ROHO SOFFLEX 2 User manual

1
ROHO®SOFFLEX®2
Mattress Replacement System
SUPPLIER: This manual must be kept with this product.
CAREGIVER: Before using this product, read these instructions and save for future reference.
shape fitting technology®
Operation Manual

1
TABLE OF CONTENTS
WARNINGS AND CAUTIONS 2-3
INTENDED USE 3
PRODUCT SPECIFICATIONS 3
PARTS DETAIL 4
ADJUSTMENT INSTRUCTIONS 5-6
LINENS 7
TROUBLESHOOTING 7
CONTACT INFORMATION 7
CLEANING AND DISINFECTING 8
DISPOSAL 9
RETURN POLICY 9
LIMITED WARRANTY 9
ROHO, Inc. has a policy of continual product improvement and reserves the right to amend this
document. The current version of this document is available at www.roho.com.
ROHO, Inc.
100 North Florida Avenue, Belleville, Illinois 62221-5429
U.S.A.: 800-851-3449 Fax [phone] e-mail: [email protected]
Outside the U.S.A.: 618-277-9150 Fax [phone] e-mail: [email protected]
© 2013, 2014 ROHO, Inc.
The following are registered trademarks of ROHO, Inc.: ROHO®, SOFFLEX®and shape fitting
technology®.
Products in this manual may be covered by one or more U.S. and foreign patents and trademarks.
For further details please refer to www.roho.com

2
WARNINGS
Mattress - Entrapment and Fall Risks: Medical experts and governmental entities in various
countries have determined that the use of side rails on beds may present a life-threatening
entrapment danger to the individual. Bed frame side rail usage is not a requirement for the
functional operation of any ROHO product; however, the use of side rails may be clinically
indicated for certain individuals. The decision whether to use side rails should be based
upon the intended use of the product, facility protocol, applicable laws, regulations, the
individual’s condition and needs, and a case-by-case assessment by clinicians and / or
healthcare providers actively involved in the individual’s care. Knowledgeable and properly
trained caregivers should assess the individual to determine the risk of entrapment and
whether side rails should be used.
• In the event that a decision is made to use side rails, ensure that any risks associated with the
individual becoming entrapped in the side rails are identified and steps are taken to minimize
such risks.
• In the event that a decision is made not to use side rails, ensure that any risks associated with
the individual falling out of bed are identified and steps are taken to minimize such risks.
Suffocation Risk: Clinicians and/or caregivers must assess the individual’s risk of
suffocation and make decisions according to facility protocol and the intended use of the
product. The ROHO®SOFFLEX®2 Mattress Replacement System (SOFFLEX 2 Mattress)
should NOT be used by infants or other individuals who are at risk of suffocation.
• Skin/soft tissue breakdown can occur due to a number of factors, which vary by
individual. Check skin daily. Redness, bruising, or darker areas (when compared to
normal skin) may indicate the beginning of soft tissue breakdown and needs to be
addressed. If any discoloration does NOT disappear within 30 minutes of discovery,
consult a healthcare professional immediately.
• Check inflation and adjustment frequently, at least once a day! If the individual is not
properly immersed, it may reduce the benefit desired and increase the risk of tissue
trauma. If product does not appear to be holding air, see TROUBLESHOOTING.
• Check the SOFFLEX 2 Mattress Replacement Cover routinely for any visible signs of cuts,
tears, cracks, pinholes, snags, or stains, as damaged or worn covers may allow blood and
other body fluids to penetrate the mattress, posing a risk of infection. See WARNINGS
under CLEANING AND DISINFECTION.
• The SOFFLEX 2 Mattress should NOT be used by an individual who exceeds the surface
area or weight limit of the product.
• The SOFFLEX 2 Mattress should be correctly sized to the bed. Additional care should
be taken to ensure a tight fit of the mattress to the bed system. If the product is NOT
properly sized to the bed system, entrapment may occur.
• While properly adjusted mattress replacement systems may protect the individual from
tissue trauma, they DO NOT eliminate the need for periodic individual turning.
• It is important that the product be set up by knowledgeable caregivers who are
properly trained in the use of this product.
• DO NOT use the cover handles to lift or slide the individual, as it may result in injury.
• DO NOT use the product as a transfer surface. DO NOT reposition the product while it is in
use. Grasp mattress sections by the base or the outside edges.
• Placing too many linens or other materials between the product and the individual will
reduce the product’s effectiveness. See LINENS.

