Documente Academic
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Electrical Safety of
Medical Equipment
Dr Fadhl Al-Akwaa
fadlwork@gmail.com
www.Fadhl-alakwa.weebly.co
m
Please contact Dr Fadhl to use this material
Definitions
Calibration: process of comparing an unknown against
a reference standard within defined limits, accuracies
and Uncertainties
Verification: process of comparing an unknown against
a reference standard at usually one data point
When to test
On newly acquired equipment prior
to being accepted for use
During routine planned preventative
maintenance.
After repairs have been carried out
on equipment.
Why do we do electrical
safety?
Ensure patient safety
Protect against macroshock
Protect against microshock
International Electrotechnical
Commission
The International Electrotechnical
Commission[1] (IEC) is a non-profit,
non-governmental international
standards organization that prepares
and publishes International Standards
for all electrical, electronic and related
technologies collectively known as
"electrotechnology".
International Electrotechnical
Commission
International Electrotechnical
Commission
IEC 60601-x-xx
the IEC 60601-1-xx series of collateral
standards for MEDICAL ELECTRICAL
EQUIPMENT;
the IEC 60601-2-xx series of particular
standards for particular types of MEDICAL
ELECTRICAL EQUIPMENT; and
the IEC 60601-3-xx series of performance
standards for particular types of MEDICAL
ELECTRICAL EQUIPMENT.
IEC 60601-x-xx
IEC 60601-1-2, Medical electrical
equipment Part 1-2: General
requirements for safety Collateral
standard: Electromagnetic compatibility
Requirements and tests
IEC 60601-1-3, Medical electrical
equipment Part 1: General requirements
for safety 3. Collateral standard: General
requirements for radiation protection in
diagnostic X-ray equipment
IEC 60601-x-xx
IEC 60601-1-6, Medical electrical equipment
Part 1-6: General requirements for safety
Collateral standard: Usability
IEC 60601-1-8, Medical electrical equipment
Part 1-8: General requirements for safety
Collateral standard: General requirements,
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
Physiological Effects of
Electricity
Class I
Class I equipment has a protective earth. The basic
means of protection is the insulation between live
parts and exposed conductive parts such as the
metal enclosure.
In the event of a fault that would otherwise cause
an exposed conductive part to become live, the
supplementary protection (i.e. the protective earth)
comes into effect. A large fault current flows from
the mains part to earth via the protective earth
conductor, which causes a protective device
(usually a fuse) in the mains circuit to disconnect
the equipment from the supply.
Class I
Class I
term referring to electrical
equipment in which protection
against electric shock does not rely
on BASIC INSULATION only, but which
includes an additional safety
precaution in that means are
provided for ACCESSIBLE PARTS of
metal or internal parts of metal to be
PROTECTIVELY EARTHED
CLASS II
term referring to electrical 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 REINFORCED
INSULATION are provided, there being
no provision for protective earthing or
reliance upon installation conditions
Class II
Equipments Type
Terminology and
definitions
http://www.601help.com/Disclaimer/g
lossary.html#ProtectiveEarthTerminal
Terminology and
definitions
L1 Hot
L2
Neutral
Earth
Ground
Mains Line
Voltage
Applied Parts
Patient Leads
Enclosure/Case
Chassis
Protective Earth
Ground Wire
Earth Leakage Current Leakage in Ground
Wire
Terminology and
definitions
Enclosure Leakage
Chassis Leakage
Patient Leakage
Lead Leakage
Patient Auxiliary
Leakage between
Patient Leads
Mains on Applied Parts
Lead Isolation
Insulation Resistance Dielectric Strength
or Insulation Resistance between Hot and
Neutral to Ground
Earth Resistance Ground Wire Resistance
Calculate RMS
0.707 Vpk
Crest Factor
Applied Part
No applied part
table
Accessible Part
Part of equipment which can be touched
without the use of a tool.
EXAMPLE 1 Illuminated push-buttons
EXAMPLE 2 Indicator lamps
EXAMPLE 3 Recorder pens
EXAMPLE 4 Parts of plug-in modules
EXAMPLE 5 Batteries
Leakage currents
Current that is not functional.
several different leakage currents are
defined according to the paths that the
currents take.
Earth Leakage Current
Enclosure Leakage Current
Patient Leakage Current
Patient auxiliary current
Causes of Leakage
currents
If any conductor is raised to a potential
above that of earth, some current is bound
to flow from that conductor to earth.
The amount of current that flows depends
on: 1- the voltage on the conductor.
2- the capacitive reactance between the
conductor and earth.
3-the resistance between the conductor and
earth.
