Description

Designed specifically for shoulder arthroscopy procedures, this Shoulder Arthroscopy Pack is a comprehensive, sterile, and disposable surgical kit. It aims to enhance surgical efficiency by providing all necessary components to maintain a sterile field, thereby reducing the risk of contamination and infection.

Key Features

• Versatile Design: Suitable for both left and right shoulder procedures, ensuring broad applicability in orthopedic surgeries.
• Comprehensive Components: Includes essential items such as drapes, covers, and select accessories, all tailored for effective surgical site isolation and fluid management.

Material and Construction

• High-Quality Materials: Components are made from SMS non-woven or bi-laminate materials, known for being latex-free, hypoallergenic, antistatic, and lint-free.
• Durability: Tear and wear-resistant with fluid repellent properties, providing high absorbency.
• Color: Predominantly light blue, with some components like towels in white.

Specialized Features

• Integrated Fluid Management: Features a fluid collection pouch with suction ports and malleable wires.
• Secure Placement: Adhesive incise film with pear-shaped or fenestrated aperture, along with U-shaped or split drapes.
• Enhanced Safety: Integrated adhesive edges to minimize micro-organism migration.

Certification and Compliance

• Flammability and Safety: Certified as Class I for low flammability.
• Standards Compliance: Meets EC Certificate, ISO 13485:2016, and relevant EN ISO standards.
• Sterilization: Sterilized using Ethylene Oxide (EO) with a 3-year expiry date.

Packaging and Storage

• Packaging: Typically includes 1 pack per unit, with 6–10 packs per box. Packaged under clean room conditions with medical folding and a peelable label.
• Storage: Store in original closed carton in a dry place, away from humidity, heat, and sunlight.

Intended Use and Safety

• Single-Use Design: Intended for single-use only to prevent bacterial transfer and reduce infection risk.
• Latex-Free: Minimizes the potential for allergic reactions, making it safe for diverse medical environments.

This pack is an essential tool for operating rooms, designed to meet the core requirements for safe, sterile, and efficient shoulder arthroscopy procedures.