Search Results

The Dash 3000 Patient Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.

The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e., ambulance, etc.) and fixed and rotary winged aircraft, and prehospital emergency response.

Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, and carbon dioxide as summarized in the operators manual. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL).

The Dash 3000 Patient Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care.

This information can be displayed, trended, stored, and printed.

The Dash 3000 Patient Monitor is a device that is designed to be used to monitor, display, and print a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, noninvasive blood pressure, oxygen saturation, temperature, impedance respiration, and end-tidal carbon dioxide. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL). Additionally, the network interface allows for the display and transfer of network available patient data.

The provided text is a 510(k) summary for the GE Marquette Medical Systems Dash 3000 Patient Monitor. It focuses on establishing substantial equivalence to predicate devices and describes the device's intended use and technological similarity. It does not include detailed studies on acceptance criteria or device performance data. Therefore, I cannot provide the requested information from the given text.

The document states:

• "The results of these measurements demonstrated that the Dash 3000 is as safe, as effective, and performs as well as the predicate devices." This is a high-level conclusion, but no specific performance metrics, acceptance criteria, or study details are provided.
• "The Dash 3000 complies with the voluntary standards as detailed in Section 9 of this submission." This indicates compliance with various standards, but the specifics of what those standards are, what performance metrics they define, and how the device met them are not included in this summary.
• "The following quality assurance measures were applied to the development of the Dash 3000: . Requirements specification review . Code inspections Software and hardware testing ● . Safety testing . Environmental testing Final validation ." These are general development and testing procedures, not detailed clinical or performance studies with specific acceptance criteria and results.

To answer your request, a document containing detailed performance study results with explicit acceptance criteria would be needed. This 510(k) summary does not contain that level of detail.

Ask a specific question about this device