PROTAC BallBase The sensory corner User Guide

: June 13, 2024
: PROTAC

PROTAC BallBase The sensory corner

Product Information

The Protac product is a medical device designed in collaboration with healthcare professionals. It is developed based on theories of sensory integration and has been extensively researched and documented. Protac products are widely used in the healthcare sectors of Denmark, Europe, Australia, and New Zealand.

The theory of sensory integration, which forms the basis of all Protac products, was developed by A. Jean Ayres, an occupational therapist and psychologist, in the 1970s in the United States.

The Protac product is a top mattress with sensory-stimulating balls embedded inside. It provides sensory stimuli that promote relaxation and body awareness.

Product Usage Instructions

Product Usage The Protac product is used when there is a need to calm down and relax.

Product Lifespan The lifespan of the product depends on proper maintenance and adherence to the recommended usage guidelines.

Maintenance Regularly inspect the top mattress before use.

Transport and store the product properly.

Dispose of the product according to local regulations.

General Precautions – Safety

Incontinence covers are dangerous toys for children.
The top mattress with incontinence cover must not be used for children without supervision.
The top mattress with incontinence cover must not be used by people who cannot take care of themselves without supervision.
Avoid placing heat-emitting appliances, such as a BallBase, on the top mattress as it can be harmful to the blanket and may cause the appliance to ignite.
In case of incidents, report them to the competent authority of the country where the incident takes place.

Product Purpose and Areas of Use The Protac product is used to promote relaxation, body awareness, and enhanced wellness. It can be used for sleeping or during the day. The varying pressure of the balls on the body provides sensory stimuli that create boundaries for the body, giving comfort and calm.

The product is particularly beneficial for individuals with brain damage and those who benefit from enhanced body awareness.

Directions for use

Protac® BallBase
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 sensorystimulating 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. The Protac® BallBase is 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. CE- and carelabels with information about the manufaturer, raw materials and washing instructions are placed inside the top mattress.
Key to label symbols: please refer to Key to symbols

General precautions – Safety

Not for unsupervised use by users unable to care for themselves.
Pay attention to the user’s reaction if the user does not like to lie on the top mattress.
The same risk precautions apply as for the use of a plastic bag:
- Incontinence covers are dangerous toys for children.
- Top madras with incontinence cover must not be used for children without supervision.
- Top mattress with incontinence cover must not be used by people who cannot take care of themselves without supervision.
- Top mattress with incontinence cover must not be pulled over the head.
Avoid smoking while lying on the top mattress. Dropped embers or cigarettes can cause burns.
Never leave a computer or other electrical appliances switched on in a bed with a Protac® BallBase, as they emit heat which can be harmful to the blanket, or in extreme circumstanc-es, cause the appliance to ignite, due to a build-up of heat.
Must not be used to lie on if you have pressure ulcers.
Take precautions to avoid pressure sores when using the top mattress.
Must not be used near an open fire.

Incidents

Incidents related to the use of Protac® BallBase must be reported to Protac.
Serious incidents related to the use of Protac® BallBase be reported to Protac and the competent authority of the country where the incident takes place.

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 and movement of the balls act on these senses in particular.
The Protac® BallBase was developed to help sufferers of function impairment.
Children, young people, adults and elderly can benefit from the Protac® BallBase:

Brain damage and other neurological diseases.
ADHD and autism.
Psychiatric diseases.
Developmental disorders, sensory disorders.
Physical and psychological unrest.
Concentration problems and learning disorders.

The Protac® BallBase can be used for patients with brain damage e.g characterized by
spasticity. The varying pressure of the balls help suppress spasticity, and calm the body of patients with brain damage. Furthermore, the patient benefits from enhanced body awareness.

For people with ADHD and autism, the Protac® BallBase is used to sleep on, but can also be used with advantage during the day. Through the varying pressure of the balls on the body, the top mattress provides sensory stimuli that create boundaries for the body, giving comfort and calm. ADHD sufferers often have a problem winding down at night, and the Protac® BallBase gives the body a signal to relax and calm down.

