1. General Guidance (as compiled list, without discussion)
Overview
This guidance is based on adapting aspects of existing guidelines to medical devices, considerations of universal design principles, and applying accessible design approaches for specific types of medical equipment. Some of the guidance is based on research (and often closely related to other sections of this standard) and some is based on technical specifications developed for the implementation of federal legislation.
This page provides a compiled list of all the numbered Section 1 guidance statements, without the discussions that are included for the General Guidance sections. It is intended as an abbreviated reference. Numbered links to the 5 individual General Guidance documents are provided for more details.
Page Navigation
To view the General Guidance details, click the numbered link beside each statement to navigate to the relevant detailed document.
Click to navigate on this page to the abbreviated list for:
- Functional Access Modes
- Design for All / Universal Design
- Telecommunications and Personalized Interfaces
- Patient Support Surfaces
- Accessible Device Controls and Displays, Including Alarm Systems
1.1 General Guidance on Functional Access Modes
1.1.1 Provide at least one mode of operation and information retrieval that does not require user vision, or support for assistive technology used by people who are blind or visually impaired, where readily achievable for the user population.
1.1.2 Provide at least one mode of operation and information retrieval that does not require visual acuity greater than 20/70 in audio and enlarged print output working together or independently, or support for assistive technology used by people who are visually impaired, where readily achievable for the user population.
1.1.3 Provide at least one mode of operation and information retrieval that does not require color vision.
1.1.4 Provide at least one mode of operation and information retrieval that does not require user hearing, or support for assistive technology used by people who are deaf or hard of hearing, where readily achievable for the user population.
1.1.5 Provide at least one mode of operation and information retrieval in an enhanced auditory fashion, or support for assistive hearing devices, where readily achievable for the user population.
1.1.6 Provide at least one mode of operation and information retrieval that does not depend on tactile sensation, such as a video or audio mode, where readily achievable for the user population.
1.1.7 Provide at least one mode of operation and information retrieval that does not require user speech, or support for assistive technology used by people with disabilities, where readily achievable for the user population.
1.1.8 Provide at least one mode of operation and information retrieval that does not require fine motor control or simultaneous actions, where readily achievable for the user population.
1.1.8.1 Controls or keys should be operable with one hand, either the right or the left, and should not require tight grasping, pinching, or twisting of the wrist. The force required to activate controls and keys should be 5 lbs (22.2 N) maximum
1.1.8.2 Controls or keys should be spaced far enough apart to allow operation by a person with limited fine motor control. (To test this, the designer may try to operate the controls while wearing moderately thick gloves.)
1.1.9 Provide at least one mode of operation and information retrieval that is operable with limited reach and strength or stamina, or support for assistive technology that enables alternate use by people with disabilities, where readily achievable for the user population.
1.1.9.1 The position of any operable control should be determined with respect to a vertical plane, which is 48 inches in length, centered on the operable control, and at the maximum protrusion of the product within the 48 inch length
1.1.10 Provide at least one mode of operation and information retrieval that enables relative positioning and orienting between the user and the medical device without requiring the user to walk, stand, or maintain a specific arm or head orientation posture, including full access for users of assistive technologies such as wheelchairs.
1.1.11 Provide at least one mode of operation and information retrieval that minimizes the cognitive, memory, language and learning skills required of the user, where readily achievable for the user population.
1.1.12 Provide at least one mode of operation and information retrieval that does not require a timed response for tasks that are not time-critical, where readily achievable for the user population.
1.1.13 When the user is expected to respond within a certain amount of time, the device should provide sufficient time for the user to indicate more time is needed.
1.1.14 Provide text descriptions of key visual information, where readily achievable for the user population.
1.1.15 Standard computer-based monitors should be used, where readily achievable for the user population.
1.1.16 Appropriate visual displays should accommodate captioning, where readily achievable for the user population.
1.1.17 Multimedia video should follow standard multimedia formats, where readily achievable for the user population.
1.1.18 Modes of hearing should be integrated with modes of vision and touch, where readily achievable for the user population.
1.1.19 Performance advantages of hearing should be optimized within designs, where readily achievable for the user population.
1.1.20 Provide embedded speakers and a standards-compliant audio jack, where readily achievable for the user population.
1.1.21 Provide volume controls for audio channels that do not require users to perform twisting movements, where readily achievable for the user population.
1.1.22 Speech recognition should be considered as a control input mode, where readily achievable for the user population.
1.1.23 Tactile features should be integrated into the interface surface, where readily achievable for the user population.
1.1.24 Designs should consider user reach abilities for seated persons and users of wheelchairs or scooters, where readily achievable for the user population.
1.1.24.1 Forward Reach. If the clear floor space only allows forward approach to an object (e.g., by a person in a wheelchair), the maximum high forward reach allowed should be 48 in (1220 mm). The minimum low forward reach should be15 in (380 mm). If the high forward reach is over an obstruction, reach and clearances should be as shown in Fig. 5(b).