EARTH LEAKAGE
CURRENT
current flowing
from the MAINS
PART through or
across the
insulation into the
PROTECTIVE EARTH
CONDUCTOR
EARTH LEAKAGE
CURRENT
Under normal conditions, a person who is in contact
with the earthed metal enclosure of the equipment and
with another earthed object would suffer no adverse
effects even if a fairly large earth leakage current were
to flow. This is because the impedance to earth from
the enclosure is much lower through the protective
earth conductor than it is through the person. However,
if the protective earth conductor becomes open
circuited, then the situation changes. Now, if the
impedance between the transformer primary and the
enclosure is of the same order of magnitude as the
impedance between the enclosure and earth through
the person, a shock hazard exists.
EARTH LEAKAGE
CURRENT Measurement
Measurement of earth
leakage current
Enclosure leakage
current /
touch
current
LEAKAGE CURRENT
flowing from the
ENCLOSURE to
earth or to another
part of the
ENCLOSURE
through a
conductor other
than the protective
earth conductor.
Enclosure leakage
current/
touch current
Measurement of enclosure
leakage current
Measurement of patient
leakage current
Measurement of patient
leakage current
Measurement of patient
auxiliary current.
Protective Earth
Continuity
The resistance of the
protective earth conductor
is measured between the
earth pin on the mains plug
and a protectively earthed
point on the equipment
enclosure (see figure 6).
The reading should not
normally exceed 0.2 at
any such point. The test is
obviously only applicable
to class I equipment.
Protective Earth
Continuity
In IEC60601, the test is
conducted using a 50Hz
current between 10A and 25A
for a period of at least 5
seconds. Although this is a
type test, some medical
equipment safety testers
mimic this method. Damage
to equipment can occur if
high currents are passed to
points that are not
protectively earthed, for
example, functional earths.
Leakage current
summary
The following table summarises the
leakage current limits (in mA) specified by
IEC60601-1 (second edition) for the most
commonly performed tests. Most
equipment currently in use in hospitals
today is likely to have been designed to
conform to this standard, but note that the
allowable values of earth leakage current
have been increased in the third edition of
the standard as discussed above.
Leakage current
summary
The following table summarises the
leakage current limits (in mA)
specified by IEC60601-1 (second
edition)
http://www.ebme.co.uk/arts/safety/part6.htm
An Introduction to Safety
Analyzer
Electrical Shock
Hazard
common experience due to electric
A
shock
Associated with equipments
Electric current can flow through the
human body either
Accidentally or Intentionally
An Introduction to Electric
Shock Hazard
An Introduction to Electric
Shock Hazard
Gross shock
Experienced
by
the
subject by an accidental
contact
with
electric
wiring at any point on
the surface of the body
Current flows through
the body of the subject
(ex. from arm to arm)
Body acts as a volume
conductor at the mains
frequency
Degree of simulation
varies from individual to
individual
An Introduction to Electric
Shock Hazard
Physiological Effects of
Electricity
Tissue Resistance
An Introduction to Electric
Shock Hazard
Leakage Current
Inherent flow of non functional
current from live electric parts
of instrument to accessible
metal parts
Usually flow through 3rd wire
connection to ground
Magnitude of leakage current is
determined by the value of the
capacitance present
Originates due to capacitive
coupling
from
the
power
transformer primary to other
parts of the transformer (or
instruments)
An Introduction to Electric
Shock Hazard
Types of Leakage
Current
An Introduction to Electric
Shock Hazard
Threshold of perception of
electric shock is about 1mA
Tingling sensation is felt
when
contacted
with
electrified object through
intact of skin
As magnitude of alternating
current is increased
Tingling sensation leads to
contraction of muscles
Muscular
contraction
increases
Finally value of current is
reached where grip of current
cannot be released
An Introduction to Electric
Shock Hazard
An Introduction to Electric
Shock Hazard
Recommendations of
IEC
International Electrotechnical
Commission (IEC)
Continuous
medical
equipment current should
not exceed 100 uA
Should
be
with
in
a
frequency range of 0 to 1kHz
In
abnormal
situations
recommended max. current
is 500 uA
Should be in a frequency
upto 1 kHz
Above 1 kHz max increases
is
proportionally
with
frequency
An Introduction to Electric
Shock Hazard
Precautions
Use apparatus or appliances
with three wire power cord
Provide isolated input circuits on
monitoring equipment
Have periodic checks of ground
wire continuity
No other equipment to be
connected
when
patient
monitoring
equipment
is
connected
Clearly mark functional controls
Take care of adapter plugs that
do not ensure proper grounding
circuit
Direct operating instructions to
the operators
Maintaining voltage differences
Macroshock and
Microshock
History
The expansion of technology was unregulated, and
unexplained deaths in hospitals were attributed
by
some to electrical shocks
Studies showed that electrical shock risks were the
greatest when the patient had conductors internal
to the body
If a conductive catheter is placed in the heart, 100
micro amps at 60 Hz can cause fibrillation of heart
and death
601PRO Series XL
Standard Features
The most advanced Electrical Safety
Analyzer on the market
EN60601-1, EN601010-1, and AAMI
& ESI test loads (user selectable)
into one device
The One-Touch-Testing user interface
Allows user to perform rapid tests on
various medical devices
Multiple enclosure-leakage points
Multiple patient-applied-part types
601PRO Series XL
Standard Features
Power ON/OFF delay
DC only for patient- and auxiliary-leakage
tests
User-programmable test sequences
Offers manual, auto, step, and computercontrol mode operations
ASCII data transfer
Memory for up to 1000 device-information
records
Conducts electrical safety testing in
accordance with IEC 601-1, VDE 751, VDE
701, HEI 95, IEC 1010, AAMI, and AS/NZS
3551 requirements
601PRO Series XL
Standard Features
Flags
failures,
and
simulates
performance,
ECG,
and
arrhythmia,
waveforms.
