INVACARE 5411IVC Full Electric Bed User Guide

: June 8, 2024
: INVACARE

Table of Contents

INVACARE 5411IVC Full Electric Bed
NOTICE TO EQUIPMENT PROVIDER
Bed Rail Entrapment Risk Notification
Appendix
Contact Information
References
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INVACARE 5411IVC Full Electric Bed

INVACARE-5411IVC-Full-Electric-Bed-product

NOTICE TO EQUIPMENT PROVIDER

These instructions, in their entirety, must be provided to the user, the user’s family and/or the user’s primary day-to-day caregiver at the time of installation of the equipment. Failure to do so may expose the user to risk of injury or death as the result of Bed Rail Entrapment.

Bed Rail Entrapment Risk Notification

NOTICE TO USER, USER’S FAMILY AND/OR PRIMARY DAY-TO-DAY CAREGIVER
DO NOT use this product without first completely reading and understanding this Bed Rail Entrapment Risk Notification Guide and any additional instructional material such as owner’s manuals, instruction sheets and on- product warnings supplied with this product. If you are unable to fully understand this Bed Rail Entrapment Risk Notification Guide, the on-product warnings or any additional instructional material, contact the user’s health care provider and/or your equipment provider before using this equipment. Failure to understand and comply with the information contained in this Bed Rail Entrapment Risk Notification Guide can result in serious injury or death.

BED RAIL ENTRAPMENT
The term “Bed Rail Entrapment” describes an event in which a user using the bed is caught, trapped, or entangled in the space in or about the bed rail, mattress, or bed frame. Bed Rail Entrapment may result in serious injuries or death by the user becoming entrapped as shown below: Entrapment within the bed rail

Entrapment under the bed rail
Entrapment between the rail and mattress
Entrapment under the bed rail and the ends of the bed rail
Entrapment between split bed rails
Entrapment between the end of the rail and the side edge of the head board or foot board
Entrapment between the head or foot board and the end of the mattress

Bed Rail Entrapment is a known risk in the use of beds equipped with bed rails.
Every user is unique. Only the user’s medical care provider is familiar with the user’s unique medical condition and needs. Only the user’s medical care provider and/or the dealer from whom you obtained this equipment, upon proper assessment of the user’s medical condition and needs, can evaluate whether this equipment is appropriate for use by any particular user and assist the user, the user’s family and/or the user’s primary day-to-day caregiver in assessing the Risk of Entrapment.
Proper user assessment, equipment selection, frequent user monitoring, and compliance with instructions, warnings and this Bed Rail Entrapment Risk Notification Guide is essential to reduce the risk of entrapment.
Accessories have been developed in the industry to reduce the openings in existing bed systems that could cause entrapment. Any modification through the use of accessories must be used in conjunction with proper user assessment prior to intervention. For a full discussion on this topic, visit the FDA website at http://www.fda.gov to learn about the risks of entrapment, including “A Guide to Bed Safety”. Use the links located under each bed rail product at www.invacare.com to access the Bed Rail Entrapment Risk Notification Guide and other product safety information and instructions. Conditions such as restlessness, mental deterioration and dementia or seizure disorders (uncontrolled body movement), sleeping problems, and incontinence can significantly impact a user’s risk of entrapment. Pediatric users or users with small body size may also have an increased risk of entrapment.

Bed rails are intended to prevent an individual from inadvertently rolling out of bed, provide assistance to a user when repositioning and to provide a sense of security. NEVER use bed rails for restraint purposes where “restraint” means preventing or hindering the user within the bed from exiting the bed as they wish. Use of rails as a means of restraint significantly increases a user’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 user 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 user 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 user on an air mattress or specialized foam layer, may present an increased risk of entrapment for some users. 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 representatives from national health care organizations and provider groups, consumer advocacy groups, and medical bed and equipment manufacturers, published guidelines regarding body part dimensions as they relate to a bed system’s safety. These guidelines, “Bed System Dimensional and Assessment Guidance to Reduce Entrapment” contain additional information on the risk of entrapment and can be found at www.fda.gov along with other bed rail entrapment safety information. 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 user, the user’s family and/or the user’s primary day-to-day caregiver discuss entrapment risks with the user’s medical care provider.

