Etac Star StabilAir Serie Manuel D'instructions page 7

en
English
General
Thank you for choosing an Etac product.
In order to avoid damage during assembly,
handling and use, it is important to read this
manual and save it for future reference. You
can also find it at www.etac.com. You can
select your language via the "International"
and "Local websites" link. Here you will also
find other product documentation, such as
prescriber information, pre purchase guide,
and reconditioning instructions.
In the manual, the user is the person sitting
on the cushion. The carer is the person help-
ing the user.
Information on how people with impaired
vision can get access to the manual can be
found in our pre-sales information guide in
www.etac.com.
Etac is continuously improving its products.
We therefore reserve the right to change the
products without prior notice. The dimensions
given in the drawings or other materials are
only indicative.
We will not be responsible for printing errors
and incompleteness.
Product description
Star cushions (hereafter also referred to as
'the product') are vertical air cell cushions,
which are manually adjustable to suit an
individual's weight, body shape, and their
pressure redistribution, postural and offload-
ing requirements.
Intended use
The product is intended to be used as a
pressure injury prevention cushion in a
wheelchair.
Intended user
Individuals at risk of pressure injuries. There
is no minimum age or minimum/maximum
weight limit on the product. The product can
also be used by individuals with existing
pressure injuries up to and including category
4 when used in-line with national and interna-
tional guidelines, for example, EPUAP/NPIAP
Best Practice Guidelines.
Limitations of use
The product must be properly sized for the
user buttocks and thighs, and the wheelchair
seat size. It must not be used as a seat in
aeroplane.
Contraindications
There are no known contraindications.
Special Considerations
The assessment for and set up of the product
should be carried out by a suitably qualified
and experienced professional (e.g. physical/
occupational therapist), including the appro-
priate adjustment of air to suit the individual's
pressure and postural needs. For category
3 and 4 pressure injuries, 10 cm or 13 cm
heights should be used. Consider using the
product's individual cell locking capabilities
to offload localised pressure from vulnerable
or damaged skin to allow for natural wound
healing. Training is available from Etac upon
demand.
CE-marking, tests
The product conforms to the requirements
of the Medical Devices Regulation (EU)
2017/745.
Delivery content, description .........
1. Seat cushion with air cells. 2. Hand
inflation pump. 3. Inflation valve. 4. Cover (a.
standard or b. incontinence cover). 5. Pocket.
6. User manual. 7. Repair kit.
Cleaning ............................................
1. Remove the cover, turn inside out and
close the zipper.
2. Washing
Standard cover (see cover label for model):
Machine wash in warm water, maximum
60°C/140°F. Use a mild detergent. Do not
bleach. Rinse in cold water and tumble dry
on low temperature or line dry.
Incontinence cover (see cover label for
model):
As above but maximum 80°/176°F.
The cushion:
Before cleaning/disinfecting, remove the
cover and wash separately (see step 2,
'Washing'). Close the inflation valve. Clean
the cushion by hand with soap, bicarbonate
or vinegar. Or, machine wash in 60°/140°F
for maximum 10 min. (not StabilAir). Use a
mild detergent. Rinse in cold water. After
rinsing, overinflate the cushion and leave
to air dry for 24 hours, or dry in a drying
cabinet on low heat. N.B. The cushion must
be filled with some air when washing in
machine. Mesh laundry bags that are big
enough to loosely fit around the cushion,
can be used if additional protection is
desired during machine washing.
3. Disinfection
Standard Cover:
Standard cover can only be washed (see
"2. Washing, standard cover"). If disinfec-
tion is needed, we recommend to use
incontinence cover.
Incontinence cover:
Use a 70% alcohol-based disinfectant solu-
tion or a chlorin based solution, maximum
5000 ppm. Rinse in cold water and tumble
dry on low temperature or line dry.
The cushion:
Use a 70% alcohol-based disinfectant solu-
tion or a chlorin based solution, maximum
5000 ppm. Rinse in cold water and dry (see
washing cushion).
Guarantee, lifetime:
2-years guarantee (cushion) and 6-months
guarantee (cover) against material and manu-
facturing defects. For terms and conditions,
see www.etac.com.
Service life of 5 years based on typical use
by a single user. For complete information
regarding the service life of the product, see
www.etac.com.
Storage
The product should be stored indoors in a
dry place at a temperature above 5°C. If
the product has been stored for a long time
(more than four months), its function must be
checked by an expert before use.
Check inflation of the seat
cushion: At least once per day.
Check skin: Check skin frequently,
at least once per day. Skin and soft
tissue breakdown can occur due
to many reasons, which may vary
by individual. Redness, bruising,
or discolored skin may indicate
the beginning of soft tissue or skin
breakdown. If this occurs, consult
Figure A
with a clinician immediately.
Figure B
In case of an adverse event occurred in
7
Etac / Star Standard Air/StabilAir / www.etac.com
Cushion and cover matching: The
cushion and cover must be compat-
ible sizes and must be used as
directed in this manual (Instructions
for Use). If they are not, the benefits
provided by the cushion may be
decreased or eliminated, which
increases risk to the skin and/or soft
tissue. Further, it may increase the
risk of instability and falling. Never
use the cushion without a cover.
Cushion and cover orientation: A
Star Cushion must be used with the
air cells facing up according to this
manual. If the cushion is not facing
up, or the cover is not used correctly,
it may reduce or eliminate the cush-
ions' benefits and could increase risk
to the skin and other soft tissue.
Under-inflation: DO NOT USE an
under-inflated product. Ensure the
user is not resting on the base or bot-
tom of the cushion, as it can result
in peak pressure areas. Prolonged
exposure to peak pressures could
increase risk of breakdown to the
skin and other soft tissue.
Over-inflation: DO NOT USE an
over-inflated product. If the cushion
remains over-inflated for daily use,
the body will not immerse into the air
cells, which may reduce or eliminate
the product's benefits, and increase
risk of break down to the skin and
other soft tissue.
Climate: If a cushion has been in
temperatures less than 32°F /
0°C and exhibits unusual stiffness,
allow the cushion to warm to room
temperature. Then, knead the cush-
ion with your hands, or roll up the
cushion and then unroll it (with the
valve open) until the chloroprene is
soft and pliable again. Repeat proper
adjustment instructions before using.
Avoid extreme heat and keep away
from heat sources, hot ashes, open
flames or direct sunlight.
Pressure: Changes in altitude may
require you to readjust your cushion
for proper inflation. Check inflation
each time you change altitude.
Never use the cushion on an aircraft
seat.
Puncture: In order to prevent your
cushion from being punctured, keep
your cushion away from sharp objects
and clawed pets.
Handling: DO NOT attempt to carry
your cushion by the valve or bulb
pump or pull your cushion by the
valve. Carry your cushion by the
cover's handle, or lift underneath the
base of the cushion to carry.
Instability/Fall hazard: DO NOT use
your cushion in conjunction with, or
place on top of any other products
or materials, except as listed in the
Intended Use section. This may result
in instability and/or falls.