Untitled Quiz

System Engineering - Implementation

• The book demonstrates converting theoretical concepts into practical medical instruments, exemplified by the ECG designed by Gamma Cardio Soft.
• Gamma Cardio Soft aims to provide high-performance, low-cost medical devices, offering transparency in their design processes.

ECG Overview

• The ECG, classified as a medical device by the FDA, processes electrical signals from electrodes to visualize heart activity.
• It is essential for conducting electrocardiograms, aiding in diagnosing various cardiovascular diseases such as myocardial infarction and arrhythmia.

Diagnostic Relevance of ECG

• ECG is crucial for preventing cardiovascular diseases (CVDs), accounting for 23.6% of global deaths.
• In 2008, approximately 17.3 million deaths were attributed to CVDs, with an expectation to rise to 23 million by 2030.

ECG Usage in the USA

• CVDs constitute 17% of national healthcare expenditures in the USA.
• Routine ECG assessments are recommended for individuals over 40 years old.

Types of ECG

• Holter Monitors: Record long-term heart activity with low resolution, suitable for diagnosing conditions needing extended monitoring.
• Event Monitors: Feature better signal resolution and alert for patient issues, commonly used in hospital settings.
• Diagnostic ECG: Focuses on diverse cardiovascular diseases with superior signal resolution and forms the basis of this course.

ECG Architecture

• The diagnostic ECG consists of 10 electrodes and derives 12 leads to capture and display heart electrical activity.

Design Problem Formulation

• Medical instrument design involves setting clear goals, expected outcomes, inputs, assumptions, risks, and constraints.

Market Research and Business Plan

• Preliminary market analysis is vital to assess opportunities, market size, regulations, competition, and client expectations.
• Market trends predict ECG market growth to USD 4.1 billion by 2015, with a CAGR of 9.7% from 2009-2015.

ECG Core and Distinctive Features

• Core Features: Quality data recording, patient/user safety, adequate mean time before failure (MTBF), and user-friendly interfaces.
• Distinctive Features: Capability for simultaneous lead recording, automated interpretation capabilities, preview display for recordings, and networking for telemedicine.

ECG Design Process

• Compliance with medical standards and regulations is crucial for product certification in various markets.

Hardware and Software Platform Decomposition

• The hardware divides into analog and digital units; the analog unit processes patient signals, while the digital unit includes ADCs and a controlling microprocessor.
• The software application manages the hardware, performs signal acquisition, and adapts displays based on user requirements.

Product Life Cycle

• The cost of repairing design errors increases significantly with time, underscoring the importance of early testing and simulations during design.
• Circuit simulators like SPICE can help visualize expected outcomes and analyze design effects, including parasitic components.

Conclusion

• A robust design process and established standards are critical in developing effective ECG devices for medical diagnostics.### Phase Distortion and Aliasing
• Square waves are utilized to assess phase distortion in signal processing.
• Aliasing occurs when signals are undersampled, leading to distortion and artifacts.

ECG Product Life Cycle

• Key requirements to monitor during the ECG project include:
  • Signal quality evaluated through frequency response testing and simulations.
  • Electrical safety performance assessed via theoretical analysis and simulations.
  • Electromagnetic compatibility analyzed using theoretical methods and simulations.
  • MTBF (Mean Time Before Failure) considered through theoretical analysis and simulations.
  • Power consumption derived from theoretical analysis and simulations.
  • Production costs calculated, including materials, PCB, packaging, testing, and labor.
  • Hardware resource utilization evaluated by analyzing memory and computational power.

ECG Development Plan

• The System Development Plan (SDP) addresses critical issues prior to design initiation.
• Adaptation of the DI-IPSC-81427A template, originally for software, is applicable for ECG design projects.
• Templates for project management are available on Moodle for course and graduation projects.

Intellectual Property Rights and Reuse Strategy

• Patents confer exclusive rights for making, selling, or using inventions in recognized jurisdictions.
• Key features necessary for utility patents include:
  • Novelty: Inventions must be original and previously unshared globally.
  • Industrialization: Inventions should be reproducible through industrial processes rather than personal skills, covering processes, machines, products, compositions, and innovative uses.
  • Limited Time Validity: Patents typically last for 20 years.
• ECG technology is referenced in over 26,000 US patents, with only 2,000 directly associated with PC ECG applications.
• Open-source software carries a risk of quality and safety concerns, although non-free libraries can be viable cost-effective options.