11
1-800-634-7328 DirectSupply.com
• Supervision is required when this product is operated by or near children or people with disabilities.
• Do not let any limbs or body parts protrude over the side or between bed components, especially
when the bed is being moved or operated.
• Caster locks shall be used, except when bed is being moved. Bed is not intended for patient/
resident transport.
• Bed should be at lowest suitable height for entry and exit.
• Assembly of this bed and modifications made during the actual service life require evaluation
to comply with the requirements of IEC 60601-1 and IEC 60601-2-52. No modification of this
equipment is allowed.
• Only items that have been specified as part of this bed or as being compatible with this bed shall be
connected to it.
• This bed frame complies with EMC requirements of IEC 60601-1-2. Radio transmitting equipment, cell
phones or similar electronic devices used in proximity of the bed may affect the beds performance.
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 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 assist rails are secured to frame to decrease 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, titled, “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 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 assist devices when
improperly installed. Panacea’s Long Term Care beds and approved accessories are manufactured to be
in conformance with these guidelines.
Please be aware 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/ucm072662.htm
Assist Rail Warning
Other manufacturers’ assist rails may not be compatible and can lead to entrapment issues or harm to
patients/residents. Only compatible assist rails may be used on this bed. Ensure mattress is the correct
size for bed frame and assist rails are secured to frame to decrease risk of entrapment.
