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1.1 General information
1. Introduction
1.2 Intended use
This product is a medical device and CE marked according to EU Medical Device Regulation MDR
2017/745.
According to the regulations of the authorities regarding medical devices, it is the duty of the
manufacturer and healthcare professionals to report any accidents and serious adverse events
involving their products. We kindly ask that all information on any accidents and serious adverse
events involving our products be reported immediately to ZiboCare and the competent authority of
the Member State where the user and/or patient is established.
Sens-Aid is a weighted blanket intended to be used at home, at school or in institutions when there
is a need for the stimulation that Sens-Aid provides, primarily in order to create a sense of calm,
physically and mentally.
Sens-Aid has six heavy wings that wrap around the body, according to the user’s individual needs
and preferences.
By using Sens-Aid, you may experience a reduction in restlessness, racing thoughts, anxiety and
insecurity, including an overall feeling of balance and well-being. The weight of the wings hugs,
gathers and calms the body. This is because the hormone oxytocin is released and sends signals to
the brain that it is safe to ”gear down”, calm down and recharge.
Sens-Aid is used in a chair, for example, an armchair, school chair, wheelchair, during transport or in
a sofa – in both indoor and outdoor areas. It is recommended to use a chair with a backrest.
1.3 Typical applications
Sens-Aid is intended for children and adults of all ages experiencing a general failure to thrive,
burnout and a reduced amount of energy. The adult model is recommended for teenagers and
adults and the junior model is for children aged 4 and above. The user may have a diagnosis, but
Sens-Aid also caters to people with diverse challenges, even without a diagnosis. Sens-Aid is often
used for:
•
Motor restlessness
•
Mental imbalance
•
Eating disorders
•
Concentration issues
•
Neurological disorders
•
Dementia
•
Brain Injury
•
Mental disorders, e.g., restlessness and anxiety
•
Neuropsychiatric diagnoses, e.g., ADHD, ADD,
Asperger’s syndrome, autism and Tourette
syndrome
•
Spasticity
•
”Racing thoughts”
•
Involuntary movements
•
Social anxiety
EN - Instructions for use
EN
