Guardian™ 4 Sensor User Guide

Introduction

The Guardian™ 4 sensor is part of the continuous glucose monitoring (CGM) system. The sensor converts small amounts of glucose from the subcutaneous tissue into electrical signals. The system then uses these signals to provide the sensor glucose value.

The Guardian 4 sensor (MMT-7040Q) is intended for use with the Guardian™ 4 transmitter (MMT-7841Q) to monitor glucose levels in people with diabetes. The sensor is intended to replace fingerstick blood glucose measurements for making decisions about diabetes management.

The sensor is intended for insertion into individuals 7 years of age or older. For individuals between 7 and 17 years of age, the sensor is intended for insertion into the back of the upper arm or the upper buttock. For individuals 18 years of age or older, the sensor is intended for insertion into the back of the upper arm or the abdomen.

Contraindications

There are no contraindications for the use of the Guardian 4. Contraindications related to continuous glucose monitoring can be found in the Guardian application user guide.

Clinical Benefits

The Guardian 4 sensor is part of the continuous glucose monitoring (CGM) system that provides sensor glucose values. The clinical benefits of the system using the Guardian 4 sensor can be found in the Guardian application user guide.

User Safety

Warnings

Read this entire user guide before inserting the Guardian 4 sensor. The one-press insertion device (MMT-7512) is the only insertion device approved for use with the sensor. Failure to follow instructions or using a different insertion device may result in improper insertion, pain, or injury.

Do not attempt to connect a transmitter or data logger that is not compatible with the sensor. The sensor is designed to work only with approved transmitters. Connecting the sensor to an unapproved transmitter or data logger may damage the components and may lead to inaccurate glucose readings. Refer to the Guardian application user guide for a list of compatible products.

Do not use continuous glucose monitoring while taking hydroxyurea (also known as hydroxycarbamide). Hydroxyurea is used to treat certain diseases, such as cancer and sickle cell anemia. The use of hydroxyurea may result in sensor glucose values that are higher than the actual blood glucose values. If you are taking hydroxyurea, your reported sensor glucose values may be significantly higher than your actual blood glucose values.

Check the label of all medications you are currently taking to see if they contain hydroxyurea or hydroxycarbamide as an active ingredient. If you are taking hydroxyurea, consult with a healthcare professional. Use supplemental blood glucose meter values to monitor your glucose levels.

If you are taking medications that contain acetaminophen or paracetamol (including fever reducers and cold medications) while wearing the sensor, your sensor glucose values may be falsely high. The degree of inaccuracy depends on the amount of active acetaminophen or paracetamol in your body and may vary between individuals. For all medications, read the package insert to ensure that the active ingredients do not contain acetaminophen or paracetamol.

Do not operate the sensor near MRI equipment, diathermy equipment, or other devices that generate strong magnetic fields. The sensor's performance has not been tested under these conditions, and its use may not be safe. If the sensor is exposed to strong magnetic fields, do not continue to use it and contact your local Medtronic representative for assistance.

Always check the packaging for damage before use. If the packaging is intact and undamaged, the sensors are sterile and non-pyrogenic. If the sensor packaging is open or damaged, dispose of the sensor immediately in a sharps disposal container. Using a non-sterile sensor may cause infection at the insertion site.

Keep small parts away from children. This product can cause choking, which can lead to serious injury or death.

For Healthcare Professionals and Caregivers:

• Always wear gloves when inserting the sensor. The sensor has a retractable needle. Minor bleeding may occur.
• To remove the needle cover from the sensor, cover the sensor with a sterile gauze.

Precautions

After inserting the sensor, dispose of the needle cover immediately in a sharps disposal container to prevent accidental needle-stick injuries.

Observe the insertion site for bleeding (under, around, or on the sensor).

If bleeding occurs, do the following:

1. Apply even pressure to the area with a sterile gauze or clean cloth for up to three minutes. Using non-sterile gauze may lead to infection at the insertion site.
2. If bleeding stops, connect the transmitter (or data logger) to the sensor.

If bleeding does not stop, do not connect the transmitter to the sensor, as blood may enter the transmitter's connector and damage the device.

If bleeding does not stop, and causes significant pain or discomfort, or if there is excessive leakage from the plastic base of the sensor, do the following:

1. Remove the sensor and apply even pressure until bleeding stops. Dispose of the sensor in a sharps disposal container.
2. Examine the site for redness, bleeding, irritation, pain, tenderness, or swelling. Treat these conditions according to your doctor's instructions.
3. Insert a new sensor at a different site.

For questions or concerns about using the sensor, contact your local Medtronic customer service for assistance.

For medical questions or concerns, consult a healthcare professional.

If a serious incident occurs with the device, report it to a healthcare professional immediately.

Healthcare professionals: Report serious incidents to Medtronic and the relevant authorities.

Precautions

• Wash your hands thoroughly with soap and water before inserting the Guardian 4 sensor to prevent infection at the insertion site.
• Do not insert the sensor through a bandage. Inserting the sensor through a bandage may cause improper insertion and function of the sensor.

