ELECTRICAL SAFETY

For

MEDICAL EQUIPMENT By

Ismail Yusof

Electrical Safety Medical Equipment Contents:

1 Various Test Equipment used in Biomedical Engineering

2 Introduction to Electrical Safety

3 Electricity - Physiological Effects

4 General Electrical Safety 5 Electricity Leakage Current 6 Electrical Equipment Classes and Types 7 Electrical Safety Tests

INTRODUCTION TO VARIOUS TEST EQUIPMENT USED IN BIOMEDICAL ENGINEERING

Workshop Tool & Equipment

Toolkit for general repair

Workshop Tool & Equipment

Insulation and Resistance Measuring Instrument, 1000 V, Digital

Workshop Tool & Equipment

Soldering Station with temperature controller

Workshop Tool & Equipment

Analog Multimeter Digital Multimeter

Test Instrument

Electrical Safety Analyser

Test Instrument

Electrical Safety Analyser

Test Instrument

Test Instrument

It measures delivered energy on its internal load.

The defibrillator pulse is stored and it can be viewed via ECG output leads, paddles or scope output.

Test Instrument

Blood pressure simulator that provides simulation to test blood pressure monitors.

Test Instrument

The pulse oximeter testing method to simulate the light absorption and arterial blood flow of a human finger

Test Instrument

Power meter to service the 1 MHz and 3 MHz therapy level ultrasound generators.

Test Instrument

External pacemaker tester designed for

accurately testing all types of external pacemaker.

Test Instrument

Test Instrument

ESU Analyser

Measure output power and RF leakage

Test Instrument

Infusion Pump Analyzer

SAFETY TESTERS
Safety Check

Electrical Safety Tests (IEC 601)

The basic purpose of safety testing in medical electrical
equipment is to be sure that a device is safe for the patient and user. Such as: Grounding resistance of portable medical equipment measured between equipment chassis and ground pin of power plug shall not exceed 0.50 ohms.

ELECTRICAL SAFETY

Biomedical Engineer-definition
Biomedical Engineers assist in struggle against illness and disease by providing support for materials and tools that can be utilized for diagnosis and treatment by health care professionals. Biomedical Engineer have achieved this position by assuming responsibility for managing the safe use of medical equipment within the hospital environment

A Historical Perspective
Engineers first enter to clinical scene : late 1960s in response to concerns about electrical safety of hospital patient Ralph Nader (consumer activist) : at the very least, 1200 Americans are electrocuted annually during routine diagnostic and therapeutic procedures in hospitals Ladies Home Journal, April 24, 1970 Raise the level of concern about safe use of medical device

A Historical Perspective
Overnight growth of a new industry : hospital electrical safety Joint Commission on the Accreditation of Hospital : hospital must inspect all equipment used on or near a patient for electrical safety at least every 6 months Hospital administrators options Paying medical device manufacturer Service contracting In-house staff

Safety Issue
In USA, about 10,000 device-related patient injuries each year Most injuries are attributable to improper use of a device as a result of inadequate training and lack of experience Medical personnel rarely read user manuals until a problem occurred Everything that can go wrong eventually will go wrong Murphys law

Electrical Shock
Electric Shock : unwanted or unnecessary physiological response to current.

Three phenomena :
(1) electrical stimulation of excitable tissue (nerve & muscle)

(2) resistive heating of tissue, and

(3) electrochemical burns and tissue damage

Electrical Safety
Electric Safety is the best possible limitation of hazardous electrical Macro and/or Microshocks, sustained by patients, as well as explosion, fire or damage to equipments and buildings.

Single Phase Power Supply

The application of the safety testing on this training will only apply to the Single Phase ( 3 wires ) 100 to 240 Volt power supply. Any medical equipment use either 3 or 2 pins plug which connected to the wall socket shall follow this electrical safety procedure.

The IEC 601.1 Standard

Several standard serve as ruling authority in determine how medical equipment are to be tested such UL, CSA, CE, TUV

The International Electro Technical Commissions IEC 601-1 standard is accepted and implemented around the world.
All this explanation will be based on IEC 601-1 Standard

The IEC 601.1 Standard

Medical Electrical Equipment

Medical Electrical Equipment provided with no more than one connection to a particular supply mains and intended to; Diagnose the patient, Treat the patient,

1. 2.

3.
4. 5.

Monitor the patient under medical supervision,

Makes physical or electrical contact with the patient , Transfers energy to or from the patient and/or detects such energy transfer to or from patient. The equipment includes those accessories as defined by the manufacturer which are necessary to enable the normal use of the equipment.

Safety of Medical Equipment

The purpose of safety testing medical electronic equipment is to ensure that a device is safe from electrical hazards to patients, maintenance personnel's and users.
Electric shock are caused by electricity flowing through the body after touching a damaged electrical device and results muscle spasms, burns, cardiac and respiratory arrest and Ventricular Fibrillation

Electrical Safety
Electric safety in hospital is a shared responsibility between several parties, in addition to the physician, including:
The nurses All engineers (electrical, biomedical, facility, etc)

Manufacturers
The hospital

Electrical Safety Critical Points

The electrical installation, no matter how safe, is only part of the safety requirements. Plugs and cords must be checked and rejected if defective. Only devices tested for safety should be used. Electrical compatibility of the entire electrical system must be tested regularly. Patients leads must be attached and connected properly. Radio-frequency devices (including mobile telephones) must be excluded.