Appendix

The following guidelines are based on FDA’s bed safety guidelines published by Hospital Bed Safety Workgroup, which is available at http://www.fda.gov.
A Guide to Bed Safety Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts DO NOT use this product without first completely reading and understanding this Bed Rail Entrapment Risk Notification Guide and any additional instructional material such as owner’s manuals, instruction sheets and on-product warnings supplied with this product. If you are unable to fully understand this Bed Rail Entrapment Risk Notification Guide, the on-product warnings or any additional instructional material, contact the user’s health care provider and/or your equipment provider before using this equipment. Failure to understand and comply with the information contained in this Bed Rail Entrapment Risk Notification Guide can result in serious injury or death.

Consumer or User Safety
Users who have problems with memory, sleeping, incontinence, pain, uncontrolled body movement, or who get out of bed and walk unsafely without assistance, MUST be carefully assessed for the best ways to keep them from harm, such as falling. Assessment by the user’s health care team will help to determine how best to keep the user safe. In recent years, the health care community has recognized that physically restraining users can be dangerous. Although not indicated for this use, bed rails are sometimes used as restraints**. Regulatory agencies, health care organizations, product manufacturers and advocacy groups encourage hospitals, nursing homes and homecare providers to assess users’ needs and to provide safe care without restraints. Invacare bed rails MUST NEVER be used as a means of restraints.

The Benefits and Risks of Bed Rails
Potential benefits of bed rails include:

Aiding in turning and repositioning within the bed.
Providing a hand-hold for getting into or out of bed.
Providing a feeling of comfort and security.
Reducing the risk of users falling out of bed when being transported.
Providing easy access to bed controls and personal care items.

Potential risks of bed rails may include:

Strangling, suffocating, bodily injury or death when users or part of their body are caught between rails or between the bed rails and mattress.
More serious injuries from falls when users climb over rails.
Skin bruising, cuts, and scrapes.
Inducing agitated behavior when bed rails are used as a restraint.
Feeling isolated or unnecessarily restricted.
Preventing users, who are able to get out of bed, from performing routine activities such as going to the bathroom or retrieving something from a closet.

Meeting Users’ Needs for Safety
Most users can be in bed safely without bed rails. Consider the following:

Use beds that can be raised and lowered close to the floor to accommodate both user and health care worker needs.
Keep the bed in the lowest position with wheels locked.
When the user is at risk of falling out of bed, place mats next to the bed, as long as this does not create a greater risk of accident.
Use transfer or mobility aids.
Monitor users frequently.
Anticipate the reasons users get out of bed such as hunger, thirst, going to the bathroom, restlessness and pain; meet these needs by offering food and fluids, scheduling ample toileting, and providing calming interventions and pain relief.

When bed rails are used, perform an on-going assessment of the user’s physical and mental status; closely monitor high-risk users. Consider the following:

Lower one or more sections of the bed rail, such as the foot rail.
Use a proper size mattress or mattress with raised foam edges to prevent users from being trapped between the mattress and rail.
Reduce the gaps between the mattress and side rails.

Which Ways of Reducing Risks are Best?
A process that requires ongoing user evaluation and monitoring will result in optimizing bed safety. Many users go through a period of adjustment to become comfortable with new options. Users and their families should talk to their health care planning team to find out which options are best for them.

User or Family Concerns About Bed Rail Use
If users or family ask about using bed rails, health care providers should:

Encourage users or family to talk to their health care planning team to determine whether or not bed rails are indicated.
Reassure users and their families that in many cases the user can sleep safely without bed rails.
Reassess the need for using bed rails on a frequent, regular basis.