(29 days)
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.
I am sorry; this document does not contain the information you are looking for. None of the pages reference acceptance criteria or study data demonstrating that the device meets these criteria.
§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.
(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).