Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
For
MEDICAL EQUIPMENT By
Ismail Yusof
Test Instrument
Test Instrument
Test Instrument
Test Instrument
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
Test Instrument
Test Instrument
ESU Analyser
Test Instrument
SAFETY TESTERS
Safety Check
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)
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.
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
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.
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
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.
Burns
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
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
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.
e-
e-
ions
Tissue
Electrolyte/Dielectric
electrode(metal)
Electrochemical Reactions
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.
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.
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.
Patient leakage current Patient leakage current is the leakage current that flows through a patient connected to an applied part or parts.
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.
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.
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.
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.
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.
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.
Insulation Tests
Insulation Tests
Applicable to Class II, all types having applied parts Limit : > 50 MOhms
Applicable to: Class 1 equipment all types Limits: 0.5mA in NC, 1mA in SFC or 5mA and 10mA respectively for permanently installed equipment
Applicable to Class 1 and class II equipment , all types. Limit0.1mA in NC, 0.5mA in SFC
Applicable to All Classes B and BF equipment having applied parts Limits 0.1mA in NC, 0.5mA in SFC
Applicable to All equipment having applied parts. Limits 0.1mA in NC, 0.5mA in SFC
Applicable to Class 1 and class II equipment , types BF&CF equipment having applied parts. Limits BF 5mA; CF 0.05mA per electrode
Report, tag, and do not use equipment with: Frayed wires or cracked insulation
Always use your common sense Do not end up like this person!
ELECTRICAL SAFETY
Thank You