3
CAUTIONS
• Changes in altitude may require adjustment to your product.
• Keep the product away from sharp objects, which may puncture the air cells and cause
deflation.
• DO NOT expose the product to high heat, open flames or hot ashes.
• If a product has been in temperatures less than 32°F / 0°C and exhibits unusual
stiffness, allow the product to warm to room temperature.
• The use of any inflation device other than those supplied by ROHO may damage the
product and void the warranty.
• Prolonged exposure to ozone will degrade the product and may affect the performance of
the product and invalidate the product warranty.
INTENDED USE
The SOFFLEX 2 Mattress Replacement System (SOFFLEX 2 Mattress) is a non-powered,
reactive, complete support surface with adjustable, zoned, air-filled cell pads that is
intended to conform to an individual’s shape to provide skin/soft tissue and deep tissue
injury protection and an environment to assist in wound healing.
The SOFFLEX 2 Mattress must be used as a complete mattress replacement on hospital,
nursing home, or home care bed frames. There is a weight limit of 650 lbs. (295 kg).
ROHO medical products are intended to be part of an overall care regimen. ROHO, Inc.
recommends that a clinician make product recommendations based upon an evaluation of
the individual’s medical and therapeutic needs and overall condition.
CPR may be performed without deflating the product. A cardiac board is not necessary.
PRODUCT SPECIFICATIONS*
Components of the SOFFLEX 2 Mattress comply with CAL 117.
The SOFFLEX 2 Mattress complies with 16 CFR 1632 and 16 CFR 1633 for use without a
foundation.
Width x Length x Height (without load)
36" x 80" x 8.5" 91.5 cm x 203 cm x 21.5 cm
36" x 84" x 8.5" 91.5 cm x 213.5 cm x 21.5 cm
39" x 80" x 8.5" 99 cm x 203 cm x 21.5 cm
39" x 84" x 8.5" 99 cm x 213.5 cm x 21.5 cm
42" x 80" x 8.5" 106.5 cm x 203 cm x 21.5 cm
42" x 84" x 8.5" 106.5 cm x 213.5 cm x 21.5 cm
48" x 80" x 8.5" 122 cm x 203 cm x 21.5 cm
48" x 84" x 8.5" 122 cm x 213.5 cm x 21.5 cm
Sizes:
*Note: All measurements are approximate.

4
PARTS DETAIL
Package Contents:
Mattress Cover Top
Inner Liner
Deflation Adapters
Inflation Port
Inflation Port Tabs
Mattress Cover Bottom
1
ROHO®SOFFLEX®2
Mattress Replacement System
SUPPLIER: This manual must be kept with this product.
CAREGIVER: Before using this product, read these instructions and save for future reference.
shape fitting technology®
Operation Manual
Operation Manual
Product
Registration Card
Product Registration Card
Hand Pump with Quick Connect
Inflation Port Valves
Air Cell Pads
Bolsters (Models >36 in. / 91.5 cm wide)
Tubing
Foam Base

5
ADJUSTMENT INSTRUCTIONS
The SOFFLEX 2 Mattress MUST be used with the provided cover. (For demonstration
purposes only, top of cover may not be shown.)
1. Place SOFFLEX 2 Mattress directly on the bed frame.
2. Secure the SOFFLEX 2 Mattress to the bed frame using the straps on the bottom of the
cover.
5. Push down on the Inflation Port Tab (A) to disconnect the manual Hand Pump (B).
(Repeat steps 3-5 for the remaining Air Cell Pad sections.)
3. Insert the Quick Connect on the manual Hand Pump into an Inflation Port Valve until a
click is heard. Note: If the Quick Connect on the Hand Pump cannot be inserted into an
Inflation Port Valve, push down on the valve’s Inflation Port Tab while inserting until click
is heard.
4. Inflate each air section until it arches slightly upward.
A
B

6
ADJUSTMENT INSTRUCTIONS, Continued
6. While the SOFFLEX 2 Mattress is still unloaded, insert a Deflation Adapter into each
Inflation Port Valve and allow air to bleed out of each section until the internal air
pressure reaches atmospheric pressure. Note: You will know when the atmospheric
adjustment is completed when no additional air is escaping from the Inflation Valve Port.
This will take approximately five (5) minutes. Once completed, remove the Deflation
Adapters by pressing the Inflation Port Tab located on each Inflation Port Valve. Place
the Deflation Adapters into the storage holes.
7. Place the individual on the SOFFLEX 2 Mattress in their normal lying position (e.g. on
their back or side). Add or remove additional amounts of air from any section to insure
the individual is comfortable and immersed into the SOFFLEX 2 Mattress.
Notes:
• Proper immersion is achieved when the individual has sunk into the product so the air
cells envelop and support their body; diagrams above show examples of proper immersion
into the SOFFLEX 2 Mattress.
• The lowest bony prominence may be gently touching the foam.
• Adjustments may be needed if the position of the head or foot of the bed are changed.
• A SOFFLEX 2 Mattress that has been properly adjusted may appear under-inflated when
unoccupied; this is because the individual’s body mass is no longer loading the product.
8. Snap in place the Inflation Port
flap over the Inflation Port and
be sure that the cover side flap
is down and snapped concealing
the cover’s zipper.
Confirm:
• Product has been set up according to the directional arrows on the cover.
• Product is appropriate for the bed frame.
• Straps on the cover are secured to the bed frame when the product is in use.
• All enclosure flaps are down and snapped.
• Individual is properly immersed. (See ADJUSTMENT INSTRUCTIONS).
CAUTION

7
LINENS
TROUBLESHOOTING
Too many linens between the product and the individual will compromise the product’s skin
protection characteristics. Please use as few linens and incontinent pads as possible.
If the product does not appear to be maintaining adjustment, reinflate, and redo the
adjustment procedure. If concern persists, contact your service provider, clinical caregiver,
distributor, or ROHO, Inc. immediately.

