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The MONOLYTH C Hollow Fiber Membrane Lung with Integrated Softshell Venous Reservoir is intended for use in an extracorporeal bypass circuit. The device provides oxygenation and removal of carbon dioxide from venous or suctioned blood. The integral heat exchanger provides blood temperature control, allows for the use of hypothermia, or aids in the maintenance of normothermia during surgery. The integral venous reservoir is intended for use as a storage reservoir for blood. The device is indicated for use with blood flows of 1.0 - 8.0 liters per minute (LPM). The MONOLYTH C 600 and the MONOLYTH C 1200 have been tested for 6 hours of continuous use. Use longer than 6 hours is not advised.

The MONOLYTH C is a high efficiency hollow fiber oxygenator with integral heat exchanger and a softshell venous reservoir. The venous reservoir is available both integrated with the device or as a separate device. The oxygenator consists of microporous capillary polypropylene fibers wound around a perforated core in a crossed mat configuration. The fiber bundle has a surface area of approximately 2,2 m2. The blood path is around the outside of the fibers, while the gas path is through the lumens of the fibers. An arterial temperature probe is located close to the arterial outlet. The arterial sampling line contains an integrated one-way valve to prevent accidental air injection. The gas outlet is equipped with a capnograph connector for CO2 measurement. The gas outlet cap has a safety anti-occlusion feature to aid in gas venting. A line between the gas module and the venous reservoir facilitates gravity priming of the system and allows for recirculation. This line is accessed via a high-pressure stopcock located at the lower portion of the membrane. The stopcock provides access to arterial blood throughout the procedure for cardioplegia, perfusion, or blood concentration. The heat exchanger is on the venous side of the device and is comprised of epoxy-coated pleated stainless steel. The heat exchanger has a surface area of 0.17 m2. The softshell venous reservoir is attached to a rigid external shell which is mounted on top of the oxygenator module. The softshell venous reservoir is a soft, flexible plastic bag with an integral screen and a rigid backplate. The backplate contains two inlet ports, a recirculation port, and a temperature probe port. The reservoir collects blood coming from venous return and from the cardiotomy reservoir. Blood from venous return and from the cardiotomy reservoirs is collected via separate inlet ports. Blood is then filtered through the screen to deflect air bubbles to the top of the reservoir. Bubbles may be purged through a double purge line with an additional luer port located at the top of the reservoir, which join together into a common line. The common purge line contains a one-way valve which prohibits air from returning into the reservoir. The temperature port, located below the venous inlet port, is designed to receive a YSI series 400 compatible probe. The venous reservoir has one outlet line located at the bottom center of the bag. A 1/4-inch recirculation line is attached to a port on the back of the reservoir. This line may be connected to the arterial outlet or the recirculation port of the oxygenator to recirculate blood back to the venous reservoir.

Code 150 Blood Component Collection Set is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected into transfer bags. Code 151 Blood Component Set with Direct Draw Line is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected from directly the patient. The process of PRP/PPP is to be performed in the immediate preoperative period, prior to the surgical procedure and before the establishment of cardiopulmonary bypass. The collected PRP/PPP shall be administered during or after the operation to aid in the normalization of the patient's hemocoagulative state. The Electronmedics PRP/PP Sequestration Kits are indicated for the same use as the Code 150 and Code 151 Blood Component Collection Sets.

The Blood Components Collection Set consists of a four-way adapter, a bag spike assembly, and two (2) collection bags. The four way adapter is inserted between the wash bowl and waste bag components of a preassembled surgical wash. The collection bags are attached to the free arms of the adapter. Whole blood to be processed may be collected in the immediate preoperative period into a transfer bag, which is then attached to the inlet side of the wash set using the bag spike assembly. In addition, blood may be collected directly from the patient by utilization of a filtered burette assembly intended for the administration of anticoagulation solution during preoperative collection of patient blood for sequestration of PRP/PPP. Alternately, whole blood from the extracorporeal circuit (e.g. cardiotomy reservoir or oxygenator) may be processed during the intraoperative period in the same manner.

The Dideco Compact-A and Compact-M Autotransfusion Systems are intended to process, shed or collect blood for autologuous transfusion. The Compact-A and Compact-M autotransfusion systems are to be used with disposables for the collection of shed blood and aspirated body fluids, and the separation of erythrocytes from other components of the aspirated blood prior to, during and/or after a surgical procedure. The systems are also recommended to collect platelet-rich plasma (PRP) and/or platelet-poor plasma (PPP) from the patient's whole blood immediately preoperative to a surgical procedure.

The Dideco Compact-A and Compact-M Autotransfusion Systems are composed of the a high-speed lightweight automatic autotransfusion system following equipment: including a rolling cart for the system with an IV pole and a portable vacuum pump module.

The VRF40 Venous Reservoir with Integral Cardiotomy Filter is intended to allow for the collection and autotransfusion of shed mediastinal blood following cardiopulmonary bypass procedures or other procedures where shed blood is expected. The VRF40 Venous Reservoir with Integral Cardiotomy Filter is intended for use in CPB circuits and postoperative blood salvage procedure

The VRF40 is a sterile, nonpyrogenic, disposable, hardshell venous reservoir with an integral cardiotomy filter. It contains a polyurethane defoamer sponge and outer gross filter screen,

The Dideco Venomidicard and Midicard are hardshell blood collection reservoirs intended for use in CPB circuits and postoperative blood salvage procedures.

The Venomidicard and Midicard are sterile, nonpyrogenic, disposable, hardshell reservoirs that contain an integral cardiotomy filter. Each device contains a polyurethane defoamer sponge and outer gross filter screen.