2. Guidance on Functional Modes for Access

Overview

This guidance on medical device access for individuals with disabilities is based on multimodal interface design, and on the conceptual framework used in the U.S. Access Board’s regulations for Section 508 of the Rehabilitation Act, Section 255 of the Telecommunications Act, and the Americans with Disabilities Act. This guidance consists of 25 items that can be divided into two parts: 12 functional performance criteria that are based on current US regulations followed by 13 modal considerations. Nine of the first twelve guidelines introduced here are based on one or both of the first two of these existing guidelines. More info ...

Guidelines

2.1 At least one mode of operation and information retrieval that does not require user vision should be provided, or support for assistive technology used by people who are blind or visually impaired should be provided, where readily achievable for the user population

2.2 At least one mode of operation and information retrieval that does not require visual acuity greater than 20/70 should be provided in audio and enlarged print output working together or independently, or support for assistive technology used by people who are visually impaired should be provided, where readily achievable for the user population

2.3 At least one mode of operation and information retrieval that does not require color vision should be provided, in all cases

2.4 At least one mode of operation and information retrieval that does not require user hearing should be provided, or support for assistive technology used by people who are deaf or hard of hearing should be provided, where readily achievable for the user population

2.5 At least one mode of operation and information retrieval should be provided in an enhanced auditory fashion, or support for assistive hearing devices should be provided, where readily achievable for the user population

2.6 At least one mode of operation and information retrieval should be provided that does not depend on tactile sensation, such as a video or audio mode, where readily achievable for the user population

2.7 At least one mode of operation and information retrieval should be provided that does not require user speech, or support for assistive technology used by people with disabilities, where readily achievable for the user population

2.8 At least one mode of operation and information retrieval should be provided that does not require fine motor control or simultaneous actions, where readily achievable for the user population

2.8.1 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

2.8.2 Controls or keys should be spaced far enough apart to allow operation by a person with limited fine motor control

2.9 At least one mode of operation and information retrieval should be provided 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

2.9.1 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

2.10 At least one mode of operation and information retrieval should be provided 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, where readily achievable for the user population

2.11 At least one mode of operation and information retrieval should be provided that minimizes the cognitive, memory, language and learning skills required of the user, where readily achievable for the user population

2.12 At least one mode of operation and information retrieval that does not require a timed response should be provided for tasks that are not time-critical, where readily achievable for the user population

2.13 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

2.18 Modes of hearing should be integrated with modes of vision and touch, where readily achievable for the user population

2.19 Performance advantages of hearing should be optimized within designs, where readily achievable for the user population

2.20 Embedded speakers and a standards-compliant audio jack should be provided, where readily achievable for the user population

2.21 Volume controls for audio channels should be provided that do not require users to perform twisting movements, where readily achievable for the user population

2.22 Speech recognition should be considered as a control input mode, where readily achievable for the user population

2.23 Tactile features should be integrated into the interface surface, where readily achievable for the user population

2.24 Designs should consider user reach abilities for seated persons and users of wheelchairs or scooters, where readily achievable for the user population

2.24.1 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).

2.24.2 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.

2.25 Difficulties in using mechanically operated controls and keys should be anticipated and addressed, where readily achievable for the user population

2.25.1 If key repeat is supported, the delay before repeat should be adjustable to at least 2 seconds, with key repeat rate of 2 seconds per character. This pertains to actions associated with configuring the device as well as those associated with operating the device.

2.25.2 The status of all locking or toggle controls or keys should be visually discernible, and discernible either through touch or sound

2.25.3 For products that are freestanding, non-portable, intended to be used in one location, and which have operable controls, the operable control area or workstation should be no more than 48 in. wide, and between 15-54 in. from the floor if the depth is under 10” or between 15-46” from the floor if the depth is 10-24 in.

2.25.4 For products that are mobile, modes of operation that do not require bimanual operation should be considered.

2.25.5 Where a product utilizes touch screens or contact-sensitive controls, an input method should be provided for mechanically operated controls or keys that meets the following:

Controls and keys should be tactilely discernible without activating the controls or keys.
When readily achievable, controls and keys should be operable with one hand and 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.
When readily achievable and safe, if key repeat is supported, the delay before repeat should be adjustable to at least 2 seconds, and key repeat rate should be adjustable to 2 seconds per character.
When readily achievable, the status of all locking or toggle controls or keys should be visually discernible, and discernible either through touch or sound.

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