Medtronic Guardian 4 Sensor – Continuous Glucose Monitoring

Product Overview

The Guardian 4 sensor is a part of the Continuous Glucose Monitoring (CGM) system, which is used to manage diabetes more effectively. It functions by changing minute levels of glucose from the interstitial fluid beneath the skin into an electronic signal. It is utilized to offer real-time glucose data. This sophisticated system provides glucose values in real-time to facilitate improved diabetes management.

Indications for Use:

The Guardian 4 sensor (MMT-7040) is designed specifically for patients seven years and older to track glucose levels for diabetes care. It is an adjunctive device that is meant to supplement, not replace, standard blood glucose monitoring. The sensor is single-use and should be prescribed by a healthcare provider. The Guardian 4 sensor is capable of up to seven days’ continuous glucose monitoring. Always see the system user guide for treatment information.

Components:

1. One-Press Serter:

• Bump on both buttons
• Thumbprint marking

2. Glucose Sensor Assembly:

• Pedestal
• Needle housing
• Sensor
• Clear liner

3. Sensor Base:

• Sensor connector
• Sensor snaps

4. Transmitter

5. First and Second Pieces of Oval Tape

Where to Insert the Guardian 4 Sensor:

Choosing the correct insertion point is important for optimal sensor glucose performance. Choose a site with sufficient subcutaneous fat and avoid muscle, scar tissue, or hard skin sites.

• 7-17 years of age: Upper back of arm
• 18 years of age and above: Upper back of arm

For optimal functioning and to avoid sensor removal:

• Avoid sites that are restricted by clothes or accessories.
• Stay away from locations exposed to strong movements in the course of physical activity.

How to Insert the Sensor:

1. Prepare the Site of Insertion:

Wash hands thoroughly using soap and water. Select an appropriate site with adequate subcutaneous fat and disinfect the site using alcohol. Let the area air dry.

2. Prepare the Sensor:

Open the package of the sensor, take out the glucose sensor assembly, and position the pedestal on a clean flat surface such as a table. Make sure adhesive tab is folded under the sensor connector and sensor snaps.

3. Using the Serter:

Grip the serter with one hand, ensuring your fingers don’t touch the buttons. Push the serter down onto the pedestal until it clicks. With two fingers on the base of the pedestal, pull the serter upwards.

4. Insert the Sensor:

Position the serter on the prepared site of insertion. Press and release both buttons on the serter simultaneously. Keep the serter in position for a minimum of five seconds to allow the adhesive to adhere to the skin.

5. Securing the Adhesive:

Lift the serter off without pressing the buttons. Take off the adhesive liner from beneath the adhesive pad, hugging the skin closely. Press the adhesive pad tightly against the skin so that the sensor will remain in position.

6. Place the Transmitter:

Straighten the sensor adhesive tab flat against the skin. Remove the liners labeled “1” and “2” and apply the tape as directed, pressing firmly. Secure the transmitter to the sensor and verify a flashing green light. If the light fails to flash, see the troubleshooting section of the Guardian 4 transmitter user guide. Lastly, cover the transmitter with the adhesive tab.

MiniMed Guardian Sensor 4 Features:

High Accuracy: Medtronic’s most accurate sensor with a MARD rating of 8.7% when used with the CONTOUR®NEXT LINK 2.4 Meter.

• Easy Insertion: Simple and convenient insertion process.
• Flexible Design: Designed to move with your body for maximum comfort.
• Real-time Glucose Monitoring: Provides continuous updates on your glucose levels and trends.

Additional Information

• The Guardian 4 sensor is for prescription use only and offers real-time glucose monitoring for seven days.
• Make sure you read all the instructions and safety precautions in the user guide to achieve the best results.

How to Remove the Guardian 4 Sensor

• Remove the transmitter from the sensor as outlined in the Guardian 4 transmitter user guide.
• Carefully remove the sensor from the body.
• Dispose of the sensor in a sharps container.

Warnings

Read this entire user guide before trying to insert the Guardian 4 sensor. The one-press serter (MMT-7512) is the only approved serter for use with the sensor. Not following instructions or using another insertion device can lead to improper insertion, pain, or injury.

Never try to couple an approved transmitter or recorder that is not compatible with the sensor. The sensor is only compatible with approved transmitters. Coupling the sensor with a transmitter or recorder not recommended for use with the sensor can cause damage to the components. Consult the system user guide to obtain a list of compatible products.

Precautions:

• Before inserting the sensor, clean your hands with soap and water to avoid any infection of the site.
• Avoid inserting the sensor through tape, which can result in incorrect insertion and operation.
• Prepare the insertion site only with alcohol and make sure no residue remains on the skin.
• Rotate the sensor insertion site to maximize the sites being utilized.
• Do not try to clean, resterilize, or remove the needle from the needle housing because this can lead to accidental needlestick or puncture.
• Do not reuse the sensor; it can damage the sensor surface and result in inaccurate glucose values, site irritation, or infection.