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The VitalFlow Console controls the speed of the VitalFlow Centrifugal blood pump during extracorporeal cardiopulmonary life support for adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The VitalFlow Centrifugal pump is driven by the VitalFlow Motor Drive or the VitalFlow Emergency Handcrank.

The VitalFlow Console provides control of blood pumping through an extracorporeal circuit during extracorporeal membrane oxygenation (ECMO) procedures. The console powers the VitalFlow motor drive unit which provides rotation of the VitalFlow Centrifugal pump. Pump motor speed (RPM) can be adjusted by the user and flow and bubble detection is provided by an ultrasonic flow probe and displayed on the touchscreen. The touchscreen display allows users to set alarm limits for all measured parameters. The device will alarm visually and audibly when limits are exceeded. Status indicators, power/battery life and secondary RPM indicator are provided. Data download and data streaming from the console is available for ECMO circuit data only; no patient data is stored for output.

The CentriMag Extracorporeal Blood Pumping System is a non-roller-type cardiopulmonary and circulatory bypass blood pump used to pump a patient's blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i. Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels: or ii. Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava The CentriMag™ Blood Pump for use with the CentriMag™ Acute Circulatory Support System (Motor, Monitor, Console, and Flow Probes) is indicated for controlling blood flow as part of an extracorporeal membrane oxygenation (ECMO) circuit. ECMO is intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patients' blood for adult patients with acute respiratory failure and/or acute cardiopulmonary failure. where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

The CentriMag™ Acute Circulatory Support System, hereafter referred to as the CentriMag System, was designed to provide temporary mechanical circulatory support. To date, the CentriMag system in the United States (US) is indicated as a component of an extracorporeal bypass circulatory support circuit for use during cardiopulmonary bypass (CPB) surgery (up to 6 hours), it is also indicated for controlling blood flow as part of an extracorporeal membrane oxygenation (ECMO) circuit. The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited. The CentriMag System is composed of: - CentriMag Primary Console - CentriMag Motor - CentriMag Blood Pump - CentriMag Flow Probe - · Mag Monitor The CentriMag Motor is a reusable, non-sterile component of the CentriMag System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. The motor turns the magnet (and impeller) within the blood pump (Full MagLev™ technology) at a speed that is set on the console by the user. When the impeller is rotated, a pressure gradient develops between the center and outside edge of the pump, causing blood to flow from the inflow to the outflow port of the pump. The amount of flow through the pump depends on the speed of the impeller, and the difference between the inlet and outlet pressures.

Extracorporeal Membrane Oxygenation The LifeSPARC System is a centrifugal blood pump system intended to assist in circulation of the patient's blood when part of an extracorporeal circuit including physiologic gas exchange of the patient's blood in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include: · Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients; · ECMO-assisted cardiopulmonary resuscitation in adults. Cardiopulmonary Bypass The LifeSPARC System is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The LifeSPARC Pump is a sterile, single-use, low prime volume centrifugal pump with an integrated motor and a single-point, pivot bearing. It is sterilized using ethylene oxide (EO) and sized to fit in the palm of the hand or to secure to the patient. The LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump. It is a microprocessor-based electromechanical pump drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.

The VitalFlow™ Centrifugal Pump is intended to pump blood through the extracorporeal circuit for circulatory support up to 48 hours, in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The VitalFlow™ Centrifugal Pump is driven by the VitalFlow™ Console and Drive Motor, or the Emergency Handcrank.

The VitalFlow Centrifugal Pump is a sterile, single-use centrifugal blood pump. It is a non-invasive, nonpyrogenic device designed to move blood through the extracorporeal circuit by centrifugal force. The pump is the disposable portion of the pumping system and it is electromagnetically coupled to an instrument that monitors and displays the flow and pressure of the blood. Blood enters the inlet port of the pump, where a cone with impeller blades within the pump housing rotates and the blood is gently accelerated toward the outlet of the pump. The VitalFlow Centrifugal Pump can be driven through magnetic coupling by an External Drive Motor or the Emergency Handcrank.

