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

In the Name of Allah, the Most Beneficent, the Most Merciful University and science of Faculty of Scienc & Technology Engineering Department of Electronic Engineering Major: Biomedical Engineering

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

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  1. In the Name of Allah, the Most Beneficent, the Most Merciful University and science ofFaculty of Scienc& Technology Engineering Department of Electronic Engineering Major: Biomedical Engineering Report about: Association for the Advancement of Medical Instrumentation AAMI By: -KahledMohammed Altifi Under the supervision of: Dr. Eng. FadelAlakwa. 2010-2011

  2. AAMI Technical Information Report

  3. *CONTENTS 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-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.

  4. *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 of MEDICAL 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 by the experts in IEC/SC 62A/WG 14 available to those interested in the application of the second edition of IEC 60601-1.

  5. -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.

  6. 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.

  7. 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. 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.

  8. 3- Recommendation sheets:

  9. 2-Graphical symbols for electrical equipment in medical practice. 1-scop 2-general 3-nomative reference 4-Title and description of graphical symbols

  10. 1-scope This 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-General This technical information report primarily identifies graphical symbols published in IEC 60417 or ISO 7000. A reference to the corresponding symbol numbers is given.

  11. 3- Normative references 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 machines IEC 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 in workplaces 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.

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

  13. 4-Title and description of graphical symbols This clause holds graphical symbols for use on medical electrical equipment, sorted by application areas. 1—General: Controls

  14. 2-Classification and identification of equipment

  15. 3-Guidance on electromagnetic compatibility of medical devices for clinical/biomedical engineers -: Radiated radio-frequency electromagnetic energy 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

  16. *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 for immunity 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.

  17. 2 Abbreviations : ANSI : American National Standards Institute CCU : Critical Care Unit CT : Computed tomography CW : Continuous wave DC : Direct current EEG : Electroencephalography or electroencephalogram EMC : Electromagnetic compatibility EMD : Electromagnetic disturbance EMG : Electromyography or electromyogram EMI : Electromagnetic interference ER : Emergency Room ESD : Electrostatic discharge FOI : Freedom of Information GSM : Global System for Mobile Communications ICD : Implantable cardioverter defibrillator ICU : Intensive Care Unit IEC : International Electrotechnical Commission IEEE : Institute of Electrical and Electronics Engineers ISO : International Organization for Standardization LAN : Local area network MRI : Magnetic resonance imaging NBICU: New Born Intensive Care Unit

  18. NPF: No problem found OR : Operating Room PCA : Patient-controlled analgesic PCS : Personal communication services RF : Radio frequency SMDA : Safe Medical Devices Act

  19. *Definitions 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 the audio-frequency portion and the infrared portion. Note: The present practical limits of radio frequency are roughly 9 kHz to 3000 GHz.

  20. 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-Radiation In 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 the susceptible device. If the source is sufficiently intense and the medical device sufficiently susceptible, they do not need to be in proximity.

  21. 2- Conduction In coupling by conduction, there is a direct electrical path between the electromagnetic source and the susceptible 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.

  22. *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

  23. 2- Radiated power The 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 strength The 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 “dipole equation” 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

  24. 4 -Absorption and reflection Due 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.

  25. 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 of existing devices. In some cases, upgrade or replacement of existing devices may be appropriate. 1- New medical devices Manufacturers should be requested to provide EMC specifications and/or information on device-related EMI 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 which the device is expected to be used. IEC 60601-1-2 (1993) specifies general EMC requirements for medical electrical equipment.

  26. 2- Existing medical devices Many electronic medical devices now in the inventory of health care organizations were not designed or tested for EMC. Some of this equipment can be very susceptible to EMI, with RF immunity as low as 0.1 V/m. 2.1-User training. 2.2 Service/maintenance.

  27. END

  28. General symbols:

  29. :Safety signs

  30. :Safety signs

  31. Figure 15—Measuring circuit for the PATIENT LEAKAGE CURRENT from the PATIENT CONNECTION to earth Go Back

  32. 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 Go Back

  33. 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: Go Back

  34. 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 Go Back

  35. Figure 19—Measuring circuit for the PATIENT AUXILIARY CURRENT: Go Back

  36. 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: Go Back

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

  38. Go back

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