UroNav Version 4.4: Instructions for Use

Introduction to UroNav

The UroNav is an advanced medical imaging device developed by Philips. It is designed to assist clinicians by providing crucial image-guided intervention and diagnostic information. This system plays a vital role in guiding interventional instrumentation towards targets precisely defined by physicians.

This comprehensive guide offers detailed instructions for the safe and effective operation of the UroNav system. It covers essential aspects such as system setup, safety protocols, operating principles, and system configuration. Users will find information on cleaning procedures, maintenance, and troubleshooting to ensure optimal performance.

Key Features and Applications

The UroNav system excels in providing 2D and 3D visualization of Ultrasound (U/S) images. It also offers the capability to fuse and register these images with data from other imaging modalities, including Magnetic Resonance (MR). This integration allows for the display of simulated images of tracked insertion tools, such as biopsy needles or guidewires, on a monitor. The system visualizes the target organ and the projected path of interventional instruments, accounting for patient movement.

Key software features include patient data management, multiplanar reconstruction, segmentation, image measurements, and 2D/3D image registration. The UroNav is specifically indicated for medical conditions requiring interventional and/or diagnostic procedures of the prostate gland. It is important to note that the software is not intended for diagnosis, prediction of ablation volumes, or prediction of ablation success.

Intended Use and Operator Profile

The UroNav is intended for use by trained medical professionals specializing in urology, interventional radiology, image-guided interventions, or similar medical specialties. The target patient population includes individuals at risk for prostate disease who are eligible for a diagnostic MRI scan, primarily adult males where prostate cancer risk is prevalent. The system is designed for use in clinical settings such as hospitals, outpatient clinics, and intervention centers, specifically in medical procedure rooms suitable for prostate interventions.

Safety and Support

Philips is committed to user safety and product improvement. This document emphasizes the importance of reading and adhering to all WARNINGS and CAUTION notices. For detailed safety information, refer to the "Safety" section on page 20 and cleaning procedures in "Cleaning and disinfecting UroNav" on page 45.

For additional supplies, consumable instrumentation, or accessories, please contact your Philips sales representative. For any questions or concerns regarding the UroNav system or its documentation, Philips Customer Service can be contacted at 1-877-468-4861 in the USA. Customer support representatives are available globally to provide assistance.

For the latest user documentation, including Instructions for Use (IFU), visit www.philips.com/ifu.