Appendix to - Appendix to Part 1195—Standards for Accessible Medical Diagnostic Equipment
M101.1 Purpose. These Standards (MDE Standards) contain scoping and technical requirements for medical diagnostic equipment (diagnostic equipment) to ensure accessibility to, and usability of the diagnostic equipment by patients with disabilities. The MDE Standards provide for independent access to, and use of, diagnostic equipment by patients with disabilities to the maximum extent possible.
M101.2 Application. Sections M301 through M304 shall be applied to diagnostic equipment, based on the patient positions that the equipment supports, during patient transfer and diagnostic use. Sections M306 and M307 shall be applied to diagnostic equipment where communication features or operable parts are provided for patient use.
M101.3 Existing Diagnostic Equipment. The MDE Standards do not address the applicability of scoping or technical requirements to existing diagnostic equipment. Enforcing authorities, such as the Department of Justice or the Department of Health and Human Services, have authority over the accessibility of existing equipment and any regulation of that equipment will be effective only to the extent required by such enforcing authorities.
M101.4 Equivalent Facilitation. The use of alternative designs or technologies that result in substantially equivalent or greater accessibility and usability than specified in the MDE Standards is permitted.
M101.5 Dimensions. The MDE Standards are based on adult dimensions and anthropometrics. Dimensions that are not stated as “maximum” or “minimum” are absolute.
M101.6 Dimensional Tolerances. Dimensions are subject to conventional industry tolerances for manufacturing processes, material properties, and field conditions.
M101.7 Units of Measurement. Measurements are stated in U.S. customary and metric units. The values stated in each system (U.S. customary and metric units) may not be exact equivalents, and each system shall be used independently of the other.
M102 DefinitionsM102.1 Defined Terms. For the purpose of the MDE Standards, the following terms have the indicated meaning:
End Transfer Surface. A transfer surface located at one end of an examination surface that allows patient transfer at the end and one adjoining side of the examination surface.
Enforcing Authority. An agency or other governmental entity that adopts the MDE Standards as mandatory requirements for entities subject to its jurisdiction. Enforcing authorities may include, but are not limited to the United States Departments of Justice and Health and Human Services.
Examination Chair. Diagnostic equipment with a seat in which a patient typically is positioned with buttocks approximately parallel to the ground and shins approximately perpendicular to the ground. Examination chairs typically have back support and may recline to properly position the patient during examination. Such chairs may also have footrests or stirrups. Examination chairs include, but are not limited to, equipment used for dental, ophthalmic, podiatric, gynecological, urological, and ear, nose, and throat examinations.
Imaging bed. A component of diagnostic scanning equipment that accommodates patients in supine, prone, or side-lying positions.
Imaging equipment with bores. Diagnostic scanning equipment using magnets, x-rays, or detectors into which a patient and the table on which the patient lies is inserted into the equipment through a cylindrical opening (bore) in order to achieve the positioning accuracy needed during the scan. Such equipment includes, but is not limited to, computerized axial tomography (CT or CAT), positron emission tomography (PET), and nuclear medicine (NM) scanning equipment or a combination thereof.
Medical Diagnostic Equipment (Diagnostic Equipment). Equipment used in, or in conjunction with, medical settings by health care providers for diagnostic purposes.
Operable Parts. Components of diagnostic equipment that are used by the patient to activate, deactivate, or adjust the equipment.
Side Transfer Surface. A transfer surface located within the length of the examination surface that allows patient transfer on two opposing sides of the examination surface.
Transfer Surface. Part of diagnostic equipment onto which patients who use mobility devices or aids transfer when moving onto and off of the equipment.
Wheelchair Space. Space for a single wheelchair and its occupant.
M102.2 Undefined Terms. Terms not defined in M102.1 or in regulations or policies issued by an enforcing authority shall be given their ordinarily accepted meaning in the sense that the context implies.
M102.3 Interchangeability. Words, terms, and phrases used in the singular include the plural and those used in the plural include the singular.
Chapter 2: Scoping M201 GeneralM201.1 Application by Enforcing Authority. The enforcing authority shall specify the number and type of diagnostic equipment that are required to comply with the MDE Standards.
