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The CDI OneView Monitoring System is a patient parameter monitoring system to be used on a single patient during cardiopulmonary bypass procedures. By measurement or acquisition from other devices, it displays and outputs information to provide continuous, in-line monitoring of various patient parameters contained within the extracorporeal perfusion circuit and patient. The following parameters are available, based on configuration: ·Potential of Hydrogen (pH) ·Partial Pressure of Carbon Dioxide (pCO2) ·Partial Pressure of Oxygen (pO2) ·Potassium Ion (K+) ·Oxygen Saturation (SO2) ·Hematocrit (HCT) ·Hemoglobin (Hgb) ·Blood Flow Rate (Q) ·Cardiac Index (CI) ·Base Excess (BE) · Bicarbonate (HCO3- ) ·Oxygen Consumption (VO2) ·Indexed Oxygen Consumption (VO2i) ·Oxygen Delivery (DO2) ·Indexed Oxygen Delivery (DO2i) · Cerebral Regional Oxygen Saturation (rSO2) ·Oxygen Extraction Ratio (O2ER) · Body Surface Area (BSA) ·Shunt Sensor Temperature

The CDI OneView Monitoring System is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories: - . Core: Core Processing Unit, all other elements connect to the Core - Display: Touchscreen display with cable ● - . HSAT Probe: Hematocrit/Saturation probe with cable, interfaces with disposable Cuvette(s) - BPM Probe: Blood Parameter Module with cable, interfaces with disposable . Shunt Sensor - Calibrator: Gas calibrator for BPM/Shunt Sensor with cable, interfaces with disposable gas bottles - Flow Module & Sensor: Flow sensor connected to an external interface ● module with cable. - . HLM External Device Module: Heart Lung Machine (HLM) interfacing module and cable - DMS External Device Module: Data output for data management system ● (DMS) interfacing module and cable - rSO2 External Device Module: Cerebral Oximetry device interfacing module ● and cable - . Mounting accessories: Different mounting features are used to securely mount elements of the system on an HLM pole during a cardiopulmonary bypass (CPB) case. - Disposable accessories: The CDI OneView Monitoring System hardware ● connects to disposable accessories which are in-line with the extracorporeal circuit. The BPM probe is attached to Shunt Sensors, the HSAT probe is attached to Cuvette(s) during a CPB case for blood parameters measurement during monitoring. Disposable Gas Bottles (Gas 1 & Gas 2) are used with the Calibrator. The CDI OneView Monitoring System uses the following measurement technologies: - Optical fluorescence technology to measure partial pressure of oxygen and . carbon dioxide, pH and potassium ion concentration. - . Optical reflectance technology to measure oxygen saturation, hematocrit, and hemoglobin within the blood. - Thermistor (resistive) sensing technology to measure blood temperature. ● - Non-invasive acoustical sensing technology to measure blood flowrate. ● The CDI OneView Monitoring System measures blood parameters in real time by utilizing a microprocessor-based core, electro-optics modules (i.e., BPM and H/S probe), flow probe (includes flow module and flow sensor), fluorescence chemistry technology, optical reflectance technology and non-invasive acoustical sensing technology. The electro-optics modules connect the core to the disposables (i.e., shunt sensor or cuvette) which are inserted into the extracorporeal circuit. The flow module connects the core to the flow sensor that use clamp-on mechanism to fit around tubing of the extracorporeal circuit. Light is emitted from the modules, optical responses from the blood and the Ultrasonic/acoustical generated signal measurements via the sensor(s) are measured by the core. The blood parameters are measured or calculated by the CDI OneView Processing Core in real time and displayed to the user via a Touchscreen Display.

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)

The Capiox® iCP Centrifugal Pump with Xcoating™ is a sterile, single use device, used as an extracorporeal blood pump for use in cardiopulmonary bypass procedures for up to 6 hours. The pump is intended for use with Terumo® Advanced Perfusion System 1 / Sams™ Centrifugal Pump Systems or may be used with the Stockert / Sorin Centrifugal Pump Consoles.

The Capiox® iCP Centrifugal Pump with Xcoating™ is a sterile, single use device, used as an extracorporeal blood pump.

