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The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

The Heater-Cooler System 3T is an independent (i.e., independent of the water supply) 3circuit heating/cooling base unit that includes three water circuits for the patient supplied by one tank (for the heating/cooling blanket, the oxygenator) and one interchangeable heating/cooling circuit for cardioplegia. If required, patient and cardioplegia circuits can be switched off separately, in order to increase the activated functional group's heating and/or cooling performance. The following optional components and accessories are also available for the Heater-Cooler System 3T: 1. Heating-cooling blankets; 2. Water circuit tubing; and 3. Various cables. The Heater-Cooler System 3T includes a disposable aerosol collection set that consists of a canister connected to the Heater-Cooler System 3T and the user facility's vacuum source that captures emissions that are drawn from the tank using negative pressure created by the user facility's vacuum. The changes proposed in the current 510(k) include the offering of a Deep Cleaning service by LivaNova to customers. The safety of the Heater-Cooler System 3T is ensured by the regular disinfection and cleaning, monitoring of the bacteria levels and by the aerosol collection set, as described in the Operating Manual that was cleared in K191402. The Deep Cleaning service is intended to address cases where heavily contaminated devices cannot meet the acceptable level described in section 6.5.2 of the Operating Instructions. In this situation, to allow the device to return to clinical use, the customer may choose to return the device for the Deep Cleaning service. The Deep Cleaning service is intended to reduce bioburden levels within the water circuit, thereby reducing the risk of NTM Aerosolization in the clinical setting. There are no changes to design or intended use.

The Spectrum Medical Quantum Heater-Cooler is intended to provide temperature-controlled fluid to compatible Quantum PureFlow heat exchanger devices (cardiopulmonary bypass heat exchangers and cardioplegia heat exchangers) to warm or cool a patient during cardiopulmonary bypass procedures lasting six (6) hours or less. The Quantum Heater-Cooler is only intended to be used by trained Clinicians in a clinical environment.

The Quantum Heater-Cooler consists of the following components: - . Quantum Heater-Cooler Unit (including connection hoses and heat transfer fluid) - . Quantum Pure Flow Heat Exchangers (standard and cardioplegia, manufactured by Qura S.r.l.) - External cold storage charger . The Quantum Heater-Cooler is intended for cooling and warming patients during cardiothoracic surgeries requiring cardiopulmonary bypass with extracorporeal circulation (procedures lasting six (6) hours or less). The system regulates the temperature of circulating blood and cardioplegia solution using a proprietary glycol-based heat transfer fluid. Thermal energy carried by the heat transfer fluid is transferred from the heater-cooler unit to the patient perfusion circuit via Quantum PureFlow heat exchangers specifically developed for both the arterial and cardioplegia circuits. The heater-cooler, in conjunction with the heat exchangers, forms a closed circuit and no direct contact with the patient's blood or body fluids takes place at any time. Heating of the heat transfer fluid is accomplished through electrical heaters. For fluid cooling, the Quantum Heater-Cooler utilizes a Phase Change Material as a cold energy storage. This Phase Change Material needs to be routinely recharged between surgeries using an external cold storage charger outside of the operating room environment.

The Heater-Cooler System 3T is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

The 3T System is an independent (i.e., independent of the water supply) 3-circuit heating/cooling base unit that includes three water circuits (two circuits for the patient supplied by one tank (for the heating/cooling blanket, the oxygenator) and one interchangeable heating/cooling circuit for cardioplegia. If required, patient and cardioplegia circuits can be switched off separately, in order to increase the activated functional group's heating and/or cooling performance. The following optional components and accessories are also available for the 3T System: - 1. Heating-cooling blankets; - 2. Water circuit tubing; and - 3. Various cables. The 3T System includes a disposable aerosol collection set that consists of a canister connected to the 3T System and the user facility's vacuum source that captures emissions that are drawn from the tank using negative pressure created by the user facility's vacuum.

