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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.

The Quantum Ventilation Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Ventilation Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Ventilation Module include: - Measurement of up to three blood flow channels and arterial and venous flow differential and gas bubbles - Extracorporeal gas flow measurements that includes O2 & CO2 and calculated CO2 removal - Predicted PO2 and PCO2 - Up to three temperature channels - Up to three circuit pressure channels - Reservoir level indication - Two channels of vacuum - Blend and control gas flow (air/O2/CO2) The Quantum Ventilation Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.

The Quantum Ventilation Module is an on-line, cardiopulmonary bypass, blood gas monitor that is used for extracorporeal monitoring of blood oxygen (arterial and venous) saturation, hematocrit, and hemoglobin levels. The Quantum Ventilation Module provides gas blending and continuous non-invasive monitoring of critical clinical parameters in extracorporeal circuits used in cardiopulmonary bypass (CPB) or extracorporeal membrane oxygenation (ECMO) procedures. The Quantum Ventilation Module is an accessory to the Quantum Workstation. When paired with the Quantum Workstation, the combination of the Quantum Workstation and Quantum Ventilation Module (QVM2) is known as the Quantum Ventilation System. The Quantum Ventilation Module performs five functions: - 1. Provides measurements from embedded and attached sensors to monitor gases into and out of a blood oxygenator. - 2. Provides measurements from attached sensors for blood flow, bubble detection, pressure, level, and temperature to monitor an extracorporeal blood loop. - 3. Provides gas blending to ensure the precision delivery of FiO2, CO2 and sweep flow rates. - 4. Provides regulation of vacuum supply to provide two channels of vacuum. - 5. Sends these physiological measurements to the Quantum Workstation for display to the user. The Quantum Ventilation Module, with its attached sensors, can measure flow, pressure, reservoir level, temperature and gas diagnostics, in addition to performing electronic gas blending of up to three gases and built-in vacuum management for the removal of waste anesthetic gas. The primary interface for controlling and displaying measurements is the Quantum Workstation; however, the Quantum Ventilation Module also contains a touchscreen display with control knobs. The Quantum Ventilation Module only works with the Quantum Workstation.

The intended use of the Quantum Workstation 12" Elite is for the non-invasive continuous monitoring of oxygen saturation and hematocrit / hemoglobin concentration of the blood and in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation 12" Elite is configured to measure and display the following measurements: - · SaO2 Arterial Saturation (%) - · SvO2 Venous Saturation (%) - · Hb Hemoglobin (g/L and gm/dl) - · Hct Calculated Hematocrit (%) - · Blood Flow 2 channels with arterial and venous flow differentials - · Pressure & Temperature 4 channels The Quantum Workstation 12" Elite provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms. The workstation's monitoring and alarm functionality does not directly control patient care. The User makes clinical iudgments regarding the treatment of the patient as a result of information displayed by the workstation.

The Quantum Workstation 12" Elite is an on-line, cardiopulmonary bypass, blood gas monitor that is used for extracorporeal monitoring of blood oxygen (arterial and venous) saturation, hematocrit, and hemoglobin levels. The device's enhanced functionality includes the ability to control centrifugal or roller pumps and make blood flow, blood pressure and blood temperature measurements. The Quantum Workstation 12" Elite consists of a pole-mounted 12.1" landscape high definition touch screen. The touch screen displays individual and trend readings with alarm settings. The Quantum Workstation 12" Elite provides memory storage via an SD (Secure Digital) card. The Quantum Workstation 12" Elite is powered from the AC Mains supply and incorporates a battery backup that automatically switches on in the event of an interruption to the mains power supply. The battery backup is provided via two (2) lithium-ion batteries with a two-hour minimum life. The Quantum Workstation 12" Elite includes the following ports / connections: - One (1) sensor port for the Hb / SO2 sensor - Two (2) sensor ports for blood flow ● - Two (2) sensor ports for blood pressure/temperature - One (1) LAN / Ethernet port ● - Two (2) USB 2.0 ports ● - Three (3) Spectrum Medical ports - One (1) User Serial Port Accessories for the Quantum Workstation 12" Elite include the power supply, mounting arm (long or short), Hb / SQ2 sensor, flow sensors and pressure/temperature sensors.

The Quantum Centrifugal Drive is a cardiopulmonary bypass speed control device indicated for use for exclusively with the Quantum PureFlow Centrifugal Blood Pump for speedcontrolled pumping through the extracorporeal circuit for typical durations of six hours or less.

