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The Ivenix LVP Epidural Administration Set with NRFit Connector (SET-0030-1) is intended for the controlled administration of pharmaceutical drugs or other therapies via the epidural pathway. The Ivenix LVP Epidural Administration Set is intended only for use with the Ivenix Infusion System in a hospital or outpatient.

The Ivenix LVP Epidural Administration Set with NRFit connector is comprised of a primary channel inlet tubing with a vented cap spike, a cassette which contains the fluid pumping mechanism and serves as the interface to the Ivenix LVP, and outlet tubing for connection to patient access. The end of the outlet tubing is fitted with a NRFit connector that is compliant to ISO 80369-6:2013. The Ivenix LVP Epidural Administration Set with NRFit Connector provides a sterile fluid path for the delivery of pharmaceutical drugs and other therapies via the epidural pathway, provides a means for a clinician to aseptically connect to the fluid source and to the patient access site, and interfaces with the LVP to enable measurement and control of the fluid delivery. The Ivenix LVP Epidural Administration Set with NRFit Connector is intended for use within the Ivenix Infusion System for controlled fluid delivery; it is not recommended for gravity infusion.

The Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration: intra-arterial, epidural, and subcutaneous, to adults, pediatric and neonate patients. Administered fluids may be pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures required for patient therapy. The Ivenix Large Volume Pump (LVP) is indicated for use only with the Ivenix sterile, single use, disposable administration sets, including: Primary dual inlet, single outlet, 1 Y-site Primary single inlet, single outlet Blood Set, dual inlet, single outlet, 1 Y-site, for administration of red blood cells, platelets and plasma Microbore single inlet, single outlet, for administration of epidural fluids Microbore dual inlet, single outlet, 1 Y-site Infusion Management System (IMS): The IMS provides information to the clinician regarding the use of the Ivenix Large Volume Pump (LVP) by way of a drug library, LVP configurations, and by providing remote information regarding LVP status. It also provides information on pump usage data reports to various functions within an institution.

The Ivenix Infusion System (IIS) consists of three primary components: - 1. Single channel large volume pump (LVP), - 2. Single use, sterile, disposable fluid administration sets, and - 3. Infusion Management System (IMS) server applications. The Large Volume Infusion Pump (LVP) is built around a closed-loop, pneumatically driven fluid delivery mechanism. Negative pressure is used to draw liquid from the source container into an intermediate pumping chamber (IPC). Positive pressure is then used to push the liquid out of the IPC and to the patient. The pneumatic drive allows for direct measurement of volume changes in the IPC. The pump used the ideal gas equation, P1V1 = P2V2, to accurately calculate volume of fluid delivered. Using a known reference volume, pressure measurements are taken at various intervals during the fill and empty cycles to allow the system to determine flow rate to the patient. The LVP then adjusts drive pressure and/or fluidic resistance through a variable fluidic resistor to bring the actual flow rate to match the target flow rate. The LVP System is a dual-inlet, single-outlet delivery system that can selectively draw from up to two fluid sources and deliver either of those fluids to the patient through a single outlet. Active delivery from two inlets provides for managed intermittent and "piggy-back" infusions. The system does not support concurrent delivery of the same time. The LVP can use 5 ml to 60 ml syringes, manufactured by Becton Dickinson, B. Braun, or Covidien, directly connected to the secondary inlet of the primary and microbore administration sets as a fluid source. The system delivers fluid through a single-use, dual-inlet, single-outlet, disposable administration set. There are five varieties of administration sets: - 1. Primary dual inlet, single outlet, 1 Y-site - 2. Primary single inlet, single outlet - Blood Set, dual inlet, single outlet. 1 Y-site, for administration of red blood cells, platelets and plasma 3. - Microbore single inlet, single outlet, for administration of epidural fluids 4. - 5. Microbore dual inlet, single outlet, 1 Y-site The Infusion Management System (IMS) allows the pump to share information with other pumps and applications provided by Ivenix, such as an infusate library, or other systems that reside within the hospital. In addition, the IMS provides other features, such as remote viewing dashboards, clinical analytics, and advisories that provide information about the infusion delivery both at, and away from, the point of care.