiabetes.com
dexcom.com

References

• Dexcom Continuous Glucose Monitoring | Dexcom
• Diabetes Management | Insulin Pumps | Tandem Diabetes Care
• Diabetes Management | Insulin Pumps | Tandem Diabetes Care
• Important Safety Information - Tandem Insulin Pumps

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