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Questions and Answers

What is the purpose of the graphic user interface (GUI)?

To handle user commands and show data and messages from other modules.

Which of the following statements is true regarding the cost of repairing errors at different design stages?

It remains constant regardless of the design stage.

It is exponentially proportional to the time passed from the beginning of the project. (correct)

It decreases as the project progresses.

It is inversely proportional to the time passed from the beginning of the project.

Aliasing is caused by oversampling signals.

False

Which of these requirements are suggested to monitor throughout the project? (Select all that apply)

Production cost Signup and view all the answers

What is the validity duration of utility patents?

20 years Signup and view all the answers

The _______ gives the owner the right to exclude others from making, selling or using the claimed invention.

patent Signup and view all the answers

What may patent analysis reveal in product design?

Innovative aspects worth patenting. Signup and view all the answers

What type of analysis is used for testing electrical safety performances?

Theoretical analysis and simulation. Signup and view all the answers

What is the primary function of an ECG?

To process the electrical signal produced by the heart and provide a visual display. Signup and view all the answers

CVDs account for 23.6% of all deaths in the world.

True Signup and view all the answers

Which type of ECG has the poorest signal resolution?

Holter ECG Signup and view all the answers

What are the primary components of a diagnostic ECG?

A device connected to the patient's body with 10 electrodes. Signup and view all the answers

The ECG is the primary test for assessing ________.

cardiovascular diseases Signup and view all the answers

What is the expected global market value for ECG devices by 2015?

USD 4.1 billion Signup and view all the answers

Match the following ECG features with their descriptions:

Quality and reliability = Recording all required signals without errors Safety for patients = Compliance with safety standards Mean time before failures = Related to mission-critical devices User-friendly interface = Minimizes errors and injuries Signup and view all the answers

What is one distinctive feature of ECG devices?

Automatic diagnosis interpretation capability Signup and view all the answers

What regulatory standard is applicable to the certification of the PC ECG in Europe?

European standards/regulations for medical devices. Signup and view all the answers

Study Notes

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.