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 Report about: Association for the Advancement of Medical Instrumentation AAMI By: 1-Sanad Taher Aljably Under the supervision of: Dr. Eng. Fadel Alakwa

AAMI Standard: This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic review, and users are cautioned to obtain the latest editions.

AAMI Human Factors Engineering Committee: This Committee that considered for the design of a particular medical device with a user interface have a fitting must be derived from two standpoints: (1)human factors design process. (2)human factors design principles.

Human Factors Design Process: 1- Scope. 2- Normative reference. 3- Definition. 4- Overview of the HFE process. 5- Planning the HFE process. 6- General recommendations for HFE design. 7- The human factor and the work space. 8- Signs, symbols, and markings. 9- Controls. 10- Displays. 11- Alarms and signals. 12- User-computer interface.

1- scope: 1.1 The benefits of HFE. 1.2 Avoiding design-induced error. 1.3 Improving usability.

2- Normative references: Go to Glossary of Shortcuts

3- Definitions: 3.1 anthropometry. 3.2 appearance model. 3.3 conceptual model diagram. 3.4 contextual inquiry. 3.5 criticality. 3.6 fidelity. 3.7 hazard analysis. 3.8 (HFE) 3.9 labeling operator prototype requirement risk analysis 3.14 risk management simulation specification system usability usability goal usability test use error use environment user user interface user profile. For the purposes of this recommended practice, the following definitions apply.

3.1 anthropometry: Scientific measurement and collection of data about human physical characteristics as well as the application of this data to the design and evaluation of systems, equipment, and facilities. 3.8 HFE: human factors engineering (HFE): Application of knowledge about human behavior, abilities, limitations, and other characteristics to the design of tools, machines, equipment, devices, systems, tasks, jobs, and environments to achieve productive, safe, comfortable, and effective human use 3.15 simulation: 3-cont. Definitions: Go to the remainder

4- Overview of the HFE process:

5.1 Planning: 5.2 Analysis: Tasks and products Resources Coordination Schedules Personnel resources Other resources Definition of objectives Function analysis Equipment selection Task analysis Performance requirement estimates Performance capability estimates Function allocation Gross analysis of tasks Analysis of critical tasks Workload analysis Planning Scheduling Implementation Failure analysis. 5- Planning the HFE process: 5.3 Design and development: Preliminary design Studies, experiments & laboratory tests Mock-ups and models Dynamic simulation Detailed design drawings Performance and design specifications Equipment procedure development. 5.4 Test and evaluation:

6- General recommendations for HFE design: 6.1 Consistency. 6.2 Simplicity. 6.3 Safety. 6.4 Environmental and organizational considerations Redundancy Connectors Device failure Surface temperature Vibration Noise Ambient illumination Surface temperature and vibration.

7- The human factor and the work space (Anthropometry): (Physical dimensions) For Males:For Females :

Work surfaces(1): 7- The human factor and the work space (Anthropometry):

Work surfaces(2):

8- Signs, symbols, and markings:

Suggested uses of color coding for medical devices

9-Controls ( 1- Specific control designs ): (1 = Most preferred, 3 = Least preferred) (# Lever for heavy duty power circuits) ( ## Only if sequential selection is acceptable) Go to switches

9-Controls (Design and separation): 1-Rotary selector switches: 2-Thumb Wheel controls:

3-Knobs: 9-Controls (Design and separation): 4-Cranks

5-Push Buttons : 9-Controls (Design and separation): 6-Legend switches:

9-Controls (Design and separation): 7-Levers:

10- Displays: ( Mechanical displays )

11- Alarms and signals : 2-Classification of signals: 1-Classification of alarms: 2.1-Information signal (monitoring). 2.2-Periodic audible indicator. 2.3-Audible signal comprehension.

12 User-computer interface: