Chapter 4 Part 2 CENG Electrical Safety and Standards Flashcards

1
Q

What is leakage current?

A

-Leakage current is the current that flows from either AC or DC circuit in equipment to the chassis, or to the ground, and can be either from the input or the output.

-All electrically operated devices have some low-value currents that flow from the energized electrical portions of the device to the metal chassis. This current is not a result of a fault but is a natural consequence of electrical wiring and components. This current is referred to as leakage current and has two components, capacitive and resistive.
- Small currents (µA) that flow between any adjacent insulated conductors that are at different potentials

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2
Q

What are the two leakage currents? (C and R)

A

1) Capacitive Leakage Current
2) Resistive Leakage Current

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3
Q

What is capacitive leakage current?

A

Capacitive leakage current results from distributive capacitance between two wires or between a wire and a metal chassis. For example, the “Live” copper wire forms one plate, the wire insulation forms the dielectric, and the metal chassis forms the other plate of a capacitor.

This capacitor is actually distributed over the entire length of the power cord (Length increases, capacitance increases, higher leakage currents). A 6m power cord of capacitance 500pF/m at 50Hz on a 230V power system gives 1.06MΩ of capacitive reactance and thus 217μA of leakage current.

Components that cause capacitive leakage currents are RF filters, power transformers, power wires, and any device that has stray capacitance.

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4
Q

What is resistive leakage current?

A

Resistive leakage current arises from the resistance of the insulation surrounding the power wires and transformer primary windings. Modern power cords are of very high resistance that the resultant leakage current is negligible compared to capacitive leakage.

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5
Q

What are the 2 purposes of Earth wire?

A
  • Drain off leakage current
  • Blow off the plug fuse in case of Live-to metal chassis short (thus preventing electrical shock to anyone touching the “live” chassis).
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6
Q

How do macroshocks occur?

A

A macroshock results when a person touches the live ungrounded chassis and any grounded object simultaneously.

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7
Q

What happens when the chassis and cabinet are not grounded?

A

An insulation failure or a short between the live wire and the chassis can result in a high voltage differential (230V) between the chassis and any grounded object.

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8
Q

What happens when ground wire is broken?

A

The chassis potential rises above ground.

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9
Q

How do microshocks occur?

A

If a patient who touches the chassis and has a grounded electric connection to the heart, he may receive a microshock.

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10
Q

What are some uses of electrical power in healthcare facilities?

A
  • operation of medical instruments
  • lighting
  • maintenance appliances
  • patient conveniences (TV, hair dryers, …)
  • clocks
  • nurse call buttons
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11
Q

What are the 2 ways to provide electrical safety?

A
  • control the availability of electric power
  • provide proper grounding in the patients’ environment
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12
Q

What are the 3 processes of electricity distribution? TSD

A
  1. Transmission: High voltage enters the building, usually via underground cables.
  2. Substation: The secondary of a stepdown transformer develops 240-V. This secondary has a grounded centre tap to provide two 120-V circuits.
  3. Domestic power supply: Ordinary wall receptacles and lighting are obtained from either one of the ungrounded hot transformer terminals and the neutral grounded centre tap.
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13
Q

How is a grounding system connected?

A

All receptacle grounds and conductive surfaces in the vicinity of the patient are connected to the patient-equipment grounding point.
Each patient-equipment grounding point is connected to the reference point that makes a single connection to the building ground.

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14
Q

What are the 3 different types of grounds?

A
  • signal ground
  • chassis ground
  • earth ground
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15
Q

What are ground faults?

A

Ground faults are short circuits between Live & Earth injecting large currents and thereby tripping the circuit breakers

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16
Q

What are the several techniques used to protect clinicians, patients & visitors from electrical shock? (3 methods)

A
  • Isolation transformer
  • Line Isolation Monitor (LIM)
  • Ground Fault Circuit Interrupter (GFCI)
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17
Q

How does an isolation transformer work?

A

The Isolation transformer offers electrical safety by converting grounded power into ungrounded power.

This is accomplished by grounding the primary winding of the transformer and not grounding the secondary winding.

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18
Q

What happens when single fault from either conductor to ground occurs?

A

The system simply reverts to a normal grounded system
(a second fault from the other conductor to ground is then required to inject high currents in the ground.)

A Line-Isolation Monitor (LIM) must be used with isolation transformers to detect the occurrence of the first fault from either conductor to ground.

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19
Q

When is a patient still safe?

A

If either Hot or Neutral of Isolation Transformer secondary is in contact with patient, patient is still safe.

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20
Q

What is a line isolation monitor (LIM)?