The Quantum Centrifugal Drive is a cardiopulmonary speed control device intended to be used for pumping arterial blood through the cardiopulmonary bypass circuit. The Quantum Centrifugal Drive is available in two models - High Pressure and Low Pressure. The Quantum Centrifugal Drive is designed to work with the Quantum Pump Manager software application, as part of the Quantum Pump Console (K173834). The Quantum Centrifugal Drive is magnetically coupled exclusively with Quantum Pureflow Centrifugal Blood Pumps, designed and manufactured by Qura s.r.l. The operation of the Quantum Centrifugal Drive is managed from the Quantum Workstation (K163657).

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 Ventilation Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Ventilation Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Ventilation Module include: - · Measurement of up to three blood flow channels and arterial and venous flow differential - Indication of gas bubbles - · Extracorporeal gas flow measurements (02, CO2, gas flow, and CO2 removal) - · Predicted PO2 and PCO2 - · Temperature - · Up to three circuit pressure channels - · Reservoir level indication - Two channels of vacuum - · Blend and control gas flow (air/O2/CO2) The Quantum Ventilation Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.

The Quantum Ventilation Module provides gas blending and continuous non-invasive monitoring of critical clinical parameters in extracorporeal circuits used in cardiopulmonary bypass (CPB) or extracorporeal membrane oxygenation (ECMO) procedures. The Quantum Ventilation Module is an accessory to the Quantum Workstation or can be used in place of the Quantum Diagnostic Module as part of the Quantum Pump Console. When paired with the Quantum Workstation, the combination of the Quantum Workstation and Quantum Ventilation Module is known as the Quantum Ventilation System. The Quantum Ventilation Module performs five functions: - 1. Provides measurements from embedded and attached sensors to monitor gases into and out of a blood oxygenator. - 2. Provides measurements from attached sensors for blood flow, bubble detection, pressure, level and temperature to monitor an extracorporeal blood loop. - 3. Provides gas blending to ensure the precision delivery of FiO₂ (21 to 100%), CO₂ and sweep flow rates. - 4. Provides regulation of vacuum supply to provide two channels of vacuum. One is flow-regulated to remove waste anesthesia gas, the other pressure-regulated for applications including Vacuum-Assisted Venous Drainage (VAVD) and hemoconcentration. - 5. Sends these physiological measurements to the Quantum Workstation for display to the user. The Quantum Ventilation Module, with its attached sensors, can measure flow, pressure, reservoir level, temperature and gas diagnostics, in addition to performing electronic gas blending of up to three gases and built-in vacuum management for the removal of waste anesthetic gas. The primary interface for controlling and displaying measurements is the Quantum Workstation: however, the Quantum Ventilation Module also contains a display with control knobs. The Quantum Ventilation Module only works with the Quantum Workstation.

The intended use of the Quantum Workstation 12.1" is for the non-invasive continuous monitoring of oxygen saturation and haemotocrit / haemoglobin concentration of the blood in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation 12.1" is configured to measure and display the following measurements: SaO2 Arterial Saturation (%) SvO2 Venous Saturation (%) Hb Haemogloblin (g/L and gm/dl and mmol/l) Hct Calculated Haematocrit (%) The Workstation 12.1" provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms. The Workstation 12.1"'s monitoring and alarm functionality does not directly control patient care. The User makes clinical judgments regarding the treatment of the patient as a result of information displayed by the Workstation 12.1".

The Quantum Workstation 12.1" is an online, cardiopulmonary bypass, blood gas monitor. It is used for extracorporeal monitoring of blood oxygen (arterial and venous) saturation, hematocrit, and hemoglobin levels. The Quantum Workstation 12.1" consists of a pole-mounted 12.1" landscape high definition touch screen. The touch screen displays individual and trend readings with alarm settings. The Quantum Workstation 12.1" has a Wi-Fi adapter and provides memory storage via an SD (Secure Digital) card. The Quantum Workstation 12.1" is powered from the AC Mains supply and also incorporates a battery backup that automatically switches on in the event of an interruption to the mains power supply. The battery backup is provided via two (2) lithium-ion batteries with a two-hour minimum life. The Quantum Workstation 12.1" includes the following ports / connections: - One (1) sensor port for the Hb / SO2 sensor . - One (1) LAN / Ethernet port . - Three (3) USB 2.0 ports . - Eight (8) additional LAN ports described as SAP (Spectrum Accessory ● Ports) to support a range of Spectrum Medical manufactured modules these are for future use Accessories for the Quantum Workstation 12.1" include the power supply, mounting arm (long or short), and Hb / SO2 sensor. Different Hb / SO2 sensors are available based on the diameter and thickness of the extracorporeal tubing.

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.