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XRY 125
Term 3
3 credits

Regulations, Documentation & Field Service

This course provides a comprehensive overview of the regulatory and operational frameworks essential for diagnostic X-ray repair technicians. Students will delve into FDA and state-specific regulations governing medical device servicing, ensuring compliance and patient safety. Emphasis is placed on meticulous service record keeping, including documentation best practices and legal requirements. Fundamental concepts of DICOM (Digital Imaging and Communications in Medicine) are introduced, crucial for understanding imaging network integration and troubleshooting. The course outlines a systematic field service workflow, from initial dispatch to post-service reporting. Practical skills for effective communication, safety protocols, and ethical considerations in the field are developed. The curriculum culminates with a review designed to prepare students for relevant industry certification exams, solidifying their readiness for professional practice.

Course outline

Lectures, virtual labs, and graded assignments — completed in your browser.

01Introduction to biomedical equipment regulations and compliancelecture
02FDA regulations for medical devices and X-ray equipmentlecture
03State-specific regulations and licensing for X-ray servicelecture
04Essential service documentation and record keepinglecture
05Practical application of service record managementassignment
06Introduction to DICOM standard and imaging modalitieslecture
07DICOM networking and troubleshooting basicslab
08Field service workflow: Dispatch, preparation, and arrivallecture
09On-site service procedures and safety protocolslecture
10Post-service procedures, reporting, and follow-uplecture
11Customer communication, professionalism, and ethical conductassignment
12Simulated field service scenario and documentationlab
13Midterm review for regulatory and documentation topicslecture
14Final exam review for comprehensive course contentlecture

Syllabus

# XRY 125 - Regulations, Documentation & Field Service

## Course Description
This course provides a comprehensive overview of the regulatory and operational frameworks essential for diagnostic X-ray repair technicians. Students will delve into FDA and state-specific regulations governing medical device servicing, ensuring compliance and patient safety. Emphasis is placed on meticulous service record keeping, including documentation best practices and legal requirements. Fundamental concepts of DICOM (Digital Imaging and Communications in Medicine) are introduced, crucial for understanding imaging network integration and troubleshooting. The course outlines a systematic field service workflow, from initial dispatch to post-service reporting. Practical skills for effective communication, safety protocols, and ethical considerations in the field are developed. The curriculum culminates with a review designed to prepare students for relevant industry certification exams, solidifying their readiness for professional practice.

## Learning Outcomes
Upon successful completion of this course, students will be able to:
*   Identify and apply relevant FDA and state regulations pertaining to diagnostic X-ray equipment service.
*   Accurately complete and maintain comprehensive service records, including corrective and preventive maintenance documentation.
*   Explain the fundamental principles of DICOM and its role in diagnostic imaging networks.
*   Execute a structured field service workflow, from dispatch to post-service follow-up, ensuring efficiency and safety.
*   Implement essential safety protocols and best practices during on-site diagnostic X-ray equipment servicing.
*   Prepare effectively for industry certification examinations related to diagnostic X-ray equipment repair.

## Topics by Week
*   **Week 1:** Introduction to Biomedical Equipment Regulations and Compliance
*   **Week 2:** FDA Regulations for Medical Devices and X-Ray Equipment
*   **Week 3:** State-Specific Regulations and Licensing for X-Ray Service
*   **Week 4:** Essential Service Documentation and Record Keeping
*   **Week 5:** Practical Application of Service Record Management
*   **Week 6:** Introduction to DICOM Standard and Imaging Modalities
*   **Week 7:** DICOM Networking and Troubleshooting Basics
*   **Week 8:** Field Service Workflow: Dispatch, Preparation, and Arrival
*   **Week 9:** On-Site Service Procedures and Safety Protocols
*   **Week 10:** Post-Service Procedures, Reporting, and Follow-Up
*   **Week 11:** Customer Communication, Professionalism, and Ethical Conduct
*   **Week 12:** Simulated Field Service Scenario and Documentation
*   **Week 13:** Midterm review for regulatory and documentation topics
*   **Week 14:** Final exam review for comprehensive course content

## Grading
*   Knowledge Checks: 15%
*   Assignments and Labs: 30%
*   Quizzes: 25%
*   Final Exam: 30%

## Policies
All students are expected to adhere to the Anode Technical Institute's academic integrity policies, attendance requirements, and safety guidelines. Specific policies regarding late submissions, re-takes, and accommodations will be discussed by the instructor and detailed in the course management system.