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Version: v2.2.0

Introduction

Purpose​

This document provides comprehensive instructions for the safe and effective use of MySegmenter (v2.2.0), covering installation, operation, segmentation tools, and 3D printing guidelines.

Scope​

This document applies to MySegmenter (v2.2.0) and is intended for all authorized users of the software. It describes operational procedures, tool functionality, and configuration options

Indications for use​

MySegmenter (v2.2.0) 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 operated under the supervision of qualified medical professionals. Generated 3D models and physical replicas are approved solely for pre-operative planning in orthopedic and craniomaxillofacial cases, and for educational use. They must not be used intraoperatively. Note: MR images have not been validated for craniomaxillofacial applications

Intended Patients​

MySegmenter (v2.2.0) is intended for use with adult patients (18 years of age and older) only.

Intended users​

MySegmenter (v2.2.0) is designed for use by trained professionals in the following roles:

  • Clinicians: Medical professionals — including orthopedic and craniomaxillofacial surgeons — who use the software to plan patient treatments and clinical procedures.
  • Medical imaging technologist: Professionals engaged in medical imaging research, device development, or academic investigation who require 3D anatomical models for their work.
  • Medical device designer: Engineers and designers involved in creating medical devices intended for orthopedic and maxillofacial applications.