rehabmart 7.5 cm3 Star StabilAir and Standard Air User Manual

: June 5, 2024
: RehabMart

rehabmart Star StabilAir and Standard Air User Manual

Figure A and B

Figure C

Figure C Continued

Figure D

Figure E and F

Figure G

Figure H

*StabilAir

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 helping 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 offloading 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 international 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 appropriate 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

Seat cushion with air cells.
Hand inflation pump.
Inflation valve.
Cover (a. standard or b. incontinence cover).
Pocket.
User manual.
Repair kit.

Maintenance and security … Figure B

Cleaning the cover:
Remove the cover and close the zipper. 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.
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.
To disinfect the cushion, use a 70% alcohol-based disinfectant solution only.
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 manufacturing 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 compatible 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 cushions’ 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 bottom 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 cushion 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

Inflate the cushion by opening the inflation valve (counterclockwise) and pump up the cushion using the hand inflation pump. Lock the valve (turn clockwise).
Transfer the user on to the cushion.
Open the inflation valve and let the user immerse into the cushion by letting air out. Close the valve.
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

Incontinence cover.

Label placement … Figure F

Product label (warnings, CE-marking ser. no., manufacturing date)
Positioning label

Attach/remove cover … Figure G

Technical data … Figure H

Troubleshooting

Not holding air:

Open the inflation valve by turning counterclockwise and add air to the cushion using your black hand inflation pump.
Close the valve tightly by turning clockwise. If still not holding air:
Visibly check to see if there are any holes. If no holes are visible, immerse cushion (with the valve tightly closed) in sink or tub of water and look for air bubbles.
- If pin-hole sized holes are found, use the repair kit that came with your product and follow the repair kit instructions.
- If large holes or other leaks are found, see ‘Guarantee, lifetime section’.

Uncomfortable/Unstable:

Make sure cushion is not over-inflated. (see section ‘Positioning of the user’).
Make sure the air cells and the cover’s stretch top are facing “UP”.
Make sure cushion is not too big or too small for the wheelchair.

Allow the user to sit on the cushion for a minimum of one hour to get use to the texture of the product’s surface and immersion into the air cells.

Basic repair instructions

Small puncture holes can be patched.

Moderately inflate cushion.
Place cushion under water and watch for stream of air bubbles flowing from the cushion (this is the hole you need to patch).
Circle the area with a permanent marker or ink pen.
Allow area to thoroughly dry.
Roughen area around hole with abrasive pad.
Remove all loose particles and make sure area presents roughened appearance.
IMPORTANT! Be sure area is clean and dry before proceeding to next step.
Peel off backing from patch.
Apply patch, pressing firmly, especially around edges.
Wait for ten minutes for patches to cure.