M201.2 General Exception. Medical diagnostic equipment shall not be required to comply with one or more applicable requirements in the MDE Standards in the rare circumstances where compliance would alter diagnostically required structural or operational characteristics of the equipment and would prevent the use of the equipment for its intended diagnostic purpose. Diagnostic equipment subject to M201.2 shall comply to the maximum extent practicable.
Chapter 3: Technical Requirements M301 Diagnostic Equipment Used by Patients in Supine, Prone, or Side-Lying PositionM301.1 General. Diagnostic equipment that supports patients in a supine, prone, or side-lying position shall comply with M301.
Exception: Examination chairs complying with M302 that recline to facilitate diagnosis after patients transfer onto the chair shall not be required to comply with M301.
M301.2 Transfer Surface. A transfer surface shall be provided and shall comply with M301.2.
M301.2.1 Adjustability. Transfer surfaces shall be adjustable in height measured from the floor to the top of the uncompressed transfer surface and shall provide the following:
A. A low transfer position at a height of 17 inches (430 mm);
B. A high transfer position at 25 inches (635 mm); and
C. At least 4 additional transfer positions located between the low and high transfer positions and separated by 1 inch (25 mm) minimum.
M301.2.2 [Reserved]
M301.2.3 Size. The size of the transfer surface shall comply with M301.2.3.1 or M301.2.3.2. The size of transfer surfaces shall be measured from center points of their opposing sides.
M301.2.3.1 End Transfer Surface. End transfer surfaces shall be 28 inches (710 mm) wide minimum and 17 inches (430 mm) long minimum.
Exception: Transfer surfaces for imaging equipment with bores shall be permitted to be 21 inches (535 mm) wide minimum but shall not be permitted to be less than the full width of the examination surface provided for the patient.
M301.2.3.2 Side Transfer Surface. Side transfer surfaces shall be 28 inches (710 mm) wide minimum and 28 inches (710 mm) long minimum.
Exception: Transfer surfaces for imaging equipment with bores shall be permitted to be 21 inches (535 mm) wide minimum but shall not be permitted to be less than the full width of the examination surface provided for the patient.
M301.2.4 Unobstructed Transfer. Each transfer surface shall provide two unobstructed sides for patient transfer.
Exceptions: 1. Obstructions no more than 3 inches (75 mm) deep shall be permitted to extend beyond transfer sides of transfer surfaces provided that such obstructions do not protrude above the tops of transfer surfaces.
2. Temporary obstructions shall be permitted provided that they can be repositioned during transfer to comply with M301.2.4, including Exception 1.
M301.3 Supports. Transfer supports, leg supports, and reclining surfaces shall comply with M301.3.
M301.3.1 Transfer Supports. Transfer surfaces required by M301.2 shall provide transfer supports and shall comply with M305.2.
M301.3.2 Leg Supports. Where stirrups are provided, leg supports shall also be provided and shall comply with M305.4.
M301.3.3 Head and Back Support. Where the diagnostic equipment is used in a reclined position, head and back support shall be provided and shall comply with M305.5.
M301.4 Lift Compatibility. Diagnostic equipment shall be usable with portable patient lifts and, when in use with such lifts, shall comply with M301.4.1 or M301.4.2.
Exception: Where fixed overhead patient lifts are provided, and when their use with diagnostic equipment is permitted by an enforcing authority, diagnostic equipment shall not be required to meet the lift compatibility requirements of this section provided that such equipment is clearly labeled as not compatible with portable floor lifts.
M301.4.1 Clearance in Base. The base of diagnostic equipment shall provide a clearance 39 inches (990 mm) wide minimum, 6 inches (150 mm) high minimum measured from the floor, and 36 inches (915 mm) deep minimum measured from the edge of the examination surface. Where the width of examination surfaces is less than 36 inches (915 mm), the clearance depth shall extend the full width of the equipment. Components of diagnostic equipment are permitted to be located within 8 inches (205 mm) maximum of the centerline of the clearance width.
M301.4.2 Clearance Around Base. The base of diagnostic equipment shall provide a clearance 6 inches (150 mm) high minimum measured from the floor and 36 inches (915 mm) deep minimum measured from the edge of the examination surface. The width of the base permitted within this clearance shall be 26 inches (660 mm) wide maximum at the edge of the examination surface and shall be permitted to increase at a rate of 1 inch (25 mm) in width for each 3 inches (75 mm) in depth.
