Etac Star StabilAir SA3, Manual

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)