Description

The preformed, cuffed oral endotracheal tube is an essential tool in airway management, particularly designed for oral intubation. Its unique preformed RAE design directs the tube downward, keeping it clear of the surgical field, making it especially beneficial during oral and maxillofacial surgeries.

Key Features

• Anatomical Design: The preformed shape reduces kinking and ensures the tube remains out of the way, providing unobstructed access during surgical procedures.
• High-Quality Material: Constructed from non-toxic, non-irritant medical-grade PVC or high-quality liquid silicone, this tube is latex-free and sterile, ensuring safety and compatibility with a wide range of patients.
• Inflatable Cuff: The high-volume, low-pressure cuff at the distal end provides an effective seal against the tracheal wall, preventing aspiration and enabling positive pressure ventilation. It is managed via a pilot balloon equipped with a one-way valve.

Additional Features

• Universal Connector: A 15 mm connector at the proximal end allows easy attachment to ventilator tubing or bag valve masks.
• Murphy Eye and Beveled Tip: The polished Murphy eye and smooth, atraumatic beveled tip facilitate safer intubation and prevent complete obstruction.
• Radiopaque Line: An embedded radiopaque strip along the tube allows for X-ray visualization, aiding in accurate placement confirmation.
• Depth Markings: Graduated markings in centimeters ensure precise placement.

Usage and Packaging

Each tube is individually packaged in a sterile blister pack, intended for single use only. Available in sizes ranging from 3.0 mm to 9.5 mm internal diameter, it caters to both adult and pediatric needs.

Intended Use

This endotracheal tube is designed for securing a definitive airway, providing mechanical ventilation, and protecting against aspiration during anesthesia, surgery, or respiratory failure. Its design is particularly suited for use in oral and maxillofacial surgeries.

Preparation and Guidelines

Prior to use, the cuff should be tested for leaks. Lubrication of the distal end and cuff is recommended before insertion, and a stylet may assist with shaping and insertion. Placement should be confirmed through clinical assessment and imaging, with the tube secured using tape or a securing device.

Certifications

The product is certified with CE, ISO13485, FDA, and CFDA standards, varying by manufacturer, ensuring compliance with international medical device regulations.

Contraindications and Risks

Contraindications include severe airway trauma or obstructions that may hinder safe placement. Potential complications can include defective balloons or connectors, bleeding, infection, and tracheal injury. Proper handling and adherence to guidelines can mitigate these risks.