1.1.24.2 Side Reach. If the clear floor space allows parallel approach by a person in a wheelchair, the maximum high side reach allowed should be 54 in (1370 mm) and the low side reach should be no less than 9 in (230 mm) above the floor (Fig. 6(a) and (b)). If the side reach is over an obstruction, the reach and clearances should be as shown in Fig. 6(c).
1.1.25 Difficulties in using mechanically operated controls and keys should be anticipated and addressed, where readily achievable for the user population.
1.2 General Guidance on Design for All / Universal Design
1.2.1 The same means of use should be provided for all users: identical whenever possible, equivalent when not
1.2.2 Segregation or stigmatization of any users should be avoided
1.2.3 Provisions for privacy, security, and safety should be equally available to all potential users
1.2.4 The design of the device should be appealing to all potential users
1.2.5 The device should offer choice in methods of use
1.2.6 The device should accommodate right- or left-handed access and use
1.2.7 The device should facilitate the user's accuracy and precision
1.2.8 The device should adapt to the user's pace
1.2.9 The device should have no unnecessary complexity
1.2.10 Device operation should be consistent with user expectations and intuition
1.2.11 The device should accommodate a wide range of literacy and language skills
1.2.12 Information on the device should be arranged in a manner consistent with its importance
1.2.13 The device should provide effective prompting and feedback during and after task completion
1.2.14 The device should use different modes (visual, verbal, tactile) for redundant presentation of essential information
1.2.15 The "legibility" of essential device information should be maximized
1.2.16 Elements of the device should be differentiated in ways that can be described (i.e., make it easy to give instructions or directions)
1.2.17 The device should be compatible with a variety of techniques or devices used by potential users who have sensory limitations
1.2.18 Elements of the device should be arranged to minimize hazards and errors: the most used elements should be most accessible; hazardous elements should be eliminated, isolated, or shielded
1.2.19 The device should provide warnings of hazards and errors
1.2.20 The device should have fail-safe features
1.2.21 The device should discourage unconscious action in tasks that require vigilance
1.2.22 Allow user to maintain a neutral body position
1.2.23 The forces required to operate the device should be reasonable
1.2.24 Repetitive actions should be minimized
1.2.25 Sustained physical effort should be minimized
1.2.26 The device should offer a clear line of sight to important elements for any seated or standing potential user
1.2.27 The reach to all critical components of the device should be comfortable for any seated or standing potential user
1.2.28 The device should accommodate variations in hand and grip size
1.2.29 Adequate space should be provided for the use of assistive devices or personal assistance
1.3 General Guidance on Telecommunications and Personalized Interfaces
1.3.1 The W3C Web Content Accessibility Guidelines (WCAG) should be satisfied for all web-based medical products.
1.3.2 Existing videoconferencing and multimedia standards should be supported to the greatest extent possible.
1.3.3 Existing consumer electronics and wireless standards should be supported and applied to the greatest extent possible.
1.3.4 Built-in multimodal capabilities should be recognized and used.
1.3.5 Basic electronic and information technology accessibility requirements should be integrated into medical devices that use home-based technologies.
1.3.6 Medical devices with audio interfaces should consider compliance with existing laws related to use of telecommunication products with hearing aids. [see also specific guidance provided in Section 508 under the title Telecommunications Products (1194.23), see http://www.access-board.gov/sec508/guide/1194.23.htm)].
1.3.7 Modern infrastructure with accessibility capabilities should be used for training and informational materials.
1.3.7.1 All training and informational video and multimedia productions, regardless of format, that contain speech or other audio information necessary for the comprehension of the content, should be open- or closed-captioned (based on Section 508 §1194.24 (c)).
1.3.7.2 All training and informational video and multimedia productions, regardless of format, that contain visual information necessary for the comprehension of the content, should be able to be audio described (based on Section 508 §1194.24 (b)).
1.3.7.3 Display or presentation of alternate text presentation or audio descriptions should be user-selectable unless permanent (based on Section 508, §1194.24 (e)).
1.3.8 Devices with a significant control-display interface, implemented with a monitor or control box, should consider implementing an interface that is compatible with the UI-Socket Universal Remote Console standard (ANSI/INCITS 389-393, ISO 24752).