A

To monitor the degree of system isolation, a line isolation monitor (LIM) is employed. Its function is to continually analyze the entire isolated circuit and quantify its degree of isolation from ground, i.e. to monitor the leakage current to ground. The LIM provides visual and audible alarm signals when the predicted ground-seeking current exceeds a specified magnitude.

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21
Q

How does a LIM work?

A

This monitor alternately measures the total possible resistive and capacitive leakage current (total hazard current) that would flow through a low impedance if it were connected between either isolated conductor and ground.

When the total hazard current exceeds either 2.0mA or 5.0 mA LIM setting, a red light and an audible alarm are activated.

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22
Q

What happens when the LIM detects too much power and what should be done?

A

The LIM will alarm and indicate that there is an overload. The power used must be reduced immediately by moving some equipment to another circuit as soon as possible until the alarm stops sounding.

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23
Q

What happens when load on LIM is not reduced?

A

Failure to reduce the load on the LIM will result in the circuit breaker tripping and loss of power to the circuit

24
Q

What is a Ground Fault Circuit Interrupter (GFCI)?

A

The GFCI acts like a circuit breaker when it senses an inequality of as little as 6-mA between the “hot” and neutral wires of the circuit. It shuts off the power supply within 15 – 100ms of the start of a fault current. This interruption is so fast that a person may not experience the sensation of a fault shock & may even then wonder why the instrument is not working.

25
Q

Where are GFCIs usually used in?

A
  • whirlpool bath (jacuzzi, spa)
  • swimming pool,
  • bathroom
  • construction sites

In hospitals, GFCIs are used in hydrotherapy area, where continuity of power is not essential.

26
Q

Why are GFCIs not used in patient-care areas?

A

Circuits in patient-care areas generally should not include GFCIs because the loss of power to life-support equipment due to GFCIs is probably more hazardous to the patient than most small ground faults would be.

27
Q

What do GFCIs protect you from?

A

GFCI cuts off the electricity at the first sign of an unsafe flow of current. Because GFCIs respond to the abnormal flow of current in a circuit faster than fuses or circuit breakers can, they protect you from prolonged electrical shocks by interrupting the current flow before a person can be seriously injured.

28
Q

How does a GFCI work?

A

In an electrical equipment that has negligible leakage current, the current in the hot
conductor is equal to the current in the neutral conductor. The GFCI senses the difference between these two currents and interrupts power when this difference, which
must be flowing to ground somewhere, exceeds the fixed rating.

29
Q

What is the relationship between GFCI and ground-fault current?

A

The trip time for the GFCI varies inversely with the magnitude of the ground-fault current (see the graph below).

30
Q

What are the components of a GFCI?

A

A differential transformer and solid-state circuitry

31
Q

What happens when net flux is zero in a GFCI?

A

currents are equal

32
Q

What happens when current is unbalanced in a GFCI?

A

A net flux is induced across the third coil. This current will trigger a switch opening the “hot” line.

33
Q

What does IEC stand for?

A

International Electrotechnical Commission

34
Q

What is earth leakage?

A

This is essentially the current flowing down through the ground conductor in the line cord back to earth.

35
Q

What is enclosure leakage?

A

This is essentially the current that flows from any enclosure part if you were to touch it.

36
Q

What is Applied Part Leakage?

A

It is the part that intentionally comes into contact with the patient & is commonly known as patient lead. This is any leakage that flows from an applied part, between applied parts, or into an applied part.

37
Q

Why is applied part leakage the most critical safety test?

A

It is the most critical of all safety tests because the patient leads are in direct contact with the patient, and for invasive devices they are under the skin where the resistance is the lowest.

When applied under the skin, as little as 15μA has been shown to be potentially fatal. This is also the most complicated and time consuming of all the safety tests because of the sheer number of combinations possible that you are required to test.

38
Q

What are the 3 types of applied part leakage tests?

A
  • Patient Leakage (or Lead Leakage): lead-to-ground current
  • Patient Auxiliary (or Leakage between Patient Leads): lead-to-lead current
  • Mains on applied part (or Lead Isolation): lead-to-ground current with 110% mains
    voltage applied between the lead & ground.
39
Q

What is Patient Leakage Current?

A

It measures the current flowing between a selected applied part and the mains Protective Earth. This test is performed with normal and reverse mains supply polarity using S2 and single fault conditions using S1 and S3.

40
Q

What is Patient Auxiliary Current?

A

It measures the current between a selected applied part and all others. This test is performed with normal & reverse mains supply polarity using S2 and single fault conditions using S1 and S3

41
Q

What is Lead Isolation current?

A

It measures the current flow in response to an isolated AC voltage applied between selected applied parts & Earth. The magnitude of the voltage is at least 110% of the mains voltage.