Results
automatically
analyzed and saved in
non-volatile memory
Accepts device information
that is input using an
External keyboard,
Integrated keypad,
Barcode keyboard wedge
Optional Feature
Onboard thermal printing
601PRO Series XL
Specifications
Voltage
Insulation
Resistance
Current
Consumptio
n
Range:
Accuracy:
Range:
0.5 to 400.0 M
Accuracy:
5 % of reading 2 LSD
Range:
0 to 15 A ac True RMS
Accuracy:
5 % of reading 2 LSD
Mains on
Applied
Applied Part Voltage:
Protective
Earth
Resistance
Supply
Voltage
Accuracy:
2 % of reading 6 A
Range:
0.000 to 2.999
Accuracy:
601PRO Series XL
Specifications
IEC601-1 and
AAMI Leakage
Currents
ECG Simulation
and
Performance
Testing
Range:
Accuracy:
DC-Only Frequency
Response:
DC - 5 Hz (approx)
ECG Complex:
Performance
Dimensions
Pulse:
600 to 700 s rise
and fall time
Sine Waves:
Square Wave:
Triangle Wave:
2 Hz, 2 mV
601PRO Series XL
Available electrical
safety tests
Mains Voltage
Dual Lead Voltage
Dual Lead Leakage
Current
Consumption
Insulation Resistance
Protective Earth
Resistance
Earth Leakage
Current
Enclosure Leakage
Current
Patient Leakage
Current
Mains on Applied
Part Leakage
Patient Auxiliary
Current
Accessible Voltage
Accessible
Leakage
Equivalent Device
Leakage
Equivalent Patient
Leakage
601PRO Series XL
Accessories
601PRO Series XL
Optional
Accessories
Carry Case
RS232 Cable (9M-9F)
Printer Cable
Barcode, Keyboard, Wedge
Adapter, Banana, ECG
Keyboard English
Powercord Set Australian
Powercord Set Schuko
Powercord Set US 120 V
Powercord Set UK
601PRO Series XL
System
Characteristics
Keys
grouped
by
color
and
functionality
Red keys -used to access menu
options
Include previous key, the four SOFT
KEYS, and the enter key
601PRO Series XL
601PRO Series XL
Setting Up the
601PRO
7. Configuring the Enclosure Leakage
for the Auto mode Sequence
8. Selecting Language Options
9. Selecting the DC Option
10.Selecting the Auto/Step Tests:
Controlled Power Sequences or
601CE Conventional Test
11.Sequences enabling Stop on Failure
12.Configuring for Device Records or
Templates
601PRO Series XL
Manual Mode
1. Connecting the Device Under
Test
2. The Power-Up Sequence
3. Selecting the Test Standard
4. Selecting the Class/Type
5. Saving Standard, Class, Type and
Test Current
6. Using View Present Settings
7. Manual Operation
601PRO Series XL
Auto/Step Modes
1. Selecting Auto or Step Mode
Testing
2. Executing Auto and Step Mode
Tests
3. Creating/Editing
a
Device
Record or Template
601PRO Series XL
Test Records
1. Sending Test Results from the
601PRO to the Host
2. Computer
3. Test Data Record: Serial Output
4. Printing Test Records
5. Deleting Test Records
601PRO Series XL
601PRO Series XL
Testing Devices
1. Permanently Wired Devices
2. Portable Devices
3. Portable Devices in Isolated Power
Systems
4. Testing
Three-Phase
Portable
Devices
5. Testing Conductive Surfaces
6. Detachable Power Supply Cable
7. Battery-Powered Equipment
601PRO Series XL
Standards and
Principles
1. Accessing System Setup
2. Selecting the Test Standard
3. Referring to Test Limits for the
Selected Standard