The VitalFlow™ Console controls the VitalFlow™ Centrifugal blood pump during extracorporeal cardiopulmonary life support for adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The VitalFlow Centrifugal pump is driven by the VitalFlow Motor Drive or the VitalFlow Emergency Handcrank.

The VitalFlow Console provides control of blood pumping through an extracorporeal circuit during extracorporeal life support (ECLS) procedures. The console powers the VitalFlow motor drive unit which provides rotation of the VitalFlow Centrifugal pump. Pump motor speed (RPM) can be adjusted by the user and flow and bubble detection is provided by an ultrasonic flow probe and displayed on the touchscreen. The touchscreen display allows users to set alarm limits for all measured parameters. The device will alarm visually and audibly when limits are exceeded. Status indicators, power / battery life and secondary RPM indicator is provided. Data download and data streaming from the console is available for ECLS circuit data only; no patient data are stored or exported. The VitalFlow Emergency Handcrank (drive unit) can be used in emergency situations to manually drive the centrifugal pump in the case of console and or motor drive failure.

The CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System (Motor, Monitor, Console, and Flow Probes) is indicated for controlling blood flow as part of an extracorporeal membrane oxygenation (ECMO) circuit. ECMO is intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patients' blood for adult patients with acute respiratory failure and/or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

The CentriMag™ Blood pump for use with CentriMag™ Acute Circulatory Support System (hereafter referred to as the CentriMag System) is designed to provide assisted extracorporeal circulation and physiologic gas exchange of patients' blood for adult patients with acute respiratory and/or acute cardiopulmonary failure. The CentriMag System was designed to provide temporary mechanical circulatory support. The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited. The system includes: CentriMag 2nd Generation Primary Console, CentriMag Motor, CentriMag Blood Pump, Flow Probe, and Mag Monitor (optional). The CentriMag System features a centrifugal flow pump with inflow and outflow ports that are at right angles to one another, and a magnetically levitated impeller (Full MagLev™ technology). The CentriMag Motor is a reusable, non-sterile component of the CentriMag Acute Circulatory Support System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. When the pump is inserted into the motor and activated, the internal impeller is electromagnetically levitated and centered, eliminating the need for shafts, seals, and bearings in the pump. Utilizing magnetic levitation technology (Full MagLev™ technology) to suspend and spin the impeller eliminates bearing and seal friction, resulting in minimal heat generation and wear of the pump components. the console is used to control pump speed, the resultant blood flow, and monitor the operation of the system. A cable connects the console to the motor, allowing flexibility in the pump motor and pump positioning.

The LifeSPARC System is a centrifygal blood pump system intended to assist in circulation of the patient's blood when part of an extracorporeal circuit including physiologic gas exchange of the patient's blood in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include: - Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients - ECMO-assisted cardiopulmonary resuscitation in adults

The LifeSPARC Pump is a sterile, single-use, low prime volume centrifugal pump with an integrated motor and a single-point, pivot bearing. It is sterilized using ethylene oxide (EO) and sized to fit in the palm of the hand or to secure to the patient. The LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump. It is a microprocessor-based electromechanical pump drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.

The TandemHeart System is a centrifugal blood pump system intended to assist in circulation of the patient's blood when part of an extracorporeal circuit including physiologic gas exchange of the patient's blood in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

The TandemHeart Pump is a low priming volume centrifugal blood pump with a dual chamber design. The upper chamber provides a conduit for the flow of blood; the lower chamber provides communication with the controller, a hydrodynamic bearing, cooling of the motor and local anticoagulation. The TandemHeart Escort Controller provides the interface between pump and user, the power and electrical signals to drive the pump, and the infusate fluid to the lower chamber of the pump. It is a microprocessor-based electromechanical pump drive and infusion system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport. The controller contains a backup motor control unit, and backup batteries.