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The CentriMag Return Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

The CentriMag Return Cannula Kit consists of a sterile, single-use, disposable, noncoated, Polyvinyl Chloride (PVC) Cannula and the following accessories: A) One Obturator (or Introducer) B) One Hemostasis Seal C) One Cap D) One Porous Plug E) One Needle with Sheath F) One Guidewire Assembly G) Two Stabilizer Rings Medium H) Two Stabilizer Rings Small I) Two Tip Stabilizers

The Levitronix 2nd Generation CentriMag Primary Console and Levitronix Monitor are indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

The 2nd Generation CentriMag Primary Console is a microprocessor based device. The microprocessor generates the primary motor control signal, monitors system sensors, generates display outputs, interprets the inputs through the front keypad, provides alarm functions and handles the Levitronix Monitor interface. The Console is intended to be operated on single phase AC power; however, it also has a built-in rechargeable battery with a battery charger. The rechargeable battery is field replaceable. In addition, an optional external modular battery (UPS) can be used to power the CentriMag Primary Console. The human interface of the CentriMag Primary Console consists of a graphical screen to display data and system options and touch pads to change the system status. The 2nd Generation CentriMag Primary Console is intended to be used together with the Levitronix Monitor; however it can be also operated as a stand-alone unit. The Levitronix Monitor provides a redundant user interface containing a display and touch pads. The Primary and Back-Up Consoles also provide a fullyfunctional user interface containing a display and touch pads. The Levitronix Monitor is a non-sterile, reusable device that is designed to work only with the 2nd Generation CentriMag Primary Console; therefore, it does not support the 1st Generation CentriMag Primary Console or the CentriMag Back-Up Console. The Levitronix Monitor is a 12V DC-powered device and receives its power directly from 2nd Generation CentriMag Primary Console via a power connector that mates with a connector on the back-panel of 2nd Generation CentriMag Primary Console. Based on the design of its power connector, the Levitronix Monitor cannot be plugged into a hospital AC power outlet. The Levitronix Monitor's core function is to provide multi-color alpha-numerical and graphical displays of information it receives from the 2nd Generation CentriMag Primary Console. The Levitronix Monitor is intended for use as a hospital-based unit (OR and bed-side) and is not intended for use during patient transport from one hospital to another. The Levitronix Monitor is a processor based device, with a flat color screen (e.g. LCD). In addition, it is equipped with touch pad to allow the user to enter commands. In the hospital-setting configuration, the user is able to operate and monitor the performance of the CentriMag System through the Levitronix Monitor. The Levitronix Monitor can control the functions of the 2nd Generation CentriMag Primary Console, and therefore, of the CentriMag System. The Levitronix Monitor only displays data and stores user commands without interacting directly with the primary motor control which is managed by the 2nd Generation CentriMag Primary Console. The Levitronix Monitor is connected to the 2nd Generation Primary Console through one cable, which includes data and power lines. Power is provided by the 2nd Generation CentriMag Primary Console.

The Levitronix CentriMag Primary and Back-Up Consoles are indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

The CentriMag Primary Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data, system options, and menus. Operator adjustable alarms and parameters are accessible via the system menus. The CentriMag Back-Up Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data.

The PediMag Blood Pump is indicated for use with the CentriMag Console and Motor to pump blood through a complete extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours) for surgical procedures such as a mitral valve reoperation. It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, surgery of the vena cava or aorta, liver transplants etc.). The PediMag Pump can generate a maximum pump flow equal to 1.5 liters per minute, limiting its use to pediatric patients. The Levitronix PediMag Blood Pump is indicated for use only with the Levitronix CentriMag Console and Motor.

The PediMag Blood Pump is a sterile, single-use, disposable, non-coated, polycarbonate centrifuqal blood pump. The pump has a 14 ml priming volume. The pump inlet is on the rotational axis of the impeller whereas the pump outlet is perpendicular to the inlet and tangent to the outer diameter. Both the inlet and outlet ports include standard 1/4 inch barbed connectors for easy mating to standard medical grade 1/4 inch tubing. The Pump is designed to move blood by centrifuqal force created by the magnetically suspended rotating impeller.

The Levitronix CentriMag Back-Up Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

The CentriMag Back-Up Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data.

The Levitronix CentriMag Primary Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

The CentriMag Primary Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data, system options, and menus. Operator adjustable alarms and parameters are accessible via the system menus.

The Levitronix CentriMag Primary Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

The CentriMag Primary Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data, system options, and menus. Operator adjustable alarms and parameters are accessible via the system menus.

The Levitronix CentriMag Primary Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

The CentriMag Primary Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data, system options, and menus. Oneator adjustable alarms and parameters are accessible via the system menus.

The Levitronix CentriMag Back-Up Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System and as a back-up to the CentriMag Primary Console. The Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete unloading of the ventricle during surgery of the vena cava or aorta, liver transplants etc).

The Levitronix CentriMag Back-Up Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in calculations and alarms. An alphanumeric screen is used to display monitored data. The CentriMag Back-Up Console uses single phase AC power and is capable of a flow rate of up to one of eld replaceable internal battery. In addition, each Back-Up Console contains a non-rechargeable, field replaceable internal battery that is capable of maintaining Back-Up Console functionality in the event of a loss of AC Power.

The Levitronix CentriMag® Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.q., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

System - The Levitronix CentriMag® Extracorporeal Blood Pumping System is a fault-tolerant system comprised of four (4) main assemblies which are available separately: - Blood Pump - Remote Motor Drive Unit - Control Console - Ultrasonic Flow Sensor Blood Pump - The Levitronix CentriMag® Extracorporeal Blood Pump is a sterile, single-use, disposable, non-pulsatile, non-roller pump that utilizes a rotor to impart energy to the blood in an extracorporeal circuit through centrifugal forces. The inlet to the pump runs concentric with the axis of the rotor. The outlet of the pump is perpendicular to the inlet and tangent to the outer diameter. Blood enters the pump housing via the pump's inlet port where it makes contact with the rotor. As the rotor turns, energy in the form of pressure and velocity is transferred from the rotor to the blood. The CentriMag® Extracorporeal Blood Pump moves the blood through the circuit at a desired pressure and flow rate by increasing or decreasing the speed of the rotor. This is accomplished by adjusting the The pump operates from the Levitronix Remote Motor Drive Unit and microprocessor-based console, located outside the sterile field. Remote Motor Drive Unit - The CentriMag® Motor Drive Unit is positionable on an IV pole/mast or adjacent to the console using an optional utility post. The Motor Drive Unit holds the disposable blood pump and drives the rotor inside the blood pump. Control Console - The Levitronix CentriMag Console is a microprocessorbased device, which drives and controls the speed of the blood pump in the extracorporeal circuit. The console also provides monitoring of motor speed, fluid flow, and pressure through the use of alphanumeric display, audible alarms and visible alarms. Ultrasonic Flow Sensor - The Levitronix CentriMag® Extracorporeal Blood Pumping System includes an ultrasonic flow meter.