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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.

B-Capta 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 hours.

B-Capta is intended to be used for in-line continuous monitoring of patient's blood parameters during procedures requiring extracorporeal circulation. B-Capta is designed to work with a Stöckert S5 System (K071318) heart-lung machine. Provided in-line measured parameters of B-Capta are: In the Venous line: - Haematocrit / Haemoglobin (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. B-Capta consist of the following components / disposables: - B-Capta Venous and Arterial Sensors - B-Capta Sensor Module - B-Capta Venous and Arterial Reference Element Holders - B-Capta disposable Venous and Arterial Cuvettes B-Capta is a microprocessor based device. The venous sensor is an optical sensor which measures, when connected to its dedicated disposable cuvette, hematocrit/hemoglobin and oxygen saturation using an optical reflectance technology. Moreover, an infrared technology is used to measure the temperature of the venous blood. The arterial sensor is an optical sensor which measures, when connected to its dedicated disposable cuvette, partial pressure of oxygen using an optical fluorescence technology. Moreover, an infrared technology is used to measure the temperature of the arterial blood. Both sensors are functionally connected to the compatible heart-lung machine via a cable plugged in the sensor module and communicate with B-Capta firmware via a RS232 interface according to a dedicated communication protocol. Data are displayed on the graphical user interface of the heart-lung machine.

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 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 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 Diagnostic Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Diagnostic Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Diagnostic 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 The Quantum Diagnostic 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 Diagnostic Module is an accessory to the Quantum Workstation that provides continuous non-invasive monitoring of critical clinical parameters during procedures requiring extracorporeal circulation. The Quantum Diagnostic Module is connected to the Quantum Workstation via a cable and positioned between the gas blender and the oxygenator devices in the extracorporeal circuit. When paired with the Quantum Workstation, the combination of the Quantum Workstation and Quantum Diagnostic Module is known as the Quantum Diagnostic System. The Quantum Diagnostic Module performs three 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. Sends these physiological measurements to the Quantum Workstation for display to the user. The Quantum Diagnostic Module, with its attached sensors, can measure flow, pressure, reservoir level, temperature and gas diagnostics. The Quantum Diagnostic Module only works with the Quantum Workstation.

The intended use of the Quantum Workstation is for the non-invasive continuous monitoring of oxygen saturation and hematocrit / hemoglobin concentration of the blood in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation is configured to measure and display the following measurements: - SaO2 Arterial Saturation (%) - Venous Saturation (%) Sv02 - Hb Hemoglobin (g/L and gm/dl) - Calculated Hematocrit (%) Hct The Workstation 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 judgments regarding the treatment of the patient as a result of information displayed by the Workstation.

The Quantum Workstation 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 consists of a pole-mounted 14 ¾" portrait high definition touch screen. The touch screen displays individual and trend readings with alarm settings. Third party data may also be displayed (without alarms). The Quantum Workstation has a Wi-Fi adapter and provides memory storage via an SD (Secure Digital) card. The Quantum Workstation 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 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 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 BioTrend oxygen saturation and hematocrit system measures percent oxygen saturation and hematocrit of the blood in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closedchest support, and limb perfusion.

The Medtronic Tri-optic Measurement Cell is a sterile, single-use cell used with the BioTrend Oxygen Saturation and Hematocrit System. This 510(k) premarket notification was submitted to add Balance Biosurface to the disposable cell as update the labeling information for all Tri-optic Measurement Cell versions. The disposable cell is coated on its blood contacting surfaces with Balance Biosurface. Previously cleared disposable cells are also available in uncoated form, and with Carmeda BioActive Surface coating or Trillium Biosurface coating.

The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the system 500's integral printer provides a hard copy of displayed parameters.

The CDI™ System 500 is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories: - CDI™ 500 Monitor . - Arterial and/or Venous Blood Parameter Modules (BPM) . - CDI™ 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 500 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 electrooptics 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™ 500 Monitor in real time, and displayed to the user via a graphical LCD display.

The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the system 500's integral printer provides a hard copy of displayed parameters.

The CDI™ System 500 is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories: - CDI™ 500 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 500 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 electrooptics 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™ 500 Monitor in real time, and displayed to the user via a graphical LCD display.