Basic Safety
Basic safety should be performed on line powered before installation and after every repairs are; Ground wire integrity ( Resistance ) Ground wire leakage The basic electrical characteristic usually cause the most leakage currents in modern equipment is Capacitive Reactance Coupling in power cord. The typical range of human body resistance with the skin intact is 500 Ohm to 1,000 Ohm. The let go current of a shock is 14 mA in most people.

Why Electrical Safety?

Electrical safety NOT dependent on voltage but on Leakage Current. At low voltage, leakage current flow through body may be fatal to us. Patient may connected to several device simultaneously . (ICU.) Patient may connected conductively with electronic circuit. (ECG.) Contact directly to internal tissue. ( natural orifices or break in the skin.)

Electricity - Physiological Effects

Burns When an electric current passes through any substance having electrical resistance, heat is produced. The amount of heat depends on the power-dissipated (I2R or VI). Whether or not the heat produces a burn depends on the current density.

Burns

Electricity - Physiological Effects

Muscle Cramps
When an electrical stimulus is applied to a motor nerve or muscle, the muscle does exactly what it is designed to do in the presence of such a stimulus i.e. it contracts. The prolonged involuntary contraction of muscles (tetanus) caused by external electrical stimulus is responsible for the phenomenon where a person who is holding an electrically live object can be unable to let go.

A muscle cramp is a painful, involuntary muscle contraction.

Electricity - Physiological Effects

Respiratory Arrest The muscles between the ribs (intercostal muscles) need to repeatedly contract and relax in order in order to facilitate breathing. Prolonged tetanus of these muscles can therefore prevent breathing.

Respiratory Arrest

Electricity - Physiological Effects

Cardiac Arrest The heart is a muscular organ which needs to able to contract and relax repetitively in order to perform its function as a pump for the blood. Tetanus of the heart musculature will prevent the pumping process.

Cardiac Arrest

Electricity - Physiological Effects

Ventricular Fibrillation The ventricles of the heart are the chambers responsible for pumping blood out of the heart. When the heart is in ventricular fibrillation, the musculature of the ventricles undergoes irregular, uncoordinated twitching resulting in no net blood flow. The condition proves fatal if not corrected in a very short space of time.

Ventricular fibrillation (VF) is a deadly arrhythmia. In VF, the electrical signals that trigger the heartbeat become very fast and chaotic in the lower chambers of the heart. The heart no longer can pump blood to the brain or body.

Electricity - Physiological Effects

Electricity - Physiological Effects

Electricity - Physiological Effects

Electrolysis
The movement of ions of opposite polarities in opposite directions through a medium is called electrolysis and can be made to occur be made to occur by passing DC currents through body tissues or fluids.

Electricity Conduction Mechanism

Charge carrier

e-

Charge carrier Charge carrier skin

e-

ions

cell wire(metal) electrode(metal) wire(metal)

Tissue
Electrolyte/Dielectric

electrode(metal)

Electrochemical Reactions

Important Susceptibility Parameters

For dog: 20A, human : 80~600 A Safety limit : 10 A

Effect of entry point on current distribution

Macroshock Hazards
Macroshock is the most common type of shock received and occurs when the human body becomes a conductor of electric current passing by means other than directly through the heart.

Microshock Hazards
Electrically conducting devices unintentionally make direct contact with heart muscles, ventricular fibrillation may be induced by minute current (e.g. 200 uA) well below the threshold of feeling.

General Electrical Safety

General Electrical Safety

General Electrical Safety

General Electrical Safety

General Electrical Safety

General Electrical Safety

General Electrical Safety

General Electrical Safety

Electricity - Leakage Currents

Leakage Currents
Current that is not functional. The following leakage currents are defined: Earth Leakage Current , Enclosure Leakage Current , and Patient Leakage Current .
Earth Leakage Current Enclosure Leakage Current Patient Leakage Current

Electricity - Leakage Currents

Causes of leakage currents If any conductor is raised to a potential above earth potential, then some current is bound to flow from that conductor to earth. This is true even of conductors that are well insulated from earth, since there is no such thing as perfect insulation or infinite resistance. The amount of current that flows depends on: The voltage on the conductor The capacitive reactance between the conductor and earth The resistance between the conductor and earth

Leakage Current
Leakage current flows between power supply wires and earth ground within the rated value. In case of the multiple operation, however, the total leakage current will be the sum of the leakage current flows from each power supply.

Electricity - Leakage Currents

Earth leakage current Earth leakage current is the current which normally flows in the earth conductor of a protectively earthed piece of equipment.

Electricity - Leakage Currents

Electricity Enclosure Leakage Currents

Enclosure leakage current Enclosure leakage current is described as the current that flows from an exposed conductive part of the conductor to earth through a conductor other than the protective earth conductor.

