Description

The Shiley Paediatric Tracheostomy Tube is a specialized medical device designed to provide reliable airway management for neonatal and paediatric patients. Available in both cuffless and cuffed variants, it offers versatility to meet diverse clinical needs. The cuffed version features a Taper Guard cuff, enhancing air leak management and minimizing removal force.

Key Features

• Transparent, Soft Flange: Enhances comfort and allows for easy visualization of the skin.
• Comfort Recess on Connector: Minimizes stoma irritation.
• Higher Flange Angle: Provides an improved fit, with specific models (PEF, PCF, PELF, PLCF) incorporating this design.
• Single Cannula Design: Simplifies use and maintenance.

Usage and Compatibility

Each tube is intended for single use, supplied in sterile packaging, and should not be re-sterilized or reused. The device includes a neck strap for secure placement and an introducer/obturator to assist with insertion. A standardized 15 mm connector ensures compatibility with ventilation and anesthesia equipment. Additionally, the tube is MRI compatible, offering an alternative when other tubes are unsuitable.

Sizing Options

The tube is available in multiple sizes, with internal diameters ranging from 2.5mm to 6.5mm and lengths from 39mm to 56mm, including extra-long options. This range allows for tailored fitting to individual patient needs.

Materials

Constructed from medical-grade polyvinyl chloride (PVC) with a citric-based non-phthalate plasticizer, the tube and flange are designed for safety and biocompatibility. The connector is also made from PVC, while the obturator is crafted from medical-grade polypropylene. The tie strap is made of cotton.

Regulatory Compliance

The Shiley Paediatric Tracheostomy Tube meets several international standards, including ISO 5366-1:2000 and ISO 5356-1:2004. It holds FDA 510(k) clearance (K122531) and is classified as a Class II medical device. It is intended for prescription use only.

Care Guidelines

Proper care and maintenance are essential for safe use. Suctioning should be performed with appropriate catheter sizes and pressures, and tie changes should be conducted with care. Tube changes should follow medical team recommendations, employing aseptic techniques. Reusable tubes require thorough cleaning and inspection to ensure continued functionality.

Additional Considerations

The tube may affect vocalization and swallowing, necessitating assessment by speech pathologists. It is compatible with one-way speaking valves, except when the cuff is inflated or foam-filled. As the Shiley Paediatric Tracheostomy Tube transitions to the Shiley Flex line, users can expect design enhancements such as a clear flange and updated cuff design.