PROTAC Product GroundMe User Manual

PROTAC Product GroundMe

Directions for use

Protac GroundMe

You have chosen a Protac quality product. Protac guarantees that you have purchased an original Danish designed product developed in partnership with professionals. Since 1994, Protac has developed, manufactured and sold sensory stimulating aids to the healthcare sectors in Denmark, Europe, Australia and New Zealand. Protac products are developed from the theory of sensory integration and are well documented with respect to research, documentation and case descriptions. Protac production process focuses on environment and safety. 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.
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.

Incidents

• Incidents related to the use of Protac GroundMe® must be reported to the manufacturer
• Serious incidents related to the use of f Protac GroundMe® must be reported to the manufacturer 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 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.
• 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 discolouring. 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 specifications

Dimensions

• Protac GroundMe®: Height: 10 cm
• Protac GroundMe®: Height: 20 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.

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

1. All parts are in place, no loose parts
2. No sign of holes, damage to the textile or seams

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

References

• Protac.dk | Beroligende og sansestimulerende hjælpemidler med kugler

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