The Sorin FlexTherm Heater-Cooler System is used with a Stöckert S3 heart-lung machine and / or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

Sorin FlexTherm is designed to provide temperature control during extracorporeal procedures. The device can be used in conjunction with heat exchangers tubing sets and heating/cooling blankets present on the market with an intended use in ECC (cardiopulmonary bypass heat exchangers, cardioplegia heat exchangers) and able to withstand a pressure of at least 2 bar. The device is used to warm or cool a patient during cardiopulmonary bypass procedures lasting up to six (6) hours. As the unmodified device, the Sorin FlexTherm is a software-controlled device provided with hardware elements. The main components for both devices are the housing provided with wheels, compressor, condenser unit, evaporator, expansion valves, water tanks, heaters, pumps, valves, sensors and a user interface/display.

The HCU 40 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

The Heater-Cooler Unit HCU 40 is used to supply temperature-controlled water to regulate the patient temperature during extracorporeal circulation (ECC). Further application areas are warming and/or cooling therapies. The device can also be used to control the temperature of a cardioplegia solution. Therefore the Heater-Cooler Unit HCU 40 contains two independent water circuits. One circuit (main circuit) can be connected to the blood heat exchanger (part of the oxygenator) and/or to the warming/cooling blanket. The other circuit (cardioplegia circuit) can be connected to the cardioplegia heat exchanger. The use of an UV treatment does significantly enhance the water quality between the water change intervals. The heat exchange with the patient and the cardioplegia fluid occurs when the water passes the heat exchangers and/or the blanket. The water temperature of the main and the cardioplegia circuit can be regulated independently from each other.

The Hemotherm Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.

The Hemotherm® Model 400CE Cooler/Heater System is a dual reservoir, water recirculating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients. The device uses conductive heat transfer. When ordered by the health care professional, the device can also simultaneously supply temperature controlled water to a blanket to provide additional patient re-warming therapy. If the blanket is used at the same time as the heat exchanger, the blanket is supplied the same water that circulates to the heat exchanger.

The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.

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The Terumo® HX2™ Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.

The Terumo® HX2™ Temperature Management System provides temperature control of two independent water circuits that directly control the temperature of patient blood and cardioplegia solution during cardiovascular bypass surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right). The system will have the capacity to circulate water at least 6.5 gal/min (25 L/min) with no load connected. The system is capable of heating and cooling for a single channel or for both channels. Channels are configurable such that different waterlice mixture ratios can be obtained. Manually added ice is the only means of obtaining the cool water supply. If a channel should fail during use, the user may switch the water hose connections to the other channel allowing the user to be operational in less than or equal to a minute. Software is used to adjust and display channel set temperatures, acquire and display actual temperatures, automatically regulate temperatures to the entered setpoint, perform system diagnostics, and present visual and audible indications of faults that may occur.

The Stöckert Heater-Cooler System 3T is intended to provide temperature-controlled water to heat exchanger devices (cardiopulmonary bypass heat exchangers, cardioplegia heat exchangers, and thermal regulating blankets) to warm or cool a patient during cardiopulmonary bypass procedures lasting six (6) hours or less. The Stöckert Heater-Cooler System 3T is used with a Stöckert S3 heart-lung machine and/or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

The Sorin Group Deutschland GmbH Stöckert Heater-Cooler System 3T consists of standard and optional components. The standard components comprise the heater-cooler base unit, water connectors, CAN-connecting cable for the S3 System, potential equalization cable, and Operating Instructions. Patient blankets used with the System are already legally marketed in the United States.

The Jostra HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

The Jostra Heater-Cooler Unit HCU 30 supplies temperature-controlled water for cardioplegia heat exchangers, for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The water temperature is adjustable from 1°C to 41°C. A 26 litre tank with ice and approx. 1ºC cold water assures quick cooling of the patient. Two independent circuits with separate temperature controls can be attached (the main side has two connections). A safety system monitors the regulation in order to prevent the temperature from rising above 42°C.