Electricity Enclosure Leakage Currents

Electricity Patient Leakage Current

Patient leakage current Patient leakage current is the leakage current that flows through a patient connected to an applied part or parts.

Electricity Patient Leakage Current

Electricity Patient Auxiliary Current

Patient auxiliary current The patient auxiliary current is defined as the current which normally flows between parts of the applied part through the patient which is not intended to produce a physiological effect.

Electricity Patient Auxiliary Current

Electricity Class and Types of Equipment

Classes of Equipment
All electrical equipment is categorized into classes according to the method of protection against electric shock that is used.

Types of Equipment
The degree of protection for medical electrical equipment is defined by the type designation.

Electricity Class of Equipment Classes of Equipment

All electrical equipment is categorized into classes according to the method of protection against electric shock that is used.

CLASS I

CLASS II

CLASS III

Electricity Class of Equipment Class I equipment Class 1 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 which would otherwise cause an exposed conductive part to become live, the supplementary protection (i.e. protective earth) comes into effect.

General Electrical Safety

CLASS I EQUIPMENT

Electricity Class of Equipment Class II equipment The method of protection against electric shock in the case of class II equipment is either double insulation or reinforced insulation. In double insulated equipment the basic protection is afforded by the first layer of insulation. If basic protection fails then supplementary protection is afforded by a second layer of insulation preventing contact with live parts.

Electricity Class of Equipment

Class II equipment The symbol for class II equipment is 2 concentric squares indicating double insulation as shown below.

General Electrical Safety

CLASS II EQUIPMENT

Electricity Class of Equipment Class III equipment Class III equipment is defined as that in which protection against electric shock relies on the fact that no voltages higher than safety extra low voltage (SELV) are present.SELV is defined in turn in the relevant standard as a voltage not exceeding 25V ac or 60V dc.

Electricity Types of Equipment

Types of Equipment
The degree of protection for medical electrical equipment is defined by the type designation.
Type B Type BF Type CF

Electricity Types of Equipment

Type
Symbol

Definition
Equipment providing a particular degree of protection against electric shock, particularly regarding allowable leakage currents and reliability of the protective earth connection (if present).
As type B but with isolated or floating (F type) applied part or parts

BF

CF

Equipment providing a higher degree of protection against electric shock than type BF, particularly with regard to allowable leakage currents, and having floating applied parts.

Electrical Safety Tests

Normal Condition A basic principle behind the philosophy of electrical safety is that in the event of a single abnormal external condition arising or of the failure of a single means of protection against a hazard, no safety hazard should arise.

Electrical Safety Tests

Single Fault Condition Condition in which a single means of electrical safety protection is defective or an abnormal condition is present. Examples of a single fault condition would be interruption of the ground conductor on a Class I equipment or opening of the neutral supply conductor to the equipment.

Electrical Safety Tests

Single Fault Condition

Protective Earth Continuity

Applicable to Class1, all types Limit 0.2 ohms

Insulation Tests

Applicable to Class 1, all types Limit Not less than 50Mohms

Insulation Tests

Applicable to Class II, all types having applied parts Limit : > 50 MOhms

Earth Leakage Current

Applicable to: Class 1 equipment all types Limits: 0.5mA in NC, 1mA in SFC or 5mA and 10mA respectively for permanently installed equipment

Enclosure Leakage Current

Applicable to Class 1 and class II equipment , all types. Limit0.1mA in NC, 0.5mA in SFC

Patient Leakage Current

Applicable to All Classes B and BF equipment having applied parts Limits 0.1mA in NC, 0.5mA in SFC

Patient Auxiliary Current

Applicable to All equipment having applied parts. Limits 0.1mA in NC, 0.5mA in SFC

Mains on Applied Parts

Applicable to Class 1 and class II equipment , types BF&CF equipment having applied parts. Limits BF 5mA; CF 0.05mA per electrode

Safety Test as done by BEMS

Electrical Safety Review

Electrical Safety and the Patients Depends on Three Things: -

An alert, caring, knowledgeable person

Properly maintained, and applied equipment Proper grounding or double insulation of linepowered equipment

Electrical Safety Review

Report, tag, and do not use equipment with: Frayed wires or cracked insulation

Damaged plugs or missing ground prongs

Electrical Safety Review

Report, tag, and do not use receptacles with: Only two slots Missing cover plates Loose mountings Weak gripping force

Electrical Safety Review

Inspections of Equipment: Check of Strain-Relief

Electrical Safety Review

Avoid:
Using cheaters (three-prong adapters) Using extension cords Placing liquids on electrical equipment Pulling plugs out of receptacles by the cord Rolling equipment over power cords

Using defective equipment or receptacles

Using equipment that sparks, smokes, or shocks

Electrical Safety Review

Be sure that users know how to use equipment properly. Also be sure to: Check that line-powered equipment has threewire grounding cords, unless device is double insulated Ask for help and instruction when needed Report defective equipment and receptacles

Electrical Safety Review

Always use your common sense Do not end up like this person!

ELECTRICAL SAFETY

THE END THANK YOU

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