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The Small (4") and Large (6") Roller Pumps for the Terumo® Advanced Perfusion System 1 are indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The Small (4") and Large (6") Roller Pumps of the Terumo® Advanced Perfusion System 1 (System 1) are peristalic pumps with 4 inch and 6 inch diameter raceways. The pumps can be mounted on the base of the System 1 console or can be positioned in an optimal location in the perfusion circuit by mounting to the system poles. Operation of the pumps can be configured using the System 1 Central Control Monitor (CCM). Local user interface displays and control panels are also located on the front of the large and small roller pumps. The small roller pump can accommodate applications requiring flow rates up to 4 L/min including pediatric arterial, adult and pediatric cardioplegia, vent and suction pumping, whereas the large roller pump can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping. The small and large roller pumps both have variable tube clamp mechanisms that accommodate a variety of tubing sizes, including dual tube sets.

The Large (6") Roller Pump for the Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The Large (6") Roller Pump for the Terumo Advanced Perfusion System 1 is a component of the Terumo Advanced Perfusion System 1. It is a large roller pump with a 6" race that can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping. It uses commercially available medical grade PVC tubing with 11/16" OD (max) and 1/16" - 3/32" wall thickness. It has a front panel for user interface controls, functional displays, and alarm conditions. The pump can be configured using the System 1 Central Control Monitor (CCM) as an Arterial pump or Cardioplegia pump. The Arterial pump can be run in Continuous, Pulse, Servo, or Master/Follower mode. The pump continuously monitors its own performance and reports status information and problems to the user via the pump display panel alarms and to the CCM. Pump responses to detected problems can include Stop, Pause, Reduce Speed, or Message Only. The pump can be mounted on System 1 base or pole.

The Large (6") Roller Pump for the Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The image shows a device description and indications for use of the APS 1 Large (6") Roller Pump. The device is a peristaltic pump with a 6 inch diameter race that can be mounted on the base of the Advanced Perfusion System 1 (APS1) console or positioned in an optimal location in the perfusion circuit by mounting on the pole. The large roller pump can accommodate applications requiring flow rates up to 10 L/min.

The Medtronic CSS™ Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures.

The Medtronic CSS Cardioplegia Safety System Model 990 consists of an electro-mechanical instrument and disposable Cardioplegia Sets. The instrument delivers cardioplegia solution through dual peristaltic independently operated pumps (one for blood, one for crystalloid). It monitors volume delivered, flow rate (adjustable from 0 - 990 ml/min), and pressure (line and external). It also includes temperature monitoring capabilities, gross air detection using ultrasonic technology, and two independent elapsed timers. The instrument has a color central information display and a two-stage alert-alarm process. It has battery backup for 60 minutes of "On" time and 15 minutes of pumping time. The disposable sets are single use, sterile, and nonpyrogenic, designed to mix arterial blood and asanguineous cardioplegia solution at various ratios. The sets include silicone tubing and polycarbonate connectors and are available in four configurations, with or without a heat exchanger and with standard or dual lumen patient lines.

The Stockert S3 Mast Pump is a modular component of the Stockert S3 Perfusion System. The S3 Mast Pump is intended to provide speed controlled pumping of blood through the cardiopulmonary bypass circuit for durations of normally six hours or less, left ventricular venting, cardiotomy suction, or the administration of cardioplegia solution, when used by a qualified perfusionsist who is experienced in the operation of the S3 System.

The Stockert S3 (cardiopulmonary bypass) Mast Pump Module is intended for use during cardiopulmonary bypass surgery. The S3 Mast Pump Module is a component of the Stockert S3 Perfusion System, and is intended to provide speed controlled pumping of fluid through the cardiopulmonary bypass circuit, left ventricular venting, cardiotomy suction, or the administration of cardioplegia solution. The predicate and predecessor device to the S3 Mast Pump Module is the S3 Double Head Pump Module. The S3 Mast Pump has the same double head pump design and intended use as the S3 Double Head Pump Module(K955038). The basic difference between these two double head pumps is that for the Mast Pump, the pump heads are mounted on the mast of an S3 Mast Pump Extension Unit, and the control/operating unit is placed on a swivel plate on the console, whereas for the standard 69 double head pump module, the control unit is mounted directly over the pump theads and the entire module is installed on the S3 Console Base. The Mast Pump configuration enables the perfusionist to position the pump heads in close proximity to the patient, thus reducing the length of tubing required for the extracorporeal blood circuit and the associated priming volume required. This option is useful in clinical situations where it is important to minimize the amount of tubing in the circuit, e.g. infant perfusion.

The Stöckert S3 Cyclic RPM Control Module is an accessory to the S3 Cardiopulmonary Bypass System Console which allows for the cyclicapm control offan;S3:pump.

The Stöckert S3 Cyclic RPM Control Module is an accessory module to the Stöckert S3 (cardiopulmonary bypass) Perfusion System, and is intended to allow the roller pump or double head pump to operate in the pulsed flow mode. The predicate and predecessor device to the S3 Cyclic RPM Control Module is the Stöckert-Shiley CAPS PFC 100 S Control unit (K883456). Similar devices have been used for many years for this same intended purpose. The new S3 Cyclic RPM Control Module is a simple upgrade of the technological aspects of the predicate device, e.g., the software controls and have been updated and the control and display panels have been updated for user convenience in operating the system.

The COBE Century™ Precision Blood Pump is intended for use in cardiopulmonary surgical procedures requiring pumping of fluids in an extracorporeal circuit for periods up to 6 hours.

The COBE Century Perfusion Pump is the principal component of the COBE Century Perfusion System. It is a peristaltic-type roller pump that functions by tube-occluding rollers that move along a piece of tubing. As the pump head rotates, the rollers draw fluid through the tubing. Pumped fluids are contained within the tubing and have no contact with the pump. The pump has positive displacement over a wide range of flow rates and delivery pressures. The COBE Century Perfusion Pump consists of: - a front panel containing displays and operational switches - a pump head with the roller pump mechanism and shields - a chassis containing control cards, a power supply, and connectors for external devices

The Sarns 8000 Roller Pump is indicated for use in extracorporeal circulation of blood for arterial regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.

The Sarns 8000 Roller Pump consists of a Universal Roller Pump, which is a microprocessor controlled 2-roller peristaltic pump with adjustable occlusion, and a power supply. The pump is capable of flows up to 9.99 L/min (depending on pump head tubing used) at pump speeds up to 250 RPM. The Sarns 8000 Roller Pump can be used as a stand-alone device or it is compatible with the Sarns 8000 Modular Perfusion System.

The Sarns 9000 Universal Roller Pump is indicated for use in extracorporeal circulation of blood for arterial regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.

The Sarns 9000 Universal Roller Pump is a microprocessor controlled 2-roller peristaltic pump with adjustable occlusion. The pump is capable of flows up to 9.99 L/min (depending on pump head tubing used) at pump speeds up to 250 RPM. The Sarns 9000 Universal Roller Pump is dependent on the Sarns 9000 Perfusion System to provide power.