Description

The ENTERAL ENFIT SYRINGE is a specialized medical device crafted for the safe administration of enteral nutrition, hydration, and medication through feeding tubes. Its design incorporates the ENFit connector system, aligning with ISO 80369-3 standards, to significantly reduce the risk of misconnections with non-enteral systems, thereby enhancing patient safety.

Key Features

• Connector Design: The ENFit connector features a female small-bore design with a secure locking mechanism, ensuring compatibility only with appropriate enteral devices. This prevents wrong-route errors commonly associated with intravenous or luer connectors.

• Size Variability: Available in a range of sizes from 0.5 ml to 100 ml, the syringe caters to diverse needs across neonatal, pediatric, and adult care. Options include standard, low-volume, and high-volume syringes, with specialized versions for rapid delivery or improved ergonomics.

• Material Composition: Constructed from polypropylene and silicone oil, the syringe is free from DEHP, latex, and PVC, ensuring biocompatibility as per ISO 10993 standards. Single-use syringes are sterilized with ethylene oxide for added safety.

Design and Usability

• Construction: Each syringe comprises a three-piece design with a barrel, plunger, and silicone gasket. Clear measurement markings and a distinctive purple color aid in precise dosing and easy identification as an enteral device.

• Reusable Features: Reusable syringes include an O-ring to prevent swelling during cleaning, enhancing longevity and performance.

Intended Use

Suitable for use in both clinical and home care settings, the ENFit syringe is ideal for healthcare professionals and laypersons under supervision. It supports:

• Administration of tube feeds, water flushes, and medications
• Aspirating feeding tubes
• Compatibility with enteral infusion pumps and extension sets

Cleaning and Maintenance

• Single-Use Syringes: Should be discarded after one use and stored in a clean, dry environment.

• Reusable Syringes: Require thorough cleaning with warm soapy water, rinsing with cold tap water, and air drying. They should be stored in a clean container and discarded after 7 days or 40 washes. Special care instructions apply for vulnerable patients, including the use of sterile water or cold sterilizing solutions.

Safety and Compliance

The ENFit system is part of a global initiative to improve safety in enteral feeding, ensuring incompatibility with IV systems. It meets rigorous standards, including ISO 7886-1 and ISO 7886-2, and undergoes extensive testing for performance, sterility, and usability.

Additional Information

Transition adapters may be available for compatibility during system changeovers, as ENFit syringes are not compatible with legacy luer or oral connectors. Intended for prescription use, these syringes should be used under appropriate medical supervision, aligning with the industry standard for enteral feeding and medication administration.