TANDEM G7 CGM Mobi System with Dexcom Instruction Manual

: June 24, 2024
: Tandem

Table of Contents

TANDEM G7 CGM Mobi System with Dexcom
Product Usage Instructions
FAQ
Troubleshooting
Automatic Sensor Shut-Off
Sensor Time Remaining
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

TANDEM G7 CGM Mobi System with Dexcom

Specifications

Product: Tandem Mobi System with Dexcom G7 CGM
Compatibility: Dexcom G7 sensor
System Authentication: Device authentication for data security
Age Restriction: Not suitable for individuals under 6 years old
Insulin Requirement: Not suitable for patients requiring less than 10 units of insulin per day or weighing less than 55 pounds

Product Usage Instructions

Pairing the Sensor:

Tap Settings from the Navigation bar.
Tap CGM and then Dexcom G7 from the Select Sensor screen.
Enter the 4-digit pairing code found on the sensor applicator or Dexcom mobile app.
Tap Done and then Save to continue.
Confirm pairing on both Tandem Mobi and Dexcom G7 mobile apps if using both.

Sensor Startup:

After pairing, the Sensor Paired screen will confirm the connection.
A CGM trend graph and sensor startup countdown symbol will appear on the Dashboard.
The sensor session will start after the startup period (5-10 minutes).

Automatic Sensor Shut-Off:

The Sensor Expiring Soon screen will notify the user about remaining sensor session time. The user can manually stop the session or let it shut off automatically after expiration, with a 12-hour grace period for continued use.

Sensor Time Remaining:

Users can check the start time and remaining session time by tapping CGM, then CGM Info from the Settings menu. Current session time is also available on the Dashboard.

Troubleshooting:

If Out of Range Alert appears, follow Connection Tips Quick Reference. If sensor glucose reading is unavailable, wait 30 minutes without calibration. Contact technical support for assistance if needed.

FAQ

Q: Can I restart a sensor session with the same sensor if it’s ended early?

A: No, a new sensor must be used if a session is ended early.

Sensor Sessions

These instructions are specific to Dexcom G7 sensor.* For information on Dexcom G6, please refer to the Tandem Mobi 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 Tandem Mobi system, please refer to its user guide.

Tap Settings from the Navigation bar.
Tap CGM and then Dexcom G7 from the Select Sensor screen.

Note: The system uses device authentication to ensure data security and patient confidentiality.

Tap the Pairing Code field to enter the 4-digit pairing code, which can be found on sensor applicator or Dexcom mobile app. Enter pairing code again.
Tap Done and then Save to continue.

Note: If using the Dexcom G7 mobile app, you must start a sensor session and enter the pairing code on both the Tandem Mobi mobile app and Dexcom G7 mobile app.

The Sensor Paired screen will appear to confirm. Tap Done to continue.
A CGM trend graph and sensor startup countdown symbol will appear on the Dashboard.

Note: If continuing an active sensor session, the startup period will take five to 10 minutes.

The symbol fills in over time to show how much time is left.
After the startup period, the new sensor session will begin.

Troubleshooting

If the Out of Range Alert is on the screen (pictured on the right), then the sensor is not communicating with the pump. Refer to the Connection Tips Quick Reference for guidance.
When a sensor glucose read-ing cannot be provided, “- – -” shows in the place where the sensor glucose value is normally shown. Wait 30 minutes and do not enter blood glucose values for calibration.

Need technical help? See who to contact when experiencing issue(s).

CGM sold separately.

Important Safety Information: RX ONLY. Tandem Mobi system: The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in per-sons 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 intended for single patient, home use and requires a prescription. The pump is indicated for use in individuals 6 years of age and greater. Control-IQ technology: Control-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM, sold separately) and alternate controller enabled (ACE) pumps 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 6 years of age and greater. Control-IQ technology is intended for single patient use. Control-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin.

WARNING: Control-IQ technology should not be used by anyone under the age of 6 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 a Tandem insulin 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 Tandem 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.

Dexcom Brief Safety Statement: Failure to use the Dexcom Continuous Glucose Monitoring System and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety- information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the Dexcom CGM do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency.

© 2024 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, the Tandem logo, Tandem Mobi, and Control-IQ 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. All third-party marks are the property of their respective owners. ML-1013966_A

Automatic Sensor Shut-Off

The Sensor Expiring Soon screen will appear 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.

Note: After the sensor has expired, a 12-hour grace period will begin with additional reminders. During this period, the pump will continue to receive sensor glucose readings and allow use of Control-IQ technology.

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 CGM, then CGM Info from the Settings menu to view.

Note: The amount of time left on the current CGM sensor session can also be found under the Current Status section of the Dashboard.

These instructions will show pump users how they can manually stop a sensor session. If a sensor session is ended early, the user cannot start the session again with the same sensor. A new sensor must be used.