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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 individual. Bed frame side rail usage is not a
requirement for the functional operation of any ROHO product; however, the use of side rails
may be clinically indicated for certain individuals. The decision whether to use side rails
should be based upon applicable laws, regulations, the individual’s condition and needs, and
a case-by-case assessment by clinicians and / or healthcare providers actively involved in
the individual’s care. Such an assessment may include, but not be limited to: the individual’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 risks associated with
the individual becoming entrapped in the side rails are identified and steps are taken to
minimize such risks.
• In the event a decision is made not to use side rails, ensure that any risks associated
with the individual 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.
• Skin/soft tissue breakdown can occur due to a number of factors, which vary by
individual. Check skin daily.
Redness, bruising, or darker areas (when compared to normal
skin) may indicate the beginning of soft tissue breakdown and needs to be addressed.
STOP
USE
if any discoloration does
NOT
disappear within 30 minutes after transferring from the
product. Consult a healthcare professional immediately.
• Check inflation and adjustment frequently, at least once a day!
• Ensure that product sections are snapped together before and during use.
• Weight Limit:
The mattress overlay should be correctly sized to the individual and the bed
mattress. If it is
NOT
, the product’s benefits may be reduced or eliminated, increasing risk
to skin and other soft tissue.
• DO NOT use ROHO
®
Mattress Overlay Enclosure Cover (Overlay Enclosure Cover) handles
to lift or slide the individual, as it may result in injury.
• While properly adjusted mattress overlays will protect the individual from tissue trauma,
they do not eliminate the need for periodic individual turning.
• It is important that the product be set up by knowledgeable caregivers who are properly
trained in the use of this product.
WARNINGS