Intended Use
The ROHO
DRY FLOATATION
Isolette (Isolette) is a non-powered, air-filled, adjustable, reactive, support surface that is intended to conform to an
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individual's shape to provide skin/soft tissue and deep tissue injury protection and an environment to facilitate wound healing. The Isolette is designed
for infants for use in standard hospital isolettes, home isolettes, and pediatric beds. There is no weight limit.
The ROHO
DRY FLOATATION
Nesting Pad (Nesting Pad) is a non-powered, air-filled, adjustable, reactive, support surface that is intended to conform to
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an individual's shape to provide skin/soft tissue and deep tissue injury protection and an environment to facilitate wound healing. The Nesting Pad is
designed for infants for use in standard hospital isolettes and home isolettes. There is no weight limit.
The ROHO
DRY FLOATATION
Head / Neck Pillow (Head / Neck Pillow) is designed to provide cushioning and support to the head and neck for individuals
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who may require skin/soft tissue protection.
An experienced clinician should determine whether the product is appropriate for the individual's particular equipment 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 therapeutic equipment and
interventions. An experienced clinician 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:
- The support surface products featured in this manual will function without side rails; however, side rails may be necessary for some
individuals. The decision whether to use side rails should be made by the individual's clinician and/or healthcare provider. If side rails are
necessary for an individual, the following points should be considered by the individual in conjunction with his/her clinician or healthcare
provider to reduce the risk of falling or entrapment.
- If it has been determined that side rails are clinically indicated for an individual, knowledgeable and properly trained caregivers should
identify and minimize any risks of entrapment in side rails.
- If it has been determined that side rails are NOT clinically indicated for an individual, knowledgeable and properly trained caregivers
should identify and minimize any risks of falling out of bed.
- Whether side rails are used or not used, knowledgeable and properly trained caregivers should assess the need for devices or aids that
will reduce the risk of falling out of bed or entrapment in side rails.
- The cushioning product should be correctly sized to the individual and the surface (isolette, crib, bed, or other). If it is NOT, the product's
benefits may be reduced or eliminated, increasing risk to skin and other soft tissue.
- 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 clinician.
- DO NOT use a product that is underinflated or overinflated, because the product benefits will be reduced or eliminated, resulting in an
increased risk to skin and other soft tissue. Carefully follow the instructions for inflation and adjustment. 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 your equipment provider,
distributor, or Customer Support if the problem persists.
- The product should be set up by your equipment provider or clinician.
- While the product is in use, continue to follow all clinician recommendations for skin protection, including any schedule for regularly
repositioning the individual.
- The cushioning products featured in this operation manual may introduce radiopacities and are therefore NOT recommended for use with
x-rays. Radiopacities may interfere with diagnoses or surgical procedures that require radiographic images.
ROHO Specialized Hospital Products Operation Manual
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