The CDI System 550 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, oxygen delivery and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the systems integral printer provides a hard copy of displayed parameters.

The CDI System 550 is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories: - CDI 550 Monitor ● - Arterial and/or Venous Blood Parameter Modules (BPM) ● - CDI Hematocrit/Saturation (H/S) Probe ● - CDI 540 Gas Calibrator and Calibration Gases (A and B) ● - CDI 510H Shunt Sensor ● - Shunt Bypass Line - CDI H/S Cuvette with or without extension tubing ● - Monitor Mounting Hardware (Pole Clamp and Cable Head Bracket) ● - Printer Paper ● The CDI System 550 measures blood parameters in real time by utilizing a microprocessor based monitor, electro-optics modules (i.e., BPM and H/S probe), fluorescence chemistry technology, and optical reflectance technology. The electro-optics modules connect the monitor to the disposables (i.e., shunt sensor or cuvette) which are inserted into the extracorporeal circuit. Light is emitted from the modules, and the optical responses from the blood via the sensor(s) are measured by the monitor. The blood parameters are measured or calculated by the CDI 550 Monitor in real time, and displayed to the user via a graphical LED display.

The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of adult and small adult patients during cardiopulmonary bypass surgery. The integrated arterial filter is intended to filter non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit. The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device. The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The 4-liter reservoir may be used for Vacuum Assisted Drainage procedures and Post-Operative Chest Drainage Procedures. The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is for use with patients when the required blood flow rate will not exceed 8.0 L/min. The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology can be used in procedures lasting up to 6 hours.

The Capiox® NX19 Oxygenator utilizes porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion. The Capiox® NX19 Oxygenator device has an integrated heat exchanger that is comprised of Polyethylene Terephthalate tubes arranged in a cylindrical shape. The circulating blood contacts the exterior surface of these tubes. Temperature-controlled water distributed from an external water bath fills the interior of the tubes. The heat exchanger material permits heat transfer to occur across the walls of the heat exchanger tubes to achieve the necessary temperature of the circulating blood. The Capiox® NX19 Oxygenator device can be operated at flow rates up to 8 liters per minute (1/min) and at a minimum flow rate of 2.0 liters per minute (1/min) or 0.5 liters per minute (1/min) for up to 2 hours. The integrated arterial filter of the Capiox® NX19 Oxygenator device relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood. The Capiox® NX19 Oxygenator device also includes a 4-liter hardshell reservoir used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section with a filter and defoamer and a cardiotomy section with a filter and defoamer.

The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of adult and small adult patients during cardiopulmonary bypass surgery. The integrated arterial filter is intended to filter non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit. The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device. The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The 4-liter reservoir may be used for Vacuum Assisted Drainage procedures and Post-Operative Chest Drainage Procedures. The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is for use with patients when the required blood flow rate will not exceed 8.0 L/min. The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology can be used in procedures lasting up to 6 hours.

The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is a device used during cardiopulmonary bypass surgery. It includes an oxygenator that utilizes porous fiber technology for gas exchange, an integrated heat exchanger made of Polyethylene Terephthalate tubes for warming or cooling blood, an integrated arterial filter for removing particles and emboli, and a hardshell reservoir for storing blood. The reservoir has sections for venous and cardiotomy blood, each with filters and defoamers. The device is designed for blood flow rates up to 8.0 L/min and procedures lasting up to 6 hours.

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 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 VirtuoSaph® Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting or radial artery for use in coronary artery bypass grafting.

The VirtuoSaph® Plus Endoscopic Vessel Harvesting System is an endoscopic vessel harvesting system that relies upon bipolar radio frequency (RF) energy to cauterize and seal vessels that are to be harvested. The RF current is transmitted across two electrodes in order to effect the necessary cauterization/sealing of the tissue when the tissue is appropriately positioned between the two electrodes. The device also uses bipolar RF energy for cutting tissue. The system is designed to be used with an endoscope. Components include a Trocar, Dissector Rod, Harvester Rod, and Endoscope (reusable device packaged separately).