In the Name of Allah,the Most Beneficent, the Most Merciful

University and science of Faculty of Scienc& Technology Engineering

Department of Electronic EngineeringMajor: Biomedical Engineering

Report about: Association for the Advancement of Medical Instrumentation

AAMI

By:-Kahled Mohammed Altifi

Under the supervision of:Dr. Eng. Fadel Alakwa.

2010-2011

AAMI Technical Information Report

*CONTENTS1- Considerations of unaddressed safety aspects in the second edition of IEC60601-1 and proposals for new requirements. 1-scope. 2-object. 3-Recommendation sheets.2-Graphical symbols for electrical equipment in medical practice.

3-Guidance on electromagnetic compatibility of medical devices for clinical/biomedical Engineers.

• 1-scop.• 2-general.

• 3-nomative reference.• 4-Title and description of graphical symbols.

1- Introduction and scope.2-Abbreviations and definitions.3- Recommendations.4 -Principles of electromagnetic energy and interference mechanisms.5-Management of medical devices for electromagnetic compatibility.

*AAMI Technical Information Report-This Technical Report contains a series of recommendations developed by an expert working .group of IEC subcommittee 62A in response to questions of interpretation of the second edition of IEC 60601-1. -This Technical Report is primarily intended to be used by manufacturers ofMEDICAL ELECTRICAL EQUIPMENT; test houses and others responsible for assessment of compliance with IEC 60601-1; and those developing subsequent editions of IEC 60601-1.-The object of this Technical Report is to make the recommendations/interpretations developed bythe experts in IEC/SC 62A/WG 14 available to those interested in the application of the second edition of IEC 60601-1.

-All standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and

professional judgment of the user of the document .Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations.

1- Considerations of unaddressed safety aspects in the second edition of IEC60601-1 and proposals for new requirements

1-scope.2-object.3-Recommendation sheets.

2-Object The object of this technical report is to make the recommendations- interpretations developed by the experts in IEC/SC 62A/WG 14 available to those interested in the application of the second edition of IEC 60601-1.

1-Scope:-This technical report contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of the second edition of IEC 60601-1.-This technical report is primarily intended to be used by:*manufacturers of MEDICAL ELECTRICAL EQUIPMENT*test houses and others responsible for assessment of compliance with IEC 60601-1:1988*developing subsequent editions of IEC 60601-1.

3- Recommendation sheets:

1-scop2-general3-nomative reference4-Title and description of graphical symbols

2-Graphical symbols for electrical equipment in medical practice.

1-scopeThis technical information report provides a comprehensive compilation, for easy reference, of graphical symbols (graphics, title, description) and safety signs for medical electrical equipment.The graphical symbols are grouped in sections according to their specific field of application.

2-GeneralThis technical information report primarily identifies graphical symbols published in IEC 60417 or ISO 7000.A reference to the corresponding symbol numbers is given.

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

IEC 60204-1:2000, Safety of machinery—Electrical equipment of machinesIEC 60417-DB:2002,1 Graphical symbols for use on equipment.IEC 60601-1, Medical electrical equipment— General requirements for safety.ISO/IEC 80416 (all parts), Basic principles for graphical symbols for use on equipment.ISO 361:1975, Basic ionizing radiation symbol.ISO 3864-1:2002, Graphical symbols—Safety colours and safety signs—Part 1: Design principles for safety signs inworkplaces and public areas.ISO 7000, Graphical symbols for use on equipment—Index and synopsis.ISO 7010, Graphical symbols—Safety colours and safety signs—Safety signs used in workplaces and public areas.

3- Normative references

*Glossary of equivalent standardsInternational Standards adopted in the United States may include normative references to other InternationalStandards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives thecorresponding U.S. designation and level of equivalency to the International Standard.

Equivalency U.S. designation International designation

Identical ANSI/AAMI/IEC 60601-1-2:2001

IEC 60601-1-2:2001

Major technical variations ANSI/AAMI DF80:2003 IEC 60601-2-04:2002

Identical ANSI/AAMI/ISO 10993-1:2003 ISO 10993-1:2003

Identical ANSI/AAMI/IEC TIR60878:2003

IEC TR 60878:2003

Minor technical variations ANSI/AAMI BE78:2002 ISO 10993-10:2002

4-Title and description of graphical symbolsThis clause holds graphical symbols for use on medical electrical equipment, sorted by application areas.

