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Version: v2.4.0

Introduction

Purpose​

This document provides comprehensive instructions for the safe and effective use of MySegmenter (v2.4.0), covering installation, operation, segmentation tools, and 3D printing guidelines.

Scope​

This document applies to MySegmenter (v2.4.0) and is intended for all authorized users of the software. It describes operational procedures, tool functionality, and configuration options.

Indications for use​

MySegmenter (v2.4.0) is a medical image segmentation tool that converts CT and MRI scans into three-dimensional anatomical models. The resulting models are intended for preoperative planning and educational purposes only and must not be brought into or used within the operating room.

The software must be used under the supervision of qualified medical professionals. The 3D models and replicas are to be utilized solely for pre-operational planning in orthopedic and craniomaxillofacial cases, and for educational purposes; they must not be used in the operating room. The MR images have not been tested for craniomaxillofacial applications.

Intended Patients​

The MySegmenter (v2.4.0) is intended to be used only Adults (18+)

Intended users​

The MySegmenter (v2.4.0) should only be used by trained medical professionals, this includes:

  • Clinicians: These are medical professionals such as surgeons in the fields of orthopaedics, and craniomaxillofacial involved in the planning of treatments for clinical conditions.
  • Medical imaging technologist: Professionals in the development and research of solutions and academic researchers in the field of medical imaging.
  • Medical device designer: Professionals involved in the design of medical devices for treatment of orthopaedic and maxillofacial diseases.