M302 Diagnostic Equipment Used by Patients in Seated PositionM302.1 General. Diagnostic equipment that supports patients in a seated position shall comply with M302.
Exception: Where weight scales contain wheelchair spaces complying with M303 and also provide a seat integral to the equipment, the scales shall not be required to comply with M302.
M302.2 Transfer Surface. A transfer surface shall be provided and shall comply with M302.2.
M302.2.1 Adjustability. Transfer surfaces shall be adjustable in height measured from the floor to the top of the uncompressed transfer surface and shall provide the following:
A. A low transfer position at a height of 17 inches (430 mm);
B. A high transfer position at 25 inches (635 mm); and
C. At least 4 additional transfer positions located between the low and high transfer positions and separated by 1 inch (25 mm) minimum.
M302.2.2 [Reserved]
M302.2.3 Size. Transfer surfaces shall be 21 inches (610 mm) wide minimum and 17 inches (430 mm) deep minimum. The size of transfer surfaces shall be measured from center points of their opposing sides.
M302.2.4 Transfer Sides. Options to transfer from a mobility device shall be provided on two adjoining sides of transfer surfaces.
Exception: Options to transfer to or from a mobility device onto opposing sides of transfer surfaces shall be permitted where the transfer surface is obstructed by fixed footrests.
M302.2.5 Unobstructed Transfer. Each transfer side complying with M302.2.4 shall provide unobstructed access to transfer surfaces.
Exceptions: 1. Obstructions no more than 3 inches (75 mm) deep shall be permitted to extend beyond transfer sides of transfer surfaces provided that such obstructions do not protrude above the tops of transfer surfaces.
2. Temporary obstructions shall be permitted provided that they can be repositioned during transfer to comply with M302.2.5, including Exception 1.
M302.3 Supports. Transfer supports, leg supports and reclining surfaces shall comply with M302.3.
M302.3.1 Transfer Supports. Transfer supports shall be provided for use with transfer sides required by M302.2.4 and shall comply with M305.2.1.1, M305.2.2.1, and M305.2.3 through M305.2.8.
M302.3.2 Leg Supports. Where stirrups are provided, leg supports shall also be provided and comply with M305.4.
M302.3.3 Head and Back Support. Where the diagnostic equipment is used in a reclined position, head and back support shall be provided and shall comply with M305.5.
M302.4 Lift Compatibility. Diagnostic equipment shall be usable with portable patient lifts and, when in use with such lifts, shall comply with M302.4.1 or M302.4.2.
Exception: Where fixed overhead patient lifts are provided, and when their use with diagnostic equipment is permitted by an enforcing authority, diagnostic equipment shall not be required to meet the lift compatibility requirements of this section provided that such equipment is clearly labeled as not compatible with portable floor lifts.
M302.4.1 Clearance in Base. The base of the diagnostic equipment shall provide a clearance 39 inches (990 mm) wide minimum, 6 inches (150 mm) high minimum measured from the floor, and 36 inches (915 mm) deep minimum measured from the edge of the examination surface. Where the width of the examination surface is less than 36 inches (915 mm), the clearance depth shall extend the full width of the equipment. Equipment components are permitted to be located within 8 inches (205 mm) maximum of the centerline of the clearance width.
M302.4.2 Clearance Around Base. The base of the diagnostic equipment shall provide a clearance 6 inches (150 mm) high minimum measured from the floor and 36 inches (915 mm) deep minimum measured from the edge of the examination surface. The width of the base permitted within this clearance shall be 26 inches (660 mm) wide maximum at the edge of the examination surface and shall be permitted to increase at a rate of 1 inch (25 mm) in width for each 3 inches (75 mm) in depth.
M303 Diagnostic Equipment Used by Patients Seated in a WheelchairM303.1 General. Diagnostic equipment used by patients seated in a wheelchair shall comply with M303.
M303.2 Wheelchair Spaces. Wheelchair spaces complying with M303.2 shall be provided at diagnostic equipment.
M303.2.1 Orientation. Wheelchair spaces shall be designed so that a patient seated in a wheelchair orients in the same direction that a patient not seated in a wheelchair orients when the diagnostic equipment is in use.
M303.2.2 Width. Wheelchair spaces shall be 36 inches (915 mm) wide minimum.
