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What does FDA stand for?
Food Drug Administration
What is the FDA and what do they regulate?
*is a federal agency that is charged with oversight and safety of medical devices (apparatus, implement, machine, in vitro reagent, or any component/part or accessory)
*intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in human or animal
*intended to affect the structure or any function of the body of human or animal
What does NFPA stand for?
National Fire Protection Association.
What is the NFPA and what do they regulate?
National fire Protection Association.
Public safety and fire protection.
NFPA 99 fire standard/regulation.
Establishes criteria to min hazards of fire, explosion and electricity in the health care facility.
What is NFPA 99?
the primary reference for electrical safety for clinical engineering departments in the us
most U.S. states adopt NFPA 99 as regulation
What does AAMI stand for?
Association of Advanced Medical Instrumentation
Association for the Advancement of Medical Instrumentation.
What does AAMI do?
dedicated to the understanding, safety and efficacy of medical instrumentation through certification.
What is the Joint Commission?
Provides accreditation services for organizations (including hospitals, nursing homes, rehab centers, home care companies).
They service once every 3 years or unannounced.
It is not required, but is important for federal reimbursements and hospital insurance coverage.
When surveyed by the joint commission, what 2 standards must the clinical engineering department be in compliance of?
Environment of care (EC) and Human Resources (HR)
What is a "Sentinel Event"?
any unanticipated event resulting in death or serious physical or psychological injury to a patient (not related to the natural course of the patient's illness).
What is NRTL's
Nationally Recognized Testing Laboratories.
Is NRTL's private or public?
What do they do?
In the U.S., what is a commonly used company?
They provide tsting and certification services to manufacturers.
Underwriter's Laboritories (UL)
What is HIPAA and what do they protect?
Health Insurance Portability Accountability Act.
standardization of electronic patient health, administrative and financial data.
What do the classes cover under the FDA's medical device classification?
Class I: least regulatory: bandages, gloves, IV sets, most instruments
Class II: more controls & performance requirements: sterile drapes, most medical electronics, wheelchairs
Class III: tightest controls and pre-market approvals: defibrillators, ventilators, heart valves, artificial joints
What is the pre-market approval called for medical devices or test equipment?
What is an Ag/AgCl electrode?
Silver/Silver Chloride - stable reference electrode
What are the types of electrodes?
- polarizable and nonpolarizable
- shapes: button or bar
- configurations: mono or bi polar
- skin-surface electrodes
- needle electrodes
- cup electrodes
List the characteristics of sensors:
detects change in physical stimulus - turns it into a signal.
what is sensitivity?
output change divided by input change
what is accuracy?
the closeness of many measurement points to a reference
what is precision?
the closeness of many measurement points to each other
what is hysteresis?
unable to repeat data in opposite direction
what is frequency response?
range of frequencies - bandwidth
what is resolution?
smallest step of meaningful output - measurement over range
what is a pressure transducer?
metal strain gaugelinear variable differential transformer(LVDT)
what is a temperature transducer?
- resistance temp detector (RTD)
what is the difference between a thermistor and a thermocouple?
Thermistor - semiconductor device, negative or positive temp coefficient
Thermocouple - coverts temp reading into voltage reading, uses two dissimilar metals (Seebeck effect).
What are the advantages of the instrumentation amplifier?
What are the cardiac actions that create the P, Q-R-S and T waves?
Atrial depolarization - P
Septal depolarization - PQ or PR
early ventricular depolarization - QR
late ventricular depolarization - QR or PRS
repolarization - PQRST
What and where are the 12 leads?
The configuration of electrodes:
RA, LA, RL, LL, Chest (6 precordial positions - V1-V6)
What are the 5 connector colors used in the US?
- White - RA
- Black - LA
- Green - RL
- Red - LL
- Brown - Chest
What is the standard speed of ECG recorders and/or displays?
how is the respiratory rate detected from the ECG?
What is the reason for S-T segment analysis?
Displays whether there is significant change in the cardiac condition. It is very useful when monitoring surgery.