Use alcohol to prepare the insertion site. Using alcohol to prepare the insertion site ensures that no residue remains on the skin.

Rotate the sensor insertion site so that no single site is used too often. Do not clean, re-sterilize, or attempt to remove the needle cover from the needle. Doing so may cause accidental injury or puncture.

Sensors are for single use only. Reusing a sensor can damage the sensor surface, lead to inaccurate glucose readings, or cause irritation or infection at the insertion site.

Risks and Side Effects

The Guardian 4 sensor is not intended for use by children. The sensor can cause choking, which can lead to serious injury or death.

Other risks associated with using the sensor include:

• Skin irritation or other reactions
• Bruising
• Discomfort
• Redness
• Bleeding
• Pain
• Rash
• Infection
• Lumps or bumps at the insertion site
• Small, freckle-like spots at the needle insertion site
• Allergic reactions
• Fainting associated with anxiety or fear related to needle insertion
• Pain or tenderness
• Swelling at the insertion site
• Sensor splitting, breaking, or other damage
• Minor blood leakage associated with removing the sensor needle
• Redness from adhesives or tape, or both
• Scarring

Hazardous Substances

Allergens

None known.

Reagents

The Guardian 4 sensor contains two biological reagents: glucose oxidase and human serum albumin (HSA). Glucose oxidase is derived from Aspergillus niger and manufactured using proprietary technology to meet industry requirements for the extraction and purification of enzymes used in diagnostics, immunodiagnostics, and biotechnological processes. The HSA used in the sensor consists of purified and dried V. albumin fraction, derived from pasteurized human serum cross-linked with glutaraldehyde. Approximately 3 µg of glucose oxidase and approximately 10 µg of HSA are used per sensor. HSA has been approved for use in intravenous infusions for human use in much larger quantities than what the sensor contains.

Sensor Removal

To replace the Guardian 4 sensor, disconnect the Guardian transmitter from the sensor as described in the transmitter user guide. To remove, gently pull the sensor from the body. Dispose of the sensor in a sharps disposal container.

Components

• One-press insertion device: A. Bulge on both buttons, B. Fingerprint indicator
• Glucose sensor assembly: A. Socket, B. Needle cover, C. Sensor, D. Clear protective layer
• Sensor base: A. Sensor connector, B. Sensor lock tabs
• Transmitter
• First oval adhesive patch: A. Liner 1, B. Liner 2
• Second oval adhesive patch: A. Liner 1, B. Liner 2

Sensor Insertion Site

Choose an insertion site appropriate for your age. Focus on the shaded areas and ensure the insertion site has sufficient adipose tissue.

Ages 7-17

Upper buttock

Back of upper arm

Insertion into the abdomen has not been evaluated for accuracy in individuals aged 7-17.

Note: For insertion into the upper buttock, focus on the upper third of the buttock. Insertion of the sensor into the back of the upper arm or upper buttock may require assistance from another person. If you do not need assistance, a mirror may be helpful for self-insertion.

Ages 18 and Older

Back of upper arm

Abdomen

Insertion into the upper buttock has not been evaluated for accuracy in individuals aged 18 and older.

CAUTION! Avoid the area within 5.0 cm (2 inches) of the navel to ensure a comfortable insertion site and proper adhesion of the sensor.

To ensure the best possible sensor glucose measurement and to prevent accidental dislodgement of the sensor:

• Do not insert the sensor into a muscle, hardened skin, or scar tissue.
• Avoid areas covered by clothing or accessories.
• Avoid areas under the waistband of your belt or pants.
• Avoid areas that are subject to increased movement during physical activity.

Sensor Insertion

CAUTION! Always wear gloves when inserting the sensor into another person to avoid contact with the patient's blood. Minor bleeding may occur. Contact with the patient's blood can cause infection.

1. Wash hands thoroughly with soap and water.
2. Select an insertion site that has sufficient adipose tissue.
3. Clean the insertion site with alcohol. Allow the area to dry.
4. Open the sensor package.
5. Grasp the base and remove the glucose sensor assembly from the package. Place the base on a clean, flat surface, such as a table.
6. Ensure the sensor's adhesive tab is under the sensor connector and sensor lock tabs. Correct ❌ Incorrect ✔️
7. Place one thumb on the fingerprint indicator to hold the insertion device. Your fingers should not touch the insertion buttons. Correct ✔️ Incorrect ❌ Use thumb on the fingerprint indicator.
8. Press the insertion device onto the base until it snaps into place, ensuring the bottom of the insertion device remains flush with the table surface.
9. Place two fingers of one hand on the bottom of the base. With your other hand, grasp the insertion device and pull it upward. Note: The arrow on the side of the insertion device indicates the alignment of the needle inside the insertion device.

CAUTION! Never point the loaded insertion device at any part of your body where you do not intend to insert it. Accidental pressing of the button can inject the sensor needle into an unintended location, causing minor injury.

