Contents of ANSI/AAMI HE75:2009 Page

Transcription

1 Contents of ANSI/AAMI HE75:2009 Page Glossary of equivalent standards...xiii Committee representation...xv Acknowledgments...xvi Foreword...xvii Introduction Scope General Inclusions Exclusions Normative references Definitions and abbreviations...7 General Considerations and Principles 4 General principles Introduction Seek user input Involve users early and often Refine designs through usability testing Establish design priorities Keep it simple Ensure safe use Ensure essential communication Anticipate device failures Facilitate workflow Accommodate user characteristics and capabilities Do not expect users to become masters Expect user errors Accommodate diverse users Maximize accessibility Consider external factors that influence task performance Accommodate users' needs and preferences Prioritize user input Do not rely exclusively on "thought leaders" Let users set the pace Establish realistic expectations of users Do not rely on training Do not rely on instructions for use Do not rely on warnings Do not rely on users' memory Avoid information overload Do not assign users tasks that are better suited to the device Consider real-world demands Consider the context of use Consider worst-case scenarios Make devices as rugged as necessary Limit user workload Consider the potential for device migration into other uses or use environments Develop compatible designs Accommodate mental models Establish natural or conventional mappings Follow industry conventions and consensus standards Optimize user interactions to enhance safety and effectiveness Make devices error-tolerant and fail in a safe manner Avoid physical strain, repetitive motions, and cumulative traumas...24

2 4.9.3 Help users anticipate future events Confirm important actions Make critical controls robust and guard them Clarify operational modes Employ redundant coding Design to prevent user confusion Don't neglect device appeal Summary References Managing the risk of use error Introduction Overview Use-related hazards vs. traditional device-failure hazards Behavioral variability in human users Definition of use error Types of use errors General considerations for managing use-related hazards Use-error consequences in regulatory submissions General considerations for managing risk Methods of managing the risk of use errors Overview Risk, risk management, and use safety Use-error risk management process Definition of intended use, user, and the use environment Identification of use-related hazards Overview Analysis of predecessor and similar devices Analysis of device use tasks Application of best practice for user-interface design Consideration of user workload in device use Estimation and prioritization of risk of use-related hazards Overview Failure mode effects analysis Fault tree analysis Usability testing Implementation of risk controls Overview Most preferred use-related hazard mitigation strategies Less preferred use-related hazard mitigation strategies Validation of safety of use (effectiveness of risk controls) Decision on whether risks are acceptable Determination of whether new risks were introduced Documentation of the use-related risk management process Monitoring, identification, and control of use-related issues post-marketing Summary References Basic human skills and abilities Introduction Design guidelines Overview Vision Audition and speech Other sensory modalities Human information processing Human memory Human response capabilities Human vs. machine capabilities References Anthropometry and biomechanics Introduction General considerations...71

3 7.3 Anthropometric design guidance Overview Anthropometric data One-dimensional measurements Mobility and functional measurements Strength Derivation of missing data Biomechanical design guidance Overview Critical design considerations Special considerations Design guidelines for tasks involving lifting References Environmental considerations Introduction General considerations Design guidelines Interruptions and distractions Acoustic noise Lighting Temperature and humidity Vibration Slipperiness and friction Atmospheric pressure Ease of maintenance Storage Mounting of devices Radiant energy Emergency environment Home environment References Usability testing Introduction General considerations Design guidelines Types of usability tests Principles of good usability test design Overview of usability testing Content of the usability test plan Logistics Protocol-related activities Supplemental usability evaluation methods References Signs, symbols, and markings Introduction General considerations Design guidelines Overview Labels for equipment identification Descriptions of equipment functions Hazard labels Electrical receptacle and connector labels Fuse and circuit-breaker labels Labels on controls, keyboards, and keypads Positioning and mounting of labels Label orientation Indications of functional relationships Permanence and durability of labels Specific design guidance Consistency Label content...144

4 Use of symbols Legibility Coding Application of color to mimics and flow lines Flow lines Language Package labels Hierarchical schemes References User documentation Introduction General considerations Overview Overall process for user documentation development Basic design principles for layout, comprehension, and organization Control of user risks Documentation design for diverse environments Specific design guidelines for various types of user documentation Overview User guides, operator manuals, and owner s manuals Quick-reference guides Electronic documentation References Packaging design Introduction General considerations Overview The user The use environment Principles of good medical packaging design Overview Opening packages Assembling or sequentially using components Labeling packages Identifying devices Indicating sterilization status Storing packaged devices Handling packaged devices Disposing of packaging References Design for post-market issues Introduction General considerations Type of user: health care professional or home-use consumer Type of use environment: health care facility or home Device longevity Design guidelines Overview Disposables Single-use devices Labeling Setup and installation Routine maintenance Repair Upgrades Obsolescence Disposal References Cross-cultural/cross-national design Introduction...185

5 14.2 General considerations Differences among nations and cultures National issues Cultural issues Culture-specific or nation-specific user profiles Guidelines for cross-cultural/cross-national design Overview Direct issues associated with the user device interface Indirect issues associated with the user device interface Cross-cultural/cross-national design process Summary References Alarm design Introduction General considerations Overview Goals Verifying that the alarm system works Initializing alarm monitoring Avoiding false alarms Considerations regarding specific requirements from IEC Attended-use model Distributed alarm systems Alarm priority, urgency of response, and allowable latency Distributed-alarm-system requirements of IEC Latching alarm signals Initiation and termination of alarm signals Default alarm limits and alarm-limit adjustment Alarm-system inactivation states Simultaneous monitoring of multiple physiological states Step-by-step guidelines for developing an alarm system Developing an alarm system Gathering information Generating a list of alarm conditions that require alarm signals Creating signal-processing algorithms Identifying the information to communicate about alarm conditions Allocating signaling modalities to alarm signals Creating alarm signals for each signaling modality: visual alarm signals Creating alarm signals for each signaling modality: auditory alarm signals Creating alarm signals for each signaling modality: other alarm signals Creating a simulated use environment Testing prototype alarm systems with potential users Refining alarm systems on the basis of testing results References Accessibility considerations Introduction General considerations User considerations Design considerations Design guidelines based on legislative guidance documents Overview Users with lower-extremity disabilities Users with upper-extremity disabilities Users who are deaf or hard of hearing Users who are blind or have visual impairments Users with limited tactile sensitivity Users with cognitive or memory impairments Users who could benefit from having more time for device operation Users with speech impairments Research-based design guidelines for patient-support surfaces Overview Width of device base...237

