Instrumentation CA1 Flashcards
Transducer +3 clinical examples
Anything that converts one electrical source to another electrical source
Electrodes
Piezoelectric crystal
Spirometer
Filters
Mitigate any unwanted frequencies
Amplifiers
Electric bio signals are very small, so amplifiers increase the signal but is also used for filtration
Signal digitisation
electric bio signals are analogue and will need to be converted into digital form using an analogue to digital converter
When assessing the usefullness of a device, what two peramiters do we take into account
Specificity and Sensitivity
In what cases to we want a high specificity and in what cases do we want a high sensitivity
Want high sensitivity when screening for a disease
High specificity when confirming a disease
When assessing the quality of the medical devices the performance if determine by what 4 values
accuracy, resolution, precision, reproducibility
ROC curve
- what does it plot
- where on the graph would a device be deemed an acceptable classifier
ROC curve asseses the ability of the binary classifier. Plots sensitivity vs specificity
Anything above the positive slanted line is acceptable
What are the 4 rules in classifying non-invasive devices
- either do not touch the patient or contact only intact skin (I)
- intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion into the body (I)
- unless using with blood/body fluids (II1)
- unless connected to a active device class IIa or higher (IIa)
- unless bloodbags
- modifying the biological or chemical composition of human tissues, or cells, blood, other body liquids, or other liquids intended for implantation or administration into the body (IIb)
- unless only filtration, centrifugation or exchange of gas or heart (IIa)
- consisting of a substance intended to be used in vitro in direct contact with human cells (embryo) (III)
- In contact with injured skin or mucous membrane (or invasive device) (IIa)
- unless as a mechanical barrier, compression or absorption (I)
- unless intended for wounds which breach dermis and heal only by secondary intent (IIb)
Qualities of class 1 device
mostly non-sterile and non-invasive
e.g blood pressure machine, stethoscope, reusable surgical instruments
qualities of class IIa devices
short term, non-invasive devices intended for channelling or storing blood, body liquids for eventual administration into the body
If they are principally intended to manage the microenvironment of the cell
e.g ultrasound, diagnostic software
Qualities of class IIb devices
long term, intended to be used principally for injuring the skkin which can breach the dermis
e.g equipment used for intraoperative monitoring, ionizing radiation
intended to administer medicinal product by means of a delivery system
qualities of class 3 device
critical for patients life
e.g pacemaker, stent
What is not the responsibility of the regulatory bodies in medical device standardisation
designing specific safety tests that medical devices must pass
What are the two independent testing agencies
ISO and IEC
What are the 4 levels of risk severity
- Minor - recoverable
- Major - very slow to recover or permanent
- Critical - immediate or prolonged treatment
- Fatal - may result in death
What two components is risk made up of
Probability and consequence
What is requirement for hardware failures
A medical device must be safe in the case of a single fault
2 independent failures should not harm the patient
Therefore equipment must be designed so that the combination of the first and second failures cannot cause a hazard
What are the two primary principles behind software verification
- describe the exact function the software is supposed to perform
- device a very specific test to verify that the software works s designed
Resolution
The smallest differential value that can be measured
An electric shock of 80-600uA is likely to cause what to happen in a body
Ventricular Fibrillation
What is the difference in the travel path between macro and micro electric shocks
Macro - only a small amount of the current flows through the heart
Micro - introduced directly into the body via a high conducting avenue with a direct conduction path to the heart
What two parameters depend how bad an electric shock is
skin resistance and spatial distribution
How do you protect someone after having a macro shock
isolate patient from any grounded surface and all current sources.
electric field force eququation
F = qE
What does Coulombs law state
As you move away from the electric field, the strength gets weaker
Electric force is inversely proportional to R (electric field gets really weak, really quickly as yo move away from it)
What does Gauss Law explain
Explains how there are negative and positive charges that interact with each other without touching through electric fields
What will the net force of the magnetic field be in a magnet
Always 0
What is the role of a battery
A battery chemically rips apart charge allowing them to then snap together again (creating energy)
How do we measure the strength of a battery
put a single charge into the electric field of the batter and measure the electric potential of that single charge using (W=qEd)
What direction is conventional current
Positives moving towards negative
What makes a good conductor (theory and examples)
Good conductors font allow many collision between charges
Gold, platinum, copper
Capacitor + equation
A device with the ability to store electrical charge
C=Q/V
What determines the quality of conductivity of a material
The number of electrons on the outer shell and how bounded they are to the atom
What is the frequency of AC and DC circuit
AC - 50Hz
DC - 0
Are medical devices AC or DC
Medical devices can often use a combination of bothAC and DC circuits and need to change to either between one another. An inverter converts DC to AC while a rectifier converts AC to DC
What do electrodes do
Conduct electricity through non-metallic mediums
What is reactance
The opposing force to current in AC circuit
What is a semiconductor and an example of one
A semiconductor has properties of a conductor and insulator
e.g silicone
What is dopping
This is the process of introducing foreign material to pure crystal form semiconductors that improves their conductivity
n-type vs p-type dopping
n-type: created by doping in extrinsic semiconductor with an element with an additional election
p-type: created by doping in extrinsic semiconductor with an element with notable fewer electrons
How does a semiconductor work
The free electrons from the n-type migrate to the p-type to donate their electrons. There is a region close to where the two sides meet called the depletion layer, where there is no charge as there are no free flowing electrons.
This depletion layer allows of current flow only in one direction (anode>cathode)
What is a photodiode and how does it effect a semiconductor
A photodiode is light sensitive conductor that produces current when it absorbs photons
the direction of the electric current in the diode forces the electrons to move towards the n-side and consequently the holes move towards the p-side. This results in an increase in the number of electrons on the n-side and hold on the p-side, a rise in the electromotive force is observed
What is an LED and how does it effect a semiconductor
A LED is a semiconductor that emits light when a voltage is applied
The electrons from the n-side gain enough energy to cross the junction and recombine with the p-side. The energy released when the free electrons from the n-side combine with the p-side is released in the form of light.
What sort of sensor measure blood oxygen saturation
Optical sensor