10. Place the insertion device onto the prepared insertion site.
11. Press both buttons of the insertion device simultaneously, then release them. Keep the insertion device on the insertion site for at least five more seconds to allow the adhesive to stick to the skin.
12. Lift the insertion device off the insertion site. When lifting the insertion device, do not press the buttons with your fingers.

Sensor base: A. Sensor lock tabs, B. Sensor connector, C. Adhesive tab, D. Adhesive liner, E. Adhesive pad.

If you are inserting the sensor without assistance, proceed to step 13a. If a healthcare professional or caregiver is assisting with sensor insertion, proceed to step 13b.

Patient:

13. a. Hold the sensor base against the skin at the sensor connector and at the opposite end of the sensor base. Hold the needle cover at the top and slowly pull it straight up, away from the sensor.

Healthcare Professional or Caregiver:

13. b. Wrap sterile gauze around the sensor. Hold the sensor base against the skin at the sensor connector and at the opposite end of the sensor base. Hold the needle cover at the top and slowly pull it straight up, away from the sensor.

CAUTION! Always observe the insertion site for bleeding. If bleeding occurs under, around, or on the sensor, apply even pressure to the area with sterile gauze or a clean cloth for up to three minutes. Using non-sterile gauze may lead to infection. If bleeding does not stop, remove the sensor and apply even pressure to the area until bleeding stops.

Note: An additional adhesive (e.g., Skin Tac™) may be used after applying the oval patch. If using an additional adhesive, apply it to the skin, under the adhesive pad, before removing the liner. Adhesives can also be applied to the adhesive pad or the skin around the sensor base. Allow the adhesive to dry before proceeding.

14. Remove the adhesive liner from the adhesive pad. Pull the liner off the sensor while keeping it close to the skin. Do not pull the sensor when removing the liner.

Note: Do not pull the liner off the square adhesive tab. This tab will be used later to secure the transmitter.

Note: If the sensor base moves, hold the sensor base.

15. Press the adhesive pad firmly onto the insertion site to ensure the sensor base remains on the skin.
16. Pull the adhesive from under the sensor connector.
17. Straighten the sensor's adhesive tab so that it lies flat against the skin.

Oval Patch Placement

1. Remove the liner labeled 1.
2. Place the patch and press down firmly. The wider part of the patch covers half of the sensor base.
3. Remove the liners labeled 2 on both sides.
4. Smooth the patch.
5. Attach the transmitter to the sensor. Note: Wait until the transmitter's green light flashes. If the green indicator light does not flash, refer to the troubleshooting section of the Guardian 4 transmitter user guide.
6. Cover the transmitter with the adhesive patch. Note: Do not pull the tab too tight.
7. To apply the second patch, remove the liner labeled 1.
8. Place the second patch in the opposite direction of the first patch, then place it on the transmitter. Press down firmly. The wider part of the patch covers the end of the transmitter and the skin.
9. Remove the liners labeled 2 on both sides.
10. Smooth the patch.

Note: For details on entering sensor settings on a compatible display device, refer to the Guardian application user guide.

Maintenance

Cleaning

The Guardian 4 sensor is a single-use, disposable device. It does not require cleaning or maintenance.

Storage

CAUTION! Do not freeze, expose to direct sunlight, extreme temperatures, or high humidity. These conditions may damage the sensor.

Sensors should only be stored at room temperature between 2 °C and 27 °C (36 °F and 80 °F).

Dispose of the sensor after the expiration date indicated on the label, or if the packaging is damaged or the protective film has been opened.

Disposal

Dispose of the Guardian 4 sensor in a sharps disposal container.

Technical Specifications

Approximate Dimensions

3.8 x 6.7 x 5.2 centimeters (1.5 x 2.6 x 2.0 inches)

Approximate Weight

2.80 grams (0.09 ounces)

Sensor Usability

The Guardian 4 sensor is for single use and has a maximum lifespan of 170 hours (seven days). The 170-hour lifespan of the sensor begins when the sensor is connected to the transmitter.

Symbol Explanation

• Expiration Date
• MD Medical Device
• Import
• Do not reuse
• Attention! Refer to the user manual for important warnings or precautions not indicated on the label.
• (1x) One sensor per box/package
• (5x) Five sensors per box/package
• (2x) Two patches per package
• (10x) Ten patches per package
• i Refer to the user manual.
• REF Catalog Number
• LOT Lot Number
• STERILE R Sterilized by radiation
• XX°C / XX°F Storage temperature limits
• Do not use if packaging is damaged!
• Single sterile barrier system
• Open here
• Manufacturer
• Date of manufacture
• Not reusable
• Fragile, handle with care
• Keep dry
• Contains recyclable, recycled components
• EC REP Authorized representative in the European Community
• CE0459 Conformité Européenne (European conformity). This symbol indicates that the device fully complies with the relevant European Union legislation.
• MR Unsafe Magnetic resonance imaging is not safe
• Not pyrogenic
• Rx Only Available in the United States by prescription only

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