8
CLEANING AND DISINFECTING
Cleaning and disinfecting are two separate processes. Cleaning must precede disinfection.
Note: SOFFLEX 2 Mattress must be cleaned, disinfected and checked for proper functioning
between use by different individuals.
PRIOR TO CLEANING AND DISINFECTING: Remove linens. Examine the cover to be sure
that it has NOT been damaged in such a way to cause internal parts to come in contact
with bodily fluids, e.g., punctured, torn, worn area.
• If damage exists, DO NOT continue to use the product. Contact your service provider
immediately.
• If no damage exists, the cover should be cleaned and disinfected as instructed
below.
DO NOT unzip the mattress cover during use.
DO NOT:
• Disassemble the internal components of the SOFFLEX 2 Mattress
• Allow water or cleaning solution to come in contact with the internal components
• Use abrasives such as steel wool or scouring pads
• Use caustic detergents
• Use cleaning products containing petroleum or organic solvents including acetone,
toluene, Methyl Ethyl Ketone (MEK), naphtha, dry cleaning fluids,
adhesive removers, etc.
• Expose the product to ultraviolet light or ozone gas cleaning methods
• Dry clean
To Clean:
Wipe the cover surface with a neutral detergent and water. Rinse and allow to
dry thoroughly.
To Disinfect:
Wipe the cover surface with a dilution of 1 part household bleach to 9
parts water. Follow safety guidelines on bleach container. Quaternary
type disinfectants may also be used in concentrations recommended by
the manufacturer. Rinse and allow to dry thoroughly.
The top of the cover can also be occasionally machine washed in hot water
(60˚C) for disinfection. However, ROHO, Inc. recommends against repeated
washings at high temperatures, as this can accelerate degradation of the cover.
Tumble dry thoroughly on low.
Sterilization: ROHO products are not packaged in a sterile condition, nor are they intended
or required to be sterilized for use.
1:9
+
= Wipe the cover surface as instructed.
WARNINGS
CAUTIONS

9
DISPOSAL
When properly used and disposed of, the components of the products in this manual are
associated with no known environmental hazards. Dispose of the product and/or components
in accordance with the applicable regulations in your jurisdiction. DO NOT INCINERATE.
RETURN POLICY
All products returned must be new and unused, require prior authorization from ROHO, Inc.,
and are subject to a restocking charge. Before returning a product: In the U.S.A.,
contact our Warranty Service Department; outside of the U.S.A., contact your country’s ROHO
distributor.
LIMITED WARRANTY
What is covered and for how long?
• Every SOFFLEX 2 Mattress Replacement System, excluding the removable, external cover
and inner liner, is guaranteed to be free from defects in materials or workmanship for a
period of 5 years (60 months) from the date the product was originally purchased.
• The removable, external cover and inner liner of a SOFFLEX 2 Mattress Replacement
System are guaranteed to be free from defects in materials or workmanship for a period of
18 months from the date the product was originally purchased.
What is not covered?
This warranty does not apply to products that have been subjected to damage resulting
from accident, misuse, an “Act of Nature”, or abuse including, but not limited to: floods,
tornadoes, earthquakes, fires, punctures, tears, harsh chemicals or burns.
What the customer must do?
• Should a defect in materials or workmanship occur during this period, ROHO will, at its
option, repair or replace it free of charge.
•Within the U.S.A., the customer must contact ROHO, Inc. Warranty Service Department.
Note: Any items sent to ROHO, Inc. without prior authorization will not be returned to the
customer. Outside the U.S.A., contact your country’s ROHO distributor.
Questions?
See CONTACT INFORMATION.
Disclaimer.
Any implied warranties, including the MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE are limited to the same time period of the product types referenced above in the
“What is covered and for how long” section and any action for a breach of such warranties
or any express warranties herein must be commenced within that time. ROHO, Inc. shall not
be responsible for any incidental or consequential damages with respect to economic loss to
property, whether as a result of a breach of express or implied warranties or otherwise.
Your rights and the effect of this warranty upon them.
This warranty restricts the duration of all implied warranties as noted above and limits or
excludes recovery for incidental or consequential damages. Some jurisdictions do not allow
limitations on how long implied warranties will last and some jurisdictions do not allow the
exclusion or limitation of consequential or incidental damages, so those provisions may not apply
to you. While this warranty gives you specific legal rights, you may also have other rights which
vary from jurisdiction to jurisdiction.