1—General: Controls

2-Classification and identification of equipment

3-Guidance on electromagnetic compatibility of medical devices for clinical/biomedical engineers

-: Radiated radio-frequency electromagnetic energy

1- Introduction and scope2-Abbreviations and definitions3- Recommendations4 -Principles of electromagnetic energy and interference mechanisms5-Management of medical devices for electromagnetic compatibility

*Abstract:This AAMI Technical Information Report (TIR) provides information and guidance to clinical engineers and other biomedical personnel on electromagnetic compatibility (EMC) of medical devices.

*1- Introduction and scope:RF sources have proliferated in health care facilities, creating the potential for EMI with electronic medical devices and with other equipment (e.g., personal pagers, bar code systems, security systems, fire alarm systems, nurse call systems)

Many electronic medical devices presently in use have not been tested forimmunity to EMD, and some are at risk of failure or malfunction due to interference from portable, mobile, and fixed RF sources both within and outside the health care facility.

2 Abbreviations :

ANSI : American National Standards InstituteCCU : Critical Care UnitCT : Computed tomographyCW : Continuous waveDC : Direct currentEEG : Electroencephalography or electroencephalogramEMC : Electromagnetic compatibilityEMD : Electromagnetic disturbanceEMG : Electromyography or electromyogramEMI : Electromagnetic interferenceER : Emergency RoomESD : Electrostatic dischargeFOI : Freedom of InformationGSM : Global System for Mobile CommunicationsICD : Implantable cardioverter defibrillatorICU : Intensive Care UnitIEC : International Electrotechnical CommissionIEEE : Institute of Electrical and Electronics EngineersISO : International Organization for StandardizationLAN : Local area networkMRI : Magnetic resonance imagingNBICU: New Born Intensive Care Unit

NPF: No problem foundOR : Operating RoomPCA : Patient-controlled analgesicPCS : Personal communication servicesRF : Radio frequencySMDA : Safe Medical Devices Act

electromagnetic compatibility:The ability of an equipment and/or system to function satisfactorily in its electromagnetic environment without introducing intolerable EMD to anything in that environment.

electromagnetic interference:Degradation of the performance of a piece of equipment, transmission channel, or system caused by an EMD.

radio frequency: A frequency in the portion of the electromagnetic spectrum that is between theaudio-frequency portion and the infrared portion. Note: The present practical limits of radio frequency areroughly 9 kHz to 3000 GHz.

*Definitions

4-Principles of electromagnetic energy and interference mechanisms:

To solve and prevent EMI problems, it is important to understand the physics of the coupling of electromagnetic energy from electromagnetic sources into electronic medical devices and the ways in which this electromagnetic energy can interfere with device function.

*Coupling of electromagnetic energy:

Electromagnetic energy is coupled from one piece of equipment to another by radiation, conduction, and/or induction.

1-RadiationIn coupling by radiation, the energy propagates through space (and through the air) in the form of electromagnetic waves that are “launched” by the source and “received” by a wire or other conductor in thesusceptible device. If the source is sufficiently intense and the medical device sufficiently susceptible, they do not need to be in proximity.

2- ConductionIn coupling by conduction, there is a direct electrical path between the electromagnetic source and thesusceptible device, i.e., a physical connection between devices.

3 -Induction

In coupling by induction, there is magnetic or capacitive coupling of electromagnetic energy from the source to a near by susceptible device.

*Mechanisms of EMI

Electromagnetic interference occurs when an electromagnetic signal intended for another “receiver” is coupled into a susceptible device, is processed with or in place of the intended signal within the device, and causes deviation from normal performance.

*Factors affecting the degree of EMI:The degree to which an electronic medical device is affected by radiated electromagnetic energy is influenced by the frequency, power, field strength, modulation, and absorption and reflection of the electromagnetic energy, and by the design and maintenance of the medical device.

