About the UroNav 4.1
The UroNav 4.1 is a medical device designed for urological procedures, specifically for transperineal ultrasound-guided biopsies.
Intended Use and Operator Profile
The device is intended for use by trained healthcare professionals in a clinical setting, targeting a specific population and environment.
Operating Principle and Safety
The UroNav 4.1 operates on the principle of electromagnetic tracking and ultrasound imaging, with emphasis on safety features, including warnings, cautions, and electromagnetic compatibility.
System Setup and Biopsy Workflow
The device requires setup, including connections to peripheral equipment, and follows a specific workflow for biopsy procedures, involving review of segmentation and targets, setup, sweep and segmentation, alignment of ultrasound volume with MR, and navigation.
Manual:
Download: UroNav 4.1 Instructions for Use
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