Note: Only qualified personnel should fit the orthosis for the first time! Read these instructions
carefully before use.
PRECAUTIONS AND MAINTENANCE
• This device is intended for one patient only. It is not intended for re-use by another patient.
• If additional pain, swelling or other symptoms occur while using the device, discontinue use and
contact your doctor.
• This device is designed to protect the injured area with a limited range of movement in
accordance with the rehabilitation programme or other rehabilitation measures prescribed by the
doctor.
• The sponge liners can be removed and washed with mild soap. Once the liner has dried, it can be
installed in the unit and used again.
• Storage: in a dry and clean environment, well ventilated, without corrosive gases, at room
temperature.
NOTES:
In the event of a product-related 'serious ' 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) a temporary or permanent deterioration in the health of a patient, user or other person, or
c) a serious threat to public health
this 'serious incident' should be reported to the manufacturer and to the competent authority of the
Member State in which the user or patient is resident. For Poland, the competent authority is the
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
NOTES:
In the event of pain, allergic reactions or other disturbing, unclear symptoms related to the use of
the medical device, a healthcare professional should be consulted.
: The manufacturer cannot be held responsible for damage caused by negligent cleaning, improper
storage or as a result of not following the instructions in this manual.
ATTENTION: It is forbidden to use the product in any other way than in accordance with its intended use!
STORAGE
Store the product in a dry cool room, away from moisture and direct sunlight.
HOW TO DISPOSE OF THE PRODUCT
A medical device can be disposed of as normal municipal waste
TARGET PATIENT GROUP
Persons suffering from diseases, dysfunctions or injuries for the treatment/rehabilitation or
compensation of which this device is intended (see section on intended use of the device in these
instructions). The device can be purchased by the user on their own or on the recommendation of a
doctor, therapist or other specialist. Whether you purchase the device yourself or on the
recommendation of a doctor/therapist/other specialist, you must take into account the available
sizes/necessary functions/sizes/variants of the device, the indications and contraindications for use, as
well as the information provided by the manufacturer.
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