Exception: Wheelchair spaces located on raised platforms shall be permitted to be 32 inches (815 mm) wide minimum to a height of 4 inches (100 mm) measured from the platform surface.
M303.2.3 Depth. The depth of wheelchair spaces shall comply with M303.2.3.
M303.2.3.1 Front or Rear Entry. Where wheelchair space entry and exit is provided at only one end (front or rear) the wheelchair space shall be 48 inches (1220 mm) deep minimum.
M303.2.3.2 Pass Through Entry. Where wheelchair space entry and exit permits pass through from one end to the other, the wheelchair space shall be 40 inches deep (1015 mm) minimum.
M303.2.3.3 Side Entry. Where wheelchair space entry is only from the side, the wheelchair space shall be 60 inches (1525 mm) deep minimum.
M303.2.4 Equipment Clearances. Where wheelchair spaces are entered from the rear and includes space beneath components, wheelchair spaces shall include knee and toe clearances complying with M303.2.4.1 for breast platforms and M303.2.4.2 for all other equipment.
M303.2.4.1 Breast Platforms. Wheelchair spaces beneath breast platforms shall comply with M303.2.4.1.
M303.2.4.1.1 Depth. Wheelchair spaces shall include knee and toe clearance 25 inches (635 mm) deep minimum and 28 inches (710 mm) deep maximum.
M303.2.4.1.2 Height. Wheelchair spaces shall include toe clearance 9 inches (230 mm) high minimum above the floor measured to a depth of 6 inches (150 mm) maximum from the toe end of the wheelchair space. Knee clearance shall be provided at a depth of 19 inches (485 mm) minimum and 22 inches (560 mm) maximum at 9 inches (230 mm) above the floor and at a depth of 16 inches (405 mm) minimum at 27 inches (685 mm) above the floor measured from the leading edge of the breast platform. Between 9 inches (230 mm) and 27 inches (685 mm) above the floor, the knee clearance shall be permitted to reduce at a rate of 1 inch (25 mm) in depth for every 6 inches (150 mm) in height.
Exception: Components shall be permitted to extend into the wheelchair space at a height of 1 1/2 inches (38 mm) maximum between 17 inches (430 mm) minimum and 25 inches (635 mm) maximum in depth measured from the leading edge of the breast platform. From 25 inches (635 mm) to 28 inches (710 mm) in depth the height of a component above 1 1/2 inches (38 mm) shall be beveled at a rate of 2.5:3 maximum.
M303.2.4.2 Other Equipment. Wheelchair spaces beneath diagnostic equipment other than breast platforms shall comply with M303.2.4.2.
M303.2.4.2.1 Depth. Wheelchair spaces shall include knee and toe clearance 17 inches (430 mm) deep minimum and 25 inches (635 mm) deep maximum.
M303.2.4.2.2 Height. Wheelchair spaces shall include toe clearance 9 inches (230 mm) high minimum above the floor measured to a depth of 6 inches (150 mm) maximum measured from the toe end of the wheelchair space. Knee clearance shall be provided at a depth of 11 inches (280 mm) minimum and 25 inches (635 mm) maximum at 9 inches (230 mm) above the floor and at a depth of 8 inches (205 mm) minimum at 27 inches (685 mm) above the floor measured from the leading edge of the equipment. Between 9 inches (230 mm) and 27 inches (685 mm) above the floor, the knee clearance shall be permitted to reduce at a rate of 1 inch (25 mm) in depth for every 6 inches (150 mm) in height.
M303.2.5 Surfaces. Wheelchair space surfaces shall not slope more than 1:48 in any direction.
M303.2.6 Edge Protection. Where wheelchair spaces are provided on a platform raised more than 1 1/2 inches (38 mm) in height, edge protection 2 inches (51 mm) high minimum measured from the surface of the platform shall be provided on each side not providing entry to or exit from the equipment.
M303.3 Entry. Where there is a change in level at the entry to wheelchair spaces, the change in level shall comply with M303.3.
M303.3.1 Vertical. Changes in level of 1/4 inch (6.4 mm) high maximum shall be permitted to be vertical.
M303.3.2 Beveled. Changes in level between 1/4 inch (6.4 mm) high and 1/2 inch (13 mm) high maximum shall be beveled with a slope not steeper than 1:2.
M303.3.3 Ramped. Changes in level greater than 1/2 inch (13 mm) high shall be ramped and shall comply with M303.3.3.
M303.3.3.1 Running Slope. Ramp runs shall have a running slope not steeper than 1:12.
Exception: A running slope not steeper than 1:8 shall be permitted for ramp runs with a maximum height of 2 1/2 inches (64 mm).
M303.3.3.2 Cross Slope. The cross slope of ramp runs shall not be steeper than 1:48.
M303.3.3.3 Clear Width. The clear width of ramp runs shall be 36 inches (915 mm) minimum.
M303.3.3.4 Edge Protection. Ramps with drop offs 1/2 inch (13 mm) or greater shall provide edge protection 2 inches (50 mm) high minimum on each side with a drop off.
M303.3.3.5 Handrails. Ramps with a rise greater than 6 inches (150 mm) shall provide handrails on both sides.
M303.4 Components. Where components of diagnostic equipment are used to examine specific body parts, the components shall be capable of examining the body parts of a patient seated in a wheelchair. Breast platforms shall comply with M303.4.1.
M303.4.1 Breast Platform Adjustability. Breast platforms shall be continuously adjustable from a low height of 26 inches (660 mm) to a high height of 42 inches (1065 mm) above the floor.
M304 Diagnostic Equipment Used by Patients in Standing PositionM304.1 General. Diagnostic equipment used by patients in a standing position shall comply with M304.
M304.2 Standing Surface. Equipment surfaces on which patients stand must comply with M304.2
M304.2.1 Slip Resistant. The surface on which the patient stands shall be slip resistant.
M304.2.2 Standing Supports. Standing supports shall be provided on two sides of the standing surface and shall comply with M305.3.
Exception: Diagnostic equipment with entry and exit permitting pass-through from one end to the other shall be permitted to provide one standing support on one side of the standing surface provided that the standing support complies with the requirements for standing supports in a horizontal position in M305.3.
M305 SupportsM305.1 General. Supports shall comply with M305.
M305.2 Transfer Supports. Transfer supports shall comply with M305.2.
M305.2.1 Location. Transfer supports shall comply with M305.2.1.1 or M305.2.1.2 and shall be located 1 1/2 inches (38 mm) maximum measured horizontally from the plane defined by the nearest edge of the transfer surface.
Exception: Where the support folds, collapses, or articulates, the transfer support shall be permitted to be located 3 inches (75 mm) maximum from the plane defined by the nearest edge of the transfer surface.
M305.2.1.1 End Transfer Supports. Transfer supports for transfer surfaces complying with M301.2.3.1 and M302.2 shall be located on the short side (length) opposite the transfer side.
M305.2.1.2 Side Transfer Supports. Transfer supports for transfer surfaces complying with M301.2.3.2 shall be capable of supporting transfer on each side of the transfer surface.
M305.2.2 Length. The length of transfer supports shall comply with M305.2.2.1 or M305.2.2.2.
M305.2.2.1 End Transfer Supports. Transfer supports for transfer surfaces complying with M301.2.3.1 and M305.2.2.1 shall be 15 inches (380 mm) long minimum. Transfer supports shall be positioned along 13 1/2 inches (345 mm) minimum of the depth of the transfer surface.
M305.2.2.2 Side Transfer Supports. Transfer supports for transfer surfaces complying with M301.2.3.2 shall be 28 inches (710 mm) long minimum and shall be positioned along the width of transfer surfaces.
Exceptions: 1. Where transfer surfaces are part of an articulating surface, the support shall be permitted to be 15 inches (380 mm) long minimum.
2. Where the width of an imaging bed is more than 24 inches (533 mm), transfer supports shall be permitted to be 12 inches (305 mm) long minimum.
M305.2.3 Height. During use, the tops of transfer support gripping surfaces shall be 6 inches (150 mm) minimum and 19 inches (485 mm) maximum higher than the top of the associated uncompressed transfer surface.
Exception: Where the width of the transfer surface for imaging beds exceed 24 inches (610 mm), the tops of the gripping surfaces shall be permitted to be 3 inches (75 mm) minimum and 6 inches (150 mm) maximum higher than the top of the associated uncompressed transfer surface.
