The Guardian 4 is a continuous glucose monitoring (CGM) sensor developed by Medtronic. It is designed for single use, measuring glucose levels in the interstitial fluid under the skin and transmitting data via Bluetooth to compatible devices such as the Guardian 4 transmitter and MiniMed™ 780G insulin pump systems. It is intended for people with type 1 or type 2 diabetes, aged 7 years and older.

Indications:

• Continuous monitoring of glucose levels in people with type 1 or type 2 diabetes.

• Used as a complementary device for diabetes treatment decisions.

• Suitable for use in both children and adults.

• Single-use sensor with up to 7 days of wear.

The sensor must be inserted subcutaneously using the approved inserter MMT-7512.

After insertion, the sensor transmits glucose data to the Guardian 4 transmitter via Bluetooth.

The transmitter sends data to compatible devices, such as the MiniMed™ 780G system.

Follow the user guide instructions to ensure proper insertion and sensor operation.

Do not use if taking medications containing acetaminophen (paracetamol), as this may interfere with glucose readings.

Do not use the sensor with MRI machines or other equipment that generates strong magnetic fields.

Avoid use if taking hydroxyurea, as it may affect sensor accuracy.

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