Description

Eitan Medical's Sapphire Infusion Sets are meticulously engineered for seamless integration with the Sapphire family of infusion pumps. These sterile, single-use sets are crafted to deliver precise fluid and medication administration across various medical settings, including hospitals, ambulatory care, and homecare environments.

Compatibility and Versatility

Designed exclusively for Sapphire Infusion Pumps, these sets support a wide array of delivery modes such as continuous, PCA, intermittent, TPN, PCEA, and epidural infusions. This versatility ensures they meet the diverse needs of both adult and pediatric patients, providing reliable performance in intravascular, subcutaneous, intra-arterial, perineural, and epidural routes.

Advanced Safety Features

Each infusion set is equipped with a dedicated administration cassette featuring a dual anti-free-flow mechanism, significantly enhancing patient safety. Additional safety measures include air-in-line detection, flow error alarms, and end-of-infusion alerts. These features, combined with programmable alarms and security lock levels, offer healthcare providers peace of mind during critical care delivery.

Material Specifications

Manufactured without natural rubber latex or DEHP, the sets are made from non-pyrogenic, biocompatible materials, ensuring they meet high safety standards. The availability of NRFit™ connectors in epidural sets further reduces the risk of misconnections, aligning with ISO 80369-6 compliance for safer neuraxial therapy.

Diverse Configurations

Sapphire Infusion Sets come in a variety of configurations, including primary, secondary, microbore, macrobore, and epidural options. Features such as filters, Y-sites, backcheck valves, and different tubing lengths and diameters provide tailored solutions for specific clinical needs. Enhanced labeling and packaging improvements, such as enlarged fonts and transition to pouch packaging, contribute to better usability and reduced waste.

Accessory Options

Complementary accessories like mini cradles, PCA lockboxes, travel cases, and bolus handles enhance the functionality and convenience of the infusion system. These accessories are designed to integrate smoothly with the infusion sets, offering comprehensive support for healthcare professionals.

Regulatory Compliance

Classified as a Class II medical device by the FDA, these infusion sets are intended for use by licensed healthcare professionals and lay users in various clinical and home settings. Their design ensures compliance with stringent regulatory standards, providing controlled delivery of a wide range of fluids and medications, including saline, TPN, lipids, IV medications, and blood products.

Operational Guidelines

The sets require priming before use, with instructions provided in the dedicated Directions for Use. They are prescription-only devices, emphasizing the importance of adhering to proper operational protocols to ensure safe and effective infusion therapy.