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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 Quantum Mini Ventilation Module is intended to provide independently regulated O2 outputs for a controlled flow of O2 into the ECC circuit. The Quantum Mini Ventilation Module is an accessory that works with the Quantum workstation. The following parameters are provided by the Quantum Mini Ventilation Module: · Control of gas flow (02) · Extracorporeal gas flow measurements for O2 The Quantum Mini Ventilation Module is only to be used by an experienced and trained clinician. It is not intended to be used by a patient or other untrained personnel.

The Quantum Mini Ventilation Module is a gas control unit that is intended to provide independently regulated oxygen outputs for a controlled flow for procedures involving an extracorporeal circuit. The Quantum Mini Ventilation Module provides a simplified patient ventilation capability. The device consists of a single O2 input port that receives oxygen from the hospital infrastructure and two (2) oxygen outputs that are designed to provide O2 sweep and pO2 Reg. The device interfaces with and is powered by any model of the Quantum workstation. The Quantum Mini Ventilation Module does not contain any user interface; instead, all measurements are displayed on the Quantum workstation.