Product Manual

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WARNING
No modification of this equipment is allowed.
Only items that have been specified as part of this bed or that have been specified as being
compatible with this bed shall be connected to it.
ENTRAPMENT WARNING
Accurate assessment of the resident and monitoring of correct maintenance and equipment
use are required to prevent entrapment. For additional information on product and safety issues
for bed frames and rails refer to product manuals specific to the product or accessories you
have or are planning to install. If bed frames have been serviced or any other adjustments have
been made, you must ensure all parts are securely back in place before operating the bed.
Other manufacturers assist bars or side rails may not be compatible and can lead to entrapment
issues or harm to residents and staff. Make sure mattress is the correct size for bed frame and the
assist bars are secured to frame to decrease the risk of entrapment.
On March 10, 2006, the U.S. Food and Drug Administration (FDA) released guidelines for reducing
the risk of hospital bed entrapment entitled; “Hospital bed System Dimensional and Assessment
Guidance to Reduce Entrapment”. This guidance document identifies potential entrapment
areas within the bed frame, rails and mattress and identifies those body parts most at risk for
entrapment. It also provides manufacturers with basic design criteria to consider when
developing hospital/convalescent beds; recommends specific test methods to assess the
conformance of existing hospital/convalescent bed systems; and answers frequently-
asked questions about entrapment issues.
The FDA Guidance document identifies specific dimensional criteria on potentially injury-
threatening gaps and spaces that can occur between bed system components, such as side
rails when improperly installed. Drive Medical’s Long Term Care beds and approved
accessories are manufactured to be in conformance with these guidelines.
Please be aware that entrapment issues can still arise when components and accessories are
not properly installed on the bed. It is important for the provider or facility staff to recognize they
have an equal role in complying with the FDA guidelines to help ensure resident safety and
avoid injuries.
Copies of this document can be obtained from the FDA website:
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm
072662.htm