Calibration and Electrical Safety of Medical Equipment

Dr Fadhl Al-Akwaa fadlwork@gmail.com www.Fadhl-alakwa.weebly.com

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Why Test & Calibration

What you cannot measure you cannot control
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As components age and equipment undergoes changes in temperature or humidity or sustains mechanical stress, performance gradually degrades.
This is called drift.

When this happens your test results become unreliable and both design and performance quality suffer.
While drift cannot be eliminated, it can be detected and either corrected or compensated for through Please contact Dr Fadhl to use this material the process of calibration.

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

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Requirements of Test & Calibration service

Written Program
Routine calibration or verification at suitable intervals Control of inspection, measuring and test equipment. Calibration procedures including specific directions and limits for accuracy and precision Deviation or discrepancies should be investigated Traceable Calibration Standards Calibration records Visible Calibration status
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What to TEST for?

Performance Testing Safety Testing

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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.

Need for Medical Equipment Testing Medical device incidents resulting in patient injury and death Ensure that the equipment is performing to the expected standards of accuracy, reliability, free of hysteresis and linear (as designed). Safe and effective devices need to be available for patient care Downtime costs money Regulations, accreditation requirements and standards.
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Why do we do electrical safety?

Ensure patient safety
Protect against macroshock Protect against microshock

Test for electrical internal breakdown / damage to power cord, AC mains feed, etc. Meet codes & standards
AAMI, IEC, UL, NFPA, etc.

Protect against legal liability

In case of a patient incident

International Electrotechnical Commission

The International Electrotechnical Commission[1] (IEC) is a non-profit, nongovernmental international standards organization that prepares and publishes International Standards for all electrical, electronic and related technologies collectively known as "electrotechnology".

International Electrotechnical Commission

IEC standards cover a vast range of technologies from power generation, transmission and distribution to home appliances and office equipment, semiconductors, fibre optics, batteries, solar energy, nanotechnology and marine energy as well as many others. The IEC also manages three global conformity assessment systems that certify whether equipment, system or components conform to its International Standards.

International Electrotechnical Commission

Today, the IEC is the world's leading international organization in its field, and its standards are adopted as national standards by its members. The work is done by some 10 000 electrical and electronics experts from industry, government, academia, test labs and others with an interest in the subject. They also first proposed a system of standards, the Giorgi System, which ultimately became the SI, or Systme International dunits (in English, the International System of Units).

IEC, ISO, ITU, IEEE

The IEC cooperates closely with the International Organization for Standardization (ISO) and the International Telecommunication Union (ITU). In addition, it works with several major standards development organizations, including the IEEE with which it signed a cooperation agreement in 2002, which was amended in 2008 to include joint development work. Other standards developed in cooperation between IEC and ISO are assigned numbers in the 80000 series, such as IEC 82045-1.

List of IEC standards

IEC standards have numbers in the range 6000079999 and their titles take a form such as IEC 60417: Graphical symbols for use on equipment. The numbers of older IEC standards were converted in 1997 by adding 60000, for example IEC 27 became IEC 60027.

List of IEC standards

IEC 60027 Letter symbols to be used in electrical technology... IEC 60034 Rotating electrical machinery IEC 60038 IEC Standard Voltages IEC 60044 Instrument transformers IEC 60050 International Electrotechnical Vocabulary IEC 60062 Marking codes for resistors and capacitors IEC 60063 Preferred number series for resistors and capacitors IEC 60065 Audio, video and similar electronic apparatus - Safety requirements IEC 60068 Environmental Testing IEC 60071 Insulation Co-ordination IEC 60073 Basic Safety principles for man-machine interface, marking and identification
http://en.wikipedia.org/wiki/List_of_IEC_standards

List of IEC standards

IEC 60601 Medical Electrical Equipment IEC 62304 Medical Device Software Software Life Cycle Processes IEC 62366 Medical devicesApplication of usability engineering to medical devices IEC 62464 Magnetic resonance equipment for medical imaging
http://en.wikipedia.org/wiki/List_of_IEC_standards

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

The human body can easily detect macroshock and violent reactions occur to high current flow level in the body Below 1 ma (1,000 a), it is often much more difficult to detect the presence of a shock hazard from simple perception

Classes and types of medical electrical equipment

Equipment Class{I,II,III} method of protection against electric shock Equipment Type{B,BF,CF} degree of protection

Classes and types of medical electrical equipment

All electrical equipment is categorised into classes according to the method of protection against electric shock that is used. For mains powered electrical equipment there are usually two levels of protection used, called "basic" and "supplementary" protection. The supplementary protection is intended to come into play in the event of failure of the basic protection.

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

Class III equipment

Class III equipment is defined in some equipment standards 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. In practice such equipment is either battery operated or supplied by a SELV transformer.

 If battery operated equipment is capable of being operated when connected to the mains (for example, for battery charging) then it must be safety tested as either class I or class II equipment. Similarly, equipment powered from a SELV transformer should be tested in conjunction with the transformer as class I or class II equipment as appropriate. It is interesting to note that the current IEC standards relating to safety of medical electrical equipment do not recognise Class III equipment since limitation of voltage is not deemed sufficient to ensure safety of the patient. All medical electrical equipment that is capable of mains connection must be classified as class I or class II. Medical electrical equipment having no mains connection is simply referred to as "internally powered".

