Description

The SG Anaesthetic Pack, also known as the Sage® Anaesthetic Pack, is a meticulously designed sterile, single-use solution tailored for anaesthetic procedures in medical settings. This pack is crafted to enhance convenience and efficiency, providing a complete sterile setup on demand, thereby minimizing infection risks and saving valuable setup time.

Key Features

• Single-Use Sterility: Each pack is designed for one-time use, ensuring a consistently sterile environment for both surgical and outpatient procedures.
• Aseptic Design: The pack's aseptic design significantly reduces the risk of infection, making it an ideal choice for healthcare professionals.
• Puncture-Resistant Tray: Equipped with a puncture-resistant tray, the pack ensures durability and reliability without compromising sterility.
• Compact Size: Its small size allows for minimal storage requirements, making it a practical addition to any medical facility.

Environmental and Safety Compliance

• Latex-Free and PVC-Free: The pack is free from latex and PVC, reducing potential allergic reactions and environmental impact.
• Safe Disposal: Designed for environmentally safe disposal through incineration.
• Certification: CE certified and compliant with ISO 13485 standards, ensuring adherence to international quality management systems.

Sterilization and Biocompatibility

• Sterilization Methods: Depending on the variant, sterilization is validated by EN ISO 11135-1 (ethylene oxide) or EN ISO 11137-1 (radiation).
• Biocompatibility: Complies with ISO 10993 standards, ensuring the materials used are safe for medical applications.

Shelf Life and Storage

• Shelf Life: Offers a shelf life of up to 5 years, with the exception of SKU 300605, which has an 18-month shelf life.
• Storage Conditions: Recommended to store in a dry, warm place away from strong light to maintain integrity.

Common Components

The pack includes essential components such as:

• Multipurpose tray
• Green gauze swabs
• Towels
• Field drapes
• Syringes and needles

These components are designed to meet the diverse needs of anaesthetic procedures, providing versatility and reliability.

Material Specifications

• Polypropylene Construction: The tray, barrel, and plunger are made from polypropylene, with polycarbonate used in specific variants.
• Medical Grade Materials: Includes medical grade silicone oil as a lubricant and latex-free elastomer for stoppers.
• Trace Chemicals: Contains trace amounts of animal-derived chemicals, compliant with relevant safety standards.

Variants

The SG Anaesthetic Pack is available in several configurations, each tailored to specific procedural needs. These variants include different assortments of swabs, needles, syringes, and drapes, providing comprehensive solutions for various medical environments.

Compliance and Standards

The pack meets rigorous international standards for medical devices, including:

• EN ISO 11607 (Packaging)
• EN ISO 14971 (Risk Management)
• IEC 62366-1 (Usability Engineering)

This comprehensive compliance ensures that the SG Anaesthetic Pack is a trustworthy and effective tool for healthcare professionals, enhancing the standardization and safety of anaesthetic procedures.