TR61258IEC:2008(E) 4.2.5 Standards-writing organizations Standards-writing organizations should incorporate USABILITY ENGINEERING G principlesinto standards dealing with equipment and include in those standards the elements of the process outlined in this report. 4.3 Datacollection Data and information regarding the use of the selected equipment should be gathered by means of theoretical or technical evaluation, focus groups or clinical evaluation in view of putting together the educational program. 4.3.1 Information to consider concerning equipment Information to consider concerning equipment includes the following: a) manufacturer(s) of the equipment; EN b)model(s)available; c) INTENDED PURPOSE of the equipment; d) intended for single or multiple use; intended oPERATOR (e.g.health professional, layperson); f) g) OPERATOR responsibilities (what is expected to bedone by the OPERATOR): correctly operate the equipment; properly maintain the equipment; identify malfunctions and take appropriate action. 3A h) physical and clinical fundamentals on which operational procedures are based (e.g.infusion YSUIP interaction of the equipment, patient, oPERAToR, facility, and environment; problems associated with the equipment and its use; k) equipment design and manufacture: human interface design; QUALITY ASSURANCE Systems; information supplied bythe manufacturer. NOTE See the future IEC 60601-1-11 for specific requirements beyond those in IEC 60601-1 for equipment I)environment: organization of the OPERATOR work area; supervisory and administrative support; support systems for handicapped, elderly, impaired lay OPERAToRs; atmosphere (heat, light, sound); - electromagnetic compatibility; decontamination(e.g.cleaning,sterilization); types of other equipment used with or in the vicinity of the equipment in question; maintenance of equipment. m)Choice of accessories: recommended; third party. n) information and training programs provided. - 12 - TR61258@IEC:2008(E) 4.3.2 Information to consider about the audience(s)for the EDUcATIONAL MATERIALS a)audience: direct audiences: nurses, medical doctors, technicians, non-technically trained persons including patients; -indirect audiences: teachers, supervisors and managers, biomedical or clinical engineers or physicists,trainers, and auxiliary health care personnel such as pharmacists; b) individual characteristics of the OPERATOR, for instance: physical characteristics (e.g. colour blindness); dexterity; AEDBYOOKSPLYBURA illnesses; use of medications; personality; socio-economic factors; OPERATOR knowledge and skill; quality and timeliness of training and follow-up proficiency checks; Ll nite motivation; experience. NOTE 1 The patient or a relative can, in some cases, be the OPERATOR. NOTE 2 The equipment OPERATOR as well as the patient can have a handicapping condition. 4.4 Selection of mediaandformats /reachthe audience and meet the selected goal(s) of developing proper attitudes, encouraging appropriate behaviour, providing adequate knowledge, and developing skills necessary for a) Written media: ACCOMPANYING DOCUMENTS; marking on the equipment; brochures; manuals; patient package inserts; checklists/sheetforminstructionsforuse/instruction cards; posters-text; training packages; standards; journal articles. b) Audio: cassettes; audio conferences; voice synthesizers; radio networks. TR61258@IEC:2008(E) - 13 - c) Audio-visual: slides and tapes; videotapes; television networks; interactive video; computers; simulators d) Instructions: demonstrations; lectures; seminars; in-service training; college courses; on-the-job training; - simulation. e) dummy or training devices. Ll EXAMPLE Training defibrillator. 4.5 Development and presentation of messages and materials NCHI In developing the educational messages and materials, it is recommended that they be presented in a manner that is: interesting,motivating,targeted atoPERAToR interests; logically presented, simple, clearly stated text; liberal in t