LC Engineering flashcards
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32 cards. Read the term and the definition here. The deck at the top of this page is optional.
- Acceptance testing
- Verification that a new medical device meets manufacturer specifications and local safety standards before clinical use, including electrical safety, performance, and documentation.
- Preventive maintenance
- Scheduled inspection, cleaning, calibration, and performance verification of medical equipment to prevent failures and ensure safe operation, typically based on manufacturer recommendations and risk level.
- Risk-based PM
- A maintenance strategy that prioritizes devices by function, physical risk, incident history, and maintenance requirements, allocating more frequent attention to higher-risk equipment.
- MTBF
- Mean time between failures, calculated as total operating time divided by number of failures; used to assess reliability and plan equipment replacement.
- FDA device classes
- Class I (low risk, general controls), Class II (moderate risk, general and special controls, often 510(k)), Class III (high risk, premarket approval).
- 510(k) premarket notification
- A FDA submission demonstrating that a new device is substantially equivalent to a legally marketed predicate device, allowing marketing without clinical trials.
- Medical Device Reporting
- FDA requirement for manufacturers and user facilities to report device-related deaths, serious injuries, and malfunctions to detect and address safety issues.
- Recall classes
- Class I: reasonable probability of serious adverse health consequences or death; Class II: temporary or reversible health consequences; Class III: unlikely to cause harm.
- Ground continuity test
- Electrical safety test verifying low resistance (typically <0.5 Ω) between the protective earth pin and exposed conductive parts, ensuring a safe fault current path.
- Leakage current limits
- IEC 60601-1 limits: earth leakage ≤500 µA normal; patient leakage ≤100 µA (Type B/BF) or ≤10 µA (Type CF) under normal conditions.
- Defibrillator energy test
- Verification that delivered energy is within ±15% of selected energy, charge time is acceptable, and synchronized cardioversion timing is accurate.
- Calibration traceability
- An unbroken chain of measurements linking test equipment to national or international standards (e.g., NIST) with documented uncertainty.
- CMMS
- Computerized maintenance management system: software tracking equipment inventory, work orders, PM schedules, parts, and costs for healthcare technology management.
- MTTR
- Mean time to repair: average time to restore a failed device to service, a key performance indicator for maintenance efficiency.
- Capital equipment planning
- Aligning technology acquisition with clinical strategic goals and budget cycles, including needs assessment, prioritization, and lifecycle cost analysis.
- Technology assessment
- Evaluation of clinical efficacy, safety, cost-effectiveness, and integration of a medical technology to inform adoption and management decisions.
- HIPAA Security Rule
- Requires administrative, physical, and technical safeguards to protect the confidentiality, integrity, and availability of electronic protected health information (ePHI).
- Network segmentation
- Isolating medical devices from enterprise IT networks to limit attack surface, contain breaches, and protect clinical operations.
- HL7
- A standard for exchanging clinical and administrative health data between healthcare information systems, enabling interoperability.
- DICOM
- A standard for storing, transmitting, and displaying medical imaging information, ensuring interoperability among imaging devices and systems.
- Ohm's law
- V = I × R; voltage equals current times resistance. Power P = V × I = I²R = V²/R.
- Impedance
- Total opposition to alternating current, combining resistance and reactance: Z = √(R² + X²), where X is reactance.
- CMRR
- Common-mode rejection ratio: a differential amplifier's ability to reject common-mode signals; higher values improve signal quality in biopotential measurements.
- Microshock
- Very small current (as low as ~100 µA) applied directly to the heart, which can cause ventricular fibrillation; requires strict isolation in intracardiac procedures.
- Cardiac conduction system
- SA node (pacemaker), AV node (delay), bundle of His, bundle branches, and Purkinje fibers, coordinating atrial and ventricular contraction.
- ECG waveforms
- P wave (atrial depolarization), QRS complex (ventricular depolarization), T wave (ventricular repolarization).
- Cardiac output
- Heart rate multiplied by stroke volume; normal resting value approximately 5 L/min.
- Pulse oximetry
- Noninvasive measurement of arterial oxygen saturation (SpO2) using light absorption; normal range 95–100%.
- Environment of care
- Standards addressing safety, security, hazardous materials, fire safety, medical equipment, and utilities to provide a safe healthcare facility.
- Emergency power testing
- Monthly and annual testing of emergency generators and essential electrical systems to ensure backup power for life safety and critical care.
- Medical gas systems
- Piped oxygen, vacuum, medical air, and other gases requiring verification, labeling, and alarm systems to ensure patient safety.
- Clinical engineering ethics
- Professional principles emphasizing patient safety, competence, confidentiality, integrity, and disclosure of conflicts of interest.