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Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. Essenz ILBM is indicated for supplementary, in-line monitoring of the extracorporeal arterial oxygen partial pressure, venous oxygen saturation, venous hematocrit/hemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures up to six (6) hours.

Essenz HLM is a modular heart-lung machine. The device consists of a central console base for support, positioning mobility and power supply, roller and centrifugal pumps, user interface displays, controls, clamps and sensors for the monitoring of extracorporeal perfusion. The Essenz HLM is configurable to user needs with different system components. The main configurable and optional system components consist of: Console, Cockpit, Control Units/ Console Control Units, Pumps, Bubble sensor, Level sensor, Temperature sensor, Pressure sensor, Flow Sensor, Manual Venous Occluder, Venous Clamp, Arterial Clamp, EP-Pack/ Power Pack, Cabinet (Enclosure), Mast. Essenz ILBM is used for in-line continuous monitoring of patient's blood parameters during procedures requiring extracorporeal circulation when used with a compatible heart-lung machine. Provided in-line measured parameters of Essenz ILBM are: In the Venous line: Haematocrit / Haemoqlobin (Hct/Hb), Venous blood oxygen saturation (sO2), Venous blood temperature (venT). In the Arterial line: Arterial blood oxygen partial pressure (pO2), Arterial blood temperature (artT). The duration of application is limited to 6 hours of continuous use. Essenz ILBM consists of the following components / disposables: B-Capta Venous and Arterial Sensors, Essenz ILBM Sensor Module, B-Capta Venous and Arterial Reference Element Holders, B-Capta disposable Venous and Arterial Cuvettes. The B-Capta venous sensor is an optical sensor which measures hematocrit/hemoglobin and oxygen saturation using an optical reflectance technology when connected to its dedicated disposable cuvette. Infrared technology is used to measure the temperature of the venous blood. The B-Capta arterial sensor is an optical sensor which measures, partial pressure of oxygen using an optical fluorescence technology when connected to its dedicated disposable cuvette. Infrared technology is used to measure the temperature of the arterial blood. Both sensors are functionally connected to the compatible heart-lung machine. Data are displayed on the graphical user interface of the compatible heart-lung machine.

The Terumo® Advanced Perfusion System 1 is indicated for use for up to six 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 centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

The Terumo® Advanced Perfusion System 1 (System 1) is a configurable heart-lung system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. The system is designed to enable users to choose from the Terumo CVS supplied components to define and configure a heart-lung system to meet individual institution requirements. The System 1 components are listed below. - . System 1 Base: - Chassis platform Provides operating power and back up battery power for all system O components (100/120V or 220/240V) - Central Control Monitor (CCM) A display used for configuration and control of o system components - Two roller pump hand cranks and hand crank bracket O - Pump(s) and pump mounting hardware Up to eight pumps can be used with System 1, ● including the following: - 0 6" Roller Pump - 0 4" Roller Pump - O Centrifugal Control Unit with Centrifugal Drive Motor (up to 2) - Pods - Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal circuit, in O conjunction with the air sensor - Level Detection Pod Used to monitor liquid levels within a hard shell reservoir. O - O Pressure Pod - Used to monitor the pressure in the extracorporeal circuit - Temperature Pod Used to monitor the temperature in the extracorporeal circuit and / O or the patient - Flowmeter Pod Used to monitor flow volume and generate an alarm if backflow is O detected - Venous Line Occluder Pod Used with the Occluder Head to provide a computer O controlled tube clamping mechanism to regulate flow in the venous line - Interface Pods to enable data transfer between cardiac monitoring and data display o systems (i.e., Terumo CDI™ 500 Monitor, and TLink™ Data Management System) - Electronic Patient Gas System (EPGS) Provides control and monitoring of the gas output to . the oxygenator - Flexible Lamps (15 inch or 33 inch) for local illumination . - . Mounting hardware (e.g., center poles, crossbars, and brackets)

Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Essenz HLM is a modular heart-lung machine like its primary predicate Stöckert S5 System. The device consists of a central console base for support, positioning mobility and power supply, roller and centrifuqal pumps, user interface displays, controls, clamps and sensors for the monitoring of extracorporeal perfusion. The Essenz HLM is configurable to user needs with different system components. The main configurable and optional system components consist of: Console, Cockpit, Control Units/ Console Control Units, Pumps, Bubble sensor, Level sensor, Temperature sensor, Pressure sensor, Flow Sensor, Manual Venous Occluder, Electrical venous occluder (EVO), Arterial Clamp/ Electric Remote Control, EP-Pack/ Power Pack, Cabinet (Enclosure), Mast.

The Stöckert SS System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

The S5 System is configurable to user needs with different system components. The main configurable and optional system components consist of: Console, System Panel, Pumps, Bubble detector, Level control, Temperature monitor, Pressure control, Cardioplegia Control, Electronic gas blender, Serial Data interface, Venous line clamps (manual), Electrical venous occlude (EVO).

The Century Perfusion System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

The Century Perfusion System is a modular system, like the Stöckert S5 System, consisting of a console base with peristaltic pumps, monitors, displays, controls, and user interfaces.

The Quantum Smart Occluder is indicated for use as an accessory with the Quantum Pump Console for up to 6 hours in the extracorporeal circulation of blood for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The Quantum Smart Occluder is a clamping system for the occlusion of both arterial and venous blood lines. The Quantum Smart Occluder is designed to work with the Quantum Pump Manager software application, as part of the Quantum Pump Console (K173834). The operation of the Quantum Smart Occluder is managed from the Quantum Workstation (K163657). The Quantum Smart Occluder has the availability for 5 sensor attachments: - . 2 Flow Sensors - 2 Pressure Sensors - 1 Level Sensor . These sensors are identical with the use of the same sensor PCB boards previously cleared with the Quantum Diagnostic Module (K173591) and Quantum Ventilation Module (K181942). These sensor connections can be used in conjunction with the sensor connections used on the Quantum Diagnostic Module (K173591) or Quantum Ventilation Module (K181942) to provide additional readings. Or used solely on the Quantum Smart Occluder to reduce the amount of cabling that is attached to the Quantum Pump Console (K173834).

The Quantum Pump Console is indicated for use for up to 6 hours in cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The Quantum Pump Console is a configurable heart-lung machine consisting of various components controlled by a central workstation. The system is intended to be used in any surgery in which the patient's blood is being oxygenated extracorporeally. The modular system consists of a frame, power supply with battery backup, roller pumps, pump control module, diagnostic module and a central workstation with the user interface. The roller pumps are available in three sizes (4", 6" and 8") and can be controlled via a centralized interface on the Quantum Workstation touchscreen or through the Quantum Pump Console, which contains five knobs and displays in one integrated console.

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 centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

The Advanced Perfusion System 1) is a configurable heart-lung system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. The system is designed to enable users to choose from the Terumo CVS supplied components to define and configure a heart-lung system to meet individual institution requirements. The System 1 components are listed below. - · System 1 Base: - Chassis platform Provides operating power and back up battery power for all o system components (100/120V or 220/240V) - Central Control Monitor (CCM) A touch screen display used for o configuration and control of system components - o Two roller pump hand cranks and hand crank bracket - · Pump(s) and pump mounting hardware Up to eight pumps can be used with System 1, including the following: - 6' Roller Pump O - o 4" Roller Pump - Centrifugal Control Unit with Centrifugal Drive Motor (up to 2) O - Pods - Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal O circuit, in conjunction with the air sensor - o Level Detection Pod Used to monitor liquid levels within a hard shell reservoir. - O Pressure Pod - Used to monitor the pressure in the extracorporeal circuit - Temperature Pod Used to monitor the temperature in the extracorporeal O circuit and / or the patient - Flowmeter Pod Used to monitor flow volume and generate an alarm if O backflow is detected - Venous Line Occluder Pod Used with the Occluder Head to provide a O computer controlled tube clamping mechanism to regulate flow in the venous line - Interface Pods to enable data transfer between cardiac monitoring and data o display systems (i.e., Terumo CDI™ 500 Monitor, and TLink™ Data Management System) - · Electronic Patient Gas System (EPGS) Provides control and monitoring of the gas output to the oxygenator - Flexible Lamps (15 inch or 33 inch) for local illumination - · Mounting hardware (e.g., center poles, crossbars, and brackets)