1.4 General Guidance on Patient Support Surfaces
1.4.1 The base of the device should not extend beyond the horizontal edge of the support surface
1.4.2 The base of the device should provide clearance for lift equipment
1.4.3 The height of the support surface should enable easy patient transfers
1.4.4 The height of the support surface should be easy to adjust to suit the needs of potential healthcare professionals and patients
1.4.5 The stiffness of the surface padding should be appropriate to the application
1.4.6 The support surface should be stable and safe for the patient
1.4.7 The support surface contact surfaces should be safe and comfortable for the patient
1.4.8 The support surface should be wide enough for all potential patients
1.4.9 The shape of the support surface should be adjustable
1.4.10 Effective leg supports should be provided
1.4.11 Straps and safety rails and be provided
1.4.12 A non-obstructed path should be available for transferring
1.4.13 The device should have integrated handholds to facilitate patient transfers
1.4.14 Controls for support surfaces should be located appropriately
1.4.15 Consider providing audio or music output for patient orientation or comfort
1.4.16 The device should enable continuous communication between patients and providers
1.5 General Guidance on Accessible Device Controls and Displays, Including Alarm Systems
Guidance on Controls (1.5.1 to 1.5.11)
1.5.1 Users with disabilities should be included in the testing of controls.
Control Type |
Accessibility Advantages |
Accessibility Disadvantages |
Pushbuttons |
Can be activated with various body parts of assistive technologies (e.g., finger, palm, pointer stick) |
Requires a force component in a single direction, can be too small, low friction, or low deflection |
Toggle Switches |
Does not require fine motor control, can be activated with various body parts |
Requires a force component in a certain direction |
Continuous Thumb Wheels |
Often can rest hand/arm during use |
Requires fine motor control |
Discrete Thumb Wheels |
Often can rest hand/arm during use |
Requires fine motor control |
Rotary Knobs |
None |
Requires fine motor control and simultaneous actions (e.g., grasping and turning) |
Levers |
Requires minimal fine motor control |
Can be accidentally activated, requires force in a certain direction |
Rocker Switches |
Can be activated with various body parts or assistive technologies (e.g., finger, palm, pointer stick) |
|
Sliders |
Good visual and tactile feedback of control state |
Requires some fine motor control, including sliding in a single direction |
Key-operated Controls |
None |
Requires simultaneous grasping and turning motions |
Membrane Controls |
If tactile feedback, provides systematic grid of controls, integrated signage |
Minimal tactile feedback for control placement and operation |
Pedals |
Provides means for using feet for discrete or continuous controls |
Requires coordinated leg movement |
Large Levers |
Good visual and tactile feedback of control state |
May require larger forces/motions to operate, can be accidentally activated |
Wheels |
Bimanual or either hand can be an advantage |
May require larger forces/motions to operate |
Palm Buttons |
Can be activated with various body parts or assistive technologies (e.g., finger, palm, pointer stick) |
|
1.5.2 The force required to activate controls should be as low as possible, but high enough to provide tactile feedback and prevent inadvertent activation.
1.5.3 Controls that use a pushing motion are preferred over rotating controls for people with disabilities and elder
1.5.4 Controls should have redundant feedback mechanisms with different sensory modalities.
1.5.5 Controls should have adequate space surrounding frequently used controls so users can rest their fingers or palms when activating the control, especially for horizontally oriented displays.
1.5.6 Controls should be labeled with icons and/or text.
1.5.7 Concave surfaces with surface texture should be used on controls requiring pushing to help users keep their fingers from sliding off the control surface.
1.5.8 Rotary knobs and toggle switches should have increments/travel distance of at least 30 degrees so that control activation is easier for users with disabilities.
1.5.9 Controls should be mounted on a vertical or horizontal surface, or on a diagonal surface that is adjustable. For controls on interfaces that require sustained use, the control should be mounted on a horizontal surface.
1.5.10 Tactile control/display cues should be provided on control surfaces, especially membrane control surfaces, to make it easier for users to navigate the surface.
1.5.11 Hands free alternative controls such as eye tracking, sip and puff, mouth sticks, head controls, and voice controls, should be available when possible for users with disabilities or other users who need to multi-task.
Guidance on Displays (1.5.12 to 1.5.15)
1.5.12 Displays should accommodate large ranges of use postures for the user relative to the device.
1.5.13 For visual displays, temporal video byproducts such as flicker and jitter should be minimized, and indeed through use of modern technology should no longer provide challenges for persons with disabilities.
1.5.14 For visual displays, adequate luminance, contrast and use of color characteristics should be designed into the presentation of content on the display.
1.5.15 The character height of text on displays should be of adequate size, or provide accommodations for users’ assistive technologies.
Guidance on Alarm Systems (1.5.16 to 1.5.22)
1.5.16 This is especially important when designing medical devices used by lay users in the home environment. Motivated in part by AAMI/ANSI HE-75: Alarm Design-13.3.10.
1.5.17 The alarm signal should be designed to be compatible with the full range of human perceptual/cognitive capabilities.
1.5.18 Designers should assume that users of medical devices may have a physical limitation such as impaired hearing or vision when selecting alarm-signaling modalities, unless there is strong evidence to the contrary for the full population of possible users.
1.5.19 Alarms should be perceivable by users with some hearing loss.
1.5.20 For auditory alarm signals, a fundamental frequency as well as at least 3 additional frequencies should be used.
1.5.21 Designers should minimize the number of false alarms generated by an alarm system.
1.5.22 Alarm signals should be adjustable (within reason) with the option to store user settings. The device should clearly indicate when the limits have been adjusted from the factory settings.