Etac Star StabilAir SA3, Manual

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6
Etac / Star Standard Air/StabilAir / www.etac.com
English
en
General:
Thank you for choosing an Etac product.
In order to avoid injury during handling and
use, please read through this manual first.
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 .........
Figure A
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.
Maintenance and security ..............
Figure B
1. Cleaning the cover:
Remove the cover and close the zipper.
Turn inside out and machine wash in warm
water (maximum 60°C/140°F standard
cover, maximum 80°/176°F incontinence
cover). Do not bleach. Rinse in cold water
and machine dry on low temperature or
line dry.
To disinfect the Cover:
The cover can be machine washed in hot
water (80°C/176°F) to disinfect. Tumble
dry on low temperature.
2. Cleaning the cushion:
Before cleaning/disinfecting, remove the
cover and wash separately (see step 1,
‘Cleaning the cover’ ). Close the inflation
valve. Clean the cushion by hand with
soap, bicarbonate or vinegar. Or, machine
wash (only Standard Air) in 40°/104°F (or
60°/140°F for 10 min.) Rinse and dry. N.B.
The cushion must be filled with some air
when washing in machine.
3. To disinfect the cushion, use a 70% alco-
hol-based disinfectant solution only.
4. A defective product must not be used (see
also section ‘Troubleshooting’).
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 .
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
with a clinician immediately.
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.
In case of an adverse event occurred in
relation to use of the device, it should be
reported to the organisation that supplied
you the cushion, e.g. dealer and the national
competent authority in a timely manner. The
local dealer will forward information to the
manufacturer.
Positioning of the cushion ..............
Figure C
Set up and assess ............................
Figure D
1. Inflate the cushion by opening the inflation
valve (counterclockwise) and pump up the
cushion using the hand inflation pump.
Lock the valve (turn clockwise).
2. Transfer the user on to the cushion.
3. Open the inflation valve and let the user
immerse into the cushion by letting air out.
Close the valve.
4. Perform a hand check to ensure 2–3 cm
distance between the base of the cushion
and the user’s lowest bony prominence. If
needed, let more air out. And if too much
air has been let out, it can easily be topped
up using the hand inflation pump.
Accessories ......................................
Figure E
1. Incontinence cover.
Label placement ...............................
Figure F
1. Product label (warnings, CE-marking ser.
no., manufacturing date)