Guardian™ 4 Sensor User Guide

Introduction

The Guardian 4 sensor is a key component of the Continuous Glucose Monitoring (CGM) system. It works by converting small amounts of glucose from the interstitial fluid beneath the skin into an electronic signal. This signal is then processed by the system to provide accurate sensor glucose values.

Indications for Use

The Guardian 4 sensor (MMT-7040) is designed for monitoring glucose levels in individuals aged seven and older for diabetes management. It serves as an assistive device, complementing rather than replacing standard blood glucose monitoring devices. The sensor is intended for single use and requires a prescription. It is approved for continuous use of up to seven days. For treatment decisions, users should refer to the system user guide.

User Safety and Precautions

It is crucial to read the entire user guide before attempting sensor insertion. The one-press serter (MMT-7512) is the only approved device for insertion. Failure to follow instructions or using a different insertion device may lead to improper insertion, pain, or injury. Ensure compatibility with approved transmitters and recorders, as using unapproved devices may cause damage. Avoid using continuous glucose monitoring if taking hydroxyurea, as it can lead to inaccurate readings and potential hypoglycemia. Medications containing acetaminophen or paracetamol may also falsely elevate readings. Protect the sensor from strong magnetic fields like MRI equipment. Always inspect the packaging for damage before use; a damaged package may compromise sterility and lead to infection. Keep small parts away from children due to choking hazards. Pregnant or critically ill individuals should consult a healthcare professional before use, as sensor performance in these populations is not fully studied.

Healthcare professionals and caregivers: Always wear gloves during insertion. Minimal bleeding may occur. Use sterile gauze to remove the needle housing and discard it in a sharps container. Monitor the insertion site for bleeding.

If bleeding occurs: Apply steady pressure with sterile gauze for up to three minutes. If bleeding stops, connect the transmitter. If it persists, do not connect the transmitter to avoid device damage.

If bleeding continues or causes significant discomfort: Remove the sensor, apply pressure, and discard it. Check the site for adverse reactions and consult a healthcare professional. Insert a new sensor in a different location.

Precautions for use: Wash hands thoroughly before insertion. Do not insert the sensor through tape. Use only alcohol to clean the insertion site. Rotate insertion sites to prevent overuse. Do not attempt to clean or resterilize the needle housing. Do not reuse sensors, as this can lead to inaccurate readings and site irritation.

Risks and Side Effects

Potential risks associated with sensor use include skin irritation, bruising, discomfort, redness, bleeding, pain, rash, infection, raised bumps, allergic reactions, fainting, soreness, swelling at the insertion site, sensor fracture, and scarring. Some users may experience a small "freckle-like" dot at the insertion site.

Reagents

The Guardian 4 sensor contains glucose oxidase derived from Aspergillus niger and human serum albumin (HSA) from pasteurized human serum. These reagents are manufactured to meet industry standards for diagnostic and biotechnical applications.

Removing the Sensor

To change the sensor, disconnect the transmitter as per the transmitter user guide. Gently pull the sensor from the body and discard it in a sharps container.

Components

• One-press serter: Features buttons and a thumbprint marking for secure handling.
• Glucose sensor assembly: Includes a pedestal, needle housing, sensor, and clear liner.
• Sensor base: Comprises a sensor connector and sensor snaps.
• Transmitter: The device that communicates with the sensor.
• Oval tape: Used for securing the sensor, with distinct liner pieces.

Where to Insert the Sensor

Choose an insertion site with adequate subcutaneous fat, suitable for the user's age group. The Guardian 4 sensor is indicated for use on the back of the upper arm only. Using other sites, such as the abdomen or buttocks, may result in performance differences leading to hypoglycemia or hyperglycemia. Assistance may be needed for insertion into the back of the upper arm. Avoid inserting the sensor into muscle, tough skin, or scar tissue, and areas constrained by clothing or subjected to vigorous movement.

Inserting the Sensor

Follow these steps for sensor insertion:

1. Wash hands thoroughly with soap and water.
2. Select an insertion site with sufficient fat.
3. Clean the site with alcohol and allow it to air dry.
4. Open the sensor package.
5. Hold the pedestal and remove the glucose sensor assembly from the package. Place the pedestal on a flat surface.
6. Confirm the adhesive tab of the sensor is correctly tucked under the sensor connector and snaps.
7. Place your thumb on the thumbprint marking to hold the serter, ensuring fingers do not touch the serter buttons.
8. Push the serter down onto the pedestal until it clicks into place.
9. Grip the serter and pull it upwards, ensuring the arrow on the serter aligns with the needle inside. Warning: Never point a loaded serter at any body part where insertion is not desired.
10. Place the serter on the prepared insertion site.
11. Press and release both serter buttons simultaneously. Hold the serter in place for at least five seconds to ensure the adhesive adheres to the skin.
12. Lift the serter away from the insertion site without pressing the buttons.
13. For patients: Hold the sensor base against the skin at the connector and opposite end. Hold the needle housing and pull away from the sensor.
14. For healthcare professionals/caregivers: Wrap sterile gauze around the sensor. Hold the sensor base against the skin and pull the needle housing away from the sensor.