PROTAC MyFit Sensory Stimulation Bullet Vest Instructions

PROTAC MyFit Sensory Stimulation Bullet Vest

Directions for use

Protac MyFit®

You have selected a quality Protac product. Protac guarantees that you have purchased an original, Danish designed product developed in consultation with experts.
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 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 sewn into the sideseam inside the MyFit
Key to label symbols: please refer to Key to symbols

General precautions Safety

• Please be aware of how the user reacts.
• The Protac MyFit® vest must not be used as a swimming aid or life vest.
• Not for unsupervised use by users with a poor sense of balance.
• Not for unsupervised use by users unable to care for themselves.
• Do not use near open fire.
• Must not be used while sleeping.
• Must not be used by driver nor passengers when driving in a car
• The vest must be removed before the Heimlich method is performed

Incidents

• Incidents related to the use of Protac SenSack® must be reported to the manufacturer
• Serious incidents related to the use of Protac SenSack® must be reported to the manufactu-rer 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, movement and weight of the balls act on these senses in particular.

The Protac MyFit® was developed to help sufferers of function impairment. Children, young and old people can benefit from the vest:

• 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 MyFit® is used for treatment of the after-effects suffered by brain damage patients, to strengthen balance and body awareness.  It is used for ADHD and autism sufferers to help with concentration and learning difficulties, as the thickness and pressure of the balls give extra sensory stimuli and better body awareness. Psychiatric patients often suffer from muscular and psychological unrest. The Protac MyFit® vest is  used to create calm and comfort for the user. The weight and pressure of the balls also give a better feeling of body awareness and enhanced wellness.It is used for sufferers of a range of development problems, sensory problems, deaf/blindness and to create enhanced sensory stimuli in the body.

It is used for sufferers of stress to provide calmness, comfort and better body awareness. The Protac MyFit® can be used in institutions, sheltered housing, day centres, hospitals, patient lounges and private homes. Schoolchildren can wear the vest in the classroom or playtimes. At home, the vest can be worn at mealtimes, when doing homework or whenever extra concentration is needed.

Using the product

Product service life

• The product has an expected service life of 2 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. Respon-sibility for using the product beyond the stated service life rests with the user.

Cleaning
The Protac MyFit® must be washed in the wash bag supplied. The regularity and need for washing depends on use. See below for washing and cleaning instructions.

• The vest can be machine washed in a min. 7 kg capacity washing machine with washing deter-gent with no bleaching agents and perfume – see also the washing instructions in the vest. The enclosed wash bag must be used. Spinning at low speed.

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 airing the vest regularly.

Transport and storage
The vest is ready for use. For transport, Protac MyFit® is packed in a carrying bag to protect the vest against dirt and damp. We recommend storing the vest flat and covered to protect against dirt and damp.

Disposal
Protac MyFit® can be divided into the following components for waste disposal purposes: Plas tic and fabric. The plastic balls can be disposed of as hard plastic.

• All parts of the vest can be disposed of as combustible waste.
• Waste must be disposed of in accordance with applicable 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: Production month, year and batch number are marked on the 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

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 MyFit® than those used by the manufacturer.

Guide: to daily inspection of the Protact MyFit® before use

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

ADDRESS: 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

References

• Protac.dk | Beroligende og sansestimulerende hjælpemidler med kugler

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