Multiple physiological parameter simulation kit

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Available from:

GE Healthcare Australia Pty Ltd

Class:

Class I

Manufactured by:

GE Medical Systems Information Technologies 8200 West Tower Avenue, Milwaukee, WI, 53223 United States Of America

Therapeutic area:

60264 - Multiple physiological parameter simulation kit

Therapeutic indications:

This device is an accessory of the CardioLab system. It connects to the CardioLab Amplifier and is a physiological simulator that plays back waveforms that emulate data types (Invasive Pressure, Intracardiac ECG, Surface ECG, Stimulation). The simulated waveform data is intended to be used for training, testing, development, troubleshooting, and demonstration of the CardioLab system. The simulator is not intended to be used for calibration of other devices. The simulator can be used in various types of environments including both clinical and non-clinical settings where a CardioLab system and CardioLab Amplifier are present. However, the simulator is not intended to be used while a patient is present and connected to the CardioLab system.

Authorization status:

A

Authorization date:

2013-12-06

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