Intended Use; Important Safety Information - Permobil ROHO AGILITY Operation Manual

Intended Use

ROHO AGILITY Back Systems (AGILITY) are replacement backrest systems for wheelchairs that are intended to provide trunk/pelvis support and positioning.
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AGILITY contours include:
- ROHO AGILITY Minimum Contour Back System (AGILITY Minimum Contour)
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- ROHO AGILITY Mid Contour Back System (AGILITY Mid Contour)
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- ROHO AGILITY Max Contour Back System (AGILITY Max Contour)
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AGILITY have a weight limit of 300 lbs. (136 kg) and must be properly sized to the individual.
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.
CONTRAINDICATION: AGILITY Max Contour is NOT intended to be used with ROHO AGILITY Laterals.
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:
- DO NOT use the product without first reading and understanding all of the provided instructions. If you are unable to perform any tasks in this manual,
seek assistance by contacting your clinician, equipment provider, distributor, or Customer Support.
- Follow all instructions and safety information provided with the product and provided by the manufacturer of your wheelchair or other accessories.
- 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.
- The product should be installed by your equipment provider or clinician.
- The product must be sized correctly to the individual and the wheelchair.
- As with any addition to a wheelchair, the product may affect your wheelchair's stability. Before using the product, consult with a clinician or your
equipment provider to determine whether your wheelchair should be modified.
- DO NOT lean over the top of an AGILITY Back System. Doing so may cause a change in the center of gravity, and the wheelchair could tip over.
- DO NOT lift or push a wheelchair using any part of an AGILITY because it may become detached from the wheelchair.
- 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.
- Metal components may become hot if exposed to high temperatures or cold if exposed to low temperatures. The cover assembly surface will acclimate to
the surrounding temperature. Take appropriate precautions, especially when the product will contact unprotected skin.
- Use of any hardware or components other than those approved for use with the product may result in product damage or failure and may void the
warranty.
- Altering the product may affect its performance and void the warranty.
Cautions:
- AGILITY is intended to be used with an AGILITY cover, foam pad, lumbar support pad (if applicable), and either the air insert or the foam insert (if applicable).
- Changes in altitude may require adjustment to air insert(s).
- Protect the AGILITY from blunt force shocks that may cause damage and/or breakage.
- The components of an AGILITY are not intended to be used separately from an AGILITY or in conjunction with other wheelchair back systems.
- Check AGILITY components for wear or damage. DO NOT use an AGILITY if any component is not functioning properly or is broken. Periodically, the AGILITY should
be thoroughly inspected by a qualified technician.
Warnings - Motor Vehicle Transportation Important Safety Information:
- Whenever possible, transfer out of your wheelchair installed with AGILITY and into a manufacturer-installed vehicle seat, and use the vehicle's crash-
tested occupant restraint system.
- To determine whether motor vehicle third-party testing has been performed with your specific hardware-AGILITY combination, refer to the operation
manual provided with your AGILITY hardware.
ROHO AGILITY Back System Operation Manual
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