ROHO SOFFLE 2 mattress overlay system operation manual - Manual (Page 4)

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• MATTRESS OVERLAY ENTRAPMENT AND FALL RISKS: Medical experts
and governmental entities in various countries have determined that the use
of side rails on beds may present a life threatening entrapment danger to the
end-user. Bed frame side rail usage is not a requirement for the functional
operation of any ROHO product, however, use of side rails may be clinically
indicated for certain end-users. The decision whether to use side rails
should be based upon applicable laws, regulations, the end-user's individual
condition and needs, and on a case-by-case assessment by clinicians and
/ or healthcare providers actively involved in the end-user's care. Such an
assessment may include, but not be limited to: the end-user's physique,
overall condition, level of confusion or cognitive impairment (with or without
medication), mobility (or lack thereof), history of falls, combativeness,
attempts to get out of bed, uncontrolled body movement, and frustration when
confined.
Knowledgeable and properly trained caregivers should:
• In the event a decision is made to use side rails, ensure that any identified
risks associated with the end-user becoming entrapped in the side rails are
identified and steps are taken to minimize such risks.
• In the event a decision is made to not use side rails, ensure that any identified
risks associated with the end-user falling out of bed are identified and steps
are taken to minimize such risks.
• Determine whether to use pads, bolsters, alarms, high-low beds, or other
positioning aids and safety devices that are available on the market to reduce
the risk of entrapment or falls.
• SUFFOCATION RISK: The ROHO SOFFLEX 2 Mattress Overlay (SOFFLEX 2)
and ROHO PRODIGY Mattress Overlay (PRODIGY) should not be used by infants
or other individuals who are at risk of suffocation.
• DO NOT use ROHO® Mattress Overlay Enclosure Cover (Overlay Enclosure
Cover) handles to lift or slide the end-user, as it may result in injury.
WARNINGS