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 centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

The Advanced Perfusion System 1) is a configurable heart-lung system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. The system is designed to enable users to choose from the Terumo CVS supplied components to define and configure a heart-lung system to meet individual institution requirements. The System 1 components are listed below. - · System 1 Base: - Chassis platform Provides operating power and back up battery power for all o system components (100/120V or 220/240V) - Central Control Monitor (CCM) A touch screen display used for o configuration and control of system components - o Two roller pump hand cranks and hand crank bracket - Pump(s) and pump mounting hardware Up to eight pumps can be used with System 1, including the following: - 6'' Roller Pump O - o 4" Roller Pump - Centrifugal Control Unit with Centrifugal Drive Motor (up to 2) O - Pods - Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal O circuit, in conjunction with the air sensor - o Level Detection Pod Used to monitor liquid levels within a hard shell reservoir. - O Pressure Pod - Used to monitor the pressure in the extracorporeal circuit - Temperature Pod Used to monitor the temperature in the extracorporeal O circuit and / or the patient - Flowmeter Pod Used to monitor flow volume and generate an alarm if O backflow is detected - Venous Line Occluder Pod Used with the Occluder Head to provide a o computer controlled tube clamping mechanism to regulate flow in the venous line - Interface Pods to enable data transfer between cardiac monitoring and data o display systems (i.e., Terumo CDI™ 500 Monitor, and TLink™ Data Management System) - · Electronic Gas Blender Provides control and monitoring of the gas output to the oxygenator - Flexible Lamps (15 inch or 33 inch) for local illumination - · Mounting hardware (e.g., center poles, crossbars, and brackets)

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 centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

The Advanced Perfusion System 1) is a configurable heartlung system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. The system is designed to enable users to choose from the Terumo CVS supplied components to define and configure a heart-lung system to meet individual institution requirements. The System 1 components are listed below. - · System 1 Base: - Chassis platform Provides operating power and back up battery power for all O system components (100/120V or 220/240V) - Central Control Monitor (CCM) A touch screen display used for O configuration and control of system components - Two roller pump hand cranks and hand crank bracket O - · Pump(s) and pump mounting hardware Up to eight pumps can be used with System 1, including the following: - 6" Roller Pump O - 4" Roller Pump o - Centrifugal Control Unit with Centrifugal Drive Motor (up to 2) O - Pods - Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal O circuit, in conjunction with the air sensor - Level Detection Pod Used to monitor liquid levels within a hard shell o reservoir. - Pressure Pod Used to monitor the pressure in the extracorporeal circuit O - Temperature Pod Used to monitor the temperature in the extracorporeal O circuit and / or the patient - Flowmeter Pod Used to monitor flow volume and generate an alarm if O backflow is detected - Venous Line Occluder Pod Used with the Occluder Head to provide a O computer controlled tube clamping mechanism to regulate flow in the venous line - Interface Pods to enable data transfer between cardiac monitoring and data o display systems (e.g., Terumo CDI™ 100 Monitor, CDI™ 500 Monitor, and TLink™ Data Management System) - · Electronic Gas Blender Provides control and monitoring of the gas output to the oxygenator - Flexible Lamps (15 inch or 33 inch) for local illumination - · Mounting hardware (e.g., center poles, crossbars, and brackets)