The Ivy MR Wireless Gating System’s intended use is to acquire physiologic signals, comprising ECG, PP, and RESP, to provide reference outputs to trigger the acquisition and synchronization of gated images during MRI scanning in systems operating at 3.0 Tesla in strength. The MR Wireless Gating System is intended for use on adult and pediatric patients. This product is limited to use by trained and qualified medical professionals. This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment. The product is restricted for use on one patient at a time and is not intended for use in home care monitoring. This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring. The Ivy MR Wireless Gating System is to be used in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners.
A physiological monitoring unit used as a component of a diagnostic magnetic resonance imaging (MRI) system, that produces a signal which enables image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., the beginning of a patient's respiratory or cardiac cycle. It is primarily used for the purpose of artifact reduction or enhancement of signal-to-noise ratios in various real-time or dynamic MRI applications. It is sometimes referred to as a gated imaging accessory or trigger.
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