Permobil ROHO Hybrid Elite User manual

shape fitting technology
®
ROHO®Hybrid Elite®Cushion
Operation Manual

ROHO Hybrid Elite Cushion Operation Manual
Contents
Intended Use
Important Safety Information
2-3
Parts Detail and Product Specications 4
Cushion Setup 5
Cover Removal and Replacement
Cushion Insert Removal and Replacement
6
Foam Insert Removal and Replacement 6-7
Troubleshooting 7
Cleaning and Disinfecting 8-9
Storage, Transport, Disposal and Recycling
Limited Warranty
9
Español 10 Português 91
Français 19 hrvatski 100
Deutsch 28 Čeština 109
Italiano 37 Íslenska 118
Nederlands 46 Polski 127
Dansk 55 Română 136
Svenska 64 Slovenčina 145
Norsk 73 Slovenščina 154
Suomi 82 Türkçe 163
Contact Information
ROHO, Inc.
1501 South 74th St.
Belleville, IL 62223 U.S.A.
U.S.A.:
800-851-3449
Fax [phone]
Customer Support:
[email protected]
Outside the U.S.A.:
618-277-9150
Fax [phone]
[email protected]
permobil.com
Please Note
Supplier: This manual 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 DRY FLOATATION®, Hybrid Elite®, Hybrid Elite SR™,
ROHO®, Sensor Ready®, shape tting technology®, Smart Check®and Yellow
Rope®. Zytel®is a registered trademark of DuPont.
Product information is changed as needed; current product information is
available at permobil.com. Contact Customer Support for previous versions of
product information.
ROHO, Inc. is part of Permobil.
© 2009, 2021 Permobil
Rev. 2021-04-20
The following products are featured in this operation manual:
ROHO Hybrid Elite Dual Compartment Cushion
ROHO Hybrid Elite SR Single Compartment Cushion
Warning
Indicates that not following the specied procedure could lead to
potentially hazardous conditions resulting in serious injury.
Caution
Indicates that 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 Fits Size (width x depth x height) Front of product
Date of manufacture Model number Weight limit Back of product
Consult instructions for use Serial number Medical Device Bottom of product
Quantity Authorized representative in the European Community

2
ROHO Hybrid Elite Cushion Operation Manual
Intended Use
The ROHO Hybrid Elite Cushion (Hybrid Elite Cushion) is an adjustable, air-lled, 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. There is a weight limit of 500
lbs. (225 kg), and the cushion must be properly sized to the individual. The Hybrid Elite Cushion must be used with the supplied cover. Cushion
models include:
- ROHO Hybrid Elite SR Single Compartment Cushion (Hybrid Elite SR)
- ROHO Hybrid Elite Dual Compartment Cushion (Hybrid Elite Dual Compartment Cushion)
Contraindication: Based on clinical, scientic or engineering evidence, the Hybrid Elite Dual Compartment Cushion may not be suitable for
individuals who require accommodation of pelvic asymmetry greater than 2 in. (5cm). The Hybrid Elite SR Cushion is not suitable for individuals
who require accommodation of pelvic asymmetry.
Compatibility: Hybrid Elite Cushions are NOT COMPATIBLE with the ROHO Contour Base.
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 supercial 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.
- 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
covers listed in “Product Specications” in this manual, placement
of any items between the individual and the cushion: 1) may reduce
or eliminate the benets 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 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 benets 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.
Warnings:
- DO NOT expose the product to high heat, open ames or hot ashes.
Testing or certication claims, including for ammability, may no
longer apply to this device when it is combined with other products or
materials. Check testing and certication claims for all products used
in combination with this device.
- The cushion surface will acclimate to the surrounding temperature.
Take appropriate precautions, especially when the cushion will
contact unprotected skin.
- If you are unable to perform any tasks described in this manual, seek
assistance by contacting the clinician, equipment provider, distributor,
or Customer Support.
- DO NOT use the components of this product separately. The cushion
must be used with all components assembled.
- DO NOT use the cushion as a water otation device (e.g., a Life
Preserver). It will NOT support you in water.

3
ROHO Hybrid Elite Cushion Operation Manual
Important Safety Information, continued
Cautions:
- Keep the cushion away from sharp objects.
- Changes in altitude may require adjustment to the cushion.
- If the cushion has been in temperatures lower than 32° F (0° C)
and exhibits unusual stiffness, allow the cushion to warm to room
temperature.
- DO NOT use a pump, cover or repair kit other than those
compatible with the product.
- DO NOT modify the cushion or any components. Doing so may
result in damage to the product and will void the warranty.
- DO NOT allow the cushion to come into contact with oil-based
lotions or lanolin. They may degrade the material.
- Prolonged exposure to ozone may degrade materials used in the
cushion, affect the performance of the cushion, and void the product
warranty.
- Periodically, check components for damage and replace if
necessary. See “Troubleshooting”.
- DO NOT use any of the following as a handle for carrying or pulling
the cushion: ination valve(s), hose(s), or quick disconnect (Sensor
Ready Cushion). Carry by the base of the cushion insert, by the foam
base, or by the carrying handle on the Hybrid Elite Cover. Using any
other components to carry or pull the cushion may damage the
product.
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.
- Whenever possible, transfer out of the wheelchair and into a
manufacturer-installed vehicle seat without the cushion, and use the
vehicle’s crash-tested occupant restraint system.
- The cushion must be correctly and securely installed, used, and
maintained according to the instructions and warnings provided by
the cushion manufacturer.
- When the wheelchair is used as the vehicle seat, the cushion
should only be used with wheelchair frames that are equipped with
securement points specied in ANSI/RESNA WC-4:2017, section
19 (WC19) or ISO 7176-19, and that have been successfully crash
tested on a wheelchair in the forward-facing position.
- The wheelchair with the cushion must be used with an effective
wheelchair securement system and a properly positioned, crash-
tested pelvic and shoulder-belt restraint, or Wheelchair Tiedown and
Occupant Restraint System (WTORS), following the manufacturer’s
instructions.
- If the cushion has been involved in an accident during transport,
check the cushion for damage and replace if necessary. See the
“Troubleshooting” section in this manual.
- For more information about safely transporting wheelchair users,
refer to: http://wctransportation-safety.umtri.umich.edu/ridesafe-
brochure.
- A ROHO QUADTRO SELECT Cushion was included in a wheelchair
seating system that was dynamically tested by a third-party testing
facility for use in a motor vehicle. The system tested meets all
applicable criteria for wheelchair seating systems proposed in
Section 5.1 of ANSI/RESNA WC-4:2017 Section 20 “Wheelchair
Seating Systems for Use in Motor Vehicles.
- Test results apply to seating systems intended for use by adults
and children with a total body mass greater than 23 kg (51 lb, or
approximately 6 years of age) who are transported facing forward in
their wheelchairs in all types of motor vehicles.
- To determine whether motor vehicle third-party testing has been
performed with a specic seating system combination, refer to all
provided equipment operation manuals or contact the equipment
manufacturer.