Description

Sensor Guardian 4

A medical device that is part of the Smart CGM system – continuous glucose monitoring for people with diabetes (CGM). This system operates independently of an insulin pump. The sensor is designed to replace fingerstick blood glucose tests when making diabetes treatment decisions. The sensor measures glucose levels every five minutes and has a lifespan of up to seven days.

Action

The sensor converts small amounts of glucose from the user's subcutaneous tissue fluid into an electronic signal. The system then uses these signals to produce glucose values ​​from the sensor. The transmitter receives and calculates the data from the sensor and transmits it via Bluetooth® to a compatible smartphone and the Guardian™ app.

Product purpose

Monitoring glucose levels in people with diabetes.

The sensor is intended for insertion in individuals aged 7 years and older. The sensor is intended for insertion in the back of the upper arm or in the upper buttocks in individuals aged 7 to 17 years. The sensor is intended for insertion in the back of the upper arm or in the abdomen in individuals aged 18 years and older.

How to use a medical device

Before attempting to insert the Guardian 4 sensor, read all instructions in the user guide. The one-press serter (MMT-7512W) is the only serter approved for use with the sensor. Failure to follow these instructions or to use a different insertion device may result in improper insertion, pain, or injury.

The Guardian 4 sensor can only be used once and has a maximum lifespan of 170 hours (seven days). The sensor's 170-hour lifespan begins when it is connected to the transmitter.

Contraindications and precautions

Before use, please read the instructions for use or the label.
Do not use if you are allergic to any of the product ingredients.
Keep out of reach of children.
Store in a dry, cool, and dark place. Protect from light and moisture.

Comments

The complete Guardian™ 4 Smart CGM System includes the following components:

• Guardian™ iOS app* (MMT-8200) or Guardian™ Android app*(MMT-8201),
• Guardian™ 4 transmitter (MMT-7841QW2),
• Guardian™ 4 sensor (MMT-7040QD2/QC2) and a compatible tester (MMT-7736L) and charger (MMT-7715).