The test is performed with normal & reverse mains supply polarity using S2, and normal & reverse isolated voltage supply using S4.

42
Q

What is Chassis Ground Resistance?

A

This test is only applicable to devices utilizing three-wire (grounded) power cords. This test measures the power cord resistance and ensures that the casing is effectively connected to Earth pin of the socket.

43
Q

What is Dielectric withstand?

A

It is also commonly known as hipot (high potential) testing to test the strength of insulation. A high voltage (5.5kV) is applied between insulated parts to be sure insulation will withstand the high voltage for a specified time.

44
Q

What is residual voltage?

A

This is the voltage present between any 2 of the 3-pin power plug one second after the plug is disconnected from socket and must be less than 60V. If the 60V is exceeded, the total energy present must be less than 2mJ.

The reason for these tests is to insure that when a piece of equipment is unplugged, the user does not get a shock if they inadvertently touch the pins of the power cord plug immediately after disconnection. Usually this voltage is caused by excess capacitance to ground, which discharges slowly when the power is disconnected.

45
Q

What is Accessible parts voltage?

A

This is the voltage present on any accessible part, including those covered by service or access doors. The IEC60601-1 specifies that the voltage between accessible parts and earth/safety ground must not exceed 25VAC or 60VDC.

This makes sure that no excessive potential difference exists between accessible parts and ground during normal operation or after equipment has been de-energized and access covers are removed. If a label is on the unit specifying a delay time before touching or opening the equipment, then this test can be used to verify that the label is correct.

46
Q

What is Retained Energy?

A

The energy that is stored in an accessible part. This test is only necessary if the Accessible Parts Voltage you measured in the previous test is over the 60V DC or 25V AC limit.

You are essentially verifying that there is less than 2mJ of charge stored in the accessible part.

47
Q

What is Current draw?

A

Current consumed by the product. The actual current must be within 10-25% (depends on the type of equipment) of the rating on the equipment.

This test measures the current that the product under test is consuming through the power cord.

48
Q

What is Power consumption?

A

Power that is consumed by the product. This is to verify that the power consumption is not more than 10-15% over what the equipment is rated.

True power is essential for this measurement because phase shift errors can cause 15% variations in the measurements. It is important to adjust the controls on your equipment to maximum output for this measurement so you get the true maximum, not just the nominal value.

49
Q

What is the purpose of testing medical electrical
equipment?

A

To ensure that a device is safe for the patient and the caregiver

50
Q

What are the 3 stages of a product where electrical safety testing is important? PPS

A

-product development
-production line
-service department

51
Q

Why is Safety testing crucial in the design stages?

A

Safety testing is crucial in the design stages, because safety must be designed into the product, not just tested afterwards. If the designers are aware of the standards, they can design it to be safe originally rather than having to troubleshoot it out at the end of the development.

Testing during design can save a great deal of cost of
redesigning and retesting at the test lab. However, even
though a design is verified to be safe, the only way a
manufacturer can be sure they are shipping safe products is to safety test them at the end of the production line.

Even if the original design was safe, a solder short, mis-wired connector, bad component or other assembly errors can cause leakage in the product that makes it unsafe. If you are not testing your products at the end of the production line, you simply cannot be certain they are safe for your customers and their patients.

52
Q

What are the 4 collateral standards?

A
  • IEC 60601-1-1
    Safety Requirements For Medical Electrical Systems
  • IEC 60601-1-2
    Electromagnetic Compatibility - Requirements And Tests
  • IEC 60601-1-3
    General Requirements For Radiation Protection In Diagnostic X-ray Equipment
  • IEC 60601-1-4
    General Requirements For Collateral Standard: Programmable Electrical Medical Systems
53
Q

What is class I?

A

Equipment in which protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution. Means are provided for the connection of the equipment to the protective earth conductor in the fixed wiring of the installation in such a way that accessible metal parts cannot become live in the event of a failure of the basic insulation.

54
Q

What is class II?

A

Equipment in which protection against electric shock does not rely on basic insulation only, but in which additional safety precautions such as double insulation or reinforces insulation are provided, there being no provision for protective earthing or reliance upon installation conditions

55
Q

What is Single Fault Conditions?

A

During leakage tests, single faults and normal conditions are used to simulate all electrical possibilities that may occur in the field.

Single faults are essentially problem conditions that could occur. Since it is very unlikely that two faults would occur at one time, faults are tested one at a time.

56
Q

What is Normal conditions?

A

They are electrical conditions that normally occur on a daily basis and are not considered to be a problem.

For example, grounding a patient applied part would not be a fault, since this happens anytime an ECG lead touches a metal bed frame.