Protac GroundMe User Guide

: June 8, 2024
: PROTAC

Protac GroundMe

Directions for use

Protac GroundMe®

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 STANDARD 100 by OEKO-TEX® nr. 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 placed inside the cushion to avoid irritating the user.
Key to label symbols: please refer to Key to symbols

General precautions – Safety

Must not be thrown.
Not for unsupervised use by users with balance problems.
Not for unsupervised use for standing on.
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 and movement of the balls act on these senses in particular

The Protac GroundMe® cushion was developed to help sufferers of function impairment. Children, young and old people can benefit from a Protac GroundMe® cushion:

ADHD and autism
Psychiatric diseases, such as dementia, schizophrenia, depression, anxiety, anorexia etc.
Development problems, sensory problems, deaf/blind, etc.
Stress

The Protac GroundMe® cushion can help ADHD and autism sufferers with relaxation and concentration. Children with ADHD and autism in particular benefit from using the cushion to reach the ground with their feet when sitting on a chair, creating calm in the body to allow them to concentrate on school work.

The Protac GroundMe® cushion is used for sufferers of a range of development problems, sensory problems, deaf/blindness, to create enhanced sensory stimulation in the body.
Protac GroundMe® is used by sufferers of restless legs syndrome. The movement of the feet over the balls gives multiple sensory stimulation, providing more feeling in the feet.

The Protac GroundMe® cushion can be used in institutions, sheltered housing, day centres, hospitals, patient lounges and private homes. The product is used in schools in the classroom and association areas. At home, Protac GroundMe® can be used in a bedroom, the dining room or lounge.

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

The cover (with balls inside) can be washed in a min. 6 kg capacity washing machine with detergent with no bleaching agents or perfume – see also the washing instructions on the cover.
The foam element cannot be washed.
The enclosed laundry bag must be used.

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

Maintenance

The Protac GroundMe® can be wiped with a well-wrung cloth soaked in warm soapy water.
Can be wiped off with alcohol.

Transport and storage

The cushion is ready for use.
Protac GroundMe® is supplied in a non-woven bag, to protect against damp and dirt.
If you are not using the cushion, store it carefully in its case to protect from damp and dirt.

Disposal

The Protac GroundMe® cushion can be divided into the following components for waste disposal purposes: Plastic, fabric and foam elements.
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:

overloading
misuse
non-maintenance or incorrect maintenance
Traceability: Production month, year and batch number are marked on the CE- and washing label.

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)
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

Technical specification

Dimensions :
Protac GroundMe®: Height: 10 cm
Protac GroundMe®: Height: 20 cm

Standards: Comply with general requirements for aids acc. to the following harmonized standards:
Clinical evaluation: EN 12182:2012
Risk analysis: DS/EN ISO 14971:2019
Quality management systems: EN ISO 13485:2016

Service information

No other balls can be used in a Protac GroundMe® cushion than those used by the manufacturer.

Guide

to daily inspection of the Protac GroundMe® cushion before use

No.	Check	Remarks
1

All parts are in place, no loose parts

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2|

No sign of holes, damage to the textile or seams

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Protac A/S
Niels Bohrs Vej 31 D, Stilling
DK-8660 Skanderborg
Tel.: 86 19 41 03
e-mail: protac@protac.dk
Distributor list: Please refer to: www.protac.dk/kontakt