Intended Use Statement; Important Safety Information - Permobil ROHO Hybrid Select Operation Manual

Intended Use Statement

The ROHO Hybrid Select Cushion (Hybrid Select) is an adjustable, air-filled, wheelchair support surface combining a ROHO DRY FLOATATION
cellular design cushion insert with a contoured foam base, and is intended to conform to an individual's seated shape in the pelvic loading area
to provide skin/soft tissue protection, positioning, and an environment to facilitate wound healing. Optionally, through removal of the IT Air Pad
insert, the Hybrid Select is also intended for offloading of the ITs. There is a weight limit of 500 lbs. (227 kg), and the cushion must be properly
sized to the individual. The Hybrid Select must be used with the supplied cover.
Contraindication: Based on clinical, scientific or engineering evidence, the Hybrid Select may not be suitable for individuals who require
accommodation of pelvic asymmetry greater than 1 in. / 2.5 cm.
Compatibility: The Hybrid Select is
NOT COMPATIBLE with the following:
A clinician who is experienced in seating and positioning should determine whether the product is appropriate for the individual's particular
seating needs. The product's intended use statement alone should not be relied upon to make that determination.
The medical products featured in this document are intended to be only one part of an overall care regimen that includes all seating and mobility
equipment and therapeutic interventions. A clinician who is experienced in seating and positioning should identify this care regimen after
evaluating the individual's physical needs and overall medical condition.
A clinician should also evaluate for visual, reading, and cognitive impairment to determine the need for caregiver assistance or the need for
other assistive technology, such as large-print instructions, to ensure proper product use.

Important Safety Information

Warnings:
- Skin/soft tissue breakdown can occur due to a number of factors,
which vary by individual. Check skin frequently, at least once
a day. Redness, bruising, or darker areas (when compared to
normal skin) may indicate superficial or deep tissue injury and
should be addressed. If there is any discoloration to skin/soft
tissue, STOP USE immediately. If the discoloration does not
disappear within 30 minutes after disuse, immediately consult a
healthcare professional.
- Check inflation frequently, at least once a day.
- DO NOT use a product that is underinflated or overinflated,
because 1) the product benefits will be reduced or eliminated,
resulting in an increased risk to skin and other soft tissue, and
2) the individual may become unstable and vulnerable to falling.
Carefully follow all "Setup" instructions. If the product does
not appear to be holding air, or if you are not able to inflate or
deflate the product, see "Troubleshooting". Immediately contact
the equipment provider, distributor, or Customer Support if the
problem persists.
- DO NOT use the components of this product separately.
Assemble and use this product only as instructed in this manual.
- The cushions, foam and cover MUST be compatible sizes and
MUST be used as directed in this manual. IF THEY ARE NOT:
1) The benefits provided by the product may be reduced or
eliminated, increasing the risk to skin or to other soft tissue, and
2) the individual may become unstable and vulnerable to falling.
ROHO Hybrid SELECT Operation Manual
- the ROHO Contour Base.
- the standing function available on some power wheelchairs.
- 10 degrees or more of anterior tilt available on power wheelchairs.
- more than 110 degrees of backrest recline on power wheelchairs or manual wheelchairs.
Warnings:
- DO NOT use the cushion on top of, or in conjunction with, any other
products or materials, except as indicated in this manual. Using
non-compatible products or materials, whether inside or outside
the cover: 1) may reduce or eliminate the benefits of the cushion,
increasing the risk to skin or to other soft tissue, and 2) may cause
the individual to become unstable and vulnerable to falling.
- DO NOT place obstructions between the individual and the cushion.
The cushion and the cover MUST be compatible sizes and MUST
be used as directed in this manual. Except for the compatible cover
provided with this product, placement of any items between the
individual and the cushion: 1) may reduce or eliminate the benefits
of the cushion, increasing the risk to skin or to other soft tissue, and
2) may cause the individual to become unstable and vulnerable to
falling.
- DO NOT use any part of the product as a water flotation device (e.g.
a Life Preserver). It will NOT support you in water.
- The cushion surface will acclimate to the surrounding temperature.
Take appropriate precautions, especially when the cushion will
contact unprotected skin.
- DO NOT expose the product to high heat, open flames, or hot
ashes. Testing or certification claims, including for flammability,
may no longer apply to this device when it is combined with other
products or materials. Check testing and certification claims for all
products used in combination with this device.
- If you are unable to perform any tasks described in this manual,
seek assistance by contacting the clinician, equipment provider,
distributor, or Customer Support.
2