Equipments Type

different pieces of medical electrical equipment {APPLIED PARTS} have different areas of application and therefore different electrical safety requirements. For example, it would not be necessary to make a particular piece medical electrical equipment safe enough for direct cardiac connection if there is no possibility of this situation arising.

Normative Reference Page 371

Current density and electrically induced ventricular fibrillation. Medical Instrumentation, January-February 1973, Vol. 7, No. 1. WATSON, AB. and WRIGHT, JS., Electrical thresholds for ventricular fibrillation in man. Medical Journal of Australia, June 16, 1973.

Terminology and definitions

http://www.601help.com/Disclaimer/glossary. 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

R.M.S and Peak to Peak

Vrms is the value indicated by the vast majority of AC voltmeters.

The RMS value of an alternating voltage or current is the same as the level of direct voltage or current that would be needed to produce the same effect in an equal load. For example, 1 V applied across a 1 resistor produces 1 W of heat. A 1 Vrms square wave applied across a 1 resistor also produces 1 W of heat. That 1 Vrms square wave has a peak voltage of 1 V, and a peak-to-peak voltage of 2 V.

Calculate RMS

0.707 Vpk

 RMS is a sort of average and peak is the top level A peak is an instant reading - RMS is an "average" reading. RMS means to take the root of the mean and square it. RMS value is the DC equivalent value to an AC stream. The RMS value of an alternating voltage or current is the same as the level of direct voltage or current that would be needed to produce the same effect in an equal load.

Crest Factor

The Crest Factor is equal to the peak amplitude of a waveform divided by the RMS value. Electrical engineering for describing the quality of an AC power waveform

Applied Part

No applied part table

Parts that contact PATIENTS

Applied Part A part of the equipment which in normal use: necessarily comes into physical contact with the patient for the equipment to perform its function; or can be brought into contact with the patient; or needs to be touched by the patient

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

Patient leakage current

Patient leakage current is the leakage current that flows through a patient connected to an applied part or parts. It can either flow from the applied parts via the patient to earth or from an external source of high potential via the patient and the applied parts to earth.

Patient leakage current

Measurement of patient leakage current

Measurement of patient leakage current

Patient auxiliary current

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

Patient auxiliary current

Measurement of patient auxiliary current.

Mains on applied parts

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

Applicable to Class I, all types Limit: 0.2 DB9801 recommended?: Yes, at 1A or less. HEI 95 recommended?: Yes, at 1A or less. Notes: Ensure probe is on a protectively earthed point

Insulation Tests Class I

HEI 95 and DB9801 recommended that for class I equipment the insulation resistance be measured at the mains plug between the live and neutral pins connected together and the earth pin. Whereas HEI 95 recommended using a 500V DC insulation tester, DB 9801 recommended the use of 350V DC as the test voltage.

Applicable to Class I, all types Limits: Not less than 50M DB9801 recommended?: Yes HEI 95 recommended?: Yes Notes: Equipment containing mineral insulated heaters may give values down to 1M. Check equipment is switched on.

Insulation Tests Class II

HEI 95 further recommended for class II equipment that the insulation resistance be measured between all applied parts connected together and any accessible conductive parts of the equipment. The value should not normally be less than 50M (see figure 10).

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

Limitation of voltage, current or energy(87)

Electrical Safety Tests

Available electrical safety tests include: Mains Voltage Dual Lead Voltage Dual Lead Leakage Current Consumption Insulation Resistance http://www.ebme.co.uk/arts/safety/part6.htm 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

How to measure resistance?

Proper grounding is the best defense against macroshock & microshock! The 2-terminal method is less accurate due to the effects of test lead resistance, especially with long leads and low resistance value measurements. The much preferred 4-terminal Kelvin technique negates the effects of test lead resistance and gives more accurate readings

An Introduction to Safety Analyzer

Electrical Shock Hazard

A common experience due to electric shock Associated with equipments Electric current can flow through the human body either
Accidentally or Intentionally

Other reasons of electric shock include

Careless use of electricity Usage of faulty cords and appliances Lack of concept/Faulty design Relied upon life support devices (Pace maker/ respirators)

An Introduction to Electric Shock Hazard

Electrical Shock Hazard

Use of medical equipments in conjunction with other instruments and equipments Environmental conditions Patient/Operator not realizing potential hazards 2 situations account hazards from electric shock
Gross shock Micro - current shock

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

Micro - current shock

Current passes directly through the heart wall Thresholds of sensation of electric currents differ widely Greater % of current may flow via the arterial system directly through the heart Requires much less currents to produce ventricular fibrillation
EX. Catheter laboratory or operating room where patient connected to catheter in the heart

Here patients have very little resistance to electric currents

Physiological Effects of Electricity

Tissue Resistance
Skin - 5000 ohms/cm2 Blood - 100 ohms/cm2 Muscle - 200-400 ohms/cm2 Fat - 2000-3000 ohms/cm2 Bone - 3000+ ohms/cm2 Current goes to the path of least 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

