Intended Use; Important Safety Information - General - Permobil Tru-Shape Operation Manual

Intended Use

The Tru-Shape is a custom-made seating system that is made specifically for a wheelchair and designed to meet
the needs of a specific user.
The Tru-Shape is high-quality urethane foam carved to create an intimate fit with the user for optimal contact
surface area and improved pressure redistribution. Tru-Shape can be designed as a complete seat and back
system or as separate seat or back components.
A clinician who is experienced in seating and positioning, along with a full risk assessment and program of care, 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 - General

WARNINGS:
- DO NOT REUSE. This product is designed to be
uniquely shaped to its user. DO NOT use this
product for another individual.
- DO NOT use the components of this product
separately. Assemble and use this product only as
instructed in this manual.
- Altering the seating system or using any hardware
or components other than those supplied by
The Comfort Company / Permobil may result in
product damage and may void the warranty.
- Follow all instructions and safety information
provided with the seating system and provided
by the manufacturer of the 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.
- If skin irritation and/or skin reddening occur,
consult the qualified personnel who adapted and
adjusted the product. Do not continue using the
product without consultation.
- Leaning too far forward or to the side may lead to
instability and tipping.
Tru-Shape Operation Manual
WARNINGS, continued:
- DO NOT expose the product to high heat, open flames
or hot ashes. Testing or certification claims, including
flammability, may no longer apply to this device once it
is combined with other products and 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 a clinician,
equipment provider, distributor, or Customer Support.
WARNINGS - MOTOR VEHICLE TRANSPORTATION:
- Failure to pay attention to these warnings could result
in severe injury to the individual in the wheelchair or to
others.
- The Permobil Tru-Shape has not been tested for use in a
motor vehicle.
- Transfer out of the wheelchair installed with the custom
seating system and into a manufacturer-installed
vehicle seat, and use the vehicle's crash-tested occupant
restraint system.
- If the seating system has been involved in an accident
during transport, see the "Maintenance" section in this
manual.
CAUTIONS:
- Periodically, check the cover and components for
damage and wear, and replace if necessary.
- Keep the seating system away from sharp objects.
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