Protac MyFit Instrucciones De Uso página 8

GB - 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.
DK
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.
GB
For more details, go to www.protac.dk
DE
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
FI
the sideseam inside the MyFit
Key to label symbols: please refer to Key to symbols
FR
General precautions - Safety
NL
• Please be aware of how the user reacts.
• The Protac MyFit
• Not for unsupervised use by users with a poor sense of balance.
SE
• Not for unsupervised use by users unable to care for themselves.
• Do not use near open fire.
• Must not be used while sleeping.
ES
• Must not be used by driver nor passengers when driving in a car
• The vest must be removed before the Heimlich method is performed
IT
Incidents
• Incidents related to the use of Protac SenSack
• Serious incidents related to the use of Protac SenSack
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.
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vest must not be used as a swimming aid or life vest.
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must be reported to the manufacturer
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must be reported to the manufactu-
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