M305.2.4 Cross Section. Transfer supports shall have a cross section complying with 305.2.4.1 or 305.2.4.2.
M305.2.4.1 Circular Cross Section. Transfer supports with circular cross sections shall have an outside diameter of 1 1/4 inches (32 mm) minimum and 2 inches (51 mm) maximum.
M305.2.4.2 Non-Circular Cross Section. Transfer supports with non-circular cross sections shall have a cross-section dimension of 2 inches (51 mm) maximum and a perimeter dimension of 4 inches (100 mm) minimum and 4.8 inches (120 mm) maximum.
M305.2.5 Surface Hazards. Transfer supports and surfaces adjacent to transfer supports shall be free of sharp or abrasive components and shall have eased edges.
M305.2.6 Gripping Surface. Transfer support gripping surfaces shall be continuous along their length and shall not be obstructed along their tops or sides. The bottoms of transfer support gripping surfaces shall not be obstructed for more than 20 percent of their length.
M305.2.7 Clearance. Clearance between the transfer support gripping surface and adjacent surfaces or obstructions shall be 1 1/2 inches (38 mm) minimum.
M305.2.8 Fittings. Transfer supports shall not rotate within their fittings when in place for transfer.
M305.3 Standing Supports. Standing supports shall provide continuous support throughout use of the diagnostic equipment and shall comply with M305.3.
M305.3.1 Length. The length of gripping surfaces for standing supports shall be based on the position of the standing supports in relation to the standing surfaces they serve. Horizontal standing support gripping surfaces shall comply with M305.3.1.1, horizontal standing support gripping surfaces on diagnostic equipment containing a wheelchair space shall comply with M305.3.1.2 and, vertical standing support gripping surfaces shall comply with M305.3.1.3.
M305.3.1.1 Horizontal Position. The length of gripping surfaces on horizontal standing supports shall be 4 inches (100 mm) minimum except for diagnostic equipment containing a wheelchair space which shall comply with M305.3.1.2.
M305.3.1.2 Diagnostic Equipment Containing a Wheelchair Space. On diagnostic equipment containing wheelchair spaces with one entry that also serves as the exit, the length of the gripping surface of horizontal standing supports shall be equal to or greater than 80 percent of the overall length of the platform. On diagnostic equipment containing a wheelchair space and permitting pass-through from one end to the other, the length of the gripping surface on horizontal standing supports shall be at least equal to the length of the platform.
M305.3.1.3 Vertical Position. The length of the gripping surface on vertical standing supports shall be 18 inches (455 mm) minimum.
M305.3.2 Height. The height of gripping surfaces for standing supports shall be based on the position of the standing supports in relation to the standing surfaces they serve. Horizontal standing support gripping surfaces shall comply with M305.3.2.1 and vertical standing support gripping surfaces shall comply with M305.3.2.2.
M305.3.2.1 Horizontal Position. The height of the top of the gripping surface on horizontal standing supports shall be 34 inches (865 mm) minimum and 38 inches (965 mm) maximum above the standing surface.
M305.3.2.2 Vertical Position. The height of the lowest end of the gripping surface on vertical standing supports shall be 34 inches (865 mm) minimum and 37 inches (940 mm) maximum above the standing surface.
M305.3.3 Fittings. Standing supports shall not rotate within their fittings.
M305.4 Leg Supports. Leg supports shall provide a method of supporting, positioning, and securing the patient's legs.
M305.5 Head and Back Support. Where the diagnostic equipment is used in a reclined position, head and back support shall be provided. Where the incline of the back support can be modified while in use, head and back support shall be provided throughout the entire range of the incline.
M306 CommunicationM306.1 General. Where instructions or other information necessary for performance of the diagnostic procedure is communicated to the patient through the diagnostic equipment, the instructions and other information shall be provided in at least two of the following methods: Audible, visible, or tactile.
M307 Operable PartsM307.1 General. Operable parts for patient use shall comply with M307.
M307.2 Tactilely Discernible. Operable parts shall be tactilely discernible without activation.
M307.3 Operation. Operable parts shall be operable with one hand and shall not require tight grasping, pinching, or twisting of the wrist.
M307.4 Operating Force. The force required to activate operable parts shall be 5 pounds (22.2 N) maximum.