Description

The EQUASHIELD Syringe Unit is an advanced closed system transfer device (CSTD) meticulously designed to enhance safety in the handling of hazardous drugs. This fully encapsulated, preassembled unit is an integral part of the EQUASHIELD product line, aimed at healthcare professionals working in environments such as hospital pharmacies and oncology clinics.

Key Features

• Encapsulation: The syringe barrel and plunger rod are fully encapsulated to prevent contamination and the escape of hazardous drug vapors, aerosols, and spills.
• Pressure Equalization: Built-in closed pressure equalization with sterile air eliminates the need for exterior air chambers.
• Leak Prevention: Features a double membrane locking system and a unidirectional check valve to ensure dry, leak-free connections.
• Needle Design: Shielded, non-coring needle design reduces the risk of accidental needle sticks.

Safety and Compliance

• Microbial Ingress Prevention: Proven to prevent microbial ingress for up to 7 days with 10 repeated accesses.
• Material Composition: Constructed from materials such as polypropylene and stainless steel, free from DEHP, BPA, and natural rubber latex.
• Sterilization: Sterilized using ethylene oxide, ensuring non-pyrogenic and nontoxic properties.
• Regulatory Approvals: FDA 510(k) cleared and CE marked, complying with relevant safety standards.

Compatibility and Use

• Drug Compatibility: Suitable for use with drugs like Busulfan, Etoposide, Paclitaxel, and Treanda.
• Adaptor Integration: Designed to work seamlessly with various adaptors within the EQUASHIELD system.
• Size Variants: Available in sizes ranging from 1 mL to 60 mL, with specific needle specifications for precise application.
• Single Use: Intended for single use only, not suitable for blood products or high-pressure infusion systems.

Intended Use

The EQUASHIELD Syringe Unit is specifically intended for the preparation, compounding, and administration of antineoplastic and other hazardous drugs. It effectively minimizes exposure to drug vapors and prevents environmental contamination, making it an essential tool for healthcare settings that handle such substances.

Instructions for Use

• Connection: Attach the appropriate adaptor and align red orientation marks before connecting.
• Operation: Withdraw or inject fluids as needed, ensuring proper disconnection by following the lever mechanism.
• Flushing: Adhere to specific flushing guidelines to maintain system integrity.

Packaging

The Syringe Unit is packaged in various quantities, providing flexibility to meet the needs of different healthcare facilities. Each unit is provided sterile, ensuring readiness for immediate use by licensed professionals such as pharmacists and nurses.