Permobil Tru-Shape User manual

Tru-Shape®
OPERATION MANUAL

Tru-Shape Operation Manual
Contents
Intended Use
Important Safety Information - General
2
Before Use
Parts Detail and Product Specications
3
Healthcare Provider Instructions 4
User / Caregiver Instructions 5
ROHO Air Insert Setup
ROHO Air Insert Removal and Replacement
6-7
Cleaning and Disinfecting
Maintenance
8-9
Troubleshooting
Storage, Transport, Disposal and Recycling
10
Warranty 11
Français 12
Contact Information
The Comfort Companies, LLC
1960 South Calhoun Road
New Berlin, WI 53151 USA
USA: 800-736-0925
Outside the USA: 262-432-0830
Fax: [phone]
Customer Support:
[email protected]
permobil.com
WARNING: Indicates not following the
specied procedure could lead to potentially
hazardous conditions resulting in serious injury.
CAUTION: Indicates not following the specied
procedure could lead to potentially hazardous
conditions resulting in minor to moderate injury or
damage to the equipment or other property.
Incident Reporting
In the event of a serious incident or injury, contact
Customer Support.
Symbols Glossary
Manufacturer Date of manufacture Consult instructions for use
Please Note
Supplier: These instructions must be given to the user of this product.
Operator (Individual or Caregiver): Before using this product, read the instructions and save for future reference.
Products may be covered by one or more U.S. and foreign patents and trademarks, including COMFORT-TEK®,
Breathe 4™,ROHO®, STRETCH-AIR®and Tru-Shape®.
Zytel®is a registered trademark of DuPont.
Product information is changed as needed; current product information is available at permobil.com.
The Comfort Companies, LLC is a part of Permobil.
© 2019, 2021 Permobil
Rev. 2021-06-18
Thank you for choosing Tru-Shape

Tru-Shape Operation Manual
2
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.
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.
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.

Tru-Shape Operation Manual
3
Parts Detail and Product Specications
Package Contents:
- Tru-Shape
- Operation Manual
Product Options:
- Mounting Base
- Mounting Hardware
- Removable Cover
- T-Nuts (¼-20 or 10-32 mm)
- ROHO Air Insert (includes a
hand pump and repair kit)
Note: Some options are not
included with all systems.
Tru-Shape Back
Tru-Shape Seat
ROHO Air Insert
(Mid Prole shown)
Repair Kit
HP45 Hand Pump
Materials*:
Seating System: urethane foam
Vinyl Spray Coating: low-volatile vinyl-based coating;
made without latex
Mounting Surface: plywood, ABS plastic or hook and
loop fasteners
Mounting Hardware: aluminum and/or steel
depending on variation ordered
ROHO Air Insert: neoprene rubber (made without
latex); Zytel ination valve
Removable Textile Cover: Refer to product labels for
material content and for compliance to ammability
requirements.
* This is a made-to-order product. Materials will vary.
Covers Compatible with Tru-Shape:
Not available in all markets. Contact Customer Support.
- COMFORT-TEK Cover
- STRETCH-AIR Cover
- Neoprene Cover
- Spacer Fabric Cover
- Breathe 4 Cover
Product expected lifetime: 5 Years
Before Use
The custom seating system featured in this document is intended to be only one part of an overall care regimen
that includes all seating and mobility equipment and therapeutic interventions.
This product may only be selected and adapted by trained qualied personnel. The qualied personnel is
responsible for making sure that the user and/or caregiver has understood the proper adjustment, use,
maintenance and care of the seating system. Discuss the daily operation and preventative maintenance with the
caregiver along with all manufacturer’s instructions and safety information.
Permobil cannot be held responsible for damages or injury due to misuse of the product or failure to follow
the instructions provided in this manual. Please contact us if you require further assistance in understanding
cautions, warnings, or instructions for using or maintaining the product.