PROTAC 200-201-10-4-80 Ball Cushion for Chair Instruction Manual
- June 8, 2024
- PROTAC
Table of Contents
200-201-10-4-80 Ball Cushion for Chair
Instruction Manual
Directions for use
Protac Ball Cushion ®
You have selected a quality Protac product. Protac guarantees that you have
purchased an original, Danish designed product developed in consultation with
experts. Protac has developed, produced and sold sensory-stimulating aids to
the healthcare sector in Denmark, the rest of Europe, Australia and New
Zealand since 1994. Protac products are developed on the basis of theories on
sensory integration, and are supported by extensive research, documentation
and case studies. Protac focuses strongly on protection of the environment and
safety during its production process. Protac plastic balls are certified
according to STANDARD 100 by OEKO-TEX® no. 2076-310 DTI.
For more details, go to www.protac.dk
Labelling
The products are labeled in accordance with Regulation (EU) 2017/745 Class I
medical devices. The label with details of manufacturer, raw materials and
washing instructions is sewninto the side of the cushion.
Key to label symbols: please refer to Key to symbols
General precautions – Safety
- **** The cushion must be securely fastened to a chair
- **** Please be aware of how the user reacts
- **** Not suitable for wheelchair-users
- **** Not for unsupervised use by users with paralysis and poor sensitivity.
- **** Must not be used near an open flame
Product purpose and areas of use
Sensory integration is the idea behind the development of all Protac products.
The theory originated in the 1970s in the USA, and was developed by A. Jean
Ayres, an occupational therapist and psychologist. The theory is based on how
the brain processes sensory impressions, and how the various sensory stimuli
can be influenced via applying weight and pressure to the tactile sense (the
sense of touch) in the skin and the proprioceptive sense (the sense of
movement) in muscles and joints. The pressure, movement and weight of the
balls act on these senses in particular.
The Protac Ball Cushion® was developed to help sufferers of function
impairment.
Children, young and old people can benefit from the cushion:
- Brain damage, including spasticity, Huntington’s Chorea, Parkinson’s Disease and other ailments
- ADHD and autism
- Psychiatric diseases, such as dementia, schizophrenia, depression, anxiety, anorexia etc.
- Development problems, sensory problems, deaf/blind, etc.
- Stress
The Protac Ball Cushion® is intended for patients with brain damage suffering
from spasticity andsensitivity impairment. The weight and pressure of the
balls help suppress spasticity to give the patient enhanced body awareness. It
can also be used to train balance with.
Individuals with ADHD and autism can use the Protac Ball Cushion® to sit on
e.g. in school and at home when unconcentrated. When the user moves on the
cushion, the pressure of the balls stimulates muscles and joints, helping
improve body posture.
Psychiatric patients often suffer from muscular and psychological unrest. The
cushion can be used to enhance concentration and help calm the patient. The
cushion can be used for meetings and dining.
The Protac Ball Cushion® is used for sufferers of a range of development
problems, sensory problems, deaf/blindness and to create enhanced sensory
stimuli in the body.
The Protac Ball Cushion® is used for sufferers of stress to provide calmness,
comfort and better body awareness.
The Protac Ball Cushion® can be used in institutions, sheltered housing, day
centres, hospitals, patient lounges and private homes. The cushion is used in
schools in the classroom for instance, and at home, can be used on dining or
office chairs.
Using the product
Product service life
The product has an expected service life of 5 years.
This is based on correct use, cleaning, washing, service and maintenance.
Products used beyond the aforementioned service life should be assessed for
further use.
Responsibility for using the product beyond the stated service life rests with
the user.
Cleaning
Protac Ball Cushion® can be washed. The regularity and need for washing
depends on use. See below for washing and cleaning instructions.
Protac Ball Cushion®
- can be machine washed in a min. 6 kg capacity washing machine. Use washing detergent with no bleaching agents or perfume – see also the washing instructions on the cushion.
To remove spots using a spot remover, always try first on an area which is not
visible to test fordamage or discolouring. Protac does not recommend the use
of spot remover.
Protac cannot be held liable for incorrect washing and maintenance.
Maintenance
We recommend airing the cushion regularly.
Transport and storage
The cushion is ready for use.
It is supplied packed in a protective plastic bag.
If you are not using the cushion, store it carefully in its case to protect
from damp and dirt.
Disposal
The cushion can be broken down into the following components for disposal:
Plastic and textile.
The plastic balls can be disposed of as hard plastic.
All components can be disposed of as combustible refuse.
Always dispose of refuse according to local rules.
Guarantee
2 year guarantee against manufacturing defects.
The guarantee will be invalid in the event of the following:
- over-use
- misuse
- non-maintenance or incorrect maintenance
Traceability: The month, year of manufacturer and batch number are marked
on the CE – and care label. These must not be removed from the product.
Key to symbols
Example only. Always follow the recommended care instructions on the label
found inside the product
| Washing bowl: Maximum washing temperature (see care label)| | Warning: See
under Safety
---|---|---|---
| Triangle: Do not bleach| | User information
| Square with a circle: tumble drying possible (see care label)| | For indoor
use
| Iron: Do not iron| | CE marked according to (EU) 2017/745 Class I medical
devices
| Circle: Do not dry clean| | Manufacturer
| Batch number| |
Technical specifications
Dimensions:
Protac Ball Cushion ® for classroom chair: 40×40 cm
Protac Ball Cushion ® for baby’s high chair: 29×45 cm
Protac Ball Cushion ® for kindergarten chair: 30×35 cm
Protac Ball Cushion ® for stool: 30×30 cm
Standards: Comply with general requirements for aids acc. to the
following harmonized standards:
Clinical evaluation: EN 12182:2012
Risk analysis: DS/EN ISO 14971 : 2012
Quality management system: EN ISO 13485:2016
Service information
No other balls can be used in a Protac Ball Cushion® than those used by the
manufacturer.
Guide
– to daily inspection of the Protac Ball Cushion® before use
| No. | Check | Remarks |
|---|---|---|
| 1 | • All parts are in place, no loose parts | |
| 2 | • No sign of holes, damage to the textile or seams |
www.protac.dk
Protac A/S
Niels Bohrs Vej 31 D, Stilling
DK-8660 Skanderborg
Denmark
Tel.: +45 86 19 41 03
E-mail: [email protected]
Distributor list: Please refer to:
www.protac.dk/kontakt
Medical device TD 5.7.1-1 – Protac Kuglepuden® – Oktober 2021 Version 9