Description

The EQUASHIELD Syringe Unit is an integral component of the EQUASHIELD Closed System Transfer Device (CSTD), specifically engineered to safeguard healthcare professionals from exposure to hazardous drugs. Its design is pivotal in preventing environmental contamination during the preparation, reconstitution, compounding, and administration of such drugs.

Key Features

• Encapsulated Design: The syringe barrel and plunger rod are fully enclosed, ensuring isolation of both rear and front chambers.
• Pressure Equalization: Features a built-in, self-sufficient system with sterile air, maintaining airtight and leak-proof connections.
• Permanent Connector: The connector is permanently bonded to the syringe body, preventing accidental disconnections.
• Leak-Proof Connections: Guarantees dry, leak-free drug transfer and administration.
• Microbial Ingress Protection: Proven to prevent microbial ingress for up to 7 days with up to 10 accesses.
• Needle Stick Safety: Incorporates a non-coring, pencil-point needle design that never penetrates the vial rubber stopper.

Usage and Compatibility

The Syringe Unit is intended for single use, provided sterile, and requires no priming, making it ready-to-use. It is compatible with both hazardous and non-hazardous drugs, particularly in chemotherapy settings, and is designed exclusively for use by licensed healthcare professionals. The unit is not intended for use with blood or high-pressure infusion systems.

Material Composition

• Syringe Body and Connector Housing: Made from polypropylene.
• Plunger Rod and Cannula: Constructed from stainless steel.
• Other Components: Include materials such as polyisoprene, POM, silicone, and ABS.
• Free from DEHP, Latex, and BPA: Ensuring safety and compatibility.

Available Sizes

The Syringe Unit is available in various sizes ranging from 1 mL to 60 mL, with specific packaging options tailored to each size.

Technical Specifications

• Needle Sizes: 17G and 19G with a non-coring pencil-point tip.
• Flow Rate: 11 liters/hour under specified conditions.
• Closed System: Features a double membranous filter that is both air and water tight.

Regulatory Compliance

The EQUASHIELD Syringe Unit is FDA 510(k) cleared and complies with relevant ISO standards for medical devices. It is classified as an intravascular administration set and meets USP Class IV compliance.

Instructions for Use

Connection to adaptors is straightforward, involving alignment of red orientation marks and a secure click mechanism. It is designed for injection use with hazardous drugs and allows for fluid transfer between Syringe Units via adaptors. Disconnection is simple, involving a lever mechanism.

Use Restrictions

The unit is prescription-only and not available for over-the-counter sale, ensuring it remains within professional healthcare settings.