ROHO SOFFLE 2 mattress replacement system - Manual (Page 4)

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WARNINGS
Mattress - 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 the intended use of the product, facility protocol, 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. Knowledgeable and properly
trained caregivers should assess the individual to determine the risk of entrapment and
whether side rails should be used.
• In the event that 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 that 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.
Suffocation Risk: Clinicians and/or caregivers must assess the individual’s risk of
suffocation and make decisions according to facility protocol and the intended use of the
product. The ROHO ® SOFFLEX ® 2 Mattress Replacement System (SOFFLEX 2 Mattress)
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. If any discoloration does NOT disappear within 30 minutes of discovery,
consult a healthcare professional immediately.
• Check inflation and adjustment frequently, at least once a day! If the individual is not
properly immersed, it may reduce the benefit desired and increase the risk of tissue
trauma. If product does not appear to be holding air, see TROUBLESHOOTING.
• Check the SOFFLEX 2 Mattress Replacement Cover routinely for any visible signs of cuts,
tears, cracks, pinholes, snags, or stains, as damaged or worn covers may allow blood and
other body fluids to penetrate the mattress, posing a risk of infection. See WARNINGS
under CLEANING AND DISINFECTION.
• The SOFFLEX 2 Mattress should NOT be used by an individual who exceeds the surface
area or weight limit of the product.
• The SOFFLEX 2 Mattress should be correctly sized to the bed. Additional care should
be taken to ensure a tight fit of the mattress to the bed system. If the product is NOT
properly sized to the bed system, entrapment may occur.
• While properly adjusted mattress replacement systems may 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.
• DO NOT use the cover handles to lift or slide the individual, as it may result in injury.
• DO NOT use the product as a transfer surface. DO NOT reposition the product while it is in
use. Grasp mattress sections by the base or the outside edges.
• Placing too many linens or other materials between the product and the individual will
reduce the product’s effectiveness. See LINENS.