Enclosure leakage current: Current flows in normal condition from the enclosure (or part of enclosure) through a person in contact with an accessible part of enclosure to earth (or another part of the enclosure) Earth leakage current: Current flows in normal condition to earth from main parts of apparatus via earth conductor Patient leakage current: Current flows through patient from or to applied parts of the patient circuits

An Introduction to Electric Shock Hazard

Effects of Electric Current on Human Body

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

Effects of Electric Current on Human Body

Let -go- current: the max. current at which the subject is still capable of releasing a conductor by using muscles
Here individual can withstand with no serious effects Average let go current for males- 16mA, females-10.5mA, approx. 9-6 mA for both.

Hold-on-type: A current level higher than let go current, the subject looses ability to control his own muscle action and unable to release grip on the conductor
Such currents are very painful and hard to bear Physical injury is caused b currents in range of 20-100mA

A very high currents (6 amperes and above) lead to

Temporary respiratory paralysis Serious burns

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

Automated Electrical Safety Analyzer 601PRO Series XL Fluke Biomedical

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
601PRO Series XL
Power ON/OFF delay DC only for patient- and auxiliary-leakage tests User-programmable test sequences Offers manual, auto, step, and computer-control 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

Standard Features
601PRO Series XL
Flags failures, and simulates performance, ECG, and arrhythmia, waveforms. Results automatically analyzed and saved in nonvolatile memory Accepts device information that is input using an
External keyboard, Integrated keypad, Barcode keyboard wedge

Optional Feature
Onboard thermal printing

Specifications
Voltage Range: Accuracy: Insulation Resistance Range: 0 to 300 V True RMS (single and dual lead) DC - 100 Hz 1.5 % of reading 1 LSD 0.5 to 400.0 M

601PRO Series XL

Accuracy:
Current Consumption Range: Accuracy: Mains on Applied Part

5 % of reading 2 LSD
0 to 15 A ac True RMS 5 % of reading 2 LSD

Applied Voltage: 110 % of mains voltage Accuracy: 2 % of reading 6 A 0.000 to 2.999 5 % of reading 4 m (1 A, 10 A, and 25 A test currents) (Refer to Operators Manual for additional specs qualifying the effects on accuracy of variations in load inductance and phase angle.) 90 to 265 Vac, auto switching

Protective Earth Resistance

Range:

Accuracy: Supply Voltage

Specifications
IEC601-1 and AAMI Leakage Currents Range: 0 to 8000 A True RMS (per IEC601-1 or AAMI filter), -DC - 1 kHz 1 % of -reading 1 A -1 to 100 kHz 2 % of reading 1 A - 100 kHz to 1 MHz 5 % of reading 1 A DC - 5 Hz (approx) 30, 60, 120, 180, 240 BPM

601PRO Series XL

Accuracy: DC-Only Frequency Response: ECG Simulation and Performance Testing ECG Complex: Performance Pulse: 600 to 700 s rise and fall time Sine Waves: Square Wave: Triangle Wave:

30, 60 BPM, 63 ms pulse width

10, 40, 50, 60, 100 Hz 0.125, 2.000 Hz (50 % duty cycle) 2 Hz, 2 mV 16.62 in L x 11.75 in W x 5.56 in H 17lb / 7.7kg

Dimensions Weight

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
Probe/Safety Lead, Red - 1 Probe/Safety Lead, Black - 1 Adapter, Banana/Alligator - 5 Operators Manual - 1 Large Clamp, Red - 1 Warranty Card - 1 Printer Paper Roll (original) - 1 Printer Paper Roll (new style) - 1 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
601PRO Series XL Keys grouped by color and functionality Red keys -used to access menu options
Include previous key, the four SOFT KEYS, and the enter key

Black keys -gain access to additional functions

Include the esc/stop key, the view present settings key, the print header key, and the print data key.

Setting Up the 601PRO

1. 2. 3. 4. 5. 6. Using Factory Default Settings Selecting the Test Standard Selecting the Printer Output Selecting the RS232 Baud Rate Activating the Beeper Setting the Time and Date 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
601PRO Series XL 1. 2. 3. 4. 5. Connecting the Device Under Test The Power-Up Sequence Selecting the Test Standard Selecting the Class/Type Saving Standard, Class, Type and Test Current 6. Using View Present Settings 7. Manual Operation

Auto/Step Modes
601PRO Series XL

1. Selecting Auto or Step Mode Testing 2. Executing Auto and Step Mode Tests 3. Creating/Editing a Device Record or Template

Test Records
601PRO Series XL 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

Device Records and Templates

1. Connecting the 601PRO and the Host Computer 2. Sending Device Information Records from the 601PRO to the Host Computer 3. Receiving Device Information Records from the Host computer 4. Device Information Record: Definition of Fields 5. Device Information Record Format 6. Deleting Device Records and Templates

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

601PRO Series XL

1. Accessing System Setup 2. Selecting the Test Standard 3. Referring to Test Limits for the Selected Standard