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The SMARXT® BMR1900™ Closed Venous Reservoir Bag is intended to be used in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.

The SMARxT BMR1900 Closed Venous Reservoir Bag is a sterile device with a non-pyrogenic fluid pathway, for single use only, and is not intended to be resterilized by the user. The device is a soft-shelled blood reservoir designed for use in cardiopulmonary bypass surgery for periods up to six hours. The SMARxT BMR1900 can be operated at flow rates up to 6 liters per minute. The maximum operating volume is 1900 mL. The minimum operating volume is 300 mL. The SMARxT BMR1900 has a blood inlet port with an integral cardiotomy inlet on one side of the bag and a blood outlet port on the opposite side of the bag. Integral to the blood inlet port are connectors for measuring the temperature and saturation/hematocrit of the incoming blood using external monitoring equipment. The top edge of the bag has a dual four-way stopcock assembly that is used to purge air from the bag. The stopcock assembly may also be used for the administration of drugs or other solutions, as needed during the cardiopulmonary bypass procedure. Blood enters the bag through the inlet port and passes through a polyester screen filter before exiting the bag through the outlet port. The purpose of the filter is to facilitate the removal of large air bubbles from the blood.

The COBE® Angel Whole Blood Separation System is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. The plasma and concentrated platelets can be used for diagnostic tests.

The COBE® Angel Whole Blood Separation System consists of a blood centrifugation device and associated disposable processing set and whole blood access kit. The device is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. The Blood Access Kit contains syringes, needles, anticoagulant, and a site preparation kit for collecting the blood to be processed with the Angel System. The Processing Set utilizes a variable volume separation chamber that separates autologous whole blood cells, platelet poor plasma, and platelet rich plasma. The Processing Set is provided sterile with a non-pyrogenic fluid pathway, and is for single patient use only. The Processing Set consists of the pre-connected variable volume separation chamber, a tubing set with a platelet sensor/valve assembly, and a three-compartment reservoir bag to hold the blood products (whole blood, red blood cells, and platelet poor plasma). A syringe is provided to collect the platelet rich plasma. The primary features of the Angel System hardware are the centrifuge well and lid, roller pump, platelet sensor, valve assembly driver, touch screen user interface, and emergency stop switch. The platelet sensor detects the presence of the separated blood components as they exit the variable volume separation chamber, and switches the position of a rotating valve in the Processing Set to channel the individual blood components into their respective collection containers.

The Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter is recommended for use in the arterial line of extracorporeal circuit during any procedure that requires cardiopulmonary bypass, for periods up to six hours of use. The filters are effective in trapping and removing gaseous emboli as well as particulate debris that may be introduced through the arterial line.

The Dideco Micro 40 Ph.I.S.I.O Adult Arterial Filter is an arterial blood filter with a 40 µm screen. The fitter is designed to permit the effective separation of gaseous emboli and remove blood components aggregates present in the arterial line. The blood contact surfaces of the arterial filter have been modified to improve blood compatibility.

The COBE Cardiovascular ® SMAR x T ® VVR ™ 4000i Plus Filtered Hardshell Venous Reservoir is intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours, and for postoperative chest drainage collection and autotransfusion.

The COBE SMARxT VVR4000i Plus is a sealed hardshell venous reservoir with a defoamer and integral cardiotomy filter. It is a sterile device with non-pyrogenic fluid pathways, for single use micgrar cardroionly micer. ilized by the user. Certain blood contact surfaces of the oxygenator only, and is not to be resterined by and dified to improve blood compatibility, resulting in reduced platelet adhesion on the treated surfaces.

The pump is intended for use only with Stöckert Instrumente Centrifugal Pump Consoles in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).

The Cobe Cardiovascular Revolution Pump with PC Coating is an extracorporeal blood pump that is provided sterile, single use only, with non-pyrogenic fluid pathways, and is not to be resterilized by the user. It may be sold as a stand-alone device or as a component of a customized heart/lung pack. The Revolution Centrifugal Blood Pump with PC Coating utilizes a rotating, vaned impeller design to move blood by centrifugal force. Blood contact surfaces of the PC coated Revolution have been coated with phosphorylcholine to improve blood compatibility, resulting in reduced platelet adhesion on the coated surfaces.

The SMAR, T® BCD Vanguard™ Blood Cardioplegia System is intended to mix, cool, warm and deliver oxygenated blood and cardioplegic solution for periods up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and removes air. Blood and cardioplegic solution are delivered to the patient by a single 100 % occlusive roller pump, through the extension line and appropriate cannula.

