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The Horizon Angio is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature.

Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.

The Horizon Angio is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature. Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, analyzed and presented in a variety of report formats.

The Horizon Angio software includes graphic presentation of the abdominal, cranial and peripheral vascular system, to support reporting of vascular catheterization.

The Sun Blade 150 workstation is a uni-processor system that runs the Cathlab program on a UNIX operating system. The workstation receives the digitized signals from the CFE via the Ethernet hub, displays real-time vital signs, analyzes, processes, and calculates the vital sign data and waveforms, cardiac status in real time during the catheterization process, creating a fully documented case history. The workstation continuously displays the vital signs waveforms and data on the local LCD displays.

The hemodynamic data, waveform and numerical, can be stored, analyzed and presented in a variety of report formats.

A Laser Printer is provided in the system. This provides printouts of textual and graphical summaries of all patient data and catheterization procedures.

Base Configuration: Cathlab parameters

• . 2 Invasive Blood Pressure channels
• . Diagnostic 7 or 12 Lead ECG
• . Non-invasive Blood Pressure
• Pulse Oximetry (SpO2) .

Horizon Angio Options:

• Full Disclosure .
• Off-line workstations ●
• Remote Interactive terminal .
• . Angiography Analysis Package
• CDR, DVD or Optomagnetic drive .
• Choice of Console Table regular, enhanced, compact or without consol .

Here's an analysis of the provided text regarding the acceptance criteria and study proving device efficacy:

Device: Horizon Angio Cathlab (a sub-system of the Horizon 9000WS Cathlab)

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides extensive performance specifications for the Horizon Angio, which serve as the acceptance criteria. The accompanying information (e.g., "Meets or exceeds ANSI standard") indicates that the device's performance is intended to meet these criteria.

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