1- Frequency and wavelength

The frequency and wavelength of an electromagnetic wave are related by the following equation:frequency x wavelength = speed of light = 3.0 x 108 meters per second (m/s)

*Example solutions of equation

2- Radiated powerThe radiated power by which a transmitter “launches” an RF wave affects the field strength measured at a given distance from that source. It is a function of the output power of the transmitter and of the antenna efficiency.

3 -Field strengthThe field strength of a radiated RF wave usually refers to the magnitude of the electric (E) field vector. In the far field (farther away than several wavelengths), the field strength varies as the inverse of the distance and the square root of the output power, as shown in equation . Equation is known as the “dipoleequation” because it specifies the electric field strength at a distance from an ideal dipole antenna.

P is the radiated power in watts (W)d is the distance in meters (m)E is the electric field strength in volts per meter (V/m)k is a constant in the range of 0.45 to 7, depending on the antenna

4 -Absorption and reflectionDue to absorption and/or reflection, the field strength of a radiated electromagnetic wave measured at a point in space can be higher or lower than that predicted by the dipole equation. Conductive surfaces, particularly metallic structures, reflect electromagnetic waves. Materials such as ferrites, and even the bodies of humans and animals, can absorb as well as reflect electromagnetic energy.

5-Management of medical devices for EMC

The electromagnetic emissions and susceptibility of medical devices vary. Potential EMI problems can be prevented through prepurchase evaluation of new devices and proper evaluation and maintenance ofexisting devices. In some cases, upgrade or replacement of existing devices may be appropriate.

Manufacturers should be requested to provide EMC specifications and/or information on device-relatedEMI incidents reported by users of the electrically-powered medical devices being considered for purchase.Medical device EMC specifications should be evaluated based on the electromagnetic environment in whichthe device is expected to be used. IEC 60601-1-2 (1993) specifies general EMC requirements for medicalelectrical equipment.

1 -New medical devices

2.1-User training.

2- Existing medical devicesMany electronic medical devices now in the inventory of health care organizations were not designed ortested for EMC. Some of this equipment can be very susceptible to EMI, with RF immunity as low as0.1 V/m.

2.2 Service/maintenance.

END

General symbols:

:Safety signs

:Safety signs

Figure 15—Measuring circuit for the PATIENT LEAKAGE CURRENT from the PATIENT CONNECTION to earth

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Figure 16—Measuring circuit for the PATIENT LEAKAGE CURRENT via the PATIENT CONNECTION(s) of an F-TYPE APPLIED PART to earth caused by an external voltage on the PATIENT CONNECTION

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Figure 17—Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT CONNECTION(s) to earth caused by an external voltage on a SIGNAL INPUT/OUTPUT PART:

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Figure 18—Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT CONNECTION(s)to earth caused by an external voltage on a metal ACCESSIBLE PART that is not PROTECTIVELY EARTHED

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Figure 19—Measuring circuit for the PATIENT AUXILIARY CURRENT:

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20—Measuring circuit for the total PATIENT LEAKAGE CURRENT with all PATIENT CONNECTIONS of all APPLIED PARTS of the same type (TYPE B APPLIED PARTS, TYPE BF APPLIED PARTS, or TYPE CF APPLIED PARTS) connected togeth:

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Table 5—Legends of symbols for Figure 9 to Figure 11, Figure 13 to Figure 20,Figure A.15

Goback

Name of Shortcuts ShortcutsAmerican National Standards Institute ANSI

Critical Care Unit CCU

Computed tomography CT

Continuous wave CW

Direct current DC

Electroencephalography or electroencephalogram EEG

Electromagnetic compatibility EMC

Electromagnetic disturbance EMD

Electromyography or electromyogram EMG

Electromagnetic interference EMI

Emergency Room ER

Electrostatic discharge ESD

Freedom of Information FOI

2-Abbreviations

Back to Normative references

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For Male:

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For Female:

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Toggle THUMB WHEEL Round knobs

CRANK SWITCH

Joystick ball

Bar knobLever switchRocker Switch

Kinds of Switches: Go Back