6 Clearance for lift equipment Adjustability of surface height Transfer path Hand-holds Contact surfaces Controls for support surfaces Design guidelines for Web-based, mobile, and home-use health care products based on industry guidance documents Overview Existing guidelines and standards Built-in multimodal capabilities Devices that use home-based technologies Existing laws related to use of hearing aids with telecommunication products Training and informational materials References Design Elements 17 Connectors and connections Introduction General considerations Overview Critical design considerations Key design criteria issues Types of connection failures Prioritizing types of connections Overview Direct patient connections for therapeutic purposes Direct patient connections for diagnostic purposes Connections between patient and device Routinely connected non-patient connections Permanent exterior device connections Permanent connections inside devices Differentiating connectors Overview Active differentiators Passive differentiators Preventing disconnections Overview Rotating locking rings Push pull locking devices Locking levers Screw-captive devices Capture clips Friction fit Positive feedback Engagement of the locking mechanism Engagement indicators Facilitating connections Connector design (shape, fit, feature) Receptacle design Connector use and testing and user training Preventing misconnections Protecting connectors User documentation References Controls Introduction General considerations Steps in specifying controls Advantages and disadvantages of various types of controls Control selection Human factors principles that apply to all controls...262

7 Design considerations for medical device controls vs. controls for consumer products Design guidelines Control-panel controls Input devices Large mechanical controls References Visual displays Introduction General considerations Overview Understanding and accommodating user population characteristics Accommodating the range of user postures Determining typical mounting positions and variations in mounting positions Examining the physical environmental conditions Identifying the requirements for displayed information Performing objective display measurements Conducting usability tests Guidelines for specifying visual-display performance Overview Visual-display viewing conditions Spatial characteristics Temporal characteristics Luminance and color characteristics Guidelines for display formatting Size and spacing of displayed characters or symbols Font style Character, line, and word spacing Size of color objects and alphanumeric strings Guidelines for displaying data Precision Adequate signal duration Guidelines for selecting electronic visual displays Comparison of major types of visual displays Liquid crystal displays Active-matrix vs. passive-matrix displays Large-screen displays Scale indicators References Use of automation Introduction General considerations Types of automated systems and common issues Automation vs. human tradeoffs in medical systems Automation status User understanding of the automation Design guidelines Monitoring and alarm systems Event-sequencing systems Decision-support systems Closed-loop physiological control systems Hybrid or composite automation systems References Software user interfaces Introduction Overview Sample software user interfaces Factors influencing software user interface design General considerations Overview Make the software user interface easy to use Focus on user tasks...318

8 Provide user guidance Safeguard against use error Optimize interaction requirements Improve software and hardware integration Select the interaction style Support product evolution Special considerations Overview Screen size Compatibility Information priority Information legibility User population Standardization System integration Design guidelines Categories Conceptual model User-interface structure Interaction style Screen layout Legibility Aesthetics Data entry Color Dynamic displays Special interactive mechanisms User support Consistency References Integrated Solutions 22 Hand tool design Introduction General considerations Overview Biomechanics Hand grips and positions associated with tool use Forces associated with the use of hand tools Injuries and discomfort associated with tool use Risk factors Compensatory strategies and tradeoffs Special considerations Laparoscopic surgery Catheter-based procedures What to do if design data are not available Design guidelines Overview Context of use Location and environmental factors The end-effector (tool interactions with anatomy) Characteristics of the tool Safety User characteristics and related design considerations Controls for hand tools Sensory feedback Guidelines specifically for laparoscopic instrument design References Workstations Introduction General considerations Adaptation of design to user needs...380

9 Safety Usability User satisfaction Special considerations Overview Serve life-critical purposes Accommodate evolving clinical practices Accommodate a variety of user positions Accommodate users with varying degrees of skill, training, and experience Accommodate workstation use by individuals with disabilities Accommodate patients who might be under stress Accommodate caregivers who might be under stress Anticipate potential migration from hospital to home use Anticipate frequent or infrequent cleaning Design for compactness Design guidelines Overview Operational factors Power supply Readiness Security Privacy Communication Component configuration Physical interaction User accommodations Environmental factors References Design of mobile medical devices Introduction General considerations Overview User considerations Use-environment considerations Design guidelines General design guidance Mechanical design Electrical design Display of information on computer-based medical devices Controls and input devices Connectors and cables Security Instruction manuals and other forms of device documentation References Home health care Introduction Trends in medical device use The home user The home environment General considerations Overview Adjustability Durability Learnability and intuitiveness Freedom from calibration, maintenance, and repair Protection from unintended misuse and/or tampering Portability and maneuverability Power requirements Aesthetics and unobtrusiveness User guidance and training Design guidelines Overview...430

10 Design guidance related to sensory capabilities and limitations Design guidance related to cognitive capabilities and limitations Design guidance related to physical capabilities and limitations Design guidance related to the use environment Medical device training materials and documentation for home users References Annexes A Statistical justification for sample sizes in usability testing