Invacare 1171780 Guía De Notificación página 4

1 BED RAIL ENTRAPMENT RISK NOTIFICATION
• Bed rails are intended to prevent an individual from inadvertently rolling out of bed, provide assistance to a patient when repositioning and to provide
a sense of security. NEVER use bed rails for restraint purposes where "restraint" means preventing or hindering the patient within the bed from
exiting the bed as they wish. Use of rails as a means of restraint significantly increases a patient's risk of entrapment.
• Bed rails are intended to be used as a pair in a bed system. When in use, both side rails must be in the up position, except when the patient is
entering or exiting the bed. Use with one side rail up and one side rail down could create an increased risk of entrapment.
• Bed rails and/or their mountings should not be used if they are bent or otherwise deformed. Bent or deformed bed rails and/or bed rail mountings
increase gaps and increase the risk of entrapment. DO NOT place pressure upon bed rails while moving the bed. Although bed rails are not rated
to any specific patient weight limitation, the bed rails or their mountings may become deformed or broken if excessive side pressure is exerted on
the bed rails.
• Mattress overlays or active therapeutic support surfaces (TSS), which support the patient on an air mattress or specialized foam layer, may present
an increased risk of entrapment for some patients. The benefit of TSS product use must be weighed against the potential increased risk of
entrapment. This risk judgment must be performed by a medical professional.
• Invacare homecare beds are specifically designed and manufactured for use in conjunction with Invacare accessories, including bed rails. Accessories
designed by other manufacturers may include variations in bed rail dimensions, mattress thickness, mattress size or density or other factors that
have not been tested by Invacare. Use of other manufacturer's products in conjunction with an Invacare homecare bed, may significantly increase
the risk of entrapment; as such Invacare does not recommend their use.
The U.S. Food and Drug Administration in partnership with the U.S. Department of Veterans Affairs, Health Canada's Medical Devices Bureau and
representatives from national health care organizations and provider groups, patient advocacy groups, and medical bed and equipment manufacturers
including the Hospital Bed Safety Workgroup, a collection of experts from the United States FDA, health care professionals and manufacturers of
hospital beds, published guidelines regarding body part dimensions as they relate to a bed system's safety. These guidelines, "Hospital Bed System
Dimensional and Assessment Guidance to Reduce Entrapment" contain additional information on the risk of entrapment.
Visit the FDA website at http://www.fda.gov and search for "bed rail entrapment" to learn about the risks of entrapment or to view the FDA guidelines
document.
The above statements are not intended to be a complete or comprehensive list of all risks of entrapment. Invacare recommends that whenever bed
products are used that the patient, the patient's family and/or the patient's primary day-to-day caregiver discuss entrapment risks with the patient's
medical care provider.
Bed Rail Entrapment Risk Notification Guide
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Part No 1171780