The SMAR, T BCD Vanguard System is a cardioplegia heat exchanger with integral bubble trap, available with various tubing ratio configurations connected to the heat exchanger assembly. Surface-modifying materials have been added to the primary blood contact surfaces of the heat exchanger, tubing and connectors to improve the blood compatibility of the system. The product is sterilized by ethylene oxide, is for single use only, and has nonpyrogenic fluid pathways. The heat exchanger assembly (heat exchanger with bubble trap) contains a hydrophobic membrane, a one-way valve, a pressure relief valve, a filter screen, a temperature monitoring port and a pressure monitoring port. The housing is designed such that air entering the device rises to the membrane and is vented to the atmosphere. The one-way valve keeps air from entering the device. The pressure relief valve is designed to relieve excess pressure in the event of outlet line clamping, and has tubing attached to it to vent the solution to the cardiotomy reservoir. The temperature monitoring port is used to measure the temperature of the blood cardionlegia mixture, and the pressure monitoring line is connected to either a pressure manometer or a transducer to measure pressure.

The COBE® REVOLUTION™ Centrifugal Blood Pump is intended to be used with a Stöckert Instrumente GmbH Centrifugal Pump console in cardiopulmonary bypass procedures for periods of up to six hours. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., greater than six hours) as a bridge to transplant, for pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The COBE® Revolution™ Centrifugal Blood Pump is an extracorporeal blood pump that utilizes a rotating vaned impeller design to move blood by centrifugal force. The device is provided sterile with a nonpyrogenic fluid pathway, and is for single use only. It is indicated for use with a Stockert Instrumente GmbH Centrifugal Pump console in cardiopulmonary bypass procedures for periods of up to six hours. The device has not been qualified for longterm use (greater than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO). The Revolution Pump consists of a rotating vaned impeller within a pump housing. The pump housing has two components, a top and bottom case, and features a central, single-barbed, 3/8" inlet port and tangential, double-barbed, 3/8" outlet port. The vaned impeller is molded onto a steel shaft that supports it at its axis of rotation, with the shaft rotating on a bearing at each end. The device contains a multi-pole magnet that is fully enclosed within the magnet housing and thus does not contact the blood pathway. The magnet is designed to magnetically couple with the pump drive unit of the Stockert Instrumente GmbH Centrifygal Pump console. Rotation of the magnet causes the impeller to rotate and pump blood via centrifugal force.

The COBE® SMARxT® Optimin™ is indicated for use in surgical procedures requiring extracorporeal gas exchange support and blood procedure control. It is intended to be used in procedures requiring a tomporature comrow rate of 5 liters/min and lasting up to six hours.

The COBE SMARxT Optimin is a sterile device with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. The device is a blood oxygenator with integral heat exchanger, intended to be used in surgical procedures requiring extracorporeal gas exchange support and blood temperature control, requiring a maximum blood flow rate of 5 liters/minute and lasting up to six hours. The size and specifications of the device make it particularly suited for smaller adult and pediatric patients.

The SMAR, T® BCD Vanguard™ Surface Modified Blood Cardioplegia System is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution for periods of up to 6 hours. The device also allows monitoring of temperature and pressure, traps bubbles, and removes air. Blood and cardioplegic solution are delivered to the patient by a 100% occlusive roller pump, through the extension line and appropriate cannula.

The SMAR T BCD Vanguard is a cardioplegia heat exchanger with integral bubble trap, available with various tubing configurations connected to the heat exchanger. A surface modifying material has been added to the primary blood contact assembly, primarily to improve the blood compatibility of the device. The heat exchanger assembly, aside from the surface modifying material, is for single use only, and has nonpyrogenic fluid pathways. The heat exchanger assembly (heat exchanger with bubble trap) contains a hydrophobic membrane, a one-way valve, a pressure relief valve, a filter screen, a temperature monitoring port and a pressure monitoring port. The housing is designed such that air entering the device rises to the membrane and is vented to the atmosphere. The one-way valve keeps air from entering the device. The pressure relief valve is designed to relieve excess pressure in the event of outlet line clamping, and has tubing attached to it to vent the solution to the cardiotomy reservoir. The temperature monitoring port is used to measure the temperature of the blood cardioplegia mixture, and the pressure monitoring line is connected to either a pressure manometer or a transducer to measure pressure.