Description

The EQUASHIELD Syringe Unit is an integral component of the EQUASHIELD Closed System Transfer Device (CSTD), specifically engineered for the safe handling of hazardous drugs. This single-use, fully encapsulated syringe is designed to protect healthcare workers from exposure to hazardous drug vapors, aerosols, and spills, while also preventing environmental contamination.

Key Features

• Encapsulation: The syringe barrel and plunger rod are fully encapsulated, ensuring a closed system that minimizes contamination risks.
• Leak Prevention: Features such as leak-free disconnects and airtight vapor containment enhance safety during drug preparation and administration.
• Pressure Equalization: A built-in pressure equalization system with sterile air negates the need for external air chambers, maintaining system integrity.
• Secure Connections: The syringe includes a permanently bonded connector and a double membrane locking system, providing dry, leak-proof connections.
• Needle Safety: Dual internal needles remain within the system, eliminating the risk of needle sticks.

Compliance and Safety

This device is FDA 510(k) cleared and CE marked, classified under specific regulations for handling antineoplastic and hazardous drugs. It complies with multiple ISO standards and USP Class IV guidelines, ensuring it meets stringent safety and quality requirements. The syringe is non-pyrogenic, nontoxic, and provided sterile, free from DEHP, natural rubber latex, and BPA.

Usage Instructions

The EQUASHIELD Syringe Unit is intended for single use and should not be resterilized or reused. It is designed for use under the supervision of a pharmacist or healthcare professional and is not suitable for use with blood products or high-pressure infusion systems. Compatibility with various adaptors allows seamless integration with IV bags, vials, catheters, and infusion sets, maintaining a closed system throughout drug handling.

Technical Specifications

Available in sizes ranging from 1mL to 60mL, the syringe features non-coring needle tips and specific priming volumes to suit different medical needs. The materials used in construction, such as polypropylene and stainless steel, are carefully selected to ensure safety and compatibility.

Packaging

The syringes are packaged in quantities suitable for clinical settings, with inner boxes and cases tailored to different syringe sizes. This thoughtful packaging design supports efficient inventory management in healthcare environments.

Intended Use

Designed for licensed pharmacists and healthcare professionals, the EQUASHIELD Syringe Unit is ideal for use in hospitals and clinics, particularly in chemotherapy settings. It facilitates the safe compounding and administration of both hazardous and non-hazardous drugs, aligning with the highest standards of medical safety and efficacy.