Description

The ET Tube Preformed Cuffed Oral is a specialized medical device designed for effective airway management during anesthesia, surgery, and critical care. Its preformed shape, known as the RAE type, is engineered to maintain a patent airway while keeping the breathing circuit clear of the surgical field, particularly beneficial in oral and maxillofacial procedures.

Key Features

• Anatomical Design: The preformed curvature minimizes kinking and ensures stable positioning, enhancing surgical access by directing the tube away from the operative area.
• Cuff Design: Equipped with a high-volume, low-pressure cuff at the distal end, it provides a secure seal against the tracheal wall to prevent aspiration and support positive pressure ventilation. The cuff is managed via a pilot balloon with a one-way valve.
• Material: Constructed from medical-grade PVC or silicone, the tube is latex-free and available in clear or opaque forms for visual inspection.

Connectivity and Safety

• Universal Connector: A 15 mm connector at the proximal end allows easy attachment to ventilator tubing or bag-valve-mask systems.
• Tip Features: The smooth, beveled tip and polished Murphy eye facilitate atraumatic intubation and help prevent complete obstruction.
• Radiopaque Line: A fully embedded radiopaque strip along the tube enables X-ray visualization for accurate placement confirmation.

Usage and Packaging

• Depth Markings: Graduated markings in centimeters assist in precise depth placement.
• Sterility: Each tube is individually packaged, sterile, and intended for single use, ensuring hygiene and convenience.
• Size Variability: Available in sizes suitable for both pediatric and adult patients, with internal diameters ranging from 3.0 mm to 9.5 mm.

Intended Use

The ET Tube Preformed Cuffed Oral is ideal for securing a definitive airway, providing mechanical ventilation, and protecting against aspiration in various clinical settings. It is particularly useful in cases where oral intubation is required, and it should be used with caution in patients with severe airway trauma or specific facial injuries.

Certifications and Standards

The device adheres to high standards of quality and safety, with certifications such as CE, ISO13485, FDA, and CFDA, depending on the manufacturer. It is E.T.O. sterilized and pyrogen-free, aligning with stringent medical guidelines.

Maintenance Guidelines

Designed for single patient use, the tube should not be reused and is recommended for a maximum duration of up to 14 days. Prompt removal is advised once the patient can maintain their own airway to prevent potential complications such as tracheal injury or infection.