The Active Medical Devices Certification (ECG, Patient Monitor, Infusion Device) course, offered by the British Academy for Training and Development, provides specialized knowledge and practical skills required for the certification and maintenance of active medical devices. These devices, such as ECG machines, patient monitors, and infusion devices, play a crucial role in patient care by monitoring vital signs and delivering essential treatments. This course is designed for professionals involved in the operation, maintenance, and servicing of these devices. Participants will gain in-depth knowledge of the technology, safety standards, and troubleshooting techniques for each device, ensuring their proper functioning and compliance with medical regulations.

Who Should Attend?

• Biomedical engineers, technicians, and clinical engineers responsible for maintaining, testing, and certifying active medical devices in healthcare settings.
• Medical device service providers who require an understanding of the technical aspects and certifications associated with ECGs, patient monitors, and infusion devices.
• Healthcare professionals involved in the operation and calibration of diagnostic and therapeutic medical equipment.
• Regulatory and quality assurance professionals working in hospitals and medical device manufacturing industries.

Knowledge and Benefits:

After completing the program, participants will be able to master the following:

• Understand the key principles and functions of ECGs, patient monitors, and infusion devices.
• Perform calibration, maintenance, and troubleshooting of these active medical devices to ensure optimal performance.
• Apply relevant standards, safety protocols, and best practices for handling, certifying, and testing active medical devices.
• Ensure compliance with regulatory requirements related to active medical devices in clinical and healthcare environments.
• Diagnose and resolve common technical issues in ECGs, patient monitors, and infusion devices effectively.

• Overview of Active Medical Devices
  • Definition and categories of active medical devices.
  • Importance of ECGs, patient monitors, and infusion devices in clinical practice.
  • Role of active medical devices in patient care and safety.
• Regulatory Framework for Medical Devices
  • Introduction to global medical device standards (e.g., ISO, IEC).
  • Regulatory bodies and certification processes.
  • The importance of certifications and compliance in the medical device industry.

• Principles and Operation of ECG Machines
  • Basic ECG principles and how they function.
  • Components of an ECG machine and their roles.
  • Different types of ECG machines and their uses in healthcare.
• Maintenance and Calibration of ECG Machines
  • Regular maintenance tasks for ECG machines.
  • Steps for calibrating ECG machines to ensure accurate readings.
  • Troubleshooting common issues with ECG machines.

• Common Problems in ECG Machines
  • Identifying and diagnosing common ECG machine faults.
  • Troubleshooting power, signal, and display issues.
  • Techniques for resolving calibration discrepancies.
• Certification Process for ECG Machines
  • The process of testing and certifying ECG machines.
  • Relevant testing standards and guidelines for ECG devices.
  • Ensuring compliance with healthcare regulations and standards.

• Principles and Operation of Patient Monitors
  • Overview of how patient monitors measure vital signs.
  • Understanding different types of monitors: single and multi-parameter monitors.
  • Functionality and key components of patient monitors.
• Maintenance and Calibration of Patient Monitors
  • Routine checks and maintenance tasks for patient monitors.
  • Importance of calibrating monitoring parameters such as ECG, blood pressure, and temperature.
  • Steps for ensuring continuous accuracy and performance of patient monitors.

• Common Problems in Patient Monitors
  • Diagnosing issues with ECG, SpO2, NIBP, and other vital signs.
  • Troubleshooting display, connection, and sensor issues.
  • Common sensor calibration problems and solutions.
• Certification Process for Patient Monitors
  • Steps involved in testing and certifying patient monitors.
  • Regulatory requirements and testing protocols for certification.
  • Addressing compliance issues during certification.

• Principles and Operation of Infusion Devices
  • Types of infusion devices: syringe pumps, volumetric pumps, and PCA pumps.
  • Working principles of infusion pumps.
  • Applications of infusion pumps in healthcare settings.
• Maintenance and Calibration of Infusion Devices
  • Routine maintenance procedures for infusion pumps.
  • Calibration techniques to ensure accurate fluid delivery.
  • The role of alarms and safety features in infusion devices.

• Common Problems in Infusion Devices
  • Identifying and solving problems related to flow rates, alarms, and programming errors.
  • Troubleshooting occlusions, air bubbles, and device malfunctions.
  • Methods for ensuring the safe operation of infusion pumps.
• Certification Process for Infusion Devices
  • Testing procedures for certifying infusion devices.
  • Standards and regulatory requirements for certification.
  • Validating performance and safety of infusion pumps.

• Electrical Safety Standards for Medical Devices
  • Introduction to electrical safety regulations for medical devices.
  • The role of grounding, insulation, and leakage current testing.
  • Key international standards related to electrical safety.
• Safety Protocols in Device Servicing
  • Ensuring device safety during maintenance and repairs.
  • Best practices for minimizing electrical hazards.
  • Protocols for emergency situations and device shutdown procedures.

• Preventive Maintenance for ECG, Patient Monitors, and Infusion Devices
  • Establishing a preventive maintenance schedule for medical devices.
  • Steps for checking device performance regularly and reducing wear.
  • The impact of preventive maintenance on device longevity and reliability.
• Advanced Troubleshooting Techniques
  • Strategies for resolving complex issues in medical devices.
  • Utilizing diagnostic tools and software for troubleshooting.
  • Case studies and real-world troubleshooting examples.

• Calibration Procedures for Active Medical Devices
  • Importance of accurate calibration for ECGs, patient monitors, and infusion devices.
  • Tools and equipment required for calibration.
  • Guidelines for ensuring calibration accuracy and consistency.
• Understanding Certification Standards
  • International certification standards and how they apply to active medical devices.
  • Compliance with FDA, CE, and ISO certification requirements.
  • Certification testing methods for ECG, patient monitors, and infusion devices.

• Device Integration in Modern Healthcare
  • The role of active medical devices in integrated healthcare systems.
  • Understanding the interoperability between ECG, patient monitors, and infusion devices.
  • Data sharing and communication between devices for patient care optimization.
• Managing Data and Network Connectivity
  • Ensuring secure data transmission between devices and healthcare systems.
  • Common challenges in device network connectivity.
  • Implementing best practices for device integration.

• Regulatory Bodies and Standards for Active Medical Devices
  • Overview of key regulatory agencies such as FDA, CE, and ISO.
  • The importance of adhering to regulatory guidelines for device approval and certification.
  • Compliance with standards to ensure patient safety and device reliability.
• Certification Documentation and Reporting
  • Understanding certification documentation requirements.
  • Steps to prepare for regulatory audits and inspections.
  • Keeping accurate records for compliance purposes.