People with psychiatric diseases often have physical and psychological unrest. Protac® BallBase is used to create calm and comfort for the user. The varying pressure of the balls also gives a better feeling of body awareness and enhanced wellness. The top mattress is used both for sleeping on and during the day.

The Protac® BallBase is used for is used for people with e.g. developmental disorders, sensory disorders to create increased sensory stimuli for the body.

The Protac® BallBase is used for people with physical and psychical unrest, to provide calmness, comfort and better body awareness. The top mattress is used both to sleep with and during the day. People with e.g stress often find it difficult to feel the body and thus fall asleep in the evening. The varying pressure of the top mattress gives the body a signal to calm down.

Using the product

The user must place a plain bed sheet over the Protac® BallBase

Protac® BallBase is used as a regular top mattress to sleep on. Protac® BallBase can also be used during the day, if there is a need to calm down

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® BallBase can be washed. The regularity and need for washing depends on use. See below for washing and cleaning instructions.

The Protac® BallBase can be machine washed at a max. of 60 degrees in a min. 7 kg washing machine. Use detergent without bleaching agents and perfume. Fabric softner may not be used. Remove the ball bags from the cover. Wash cover and ball bags separately. Spinning at low speed – see also the washing instructions in the cover.

To remove spots using a spot remover, always try first on an area which is not visible to test for damage or discolouring. Protac does not recommend the use of spot remover.
Protac cannot be held liable for incorrect washing and maintenance.

Maintenance

We recommend hanging the Protac® BallBase out to air on a regular basis.

Transport and storage

The Protac® BallBase is delivered in a carrying case.
If the top mattress is not in use, store it securely in the carrying case.

Disposal

The Protac® BallBase can be broken down into the following components for disposal:
Plastic and textile.

The plastic balls can be disposed of as hard plastic
All parts can be disposed of as combustible waste.
Waste must be disposed of in accordance with current legislation.

Guarantee

2 year guarantee against manufacturing defects.

The guarantee will be invalid in the event of the following:

overloading the Protac® BallBase
misuse of the Protac® BallBase
non-maintenance or incorrect maintenance of the Protac® BallBase

Accessories

Protac Incontinence Cover

Using the product

Protac® BallBase Incontinence cover is used is used over the outside of the top mattress if there are problems with incontinence (urination problems). A regular bed sheet must should be used over the incontinence cover for comfort.

General precautions – Safety

The same risk precautions apply as for the use of a plastic bag:
- Incontinence covers are dangerous toys for children.
- Top mattress used with an incontinence cover must not be used for children without supervision.
- Top mattress with incontinence cover must not be used for patients unable to care for themselves without supervision.
- Top mattress used with an incontinence cover must not be pulled over the head.

Traceability: Production month, year and batch number are marked on the washing label. These must not be removed from the product.

Key to symbols

Example only. Always follow the recommended care instructions on the label found in the product

Washing bowl: Maximum washing temperature (see care label)
Triangle: Do not bleach
Square with a circle: tumble drying possible (see care label)
Iron: Do not iron
Circle: Do not dry clean
Warning: See under Safety
User information
For indoor use
CE marked according to (EU) 2017/745 Class I medical devices
Manufacturer
Batch number

Parts Listz

Cover for Protac® BallBase
Ball bags for Protac® BallBase

Technical specifications

Dimensions:
Protac® BallBase:

length: 200cm
width: 90 cm

Standards: Comply with general requirements for aids acc. to the following harmonized standards:
EN ISO 13485:2016/A11:2021: Medical Devices – Quality management systems
EN ISO 14971:2019/A11:2021: Medical devices – Application of risk management to medical devices DS/EN ISO 21856:2022 : Medical devices – Assistive products – General requirements and test methods.