ENG
GENERAL WARNING
Thank you for purchasing our product, please read the instructions for use carefully. Do not use the product until you have read and
understood these instructions. If you do not understand the warnings, cautions and recommendations, please contact your healthcare
professional or dealer to avoid damage to the product.
NOTE: Check all parts for damage caused during transit. If you notice such damage, DO NOT use the product. Contact the manufacturer for
more information.
APPLICATION
The back brace has been designed to provide pressure relief and correction of the lumbar and thoracic spine in the sagittal plane, where the
spine moves during bending and straightening movements, in order to strengthen the core muscle system.
This orthosis is particularly useful for people with fractures of the thoracic and lumbar vertebrae, as well as those with juvenile Scheuermann's
disease, a spinal growth disorder that can cause pain due to postural problems. It can also benefit those with hyperkyphosis and chronic back
pain, providing relief and correction.
INDICATIONS
- Conservative/post-operative treatment.
- Osteoporotic bone collapse in the thoracic and lumbar spine.
- Juvenile Scheuermann's disease.
- Hyperkyphosis with chronic back pain.
CONTRAINDICATIONS
Physical or mental limitations (e.g. visual impairment) that prevent safe handling.
FEATURES
The lightweight orthosis can be easily adapted to each patient thanks to the aluminium back support, which can be easily shaped to the
person's back. The orthosis is comfortable to wear under clothing.
SIZE (to find the right size, measure your waist circumference)
S: 75-85 cm
M: 85-95 cm
L: 95-105 cm
XL: 105-115 cm
XXL : 115-125 cm
COMPOSITION
65% polyamide
15% elastane
10% polyester
10% sponge
SCOPE OF SUPPLY
Spinal orthosis, instruction manual
NOTES:
In the event of a device-related "serious incident" that directly or indirectly led to, could have led to, or is likely to lead to any of the following:
(a) death of a patient, user or other person, or
(b) temporary or permanent deterioration of the health of a patient, user or other person, or
(c) a serious risk to public health
the above 'serious incident' must be notified to the manufacturer and to the competent authority of the Member State in which the user or
patient is resident. In the case of Poland, the competent authority is the Office for Registration of Medicinal Products, Medical Devices and
Biocidal Products.
NOTES:
In case of pain, allergic reactions or other disturbing symptoms unclear to the user related to the use of the medical device, consult a
healthcare professional.
NOTE: It is forbidden to use the product other than in accordance with its intended use.
ATTENTION: The manufacturer is not responsible for damage caused by negligent cleaning and maintenance, or resulting from non-
compliance with the recommendations contained in these instructions for use.
TARGET PATIENT GROUP
The healthcare professional shall indicate, on his own responsibility, the use of the product for adults and children, taking into account the
available variants/sizes/unnecessary functions/sizes and indications, bearing in mind the information provided by the manufacturer.
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