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This is the Preamble to the Proposed MDE Standards NPRM (2012). Click here to view the Preamble to the Final MDE Standards (2017).

Lift Compatibility (M301.4 and M302.4)

M301.4 and M302.4 would require diagnostic equipment used by patients in a supine, prone, or sidelying position, and diagnostic equipment used by patients in a seated position to be usable with a patient lift for patients with disabilities for whom independent transfer may not be possible. A patient lift may be the only means of providing access to certain equipment that cannot meet the technical criteria for transfer surface height (see M301.2.1 and M302.2.1) because of the structural or operational characteristics of the equipment. For example, full body bone densitometers usually have components that move beneath the length of the patient support surface and may prevent the equipment from meeting the technical criteria for transfer surface height. Requiring the equipment to be usable with a patient lift is critical for ensuring the safety of both patients with disabilities and health care personnel assisting with transfers.

ANSI/AAMI HE 75 recommends that the “base of the device needs to have space underneath or along both sides (if the equipment is narrow) to accommodate the legs of portable mechanical lift equipment so that the patient can be suspended over the support surface before being lowered onto it.” See ANSI/AAMI HE 75, section 16.4.3. Portable floor lifts have legs with wheels that need to fit under or around the base of the diagnostic equipment. Lifts can vary in width along their length, and are usually the widest at the front casters and narrower at the patient sling location. Manufacturers of portable floor lifts usually recommend that the lifts be used with the legs extended in the widest position to maintain stability when lifting and lowering patients.

As discussed below, the technical criteria provide two options for accommodating portable floor lifts consistent with ANSI/AAMI HE75: clearance in the base or clearance around the base. The clearances would be required at the side of the equipment where the portable floor lift is deployed so that the boom of the lift can maneuver far enough over the equipment and safely lower and raise the patient onto and off of the examination surface. The clearances do not restrict the overall size of the equipment base.

Clearance in Base (M301.4.1 and M302.4.1)

Clearance in the base of the equipment allows the legs of a portable floor lift to fit under the base of the equipment. The clearance can be an open area between the supporting posts beneath the equipment, or the equipment can be configured with a wide slot that is recessed into the base enclosure. M301.4.1 and M302.4.1 would require the clearance in the base to be 44 inches wide minimum, 6 inches high minimum measured from the floor, and 36 inches deep minimum measured from the edge of the examination surface. Where the width of the examination surface is less than 36 inches, the clearance depth would be required to extend the full width of the equipment. Equipment components are permitted to be located within 8 inches maximum of the centerline of the clearance width.

Question 25. Comments are requested on the following questions regarding the proposed dimensions for clearance in the base of the equipment to allow the use of portable floor lifts:

a) Are the proposed dimensions for clearance in the base sufficient to accommodate the various portable floor lifts used in health care facilities?

b) Do the proposed dimensions exclude certain types of lifts?

c) Should the clearance in the base be configured differently to allow additional flexibility for the use of portable floor lifts and, if so, how should it be configured?

Clearance Around Base (M301.4.2 and M302.4.2)

Clearance around the base of the equipment allows the legs of a portable floor lift to straddle the base. This option accommodates equipment with solid base enclosures that sit on or close to a floor. M301.4.2 and M302.4.2 would require the base of the equipment to provide a clearance 6 inches high minimum measured from the floor and 36 inches deep minimum measured from the edge of the examination surface. The width of the base permitted within this clearance would be 26 inches wide maximum at the edge of the examination surface and is permitted to increase at a rate of 1 inch in width for each 3 inches in depth. The permitted rate of increase in width can be distributed to each side of the base.

Question 26. Comments are requested on the following questions regarding the proposed dimensions for clearance around the base of the equipment to allow the use of portable floor lifts:

a) Are the proposed dimensions sufficient to accommodate the various portable floor lifts used in health care facilities?

b) Do the proposed dimensions exclude certain types of lifts?

c) Should the clearance around the base be configured differently to allow additional flexibility for the use of portable floor lifts and, if so, how should it be configured?

Overhead Lifts

The technical criteria do not address overhead lifts that are usually mounted on the ceiling and operate on tracks suspended over the diagnostic equipment because the configuration of the equipment does not affect the operation of overhead lifts. Overhead lifts and portable floor lifts are used in health care facilities, and the technical criteria should not be viewed as preferring portable floor lifts. Overhead lifts may be the only option for certain diagnostic equipment because the structural or operational characteristics of the equipment prevent sufficient clearance in or around the base of the equipment for a portable floor lift.

Question 27. If diagnostic equipment is designed for use with overhead lifts, should the equipment be exempted from providing clearance in or around the base for portable floor lifts?

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