Critical Safety First: Understanding LinX CGM Warnings and Contraindications

Your Safety is Our Priority

Before using any medical device, understanding its limitations and safety requirements is the most important step you can take. The LinX CGM is a powerful tool for managing diabetes, but its safe and effective use depends on your awareness of specific situations where it should not be used or where extra caution is required. This guide consolidates the most critical safety information from the user manual into a clear, easy-to-understand format.

Absolute Contraindications: When You MUST NOT Use the LinX CGM

There are certain medical procedures and situations where wearing the LinX CGM sensor is unsafe and strictly prohibited. The sensor must be removed prior to any of the following:

• Magnetic Resonance Imaging (MRI): The strong magnetic fields used in an MRI can damage the sensor's electronic components and may cause injury.
• Computed Tomography (CT) Scan: The radiation used in CT scans can interfere with the sensor and has not been evaluated for safety.
• High-Frequency Electrical Heat (Diathermy) Treatment: This medical treatment uses high-frequency electromagnetic currents to generate heat in body tissues, which can damage the sensor and cause harm.

Additionally, certain medications can interfere with the sensor's ability to accurately measure glucose.

• High Doses of Acetaminophen: Taking more than the maximum recommended dose of acetaminophen (for example, more than 1 gram every 6 hours for an adult) may interfere with the sensor's readings, causing them to appear falsely high. Always adhere to medication guidelines and consult your healthcare provider if you have questions.

Important Warnings: Situations Requiring Caution

In the following situations, the LinX CGM system has not been evaluated, or specific actions are required to ensure safety and proper function.

Populations Not Studied

The performance and safety of the LinX CGM System have not been formally evaluated in the following groups. If you fall into one of these categories, you should discuss the use of this device with your healthcare professional:

• Pregnant women
• Individuals undergoing peritoneal dialysis
• Patients with implanted medical devices, such as pacemakers
• Patients with coagulation disorders or those taking anticoagulant medications

When Readings Don't Match Symptoms: The Golden Rule

Your body is your most important indicator. The single most critical rule for using any CGM is this: If your glucose alarms and readings from the system do not match your symptoms or expectations, you must use a fingerstick blood glucose value from a traditional blood glucose meter to make diabetes treatment decisions. For example, if you feel shaky, sweaty, and confused (classic symptoms of hypoglycemia), but your CGM reads in the normal range, trust your symptoms and confirm with a fingerstick. Seek medical attention when appropriate.

Electromagnetic Interference

Your LinX CGM sensor communicates wirelessly. To ensure this communication is not disrupted, portable RF communications equipment (including peripherals like antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the sensor. Keeping your mobile phone and other wireless devices at a reasonable distance will help prevent signal interference that could lead to a degradation of the equipment's performance.

Key Precautions for Accurate Readings and Safe Wear

To get the most accurate and reliable performance from your LinX CGM, please adhere to the following precautions:

• Water Exposure: The sensor is waterproof with an IP68 rating. It can be worn during showers and swimming. However, you should not submerge the sensor in water deeper than 2 meters (about 6.5 feet) or for longer than 1 hour.
• Rapid Glucose Changes: During times of rapid change in your blood glucose (greater than 0.1 mmol/L or 2 mg/dL per minute), such as after a meal or an insulin dose, the glucose level in your interstitial fluid (measured by the sensor) may lag behind your actual blood glucose level. In these cases, sensor readings may not be the same as a fingerstick reading. When your glucose is dropping rapidly, the sensor may read higher than your blood glucose; when it is rising rapidly, the sensor may read lower.
• Dehydration: Severe dehydration or excessive water loss can negatively impact the accuracy of your sensor readings. If you suspect you are dehydrated, consult a healthcare professional immediately.
• Small Parts: The CGM system contains small parts that could be dangerous if swallowed. Keep the components out of reach of children and pets.

Frequently Asked Questions